CA2346525C - Reservoir connector - Google Patents
Reservoir connector Download PDFInfo
- Publication number
- CA2346525C CA2346525C CA002346525A CA2346525A CA2346525C CA 2346525 C CA2346525 C CA 2346525C CA 002346525 A CA002346525 A CA 002346525A CA 2346525 A CA2346525 A CA 2346525A CA 2346525 C CA2346525 C CA 2346525C
- Authority
- CA
- Canada
- Prior art keywords
- cap
- housing
- reservoir
- base
- septum
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/12—Tube connectors; Tube couplings for joining a flexible tube to a rigid attachment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
- A61M2005/1623—Details of air intake
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1033—Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/20—Closure caps or plugs for connectors or open ends of tubes
- A61M2039/205—Closure caps or plugs for connectors or open ends of tubes comprising air venting means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
- A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49764—Method of mechanical manufacture with testing or indicating
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/53—Means to assemble or disassemble
Abstract
A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. A base is provided which is adapted to receive a reservoir. The base has a base engagement member, such as a detent, projecting therefrom. A cap is provided which is adapted to receive the base. The cap includes a first cap engagement member, such as a detent opening, which is adapted to removably engage the base detent. The cap further includes a second cap detent opening which is adapted to removably engage the base detent. A piercing member, such as a needle, is disposed in the interior of the cap in such a manner that the needle is separated from the reservoir septum when the base detent is in the first cap detent opening, and the needle pierces the reservoir septum when the base detent is in the second cap detent opening. When the reservoir, the base and the cap are connected to form an integrated unit, this unit is then capable of being inserted and secured in the infusion pump housing.
Description
RESERVOIR CONNECTOR
BACKGROUND OF THE INVENTION
1. Field of the Invention This invention relates generally to improvements in syringe and reservoir interfaces for use in infusion pumps such as those used for controlled delivery of medication to a patient. More specifically, this invention relates to an improved connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump.
2. Description of the Related Art 2 0 Infusion pump devices and systems are relatively well-known in the medical arts, for use in delivering or dispensing a prescribed medication such as insulin to a patient. In one form, such devices comprise a relatively compact pump housing adapted to receive a syringe or reservoir carrying a prescribed medication for administration to the patient through infusion tubing and an associated catheter.
2 5 The infusion pump includes a small drive motor connected via a lead screw assembly for motor-driven advancement of a reservoir piston to administer the medication to the user. Programmable controls are normally provided for operating the drive motor continuously or at periodic intervals to obtain a closely controlled and accwate delivery of the medication over an extended period of time. Such infusion pumps are utilized to 3 0 administer insulin and other medications, with exemplary pump constructions being shown and described in U.S. Patent Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122.
Infusion pumps of the general type described above have provided significant advantages and benefits with respect to accurate delivery of medication or other fluids over 3 5 an extended period of time. The infusion pump can be designed to be relatively compact as well as water resistant, and may thus be adapted to be carried by the user, for example, by means of a belt clip. As a result, important medication can be delivered to the user with precision and in an automated manner, without significant restriction on the user's mobility or life-style, including the ability to participate in water sports.
Infusion sets refer to the tubing and connection apparatus which provide a path for the medication to flow from the reservoir or syringe located in the pump to the user. The connectors for attaching the infusion set tubing to the reservoirs can take various forms. A
luer connection is a commonly used connection method. Nevertheless, it remains desirable to develop improved designs of connection methods to facilitate infusion procedures and to provide suitable interface connections which are water resistant so as to permit a user to participate in water sports.
~ 5 SUMMARY OF THE PREFERRED EMBODIMENTS
An apparatus for connecting a reservoir having a septum and a base to a conduit, such as infusion set tubing, is provided. In certain aspects of the present invention, the apparatus comprises a cap and a releasable coupler which is adapted to releasably couple 2 0 the base to the cap in one of two positions. A piercing member, such as a needle, is coupled to the conduit. The needle is disposed in the cap in a position other than the interior of the reservoir when the base is in the first position. The needle is further disposed to pierce the reservoir septum when the base is in the second position.
In another embodiment, the apparatus is used for connecting a reservoir having a 2 5 septum and a base to a housing as well as to a conduit. The housing has a housing engagement member, such as a thread. The apparatus comprises a cap and a releasable coupler which is adapted to releasably couple the base to the cap in one of two positions.
A piercing member, such as a needle, is releasably coupled to the conduit. The needle is disposed in the cap in a position other than the interior of the reservoir when the base is in 3 0 the first position. The needle is further disposed to pierce the reservoir septum when the base is in the second position. The cap further includes an engagement member, such as a thread, which is adapted to engage with the housing engagement member.
In another embodiment, the cap further includes a vent port which is covered with hydrophobic material. This permits air to pass through the cap while preventing water 3 5 from doing so.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. I is an exploded, perspective view of a medication reservoir connection interface apparatus.
FIG. 2 is a perspective view of a cap used as a medication reservoir connection interface apparatus.
FIG. 3 is an exploded, perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.
FIG. 4 is a side, cut-away view of a cap used as a medication reservoir connection interface apparatus.
FIG. 5 is a side, plan cut-away view of a medication reservoir connection interface apparatus with a needle inserted into a reservoir.
FIG. 6 is a side, plan cut-away view of a medication reservoir connection interface apparatus which is inserted into a pump housing.
FIG. 7 is a perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.
2 0 FIG. 8 is a perspective top view of an alternative embodiment of a medication reservoir connection interface apparatus which is secured into a pump housing.
FIG. 9 is a perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.
FIG. 10 is an exploded, perspective view of a cap used as a medication reservoir 2 5 connection interface apparatus.
FIG. 11 is a perspective view of a medication reservoir connection interface adapter.
FIG. 12 is a cross-sectional view of a medication reservoir connection interface adapter.
30 FIG. 13 is a perspective view of an alternative embodiment of a cap used as a medication reservoir connection interface apparatus.
FIGs. 14a - 14c are cross-sectional views of various embodiments of venting ports for use with a reservoir connection interface apparatus or adapter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
In the following description, reference is made to the accompanying drawings which form a part hereof and which illustrate several embodiments of the present invention. It is understood that other embodiments may be utilized and structural and operational changes may be made without departing from the scope of the present invention.
As shown in the drawings for purposes of illustration, the invention is embodied in an interface for connecting a syringe or a medication reservoir to a conduit, such as infusion set tubing or an external needle, as well as to an infusion pump. In a one embodiment, a base is provided which is adapted to receive a reservoir. A cap is provided which is adapted to be releasably coupled to the base in one of two positions.
The releasable coupler comprises a pair of detents projecting from the base and two pairs of detent openings in the cap which are adapted to removably engage the base detents.
A piercing member, such as a needle, is disposed in the interior of the cap in such a 2 0 manner that the needle is separated from the reservoir septum when the base detents are in the first pair of cap detent openings, and the needle pierces the reservoir septum when the base detents are in the second pair of cap detent openings. When the reservoir, the base and the cap are connected, an integrated unit is formed which is then capable of being inserted in the infusion pump housing. Engagement members, such as threads, for the cap 2 5 and the pump housing are used to secure the integrated unit in the housing.
FIGs. 1 and 2 show an infusion set connector interface for attachment to a medication reservoir. The connector interface is comprised of a base 2 and a cap 4. The cap 4 includes a needle 9 located internal to the cap housing. FIG. 1 is an exploded view, and therefore, the base 2 would normally be fixedly attached to a reservoir 1 by securing it 3 0 around the swage 3. However, alternative embodiments of the present invention include a removable base so that the connector interface could be used with standard reservoirs, cartridges or syringes which were not initially manufactured with the base attached.
The cap 4 portion of the connector interface is removably attached to the base with a releasable coupler. In one embodiment, the releasable coupler is comprised of 3 5 detents formed on the base 2 and detent openings disposed in the cap 4.
Two detents 8 are disposed on the sides of the base 2 and are spaced 180 ° radially apart. Only one detent 8 is shown in FIG. 1. The detents 8 are sized to fit in the two lower detent openings 6, or w alternatively, in the two upper detent openings 7 which are formed in the cap 4. As with the pair of detents 8, each of the lower detent openings 6 and each of the upper detent openings 7, respectively, are radially spaced apart by 180 °.
In operation, the base 2 and the reservoir 1 form an integrated unit which in turn is to be connected to the cap 4. In connecting this integrated base/reservoir unit to the cap 4, the base 2 is inserted into the lower end of the cap 4 until the detents 8 snap into the lower detent openings 6. This is accomplished by moving the detents 8 over internal cam surfaces 10 toward the lower detent openings 6. The cam surfaces act as ramps which compress the detents 8 sufficiently to permit them to snap into the lower detent openings 6. Internal threads l0a guide the detents 8 into position.
When the base/reservoir unit is in this first, lower position, the needle 9 is positioned apart from the septum (not shown) of the reservoir 1. Thus the needle does not pierce the septum while the base/reservoir unit is in this first position.
When the base/reservoir unit is connected to the cap in this fashion, an integrated cap/base/reservoir unit is thereby formed. Such an integrated cap/base/reservoir unit can be sold or stored for 2 0 long periods of time in this fashion. Alternatively the end user could assemble this unit shortly prior to placing it in the pump for use.
When the user desires to insert the cap/base/reservoir unit in the pump housing and commence dispensing the medication through a conduit, such as insertion set tubing 5, the base 2 is moved to the second position within the cap 4. This is accomplished by twisting 2 5 the base /reservoir unit while pushing it further into the cap 4. The detents 8 disengage from the lower detent openings 6 and engage into the upper detent openings 7.
Additional internal threads l0a of the cap 4 serve to guide the detents 8 over additional cam surfaces 10 from their first position in the lower detent openings 6 to the second position in the upper detent openings 7.
3 0 In one embodiment, the threads and the spacing between the lower detents 6 and the upper detents 7 is such that a one quarter (1/4) turn of the base will cause the base/reservoir unit to travel from the first to the second position. The needle 9 is disposed so that whcn the basc/rcscrvoir unit is in the sccond position, the nccdlc picrccs the scptum of the reservoir 1. Thus the movement of the base/reservoir unit from the first to the 3 5 second position within the cap serves to cause the needle to pierce the reservoir's septum, thus permitting the fluid in the reservoir to flow into the needle 9 and the insertion set tubing 5.
w After this connection is made, the reservoir, base and cap form a unit which can be releasably secured in the housing of a medication infusion pump. (not shown) Detents 4a extend radially from the exterior of the cap and are adapted to engage into detent openings (not shown) in the pump housing. In an alternative embodiment, the cap 4 can include external threads (not shown) which are used to engage the threads of the pump housing in order to secure the reservoir/base/cap unit into the housing.
FIGs. 3 and 4 show an alternative embodiment of the infusion set connector interface. The connector interface is comprised of a base 11 and a cap 12. The cap 12 includes a needle 18 located internal to the cap housing (FIG. 4). The base 11 would normally be fixedly attached to the reservoir 1 by securing it around the swage 3.
However, alternative embodiments of the present invention include a removable base so that the connector interface could be used with standard reservoirs, cartridges or syringes which were not initially manufactured with the base attached.
The cap 12 portion of the connector interface is removably attached to the base 11 with a releasable coupler. In this embodiment, the releasable coupler is comprised of 2 0 detents formed on the base 11 and detent openings disposed in the cap 12.
Two detents 13 are disposed on the sides of the base 11 and are spaced 180 ° radially apart. Only one detent 13 is shown in FIG. 3. The detents 13 are sized to fit in two detent openings 14 which are formed in the cap 12. As with the pair of detents 13, each of the detent openings 14 are radially spaced apart by 180 °.
2 5 In operation, the base 11 and the reservoir 1 form an integrated unit which in tum is to be connected to the cap 12. In connecting this integrated base/reservoir unit to the cap 12, the base 11 is inserted into the lower end of the cap 12. The detents 13 slide into matingly shaped and longitudinally open entry slots 15 formed within the interior walls of the cap 12. When the base 11 is fully inserted in the cap 12, the leading edges of the 3 0 detents 13 abut an annular stop shoulder 16 formed within the cap 12.
After the detents 13 are in this position, the base 11 is rotated within the cap 12 toward a locked position.
Referring to FIG. 4, this rotation displaces the detents 13 in a rotational direction for engagement with cam surfaces 17 formed within the cap 12. The rotational force on the detents 13 over the cam surfaces 17 provides a compression force on the detents 13.
3 5 Continued rotation of the base 11 displaces the detents 13 past the cam surfaces 17 and into alignment with the detent openings 14. The detents 13 enter the detent openings 14 with a snap-action. Thus, the detents 13 are effectively locked within the detent openings 14 to prevent longitudinal separation of the base 11 from the cap 12.
In the preferred embodiment, the internal needle 18 of the cap 12 is disposed so that when the base/reservoir unit is fully inserted in the cap 12, the needle pierces the septum (not shown) of the reservoir 1. Thus the insertion force of the base/reservoir unit to the point where the detents 13 abut the annular stop shoulder 16 causes the needle 18 to pierce the septum, thus permitting the fluid in the reservoir to flow into the needle 18 and the insertion set tubing (not shown).
After this connection is made, the reservoir, base and cap form a unit which can be releasably secured in the housing of a medication infusion pump. (not shown) The cap 12 includes external threads 19 which are used to engage the threads of the pump housing in order to secure the reservoir/base/cap unit into the housing. In the preferred embodiment, the threads 19 have an eight threads per inch ("TPI"), 2 start profile.
Moreover, they have a square shaped cross section which maximizes their holding strength. Other thread profiles and cross-sections may be used however.
When disconnection of the base 11 from the cap 12 is desired, the base 11 must be 2 0 reverse-rotated within the cap 12, to move the detents 13 past the cam surfaces 17 into re-alignment with the entry slots 15. Such reverse-rotation of the coupler can be performed relatively easily, but essentially requires an affirmative intent by the user to disconnect the coupling. When the detents 13 are re-aligned with the entry slots 15, the cap 12 and base 1 I can be separated easily with minimal longitudinal force.
2 5 FIG. S shows a cross sectional view of the reservoir/base/cap integrated unit in accordance with the embodiment of FIGs. 3 and 4. The reservoir 1 includes a crimp seal swage 3 which encloses the outer periphery of the rubber septum 20 in order to secure the septum 20 to the reservoir 1 and forma water tight seal. With the base 11 in the locked position as shown, the detents 13 of the base 11 are locked into the detent openings 14 to 3 0 securely attach the base/reservoir unit into the cap 12. The needle 18 pierces the rubber septum 20, thus permitting the flow of liquid through the needle 18 and into the infusion set tubing cavity 22. Infusion set tubing (not shown) is secured into the cavity 22 to allow the liquid to continue its flow to the user.
In the preferred embodiment, the conduit from the cap 12 is infusion set tubing.
3 5 However in an alternative embodiment, the conduit comprises a second needle (not shown). This is secured into the cavity 22 with the point of the second needle extending outward. With this arrangement, the connector serves as an apparatus for permitting the refilling of the reservoir 1. The second, external needle would pierce the septum of a supply vial of fluid. The fluid could then be drawn into the cap in a reverse flow and into the reservoir 1 via the internal needle 18.
In the embodiment shown in FIG. 5, infusion set tubing is secured to the cavity 22 to allow liquid to flow to the user. The cavity 22 is disposed in the raised portion of the cap 12. In an alternative embodiment, however, the raised portion of the cap 12 can be in the shape of a standard luer fitting 47 shown in FIG. 13.
Referring to FIG. 5, in one embodiment the base 11 is formed around and fixedly attached to the crimp seal swage 3 portion of the reservoir 1. In an alternative embodiment, however, the base 11 is not fixedly attached to the reservoir.
Rather, the base 11 is a separate unit which is adapted to be releasably secured to the reservoir via a friction fit. This arrangement permits the connector apparatus to be used with standard reservoirs.
Still referring to FIG. 5, the cap 12 includes threads 19 for securing the assembly into the pump housing (not shown). A shoulder 23 is formed as part of the cap 12 and is 2 0 adapted to seat against the pump housing to form a water tight seal. This prevents any water which is exterior to the housing from entering, thus permitting the user to engage in water sports.
The construction of these pumps to be water resistant can give rise to operational problems. As the user engages in activities which expose the pump to varying 2 5 atmospheric pressures, such as for example, swimming or traveling in an air plane, differential pressures can arise between the interior of the air tight/water-resistant housing and the atmosphere. Should the pressure in the housing exceed external atmospheric pressure, the resulting forces could cause the reservoir piston to be driven inward thus delivering unwanted medication. Alternatively, should the pressure in the housing be less 3 0 than the external pressure, the resulting forces could cause the infusion pump motor to work harder to advance the reservoir piston.
To address this problem, a preferred embodiment of the invention includes a vent which permits water resistant housing construction. The cap 12 includes a plurality of vent ports 24, only one of which is shown in FIG. 5. The vent ports 24 permit 3 5 equalization of pump housing pressure to atmospheric pressure. Hydrophobic material (not shown) covers the interior openings of the vent ports 24. Hydrophobic material permits air to pass through the material while preventing water or other liquids from doing so, thus permitting water resistant venting. The preferred embodiment uses a hydrophobic material such as Gore-Tex~ , PTFE, HDPE, or UHMW polymers from sources such as W.I. Gore & Associates, Flagstaff, AZ, Porex Technologies, Fairburn, GA, DeWAL
Industries, Saunderstown, RI, or Pall Specialty Materials, Port Washington, N.Y.
These materials are available in sheet form or molded (press and sintered) in a geometry of choice. Referring to FIGS 14a - 14c, preferred methods to attach this material to the cap 12 include molding the hydrophobic material into a sphere 50 (FIG.
14a) or a cylinder 51 (FIG. 14b) and pressing it into a cavity in the pre-molded plastic housing.
Alternatively, a label 52 (FIG. 14c) of this material could be made with either a transfer adhesive or heat bond material 53 so that the label could be applied over the vent port 24.
Alternatively, the label could be sonically welded to the housing. . In either method, air will be able to pass freely, but water will not.
In an alternative embodiment which is not shown, the venting is accomplished through a vent port located in the pump housing.
Alternatively, vent ports can be placed both in the cap 12 as well as the pump housing.
An advantage of placing the vent port and hydrophobic material in the cap 12, as opposed to in the pump housing only, is that the infusion set and its related connectors are disposable and are replaced frequently with each new reservoir or vial of medication.
2 5 Thus, new hydrophobic material is frequently placed into service. This provides enhanced ventilation as compared with the placement of hydrophobic material in only the pump housing. Material in this location will not be replaced as often and thus is subject to dirt or oil build up which will retard ventilation.
As an alternative to the use of hydrophobic material, water can be prevented from flowing through the vent port by other apparatuses, such as the use of relief valves.
FIG. 6 shows a cross-sectional view of the reservoir/base%ap unit in accordance with the embodiment of FIGS. 3 and 4 which is secured into a pump housing 30.
The threads 19 of the cap 12 engage the pump housing threads. Rather that the use of threads, an alternative embodiment (not shown) of the cap 12 could include detents extending 3 5 radially from the exterior of the cap 12 which are adapted to engage detent openings in the pump housing.
The shoulder 23 portion of the cap 12 seats against the pump housing 30 to permit water tight construction. Further aiding in the water tight construction is an O-ring seal 31 which is disposed in the pump housing 30 and located just above the shoulder 23. In the preferred embodiment, the vent material 32 is comprised of hydrophobic material and is sonic welded to the upper interior surface of the cap 12. Alternatively, the vent material 32 could be attached to the cap 12 with an adhesive. The vent ports are not shown in FIG.
6.
Although the foregoing description of the venting was in connection with the embodiment of FIGs 3 - 6, this feature is also applicable to the embodiment of FIGS 1 - 2.
FIGS. 7 and 8 show an alternative embodiment of the cap 12. Referring to FIG.
7, a cap engagement member consists of a detent arm 34 which is formed in the upper portion of the cap 12. The purpose of the detent arm 34 is to securely engage the cap 12 into the pump housing. FIG. 8 shows a top view of the cap 12 positioned in the pump housing 30. The pump housing 30 has two case lock recesses 35 disposed in the circular rim of the housing. The detent arm 34 snaps into either of the case lock recesses 35. This engagement results in a "click" when the cap 12 is appropriately seated, thus providing 2 0 both tactile and audible feedback to the user that the cap is securely engaged in the pump housing. Moreover, the detent arm 34 aligning with the recess 35 also serves as a visual indicator that the cap 12 is appropriately seated.
FIG. 9 shows an alternative embodiment of the cap 12 which contains a child safety feature. The cap 12 includes a locking member which consists of a safety tab 36 2 5 disposed in a groove 37. The safety tab 36 is sized such that it is able to slide along the length of the groove 37. When the safety tab 36 is in the position shown in FIG. 9, the detent arm 34 is unable to retract from its engaged position. Thus when the cap 12 is seated into the pump housing 30 (not shown) and the detent arm is seated into the case lock recess 35 (not shown), the safety tab 36 will prevent the detent arm 34 from 3 0 disengaging from the case lock recess 35 thus more securely locking the cap 12 in the pump housing.
Thus for example, a parent could slide the safety tab 36 from the unlocked location in the groove 37 to the locked location shown in FIG. 9 so that it would be more difficult for a young child or infant to inadvertently remove the cap/baselreservoir unit from the 3 5 pump housing. On the other hand, when the safety tab 36 is moved to the opposite end of the groove 37, the detent arm 34 is able to retract thus permitting removal of the cap 12 from the pump housing.
Although the foregoing description of the cap engagement member and child safety tab was in connection with the embodiment of FIGs 3 - 9, this feature is also applicable to the embodiment of FIGs 1 - 2.
FIG. 10 shows an exploded view of the cap 12 and the vent material 32. In the preferred embodiment, the vent material is made of hydrophobic material and is formed in a circular shape with a circular hole in the center. The vent material 32 is attached to the upper interior surface 38 of the cap 12 via sonic welding or an adhesive. When it is so attached, the needle 18 protrudes through the center hole of the vent material 32 but the interior openings of the vent ports 24 (not shown) are covered.
FIGs. 11 and 12 show an embodiment of the present invention where an adapter is provided to allow a standard style syringe 41 with an integrated luer fitting 42 to be mounted and sealed in the pump housing. The syringe 41 is inserted through the center of the adapter 40 and held into place by a friction fit. The O-ring seal 43 in the adapter 40 seats against the syringe wall in order to prevent water and dirt from entering the pump housing.
2 0 A shoulder 45 is formed as part of the adapter 40 and is adapted to seat against the interior of the pump housing to form a water tight seal. Two tabs 44 are formed on the top surface of the adapter 40 and provide a surface for the user to grip the adapter 40 and twist it so that the adapter threads 19 engage the threads (not shown) of the pump housing. A
detent arm 34 is formed in the upper portion of the adapter 40. Its purpose is to securely 2 5 lock the adapter 40 into the pump housing (not shown) in the same manner as is shown in FIG. 8. Although not shown in FIGS. 11 and 12, the adapter 40 can further contain vent ports covered with hydrophobic material or a relief valve in order to permit water resistant venting of the pump housing in the same manner as previously described with other embodiments.
3 0 FIG. 13 shows another embodiment of the present invention where an interface is provided to connect a reservoir to a conduit, such as tubing, via a standard luer fitting connection. This allows a luer style disposable infusion set to connect to the pump housing (not shown). A cap 46 is formed with a luer fitting 47 portion as an integral part thereof. Except for the shape of the luer fitting 47 portion, the cap 46 has all of the other 3 5 features of the cap 12 shown in FIG. 5. Thus referring to FIG. 13, the cap 46 is comprised of, among other things, threads 19, detent openings 14, a shoulder 23, vent ports 24, a detent arm 34, and a needle (not shown) disposed in the interior of the cap 46.
While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
BACKGROUND OF THE INVENTION
1. Field of the Invention This invention relates generally to improvements in syringe and reservoir interfaces for use in infusion pumps such as those used for controlled delivery of medication to a patient. More specifically, this invention relates to an improved connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump.
2. Description of the Related Art 2 0 Infusion pump devices and systems are relatively well-known in the medical arts, for use in delivering or dispensing a prescribed medication such as insulin to a patient. In one form, such devices comprise a relatively compact pump housing adapted to receive a syringe or reservoir carrying a prescribed medication for administration to the patient through infusion tubing and an associated catheter.
2 5 The infusion pump includes a small drive motor connected via a lead screw assembly for motor-driven advancement of a reservoir piston to administer the medication to the user. Programmable controls are normally provided for operating the drive motor continuously or at periodic intervals to obtain a closely controlled and accwate delivery of the medication over an extended period of time. Such infusion pumps are utilized to 3 0 administer insulin and other medications, with exemplary pump constructions being shown and described in U.S. Patent Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122.
Infusion pumps of the general type described above have provided significant advantages and benefits with respect to accurate delivery of medication or other fluids over 3 5 an extended period of time. The infusion pump can be designed to be relatively compact as well as water resistant, and may thus be adapted to be carried by the user, for example, by means of a belt clip. As a result, important medication can be delivered to the user with precision and in an automated manner, without significant restriction on the user's mobility or life-style, including the ability to participate in water sports.
Infusion sets refer to the tubing and connection apparatus which provide a path for the medication to flow from the reservoir or syringe located in the pump to the user. The connectors for attaching the infusion set tubing to the reservoirs can take various forms. A
luer connection is a commonly used connection method. Nevertheless, it remains desirable to develop improved designs of connection methods to facilitate infusion procedures and to provide suitable interface connections which are water resistant so as to permit a user to participate in water sports.
~ 5 SUMMARY OF THE PREFERRED EMBODIMENTS
An apparatus for connecting a reservoir having a septum and a base to a conduit, such as infusion set tubing, is provided. In certain aspects of the present invention, the apparatus comprises a cap and a releasable coupler which is adapted to releasably couple 2 0 the base to the cap in one of two positions. A piercing member, such as a needle, is coupled to the conduit. The needle is disposed in the cap in a position other than the interior of the reservoir when the base is in the first position. The needle is further disposed to pierce the reservoir septum when the base is in the second position.
In another embodiment, the apparatus is used for connecting a reservoir having a 2 5 septum and a base to a housing as well as to a conduit. The housing has a housing engagement member, such as a thread. The apparatus comprises a cap and a releasable coupler which is adapted to releasably couple the base to the cap in one of two positions.
A piercing member, such as a needle, is releasably coupled to the conduit. The needle is disposed in the cap in a position other than the interior of the reservoir when the base is in 3 0 the first position. The needle is further disposed to pierce the reservoir septum when the base is in the second position. The cap further includes an engagement member, such as a thread, which is adapted to engage with the housing engagement member.
In another embodiment, the cap further includes a vent port which is covered with hydrophobic material. This permits air to pass through the cap while preventing water 3 5 from doing so.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. I is an exploded, perspective view of a medication reservoir connection interface apparatus.
FIG. 2 is a perspective view of a cap used as a medication reservoir connection interface apparatus.
FIG. 3 is an exploded, perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.
FIG. 4 is a side, cut-away view of a cap used as a medication reservoir connection interface apparatus.
FIG. 5 is a side, plan cut-away view of a medication reservoir connection interface apparatus with a needle inserted into a reservoir.
FIG. 6 is a side, plan cut-away view of a medication reservoir connection interface apparatus which is inserted into a pump housing.
FIG. 7 is a perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.
2 0 FIG. 8 is a perspective top view of an alternative embodiment of a medication reservoir connection interface apparatus which is secured into a pump housing.
FIG. 9 is a perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.
FIG. 10 is an exploded, perspective view of a cap used as a medication reservoir 2 5 connection interface apparatus.
FIG. 11 is a perspective view of a medication reservoir connection interface adapter.
FIG. 12 is a cross-sectional view of a medication reservoir connection interface adapter.
30 FIG. 13 is a perspective view of an alternative embodiment of a cap used as a medication reservoir connection interface apparatus.
FIGs. 14a - 14c are cross-sectional views of various embodiments of venting ports for use with a reservoir connection interface apparatus or adapter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
In the following description, reference is made to the accompanying drawings which form a part hereof and which illustrate several embodiments of the present invention. It is understood that other embodiments may be utilized and structural and operational changes may be made without departing from the scope of the present invention.
As shown in the drawings for purposes of illustration, the invention is embodied in an interface for connecting a syringe or a medication reservoir to a conduit, such as infusion set tubing or an external needle, as well as to an infusion pump. In a one embodiment, a base is provided which is adapted to receive a reservoir. A cap is provided which is adapted to be releasably coupled to the base in one of two positions.
The releasable coupler comprises a pair of detents projecting from the base and two pairs of detent openings in the cap which are adapted to removably engage the base detents.
A piercing member, such as a needle, is disposed in the interior of the cap in such a 2 0 manner that the needle is separated from the reservoir septum when the base detents are in the first pair of cap detent openings, and the needle pierces the reservoir septum when the base detents are in the second pair of cap detent openings. When the reservoir, the base and the cap are connected, an integrated unit is formed which is then capable of being inserted in the infusion pump housing. Engagement members, such as threads, for the cap 2 5 and the pump housing are used to secure the integrated unit in the housing.
FIGs. 1 and 2 show an infusion set connector interface for attachment to a medication reservoir. The connector interface is comprised of a base 2 and a cap 4. The cap 4 includes a needle 9 located internal to the cap housing. FIG. 1 is an exploded view, and therefore, the base 2 would normally be fixedly attached to a reservoir 1 by securing it 3 0 around the swage 3. However, alternative embodiments of the present invention include a removable base so that the connector interface could be used with standard reservoirs, cartridges or syringes which were not initially manufactured with the base attached.
The cap 4 portion of the connector interface is removably attached to the base with a releasable coupler. In one embodiment, the releasable coupler is comprised of 3 5 detents formed on the base 2 and detent openings disposed in the cap 4.
Two detents 8 are disposed on the sides of the base 2 and are spaced 180 ° radially apart. Only one detent 8 is shown in FIG. 1. The detents 8 are sized to fit in the two lower detent openings 6, or w alternatively, in the two upper detent openings 7 which are formed in the cap 4. As with the pair of detents 8, each of the lower detent openings 6 and each of the upper detent openings 7, respectively, are radially spaced apart by 180 °.
In operation, the base 2 and the reservoir 1 form an integrated unit which in turn is to be connected to the cap 4. In connecting this integrated base/reservoir unit to the cap 4, the base 2 is inserted into the lower end of the cap 4 until the detents 8 snap into the lower detent openings 6. This is accomplished by moving the detents 8 over internal cam surfaces 10 toward the lower detent openings 6. The cam surfaces act as ramps which compress the detents 8 sufficiently to permit them to snap into the lower detent openings 6. Internal threads l0a guide the detents 8 into position.
When the base/reservoir unit is in this first, lower position, the needle 9 is positioned apart from the septum (not shown) of the reservoir 1. Thus the needle does not pierce the septum while the base/reservoir unit is in this first position.
When the base/reservoir unit is connected to the cap in this fashion, an integrated cap/base/reservoir unit is thereby formed. Such an integrated cap/base/reservoir unit can be sold or stored for 2 0 long periods of time in this fashion. Alternatively the end user could assemble this unit shortly prior to placing it in the pump for use.
When the user desires to insert the cap/base/reservoir unit in the pump housing and commence dispensing the medication through a conduit, such as insertion set tubing 5, the base 2 is moved to the second position within the cap 4. This is accomplished by twisting 2 5 the base /reservoir unit while pushing it further into the cap 4. The detents 8 disengage from the lower detent openings 6 and engage into the upper detent openings 7.
Additional internal threads l0a of the cap 4 serve to guide the detents 8 over additional cam surfaces 10 from their first position in the lower detent openings 6 to the second position in the upper detent openings 7.
3 0 In one embodiment, the threads and the spacing between the lower detents 6 and the upper detents 7 is such that a one quarter (1/4) turn of the base will cause the base/reservoir unit to travel from the first to the second position. The needle 9 is disposed so that whcn the basc/rcscrvoir unit is in the sccond position, the nccdlc picrccs the scptum of the reservoir 1. Thus the movement of the base/reservoir unit from the first to the 3 5 second position within the cap serves to cause the needle to pierce the reservoir's septum, thus permitting the fluid in the reservoir to flow into the needle 9 and the insertion set tubing 5.
w After this connection is made, the reservoir, base and cap form a unit which can be releasably secured in the housing of a medication infusion pump. (not shown) Detents 4a extend radially from the exterior of the cap and are adapted to engage into detent openings (not shown) in the pump housing. In an alternative embodiment, the cap 4 can include external threads (not shown) which are used to engage the threads of the pump housing in order to secure the reservoir/base/cap unit into the housing.
FIGs. 3 and 4 show an alternative embodiment of the infusion set connector interface. The connector interface is comprised of a base 11 and a cap 12. The cap 12 includes a needle 18 located internal to the cap housing (FIG. 4). The base 11 would normally be fixedly attached to the reservoir 1 by securing it around the swage 3.
However, alternative embodiments of the present invention include a removable base so that the connector interface could be used with standard reservoirs, cartridges or syringes which were not initially manufactured with the base attached.
The cap 12 portion of the connector interface is removably attached to the base 11 with a releasable coupler. In this embodiment, the releasable coupler is comprised of 2 0 detents formed on the base 11 and detent openings disposed in the cap 12.
Two detents 13 are disposed on the sides of the base 11 and are spaced 180 ° radially apart. Only one detent 13 is shown in FIG. 3. The detents 13 are sized to fit in two detent openings 14 which are formed in the cap 12. As with the pair of detents 13, each of the detent openings 14 are radially spaced apart by 180 °.
2 5 In operation, the base 11 and the reservoir 1 form an integrated unit which in tum is to be connected to the cap 12. In connecting this integrated base/reservoir unit to the cap 12, the base 11 is inserted into the lower end of the cap 12. The detents 13 slide into matingly shaped and longitudinally open entry slots 15 formed within the interior walls of the cap 12. When the base 11 is fully inserted in the cap 12, the leading edges of the 3 0 detents 13 abut an annular stop shoulder 16 formed within the cap 12.
After the detents 13 are in this position, the base 11 is rotated within the cap 12 toward a locked position.
Referring to FIG. 4, this rotation displaces the detents 13 in a rotational direction for engagement with cam surfaces 17 formed within the cap 12. The rotational force on the detents 13 over the cam surfaces 17 provides a compression force on the detents 13.
3 5 Continued rotation of the base 11 displaces the detents 13 past the cam surfaces 17 and into alignment with the detent openings 14. The detents 13 enter the detent openings 14 with a snap-action. Thus, the detents 13 are effectively locked within the detent openings 14 to prevent longitudinal separation of the base 11 from the cap 12.
In the preferred embodiment, the internal needle 18 of the cap 12 is disposed so that when the base/reservoir unit is fully inserted in the cap 12, the needle pierces the septum (not shown) of the reservoir 1. Thus the insertion force of the base/reservoir unit to the point where the detents 13 abut the annular stop shoulder 16 causes the needle 18 to pierce the septum, thus permitting the fluid in the reservoir to flow into the needle 18 and the insertion set tubing (not shown).
After this connection is made, the reservoir, base and cap form a unit which can be releasably secured in the housing of a medication infusion pump. (not shown) The cap 12 includes external threads 19 which are used to engage the threads of the pump housing in order to secure the reservoir/base/cap unit into the housing. In the preferred embodiment, the threads 19 have an eight threads per inch ("TPI"), 2 start profile.
Moreover, they have a square shaped cross section which maximizes their holding strength. Other thread profiles and cross-sections may be used however.
When disconnection of the base 11 from the cap 12 is desired, the base 11 must be 2 0 reverse-rotated within the cap 12, to move the detents 13 past the cam surfaces 17 into re-alignment with the entry slots 15. Such reverse-rotation of the coupler can be performed relatively easily, but essentially requires an affirmative intent by the user to disconnect the coupling. When the detents 13 are re-aligned with the entry slots 15, the cap 12 and base 1 I can be separated easily with minimal longitudinal force.
2 5 FIG. S shows a cross sectional view of the reservoir/base/cap integrated unit in accordance with the embodiment of FIGs. 3 and 4. The reservoir 1 includes a crimp seal swage 3 which encloses the outer periphery of the rubber septum 20 in order to secure the septum 20 to the reservoir 1 and forma water tight seal. With the base 11 in the locked position as shown, the detents 13 of the base 11 are locked into the detent openings 14 to 3 0 securely attach the base/reservoir unit into the cap 12. The needle 18 pierces the rubber septum 20, thus permitting the flow of liquid through the needle 18 and into the infusion set tubing cavity 22. Infusion set tubing (not shown) is secured into the cavity 22 to allow the liquid to continue its flow to the user.
In the preferred embodiment, the conduit from the cap 12 is infusion set tubing.
3 5 However in an alternative embodiment, the conduit comprises a second needle (not shown). This is secured into the cavity 22 with the point of the second needle extending outward. With this arrangement, the connector serves as an apparatus for permitting the refilling of the reservoir 1. The second, external needle would pierce the septum of a supply vial of fluid. The fluid could then be drawn into the cap in a reverse flow and into the reservoir 1 via the internal needle 18.
In the embodiment shown in FIG. 5, infusion set tubing is secured to the cavity 22 to allow liquid to flow to the user. The cavity 22 is disposed in the raised portion of the cap 12. In an alternative embodiment, however, the raised portion of the cap 12 can be in the shape of a standard luer fitting 47 shown in FIG. 13.
Referring to FIG. 5, in one embodiment the base 11 is formed around and fixedly attached to the crimp seal swage 3 portion of the reservoir 1. In an alternative embodiment, however, the base 11 is not fixedly attached to the reservoir.
Rather, the base 11 is a separate unit which is adapted to be releasably secured to the reservoir via a friction fit. This arrangement permits the connector apparatus to be used with standard reservoirs.
Still referring to FIG. 5, the cap 12 includes threads 19 for securing the assembly into the pump housing (not shown). A shoulder 23 is formed as part of the cap 12 and is 2 0 adapted to seat against the pump housing to form a water tight seal. This prevents any water which is exterior to the housing from entering, thus permitting the user to engage in water sports.
The construction of these pumps to be water resistant can give rise to operational problems. As the user engages in activities which expose the pump to varying 2 5 atmospheric pressures, such as for example, swimming or traveling in an air plane, differential pressures can arise between the interior of the air tight/water-resistant housing and the atmosphere. Should the pressure in the housing exceed external atmospheric pressure, the resulting forces could cause the reservoir piston to be driven inward thus delivering unwanted medication. Alternatively, should the pressure in the housing be less 3 0 than the external pressure, the resulting forces could cause the infusion pump motor to work harder to advance the reservoir piston.
To address this problem, a preferred embodiment of the invention includes a vent which permits water resistant housing construction. The cap 12 includes a plurality of vent ports 24, only one of which is shown in FIG. 5. The vent ports 24 permit 3 5 equalization of pump housing pressure to atmospheric pressure. Hydrophobic material (not shown) covers the interior openings of the vent ports 24. Hydrophobic material permits air to pass through the material while preventing water or other liquids from doing so, thus permitting water resistant venting. The preferred embodiment uses a hydrophobic material such as Gore-Tex~ , PTFE, HDPE, or UHMW polymers from sources such as W.I. Gore & Associates, Flagstaff, AZ, Porex Technologies, Fairburn, GA, DeWAL
Industries, Saunderstown, RI, or Pall Specialty Materials, Port Washington, N.Y.
These materials are available in sheet form or molded (press and sintered) in a geometry of choice. Referring to FIGS 14a - 14c, preferred methods to attach this material to the cap 12 include molding the hydrophobic material into a sphere 50 (FIG.
14a) or a cylinder 51 (FIG. 14b) and pressing it into a cavity in the pre-molded plastic housing.
Alternatively, a label 52 (FIG. 14c) of this material could be made with either a transfer adhesive or heat bond material 53 so that the label could be applied over the vent port 24.
Alternatively, the label could be sonically welded to the housing. . In either method, air will be able to pass freely, but water will not.
In an alternative embodiment which is not shown, the venting is accomplished through a vent port located in the pump housing.
Alternatively, vent ports can be placed both in the cap 12 as well as the pump housing.
An advantage of placing the vent port and hydrophobic material in the cap 12, as opposed to in the pump housing only, is that the infusion set and its related connectors are disposable and are replaced frequently with each new reservoir or vial of medication.
2 5 Thus, new hydrophobic material is frequently placed into service. This provides enhanced ventilation as compared with the placement of hydrophobic material in only the pump housing. Material in this location will not be replaced as often and thus is subject to dirt or oil build up which will retard ventilation.
As an alternative to the use of hydrophobic material, water can be prevented from flowing through the vent port by other apparatuses, such as the use of relief valves.
FIG. 6 shows a cross-sectional view of the reservoir/base%ap unit in accordance with the embodiment of FIGS. 3 and 4 which is secured into a pump housing 30.
The threads 19 of the cap 12 engage the pump housing threads. Rather that the use of threads, an alternative embodiment (not shown) of the cap 12 could include detents extending 3 5 radially from the exterior of the cap 12 which are adapted to engage detent openings in the pump housing.
The shoulder 23 portion of the cap 12 seats against the pump housing 30 to permit water tight construction. Further aiding in the water tight construction is an O-ring seal 31 which is disposed in the pump housing 30 and located just above the shoulder 23. In the preferred embodiment, the vent material 32 is comprised of hydrophobic material and is sonic welded to the upper interior surface of the cap 12. Alternatively, the vent material 32 could be attached to the cap 12 with an adhesive. The vent ports are not shown in FIG.
6.
Although the foregoing description of the venting was in connection with the embodiment of FIGs 3 - 6, this feature is also applicable to the embodiment of FIGS 1 - 2.
FIGS. 7 and 8 show an alternative embodiment of the cap 12. Referring to FIG.
7, a cap engagement member consists of a detent arm 34 which is formed in the upper portion of the cap 12. The purpose of the detent arm 34 is to securely engage the cap 12 into the pump housing. FIG. 8 shows a top view of the cap 12 positioned in the pump housing 30. The pump housing 30 has two case lock recesses 35 disposed in the circular rim of the housing. The detent arm 34 snaps into either of the case lock recesses 35. This engagement results in a "click" when the cap 12 is appropriately seated, thus providing 2 0 both tactile and audible feedback to the user that the cap is securely engaged in the pump housing. Moreover, the detent arm 34 aligning with the recess 35 also serves as a visual indicator that the cap 12 is appropriately seated.
FIG. 9 shows an alternative embodiment of the cap 12 which contains a child safety feature. The cap 12 includes a locking member which consists of a safety tab 36 2 5 disposed in a groove 37. The safety tab 36 is sized such that it is able to slide along the length of the groove 37. When the safety tab 36 is in the position shown in FIG. 9, the detent arm 34 is unable to retract from its engaged position. Thus when the cap 12 is seated into the pump housing 30 (not shown) and the detent arm is seated into the case lock recess 35 (not shown), the safety tab 36 will prevent the detent arm 34 from 3 0 disengaging from the case lock recess 35 thus more securely locking the cap 12 in the pump housing.
Thus for example, a parent could slide the safety tab 36 from the unlocked location in the groove 37 to the locked location shown in FIG. 9 so that it would be more difficult for a young child or infant to inadvertently remove the cap/baselreservoir unit from the 3 5 pump housing. On the other hand, when the safety tab 36 is moved to the opposite end of the groove 37, the detent arm 34 is able to retract thus permitting removal of the cap 12 from the pump housing.
Although the foregoing description of the cap engagement member and child safety tab was in connection with the embodiment of FIGs 3 - 9, this feature is also applicable to the embodiment of FIGs 1 - 2.
FIG. 10 shows an exploded view of the cap 12 and the vent material 32. In the preferred embodiment, the vent material is made of hydrophobic material and is formed in a circular shape with a circular hole in the center. The vent material 32 is attached to the upper interior surface 38 of the cap 12 via sonic welding or an adhesive. When it is so attached, the needle 18 protrudes through the center hole of the vent material 32 but the interior openings of the vent ports 24 (not shown) are covered.
FIGs. 11 and 12 show an embodiment of the present invention where an adapter is provided to allow a standard style syringe 41 with an integrated luer fitting 42 to be mounted and sealed in the pump housing. The syringe 41 is inserted through the center of the adapter 40 and held into place by a friction fit. The O-ring seal 43 in the adapter 40 seats against the syringe wall in order to prevent water and dirt from entering the pump housing.
2 0 A shoulder 45 is formed as part of the adapter 40 and is adapted to seat against the interior of the pump housing to form a water tight seal. Two tabs 44 are formed on the top surface of the adapter 40 and provide a surface for the user to grip the adapter 40 and twist it so that the adapter threads 19 engage the threads (not shown) of the pump housing. A
detent arm 34 is formed in the upper portion of the adapter 40. Its purpose is to securely 2 5 lock the adapter 40 into the pump housing (not shown) in the same manner as is shown in FIG. 8. Although not shown in FIGS. 11 and 12, the adapter 40 can further contain vent ports covered with hydrophobic material or a relief valve in order to permit water resistant venting of the pump housing in the same manner as previously described with other embodiments.
3 0 FIG. 13 shows another embodiment of the present invention where an interface is provided to connect a reservoir to a conduit, such as tubing, via a standard luer fitting connection. This allows a luer style disposable infusion set to connect to the pump housing (not shown). A cap 46 is formed with a luer fitting 47 portion as an integral part thereof. Except for the shape of the luer fitting 47 portion, the cap 46 has all of the other 3 5 features of the cap 12 shown in FIG. 5. Thus referring to FIG. 13, the cap 46 is comprised of, among other things, threads 19, detent openings 14, a shoulder 23, vent ports 24, a detent arm 34, and a needle (not shown) disposed in the interior of the cap 46.
While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Claims (53)
1. An apparatus for connecting a reservoir having a septum and a base to a conduit, the apparatus comprising:
a cap having a cap engagement means adapted to engage a housing of a medical device;
a releasable coupler adapted to releasably couple the base with the cap in one of a first and a second position;
a piercing member coupled to the conduit, said piercing member disposed in the cap in a position other than the interior of the reservoir when the base is in the first position, the piercing member disposed to pierce the reservoir septum when the base is in the second position; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a cap having a cap engagement means adapted to engage a housing of a medical device;
a releasable coupler adapted to releasably couple the base with the cap in one of a first and a second position;
a piercing member coupled to the conduit, said piercing member disposed in the cap in a position other than the interior of the reservoir when the base is in the first position, the piercing member disposed to pierce the reservoir septum when the base is in the second position; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
2. An apparatus according to claim 1, comprising means for con-necting the reservoir to a housing having a housing engagement member, the cap engagement means being adapted to engage the housing engagement member.
3. An apparatus for connecting a reservoir having a septum to a conduit and to a housing having a first thread member, the appa-ratus comprising:
a base adapted to receive the reservoir;
a detent tab projecting from the base;
a cap having a cap engagement means adapted to engage a housing of a medical device and adapted to receive the base, said cap having a first detent opening adapted to removably engage the base detent tab and a second detent opening adapted to removably engage the base detent tab;
a piercing member coupled to the conduit, said piercing member disposed in the cap in a position other than the interior of the reservoir when the base detent tab is engaged in the first detent opening and said piercing member disposed to pierce the reservoir septum when the base detent tab is engaged in the second detent opening;
a second thread member disposed on the cap, the second thread member adapted to engage the first thread member; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a base adapted to receive the reservoir;
a detent tab projecting from the base;
a cap having a cap engagement means adapted to engage a housing of a medical device and adapted to receive the base, said cap having a first detent opening adapted to removably engage the base detent tab and a second detent opening adapted to removably engage the base detent tab;
a piercing member coupled to the conduit, said piercing member disposed in the cap in a position other than the interior of the reservoir when the base detent tab is engaged in the first detent opening and said piercing member disposed to pierce the reservoir septum when the base detent tab is engaged in the second detent opening;
a second thread member disposed on the cap, the second thread member adapted to engage the first thread member; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
4. A method of connecting a reservoir having a septum and a base to a conduit, the method comprising:
inserting the base into a cap having a piercing member, a coupler, a cap engagement means adapted to engage a housing of a medical device and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resis-tant venting of the housing of the medical device when the cap is operatively engaged with the housing, the piercing member coupled to the conduit, the coupler adapted to releasably couple the base with the cap in one of a first and a second position;
releasably coupling the base to the first position in the cap whereby the piercing member is disposed in a position other than the interior of the reservoir; and releasably coupling the base to the second position in the cap whereby the piercing member is disposed to pierce the sep-tum.
inserting the base into a cap having a piercing member, a coupler, a cap engagement means adapted to engage a housing of a medical device and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resis-tant venting of the housing of the medical device when the cap is operatively engaged with the housing, the piercing member coupled to the conduit, the coupler adapted to releasably couple the base with the cap in one of a first and a second position;
releasably coupling the base to the first position in the cap whereby the piercing member is disposed in a position other than the interior of the reservoir; and releasably coupling the base to the second position in the cap whereby the piercing member is disposed to pierce the sep-tum.
5. A method of connecting a reservoir to a housing and to a conduit, said reservoir having a septum and a base with a detent tab, and said housing having a first thread member, the method compris-ing:
inserting the base to a first detent position in a cap having a piercing member coupled to the conduit, a second thread member, a cap engagement means adapted to engage a housing of a medi-cal device, and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant vent-ing of the housing of the medical device when the cap is opera-tively engaged with the housing, whereby the piercing member is disposed to be at a position other than the interior of the reser-voir;
inserting the base to a second detent position in the cap whereby the piercing member is disposed to pierce the reservoir septum; and connecting the reservoir, the base and the cap to the hous-ing whereby the second thread member engages with the first thread member.
inserting the base to a first detent position in a cap having a piercing member coupled to the conduit, a second thread member, a cap engagement means adapted to engage a housing of a medi-cal device, and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant vent-ing of the housing of the medical device when the cap is opera-tively engaged with the housing, whereby the piercing member is disposed to be at a position other than the interior of the reser-voir;
inserting the base to a second detent position in the cap whereby the piercing member is disposed to pierce the reservoir septum; and connecting the reservoir, the base and the cap to the hous-ing whereby the second thread member engages with the first thread member.
6. An apparatus for connecting a reservoir having a septum and a base to a conduit, said apparatus comprising:
a cap adapted to receive the base, the cap having a cap engagement means adapted to engage a housing of a medical device;
means in the cap for piercing the septum;
means for removably coupling the base with the cap in one of a first and a second position whereby the piercing means does not pierce the septum when the base is in the first position and whereby the piercing means pierces the septum when the base is in the second position;
means for coupling the piercing means with the conduit;
and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a cap adapted to receive the base, the cap having a cap engagement means adapted to engage a housing of a medical device;
means in the cap for piercing the septum;
means for removably coupling the base with the cap in one of a first and a second position whereby the piercing means does not pierce the septum when the base is in the first position and whereby the piercing means pierces the septum when the base is in the second position;
means for coupling the piercing means with the conduit;
and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
7. An apparatus according to claim 6 wherein the cap engagement means is further adapted to removably engage the cap with the housing.
8. An apparatus for connecting a reservoir having a septum to a conduit, said conduit coupled to a piercing member disposed in a cap having a cap engagement means adapted to engage a housing of a medical device, the apparatus comprising:
a base adapted to receive the reservoir and to be received by the cap;
a releasable coupler adapted to releasably couple the base and the reservoir with the cap in one of a first and a second position;
said releasable coupler adapted to position the septum whereby the piercing member is in a position other than the interior of the reservoir when the base and reservoir are in the first position, and to position the septum to be pierced by the piercing member when the base and the reservoir are in the second position; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a base adapted to receive the reservoir and to be received by the cap;
a releasable coupler adapted to releasably couple the base and the reservoir with the cap in one of a first and a second position;
said releasable coupler adapted to position the septum whereby the piercing member is in a position other than the interior of the reservoir when the base and reservoir are in the first position, and to position the septum to be pierced by the piercing member when the base and the reservoir are in the second position; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
9. An apparatus for connecting a reservoir having a septum to a conduit, said conduit coupled to a piercing member disposed in a cap having a cap engagement means adapted to engage a housing of a medical device, said cap having a first detent opening and a second detent opening, the apparatus comprising:
a base adapted to receive the reservoir and to be received by the cap;
a detent tab projecting from the base, said detent tab adapted to removably engage one of the first detent opening and the second detent opening;
said detent tab disposed on the base to position the septum whereby the piercing member is in a position other than the interior of the reservoir when the detent tab is engaged in the first detent opening and to position the septum to be pierced by the piercing member when the base detent tab is engaged in the second detent opening; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a base adapted to receive the reservoir and to be received by the cap;
a detent tab projecting from the base, said detent tab adapted to removably engage one of the first detent opening and the second detent opening;
said detent tab disposed on the base to position the septum whereby the piercing member is in a position other than the interior of the reservoir when the detent tab is engaged in the first detent opening and to position the septum to be pierced by the piercing member when the base detent tab is engaged in the second detent opening; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
10. An apparatus for connecting a reservoir having a septum and a base to a conduit, the apparatus comprising:
a cap adapted to receive the base and having a cap engage-ment means adapted to engage a housing of a medical device;
a releasable coupler adapted to releasably couple the base with the cap;
a piercing member coupled to the conduit, said piercing member disposed to pierce the reservoir septum when the base is inserted into the cap; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a cap adapted to receive the base and having a cap engage-ment means adapted to engage a housing of a medical device;
a releasable coupler adapted to releasably couple the base with the cap;
a piercing member coupled to the conduit, said piercing member disposed to pierce the reservoir septum when the base is inserted into the cap; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
11. An apparatus according to claim 10, the housing further compris-ing a housing engagement member, the cap engagement means disposed on the cap and adapted to engage the housing engage-ment member.
12. The apparatus of claim 2 or 11 wherein the cap further comprises a second cap engagement member adapted to engage the housing.
13. The apparatus of claim 12 wherein the cap further comprises a locking member having two positions, the locking member adapted to prevent movement of the second cap engagement member when the locking member is in a first locking member position and to permit the movement of the second cap engage-ment member when the locking member is in a second locking member position.
14. The apparatus of claim 1, 2, 10 or 11, further comprising a vent port in the cap, the vent port being covered with a hydrophobic material.
15. The apparatus of claim 2 or 11 wherein the vent further comprises means for venting the housing to the atmosphere without permit-ting liquids to pass through the venting means.
16. The apparatus of claim 2 or 11, wherein the cap further comprises a shoulder adapted to sealingly engage the housing.
17. An apparatus for connecting a reservoir having a septum to a conduit and to a housing having a first thread member, the appa-ratus comprising:
a base adapted to receive the reservoir;
a detent tab projecting from the base;
a cap adapted to receive the base, said cap having a longitu-dinal entry slot adapted to receive the detent tab and having a cap engagement means adapted to engage a housing of a medical device;
an annular stop shoulder disposed in the cap at the distal end of the entry slot to prevent further longitudinal movement of the detent tab;
said cap having a detent opening formed adjacent to the annular stop shoulder and adapted to removably engage the detent tab;
a cam surface disposed between the distal end of the entry slot and the detent opening to permit the detent tab to travel from the distal end of the entry slot and to engage the detent opening;
a piercing member coupled to the conduit, said piercing member disposed in the cap to pierce the reservoir septum when the base and reservoir are inserted in the cap;
a second thread member disposed on the cap, the second thread member adapted to engage the first thread member; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a base adapted to receive the reservoir;
a detent tab projecting from the base;
a cap adapted to receive the base, said cap having a longitu-dinal entry slot adapted to receive the detent tab and having a cap engagement means adapted to engage a housing of a medical device;
an annular stop shoulder disposed in the cap at the distal end of the entry slot to prevent further longitudinal movement of the detent tab;
said cap having a detent opening formed adjacent to the annular stop shoulder and adapted to removably engage the detent tab;
a cam surface disposed between the distal end of the entry slot and the detent opening to permit the detent tab to travel from the distal end of the entry slot and to engage the detent opening;
a piercing member coupled to the conduit, said piercing member disposed in the cap to pierce the reservoir septum when the base and reservoir are inserted in the cap;
a second thread member disposed on the cap, the second thread member adapted to engage the first thread member; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
18. A method of connecting a reservoir having a septum and a base to a conduit, the method comprising:
inserting the base and reservoir into a cap having a piercing member, a coupler and a cap engagement means adapted to engage a housing of a medical device, the piercing member coupled to the conduit, the coupler adapted to releasably couple the base with the cap the cap having vent that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively engaged with the housing;
piercing the septum with the piercing member; and releasably coupling the base to the cap.
inserting the base and reservoir into a cap having a piercing member, a coupler and a cap engagement means adapted to engage a housing of a medical device, the piercing member coupled to the conduit, the coupler adapted to releasably couple the base with the cap the cap having vent that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively engaged with the housing;
piercing the septum with the piercing member; and releasably coupling the base to the cap.
19. The method of claim 4 or 18, wherein the cap further comprises a second releasable coupler, said method further comprising:
coupling the reservoir, the base and the cap to a housing whereby the second releasable coupler releasably engages with the housing.
coupling the reservoir, the base and the cap to a housing whereby the second releasable coupler releasably engages with the housing.
20. The method of claim 5 or 19, further comprising venting the housing through a vent port in the vent, said vent port containing hydrophobic material.
21. The method of claim 5 or 19, wherein the cap engagement means is further adapted to engage an exterior of the housing.
22. The method of claim 4 or 21 wherein the cap further comprises a locking member having two positions, the locking member adapted to prevent movement of the cap engagement means when the locking member is in a first locking member position and to permit the movement of the cap engagement means when the locking member is in a second locking member position.
23. A method of connecting a reservoir to a housing and to a conduit, said reservoir having a septum and a base with a detent tab, and said housing having a first thread member, the method compris-ing:
inserting the base and reservoir into a cap having:
(i) a piercing member coupled to the conduit;
(ii) a longitudinal entry slot adapted to receive the detent tab;
(iii) an annular stop shoulder disposed at the distal end of the entry slot to prevent further longitudinal move-ment of the detent tab;
(iv) a detent opening formed adjacent to the annular stop shoulder and adapted to removably engage the detent tab;
(v) a cam surface disposed between the distal end of the entry slot and the detent opening to permit the detent tab to travel from the distal end of the entry slot and to engage the detent opening;
(vi) a cap engagement means adapted to engage a housing of a medical device; and (vii) a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively engaged with the hous-ing;
sliding the base and reservoir in the cap until the detent tab abuts the annular stop shoulder, piercing the septum with the piercing member;
twisting the base and reservoir inside the cap until the detect tab releasably engages with the detent opening by traveling over the cam surface; and connecting the reservoir, the base and the cap to the hous-ing whereby a second thread member of the cap engages with the first thread member.
inserting the base and reservoir into a cap having:
(i) a piercing member coupled to the conduit;
(ii) a longitudinal entry slot adapted to receive the detent tab;
(iii) an annular stop shoulder disposed at the distal end of the entry slot to prevent further longitudinal move-ment of the detent tab;
(iv) a detent opening formed adjacent to the annular stop shoulder and adapted to removably engage the detent tab;
(v) a cam surface disposed between the distal end of the entry slot and the detent opening to permit the detent tab to travel from the distal end of the entry slot and to engage the detent opening;
(vi) a cap engagement means adapted to engage a housing of a medical device; and (vii) a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively engaged with the hous-ing;
sliding the base and reservoir in the cap until the detent tab abuts the annular stop shoulder, piercing the septum with the piercing member;
twisting the base and reservoir inside the cap until the detect tab releasably engages with the detent opening by traveling over the cam surface; and connecting the reservoir, the base and the cap to the hous-ing whereby a second thread member of the cap engages with the first thread member.
24. An apparatus for connecting a reservoir having a septum and a base to a conduit, said apparatus comprising:
a cap adapted to receive the base, the cap having a cap engagement means adapted to engage a housing of a medical device;
means in the cap for piercing the septum;
means for removably coupling the base and the reservoir with the cap whereby the piercing means pierces the septum when the base and reservoir are coupled to the cap;
means for coupling the piercing means with the conduit;
and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a cap adapted to receive the base, the cap having a cap engagement means adapted to engage a housing of a medical device;
means in the cap for piercing the septum;
means for removably coupling the base and the reservoir with the cap whereby the piercing means pierces the septum when the base and reservoir are coupled to the cap;
means for coupling the piercing means with the conduit;
and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
25. The apparatus of claim 6 or 24, further comprising means for permitting air to flow through an opening in the vent without permitting liquids to pass through the opening.
26. An apparatus according to claim 24 comprising means for con-necting the reservoir to the housing, the apparatus further com-prising means for removably engaging the cap with the housing.
27. The apparatus of claim 7 or 26 wherein the cap further comprises means for securing the cap to the housing whereby an audible, visual or tactile indication is given when the cap is secured to the housing.
28. The apparatus of claim 27 wherein the cap further comprises locking means for preventing movement of the securing means.
29. The apparatus of claim 7 or 26 wherein the cap further comprises means for securing the cap to the housing whereby water is prevented from entering the housing.
30. An apparatus for connecting a reservoir having a septum to a conduit, said conduit coupled to a piercing member disposed in a cap having a cap engagement means adapted to engage a housing of a medical device, the apparatus comprising:
a base adapted to receive the reservoir and to be received by the cap;
a releasable coupler adapted to releasably couple the base with the cap;
said releasable coupler adapted to position the septum to be pierced by the piercing member when the base and reservoir is inserted into the cap; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a base adapted to receive the reservoir and to be received by the cap;
a releasable coupler adapted to releasably couple the base with the cap;
said releasable coupler adapted to position the septum to be pierced by the piercing member when the base and reservoir is inserted into the cap; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
31. An apparatus for connecting a reservoir having a septum to a conduit, said conduit coupled to a piercing member disposed in a cap, said cap having a longitudinal entry slot, an annular stop shoulder disposed at the distal end of the entry slot, a detent opening formed adjacent to the annular stop shoulder, a cam surface disposed between the distal end of the entry slot and the detent opening, and a cap engagement means adapted to engage a housing of a medical device, the apparatus comprising:
a base adapted to receive the reservoir and to be received by the cap;
a detent tab projecting from the base, said detent tab adapted to slidably engage the entry slot until said detent tab abuts the annular stop shoulder;
said detent tab adapted to removably engage the detent opening by traveling over the cam surface;
said detent tab disposed on the base to position the septum to be pierced by the piercing member when the detent tab abuts the annular stop shoulder; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a base adapted to receive the reservoir and to be received by the cap;
a detent tab projecting from the base, said detent tab adapted to slidably engage the entry slot until said detent tab abuts the annular stop shoulder;
said detent tab adapted to removably engage the detent opening by traveling over the cam surface;
said detent tab disposed on the base to position the septum to be pierced by the piercing member when the detent tab abuts the annular stop shoulder; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
32. The method of claim 4 or 18, further comprising venting the housing through a vent port in the cap, said vent port containing hydrophobic material.
33. The method of claim 4 or 18, wherein the cap engagement means is adapted to engage an exterior of the housing.
34. An apparatus for connecting a reservoir having a septum to a conduit, the apparatus comprising:
a cap having:
a cap engagement means adapted to engage a housing of a medical device;
a piercing member that is coupled with the conduit; and a vent that permits the passage of air and inhibits the pas-sage of fluids so as to permit water resistant venting of the hous-ing of the medical device when the cap is operatively engaged with the housing;
a coupler adapted to releasably couple the reservoir with the cap;
wherein the piercing member is disposed in the cap to pierce the reservoir septum when the reservoir is releasably coupled and operatively engaged with the cap.
a cap having:
a cap engagement means adapted to engage a housing of a medical device;
a piercing member that is coupled with the conduit; and a vent that permits the passage of air and inhibits the pas-sage of fluids so as to permit water resistant venting of the hous-ing of the medical device when the cap is operatively engaged with the housing;
a coupler adapted to releasably couple the reservoir with the cap;
wherein the piercing member is disposed in the cap to pierce the reservoir septum when the reservoir is releasably coupled and operatively engaged with the cap.
35. The apparatus of claim 34, wherein the piercing member pierces the septum and is disposed in a position in the interior of the reservoir when the reservoir is releasably coupled with the cap.
36. The apparatus of claim 34, wherein the piercing member is dis-posed in a position other than the interior of the reservoir when the reservoir is releasably coupled in a first position and the piercing member pierces the reservoir septum and is disposed in a position in the interior of the reservoir when the reservoir is releasably coupled and operatively engaged with the cap in a second position.
37. The apparatus of claim 34, wherein the vent includes a hydropho-bic material.
38. The apparatus of claim 34, wherein the cap comprises a cap engagement member adapted to engage a housing engagement member of a housing when the reservoir is releasably coupled and operatively engaged with the cap and the so coupled and engaged reservoir and cap are engaged with the housing.
39. The apparatus of claim 38, wherein the cap further comprises a second cap engagement member adapted to secure the cap to the housing when the reservoir is releasably coupled and operatively engaged with the cap and the so coupled and engaged reservoir and cap are engaged with the housing.
40. The apparatus of claim 34, wherein the cap is coupleable to the reservoir via a base adapted to provide an interface between the reservoir and the cap.
41. The apparatus of claim 34, wherein the cap further comprises a cap engagement member adapted to engage a housing engagement member of a housing and a shoulder to form a seal with the housing when the cap is engaged with the housing.
42. The apparatus of claim 34, wherein the piercing member is a needle which creates a hole in the reservoir septum.
43. The apparatus of claim 37, wherein air passes through the hydro-phobic material.
44. The apparatus of claim 43, wherein the hydrophobic material comprises a sphere pressed into a cavity in the cap.
45. The apparatus of claim 43, wherein the hydrophobic material comprises a cylinder pressed into a cavity in the cap.
46. The apparatus of claim 43, wherein the hydrophobic material comprises a label affixed to the cap.
47. The apparatus of claim 43, wherein the hydrophobic material is disposed on an interior surface of the cap.
48. The apparatus of claim 43, wherein the hydrophobic material is disposed on an exterior surface of the cap.
49. An apparatus for connecting a reservoir to a conduit; the appara-tus comprising:
a cap for coupling a reservoir to a conduit, wherein the cap includes a cap engagement means adapted to engage a housing of a medical device;
a piercing member disposed in the cap; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
a cap for coupling a reservoir to a conduit, wherein the cap includes a cap engagement means adapted to engage a housing of a medical device;
a piercing member disposed in the cap; and a vent in the cap that allows the passage of air and inhibits the passage of fluids so as to permit water resistant venting of the housing of the medical device when the cap is operatively en-gaged with the housing.
50. The apparatus of claim 49, wherein the piercing member is dis-posed in the cap to pierce a reservoir septum that is coupled to the reservoir when the cap is coupled and operatively engaged with the reservoir.
51. The apparatus of claim 49, wherein the cap engagement member further comprises a shoulder to form a seal with the housing when the cap is operatively engaged with the housing.
52. The apparatus of claim 49, wherein the vent includes a hydropho-bic material.
53. The apparatus of claim 49, wherein the medical device is a medi-cation infusion pump.
Priority Applications (1)
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CA002533850A CA2533850C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
Applications Claiming Priority (3)
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US10623798P | 1998-10-29 | 1998-10-29 | |
US60/106,237 | 1998-10-29 | ||
PCT/US1999/025413 WO2000025852A1 (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
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CA002533850A Division CA2533850C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
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CA2346525A1 CA2346525A1 (en) | 2000-05-11 |
CA2346525C true CA2346525C (en) | 2006-04-11 |
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CA2832936A Expired - Fee Related CA2832936C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
CA002345439A Expired - Fee Related CA2345439C (en) | 1998-10-29 | 1999-10-28 | Compact pump drive system |
CA002346525A Expired - Lifetime CA2346525C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
CA2669175A Expired - Fee Related CA2669175C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
CA002533850A Expired - Fee Related CA2533850C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
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CA2832936A Expired - Fee Related CA2832936C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
CA002345439A Expired - Fee Related CA2345439C (en) | 1998-10-29 | 1999-10-28 | Compact pump drive system |
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CA2669175A Expired - Fee Related CA2669175C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
CA002533850A Expired - Fee Related CA2533850C (en) | 1998-10-29 | 1999-10-28 | Reservoir connector |
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JP (4) | JP3546015B2 (en) |
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US7766873B2 (en) | 1998-10-29 | 2010-08-03 | Medtronic Minimed, Inc. | Method and apparatus for detecting occlusions in an ambulatory infusion pump |
CA2832936C (en) * | 1998-10-29 | 2015-08-11 | Medtronic Minimed, Inc. | Reservoir connector |
US20020173748A1 (en) | 1998-10-29 | 2002-11-21 | Mcconnell Susan | Reservoir connector |
US7193521B2 (en) * | 1998-10-29 | 2007-03-20 | Medtronic Minimed, Inc. | Method and apparatus for detecting errors, fluid pressure, and occlusions in an ambulatory infusion pump |
US7018401B1 (en) | 1999-02-01 | 2006-03-28 | Board Of Regents, The University Of Texas System | Woven intravascular devices and methods for making the same and apparatus for delivery of the same |
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CA2832936C (en) | 1998-10-29 | 2015-08-11 | Medtronic Minimed, Inc. | Reservoir connector |
US6817990B2 (en) * | 1998-10-29 | 2004-11-16 | Medtronic Minimed, Inc. | Fluid reservoir piston |
US6260890B1 (en) * | 1999-08-12 | 2001-07-17 | Breg, Inc. | Tubing connector |
US20020138046A1 (en) | 2001-03-23 | 2002-09-26 | Douglas Joel S. | Adapter for medication cartridges |
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1999
- 1999-10-28 CA CA2832936A patent/CA2832936C/en not_active Expired - Fee Related
- 1999-10-28 WO PCT/US1999/025413 patent/WO2000025852A1/en active IP Right Grant
- 1999-10-28 AT AT99956770T patent/ATE311925T1/en not_active IP Right Cessation
- 1999-10-28 CA CA002345439A patent/CA2345439C/en not_active Expired - Fee Related
- 1999-10-28 EP EP05019057.8A patent/EP1716884B1/en not_active Expired - Lifetime
- 1999-10-28 JP JP2000579280A patent/JP3546015B2/en not_active Expired - Fee Related
- 1999-10-28 DE DE69928827T patent/DE69928827T2/en not_active Expired - Lifetime
- 1999-10-28 AT AT99971335T patent/ATE289523T1/en not_active IP Right Cessation
- 1999-10-28 US US09/428,818 patent/US6585695B1/en not_active Expired - Lifetime
- 1999-10-28 US US09/428,411 patent/US6362591B1/en not_active Expired - Lifetime
- 1999-10-28 DK DK05026578.4T patent/DK1642615T3/en active
- 1999-10-28 DE DE69923858T patent/DE69923858T2/en not_active Expired - Lifetime
- 1999-10-28 CA CA002346525A patent/CA2346525C/en not_active Expired - Lifetime
- 1999-10-28 AT AT05026578T patent/ATE498422T1/en not_active IP Right Cessation
- 1999-10-28 EP EP10157146.1A patent/EP2204203A3/en not_active Withdrawn
- 1999-10-28 EP EP99971335A patent/EP1124600B1/en not_active Expired - Lifetime
- 1999-10-28 DK DK05019057.8T patent/DK1716884T3/en active
- 1999-10-28 WO PCT/US1999/025414 patent/WO2000025844A1/en active IP Right Grant
- 1999-10-28 EP EP10157144.6A patent/EP2223713A3/en not_active Withdrawn
- 1999-10-28 AU AU13305/00A patent/AU1330500A/en not_active Abandoned
- 1999-10-28 CA CA2669175A patent/CA2669175C/en not_active Expired - Fee Related
- 1999-10-28 EP EP05026578.4A patent/EP1642615B2/en not_active Expired - Lifetime
- 1999-10-28 CA CA002533850A patent/CA2533850C/en not_active Expired - Fee Related
- 1999-10-28 EP EP99956770A patent/EP1124608B1/en not_active Expired - Lifetime
- 1999-10-28 AU AU14567/00A patent/AU1456700A/en not_active Abandoned
- 1999-10-28 DE DE69943207T patent/DE69943207D1/en not_active Expired - Lifetime
- 1999-10-28 JP JP2000579288A patent/JP4267206B2/en not_active Expired - Lifetime
- 1999-10-28 DK DK99956770T patent/DK1124608T3/en active
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2001
- 2001-12-13 US US10/017,882 patent/US6555986B2/en not_active Expired - Lifetime
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2002
- 2002-12-23 US US10/328,393 patent/US7658734B2/en not_active Expired - Lifetime
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2003
- 2003-06-26 US US10/607,340 patent/US20040003493A1/en not_active Abandoned
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2004
- 2004-08-20 US US10/923,133 patent/US7628782B2/en not_active Expired - Fee Related
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2006
- 2006-09-05 JP JP2006240860A patent/JP4489063B2/en not_active Expired - Lifetime
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2009
- 2009-01-28 US US12/361,203 patent/US7981105B2/en not_active Expired - Fee Related
- 2009-07-17 JP JP2009168463A patent/JP4759630B2/en not_active Expired - Lifetime
- 2009-11-06 US US12/614,229 patent/US7998131B2/en not_active Expired - Fee Related
- 2009-12-04 US US12/631,377 patent/US8257345B2/en not_active Expired - Fee Related
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2010
- 2010-01-25 US US12/693,232 patent/US7988683B2/en not_active Expired - Fee Related
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2011
- 2011-06-08 US US13/155,641 patent/US8303572B2/en not_active Expired - Fee Related
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2012
- 2012-09-18 US US13/622,183 patent/US8500716B2/en not_active Expired - Fee Related
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2013
- 2013-07-25 US US13/950,832 patent/US20130310807A1/en not_active Abandoned
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2014
- 2014-09-17 US US14/489,163 patent/US9579452B2/en not_active Expired - Fee Related
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Effective date: 20191028 |