CA1327926C - Implantable patient-activated fluid delivery device - Google Patents
Implantable patient-activated fluid delivery deviceInfo
- Publication number
- CA1327926C CA1327926C CA000599752A CA599752A CA1327926C CA 1327926 C CA1327926 C CA 1327926C CA 000599752 A CA000599752 A CA 000599752A CA 599752 A CA599752 A CA 599752A CA 1327926 C CA1327926 C CA 1327926C
- Authority
- CA
- Canada
- Prior art keywords
- pump
- fluid
- reservoir
- top wall
- pump housing
- 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 - Fee Related
Links
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
- A61M5/142—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
- A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
- A61M5/1428—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation with manual pumping action
Abstract
IMPLANTABLE PATIENT-ACTIVATED
FLUID DELIVERY DEVICE
Abstract of the Disclosure An implantable fluid delivery device for dispensing metered aliquots of liquid medication upon finger-pressure activation of the device by a patient. The device includes a soft, deformable needle-piercable casing having a fluid reservoir in which is located a relatively-rigid, apertured support plate that divides the reservoir into upper and lower chambers. A compressible, positive displacement pump chamber or housing is mounted upon the plate within the upper chamber and includes passages communicating with both the lower chamber and an outlet port. Force applied to a central target zone of the top wall causes compression of the pump housing and delivery through the outlet port of an amount of fluid equal to the displacement of the pump housing. The same target zone of the top wall serves as a self-sealing injection site for replenishing the fluid supply of the reservoir. A rigid, protective needle guard is disposed within the upper chamber above the pump housing to shield that housing against contact by an injection needle when the fluid supply is being replenished. The rigid plate that supports the pump housing also distributes applied pumping forces and provides a platform for supporting other elements of the device, including a fluid filter and surge protector located in the lower chamber of the reservoir at the inlet to the pump housing.
FLUID DELIVERY DEVICE
Abstract of the Disclosure An implantable fluid delivery device for dispensing metered aliquots of liquid medication upon finger-pressure activation of the device by a patient. The device includes a soft, deformable needle-piercable casing having a fluid reservoir in which is located a relatively-rigid, apertured support plate that divides the reservoir into upper and lower chambers. A compressible, positive displacement pump chamber or housing is mounted upon the plate within the upper chamber and includes passages communicating with both the lower chamber and an outlet port. Force applied to a central target zone of the top wall causes compression of the pump housing and delivery through the outlet port of an amount of fluid equal to the displacement of the pump housing. The same target zone of the top wall serves as a self-sealing injection site for replenishing the fluid supply of the reservoir. A rigid, protective needle guard is disposed within the upper chamber above the pump housing to shield that housing against contact by an injection needle when the fluid supply is being replenished. The rigid plate that supports the pump housing also distributes applied pumping forces and provides a platform for supporting other elements of the device, including a fluid filter and surge protector located in the lower chamber of the reservoir at the inlet to the pump housing.
Description
j 1327~26 IMPLANTABLE PATIE~T-ACTIVATED
FLUID DELIYERY DEVICE
Background of the Invention Various implantable devices have been d~sclosed in the prior ast that may be activated by ambulatory patients when the administration of measured doses of therapeutic agents is required. For example, cancer patients suffering from terminal lower torso cancer may require routine injections of moxphine, either epidurally or intrathecally, and~ upon receiv~ng such injections, are sufficiently relieved of the symptoms of pain to move about and perform m~ny routine and normal functions. Other chronic ailments also reguire frequent dosage~ of therapeutic agents in the treatment of chronic conditions, such as in~ulin in the case of diabete3. Implantable devices capable of delivering measured amounts of medicament on demand are disclosed in United States patents 4,634,427, 4,548,607, 4,588,394, 4,557,722, 4,544,371, and 4,543,088. Other United States patent~ of general interest pertaining to implantable pumping or infusing 3ystems ar- 4,560,375, 4,258,711, 3,769,982, 3,827,439, 4,013,074, 4,265,241, 4,360,019, 4,487,603, 4,496,343, 4,511,355, 4,604,090, and 4,627,832. Reference may also be had to United States Statutory Invention Regi~tration H150.
Summary of the Invention Despite the attention that has been directed in recent year~ to the development of lmplantable drug delivery ~ystem~, prior devices have often been deficient in significant respects. The recognition of such deficiencies i9 considered to be one of the important aspects of this invention, along with the discovery and development of the mean- for overcoming those shortcomings. Unlike many of , .
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the prior devices, the fluid delivery device of this invention is formed of soft and deformable (preferably elastomeric) material capable of being worn comfortably and effectively in implanted condition over an extended period. In spite of its compliant outer casing, the device has a relatively rigid internal structure that serves to support various operative elements, such support also performing the functions of distributing pumping forces produced by finger pressure and protecting the casing (a~ well as interior elements) against damage and possible leakage during refilling operations.
The compactne~s of the dev~ce and it3 ease of operation result partly from the fact that lts top wall has a central target zone that may be easily located by touch ~even when the device is implanted) and that serves as both the pump-actuating site against which finger pressure is exerted when drug delivery i~ needed and as the site for medicament injection when refilling of the reservoir is required.
Enhanced self-sealing properties of the top wall and its underlying structure, coupled with a relatively rigid protective shield interpo~ed between the top wall and the pu~p a4sembly, helps insure that the device may be easily refilled without ri~k of internal damage or leakage.
Even though the soft, resilient casing of the device yleld~ or deforms wlth body movements and in response to both internally and externally applled forces, fluid pressure equalization within the device insure~ that pump activation and drug delivery do not occur unle~ directed and localized orce i8 applied speclfically to the target zone -- a force that can be expected to be applied only lntentlonally.
In brie~, the implantable ~luid dellvery device includes a casing formed of soft, deformable polymeric material, ` - 1327~6 preferably elastomeric material, having top and bottom walls defining a fluid reservoir therebetween. A rigid support plate i~ disposed within the ca~ing and divides the reservoir into upper and lower chambers that communicate with each other through an opening in the plate. Compressible pumping means is mounted upon the plate within the upper chamber and includes a deformable pump housing that defines a pump cavity or chamber with a first passage connecting that cavity with the lower chamber of the reservoir. A second passage connects the same cavity with the outlet port of the device, and inlet and outlet check valves ~re positioned to control flow through tho respective passages.
The top wall of the casing includes a flexible pump-actuating zone. Connecting mean~ in the form of a self-~ealing septum combined with a rigid cover plate operatively connect the top wall' 8 pump actuating zone with the pump housing. The ~elf-sealing properties of the piercable soptum are enhanced by a construction that maintains that septum in a partially-compressed state. Although the ca~lng and many of the component~ contained within it are readlly deformabl-, being formed of silicone rubber or other ~uitable material, and although build up of fluid pressure due to unexpected compressive loads on the device is possible, pressur- equalization within the reservoir, on opposite sides of element~ such as the deformable pump housing and the check valve for th- s-cond passage, lnsure that deformation of the casing will not result in fluid delivery unless such deforma-tion specifically include~ depres~ion of the target zone of the top wall in the direction of the compre~sible pump.
A porou~ metal filter is mounted upon the support plate at the entry to the first pas~age leading from the .. . . - ~
1~27926 reservoir to the pump cavity. In addition to filtering fluid, the filter also performs a rate controlling function and therefore prevents surges of fluid, produced by compressive deformation of the device's deformable casing, that might otherwise cause damage to the pump assembly. Channel-defining ribs within the reservoir also function to equalize pressure within that reservoir and prevent obstructive contact with the rigid filter that might block fluid flow to the pump cavity.
Another aspect of this invention is as follows:
An implantable, patient-activated device for dispensing metered amounts of fluid to a patient, comprising a casing formed of soft, deformable polymeric material having a top wall and a bottom wall defining a fluid reservoir with an outlet port; a rigid support plate within said casing dividing said reservoir into upper and lower chambers and having an opening therethrough placing said chambers in communication with each other; pumping means mounted upon said plate within said upper chamber and comprising a compressible pump housing defining a pump cavity; first passage-providing means defining an inlet passage extending from said lower chamber to said cavity; inlet check valve means along said inlet passage; second passage-providing means defining an outlet passage extending from said cavity to said outlet port; outlet check valve means along said outlet passage; said top wall having a flexible pump-actuating zone; and connecting means within said upper chamber connecting said pump-actuating zone and said pump housing 80 that when said pump-actuating zone is depressed said pump hou3ing is compressed to discharge from said outlet port an amount of fluid substantially equal to the volume of said pump cavity.
Other features, object~, and advantages will become apparent from the ~pecification and drawings.
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4a Drawings Figure 1 is a perspective view of an implantable fluid delivery device embodying this invention.
Figure 2 is a top plan view.
Figure 3 is an enlarged longitudinal vertical sectional view of the device.
Figure 4 is a still further enlarged vertical longitudinal sectional view showing the filling port, needle guard, and pump assembly.
Figure 5 is a fraqmentary sectional view similar to Figure 4 but illustrating the condition of the device during a pumping step.
Figure 6 is a similar fragmentary sectional view showing the parts during a recovery step in which the pump cavity is being refilled.
Figure 7 is a transverse sectional view taken along line 7-7 of Figure 3.
Figure 8 is an exploded sectional view illustrating the deformable septum and associated parts prior to assembly.
Figure 9 is a sectional view illustrating the parts of Figure 8 in partially assembled condition.
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132792~
Detailed Description of Preferred Embodiment Referring to the drawings, and particularly to Figure3 1-3, the numeral 10 generally designate~ an implantable delivery device having a casing 11 formed of soft, deformable polymeric material. While various materials having such properties might be used, an ela~tomeric material such a~ silicone rubber has been found particularly effective because of its deformability, recoverability, durability, and biocompatability. Viewed generally, the casing includes preformed (molded) upper and lower walls 12 and 13 that are 3ealed together along a horizontal midline 14. To facilitate manufacture, the upper wall 12 may be formed in two or more sections that allow the prefabrication of subassemblies. Thu~, in the illustration given, upper wall 12 include~ main section 12a, central section 12b, and inner section 12c. The central and inner sections together define an upper chamber 15, wherea~ the bottom wall defineD a lower chamber 16. The two chamber~ communicate and together define an enlarged reservoir 17.
A relatlvely rigid support plate 18 i~ interposed between the upper and lower chambers of the reservoir and, a~ ~hown most clearly in Figures 3 and 7, extends ~ub-stantlally the full width and length of the casing. The plate i~ ~andwiched between the upper and lower wall~ 12 and 13 and, if deJired, may be provided wlth an outer layer 18a of ~lllcone rubber or other sultable materlal to enhanc- biocompatability and facilitate adhesive attachment of th part~. The core 18b of the support plate may be formed o~ any tough and rigid materlal, lncludlng metallic -~` 13~79~
and ceramlc materials, although a polymeric material such as polycarbonate is believed particularly suitable.
Opening 19 through the support plate 18 places the upper and lower chambers 15, 16 of the reservoir in communication with each other. In use of the device, at lea~t the lower chamber of the reservoir would contain a liquid medicament to be discharged in metered amount~ upon actuation of the device; however, for clarity of illustration such fluid is not depicted in the drawings.
The pumping means for the device is located in the upper chamber 15 of the reservoir and i~ supported upon plate 18. The pumping means includes a dome-sh~ped pump housing 20 formed of silicone rubber or other suitable elastomeric material. The rim 21 of the pu~p housing is secured within an annular channel 22 provided in the upper surface of inner wall section 12c, and a downwardly-pro~ecting stem portion 23 of that wall ~ection projects through an opening 24 in the rigid support plate. Inlet flow passage 25 extends through the stem portion 23 and place~ the pump chamber or cavity 26 in communication with the lower chamber 16 of the re~ervoir. An annular valve seat 27 is provided at the upper end of passage 25 and i~
normally engaged by a dish-shaped elastomeric membrane valve member 28 that ha~ its circular outer peripheral portion secured to wall section 12c. Like other components of the drug delivery device, the membrane valve member 27 may be formed of ~ilicone rubber. A~ shown most clearly in Figures 4-6, the valve member is provided with openings 29 therethrough that are located outboard of valve seat 27 and that there~ore allow flow of fluid between passage 25 and pump chamber 26 only when the valve member 28 is urged away from valve ~eat 27.
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Directly below the pump, and mounted along the underqide of the support plate 18, is a rigid filter member or disc The disc may be formed of sintered metal or a fine metallic mesh and is secured in place by an annular rim 31 adhesively bonded to the underside of the support plate 18 about the entrance to inlet passage 25 Directly below the filter disc 30, the surface of the bottom wall of the casing is provided with parallel ribsl3a that prevent the bottom wall from blocking fluid flow from lower chamber 16 into filter 30 and inlet passage 25 should the bottom wall be flexed upwardly into contact with the filter (Figure 7) A second passage 32 also communicates with the chamber 26 of the pump and leads radially away from the pump through the inner section 12c of the top wall The second passage 32 is parallel and in close proximity to rigid support plate 18 and communicates at its opposite end with a valve opening 33 defined by an annular flexible lip 34 that is preferably formed integrally with section 12c of the top wall The lip defines a valvo eat and the opening 33 is normally closed by a cup-~haped ela~tomeric valve member 35 mounted within cylindrical chamber 36~ In its normal undeformed state, valve m mber 35 engages lip 34 to maintain the valve in closed condltions however, aJ shown in Figure 5, the valve membor i~ capable of belng deformed upwardly into unseated condition to allow fluid flow from secondary passage 32 and oponing 33 lnto chamber 36 and then into outlot passage 37 Th- outlet pa-~age leads to outlet port 38 which in turn communlcate~ wlth the lumen o~ a catheter 39 A tapered ferrule or connector 40 18 secured to the caQing 11 and support~ the catheter at its polnt of exit from the casing ' All of the elements so far described, except for filter disc 30 and the core 18b of support plate 18, are composed of soft, deformable material. Sil$cone rubber of the same formulation or different formulations may be used for all of such resilient elements which, A already indicated, are secured together by any suitable adhe~ive to provide the assembly illustrated in the drawings.
The dome-shaped pump hou~ing 20 has an upstanding stem portion 41 that is anchored to a rigid disc 43 formed o polycarbonate or any other suitable mzterial having sufflcient strength, hardne~, and rigidity to resist needle penetration. In the illustration given, the di~c 43 iB formed in two ~ections 43a and 43b to facilitate assembly, or subassembly, with pu~p housing 20t however, it i~ to be under~tood that if desired the rigid disc 43 may instead be formed in one piece.
The disc 43 is surrounded by an annular plate 44 that i8 also formed of rigid material, preferably the same material ~g dLsc 43. The periphery of the annular plate is loc~ed in place botween the contral Qection 12b and the inner section 12c of upper wall 12. As shown in Pigure~
3 and 4, the opposing edges or side ~urfaces of the disc 43 and annular plate 44 are spaced apart to provide flow pa~sages 45 that maintain tho portions of the upper chamber abovo and bolow the disc and annular plate in pressure-oqualizing flow relation. A rim 46 of the disc 43 pro~ect~
outwardly and is engagable with the annular plate 44 to limit the extent of upward movement of the disc and, if de-lred, tho rim may bo serrated or discontinuous to insure that pas~age~ 45 remain open at all times.
Abovo disc 43 is an inverted cup-shaped septum 47 havlng an apertured ~ide wall 48 and, when fully assembled, - 13279~
g a planar end wall 49. The lower periphery of the side wall 48 is secured within an annular channel provided in rigid disc 43. The septum is formed of an elactomer such as silicone rubber and i~ secured to the undersids of the central section 12b of the ca~ing's top wall 12 by means of an adhesive attachment layer 50.
of particular importance is the fact th~t end wall 49 of the ela~tomeric septum i~ spaced weli above disc 43 to define a medicament-receiving chamber 51. Also, while shown in the as~embly drawings to be of generally planar configuration ~except for locating protuberance 52), the end wall in an untensioned state is dome ~haped. As shown in Figure 8, in the absence of distorting forces the convex end wall 49 curves upwardly and inwardly so that when flattened and adhesively secured to the planar under~urface of the casing's top wall section 12b, the end wall 49 will have its upper surface portion in a compre~sed state and will be maintained in that compressed state by adhesive layer or pad 50. It has been found that ~uch limited compression of the upper Jtratum of nd wall 49 greatly enhancos the self-sealing propertie~ of the septum upon withdrawal of an in~ection needle.
Ideally, the upper ~urface of the central section 12b of casing's top wall 12 is provided with an indentation 54 of circular outline. The indentatlon identifies the target site for both pump actuation and fluid in~ection and helps a user locate such site by touch even when the fluid dellvery device is implanted. When fluid i~ to be supplied to the r-servoir, the needle 55 of a syringe is simply inserted into the casing through the indented zone o~ the top wall until the tip of tho noedlo ongages rigid disc 43 within medicament-receiving chamb-r 51 -` 1327~
1~
(Figure 4). DiYcharge of fluid from the syringe flows outwardly through openings 56 in the side wall of septum 47. Since the upper and lower chzmbers of the reservoir are in communication, ~uch fluid enters the 3pace above the dome-shaped pump housing 20 and above outlet valve member 35, and is free to pas~ into the lower chamber through opening 19. Upon re~oval of needle 55, the compressed end wall 49 of the septum 47 then closes and reseals the reservoir.
~ he same target zone, as defined by indentation 54, is used for fingor actuation of the pu~p mechanism.
Depression of the top wall 12 in the area of indentation 54, as depicted in Figure 5, drive~ the septum 47 and rigid di~c 43 downwardly, deforming pump housing 20 and substantially exhausting pump cavity 26. Fluid in the pump cavity is driven outwardly into second passage 32 with the pressurQ increase beneath outlet valve 35 causing the outlet valve to flex upwardly into open position. An aliquot oi' fluid substantially equal to the volume of pump chamber or cavity 26 (when the pump housing is undeformed) is therefore dlscharged into the outlet pas~ag- 37 and through outlet port 38. When fingor pressure is removed, the top wall returns to its original positlon largely because Or the recovery forces exerted by the dome-shaped pump housing 20 and the flexible top wall portion 12b. As the pump cavity 26 expands, the pres3ur- differential causes the membrane valv- member 28 to lift away from its seat 27, allowing fluid from the lower chamber 16 Or the reservoir to enter the pump cavity 26 through the first passage 25 and opening- 29 in the membrane ~Figuro 6). Once the pump cavity ls filled ~n~ pressure is equalized, th- inlet valvo member 28 clo~o~ and the parts again assume the relation~hips depicted in Figures 3 and 4.
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Since the upper and lower chamber~ of the reservoir are in open commun$cation at all time , deformations of the re il~ent casing 11 produced by body movement or other causes do not result in unintentional delivery of medicament to the pat~ent. For example, should patient movement cause compression of the device and sub~equent upward flexure of bottom wall 13 from the po~ition shown in Figure 4, Çluid displaced from lower chamber 16 19 free to enter the upper ohamber of tho reservoir, including the area directly above outlet valve m~mher 35. The outlet valve will therefore remain closed despite the deformation of the caslng because pressure will be equal on both side~ of outlet valve 35.
The double-headed arrows in Figure 4 are intended to indicate the reversiblllty of movement of fluid throughout the upper and lower chamber~ of the reservolr that results ln pressure equallzatlon.
Whlle ln the foregoing, an embodlment of the lnvention ha~ been disclo-ed ln considerable detall for purposes of llluJtratlon, it will be under~tood by those skllled ln the art that many o~ these details may be varied without departlng from the splrit and w ope of the invention.
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FLUID DELIYERY DEVICE
Background of the Invention Various implantable devices have been d~sclosed in the prior ast that may be activated by ambulatory patients when the administration of measured doses of therapeutic agents is required. For example, cancer patients suffering from terminal lower torso cancer may require routine injections of moxphine, either epidurally or intrathecally, and~ upon receiv~ng such injections, are sufficiently relieved of the symptoms of pain to move about and perform m~ny routine and normal functions. Other chronic ailments also reguire frequent dosage~ of therapeutic agents in the treatment of chronic conditions, such as in~ulin in the case of diabete3. Implantable devices capable of delivering measured amounts of medicament on demand are disclosed in United States patents 4,634,427, 4,548,607, 4,588,394, 4,557,722, 4,544,371, and 4,543,088. Other United States patent~ of general interest pertaining to implantable pumping or infusing 3ystems ar- 4,560,375, 4,258,711, 3,769,982, 3,827,439, 4,013,074, 4,265,241, 4,360,019, 4,487,603, 4,496,343, 4,511,355, 4,604,090, and 4,627,832. Reference may also be had to United States Statutory Invention Regi~tration H150.
Summary of the Invention Despite the attention that has been directed in recent year~ to the development of lmplantable drug delivery ~ystem~, prior devices have often been deficient in significant respects. The recognition of such deficiencies i9 considered to be one of the important aspects of this invention, along with the discovery and development of the mean- for overcoming those shortcomings. Unlike many of , .
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- : . :
; . , ` -i 1327~2~
the prior devices, the fluid delivery device of this invention is formed of soft and deformable (preferably elastomeric) material capable of being worn comfortably and effectively in implanted condition over an extended period. In spite of its compliant outer casing, the device has a relatively rigid internal structure that serves to support various operative elements, such support also performing the functions of distributing pumping forces produced by finger pressure and protecting the casing (a~ well as interior elements) against damage and possible leakage during refilling operations.
The compactne~s of the dev~ce and it3 ease of operation result partly from the fact that lts top wall has a central target zone that may be easily located by touch ~even when the device is implanted) and that serves as both the pump-actuating site against which finger pressure is exerted when drug delivery i~ needed and as the site for medicament injection when refilling of the reservoir is required.
Enhanced self-sealing properties of the top wall and its underlying structure, coupled with a relatively rigid protective shield interpo~ed between the top wall and the pu~p a4sembly, helps insure that the device may be easily refilled without ri~k of internal damage or leakage.
Even though the soft, resilient casing of the device yleld~ or deforms wlth body movements and in response to both internally and externally applled forces, fluid pressure equalization within the device insure~ that pump activation and drug delivery do not occur unle~ directed and localized orce i8 applied speclfically to the target zone -- a force that can be expected to be applied only lntentlonally.
In brie~, the implantable ~luid dellvery device includes a casing formed of soft, deformable polymeric material, ` - 1327~6 preferably elastomeric material, having top and bottom walls defining a fluid reservoir therebetween. A rigid support plate i~ disposed within the ca~ing and divides the reservoir into upper and lower chambers that communicate with each other through an opening in the plate. Compressible pumping means is mounted upon the plate within the upper chamber and includes a deformable pump housing that defines a pump cavity or chamber with a first passage connecting that cavity with the lower chamber of the reservoir. A second passage connects the same cavity with the outlet port of the device, and inlet and outlet check valves ~re positioned to control flow through tho respective passages.
The top wall of the casing includes a flexible pump-actuating zone. Connecting mean~ in the form of a self-~ealing septum combined with a rigid cover plate operatively connect the top wall' 8 pump actuating zone with the pump housing. The ~elf-sealing properties of the piercable soptum are enhanced by a construction that maintains that septum in a partially-compressed state. Although the ca~lng and many of the component~ contained within it are readlly deformabl-, being formed of silicone rubber or other ~uitable material, and although build up of fluid pressure due to unexpected compressive loads on the device is possible, pressur- equalization within the reservoir, on opposite sides of element~ such as the deformable pump housing and the check valve for th- s-cond passage, lnsure that deformation of the casing will not result in fluid delivery unless such deforma-tion specifically include~ depres~ion of the target zone of the top wall in the direction of the compre~sible pump.
A porou~ metal filter is mounted upon the support plate at the entry to the first pas~age leading from the .. . . - ~
1~27926 reservoir to the pump cavity. In addition to filtering fluid, the filter also performs a rate controlling function and therefore prevents surges of fluid, produced by compressive deformation of the device's deformable casing, that might otherwise cause damage to the pump assembly. Channel-defining ribs within the reservoir also function to equalize pressure within that reservoir and prevent obstructive contact with the rigid filter that might block fluid flow to the pump cavity.
Another aspect of this invention is as follows:
An implantable, patient-activated device for dispensing metered amounts of fluid to a patient, comprising a casing formed of soft, deformable polymeric material having a top wall and a bottom wall defining a fluid reservoir with an outlet port; a rigid support plate within said casing dividing said reservoir into upper and lower chambers and having an opening therethrough placing said chambers in communication with each other; pumping means mounted upon said plate within said upper chamber and comprising a compressible pump housing defining a pump cavity; first passage-providing means defining an inlet passage extending from said lower chamber to said cavity; inlet check valve means along said inlet passage; second passage-providing means defining an outlet passage extending from said cavity to said outlet port; outlet check valve means along said outlet passage; said top wall having a flexible pump-actuating zone; and connecting means within said upper chamber connecting said pump-actuating zone and said pump housing 80 that when said pump-actuating zone is depressed said pump hou3ing is compressed to discharge from said outlet port an amount of fluid substantially equal to the volume of said pump cavity.
Other features, object~, and advantages will become apparent from the ~pecification and drawings.
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4a Drawings Figure 1 is a perspective view of an implantable fluid delivery device embodying this invention.
Figure 2 is a top plan view.
Figure 3 is an enlarged longitudinal vertical sectional view of the device.
Figure 4 is a still further enlarged vertical longitudinal sectional view showing the filling port, needle guard, and pump assembly.
Figure 5 is a fraqmentary sectional view similar to Figure 4 but illustrating the condition of the device during a pumping step.
Figure 6 is a similar fragmentary sectional view showing the parts during a recovery step in which the pump cavity is being refilled.
Figure 7 is a transverse sectional view taken along line 7-7 of Figure 3.
Figure 8 is an exploded sectional view illustrating the deformable septum and associated parts prior to assembly.
Figure 9 is a sectional view illustrating the parts of Figure 8 in partially assembled condition.
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132792~
Detailed Description of Preferred Embodiment Referring to the drawings, and particularly to Figure3 1-3, the numeral 10 generally designate~ an implantable delivery device having a casing 11 formed of soft, deformable polymeric material. While various materials having such properties might be used, an ela~tomeric material such a~ silicone rubber has been found particularly effective because of its deformability, recoverability, durability, and biocompatability. Viewed generally, the casing includes preformed (molded) upper and lower walls 12 and 13 that are 3ealed together along a horizontal midline 14. To facilitate manufacture, the upper wall 12 may be formed in two or more sections that allow the prefabrication of subassemblies. Thu~, in the illustration given, upper wall 12 include~ main section 12a, central section 12b, and inner section 12c. The central and inner sections together define an upper chamber 15, wherea~ the bottom wall defineD a lower chamber 16. The two chamber~ communicate and together define an enlarged reservoir 17.
A relatlvely rigid support plate 18 i~ interposed between the upper and lower chambers of the reservoir and, a~ ~hown most clearly in Figures 3 and 7, extends ~ub-stantlally the full width and length of the casing. The plate i~ ~andwiched between the upper and lower wall~ 12 and 13 and, if deJired, may be provided wlth an outer layer 18a of ~lllcone rubber or other sultable materlal to enhanc- biocompatability and facilitate adhesive attachment of th part~. The core 18b of the support plate may be formed o~ any tough and rigid materlal, lncludlng metallic -~` 13~79~
and ceramlc materials, although a polymeric material such as polycarbonate is believed particularly suitable.
Opening 19 through the support plate 18 places the upper and lower chambers 15, 16 of the reservoir in communication with each other. In use of the device, at lea~t the lower chamber of the reservoir would contain a liquid medicament to be discharged in metered amount~ upon actuation of the device; however, for clarity of illustration such fluid is not depicted in the drawings.
The pumping means for the device is located in the upper chamber 15 of the reservoir and i~ supported upon plate 18. The pumping means includes a dome-sh~ped pump housing 20 formed of silicone rubber or other suitable elastomeric material. The rim 21 of the pu~p housing is secured within an annular channel 22 provided in the upper surface of inner wall section 12c, and a downwardly-pro~ecting stem portion 23 of that wall ~ection projects through an opening 24 in the rigid support plate. Inlet flow passage 25 extends through the stem portion 23 and place~ the pump chamber or cavity 26 in communication with the lower chamber 16 of the re~ervoir. An annular valve seat 27 is provided at the upper end of passage 25 and i~
normally engaged by a dish-shaped elastomeric membrane valve member 28 that ha~ its circular outer peripheral portion secured to wall section 12c. Like other components of the drug delivery device, the membrane valve member 27 may be formed of ~ilicone rubber. A~ shown most clearly in Figures 4-6, the valve member is provided with openings 29 therethrough that are located outboard of valve seat 27 and that there~ore allow flow of fluid between passage 25 and pump chamber 26 only when the valve member 28 is urged away from valve ~eat 27.
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.
1327~
Directly below the pump, and mounted along the underqide of the support plate 18, is a rigid filter member or disc The disc may be formed of sintered metal or a fine metallic mesh and is secured in place by an annular rim 31 adhesively bonded to the underside of the support plate 18 about the entrance to inlet passage 25 Directly below the filter disc 30, the surface of the bottom wall of the casing is provided with parallel ribsl3a that prevent the bottom wall from blocking fluid flow from lower chamber 16 into filter 30 and inlet passage 25 should the bottom wall be flexed upwardly into contact with the filter (Figure 7) A second passage 32 also communicates with the chamber 26 of the pump and leads radially away from the pump through the inner section 12c of the top wall The second passage 32 is parallel and in close proximity to rigid support plate 18 and communicates at its opposite end with a valve opening 33 defined by an annular flexible lip 34 that is preferably formed integrally with section 12c of the top wall The lip defines a valvo eat and the opening 33 is normally closed by a cup-~haped ela~tomeric valve member 35 mounted within cylindrical chamber 36~ In its normal undeformed state, valve m mber 35 engages lip 34 to maintain the valve in closed condltions however, aJ shown in Figure 5, the valve membor i~ capable of belng deformed upwardly into unseated condition to allow fluid flow from secondary passage 32 and oponing 33 lnto chamber 36 and then into outlot passage 37 Th- outlet pa-~age leads to outlet port 38 which in turn communlcate~ wlth the lumen o~ a catheter 39 A tapered ferrule or connector 40 18 secured to the caQing 11 and support~ the catheter at its polnt of exit from the casing ' All of the elements so far described, except for filter disc 30 and the core 18b of support plate 18, are composed of soft, deformable material. Sil$cone rubber of the same formulation or different formulations may be used for all of such resilient elements which, A already indicated, are secured together by any suitable adhe~ive to provide the assembly illustrated in the drawings.
The dome-shaped pump hou~ing 20 has an upstanding stem portion 41 that is anchored to a rigid disc 43 formed o polycarbonate or any other suitable mzterial having sufflcient strength, hardne~, and rigidity to resist needle penetration. In the illustration given, the di~c 43 iB formed in two ~ections 43a and 43b to facilitate assembly, or subassembly, with pu~p housing 20t however, it i~ to be under~tood that if desired the rigid disc 43 may instead be formed in one piece.
The disc 43 is surrounded by an annular plate 44 that i8 also formed of rigid material, preferably the same material ~g dLsc 43. The periphery of the annular plate is loc~ed in place botween the contral Qection 12b and the inner section 12c of upper wall 12. As shown in Pigure~
3 and 4, the opposing edges or side ~urfaces of the disc 43 and annular plate 44 are spaced apart to provide flow pa~sages 45 that maintain tho portions of the upper chamber abovo and bolow the disc and annular plate in pressure-oqualizing flow relation. A rim 46 of the disc 43 pro~ect~
outwardly and is engagable with the annular plate 44 to limit the extent of upward movement of the disc and, if de-lred, tho rim may bo serrated or discontinuous to insure that pas~age~ 45 remain open at all times.
Abovo disc 43 is an inverted cup-shaped septum 47 havlng an apertured ~ide wall 48 and, when fully assembled, - 13279~
g a planar end wall 49. The lower periphery of the side wall 48 is secured within an annular channel provided in rigid disc 43. The septum is formed of an elactomer such as silicone rubber and i~ secured to the undersids of the central section 12b of the ca~ing's top wall 12 by means of an adhesive attachment layer 50.
of particular importance is the fact th~t end wall 49 of the ela~tomeric septum i~ spaced weli above disc 43 to define a medicament-receiving chamber 51. Also, while shown in the as~embly drawings to be of generally planar configuration ~except for locating protuberance 52), the end wall in an untensioned state is dome ~haped. As shown in Figure 8, in the absence of distorting forces the convex end wall 49 curves upwardly and inwardly so that when flattened and adhesively secured to the planar under~urface of the casing's top wall section 12b, the end wall 49 will have its upper surface portion in a compre~sed state and will be maintained in that compressed state by adhesive layer or pad 50. It has been found that ~uch limited compression of the upper Jtratum of nd wall 49 greatly enhancos the self-sealing propertie~ of the septum upon withdrawal of an in~ection needle.
Ideally, the upper ~urface of the central section 12b of casing's top wall 12 is provided with an indentation 54 of circular outline. The indentatlon identifies the target site for both pump actuation and fluid in~ection and helps a user locate such site by touch even when the fluid dellvery device is implanted. When fluid i~ to be supplied to the r-servoir, the needle 55 of a syringe is simply inserted into the casing through the indented zone o~ the top wall until the tip of tho noedlo ongages rigid disc 43 within medicament-receiving chamb-r 51 -` 1327~
1~
(Figure 4). DiYcharge of fluid from the syringe flows outwardly through openings 56 in the side wall of septum 47. Since the upper and lower chzmbers of the reservoir are in communication, ~uch fluid enters the 3pace above the dome-shaped pump housing 20 and above outlet valve member 35, and is free to pas~ into the lower chamber through opening 19. Upon re~oval of needle 55, the compressed end wall 49 of the septum 47 then closes and reseals the reservoir.
~ he same target zone, as defined by indentation 54, is used for fingor actuation of the pu~p mechanism.
Depression of the top wall 12 in the area of indentation 54, as depicted in Figure 5, drive~ the septum 47 and rigid di~c 43 downwardly, deforming pump housing 20 and substantially exhausting pump cavity 26. Fluid in the pump cavity is driven outwardly into second passage 32 with the pressurQ increase beneath outlet valve 35 causing the outlet valve to flex upwardly into open position. An aliquot oi' fluid substantially equal to the volume of pump chamber or cavity 26 (when the pump housing is undeformed) is therefore dlscharged into the outlet pas~ag- 37 and through outlet port 38. When fingor pressure is removed, the top wall returns to its original positlon largely because Or the recovery forces exerted by the dome-shaped pump housing 20 and the flexible top wall portion 12b. As the pump cavity 26 expands, the pres3ur- differential causes the membrane valv- member 28 to lift away from its seat 27, allowing fluid from the lower chamber 16 Or the reservoir to enter the pump cavity 26 through the first passage 25 and opening- 29 in the membrane ~Figuro 6). Once the pump cavity ls filled ~n~ pressure is equalized, th- inlet valvo member 28 clo~o~ and the parts again assume the relation~hips depicted in Figures 3 and 4.
, : " . . . . . .: . -, 1327~2~
Since the upper and lower chamber~ of the reservoir are in open commun$cation at all time , deformations of the re il~ent casing 11 produced by body movement or other causes do not result in unintentional delivery of medicament to the pat~ent. For example, should patient movement cause compression of the device and sub~equent upward flexure of bottom wall 13 from the po~ition shown in Figure 4, Çluid displaced from lower chamber 16 19 free to enter the upper ohamber of tho reservoir, including the area directly above outlet valve m~mher 35. The outlet valve will therefore remain closed despite the deformation of the caslng because pressure will be equal on both side~ of outlet valve 35.
The double-headed arrows in Figure 4 are intended to indicate the reversiblllty of movement of fluid throughout the upper and lower chamber~ of the reservolr that results ln pressure equallzatlon.
Whlle ln the foregoing, an embodlment of the lnvention ha~ been disclo-ed ln considerable detall for purposes of llluJtratlon, it will be under~tood by those skllled ln the art that many o~ these details may be varied without departlng from the splrit and w ope of the invention.
, - .
Claims (17)
1. An implantable, patient-activated device for dispensing metered amounts of fluid to a patient, comprising a casing formed of soft, deformable polymeric material having a top wall and a bottom wall defining a fluid reservoir with an outlet port; a rigid support plate within said casing dividing said reservoir into upper and lower chambers and having an opening therethrough placing said chamber in communication with each other; pumping means mounted upon said plate within said upper chamber and comprising a compressible pump housing defining a pump cavity; first passage-providing means defining an inlet passage extending from said lower chamber to said cavity;
inlet check valve means along said inlet passage; second passage-providing means defining an outlet passage extending from said cavity to said outlet port; outlet check valve means along said outlet passage; said top wall having a flexible pump-actuating zone; and connecting mean-R within said upper chamber connecting said pump-actuating zone and said pump housing so that when said pump-actuating zone is depressed said pump housing is compressed to discharge from said outlet port an amount of fluid substantially equal to the volume of said pump cavity.
inlet check valve means along said inlet passage; second passage-providing means defining an outlet passage extending from said cavity to said outlet port; outlet check valve means along said outlet passage; said top wall having a flexible pump-actuating zone; and connecting mean-R within said upper chamber connecting said pump-actuating zone and said pump housing so that when said pump-actuating zone is depressed said pump housing is compressed to discharge from said outlet port an amount of fluid substantially equal to the volume of said pump cavity.
2. The device of Claim 1 in which said pump-actuating zone of said top wall is piercable by an injection needle and said pump-actuating zone also functions as a target zone for the injection of fluid into said reservoir; and barrier means within said upper chamber for shielding said pump housing against contact by an injection needle inserted through said target zone.
3. The device of Claim 2 in which said barrier means includes a rigid, needle-impenetrable disc connected to and extending over said pump housing.
4. The device of Claim 3 in which said barrier means also includes a rigid, needle-impenetrable plate supported by said top wall within said upper chamber and extending about said disc when said pump housing is uncompressed.
5. The device of Claim 3 in which said connecting means includes a needle-penetrable self-sealing pump septum between said pump-actuating zone of said top wall and said disc.
6. The device of Claim S in which said pump septum is of inverted cup-shaped configuration having an apertured side wall and an end wall; said end wall being secured to said top wall in a state of radial compression.
7. The device of Claim 6 in which said end wall is maintained by said top wall in substantially planar condition but is dome-shaped in configuration in an uncompressed state.
8. The device of Claim 7 wherein an adhesive layer adhesively secures said end wall and said top wall together.
9. The device of Claim 1 in which said top wall has an outer surface provided with an indentation indicating the location of said pump-actuating zone.
10. The device of Claim 1 in which said rigid support plate extends substantially the entire length and width of said casing.
11. The device of Claim 1 in which said first passage-providing means defines an entrance to said inlet passage in said lower chamber; and a rigid, porous filter member disposed within said lower chamber at said entrance to said inlet passage.
12. The device of Claim 11 in which said rigid filter member is secured to said rigid support plate.
13. The device of Claim 1 in which said outlet check valve means is supported by said support plate in laterally-spaced relation with respect to said pump housing.
14. The device of Claim 13 in which said outlet check valve means is disposed in said upper chamber of said reservoir.
15. The device of Claim 13 in which said outlet check valve means includes an annular valve seat defining a valve opening and a flexible membrane valve member engagable with said seat; said membrane valve member having one surface exposed to fluid pressure within said outlet passage and an opposite surface exposed to fluid pressure within said reservoir, assuring pressure equilibrium when said pumping means is not activated.
16. The device of Claim 1 in which said deformable polymeric material is elastomeric.
17. The device of Claim 16 in which said polymeric material is silicone rubber.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US195,702 | 1988-05-18 | ||
US07/195,702 US4898584A (en) | 1988-05-18 | 1988-05-18 | Implantable patient-activated fluid delivery device |
Publications (1)
Publication Number | Publication Date |
---|---|
CA1327926C true CA1327926C (en) | 1994-03-22 |
Family
ID=22722427
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA000599752A Expired - Fee Related CA1327926C (en) | 1988-05-18 | 1989-05-16 | Implantable patient-activated fluid delivery device |
Country Status (4)
Country | Link |
---|---|
US (1) | US4898584A (en) |
EP (1) | EP0342946A3 (en) |
JP (1) | JPH0219171A (en) |
CA (1) | CA1327926C (en) |
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US5728061A (en) * | 1988-10-07 | 1998-03-17 | Ahmed; Abdul Mateen | Device and method for treating hydrocephalus |
US5011477A (en) * | 1989-04-21 | 1991-04-30 | Baxter International Inc. | Continuous/bolus infusor |
US5232448A (en) * | 1989-12-05 | 1993-08-03 | Prime Medical Products | Patient-controlled analgesia device |
US5152753A (en) * | 1990-04-02 | 1992-10-06 | Pudenz-Schulte Medical Research Corporation | Medication infusion device with dose recharge restriction |
US5085644A (en) * | 1990-04-02 | 1992-02-04 | Pudenz-Schulte Medical Research Corporation | Sterilizable medication infusion device with dose recharge restriction |
JPH0613736Y2 (en) * | 1991-05-15 | 1994-04-13 | ダウ コーニング アジア株式会社 | Hydrocephalus shunt device |
US5612472A (en) * | 1992-01-09 | 1997-03-18 | Sandoz Ltd. | Plant promoter |
US5306257A (en) * | 1992-05-04 | 1994-04-26 | Prime Medical Products, Inc. | Drug infuser |
US5344292A (en) * | 1992-08-20 | 1994-09-06 | Ryder International Corporation | Fluid pumping system and apparatus |
US5476368A (en) * | 1992-08-20 | 1995-12-19 | Ryder International Corporation | Sterile fluid pump diaphragm construction |
US5342313A (en) * | 1992-11-02 | 1994-08-30 | Infusion Technologies Corporation | Fluid pump for a flexible, variable geometry reservoir |
US5232439A (en) * | 1992-11-02 | 1993-08-03 | Infusion Technologies Corporation | Method for pumping fluid from a flexible, variable geometry reservoir |
ATE210474T1 (en) * | 1993-08-11 | 2001-12-15 | Thomas John Berrigan | IMPLANTABLE DRUG DELIVERY DEVICE |
DE4402380A1 (en) * | 1994-01-27 | 1995-08-03 | Hans Peter Prof Dr Med Zenner | Implantable dosing system |
AU727879B2 (en) * | 1996-10-09 | 2001-01-04 | Thomas John Berrigan | Drug delivery means |
AUPO295696A0 (en) * | 1996-10-09 | 1996-11-07 | Berrigan, Thomas John | Drug delivery means |
US6193682B1 (en) | 1998-03-16 | 2001-02-27 | Abdul Mateen Ahmed | Low profile neonatal hydrocephalus device and methods |
US5906597A (en) * | 1998-06-09 | 1999-05-25 | I-Flow Corporation | Patient-controlled drug administration device |
US20050131325A1 (en) * | 2003-12-16 | 2005-06-16 | How-Lun Chen | Flexible injection port |
US20050131383A1 (en) * | 2003-12-16 | 2005-06-16 | How-Lun Chen | Method for implanting flexible injection port |
US7488311B2 (en) * | 2004-12-23 | 2009-02-10 | Hospira, Inc. | Port closure system for intravenous fluid container |
AU2005322136B2 (en) * | 2004-12-23 | 2011-01-06 | Hospira, Inc. | Port closure system for intravenous fluid container |
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US8591456B2 (en) | 2011-12-28 | 2013-11-26 | Palyon Medical (Bvi) Limited | Multiple reservoir programmable pump |
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EP0168675B1 (en) * | 1984-06-21 | 1990-04-11 | David R. Fischell | Finger actuated medication infusion system |
US4634427A (en) * | 1984-09-04 | 1987-01-06 | American Hospital Supply Company | Implantable demand medication delivery assembly |
US4626244A (en) * | 1985-02-01 | 1986-12-02 | Consolidated Controls Corporation | Implantable medication infusion device |
EP0291509B1 (en) * | 1986-02-03 | 1994-12-14 | University Of Minnesota | Spring driven infusion pump |
-
1988
- 1988-05-18 US US07/195,702 patent/US4898584A/en not_active Expired - Fee Related
-
1989
- 1989-05-16 CA CA000599752A patent/CA1327926C/en not_active Expired - Fee Related
- 1989-05-17 EP EP89304968A patent/EP0342946A3/en not_active Withdrawn
- 1989-05-18 JP JP1125453A patent/JPH0219171A/en active Pending
Also Published As
Publication number | Publication date |
---|---|
JPH0219171A (en) | 1990-01-23 |
EP0342946A3 (en) | 1990-06-13 |
EP0342946A2 (en) | 1989-11-23 |
US4898584A (en) | 1990-02-06 |
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MKLA | Lapsed |