WO2004064637A1

WO2004064637A1 - A lancet holding device

Info

Publication number: WO2004064637A1
Application number: PCT/GB2003/005678
Authority: WO
Inventors: Richard Sammons; David Newman
Original assignee: Epsom & St Helier University Hospitals Nhs Trust; Newman, Jane
Priority date: 2003-01-23
Filing date: 2003-12-29
Publication date: 2004-08-05
Also published as: AU2003290353A8; AU2003290353A1; WO2004064637A8; GB0301587D0

Abstract

A lancet holding device for use in blood sampling, said holding device comprising lancet holding means that are adapted for securely holding a lancing device comprising a needle, and member engaging means that are adapted for removably attaching the holding device to a part of a patient's body; said holding device being configured such that, when attached to a patient's body, the lancet holding means are positioned stably to hold a lancing device juxtaposed said part of the body, with the needle directed towards said part for pricking the part.

Description

A lancet holding device

The present invention relates to a lancet holding device for use in blood sampling, and has particular reference to a lancet holding device for stably holding a lancing device juxtaposed a part of a patient's body - typically a member such as a finger or toe - whilst gently squeezing said part to promote the flow of blood to the surface of part. A lancet holding device in accordance with the present invention may also serve to reduce the pain experienced by a patient when part of his or her body is pricked for the purpose of taking a blood sample.

Lancing devices are widely used for the purpose of taking small samples of capillary blood from a patient's fingertip for analysis. A typical automatic lancing device is disclosed in US-A- 5487748. The automatic lancing device of US-A-5487748 comprises a needle which is mounted for axial reciprocating movement within a casing. A compression spring between the needle and the casing serves to urge the needle axially forwards in the direction of an aperture formed in the casing. The aperture is initially obturated by a cap which serves to prevent the needle from accidentally protruding from the casing. The automatic lancing device is primed by pushing the cap into the casing to urge the needle backwards against the spring. A sear formed on the needle engages with a bent on a trigger member to retain the needle in a retracted position. The cap is then removed, opening the aperture, and the device can be actuated by operating the trigger to disengage the bent from the sear, thereby releasing the needle which is urged axially forwards by the spring. The inertia of the needle causes the tip of the needle to protrude momentarily through the aperture in the casing, and thereafter the needle is retracted by the spring into the casing to its rest position.

By positioning the device such that the aperture is contiguous the skin of a patient's fingertip, the automatic lancing device can be used to prick the patient's finger to allow a small blood sample to be taken.

Many other lancing devices are known in the art, some operating in a manner generally similar to the lancing device of US-A-5487748.

In order to obtain a satisfactory blood sample, it is important that a lancing device is held steadily against the patient's skin during actuation of the needle, so that the needle penetrates into the skin to a depth sufficient to produce an adequate volume of blood. Automatic lancing devices of the kind disclosed by US-A-5487748 are particularly designed for self-use by patient's and it can be difficult for elderly or infirm patient's to hold the device sufficiently steadily during operation.

Additionally, pricking oneself invariably causes a sharp, transient pain, and the anticipation of this pain can cause some patient's to flinch from the automatic lancing device upon actuation of the needle, resulting in inadequate penetration of the needle in to the body. This may be particularly problematic for patient's with varying degrees of needle phobia. The amount of blood obtained by pricking a a part of a patient' s body can be improved if the part is squeezed gently prior to and during pricking. For some patient's, for example, those suffering from diabetes, it is necessary to obtain small blood samples on a regular basis. Experience has shown even for patient's who do not suffer from needle phobia, such patient's may become increasingly reluctant to prick themselves, resulting in difficulties in ensuring patient compliance. There is therefore, in general terms, a need to improve the way in which blood samples are taken by patient's themselves in order to improve patient compliance and to ensure that a satisfactory volume of blood is drawn on each pricking. Furthermore, there is a need to reduce the level of pain experienced by a patient upon pricking his or her self.

Accordingly, an object of the present invention is to provide a device for use in blood sampling which facilitates use of a lancing device by a patient on his or herself. In particular, it is an object of the present invention to provide a device which assists patients, particularly those who are elderly or infirm, in using lancing devices more reliably to ensure that a satisfactory volume of blood is obtained on each occasion.

Another object of the present invention is to reduce the level of pain experienced by a patient upon pricking his or her self. The present invention may also serve in increasing the acceptability of lancing devices to patient's with needle phobia.

In accordance with the present invention, therefore, there is provided a lancet holding device for use in blood sampling, said holding device comprising lancet holding means that are adapted for securely holding a lancing device comprising a needle, and member engaging means that are adapted for removably attaching the holding device to a part of a patient's body; said holding device being configured such that, when attached to a patient's body, the lancet holding means are positioned stably to hold a lancing device juxtaposed said part of the body, with the needle directed towards said part for pricking the part.

Said member engaging means may be adapted for encircling a member of the patient's body. Typically the engaging means are configured for encircling a digit at an extremity of one of a patient's limbs, for example a finger or toe, although the engaging means may in some cases be adapted for engaging part of a limb proper, such as part of a patient's arm or leg.

Said engaging means are preferably adapted for squeezing said member for attaching the device to the member. Said holding means may be configured such that, when attached to said member, the lancet holding means are positioned to hold a lancing device with the needle directed towards a squeezed part of said member. Preferably said holding means are adapted for holding the lancing device firmly so as to prevent unwanted movement of the lancing device in use relative to the part of the patient's body, so as to ensure that the needle penetrates the patient's body accurately, cleanly and consistently. Li some embodiments said member engaging means may comprise two opposing, spring- loaded jaw members adapted to squeeze said member.

The present invention thus provides a lancet holding device which serves to hold a lancing device in place juxtaposed part of a patient's body to ensure that the lancing device is held steadily and remains closely adjacent the patient's body during use of the lancing device. By holding the lancing device in place, the lancet holding device of the present invention makes it easier for patients, particularly those who are elderly or infirm, to use lancing devices efficiently and reliably. By squeezing the patient's member, the device of the present invention may also serve to promote the flow of capillary blood to the surface of the patient's member, so that a greater volume of blood is obtained upon pricking. The holding device of the present invention is particularly suited to use with automatic lancing devices.

Said jaw members may be adapted to define a generally cylindrical space therebetween and may be movable apart against the spring-loading to accommodate different sizes of member. Typically, the jaw members may be shaped and sized to encircle the tip of a finger or toe of a patient's hand or foot. The device may be adapted for use with any finger, including the thumb, but may be designed particularly for use with a patient's index, middle, or ring fingers. Each jaw member may comprise a generally half-cylindrical, member-engaging portion.

Said holding means may be adapted for mounting said lancing device on one of said jaw members. Said one jaw member may define a needle passage that is configured and arranged to allow the needle of the lancing device to pass therethrough into the space between the jaw members.

In some embodiments, the lancing device may be incorporated into the lancet holding device in accordance with the present invention. Preferably, however the holding means are adapted for holding releasably a separate lancing unit, such as an automatic lancing unit so that, for instance, the lancing unit can be cocked, ready for operation before it is mounted on the holding device of the present invention. Said holding means are preferably adapted to hold the lancing unit sufficiently tightly to ensure that upon actuation of the needle, the needle penetrates into the patient's skin, without movement or substantial movement of the lancing unit away from the patient's member in reaction. Preferably, the holding means comprise a socket adapted to receive the lancing unit. Said socket may be adapted to form a friction fit with the unit for holding the unit firmly in the socket. The socket may be shaped to accommodate snugly the lancing unit, and suitably the socket may have a cross-sectional profile which corresponds to the cross-sectional shape of a particular lancing unit. Thus the holding means may be adapted to for use with a particular design of lancing unit, and the socket may be generally rectilinear or curvilinear, for example, rectangular or circular. According to a particular aspect of the present invention, said socket may comprise a solid wall that is configured to conceal the needle of the lancing device when fitted. This feature may improve the acceptability of the lancing unit to patients with needle phobias.

In some embodiments, the socket may be mounted on the member engaging means, and a needle passage may be provided within the socket to extend through the engaging means to allow the needle of the lancing unit to extend therethrough into the patient's member in use.

In accordance with another aspect of the present invention, said lancet holding device may comprise manually operable jaw opening means adapted for moving said jaw members apart against the action of the spring-loading. Said jaw opening means may thus be used for moving the jaw members apart to facilitate placing the jaw members around the member of a patient and for moving said jaw members apart again after use in order to facilitate removal of the device after pricking.

In some embodiments, said jaw opening means may comprise two cooperating levers, each lever having a proximal end that is joined to a respective one of the jaw members and a distal end, and a fulcrum between said levers intermediate said proximal and distal ends, the arrangement being such that upon squeezing the distal end of the levers together, the proximal ends are moved apart thereby opening said jaw members.

Said cooperating levers may also be configured to serve as a handle for the gripping device in accordance with the present invention. More generally, the gripping device may comprise a handle portion adapted to be held by the patient's hand for stabilising the device in use.

Said spring-loading means may comprise a compression spring acting between the distal ends of the two levers. Said compression spring may comprise a leaf spring.

Suitably, said levers and leaf spring may be integrally moulded from a resilient thermoplastic synthetic resin material, e.g. polypropylene. Advantageously, said jaw members may be integrally moulded with the levers, and said holding means may be integrally moulded with the jaw members.

Alternatively the levers and jaw members may be fabricated from a suitable metal material, such as stainless steel.

In some embodiments, said leaf spring may be arcuate and may curve concavely between the levers to form an engaging portion adapted to be held by the patient for stabilising the device in use. Thus, for example, the levers of the device may be dimensioned and shaped such that when the jaw members are placed about the fingertip of a patient's index finger, the concave spring portion between the levers may be engaged by the patient's little finger to prevent rotation of the jaw members about the patient's index finger and generally to stabilise the device one-handed during actuation (by the patient's other hand) of the automatic lancing mechanism. In a different aspect of the present invention there is provide a lancet holding device for use in blood sampling, said holding device comprising: two opposing jaw members, each jaw member comprising a generally half-cylindrical, member-engaging portion, wherein said jaw members define a generally cylindrical space therebetween, which space is adapted to accommodate a member of a patient's body; two cooperating levers, each lever having a proximal end that is joined to a respective one of the jaw members, and a distal end; a fulcrum portion between said levers intermediate said proximal and distal ends, such that on squeezing the distal ends of the levers together, the proximal ends are moved apart thereby to open said jaw members; a compression spring between the distal ends of the two levers for squeezing said jaw members together for removably attaching the device stably to the member and for gently squeezing the member between said jaw members; a lancet holder positioned on one of said jaw members, said lancet holder being configured for securely holding a lancing device comprising a needle juxtaposed said member, with the needle directed towards said member for pricking the member; a needle passage that extends through said one jaw member to allow said needle to pass therethrough into the space between said jaw members for pricking said member.

Following is a description by way of example only with reference to the accompanying drawings of embodiments of the present invention.

In the drawings:

FIG 1 is an isometric view of a finger gripping device in accordance with the present invention.

FIG. 2 is another isometric view of the finger gripping device of FIG. 1. FIG. 3 is a side elevation of the finger gripping device of FIGS.1 and 2.

FIG. 4 is a plan view of the finger gripping device of FIGS. 1 to 3. FIG. 5 is an end view of the finger gripping device of FIGS. 1 to 4. A lancet holding device 10 in accordance with the present invention is illustrated in FIGS. 1 to 5 of the accompanying drawings. The lancet holding device 10 is integrally moulded as a single piece from a resilient thermoplastic synthetic resin material such as polypropylene.

(Alternatively the lancet holding device 10 could be fabricated from a suitable metal material, such, for example, as stainless steel). The lancet holding device 10 comprises two opposing, generally half-cylindrical jaw members 12, 14 which define a generally cylindrical space 16 therebetween which is adapted to accommodate a member of a patient's body, for example the tip of a finger or toe of a patient's hand or foot. One of said jaw members 12 carries a socket portion 20 which is open at one end 22 and comprises a surrounding wall 24 that defines an interior recess 26. Said socket portion 20 extends generally radially with respect to the one jaw member 12 and comprises an internal end wall 28. Said end wall 28 is formed with an aperture 30 which communicates with the space 16 between the two jaw members 12, 14.

The other jaw member 14 is shaped at 32 to accommodate the socket portion 20 on the one jaw member 12. The jaw members 12, 14 and socket portion 20 are dimensioned and shaped to accommodate different sizes of member by moving the jaw members towards or away from one another as the case may be. Each of said jaw members 12, 14 is joined to a respective lever portion 42, 44 which cooperate as shown in FIGS. 1 to 3 to form a cantilevered handle 40 for the device 10.

Each lever portion 42, 44 comprises an arcuate outer limb 46 having a proximal end 47 which is joined to the respective jaw member 12, 14 and a distal end 48. Each outer limb 46 extends convexly between its respective proximal and distal ends 47, 48 for ease of handling by a patient.

The distal ends 48 of the outer limbs 46 of the two lever portions 42, 44 are interconnected by a resilient concave web portion 50 which serves as a leaf spring to urge the distal ends 48 of the two lever portions 43, 44 away from each other as described in more detail below.

Each lever portion 42, 44 further comprises a distal inner strut 52 which extends proximally from a point on the end portion 50 adjacent the distal end 48 of the outer limb 46 of the respective lever portion 42, 44 to a common fulcrum 54. The distal struts 52 of the lever portions 42, 44 meet at said fulcrum 54. Each lever portion 42, 44 also comprises a proximal strut 56 which extends from the common fulcrum 54 to the respective jaw member 12, 14.

By squeezing the distal ends of the two lever portions 42, 44 together, the lever portions 42, 44 are caused to rock about the common fulcrum 54, causing the jaw members 12, 14 to move apart. As mentioned above, the web portion 50 serves as a leaf spring which serves to urge the distal ends of the lever portions 42, 44 apart, thereby urging the jaw members 12, 14 together. In use, a lancing unit (not shown) is made ready for operation. By way of example, the lancet holding device in accordance with the present invention may be used with an automatic lancing unit, for example of the kind disclosed by US-A-5487748, in which case the cap is manipulated to push the needle inside the casing against the action of the spring until the sear on the needle engages the bent on the trigger. The cap is then detached and the unit is inserted into the socket 20 of the lancet holding device of the present invention such that the aperture in the casing of the lancing unit is aligned with the aperture 30 in the end wall 28 of the socket 20. The lancing unit is pushed firmly into the socket 20 until the casing of the lancing unit abuts the end wall 28 of the socket. The side wall 24 of the socket 20 is shaped to form a tight, friction fit with the case of the lancing unit, such that the lancing unit is held firmly within the socket. The side wall 24 is solid and also serves to conceal the needle of the automatic lancing unit from the user.

The distal ends of the lever portions 42, 44 of the handle 40 are then urged together with open the jaw members 12, 14 to enable the patient to insert his or her member into the space 16 between the jaw members 12, 14. Upon releasing the lever portions 42, 44, the distal ends 48 of the lever portions 42, 44 are moved away from each other as a result of the resilience of the web portion 50, which is deformed when the lever portion 42, 44 are squeezed together, to close the jaw members 12, 14 firmly around the patient's member. The jaw members 12, 14 can thus accommodate different sizes of member and the resilience of the web portion 50 causes the jaw members 12, 14 to squeeze gently the patient's member to encourage blood to flow to the surface. For this purpose, the device 10 should be constructed such that when a patient's member is interposed between the jaw members 12, 14 the web portion 50 is unable to relax completely and maintains an outwardly directed force on the distal ends 48 of the two lever portions 42, 4. If the jaw members 12, 14 are fitted around the tip of a patient's index finger, for example, the lancet holding device in accordance with the present invention can be stabilised by the patient's little finger engaging the concave web portion 50. As best shown in FIGS. 2 and 3, the end portion 50 may be provided with two spaced, distally extending protrusions 60 to prevent slippage of the patient's little finger. The lancet holding device in accordance with the present invention is thus stabilised against rotation about the patient's index finger and is held steady.

The lancing unit may then be operated to cause the needle to pass through the aperture 30 in the end wall 28 of the socket 20 to prick the patient's member. For many patient's, the action of the jaw members 12, 14 squeezing the patient's member serves to ameliorate the pain experienced upon pricking. The lancet holding device may then be removed from the patient's member by squeezing together the lever portions 42, 44 to re-open the jaw members 12, 14. The patient's member may then be manipulated manually in the normal manner to cause a small droplet of blood to accumulate on the surface of the patient's member for sampling.

After use, the lancet holding device in accordance with the present invention and the lancing unit are thrown away.

The lancet holding device as hereinbefore described thus serves gently to grip a patient's member and to locate steadily a lancing unit in relation to the member during blood sampling. The lancet holding device facilitates the use of automatic lancing units by patients, particularly those who are elderly or infirm, and may also serve to reduce the pain experienced upon pricking. The gentle squeezing action of the device serves to encourage blood to flow to the surface of the patient's skin prior to and during pricking. The side wall 28 surrounding the socket 20 serves to conceal the needle of the lancing unit during operation, thereby making the use of such lancing units less objectionable to those suffering from needle phobia.

Claims

1 A lancet holding device for use in blood sampling, said holding device comprising lancet holding means that are adapted for securely holding a lancing device comprising a needle, and member engaging means that are adapted for removably attaching the holding device to a part of a patient's body; said holding device being configured such that, when attached to a patient's body, the lancet holding means are positioned stably to hold a lancing device juxtaposed said part of the body, with the needle directed towards said part for pricking the part.

2 A lancet holding device as claimed in claim 1, wherein said member engaging means are configured for encircling a member of the patient's body. 3 A lancet holding device as claimed in claim 2, wherein said member engaging means are adapted for squeezing said member.

4 A lancet holding device as claimed in claim 3, wherein said holding device is configured such that, when attached to said member, the lancet holding means are positioned to hold a lancing device with the needle directed towards a squeezed part of said member. 5 A lancet holding device as claimed in claim 3 or claim 4, wherein said member engaging means comprise two opposing, spring-loaded jaw members adapted to squeeze the member.

6 A lancet holding device as claimed in claim 5, wherein the spring-loading of the jaw members is such as to squeeze gently the patient's member to encourage blood flow towards the surface of the skin. 7 A lancet holding device as claimed in claim 5 or claim 6, wherein said jaw members are adapted to define a generally cylindrical space therebetween and can be moved apart against the spring-loading to accommodate different sizes of member.

8 A lancet holding device as claimed in claim 7 wherein each jaw member comprises a generally half-cylindrical, member-engaging portion. 9 A lancet holding device as claimed in claim 7 or claim 8, wherein said holding means are adapted for mounting a lancing device on one of said jaw members.

10 A lancet holding device as claimed in claim 9, wherein said one jaw member defines a needle passage that is configured and arranged to allow the needle of said lancing device to pass therethrough into the space between said jaw members. 11 A lancet holding device as claimed in any preceding claim, wherein said holding means are adapted to hold releasably a separate lancing unit.

12 A lancet holding device as claimed in claim 11, wherein said holding means comprise a socket adapted to receive said lancing unit.

13 A lancet holding device as claimed in claim 12, wherein said socket is adapted to form a friction fit with said unit for holding the unit firmly in the socket. 14 A lancet holding device as claimed in claim 12 or claim 13, wherein said socket comprises a solid wall portion that is configured to conceal the needle of the lancing unit when fitted.

15 A lancet holding device as claimed in claim 14, wherein said socket is mounted on said member engaging means, and a needle passage is provided within said socket which extends through said member engaging means to allow the needle of the lancing unit to extend therethrough into the patient's member.

16 A lancet holding device as claimed in any of claims 5 to 10, further comprising manually operable jaw opening means adapted for moving said jaw members apart against the action of the spring-loading. 17 A lancet holding device as claimed in claim 16, wherein said jaw opening means comprise two cooperating levers, each lever having a proximal end that is joined to a respective one of the jaw members and a distal end, and a fulcrum between said levers intermediate said proximal and distal ends, the arrangement being such that on squeezing the distal ends of the levers together, the proximal ends are moved apart thereby to open said jaw members. 18 A lancet holding device as claimed in claim 17, wherein said spring-loading means comprise a compression spring between the distal ends of the two levers.

19 A lancet holding device as claimed in claim 18, wherein said compression spring comprises a leaf spring.

20 A lancet holding device as claimed in any preceding claim, wherein said device is made of metal.

21 A lancet holding device as claimed in claim 19, wherein said levers and leaf spring are integrally moulded from a resilient thermoplastic synthetic resin.

22 A lancet holding device as claimed in claim 21, wherein said resin comprises polypropylene. 23 A lancet holding device as claimed in claim 21 or claim 22, wherein said jaw members are integrally moulded with said levers.

24 A lancet holding device as claimed in claim 23, wherein said holding means are integrally moulded with said jaw members.

25 A lancet holding device as claimed in claim 19, wherein said leaf spring is arcuate and curves concavely between said levers to form an engaging portion adapted to be held the patient for stabilising the device in use.

26 A lancet holding device as claimed in any preceding claim, further comprising a handle portion adapted to be held by the patient hand for stabilising the device in use.

27 A lancet holding device substantially as hereinbefore described with reference to and as shown in FIGS. 1 to 5 of the accompanying drawings.

28 A lancet holding device for use in blood sampling, said holding device comprising: two opposing jaw members, each jaw member comprising a generally half-cylindrical, member-engaging portion, wherein said jaw members define a generally cylindrical space therebetween, which space is adapted to accommodate a member of a patient's body; two cooperating levers, each lever having a proximal end that is joined to a respective one of the jaw members, and a distal end; a fulcrum portion between said levers intermediate said proximal and distal ends, such that on squeezing the distal ends of the levers together, the proximal ends are moved apart thereby to open said jaw members; a compression spring between the distal ends of the two levers for squeezing said jaw members together for removably attaching the device stably to the member and for gently squeezing the member between said jaw members; a lancet holder positioned on one of said jaw members, said lancet holder being configured for securely holding a lancing device comprising a needle juxtaposed said member, with the needle directed towards said member for pricking the member; a needle passage that extends through said one jaw member to allow said needle to pass therethrough into the space between said jaw members for pricking said member.