The present invention relates to blood sampling apparatus generally.

Various types of blood sampling apparatus are known in the art. The following patent documents are believed to represent the state of the art: U.S. Patents: 3,877,465; 4,763,648; 4,920,970; 4,934,015; 4,981,140; 5,002,066 & 5,084,034; European Patent Application 88906129.7 and PCT Published Patent Application WO 93/21821.

The present invention seeks to provide improved blood sampling apparatus having enhanced safety features.

There is thus provided in accordance with a preferred embodiment of the present invention blood sampling apparatus operative to selectively and removably interconnect a blood sample container with an extracorpo- real blood conduit and including: a blood interface assembly adapted to securely and removably puncture both said blood conduit and said blood sample container, the blood interface assembly comprising: an elongate housing; a needle mount removably mounted in said elongate housing; a double pointed needle fixedly adhesively mounted in said needle mount so as to have portions extending outward of said needle mount in opposite direc-

tions; and a puncturable resilient sheath formed over at least one portion of said needle and onto at least a portion of said needle mount. In accordance with a preferred embodiment of the invention, the housing is configured and the needle is mounted such that inadvert¬ ent engagement of a user's finger with either point of said needle is substantially prevented.

Additionally in accordance with a preferred embodiment of the present invention, the removable mount¬ ing of the needle mount into said housing is effected by a plurality of tabs, azimuthally distributed about the interior periphery of the housing spaced from a peripher¬ al shoulder formed therein.

Further in accordance with a preferred embodi¬ ment of the present invention, the adhesive mounting of the double-pointed needle in the needle mount is provided by application of adhesive on only one side of the needle mount and onto a roughened portion of the needle.

Preferably, the adhesive is configured so as to provide an inclined surface over which an open end of the resilient sheath is readily slid into retained engagement with an axially extending portion of said needle mount.

In accordance with a preferred embodiment of the present invention, the needle mount comprises a truncated circular disk having integrally formed there¬ with a pair of male needle attachment portions.

Further in accordance with another preferred embodiment of the present invention, there is provided blood sampling apparatus which further includes a punc¬ turable sampling appliance adapted to be mounted onto the blood conduit such that the blood conduit extends unin¬ terrupted therethrough and can be punctured thereat to draw blood therefrom.

Additionally in accordance with a preferred embodiment of the present invention, the puncturable

sampling appliance is configured and the needle is mount¬ ed such that inadvertent engagement of a user's finger with a point of the needle extending towards the punc¬ turable sampling appliance is substantially prevented.

Still further in accordance with a preferred embodiment of the present invention, the blood interface assembly is adapted to engage with the puncturable sam¬ pling appliance in first and second engagements, wherein in the first engagement, the needle is prevented from puncturing the blood conduit, and wherein in the second engagement, the needle is allowed to puncture the blood conduit.

Additionally in accordance with a preferred embodiment of the present invention, the blood interface assembly is adapted to engage with the puncturable sam¬ pling appliance in first and second engagements, wherein in the first engagement, the blood interface assembly is substantially prevented from axial movement with respect to the puncturable sampling appli¬ ance and the needle is prevented from puncturing the blood conduit, the blood interface assembly being rotata- ble azimuthally with respect to the puncturable sampling appliance, and wherein in the second engagement, the blood interface assembly may be moved axially with respect to the puncturable sampling appliance, thereby causing the needle to puncture the blood conduit.

The present invention will be understood and appreciated more fully from the following detailed de¬ scription, taken in conjunction with the drawings in which:

Fig. 1 is a simplified pictorial illustration of a blood sampling system constructed and operative in accordance with a preferred embodiment of the present invention;

Fig. 2 is an exploded view illustration of an interface assembly useful in the system of Fig. 1;

Fig. 3 is a sectional illustration of the interface assembly of Fig. 2;

Fig. 4 is a sectional illustration of punctur¬ ing engagement of the interface assembly with a blood conduit in accordance with a preferred embodiment of the present invention;

Fig. 5 is a pictorial illustration showing how the interface assembly is resistant to inadvertent en¬ gagement between a user's fingers and a needle point;

Fig. 6 is a pictorial illustration of a punc¬ turable sampling appliance constructed and operative in accordance with another preferred embodiment of the present invention;

Figs. 7A and 7B are respective exploded view and partially assembled pictorial illustrations of anoth¬ er preferred embodiment of blood sampling apparatus useful without pre-fitted blood conduit puncture defining elements;

Figs. 8A and 8B are sectional exploded illus¬ trations of the blood sampling apparatus of Figs. 7A and 7B corresponding to Figs. 9A and 9B;

Figs. 9A and 9B are sectional illustrations taken along respective lines 9A - 9A and 9B - 9B in Fig.

7B;

Fig. 10 is a pictorial illustration of the apparatus of Figs. 7 - 9B in operative engagement with a blood sampling tube;

Figs. 11A and 11B are sectional illustrations taken along respective lines 11A - 11A and 11B - 11B in Fig. 10;

Fig. 12 is a partially assembled pictorial illustration of yet another preferred embodiment of blood sampling apparatus useful without pre-fitted blood con¬ duit puncture defining elements;

Fig. 13 is a pictorial illustration of the apparatus of Fig. 12 in operative engagement with a blood sampling tube; and

Figs. 14A and 14B are sectional illustrations taken along respective lines 14A - 14A and 14B - 14B in Fig. 13.

Reference is now made to Figs. 1 and 2, which illustrates a blood sampling system constructed and operative in accordance with a preferred embodiment of the present invention. The blood sampling system com¬ prises a needle assembly 10, which is inserted into the vein of a person from whom blood is drawn, a blood col¬ lection container 12 and a conduit 14 interconnecting the needle assembly 10 to the blood collection container 12, such that blood is drawn via needle assembly 10 via conduit 14 to container 12.

A puncturable sampling appliance 16 is prefera¬ bly mounted onto conduit 14. As seen in Fig. 2, appliance 16 preferably has a hollow portion 17 such that conduit 14 extends uninterrupted therethrough and can be punc¬ tured thereat to draw blood from conduit 14. Preferably the appliance 16 also has an interface assembly receiving portion 37.

A blood sampling tube 18 is removably attached to a blood sampling interface assembly 20, which in turn is removably attached to appliance 16 for drawing blood from conduit 14 into sampling tube 18.

It is a particular feature of the invention that the interface assembly 20 is constructed so as to minimize the possibility of inadvertent engagement of a user's finger with either point of a double pointed needle forming part thereof.

Reference is now made to Figs. 2 and 3, which illustrate the construction of the interface assembly 20 of the present invention. As seen in Figs. 2 and 3, the blood interface assembly comprises an elongate housing 30, typically formed of plastic by injection molding. Housing 30 preferably comprises two generally circular cylindrical portions 32 and 34 which are joined at a shoulder 35. Portion 32 is longer and of larger radius

than is portion 34, portion 32 being intended for opera¬ tive engagement with blood sampling tube 18, while por¬ tion 34 is intended for operative engagement with the interface assembly receiving portion 37 of the sampling appliance 16. Preferably, the length of portion 32 is 35 to 50 mm and its inner radius is 9 mm, while the length of portion 34 is 22 mm and its inner radius is 5 mm.

Portion 34 terminates in an outwardly extending flange 36, which communicates with a bayonet-type socket 38. Portion 32 terminates in a circular edge 39.

In accordance with a preferred embodiment of the invention there is provided a separately formed needle mount element 40, which is removably mounted in the elongate housing 30. Element 40 is seated against shoulder 35 and is retained thereagainst by a plurality of inwardly protruding retaining tabs 42.

Needle mount element 40 is preferably formed of plastic by injection molding and includes a planar por¬ tion 43 of a truncated conical configuration, integrally formed with a pair of non-identical, hollow, male attach¬ ment portions 44 and 46, extending perpendicularly to planar portion 43 at the center of planar portion 43, which is apertured thereat. Preferably, male attachment portion 44 is undercut as clearly shown in Figs. 2 and 3.

Accordingly, planar portion 43 together with attachment portions 44 and 46 define an elongate channel through which extends a double pointed needle 48, having a roughened center section 50 and a pair of pointed ends 52 and 54.

The double pointed needle 48 is fixedly fric- tionally and adhesively mounted in the needle mount element 40 so as to have needle portions of differing lengths extending perpendicularly to planar portion 43 outward of the needle mount in opposite directions. Preferably, the point 54 of the needle 48 is spaced at a distance from the shoulder 35 such that when the needle

mount element 40 is seated against the shoulder 35 and the assembly 20 is in pierced engagement with the appli¬ ance 16, the needlepoint 54 pierces the conduit 14 and is positioned substantially along the central axis of the conduit 14, as seen clearly in Fig. 4. Preferably, point 52 of needle 48 is located at a distance of 20 to 35 mm interiorly of the end edge 39 of portion 32, while point 54 of needle 48 is located at a distance of 10 to 15 mm interiorly of flange 36.

An adhesive 56, such as U. V. adhesive, is preferably disposed about an outward edge of attachment portion 44 in such a manner so as to provide a smooth transition between the outer surface of the needle and the maximum diametral dimension of the attachment member. This particular arrangement enables relatively easy sliding of the open end of a puncturable resilient sheath 58 thereover into frictionally retained engagement with the attachment member 44, as seen particularly well in Fig. 4. It is seen in Fig. 4 that preferably, the open end of the sheath 58 engages the undercut formed in attachment portion 44, for enhanced retention thereon.

Fig. 4 illustrates operative engagement between interface assembly 20 and appliance 16 and more specifi¬ cally puncturing engagement of needle point 54 with the interior of conduit 14 via appliance 16. It is seen that bayonet type socket 38 engages the outer perimeter of the hollow portion 17 for retaining the interface assembly 20 onto appliance 16.

Fig. 5 illustrates how inadvertent engagement of a user's finger with needle point 54 is minimized by the structure of the present invention.

Reference is now made to Fig. 6, which is a pictorial illustration of a puncturable sampling appli¬ ance 60 constructed and operative in accordance with an alternative embodiment of the present invention. The appliance 60 comprises an elongate handle portion 62,

which is integrally formed, as by injection molding, with a channel defining portion 64 through which passes a blood conduit (not shown) .

Communicating with the interior of channel defining portion 64 is an interface assembly receiving portion 66 which is substantially identical in configura¬ tion and operation to the interface assembly receiving portion 37 of the sampling appliance 16 shown in Fig. 2.

Reference is now made to Figs. 7A - 11B, which illustrate blood sampling apparatus 80 constructed and operative in accordance with another preferred embodiment of the present invention. Whereas the apparatus shown in Figs. 1 - 6 is intended for use in an environment wherein a puncturable sampling appliance is prefitted onto a blood conduit, the apparatus of Figs. 7 - 11B is intended for use in environments where no puncturable sampling appliance is present on the blood conduit.

Referring particularly to Figs. 7A - 9B it is seen that the blood sampling apparatus 80 comprises a snap-engageable puncturable blood conduit engaging ele¬ ment 82 and a snap fittable interface element 84. Ele¬ ment 82 is preferably integrally formed, as by injection molding, of a single piece of plastic and includes a generally circular cylindrical portion 86 having a pair of elongate axially directed slots 88 formed on opposite sides of the interior surface thereof, for accommodating corresponding resilient protrusions 90 formed on the interface element 84.

Associated with each of elongate slots 88 are a plurality of apertures indicated by reference numerals 92, 94 and 96, whose functionality will be described in detail hereinbelow. An aperture 92 is aligned with each slot 88, while an aperture 94 is disposed azimuthally alongside each aperture 92. An additional aperture 96 is disposed in axial alignment with each aperture 94 at a location intermediate aperture 94 and an end surface 98

of the cylindrical portion 86.

Associated with portion 86 are a pair of coop¬ erating butterfly clamp portions 100 and 102, one of which is formed with a resilient hook 104 and the other with a corresponding socket 106. Clamp portions 100 and 102 are formed with corresponding mutually facing trans¬ verse recesses 108 and 110 which are configured and arranged to accommodate a blood conduit 112 (Fig. 7B) , when the clamp portions 100 and 102 are held together by the engagement of hook 104 in socket 106, as seen in Fig. 10.

As seen particularly in Figs. 8A and 8B, por¬ tion 86 defines an interior circular protrusion 114 and coaxially therewith a central needle passage 116 which communicates with sockets 108 and 110 so as to enable a needle passing through passage 116 to engage and puncture a blood conduit 112. Interior circular protrusion 114 is connected with the cylindrical wall of portion 86 by a pair of mutually 180 degree spaced ribs 118, as seen in Fig. 7A.

The interface element 84 comprises a generally circular cylindrical tube like portion 120 having at one end thereof an outwardly directed flange 122. At an end of portion 120, opposite to the end at which flange 122 is located, there are provided a pair of mutually 180 degree spaced two step notches 124. Notches 124 are preferably located azimuthally offset by 90 degrees from the protrusions 90. Each notch 124 comprises a relatively wide, axially relatively shallow step 126 and a relative¬ ly narrow, axially relatively deep step 128. The pair of ribs 118 of engaging element 82 are arranged such that when each protrusion 90 is aligned with a corresponding aperture 92, each rib 118 is aligned with each shallow step 126. When each protrusion 90 is aligned with corre¬ sponding apertures 94 and 96, each rib 118 is aligned with a corresponding deep step 128.

The operation of sampling appliance 80 will now be described in detail. The sampling appliance 80 is supplied to a user with the needle mount element 40 assembled with the interface element 84 and the interface element 84 in engagement with the engaging element 82, wherein the protrusions 90 are engaged with the corre¬ sponding apertures 92, which lie along slots 88. The foregoing configuration is hereafter termed a first engagement. The protrusions 90 and the apertures 92 are constructed such that the user can not pull the interface element 84 axially out of engagement with engaging ele¬ ment 82, but rather the protrusions 90 can only slide azimuthally from apertures 92 to apertures 94.

In the first engagement each relatively shallow step 126 butts against the corresponding rib 118, thereby preventing the needle point 54 from puncturing the blood conduit 112. It is appreciated that in the first engage¬ ment, a user's finger is substantially shielded by the engaging element 82 from needle point 54 and from inad¬ vertent puncture therewith.

In order to use the sampling appliance 80, the user rotates the interface element 84 azimuthally to a second engagement, shown in Figs. 7B and 9A - 9B, wherein each protrusion 90 engages with apertures 94 and each relatively deep step 128 aligns with each corresponding rib 118. The needle point 54 does not yet puncture the blood conduit 112. The user then pushes the interface element 84 towards the engaging element 82, thereby disengaging each protrusion 90 from each aperture 94 and causing each protrusion 90 to engage with each corre¬ sponding aperture 96. This causes the needle point 54 to puncture the blood conduit 112. As shown in Figs. 10 11B, the user then introduces a blood sampling tube 130 into the interface 84 so that it is punctured by the needle point 52, thereby allowing blood to be collected in the blood sampling tube 130.

Reference is now made to Figs. 12 - 14B which illustrate blood sampling apparatus 140 constructed and operative in accordance with yet another preferred embod¬ iment of the present invention. Blood sampling apparatus 140 is substantially identical with blood sampling appa¬ ratus 80 described hereinabove with reference to Figs. 7A

11B. Like numerals label elements of blood sampling apparatus 140 which are similar to those of blood sam¬ pling apparatus 80 shown in Figs. 7A - 11B.

Blood sampling apparatus 140 shown in Figs. 12

14B has different hardware for clamping onto a blood conduit than blood sampling apparatus 80. Blood sampling apparatus 140 comprises a foldable clamp 150 which com¬ prises a resilient hook 154 and a corresponding socket 156. Clamp 150 is formed with corresponding mutually facing transverse recesses 158 and 160, shown in Fig. 12, which are configured and arranged to accommodate a blood conduit 162, as shown in Fig. 13. As seen in Figs. 13 14B, the blood conduit 162 is clamped between the recess¬ es 158 and 160 when the hook 154 is engaged with the socket 156.

It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims which follow: