AU2013202166B2

AU2013202166B2 - IV Catheter

Info

Publication number: AU2013202166B2
Application number: AU2013202166A
Authority: AU
Inventors: Kevin Woehr
Original assignee: B Braun Melsungen AG
Current assignee: B Braun Melsungen AG
Priority date: 1997-08-20
Filing date: 2013-03-28
Publication date: 2013-11-28
Anticipated expiration: 2018-08-18
Also published as: AU2013202166A1

Abstract

: \tzs\Intrwovn\NRPortbl\DCC\TZS\5017265_l.doc-25 03/2013 An IV catheter apparatus including a tubular catheter having a proximal end and a distal end, a needle having a needle shaft and a tip and wherein the needle is attached to a distal end of a needle hub, said needle being received within said tubular catheter when the needle is in a ready position, a catheter hub attached to the proximal end of said catheter, said catheter hub having a hollow interior and an inner wall, said needle being movable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within the interior of said catheter hub, a needle guard positioned in the interior of said catheter hub; wherein the needle guard has a resilient portion having an end wall engaged by said needle shaft when said needle is in its ready position, the end wall of the needle guard resilient portion is movable within the interior of said catheter hub to a blocking position distal of said needle tip when said needle is in its retracted position in which said needle shaft no longer exerts a force on said end wall of the resilient portion of said needle guard; wherein the needle guard is retained in the catheter hub by a projection formed on the catheter hub hollow interior when the end wall of the resilient portion is engaged by the side of the needle shaft and biased radially outwardly; and wherein the needle guard further includes a needle guard proximal end, wherein the needle guard prevents accidental, inadvertent contact with the needle tip when the needle is in the retracted position by a portion of the needle guard proximal end making contact with a needle crimp and the end wall of the resilient portion blocking the needle tip. ((I f-i4 (DN f-t (NoC (1(N 03' (-A CD co

Description

I: I\ts\Intrwovn\NRPortbl\DCC\TZS\5010271-I.doc-26 03 2013 IV CATHETER The disclosure of the complete specification of Australian Patent Application No. 2012258327 as originally filed is incorporated herein by reference. The invention relates to a safety needle assembly which can form part of a safety 5 intravenous (IV) catheter device. Safety IV catheter devices comprise a needle protecting means which slides to the needle point as the needle is removed from the catheter and permanently blocks the needle point such that the needle point cannot be inserted into objects or persons. A safety intravenous catheter device is disclosed in International application WO 10 99/08 742 by the present applicant. Said catheter device comprises a tubular catheter having a catheter hub at the proximal end, a hollow needle adapted to be inserted into the catheter and provided with a needle hub at the proximal end, and a needle protecting means. The needle protecting means is located in a hollow space of the catheter hub, the hollow space being closed by the needle hub, 15 wherein the needle passes through the needle protecting means and the needle protecting means comprises a spring portion made of steel through which the needle is adapted to slide. The needle protecting means comprises an engagement element which, when the needle is retracted relatively to the catheter, engages with an irregularly configured portion of the needle in order to remove the 20 needle protecting means from the proximal end of the catheter hub. The needle protecting means comprises a bent sheet-metal portion made from spring steel which presses against the wall of the hollow space of the catheter hub, the sheet-metal portion thus being supported. Said support is no longer given when the needle protecting means is moved over the needle point when the needle is 25 retracted, the needle protecting means thus being protected. Then the needle protecting means, together with the needle, can be removed from the hollow space of the catheter hub. In the case of the known catheter device the projection, with which the needle protecting means lockingly engages, is configured as a H:\s\mwoven\NRPorb\DCC\TZ\5\ 1027 1I.doc-3/06/2013 -2 retaining protrusion molded to the inner wall of the catheter hub, or a retaining groove. A catheter device of this type protecting means poses the problem that the needle protecting means must be fastened in the catheter hub, with a bend or an elbow of 5 the needle protecting means having to be moved over the projection on the inner side of the catheter hub, such that a reliable support of the needle protecting means in the hollow space of the catheter hub is ensured. It is an object of the present invention to provide an intravenous catheter device comprising a needle protecting means where fastening of the needle protecting 10 means in the catheter hub is facilitated. According to the invention, there is provided an IV catheter apparatus including a tubular catheter having a proximal end and a distal end, a needle having a needle shaft and a tip and wherein the needle is attached to a distal end of a needle hub, said needle being received within said tubular catheter when the needle is in a 15 ready position, a catheter hub attached to the proximal end of said catheter, said catheter hub having a hollow interior and an inner wall, said needle being movable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within the interior of said catheter hub, a needle guard positioned in the interior of said catheter hub; 20 wherein the needle guard has a resilient portion having an end wall engaged by said needle shaft when said needle is in its ready position, the end wall of the needle guard resilient portion is movable within the interior of said catheter hub to a blocking position distal of said needle tip when said needle is in its retracted position in which said needle shaft no longer exerts a force on said 25 end wall of the resilient portion of said needle guard; wherein the needle guard is retained in the catheter hub by a projection formed on the catheter hub hollow interior when the end wall of the resilient portion is engaged by the side of the needle shaft and biased radially outwardly; and wherein the needle guard further includes a needle guard proximal end, H :\zdnterwven\NRortb\DCC\TZS501027 LI.doc-306f2Ol3 -3 wherein the needle guard prevents accidental, inadvertent contact with the needle tip when the needle is in the retracted position by a portion of the needle guard proximal end making contact with a needle crimp and the end wall of the resilient portion blocking the needle tip. 5 According to the invention there is also provided an IV catheter apparatus including: (i) a catheter having proximal and distal ends; (ii) a catheter hub having a hollow interior and proximal and distal ends, 10 the catheter hub being connected to the proximal end of the catheter, there being a projection formed on a wall defining the hollow interior; (iii) a needle having proximal and distal ends, the needle including a needle shaft, a needle tip at the distal end of the needle shaft, and laterally extending bulges; 15 (iv) a needle hub having proximal and distal ends, the needle being attached to the distal end of the needle hub; and (v) needle protecting means, the needle protecting means including a proximal end wall having an opening therein and first and second arms extending distally from the proximal end wall, the first arm including an end wall which is 20 biased into resilient engagement with the needle shaft; and wherein, (vi) in a ready position of the needle, the needle shaft extends through the opening in said proximal end wall and through the catheter so that the needle tip extends from the distal end of the catheter and the needle protecting means is retained within the hollow interior of the catheter hub by engagement of part of the 25 first arm with said projection; and wherein, (vii) in a retracted position of the needle, the needle is moved in a proximal direction relative to the catheter hub until the needle tip is inside the catheter hub and the end wall of the first arm disengages the needle shaft whereby said part of the first arm is displaced so that the needle protecting means 30 can move proximally past the projection when the bulges of the needle engage the proximal end wall of the needle protecting means thereby preventing further H zntenoveNR rh\CC\TZS\501027 ILdoc-306203 -4 proximal movement of the needle relative to the needle protecting means and wherein the end wall of the first arm protects the needle tip against insertion into objects or persons. Fig. 1 shows a longitudinal section across a first embodiment of an intravenous 5 catheter device, Fig. 2 shows the distal end of the needle with the needle protecting means protecting the needle point when the needle has been removed from the catheter, Fig. 3 shows a section along line ll-Ill of Fig. 1, Fig. 4 shows a similar representation as Fig. 3 of a second embodiment having an 10 essentially annular projection with a small interruption, Fig. 5 shows a section across a third embodiment with a bipartite annular projection whose segments are separated from each other by two interruptions, Fig. 6 shows a schematic side view of the distal area of the needle shown in Fig. 1, 15 Fig. 7 shows a view of the needle shown in Fig. 6 as seen from the direction indicated by arrow VII, Fig. 8 shows a perspective representation of a tool for fastening the needle protecting means, Fig. 9 shows a schematic cross-section of another embodiment of the catheter 20 with the needle protecting means being oriented such that it can be inserted into the hollow space of the catheter hub, and Fig. 10 shows by way of the same representation as Fig. 9 the condition of the needle protecting means after a rotation by approximately 450 with the needle protecting means gripping behind the segments of the projection and being in 25 engagement with the projection.

H.s~i nenvoven\NRPorbr\DCC\TZ\5010271_I.doc.3/062013 -5 The embodiment of the present invention shown in Fig. 1 comprises an elongate hollow tubular catheter 24 concentrically connected at its proximal end (remote from the patient) with the distal end of a catheter hub 26. The catheter hub 26 has a hollow space 27 communicating with the volume of the catheter 24 and being 5 open at the proximal end. The needle 16 passes through the catheter 24. The needle 16 is an elongate hollow needle made of steel and comprising a needle point 18 at the distal end. At a certain distance from the distal end 18 an irregularly configured portion 138 is provided. In the present embodiment said irregularly configured portion 138 is a 10 flattened section of the needle which increases the width of the needle in one direction and decreases it in the direction perpendicular thereto. Said irregularly configured portion 138 can alternatively be a local projection. At the proximal end of the needle 16 a needle hub 12 is attached which has a hollow space 13 communicating with the volume of the needle. The distal step in 15 said needle hub 12 abuts the proximal end of said catheter hub 26. In this position of the needle hub 12 relative to the catheter hub 26 the distal end of the needle 16 and the needle point 18 project from the distal end of the catheter 24. On the needle point 18 a needle protecting means 120 is provided which is configured generally in the same way as the needle protecting means shown and 20 described in Figs. 10A, 10B and 11 of WO 99108 742. However, the needle protecting means may also be of different configuration and numerous configurations are suggested by the prior art. In particular the needle protecting means needs not comprise any clamping means for clamping the needle in the locked position. 25 The needle protecting means 120 which is shown in the ready condition in Fig. 1 and in the protecting condition in Fig. 2 is an integral part made of spring steel. It comprises a rear wall 126 extending transversely to the needle 16 and containing an opening. Said opening forms the engagement element 127 engaging with the irregularly configured portion 138 of the needle 16. Said opening or engagement H:\tzsn cvn\NRonbl\DC TZS\10271..doc-36/lO13 -6 element 127 is dimensioned such that it can be freely shifted on the needle 16 but cannot pass the irregularly configured portion 138. Consequently, the rear wall is shiftable in the area between the irregularly configured portion 138 and the needle hub 12. 5 From the ends of the rear wall 126 of the needle protecting means 120 arms 122 and 124 project which are generally oriented in distal direction and cross each other, with each arm 122,124 being located on a different side of the needle 16. The first and second arms 122, 124 are joined at their proximal ends in a hinged arrangement to ends of the rear wall. At the end of each arm 122,124 an end wall 10 129,130 is arranged orthogonally to the arm. At the transition between the arm and the end wall a bend 128 or elbow oriented towards the outside is located. At the free end of the front wall 129 and 130, respectively, a lip 132 bent by more than 90* is provided. The arm 122 is shorter than the other arm 124 such that the front walls 129,130 do not collide with each other in the protected condition of the 15 needle protecting means. The front walls 129 and 130 are wider than the arms 122,124 such that, in said protecting condition, they can cover the needle point 18 and protect it against contact with other parts or bodies. The needle protecting means 120 is retained in the catheter hub 26. For this purpose an annular projection 136a extending about the inner wall of the catheter 20 hub 26 is provided. While the lips 132 press against the outer wall of the needle 16 from opposite sides (Fig. 1), the bends 128 grip behind the projection 136a. When the needle 16 is removed from the catheter 24 the needle protecting means 120 is retained in the catheter hub 26 such that the needle 16 slides through the catheter hub. When the needle point passes the lips 132 the arms 122,124 resiliently move 25 into the position shown in Fig. 2 in which the front walls 129,130 cover the needle point. In this condition the engagement element 127 abuts the irregularly configured portion 138 such that the needle protecting means 120 is prevented from sliding beyond the distal end of the needle 16. In the embodiment shown in Fig. 1 the projection 136a is of completely round and continuous configuration. 30 The annular projection 136a retains the needle protecting means 120 in the H:\tzs\lnterwoven\NR~ortbl\DCOTZ5\501027 1 -1oc-3106/2013 -7 catheter hub 26 when the needle 16 is removed from the catheter hub 26 until the arms 122,124 of the needle protecting means 120 are no longer supported by the needle 16 and resiliently move towards the inside. Here, the projection 136 is integrally molded to the catheter hub 26, e. g. by injection molding. 5 In the embodiment shown in Fig. 4 the projection 136b oriented towards the inside is of generally C-shaped configuration. Said C-shaped projection 136b can be made from a metal snap ring partially seated in an annular groove on the inside of the catheter hub. In this way it is possible to produce the projection 136b by inserting the snap ring into the catheter hub 26 until it lockingly engages the 10 corresponding groove. Fig. 5 shows another alternative where the projection 136c is divided into two segments with intermediate interruptions 137. Each segment has a larger circumferential extension than the intermediate interruptions 137. Further, the circumferential extension is considerably larger than the width of the distal front 15 walls 129,130 of the needle protecting means. Preferably, the generally annular projection projecting towards the inside does not have any interruptions 137 whose width is larger than the width of the distal front walls 129 and 130, respectively, of the needle protecting means. The interruptions 137 being dimensioned such that they are smaller than the width of the front walls prevents 20 the needle protecting means 120 from unintentionally passing the interruptions 137 thus sliding out of the catheter hub without covering the needle point. According to the present invention any number of separate segments forming a generally annular projection may be provided as long as the needle protecting means 120 is securely retained in the catheter hub when the needle 16 is removed 25 from the catheter 24. As shown in Figs. 6 and 7 the irregularly configured portion 138 of the needle 16 is preferably produced by deformation, with two bulges 138a oriented in opposite directions and at right angles thereto two dents 138b also located opposite each other being produced. The bulges 138a have a width W which is small enough to H AtzsM tenvovr&NRPorthl\DCCTZS\50 10271 - .doc-3106/1013 -8 allow the needle 16 to move in the catheter 24 as shown in Fig. 1, but which is too large to pass the opening forming the engagement element 127 in the basis wall 126 of the needle protecting means 120. The catheter device according to Fig. 1 is assembled by pushing the needle 5 protecting means 120 over the point 18 of the needle 16 before the irregularly configured portion 138 is produced on the needle. The needle 16 then passes the engagement element 134 which is an opening in the basis wall 126 of the needle protecting means 120. The distal arms 132 are pressed apart and the needle 16 passes between them. Then the irregularly configured portion 138 is produced on 10 the needle 16 such that the needle protecting means 120 is captured between the irregularly configured portion 138 and the needle hub. Then the needle 16 and the needle protecting means 120 located thereupon are inserted into the catheter hub 26 such that the acute needle point 18 enters the catheter 24. The needle 16 is inserted into the catheter 24 to such an 5 extent that 15 the bends 128 of the needle protecting means abut the projection 136a. When the bends 128 abut the annular projection 136a the advance movement of the needle protecting means is stopped. This advance movement may also 10 be stopped earlier since the inner wall of the catheter hub 26 tapers such that the needle protecting means 120 is compressed during its advance movement. If the 20 needle protecting means 120 cannot be advanced, a tool is used for advancing the needle protecting means 120 further into the catheter hub 26 until the bends 128 of the needle protecting means 120 lockingly engage with the projection 136a. For this purpose an adequate force must be exerted by the tool on the needle protecting means 120 such that the bends 128 resiliently move towards each other 25 to move over the projection 136a. Then they move towards the outside again and press against the inner wall of the catheter hub 26. The needle protecting means 120 is now in the ready position as 20 shown in Fig. 1. The tool for inserting the needle protecting means may have any suitable form. Preferably, the tool shown in Fig. 8 is used which comprises a simple pin 200 H :n\ ,tn oen NRonbr\DCC\TZS\5010271Ldoc-3106/2013 -9 having a longitudinal slot 202 extending over the overall length. The tool 200 can accommodate the needle 16 in said slot 202 while advancing the needle protecting means 120. The annular projection 136a retains the needle protecting means 120 when the 5 needle is retracted until the lips 132 of the needle protecting means 120 lockingly engage with the needle point such that the bends 128 work free from the annular projection 136a and the needle protecting means, together with the needle 16, can be removed from the catheter hub 26. An alternative method of assembling the intravenous catheter comprising a spring 10 clip according to the present invention is realized by employing the embodiment shown in Fig. 4 where the projection 136b is an open snap ring. In this case the open snap ring can be slipped onto the needle protecting means such that it is positioned between the proximal end and the distal end of the needle protecting means. Prior to this the needle protecting means 120 has been slipped onto the 15 needle 16 which is then deformed to produce the irregularly configured portion 138. Thereafter the needle protecting means 120 and the open ring 136b are simultaneously inserted into the catheter hub 26 by means of the same tool. Said tool preferably comprises two fingers each of which extends along one side of the needle protecting means 120. Using these fingers the open ring 136b is 20 pushed further into the catheter hub than the proximal end of the needle protecting means 120. Thus it is not necessary to push the needle protecting means 120 over the annular projection 136b. On the contrary, the needle protecting means 120 and the annular projection 136b are inserted together. Thus the annular projection 136b is inserted into the catheter hub 26 such that the needle protecting 25 means 120 lockingly engages with said lockingly annular projection 136b and remains in that condition until the needle 16 is retracted. Figs. 9 and 10 show another embodiment of the device, which allows a different fastening method. Here, the annular projection 136d is configured such that it comprises at least 4 interruptions 137 between the segments, with the corners 250 H:\tzs envo ven\NRPortbl\DCC\TZSu10271_1 doc.3/06/2013 -10 of the needle protecting means 120a being adapted to be pushed through the interruptions 137 at a low force or no force at all. When the needle protecting means 120a has been inserted into the catheter hub 26 until it is positioned behind the projection 136d, the needle protecting means 120a is rotated such that the four 5 corners 250 are positioned behind the segments of the projection 136d as shown in Fig. 10. Thus the needle protecting means 120a is retained in the catheter hub 26 until the needle 16 is retracted. It may be appropriate to configure the needle protecting means 120 such that it has a generally square profile, as shown in Figs. 9 and 10, but other rectangular or 10 polygonal contours of the needle protecting means 120a are also suitable. It is merely necessary to arrange the interruptions 137 of the projection 136d such that the needle protecting means 120 can be easily pushed through said interruptions 137 and then lockingly engages with the projection 136d when the needle protecting means 120a has been rotated such that the corners 250 abut the 15 segments of the projection 136d. Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or 20 group of integers or steps. The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general 25 knowledge in the field of endeavour to which this specification relates.

Claims

1. An IV catheter apparatus including a tubular catheter having a proximal end and a distal end, a needle having a needle shaft and a tip and wherein the needle is 5 attached to a distal end of a needle hub, said needle being received within said tubular catheter when the needle is in a ready position, a catheter hub attached to the proximal end of said catheter, said catheter hub having a hollow interior and an inner wall, said needle being movable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within 10 the interior of said catheter hub, a needle guard positioned in the interior of said catheter hub; wherein the needle guard has a resilient portion having an end wall engaged by said needle shaft when said needle is in its ready position, the end wall of the needle guard resilient portion is movable within the interior of said catheter hub to 15 a blocking position distal of said needle tip when said needle is in its retracted position in which said needle shaft no longer exerts a force on said end wall of the resilient portion of said needle guard; wherein the needle guard is retained in the catheter hub by a projection formed on the catheter hub hollow interior when the end wall of the resilient 20 portion is engaged by the side of the needle shaft and biased radially outwardly; and wherein the needle guard further includes a needle guard proximal end, wherein the needle guard prevents accidental, inadvertent contact with the needle tip when the needle is in the retracted position by a portion of the needle guard 25 proximal end making contact with a needle crimp and the end wall of the resilient portion blocking the needle tip.

2. The IV catheter apparatus of claim 1, wherein the resilient portion is an arm extending distally from the proximal end of the needle guard to the end wall. 30 H:\tzs mnwove&NRfonbr\CCTZS\5083674. Ldc-03/06/213 12

3. The IV catheter apparatus of claim 2, wherein the needle guard has a second arm extending distally from the proximal end of the needle guard.

4. The IV catheter apparatus of claim 3 wherein when in the ready position the needle 5 urges the arm and the second arm away from each other and against the inner wall of the catheter hub.

5. The IV catheter apparatus of claim 2, wherein the arm extending distally from the proximal end is joined to the proximal end in a hinged arrangement. 10

6. The IV catheter apparatus of claim 3 wherein the arm and the second arm are each joined to the proximal end in a hinged arrangement.

7. The IV catheter apparatus of claim 2. Wherein a distal end of the arm has is a 15 curved protrusion extending to the end wall of the resilient portion.

8. The IV catheter apparatus of claim 3 wherein distal ends of both the arm and the second arm have curved protrusions. 20

9. The IV catheter apparatus of claim 1, wherein the projection is in the form of an annular ring.

10. The IV catheter apparatus of claim 9, wherein the curved protrusions of both the arm and the second arm are received in an annular groove or ring. 25 H :\zsUnewvn\NRPonr CCTZS\03674_Ldo-3/6213 13

11. An IV catheter apparatus including: (i). a catheter having proximal and distal ends; (ii) a catheter hub having a hollow interior and proximal and distal ends, the catheter hub being connected to the proximal end of the catheter, there being a projection 5 formed on a wall defining the hollow interior; (iii) a needle having proximal and distal ends, the needle including a needle shaft, a needle tip at the distal end of the needle shaft, and laterally extending bulges; (iv) a needle hub having proximal and distal ends, the needle being attached to the distal end of the needle hub; and 10 (v) needle protecting means, the needle protecting means including a proximal end wall having an opening therein and first and second arms extending distally from the proximal end wall, the first arm including an end wall which is biased into resilient engagement with the needle shaft; and wherein, (vi) in a ready position of the needle, the needle shaft extends through the 15 opening in said proximal end wall and through the catheter so that the needle tip extends from the distal end of the catheter and the needle protecting means is retained within the hollow interior of the catheter hub by engagement of part of the first arm with said projection; and wherein, (vii) in a retracted position of the needle, the needle is moved in a proximal 20 direction relative to the catheter hub until the needle tip is inside the catheter hub and the end wall of the first arm disengages the needle shaft whereby said part of the first arm is displaced so that the needle protecting means can move proximally past the projection when the bulges of the needle engage the proximal end wall of the needle protecting means thereby preventing further proximal movement of the needle relative to the needle 25 protecting means and wherein the end wall of the first arm protects the needle tip against insertion into objects or persons.

12. An IV catheter apparatus as claimed in claim 11, wherein the end wall of the first arm is generally orthogonal to the first arm. 30 H:\tz\JntenvoverNnNR Ph\DCCTZS\$083674_-doc-03/06/2013 14

13. An IV catheter apparatus as claimed in claim 11 or 12 wherein in the retracted position, the needle tip can engage the end wall of the first arm to thereby retain the needle protecting means on the needle shaft. 5

14. An IV catheter device as claimed in claim 11, 12 or 13 wherein the proximal end wall, first and second arms and end wall of the first arm of the needle protecting means are integrally formed.

15. An IV catheter as claimed in claim 14 wherein the needle protecting means is 10 formed from resilient material.

16. An IV catheter as claimed in any one of claims 11 to 15 wherein there are two of said bulges which are produced by deformation of the needle shaft.