AU2008200897B2

AU2008200897B2 - Needle Safety Device for an Intravenous Catheter Apparatus

Info

Publication number: AU2008200897B2
Application number: AU2008200897A
Authority: AU
Inventors: Rishi Baid
Original assignee: Poly Medicure Ltd
Current assignee: Poly Medicure Ltd
Priority date: 2007-07-17
Filing date: 2008-02-26
Publication date: 2013-01-17
Anticipated expiration: 2028-02-26
Also published as: TR200801843U; GB0803326D0; PE20090203Z; EG25456A; SA08290445B1; HU0800132V0; BRMU8800840Y1; AT10834U1; FR2918895A3; PL65159Y1; CZ19018U1; PL68801Y1; AR067548A4; AU2008200897A1; MY145896A; ES1067206U; GB2451153A; CN201253395Y; SK5237Y1; GB2451153B

Abstract

POLY MEDICURE LTD. P10173GAU Abstract A needle safety device for an intravenous catheter apparatus that includes a base capable of receiving a needle between opposing jaws at tached to the base and capable of being influenced by the needle. The jaws move between an expanded position in which they interact with an 10 obstruction within a wing housing of the intravenous catheter apparatus. The jaws permit relative movement of the needle with the base when ex panded, close around a needle tip as it passes the jaws, and prevent rela tive movement of the needle with the base when the jaws are collapsed. The needle of the intravenous catheter apparatus may then be safely dis 15 posed with the needle tip within the needle safety device. C-T4 N3k

Description

AUSTRALIA Patents Act 1990 COMPLETE SPECIFICATION Standard Patent Applicant(s): Poly Medicure Ltd Invention Title: Needle Safety Device for an Intravenous Catheter Apparatus The following statement is a full description of this invention, including the best method for performing it known to me/us: 1A POLY MEDICURE LTD. P10173GAU NEEDLE SAFETY DEVICE FOR AN INTRAVENOUS CATHETER APPARATUS 5 The present invention relates to a guard for the needle tip of an in travenous (IV) catheter. In particular, the invention relates to a needle safety device that automatically covers the needle during withdrawal from 10 the patient to prevent accidental contact with medical professionals. Medical professionals encounter numerous occupational hazards when administering care to patients. One serious hazard is the accidental pricking by a needle after removing from an intravenous catheter. Acci dental pricking of medical professionals' skin by the needle is particularly 15 hazardous because the needle tip easily penetrates the latex gloves used by the medical professionals. The concern for accidental pricking is of particular concern in this era of blood borne disease such as Hepatitis or AIDS. Previous needle tip guards have been manufactured that recognize the need for covering the needle tip when being withdrawn from the cathe 20 ter. The prior art recognizes that the needle tip guard is placed upon the needle after the needle is being withdrawn from the catheter; however, the prior art is difficult to assemble, utilizes an awkward tapered wing hous ing that requires it to be wider than necessary, utilizes complicated struc tures and has other disadvantages. These disadvantages will become 25 evident from an examination of U. S. Patent No. 5,135,504 to McLees and U. S. Patent No. 6,117,108 to Woehr.

2 It would therefore be advantageous if the invention would provide a needle safety device in which the disadvantages of the prior art are over come. It would further be advantageous if the present invention would 5 provide a intravenous catheter apparatus in which a cylindrical non tapered wing housing cylinder is used that reduces the overall size of the intravenous catheter apparatus. It would also be advantageous if the present invention would provide a needle safety device which has a simplified form and is therefore less 10 costly in production and use. The present invention provides in a first aspect a needle safety de vice which comprises a base capable of receiving a needle and two oppos ing jaws attached to the base capable of being influenced by the needle. 15 The two opposing jaws together form a reverse collet mechanism. The jaws are moveable between an expanded position with the effective outer diameter of the jaws increased when the needle is between the jaws and a collapsed position when the needle is not between the jaws. The jaws of the needle safety device permit relative movement of the needle with the 20 base when the jaws are expanded. The jaws close around the needle tip as the needle slips through the space between the jaws. The jaws prevent relative movement of the needle with the base when the jaws are col lapsed. The needle safety device may be used with an intravenous catheter 25 apparatus that has a flexible catheter attached to a wing housing. The intravenous catheter apparatus has an inner obstruction within the wing housing. A needle having a needle tip is provided within the flexible ca theter in the wing housing. The jaws upon the needle safety device as stated above are moveable between an expandable position wherein the 30 jaws are outwardly moved by the needle and prevented from movement 3 past the inner obstruction in a collapsed position when the jaws close around a needle tip which permits the needle safety device to move past the obstruction while encasing the needle tip. According to another feature of an embodiment of the present inven 5 tion, the needle safety device has a ramp portion adapted to permit move ment of the needle safety device past an obstruction in the intravenous catheter apparatus when in the expanded position for assembly. The ob struction is most typically an annular ring within the wing housing. According to another feature of an embodiment of the present inven 10 tion, the jaws have a side perpendicular to the cylindrical side of the wing housing that prevents movement past an obstruction of the intravenous catheter apparatus while the needle safety device is in an expanded posi tion. According to another feature of an embodiment of the present inven 15 tion, the jaws are connected to each other by at least one link at a dis tance from the base. The at least one link prevents the two jaws from spreading apart two far, which could result in a permanent damage to the needle safety device. The link may be provided on only one side of the jaws. Alternatively, first and second links may be provided on opposite 20 sides of the jaws. Preferably, the at least one link is formed to have spring like properties such that the jaws can be spread apart against a restoring force of the link. The link is designed such that it retains its spring-like properties over the period of shelf live. For example, the link may have a curved shape, such as an S- or Z-like shape. Alternatively, the link may 25 have a substantially straight shape. To allow for a simplified and cost effective production of the needle safety device, the base, the jaws, and preferably also the at least one link may be integrally formed and prefera bly made from a plastic material, for example, by injection molding. Alter natively, the base, the jaws, and preferably also the at least one link may 30 be made from a metal material.

4 According to another feature of an embodiment of the present inven tion, the needle safety device is capable of receiving between 14 through 18 gauge needles. According to another feature of an embodiment of the present inven 5 tion, the needle safety device is capable of receiving between 18 through 24 gauge needles. According to another feature of an embodiment of the present inven tion, the intravenous catheter apparatus has a cylindrical wing housing. The needle safety device fits efficiently within the cylindrical wing housing. 10 According to another feature of an embodiment of the present inven tion, the needle safety device is held in place within a chamber of the nee dle hub. According to yet another feature of an embodiment of the present invention, the needle safety device is positioned with the needle safety 15 device abutting a catheter base. The present invention provides in a second aspect a needle safety device for an intravenous catheter apparatus, the needle safety device comprising: 20 a base capable of receiving a needle; two opposing jaws attached to the base and connected to each other by at least one link at a distance from the base, the jaws being capable of being influenced by the needle; the jaws moveable between an expanded position with the effective outer 25 diameter of the jaws increased when a needle is through the jaws and a collapsed position when the needle is not through the jaws; the jaws permitting relative movement of the needle with the base when expanded, closing around a needle tip, and preventing relative movement of the needle with the base when collapsed. 30 5 The present invention provides in a third aspect an intravenous catheter apparatus comprising: a flexible catheter attached to a wing housing; an inner obstruction within the wing housing; 5 a needle within the flexible catheter and the wing housing; a needle safety device having a base and jaws through which the needle passes, wherein the jaws are connected to each other by at least one link at a distance from the base, and wherein the jaws are moveable upon the needle safety device between an expanded position in which the jaws are 10 outwardly moved by the needle and prevented from movement past the inner obstruction, and a collapsed position in which the jaws close around a needle tip which permits the needle safety device to move past the ob struction while encasing the needle tip. 15 Preferred embodiments of the. invention are described in the follow ing description and in the accompanying drawings. Figure 1 is a top view of an intravenous catheter apparatus. Figure 2 is a cross sectional view of the apparatus of Figure 1 taken along line 2-2. 20 Figure 3 is an enlarged view of section 3 of Figure 2. Figure 3A is an alternative embodiment of the needle safety device of Figure 3. Figure 4 is a top view of the intravenous catheter apparatus with the needle partially removed from the catheter and wing housing. 25 Figure 5 is a side cross sectional view of Figure 4 taken along line 5-5. Figure 6 is a top view of the intravenous catheter apparatus with the needle pulled out of the catheter and the needle out from between the jaws of the needle safety device.

6 Figure 7 is a side cross sectional view taken along line 7-7 of Figure 6. Figure 8 is an enlarged view of section 8 of Figure 7. Figure 8A is an alternative embodiment of the needle safety device of 5 Figure 8. Figure 9 is an enlarged cross sectional view of an alternative em bodiment of the needle safety device having a flared needle and tension ring with jaws in an open position. Figure 10 is the needle safety device of Figure 9 with jaws in a clo 10 sed position. Figure 11 is a top view of the intravenous catheter apparatus with the needle pulled away from the catheter and wing housing. Figure 12 is a side cross-section taken along 9-9 of Figure 10. Figure 13 is the needle safety device of Figure 8 with a link connect 15 ing the jaws. Figure 13A is the needle safety device of Figure 8A with a link con necting the jaws. Referring to Figure 1, an intravenous (IV) catheter apparatus 10 of 20 an embodiment of the present invention is shown. The IV catheter appa ratus is viewed as a finished product prior to use and includes a needle cover 12, a wing housing 14, a port cap 16 in unitary assembly with the wing housing 14, and a needle hub 18 attached to the wing housing 14. As seen in the cross section depicted in Figure 2, a needle 20 ex 25 tends from the needle hub 18 through the wing housing and ends in a needle tip 22 under the needle cover 12. The needle 20 is hollow and the needle tip 22 is typically cut at a diagonal. When the needle tip 22 is inserted into a patient the needle may encounter fluid pressure which travels through the needle tip 22 through 30 the needle 20 and enters a flash back chamber 24.

7 Surrounding the needle is a catheter 26 which is attached to the wing housing 14 by catheter base 28. The catheter 26 is a flexible tube that will remain in the user to provide fluids, nourishment, or medicines. Figure 3 is an enlarged view of the needle safety device 40 of Figure 5 2. The needle hub 18 has an abutting chamber 30 that is used to hold in position the needle safety device 40 within the wing housing 14. The wing housing 14 has a wing housing chamber 32 in which the needle safety device is placed. Within the wing housing chamber 32 is an obstruction 34 that interacts with the needle safety device 40. In the illustrated em 10 bodiment, the obstruction 34 is an annular ring. The catheter base extends into the wing housing and abuts the nee dle safety device 40. As illustrated, the needle safety device 40 is held securely in place within the abutting chamber 30 and the catheter base 28. 15 The needle safety device 40 has a base 42 that has a needle pas sageway 44 within it. The needle safety device 40 also has a reverse collet 46 that is used to expand to abut the obstruction 34 and to contract to avoid the obstruction 34. The reverse collet has two jaws 48 moveable between an expanded 20 position with the effective outer diameter of the jaws increased when the needle 20 is between the jaws 48. The jaws move from the expanded posi tion to the collapsed position when the needle 20 is no longer between the jaws 48. The jaws 48 interact with the obstruction 34 to permit relative movement of the needle 20 with the base 42 of the needle safety device 40. 25 The jaws 48 permit this relative motion when they are in the expanded position as seen in the progressive movement between Figures 2, 5, 7, and 10. When the needle 20 passes beyond the jaws 48, the jaws close a round the needle tip 22 preventing accidental contact by the medical pro 30 fessional with the needle tip 22. The jaws 48, when closed around the 8 needle tip, prevent relative movement of the needle 20 with the base 42 of the needle safety device 40 because the jaws 48 slip past the obstruction 34 without the obstruction 34 pulling upon the needle safety device 40. The needle safety device 40 is required to be held in place by the obstruc 5 tion in order for the needle 20 to move relative to the needle safety device 40. The needle passageway 44 of the needle safety device 40 has a fric tional coefficient which grips the needle 20 when the needle safety device 40 is not held in place by the obstruction 34. As seen in enlarged Figures 3, 3A, 8, and 8A, the jaws 48 have a 10 ramp 50. During assembly, the needle safety device 40 is typically placed upon the needle 20 on the end attached to the needle hub 18 and then the end attached into the needle hub 18. The needle safety device 40 is thus expanded prior to being placed within the wing housing 14. As the needle is placed into the catheter the needle safety device 40 is inserted into the 15 wing housing and encounters the obstruction 34. The ramp 50 gradually rides through the obstruction 34 and then fits through the obstruction to provide a positive feel to the assembler. A side 52 opposite the ramp 50 prevents backward movement of the needle safety device 40 once in place past the obstruction 34. 20 The jaws 48 are connected to each other by at least one link 49 (Fig ures 13 and 13A) in a region between the base 42 and the ramp 50. The link may be provided on only one side of the jaws 48. Alternatively, first and second links may be provided on opposite sides of the jaws 48. The at least one link is formed to have spring-like properties such that the jaws 25 48 can be spread apart against a restoring force of the link. For example, the link may have a curved shape, such as an S- or Z-like shape. Alterna tively, the link may have a substantially straight shape. The base 42, the jaws 48, and preferably also the at least one link may be integrally formed and preferably made from a plastic material, for 9 example, by injection molding. Alternatively, the base 42, the jaws 48, and preferably also the at least one link may be made from a metal material. A reverse taper 54 is provided upon the jaws 48. This reverse taper 54 engages the needle tip 22 permitting the needle tip 22 from moving 5 past the reverse taper 54. As seen by comparing Figures 3 and 3A, the reverse taper 54 may be on one or both of the jaws 48. As seen in Figures 9 and 10, the needle safety device 40 may utilize a flared needle 23 and a tension ring 53 to keep the needle safety device 40 in protective communication with the needle tip 22. The needle 20 has 10 a flare positioned near its needle point 22 so that its effective diameter increases at that particular point. The flare 23 is created in assembly after the needle safety device 40 is placed onto the needle 20 which is attached to the needle hub 18. The flare 23 ensures that the needle safety device 40 will not be pulled out once the needle tip 22 is trapped in the 15 needle safety device 40. Additionally, a tension ring 53 is provided upon the jaws which will make collapsing of the jaws positive once the needle tip 22 moves past the front of the jaws 48 after the needle 20 is withdrawn out of the catheter 26 after use. In use, a medical professional receives the intravenous (IV) catheter 20 apparatus with a protective needle cover 12 as seen in Figures 1 and 2, the needle 20 and catheter 26 are inserted into a patient's vein. As seen in Figures 4 and 5, the needle is then withdrawn from the patient by grasping the wing housing 14 and pulling upon the needle hub 18. The needle 20 slides through the catheter 26 and the needle safety device 40. 25 The needle tip 22 passes the jaws 48 permitting the jaws to collapse to their natural position. Alternatively, the tension ring 53 on the jaws 48 makes collapsing of the jaws 48 positive. In the jaws natural position, they are permitted to pass the obstruction 34 in the wing housing 14. Alternatively, the needle safety device 40 as seen in Figures 8 and 8A may 30 still slightly contact the obstruction 34; however, the jaws 48 made of a 10 flexible material and no longer constricted by the metal syringe 22 are permitted to flex slightly to pass the obstruction 34. In this scenario, the needle passageway 44 of the base 42 grips the needle 20 sufficiently for the jaws 48 to pass the obstruction 34. Alternatively, the flare 23 as in 5 Figure 9 does not pass within the needle passageway 44 permitting the jaws 48 to pass the obstruction 34. As seen in Figures 9 and 10 the medical professional then com pletely removes the needle safety device 40 past the wing housing 14 for disposal. The device protects the medical professional from accidental 10 pricking by the needle tip 22. The needle safety device 40 remains in its assembled position as seen in Figure 1 without affecting the working and functioning of the IV catheter apparatus 10 by having a contoured back portion of the base 42 fit within the needle hub abutting chamber 30. With the base portion 42 15 in the abutting chamber 30, the jaws are ensured to always be in a plane parallel the needle 20 so that the needle 20 may properly move between the jaws 48 and ensure proper functioning of the needle safety device 40. The needle tip 22 once within the needle safety device 40 does not come out even if it is pressed against the medical professional, a work 20 surface, or other object. Once the needle safety device 40 is in place, the needle 20 is safe for disposal. 25

Claims

1. A needle safety device for an intravenous catheter apparatus, the needle safety device comprising: a base capable of receiving a needle; two opposing jaws attached to the base and connected to each other 10 by at least one link at a distance from the base, the jaws being ca pable of being influenced by the needle; the jaws moveable between an expanded position with the effective outer diameter of the jaws increased when a needle is through the jaws and a collapsed position when the needle is not through the 15 jaws; the jaws permitting relative movement of the needle with the base when expanded, closing around a needle tip, and preventing relative movement of the needle with the base when collapsed. 20

2. A needle safety device in accordance with claim 1, wherein the link is provided on only one side of the jaws.

3. A needle safety device in accordance with claim 1, wherein first and second links are provided on opposite sides of the jaws. 25

4. A needle safety device in accordance with any one of the preceding claims, wherein the or each link is formed to have spring-like prop erties such that the jaws can be spread apart against a restoring force of the link. 2

5. A needle safety device in accordance with any one of the preceding claims, wherein the or each link has a curved shape, for example, an S- or Z-like shape, or a substantially straight shape. 5

6. A needle safety device in accordance with any one of the preceding claims, wherein the jaws have a ramp portion adapted to permit movement past an obstruction of the intravenous catheter appara tus when in the expanded position for assembly. 10

7. A needle safety device in accordance with claim 6, wherein the or each link is provided in a region between the base and the ramp portion. 15

8. A needle safety device in accordance with any one of the preceding claims, wherein the jaws have a side adapted to prevent movement past an obstruction of the intravenous catheter apparatus when in the expanded position. 20

9. A needle safety device in accordance with any one of the preceding claims, wherein the base receives between 14 to 18 gauge needles.

10. A needle safety device in accordance with any one of claims 1 to 8, wherein the base receives between 18 to 24 gauge needles. 25

11. A needle safety device in accordance with any one of the preceding claims, wherein the jaws have a reverse taper adapted to create a barrier against movement of a needle tip once the jaws are moved to the collapsed position. 30 3

12. A needle safety device in accordance with any one of the preceding claims, wherein the jaws have a tension ring positively collapsing the jaws. 5

13. An intravenous catheter apparatus comprising: a flexible catheter attached to a wing housing; an inner obstruction within the wing housing; a needle within the flexible catheter and the wing housing; a needle safety device having a base and jaws through which the 10 needle passes, wherein the jaws are connected to each other by at least one link at a distance from the base, and wherein the jaws are moveable upon the needle safety device between an expanded posi tion in which the jaws are outwardly moved by the needle and pre vented from movement past the inner obstruction, and a collapsed 15 position in which the jaws close around a needle tip which permits the needle safety device to move past the obstruction while encasing the needle tip.

14. An intravenous catheter apparatus in accordance with claim 13, 20 wherein the link is provided on only one side of the jaws.

15. An intravenous catheter apparatus in accordance with claim 13, wherein first and second links are provided on opposite sides of the jaws. 25

16. An intravenous catheter apparatus in accordance with any one of claims 13 to 15, wherein the or each link is formed to have spring like properties such that the jaws can be spread apart against a re storing force of the link. 30 4

17. An intravenous catheter apparatus in accordance with any one of claims 13 to 16, wherein the or each link has a curved shape, for example, an S- or Z-like shape, or a substantially straight shape. 5

18. An intravenous catheter apparatus in accordance with any one of claims 13 to 17, wherein the jaws have a ramp portion permitting movement of the needle safety device past the obstruction during assembly. 10

19. An intravenous catheter apparatus in accordance with any one of claims 13 to 18, wherein the or each link is provided in a region be tween the base and the ramp portion.

20. An intravenous catheter apparatus in accordance with any one of 15 claims 13 to 19, wherein at least one jaw has a side that prevents movement of the needle safety device past the obstruction when the jaws are expanded.

21. An intravenous catheter apparatus in accordance with any one of 20 claims 13 to 20, wherein at least one jaw has a reverse taper to cre ate a barrier to prevent accidental movement of the needle tip out of the needle safety device.

22. An intravenous catheter apparatus in accordance with any one of 25 the claims 13 to 21, wherein the jaws have a tension ring positively collapsing the jaws.

23. An intravenous catheter apparatus in accordance with any one of claims 13 to 22, further comprising a needle hub attached to the 30 needle, an abutting chamber within the hub, the needle safety de- 5 vice based fitting within the abutting chamber to align the needle safety device with the needle.

24. An intravenous catheter apparatus in accordance with any one of 5 claims 13 to 23, further comprising a catheter base within the wing housing, the needle safety device jaws abutting the catheter base to secure the needle safety device for movement within the wing hous ing. 10

25. An intravenous catheter apparatus in accordance with any one of claims 13 to 24, wherein the obstruction is an annular ring.

26. An intravenous catheter apparatus in accordance with any one of claims 13 to 25, wherein the wing housing has an approximately cy 15 lindrical tube in which the needle and needle safety device travels.

27. An intravenous catheter apparatus in accordance with any one of claims 13 to 26, wherein the needle has a flared tip. 20

28. A needle safety device substantially as herein described with reference to the drawings.

29. An intravenous catheter substantially as herein described with reference to the drawings. 25