WO2009091505A2

WO2009091505A2 - Needle protector device

Info

Publication number: WO2009091505A2
Application number: PCT/US2009/000065
Authority: WO
Inventors: Alfredo R. Zarate
Original assignee: Zarate Alfredo R
Priority date: 2008-01-18
Filing date: 2009-01-07
Publication date: 2009-07-23
Also published as: WO2009091505A3

Abstract

A needle protector sheath includes a body having a top wall, opposing sidewalls, and a slot in each sidewall configured to engage a needle wing.

Description

NEEDLE PROTECTOR DEVICE

CLAIM OF PRIORITY

This application claims priority to U.S. Patent Application No. 61/006,545, filed January 18, 2008, which is incorporated by reference in its entirety.

TECHNICAL FIELD

The invention relates generally to the field of needle protector devices, and has application in the field of dialysis needles.

BACKGROUND

The use of guarded fistula needles for hemodialysis has been made mandatory by the Occupational Health and Safety Administration (OSHA) to protect health care workers against accidental needle sticks and exposure to blood pathogens, principally during the process of removing the needle from the patient vascular access. Health care workers who interact with dialysis patients work at great risk of acquiring infections transmitted by accidental needle sticks. In general, fistula needles have three identifiable components: a long plastic tubing connected to an artificial kidney, two wings used to hold the needle with two fingers, and a metal segment introduced into the vascular access. Needle protector sheaths generally slide from the plastic tubing toward the metal segment at the time of removing the metal segment from the dialysis vascular access, so that after the needle has been used and removed, the metal segment is covered by the sheath and the health care worker is protected from an accidental needle stick.

SUMMARY

An exemplary medical needle protector sheath can include a first ring including a generally rectangular dorsal portion, the first ring coupled to the dorsal portion proximate a midpoint thereof, and the dorsal portion disposed on a dorsal axis. The sheath can further include a generally rectangular body including a top wall, a bottom wall, and opposing sidewalls, and a slot can be formed in each sidewall, the slot including a distal region configured to receive a needle wing and a proximal region configured to engage a needle wing in an interference fit. In some embodiments, the sheath can have a closed position in which the dorsal portion and top wall are both disposed along the dorsal axis, and the sheath can have an open position in which the top wall is disposed transverse to the dorsal axis. The ring may have a closed circular shape or a slit formed in a circumference thereof. The proximal region may have a top arcuate portion and an opposing bottom arcuate portion. The proximal region may include a first top surface and a first bottom surface with a first angle defined therebetween, and the distal region may include a second top surface and a second bottom surface with a second angle defined therebetween. The first angle may be greater than the second angle. Alternatively, the first angle may be equal to the second angle. Alternatively, the first angle may be less than the second angle. The top wall may have a length greater than a length of the bottom wall.

Another exemplary medical needle protector sheath can have a first ring including a generally rectangular first dorsal portion, the first ring coupled to the first dorsal portion proximate a midpoint thereof, and the first dorsal portion disposed on a dorsal axis. The sheath also can have a second ring proximal to the first ring, the second ring including a generally rectangular second dorsal portion, the second ring coupled to the second dorsal portion proximate a midpoint thereof, the second dorsal portion disposed on a dorsal axis, and the second dorsal portion coupled to the first dorsal portion. In addition, the sheath can have a generally rectangular body including a top wall, a bottom wall, and opposing sidewalls, as well as a slot formed in each sidewall, the slot including a distal region configured to receive a needle wing, and a proximal region configured to engage a needle wing in an interference fit, for example.

In some embodiments, the sheath can have a closed position in which the dorsal portion and top wall are both disposed along the dorsal axis, and an open position in which the top wall is disposed transverse to the dorsal axis. In some embodiments, at least one of the first and second rings may have a closed circular shape. At least one of the first and second rings may have a slit formed in a circumference thereof. The proximal region may include a top arcuate portion and an opposing bottom arcuate portion. The proximal region may have a first top surface and a first bottom surface with a first angle defined therebetween, and the distal region comprises a second top surface and a second bottom surface with a second angle defined therebetween. The first angle may be greater than the second angle. Alternatively, the first angle may be equal to the second angle. Alternatively, the first angle is less than the second angle. The top wall may have a length greater than a length of the bottom wall. An exemplary dialysis method may include: coupling tubing to a needle hub, the needle hub comprising a needle metal segment; coupling a medical needle protector sheath to the tubing, the sheath comprising (1) a first ring including a generally rectangular first dorsal portion, with the first ring coupled to the first dorsal portion proximate a midpoint thereof, and the first dorsal portion disposed on a dorsal axis and (2) a generally rectangular body including a top wall, a bottom wall, and opposing sidewalls; exposing the needle metal segment by orienting the top wall of the body to be transverse to the dorsal axis; introducing the needle metal segment into a vascular access; removing the needle metal segment from the vascular access and surrounding the needle metal segment with the body so that the top wall is disposed along the dorsal axis.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a first embodiment of a needle protector device, the side view taken parallel to a central longitudinal axis of a needle; FIG. IA is a cross-section of the needle protector device of FIG. 1;

FIG. IB is an alternative cross-section of the needle protector device shown in FIG. IA;

FIG. 1C is another cross-section of the needle protector device of FIG. 1; FIG. 2 is a side view of a second embodiment of a needle protector device in a closed position; and

FIG. 3 is a side view of another embodiment of a needle protector device in an open position.

FIG. 4 is a representation of a needle protector device coupled to a plastic tubing.

DETAILED DESCRIPTION It should be understood that terms such as "top," "bottom," "upper," "lower,"

"upward" and "downward," "proximal," and "distal" as used herein are provided as non- limiting examples of the orientation of features.

Referring to FIGS. 1-lC, a medical needle protector sheath 100 can include a first ring 10 for receiving tubing for example connected to an artificial kidney. First ring 10 has a dorsal portion 11 disposed on a dorsal axis Ia. The dorsal axis Ia is parallel to a central longitudinal axis Ib of the needle protector device. In an exemplary embodiment shown in FIGS. 1 and 1C, sheath 100 further includes a generally rectangular body 12 having a top wall 13a and a parallel, bottom wall 13b, as well as opposing, parallel sidewalls 14. A slot 14a may be formed in each sidewall 14, and may taper toward first ring 10. In the exemplary embodiment of FIG. 1, body 12 is coupled to first ring 10 by a short segment therebetween proximate dorsal axis Ia, with first ring 10, body 12, and the segment defining a cutout region permitting visualization of a portion of the tubing. However, in some embodiments, the short segment may not be provided and first ring 10 may be directly coupled to body 12. In a preferred exemplary embodiment, first ring 10 and body 12 are integrally formed.

Each sidewall 14 with slot 14a includes a distal region 16 configured to receive a needle wing 15, and a proximal region 17 configured to engage the needle wing for example in an interference fit. As known in the art, a health care practitioner for example may manipulate a needle using a pair of wings 15 that may be folded toward each other and gripped by the practitioner to facilitate insertion or removal of the metal segment of the needle 1 into the vascular access of the patient. In the exemplary embodiment shown in FIG. 1, proximal region 17 of slot 14a is defined by a top arcuate region 19a and an opposing bottom arcuate region 19b which together define a space that may be configured and dimensioned to engage a needle wing 15 in an interference fit, for example.

Turning to FIG. IA, in an exemplary embodiment, first ring 10 may be generally cylindrical and can include a generally rectangular dorsal portion 11. As shown, ring 10 can form a closed circular shape when viewed in cross-section A-A. Alternatively, as shown in FIG. IB, ring 10 can form an incomplete circle when viewed in cross-section A-A, such that for example a slit is formed in the circumference of ring 10. This latter alternative embodiment may facilitate attachment and/or removal of ring 10 from the tubing that is coupled to the needle metal segment (such as by providing a snap-fit with flexible opposing portions of ring 10). In the exemplary embodiment, dorsal portion 11 is integrally formed with first ring 10 and ring 10 is coupled to dorsal portion 11 at a midpoint thereof.

Referring to FIG. 1C, showing body 12 of the exemplary embodiment in cross- section C-C, a hollow region is defined in sheath body 12 between top wall 13a, bottom wall 13b, and opposing side walls 14.

Turning next to FIG. 2, another exemplary embodiment of a medical needle protector sheath is shown. The sheath can include a first ring 20 including a first dorsal portion 21 and a second ring 25 proximal to first ring 20 and including a second dorsal portion 25a. First and second rings 20, 25, respectively, are coupled to one another for example with a short segment therebetween. Moreover, a short segment may be provided between first ring 20 and body 22, although in some embodiments no segment is provided therebetween. The sheath further includes a top wall 23a, a bottom wall 23b, and opposing sidewalls 24 (as in the embodiment of FIG. 1C with opposing sidewalls 14) with a slot formed in each sidewall. The slot includes a distal region 26 and a proximal region 27. Each of the distal and proximal regions 26, 27, respectively, may taper toward first ring 20. Distal region 26 is configured to receive and guide a needle wing, and proximal region 27 is configured to engage a needle wing in an interference fit.

In the exemplary embodiment, the sheath can have a closed position wherein dorsal portion 21 and top wall 23a lie in a dorsal axis 2a is parallel to a central longitudinal axis 2b of the needle protector device. The closed position is generally the position the sheath takes when the top wall 23a covers the exposed metal tip of a needle, and when the proximal region of the sheath slot engages a needle wing on each side. The sheath may also have an open position wherein the top wall is oriented transverse to the central longitudinal axis, and the proximal region of the sheath is not engaged to a needle wing on each side. Proximate an end of body 22 and near first ring 20 (or proximate the end of the segment that is adjacent ring 20 where the segment meets body 22), a hinge or hinge-like portion may be provided to permit the sheath to be bent and thus disposed in an open position. With continuing reference to FIG. 2, the dorsal axis 2a is parallel to a central longitudinal axis 2b of the needle protector device. In the closed position, the top portion can extend as far as the metal needle tip, e.g., the free end of the metal segment of the needle so as to cover the entire length of the metal needle segment.

In distal region 26 of body 22, the slot can be defined by a lower surface 23c of top wall 23a and an upper surface 23d of bottom wall 23b. The slot can have an upper length defined between upper distal tip 23e and upper middle tip 23f. Also, the slot can have a lower length defined between lower distal tip 23g and lower middle tip 23h, resulting in an arrow-like shape when viewed from a side perspective. Surfaces 23c, 23d can be disposed at an angle θ₂ with respect to each other, which in the exemplary embodiment may be between about 5° and about 20°.

In proximal region 27 of body 22, the slot can be defined by a proximal upper surface 23j of top wall 23a and a proximal lower surface 23k of bottom wall 23b. Upper and lower surfaces 23j, 23k, respectively, may converge at a proximal corner 23i. The proximal upper and lower surfaces 23j, 23k, respectively, may be disposed at an angle θi with respect to each other, which in the exemplary embodiment may be between about 10° and about 30°. In an exemplary embodiment, as shown in FIG. 2, the proximal region and distal region can have an overlapping region 26', particularly, where the upper middle tip and lower middle tip are positioned. Next, referring to FIG. 3, in some exemplary embodiments, the sheath of a needle protector device can have an open position wherein, for example, a dorsal tip 31 of a ring 30 and a top wall 33a of a body 32 are disposed transverse to each other. In the exemplary embodiment, the open position is generally the position in which the sheath is disposed when not protecting the metal segment of the needle. Next, referring to FIG. 4, once a user such as a health care worker decides to employ a protective sheath 40 as disclosed herein, the sheath can be coupled to plastic tubing 44 that further is connected to a needle hub. As known in the art, a needle hub is a needle assembly typically including a metal segment 49 with having a needle tip, and a butterfly wing portion proximate a distal end of the metal segment wherein the wing portion includes a first needle wing 48a, a second needle wing 48b, and a metal needle segment 49. A heath care practitioner can slide the protective sheath along the length of a plastic tubing, and once dialysis is completed, engage the needle hub, such that the protective sheath covers the metal needle segment.

Depending on the shape of the ring of the sheath, a protective sheath can be attached to plastic tubing attached to a needle before hemodialysis begins. Alternatively, the protective sheath can be attached to plastic tubing during hemodialysis, or after completion of hemodialysis. For example, as discussed above, if a ring is a complete circle, the sheath can be attached to a plastic tubing before hemodialysis begins, as the ring may be semi-permanently or permanently encircling the plastic tubing. The complete circle configuration can therefore minimize the risk of losing the sheath and simplify the packaging of multiple medical parts.

Alternatively, the ring can be in the form of an incomplete circle. For example, the incomplete circle can be formed by two arcs with a space therebetween. The ring can be pushed onto plastic tubing to engage it in an interference fit. An incomplete circle can allow the sheath to be easily detached or attached from the plastic tubing, thereby allowing the sheath to be positioned on the plastic tubing even after hemodialysis has started. The incomplete circle can therefore provide a more streamlined assembly during dialysis, and be used only when necessary, therefore minimizing risk of entanglement or other equipment interference. A two-ring configuration, such as shown in FIGS. 2 and 3, can be used to provide additional stability for the protector sheath. Various configurations are possible. For example, both rings can be complete circles. Alternatively, both rings can be incomplete circles. In other circumstances, one ring can be a complete circle, and another can be an incomplete circle. More than two rings also can be provided, for example if more stability is desired.

A slot can have two regions: a proximal and distal region. In an exemplary embodiment, the proximal region can be curved or "C" shaped, defined by two arcuate regions when viewed from a side perspective. Instead, in an exemplary embodiment, the proximal region can be angular or "V" shaped, defined by two converging straight surfaces when viewed from a side perspective. Likewise, the distal region can be curved or angular.

In some exemplary embodiments, the distal region can have a greater length than the proximal region. The distal region can have a length equal to or greater than the length of an exposed portion of a needle, such that the distal region is configured to cover the exposed metal tip. The proximal region can have a length greater than or equal to the length of a portion of a needle wing, such that the proximal region can engage a needle wing in an inference fit.

The proximal region and distal region can be joined by an upper middle tip and a lower middle tip. The upper and lower middle tips can be fingers, flanges, or protrusions, thereby maintaining an interference fit of a needle wing, and preventing a needle wing from slipping out from the proximal region.

The instant protector sheath provides pre-removal activation, protects fingers of a health care worker during needle removal, and allows for the immediate application of double finger pressure upon needle removal. The instant safety mechanism provides immediate, simple and complete protection without increasing the rigid length or diameter of a needle assembly and without restricting the overall flexibility of the plastic tubing.

A number of embodiments have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

Claims

THE CLAIMSI claim:

1. A medical needle protector sheath comprising:

(a) a first ring including a generally rectangular dorsal portion, the first ring coupled to the dorsal portion proximate a midpoint thereof, and the dorsal portion disposed on a dorsal axis;

(b) a generally rectangular body including a top wall, a bottom wall, and opposing sidewalls; and

(c) a slot formed in each sidewall, the slot including a distal region configured to receive a needle wing, and a proximal region configured to engage a needle wing in an interference fit.

2. The sheath of claim 1, wherein the sheath has a closed position in which the dorsal portion and top wall are both disposed along the dorsal axis, and wherein the sheath has an open position in which the top wall is disposed transverse to the dorsal axis.

3. The sheath of claim 1 , wherein the ring has a closed circular shape.

4. The sheath of claim 1 , wherein the ring has a slit formed in a circumference thereof.

5. The sheath of claim 1, wherein the proximal region comprises a top arcuate portion and an opposing bottom arcuate portion.

6. The sheath of claim 1 , wherein the proximal region comprises a first top surface and a first bottom surface with a first angle defined therebetween, and the distal region comprises a second top surface and a second bottom surface with a second angle defined therebetween.

7. The sheath of claim 6, wherein the first angle is greater than the second angle.

8. The sheath of claim 6, wherein the first angle is equal to the second angle.

9. The sheath of claim 6, wherein the first angle is less than the second angle.

10. The sheath of claim 1 , wherein the top wall has a length greater than a length of the bottom wall.

1 1. A medical needle protector sheath comprising:

(a) a first ring including a generally rectangular first dorsal portion, the first ring coupled to the first dorsal portion proximate a midpoint thereof, and the first dorsal portion disposed on a dorsal axis; (b) a second ring proximal to the first ring, the second ring including a generally rectangular second dorsal portion, the second ring coupled to the second dorsal portion proximate a midpoint thereof, the second dorsal portion disposed on a dorsal axis, and the second dorsal portion coupled to the first dorsal portion;

(c) a generally rectangular body including a top wall, a bottom wall, and opposing sidewalls; and

(d) a slot formed in each sidewall, the slot including a distal region configured to receive a needle wing, and a proximal region configured to engage a needle wing in an interference fit.

12. The sheath of claim 1 1 , wherein the sheath has a closed position in which the dorsal portion and top wall are both disposed along the dorsal axis, and wherein the sheath has an open position in which the top wall is disposed transverse to the dorsal axis.

13. The sheath of claim 11, wherein at least one of the first and second rings has a closed circular shape.

14. The sheath of claim 1 1 , wherein at least one of the first and second rings has a slit formed in a circumference thereof.

15. The sheath of claim 1 1 , wherein the proximal region comprises a top arcuate portion and an opposing bottom arcuate portion.

16. The sheath of claim 1 1, wherein the proximal region comprises a first top surface and a first bottom surface with a first angle defined therebetween, and the distal region comprises a second top surface and a second bottom surface with a second angle defined therebetween.

17. The sheath of claim 16, wherein the first angle is greater than the second angle.

18. The sheath of claim 16, wherein the first angle is equal to the second angle.

19. The sheath of claim 16, wherein the first angle is less than the second angle.

20. The sheath of claim 11, wherein the top wall has a length greater than a length of the bottom wall.

21. A dialysis method comprising: coupling tubing to a needle hub, the needle hub comprising a needle metal segment and a pair of wings; coupling a medical needle protector sheath to the tubing, the sheath comprising (1) a first ring including a generally rectangular first dorsal portion, with the first ring coupled to the first dorsal portion proximate a midpoint thereof, and the first dorsal portion disposed on a dorsal axis and (2) a generally rectangular body including a top wall, a bottom wall, and opposing sidewalls, each sidewall including a slot; exposing the needle metal segment by orienting the top wall of the body to be transverse to the dorsal axis; introducing the needle metal segment into a vascular access; removing the needle metal segment from the vascular access and surrounding the needle metal segment with the body so that the top wall is disposed along the dorsal axis.

22. The method of claim 21 further comprising folding the wings toward each other while inserting the needle metal segment in a mammal.

23. The method of claim 21 further comprising folding the wings toward each other while removing the needle metal segment from a mammal.

24. The method of claim 21 further comprising sliding the first ring of the protector sheath along the length of a tubing toward the needle hub.

25. The method of claim 24 further comprising inserting the needle metal segment into a mammal.

26. The method of claim 25 further comprising removing the needle metal segment from a mammal, bending the body of the protector sheath to cover the needle metal segment, and causing the slots in the opposing sidewalls to engage the pair of wings in the needle hub.