HK1129333B - Needle-based medical device including needle guide and method for constructing - Google Patents

Description

Needle-based medical device with needle guide and method for constructing same

Cross Reference to Related Applications

This application claims priority from co-pending U.S. provisional application No. 60/722163; the filing date of this No.60/722163 is 9/30 2005, which is hereby incorporated by reference.

Technical Field

This patent application relates to medical devices utilizing needles secured to hubs including, but not limited to: catheter assemblies, blood collection devices, huber needle assemblies, syringes, and other needle-based medical devices.

Background

Existing medical devices that include a needle are formed by utilizing a molded tube, a needle, and a rigid hub to which the needle is secured. The needle hub may be made from a thin extruded tube or a thin molded tube. Such devices are shown in U.S. provisional patent application nos. 60/659213, 60/659217, 60/659226 and 60/714954, all of which are incorporated herein by reference. This method of assembling a needle-based medical device has several problems associated with the use of molded tubes. One problem is the significant cost of molding the tubes used to form the device. The actual manufacture of such devices is also problematic. Molding long, thin parts for medical devices with molded tubes is difficult, especially when the core pin of the mold must be supported at its distal end. In particular, in small gauge needles, the core pin must have an extremely small diameter, making it extremely fragile, difficult to support, and difficult to center. In addition, each needle size requires a different size core pin to form the needle. Accordingly, there is a need in the art to overcome one or more of the deficiencies described herein.

Disclosure of Invention

A needle-based medical device including a needle guide and a method for constructing the same are disclosed herein. A needle-based medical device comprising: a tube having a first lumen; a needle guide sized to be inserted into the lumen of the tube; and a needle. The needle is inserted such that an end is located in the needle guide. Glue may also be provided to secure the needle guide to the tube. In one embodiment, the tube may be made of extruded plastic.

According to a first aspect of the present invention there is provided a needle-based medical device having a needle hub assembly comprising: a tube having a first lumen; a needle guide sized for at least partial insertion into the first lumen, the needle guide comprising a cylindrical body, a second lumen, at least one rib projecting longitudinally in a distal direction from the body, and a glue well, the body comprising an outer surface at a first radial distance from the longitudinal axis of the body, the at least one rib being radially spaced from the longitudinal axis of the body by a second radial distance, the second radial distance being greater than the first radial distance, wherein the at least one rib is in contact with the inner wall of the tube, a first annular space being defined between the outer surface of the cylindrical body and the first lumen of the tube; a needle having a proximal end located within the second lumen; and glue for securing the proximal end of the needle over the second lumen and securing the needle guide over the tube; the glue is in contact with the second lumen, the proximal end of the needle, the outer surface of the body, and the first lumen.

According to a second aspect of the present invention there is provided a method of constructing a needle-based medical device, the method comprising: providing a needle having a proximal end and a distal end; providing a tube having a first lumen; providing a needle guide; wherein the needle guide comprises: a cylindrical body having an outer surface at a first radial distance from a longitudinal axis of the body; a second lumen and at least one rib extending longitudinally in a distal direction from the body; and wherein the at least one rib is a second radial distance from the longitudinal axis of the body, the second radial distance being greater than the first radial distance; inserting a needle guide into the first lumen such that the at least one rib engages the first lumen and contacts the inner wall of the tube; inserting a proximal end of a needle into a needle guide; introducing glue into the glue well between the needle guide and the first lumen, thereby contacting the glue with the second lumen, the proximal end of the needle, the outer surface of the body, and the first lumen; and curing the glue.

According to a third aspect of the present invention there is provided a needle guide for use in a needle-based medical device, the needle guide comprising: a body for insertion into the first lumen of the tube, the body being cylindrical and including an outer surface at a first radial distance from a longitudinal axis of the body and a second lumen for securely positioning the proximal end of the needle; and at least two ribs extending longitudinally in a distal direction from the distal end of the body, each of the at least two ribs being radially spaced from the longitudinal axis of the body by a second radial distance, the second radial distance being greater than the first radial distance, so as to form a first annular space between the first lumen of the tube and the outer surface of the body.

The present invention provides a needle hub for a needle-based medical device, the needle hub comprising: a tube having a first lumen; a needle guide having an outer surface for engaging the inner surface and a second lumen for positioning a needle; and a glue for sealing the needle, the tube and the needle guide.

Drawings

These and other features of this invention will be more readily understood from the following detailed description of the various aspects of the invention taken in conjunction with the accompanying drawings in which:

figure 1 shows an isometric cross-sectional view of a medical device (catheter introducer) of one embodiment of the invention.

Fig. 2 shows an exploded view of a needle hub in accordance with one embodiment of the present invention.

Fig. 3 shows an isometric view of the needle guide showing the glue well.

Fig. 4 shows an isometric cross-sectional view of the assembled needle hub.

Fig. 5 shows an isometric cross-sectional view of an alternative embodiment of an assembled needle hub.

Fig. 6 shows a vertical cross-sectional view of the device of fig. 1 showing one embodiment of access to the glue well during manufacture.

Fig. 7 shows a vertical cross-sectional view of the device of fig. 1 showing another embodiment of access to the glue well during manufacture.

It should be understood that the drawings of the present invention are not necessarily to scale. The drawings are merely schematic representations, not intended to portray specific parameters of the invention. The drawings are intended to depict only typical embodiments of the invention, and therefore should not be considered as limiting the scope of the invention. In the drawings, like reference numerals denote like elements.

Detailed Description

The devices and methods disclosed herein provide improved methods for more efficiently and effectively manufacturing needle-based medical devices.

Referring now to fig. 1, one embodiment of a needle-based medical device 10 is in the form of, for example, a catheter introducer 10 having a needle shield 12. The needle shield 12 comprises components made from concentrically extruded tubes 12, 14 and 18. These concentric tubes include needle shield 12, housing 14, and needle hub 18. The use of an extrusion greatly reduces the cost of the device compared to prior devices made from moulded parts, but moulded tubes may also be used. Although the medical device 10 is shown herein as a catheter introducer assembly, it should be appreciated that the teachings of the present invention may be used with any type of needle-based device, including but not limited to catheter introducers, blood collection devices, huber needle assemblies, and syringes.

Referring now to fig. 2, tube 30, needle guide 20 and needle 16 are shown in exploded view. Needle 16 has a distal end 26 and a proximal end 28 and is secured to needle guide 20. Needle guide 20 is secured to tube 30 to form a needle and hub for needle-based medical device 10 (fig. 1). Body 22 of needle guide 20 is inserted into distal end 38 of tube 30. Proximal end 28 of needle 16 is inserted into body 22 of needle guide 20. Tube 30 may be, for example, a plastic extrusion made of polypropylene, acrylic, or other similar material, having a proximal end 36, a distal end 38, and a first lumen 32 extending between proximal end 36 and distal end 38.

Referring now to fig. 3, a more detailed view of needle guide 20 is provided. In one embodiment, needle guide 20 includes a body 22 for insertion into a first lumen 32 (fig. 2) of a tube 30 (fig. 2). Body 22 may include a second lumen 40 for positioning end 28 of needle 16 (fig. 2). In one embodiment, body 22 is generally cylindrical and further includes an outer surface 42. Body 22 is connected to distal end 38 by at least one rib 46 extending from body 22. In one embodiment, the number of ribs may be 3, and three ribs 46 may each be positioned approximately 120 degrees from the other ribs 46. It should be appreciated, however, that any number of ribs greater than one may be used. As described herein, empty space 48 is between ribs 46, and in one configuration, space 48 forms a glue well 50 adjacent the at least one rib 46 and first lumen 32 (fig. 2), and includes the space between proximal end 28 of needle 16 and second lumen 40.

Referring now to FIG. 4, there is shown a first embodiment of an assembled needle hub comprising: a tube 30 having a first lumen 32; and a needle guide 20, the needle guide 20 being sized for at least partial insertion into the first lumen 32. Needle 16 has a proximal end 28 in second lumen 40 and glue 56 is arranged to secure needle guide 20 to tube 30. Proximal end 28 of needle 16 is inserted into a second lumen 40 in needle guide 20, which is slightly larger in diameter than needle 16. In one embodiment, a friction fit is provided between second lumen 40 and proximal end 28 of needle 16 to maintain substantially circumferential contact between second lumen 40 and needle 16.

Body 22 of needle guide 20 is inserted into first lumen 32 such that it is positioned coaxially with tube 30. Needle guide 20 may include a flange 44 connected to at least one rib 46 at the distal end of needle guide 20, which is positioned to engage outer wall 34 of tube 30 when body 22 is inserted into first lumen 32. Thus, the flange 44 acts as a mechanical stop, limiting the depth to which the body 22 can be inserted into the first lumen 32. The diameter of rib 46 is just less than the diameter of first lumen 32, which provides a mechanical fit between body 22 and first lumen 32.

When the body 22 is inserted into the first lumen 32, a first annular space 52 is formed between the inner wall of the tube 30 and the outer surface 42 of the body 22. This space is theoretically measured at about 0.001-0.005 inches, which allows glue 56 to flow into first annular space 52 by capillary action as it is deposited in glue well 50. A very tight fit of the ribs 46 is not preferred as this may deform the distal end 38 of the tube 30. In one embodiment, a second annular space 54 is formed between the second lumen 40 and the outer surface of the proximal end 28 of the needle 16. In this embodiment annular space 54 is also filled with glue by capillary action as part of glue well 50; however, the second annular space 54 is not important to practice the claimed invention.

Referring now to FIG. 5, a second embodiment of the assembled needle hub is shown. According to this embodiment, needle 16 may be pre-molded in needle guide 20 and then inserted into first lumen 32. The inner surface of the tube 20 may include a depth stop to limit axial movement of the needle guide relative to the tube. The depth stop may be a pedestal 57 located on the inner surface of the tube 30. Referring to fig. 1, once needle hub 18 has been assembled, it may be used in a device such as a catheter inserter or any similar needle-based device. Needle hub 18 may also be assembled during assembly of the device.

A first embodiment of a method of constructing a needle-based medical device is also provided, wherein the device is assembled as follows. A tube 30 having a first lumen 32 is provided with needle guide 20. Needle guide 20 (e.g., body 22 of needle guide 20) is inserted into first lumen 32 until flange 44 abuts outer wall 34 of tube 30, preventing further insertion. Proximal end 28 of needle 16 is then inserted into second lumen 40 from distal end 24 of guide 20. Glue 56 is introduced into glue well 50 and then flows by capillary action into first annular space 52 between outer surface 42 of body 22 of guide 20 and the inner wall of tube 30. In embodiments including second annular space 54, glue 56 is also able to flow into second annular space 54 between needle 16 and body 22 of guide 20. Glue 56 is then cured.

A second embodiment of a method of constructing a needle-based medical device is also provided in which proximal end 28 of needle 16 is inserted into second lumen 40 from distal end 24 of needle guide 20 prior to body 22 being inserted into first lumen 32. In this case, the coefficient of friction between needle 16 and guide 20 must be greater than the coefficient of friction between guide 20 and tube 30. In alternative embodiments, a press fit or serrations in needle guide 20 may be used to hold needle guide 20 in place against the insertion force of needle 16.

Referring now to fig. 6, a first embodiment of access to glue well 50 during the manufacturing process is provided. According to this embodiment, needle shield 12 may be threaded onto needle 16 from proximal end 28 (blunt end) of needle 16. In this case, glue well 50 may be accessed through a cutout 62 in needle shield 12. Glue nozzle 64 is inserted into cutout 62 and introduces glue 56 into glue well 50.

Referring now to fig. 7, a second embodiment of access to glue well 50 during the manufacturing process is provided. According to this embodiment, glue well 50 is accessed while distal end 58 of needle shield 12 is kept separate from needle shield body 60 (but still threaded onto needle 16) during the gluing process. In this case, glue nozzle 64 is inserted into the end of lumen 66 of needle shield body 60. Glue 56 is introduced into glue well 50 and the distal end of needle shield 12 is then snapped and adhered or otherwise mounted to needle shield body 12.

The foregoing description of various aspects of the invention has been presented for purposes of illustration and description. It is not intended to limit the invention to the precise form described, and obviously, many modifications and variations are possible. Such changes and modifications as would be obvious to one skilled in the art are intended to be included within the scope of the present invention as defined by the following claims.

Claims (36)

1. A needle-based medical device having a needle hub assembly, the needle hub assembly comprising:

a tube having a first lumen;

a needle guide sized for at least partial insertion into the first lumen, the needle guide comprising a cylindrical body, a second lumen, at least one rib projecting longitudinally in a distal direction from the body, and a glue well, the body comprising an outer surface at a first radial distance from the longitudinal axis of the body, the at least one rib being radially spaced from the longitudinal axis of the body by a second radial distance, the second radial distance being greater than the first radial distance, wherein the at least one rib contacts the inner wall of the tube defining a first annular space between the outer surface of the cylindrical body and the first lumen of the tube;

a needle having a proximal end located within the second lumen; and

a glue for securing the proximal end of the needle to the second lumen and securing the needle guide to the tube; the glue is in contact with the second lumen, the proximal end of the needle, the outer surface of the body, and the first lumen.

2. The needle-based medical device of claim 1, wherein: the glue well includes a second annular space between the needle guide and the proximal end of the needle.

3. The needle-based medical device of claim 1, wherein: the glue flows into the first annular space.

4. The needle-based medical device of claim 1, wherein: a glue well is located adjacent the at least one rib and substantially within the first lumen.

5. The needle-based medical device of claim 1, further comprising: a friction fit between the proximal end of the needle and the second lumen, wherein the glue well comprises a space between the proximal end of the needle and the second lumen.

6. The needle-based medical device of claim 1, further comprising: a mechanical engagement between the first lumen and the needle guide.

7. The needle-based medical device of claim 1, further comprising: a friction fit between the proximal end of the needle and the second lumen.

8. The needle-based medical device of claim 1, wherein: the needle guide includes serrations thereon.

9. The needle-based medical device of claim 1 wherein the second lumen is in substantially circumferential contact with the proximal end of the needle.

10. The needle-based medical device of claim 1, wherein: the needle is molded onto the needle guide.

11. The needle-based medical device of claim 1, further comprising: a depth stop for limiting axial movement of the needle guide relative to the tube.

12. The needle-based medical device of claim 11, wherein: the depth stop includes one of: a flange on the needle guide or a stand in the tube.

13. The needle-based medical device of claim 11, wherein: the depth stop is a flange on the needle guide and the flange is connected to the at least one rib.

14. The needle-based medical device of claim 1, further comprising: an air tight seal between the needle guide and the tube.

15. The needle-based medical device of claim 1, wherein: the needle guide is substantially coaxial with the tube.

16. The needle-based medical device of claim 1, wherein: the needle-based medical device is a catheter introducer assembly.

17. The needle-based medical device of claim 1, wherein: the needle-based medical device is a blood collection device.

18. The needle-based medical device of claim 1, wherein: the needle-based medical device is a huber needle assembly.

19. The needle-based medical device of claim 1, wherein: the needle-based medical device is a syringe.

20. A method of constructing a needle-based medical device, the method comprising:

providing a needle having a proximal end and a distal end;

providing a tube having a first lumen;

providing a needle guide; wherein the needle guide comprises: a cylindrical body having an outer surface at a first radial distance from a longitudinal axis of the body; a second lumen and at least one rib extending longitudinally in a distal direction from the body; and wherein the at least one rib is a second radial distance from the longitudinal axis of the body, the second radial distance being greater than the first radial distance;

inserting a needle guide into the first lumen such that the at least one rib engages the first lumen and contacts the inner wall of the tube;

inserting a proximal end of a needle into a needle guide;

introducing glue into the glue well between the needle guide and the first lumen, thereby contacting the glue with the second lumen, the proximal end of the needle, the outer surface of the body, and the first lumen;

and

the glue is cured.

21. The method of claim 20, wherein: the glue well includes a first annular space between the body of the needle guide and the first lumen.

22. The method of claim 21, wherein: the glue well also includes a second annular space between the needle guide and the needle.

23. The method of claim 20, wherein: a glue well is adjacent the at least one rib and the first lumen.

24. The method of claim 20, wherein: the step of inserting the needle guide into the first lumen comprises inserting the needle guide into the tube until the needle guide abuts the end of the tube.

25. The method of claim 20, further comprising: a depth stop is provided to limit the depth of insertion of the needle guide into the tube.

26. The method of claim 20, wherein: the needle insertion is performed before inserting the needle guide into the tube.

27. The method of claim 20, wherein: needle insertion is performed after inserting the needle guide into the tube.

28. The method of claim 20, wherein: the tube is an extruded or molded tube.

29. The method of claim 20, further comprising: providing a friction fit between the needle and the needle guide.

30. The method of claim 20, further comprising: the needle shield is threaded over the needle.

31. The method of claim 20, further comprising: the needle guard is provided with an opening to access the first lumen for introducing the glue.

32. The method of claim 20, further comprising: the needle guide is press fit into the first lumen.

33. A needle guide for use in a needle-based medical device, the needle guide comprising:

a body for insertion into the first lumen of the tube, the body being cylindrical and including an outer surface at a first radial distance from a longitudinal axis of the body and a second lumen for securely positioning the proximal end of the needle; and

at least two ribs extending longitudinally in a distal direction from the distal end of the body, each of the at least two ribs being radially spaced from the longitudinal axis of the body by a second radial distance, the second radial distance being greater than the first radial distance so as to form a first annular space between the first lumen of the tube and the outer surface of the body.

34. The needle guide of claim 33, further comprising: a flange connected to the distal ends of the at least two ribs, the flange providing a depth stop by abutting the distal end of the tube.

35. The needle guide of claim 33, further comprising: a glue well for receiving glue to secure the body to the first lumen, wherein the glue well is located proximate the at least two ribs and the first lumen.

36. The needle guide of claim 35, wherein the glue well further comprises a second annular space between the needle guide and the proximal end of the needle.