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Surgical Needle Patent
 

Combined surgical needle-suture device

Surgical needle abstract

A combined surgical needle-suture device is provided by attaching the reduced shank of a needle and the tip region of a suture to each other through a heat shrinkable tubing fitted around both, the axial length of the tubing bearing a defined relationship to the effective axial length of the needle shank. In the preferred detachable needle-suture device, a removal interface having a predetermined axial length and/or contact area is defined between a shrinkable tubing having a predetermined axial length and a suture tip region.

Surgical needle claims

What is claimed is:

1. A combined surgical needle-suture device which comprises:

(a) a needle having a shank of reduced cross-section;

(b) a suture; and,

(c) a shrinkable tubing around said needle shank and a portion of said suture, the ratio of the axial length of the tubing to the effective axial length of the needle shank being at least about 4:1 when the needle is intended to be non-detachable from the suture and no more than about 3.5:1 when the needle is intended to be detachable from the suture.

2. The combined surgical needle-suture device of claim 1 wherein the device is of the non-detachable type and said ratio is at least about 4.5:1.

3. The combined surgical needle-suture device of claim 1 wherein the device is of the non-detachable type and said ratio does not exceed about 12:1.

4. The combined surgical needle-suture device of claim 1 wherein the device is of the non-detachable type and said ratio does not exceed about 9.5:1.

5. The combined surgical needle-suture device of claim 1 wherein the device is of the detachable type and said ratio does not exceed about 3.2:1.

6. The combined surgical needle-suture device of claim 1 wherein the device is of the detachable type and said ratio is not less than about 1.2:1.

7. The combined surgical needle-suture device of claim 1 wherein the device is of the detachable type and said ratio is not less than about 1.4:1.

8. The combined surgical needle-suture device of claim 1 wherein the device is of the detachable type and said ratio is in the range of about 1.6 to 2.3.

9. The combined surgical needle-suture device of claim 1 wherein the device is of the detachable type and said shrinkable tubing has an axial length of about 0.125 inch.

10. The combined surgical needle-suture device of claim 1 wherein the device is of the detachable type and said shrinkable tubing has an axial length of about 0.115 inch.

11. The combined surgical needle-suture device of claim 1 wherein the ratio of the axial length of the tubing to the effective axial length of the suture tip is in the range of from about 1.8 to about 2.6.

12. The combined surgical needle-suture device of claim 1 wherein the axial length of the tubing is in the range of from about 0.115 to about 0.160 inches.

13. A plurality of combined surgical needle-suture devices, each such device comprising:

(a) a needle having a shank of reduced cross-section;

(b) a suture; and,

(c) a shrinkable tubing around said needle shank and a portion of said suture, a surface contact area defined between said shrinkable tubing and at least one of said needle shank and/or suture to provide a detachable needle-suture device, said surface contact area having an effective axial length in the range of from about 0.045 to about 0.105 inch; and,

each said needle-suture combination meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and said plurality of needle-suture combinations exhibiting a standard deviation in average pull-out force of less than or equal to about 0.15.

14. A combined surgical needle-suture device which comprises:

(a) a needle having a shank of reduced cross-section;

(b) a suture; and

(c) a shrinkable tubing around said needle shank and a portion of said suture, a surface contact area defined between said shrinkable tubing and at least one of said needle shank and/or suture to provide a detachable needle-suture device, said surface contact area having an effective axial length in the range of from about 0.045 to about 0.105 inch,

wherein the ratio of the axial length of the tubing to the effective axial length of the needle shank does not exceed about 3.5:1.

15. The combined surgical needle-suture device of claim 14 wherein said ratio is in the range of from about 1.6 to about 2.3.

16. A combined surgical needle-suture device which comprises:

(a) a needle having a shank of reduced cross-section;

(b) a suture; and,

(c) a shrinkable tubing having an axial length in the range of from about 0.115 to about 0.160 inches, the shrinkable tubing disposed around the needle shank and a portion of said suture to join the suture and needle defining a pull-out force for a detachable needle-suture combination.

17. A method for attaching a surgical needle to a suture comprising:

(a) providing a needle having a shank of reduced cross-section;

(b) placing a shrinkable tubing around the reduced diameter shank and the suture, the axial length of the tubing to the effective axial length of the needle shank being at least about 4:1 when the needle is intended to be non-detachable from the suture and no more than about 3.5:1 when the needle is intended to be detachable from the suture; and,

(c) applying energy to the shrinkable tubing to bring the tubing into engagement with the needle shank and suture.

18. The method of claim 17 wherein the device is of the non-detachable type and said ratio is at least 4.5:1.

19. The method of claim 17 wherein the device is of the non-detachable type and said ratio does not exceed about 12:1.

20. The method of claim 17 wherein the device is of the non-detachable type and said ratio does not exceed about 9.5:1.

21. The method of claim 17 wherein the device is of the detachable type and said ratio does not exceed about 3.2:1.

22. The method of claim 17 wherein the device is of the detachable type and said ratio is not less than about 1.2:1.

23. The method of claim 17 wherein the device is of the detachable type and said ratio is not less than about 1.4:1.

24. The method of claim 17 wherein the device is of the detachable type and said ratio is in the range of from about 1.6 to about 2.3.

25. The method of claim 17 wherein the device is of the detachable type and said tubing has an axial length in the range of from about 0.115 to about 0.160 inches.

26. A method for attaching a plurality of surgical needles to sutures to provide a plurality of detachable needle-suture devices comprising:

(a) providing a plurality of needles having a shank of reduced cross-section;

(b) placing a shrinkable tubing around each reduced needle shank and a suture;

(c) applying energy to the shrinkable tubing to bring the tubing into engagement with the needle shank and suture so as to define a surface contact area between each shrinkable tubing and the needle shank, the suture or the needle shank and the suture, the surface contact area having an effective axial length in the range of from about 0.045 to about 0.105 inches, and,

(d) controlling said energy application to provide a plurality of devices meeting the pull-out force limits for removable needle attachment set forth in the United states Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.15.

27. The method of claim 26 wherein said applied energy is heat and said tubing remains shrunken after cooling, whereby said needle shank and suture remain coupled after cooling.

28. A method for attaching a plurality of surgical needles to sutures to provide a plurality of detachable needle-suture devices comprising:

(a) providing a plurality of needles having a shank of reduced cross-section;

(b) placing a shrinkable tubing having an axial length in the range of from about 0.115 to about 0.160 inches around each reduced needle shank and a suture;

(c) applying energy to the shrinkable tubing to bring the tubing into engagement with each needle shank and suture to join the needle and suture; and,

(d) controlling said energy application to provide a plurality of needle-suture devices meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.15.

29. The method of claim 28 wherein said applied energy is heat and said tubing remains shrunken after cooling, whereby said needle shank and suture remain coupled after cooling.

30. A combined surgical needle-suture device which comprises:

(a) a needle having a shank of reduced cross-section;

(b) a suture; and

(c) a shrinkable tubing around said needle shank and a portion of said suture, a surface contact area defined between said shrinkable tubing and at least one of said needle shank and/or suture to provide a detachable needle-suture device, said surface contact area having a contact area in the range of about 0.001 to about 0.008 square inches.

31. The combined surgical needle-suture device of claim 30 wherein said contact area is in the range of from about 0.001 to about 0.006 square inches.

32. The combined surgical needle-suture device of claim 30 wherein the ratio of the axial length of the tubing to the effective axial length of the needle shank does not exceed about 3.5:1.

33. The combined surgical needle-suture device of claim 32 wherein said ratio is in the range of from about 1.6 to about 2.3.

34. The combined surgical needle-suture device of claim 30 wherein the ratio of the axial length of the tubing to the effective axial length of the suture tip is in the range of from about 1.8 to about 2.6.

35. The combined surgical needle-suture device of claim 30 wherein the axial length of the tubing is in the range of from about 0.115 to 0.160 inches.

36. The combined surgical needle-suture device of claim 30 wherein the axial length of the surface contact area is in the range of from about 0.04 to about 0.105 inches.

37. A combined surgical needle-suture device which comprises:

(a) a needle having a shank of reduced cross-section;

(b) a suture; and,

(c) a shrinkable tubing around said needle shank and a portion of said suture, a surface contact area defined between said shrinkable tubing and said suture to provide a detachable needle-suture device, said surface contact area related to suture size substantially as follows:

38. The combined surgical needle-suture device of claim 37 wherein the axial contact length of said tube and suture is in the range of from about 0.045 inches to about 0.105 inches.

39. The combined surgical needle-suture device of claim 37 wherein the tip of said suture has a diameter related to suture size substantially as follows:

40. The combined surgical needle-suture device of claim 37 wherein the surface contact area is related to suture size substantially as follows:

41. The combined surgical needle-suture device of claim 40 wherein the axial contact length of said tube and suture is in the range of from about 0.060 to about 0.090 inches.

42. The combined surgical needle-suture device of claim 40 wherein the tip of said suture has a diameter related to suture size substantially as follows:

43. The combined surgical needle-suture device of claim 40 where the ratio of the axial length of the tubing to the effective axial length of the needle shank is not less than about 1.2:1.

44. The combined surgical needle-suture device of claim 40 wherein said suture is a braided suture.

45. The combined surgical needle-suture device of claim 44 wherein said suture is tipped with cyanoacrylate.

46. The combined surgical needle-suture device of claim 37 wherein said suture is a monofilament suture.

47. The combined surgical needle-suture device of claim 37 wherein said suture is a braided suture.

48. A shrinkable tubing configured and dimensioned to engage a portion of a surgical suture and a needle to attach same in a substantially axial end-to-end relationship, the shrinkable tubing having a minimum expanded inner diameter and a maximum recovered inner diameter related to suture size substantially as follows:

49. A combined surgical needle-suture device which comprises:

(a) a needle having a shank of reduced cross-section;

(b) a suture; and,

(c) a shrinkable tubing configured and dimensioned to surround at least a portion of said needle shank and suture to attach same and provide a detachable needle-suture device, said needle shank, suture and tubing dimensions related to each other substantially as follows:

50. The needle-suture combination of claim 49 wherein said tubing has a maximum recovered wall thickness substantially as follows:

51. A plurality of detachable needle-suture combinations each comprising a size 0 braided synthetic absorbable suture joined to a needle, the plurality of needle-suture combinations meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.15

wherein the suture is joined to a needle having a reduced diameter shank by a heat shrinkable tubing surrounding at least a portion of the needle shank and a portion of the suture.

52. A plurality of detachable needle-suture combinations, each comprising a size 4/0 braided synthetic absorbable suture joined to a needle, the plurality of needle-suture combinations meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.05

wherein the suture is joined to a needle having a reduced diameter shank by a heat shrinkable tubing surrounding at least a portion of the needle shank and a portion of the suture.

53. A plurality of detachable needle-suture combinations, each comprising a size 0 monofilament polypropylene suture joined to a needle, the plurality of needle-suture combinations meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.05

wherein the suture is joined to a needle having a reduced diameter shank by a heat shrinkable tubing surrounding at least a portion of the needle shank and a portion of the suture.

54. A plurality of detachable needle-suture combinations, each comprising a size 2/0 monofilament polypropylene suture joined to a needle, the plurality of needle-suture combinations meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.03

wherein the suture is joined to a needle having a reduced diameter shank by a heat shrinkable tubing surrounding at least a portion of the needle shank and a portion of the suture.

55. A plurality of detachable needle-suture combinations, each comprising a size 2/0 braided nylon suture joined to a needle, the plurality of needle-suture combinations meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.04

wherein the suture is joined to a needle having a reduced diameter shank by a heat shrinkable tubing surrounding at least a portion of the needle shank and a portion of the suture.

56. A plurality of detachable needle-suture combinations, each comprising a size 3/0 braided nylon suture joined to a needle, the plurality of needle-suture combinations meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.30

wherein the suture is joined to a needle having a reduced diameter shank by a heat shrinkable tubing surrounding at least a portion of the needle shank and a portion of the suture.

57. A plurality of detachable needle-suture combinations, each comprising a size 0 braided nylon suture joined to a needle, the plurality of needle-suture combinations meeting the pull-out force limits for removable needle attachment set forth in the United States Pharmacopeia and exhibiting a standard deviation in average pull-out force of less than or equal to about 0.11

wherein the suture is joined to a needle having a reduced diameter shank by a heat shrinkable tubing surrounding at least a portion of the needle shank and a portion of the suture.

Surgical needle description

BACKGROUND OF THE INVENTION

The present invention relates to a combined surgical needle-suture device and, more particularly, to such a device in which a shrinkable tubing attaches a suture to a surgical needle.

For many years, surgeons have employed needle-suture combinations in which the tip of the suture or ligature is attached to the blunt, or shank, end of the needle. Such needle-suture combinations are provided for a wide variety of monofilament and braided suture materials, e.g., nonabsorbable materials such as surgical gut, silk, nylon, polyester, polypropylene, linen and cotton, and absorbable materials such as the synthetic polymers and copolymers of glycolic and lactic acids.

Needle-suture combinations fall into two general classes: standard needle-suture devices and standard detachable needle-suture devices. In the case of standard needle-suture devices, the suture is securely attached to the needle and is not intended to be separable therefrom except by a deliberate cutting or severing of the suture. By contrast, in standard detachable needle-suture devices, separation of the needle from the suture is achieved by application of a separation, or pull-out, force applied by the surgeon. Minimum acceptable pull-out forces required to separate a needle from a suture (for various suture sizes) are set forth in the United States Pharmacopeia (USP). The United States Pharmacopeia prescribes minimum individual pull-out forces and minimum average pull-out forces as measured for five needle-suture combinations. The minimum pull-out forces for both standard and removable needle-suture attachment set forth in the USP are hereby incorporated by reference and are as follows.

______________________________________ Standard Needle Attachment for Absorbable And Nonabsorbable Sutures Metric Size Limits on Needle (Gauge No.) Attachment Nonabsorbable Indi- Absorbable and Synthetic Average vidual (Collagen) Absorbable UPS (kgf) (kgf) Suture Suture Size (Min.) (Min.) ______________________________________ 0.1 11-0 0.007 0.005 0.2 10-0 0.014 0.010 0.4 0.3 9-0 0.021 0.015 0.5 0.4 8-0 0.050 0.025 0.7 0.5 7-0 0.080 0.040 1 0.7 6-0 0.17 0.08 1.5 1 5-0 0.23 0.11 2 1.5 4-0 0.45 0.23 3 2 3-0 0.68 0.34 3.5 3 2-0 1.10 0.45 4 3.5 0 1.50 0.45 5 4 1 1.80 0.60 6 & larger 5 & larger 2 & larger 1.80 0.70 ______________________________________ The requirements are met if neither the average of 5 values nor any individual value is less than the limit given in the foregoing table.

______________________________________ Removable Needle Attachment for Absorbable and Nonabsorbable Sutures Metric Size (Gauge No.) Nonabsorbable Attachment Limits Absorbable and Synthetic USP Minimum Maximum (Collagen) Absorbable Size (kgf) (kgf) ______________________________________ 1.5 1 5-0 2 1.5 4-0 3 2 3-0 3.5 3 2-0 0.028 1.59 4 3.5 0 5 4 1 6 5 2 ______________________________________

One typical method for securing a suture to a needle involves providing a cylindrical recess in the shank end of a needle and securing a suture therein. For example, U.S. Pat. No. 1558037 teaches the addition of a cement material to such a substantially cylindrical recess to secure the suture therein. Additional methods for bonding a suture within a needle bore are described in U.S. Pat. Nos. 2928395 (adhesives) and 3394704 (bonding agents). Alternatively, a suture may be secured within an axial bore in a needle by swaging the needle in the region of the recess. See, e.g., U.S. Pat. No. 1250114. Additional prior art methods for securing a suture within a needle bore include expansion of a catgut suture through the application of heat (U.S. Pat. No. 1665216), inclusion of protruding teeth within the axial bore to grasp an inserted suture (U.S. Pat. No. 1678361) and knotting the end of the suture to be inserted within the bore to secure the suture therein (U.S. Pat. No. 1757129).

Methods for detachably securing a suture to a needle are also well known. For example, U.S. Pat. Nos. 3890975 and 3980177 teach swaging a suture within a needle bore such that the suture has a pull-out valve of 3 to 26 ounces. Alternative detachable attachment methods include providing a weakened suture segment (U.S. Pat. No. 3949756), lubricant tipping the end of a suture to be inserted in the axial bore of a needle (U.S. Pat. No. 3963031) and pre-tensioning a suture that is swaged within an axial needle bore (U.S. Pat. No. 3875946). See also, U.S. Pat. Nos. 3799169; 3880167; 3924630; 3926194; 3943933; 3981307; 4124027; and, 4127133.

Another method for attaching a suture to a needle involves the use of tubing which is secured to the shank end of the needle and to the suture. For example, U.S. Pat. No. 1613206 describes the use of a tubing (preferably silver) which is secured to the shank end of a needle and to a ligature. It is suggested that the tube may be attached to the needle by pressure or soldering and to the ligature by pressure or cementing. It is also suggested that the shank of the needle be of reduced cross section and that the furthest extremity of the reduced diameter shank section be provided with a spike or point upon which the suture may be secured prior to tube application.

U.S. Pat. No. 2240330 describes a tubing attachment method whereby the tubing and suture are releasably secured to the needle. In particular, the needle and tubing are provided with cooperating catch and abutment means which are released one from the other by rotating the needle 90.degree. relative to the tubing (or vice versa). The tubing is manufactured from spring-tempered carbon steel or chrome nickel steel and is secured to the suture by heating the tubing and then swaging to the suture.

U.S. Pat. No. 3311100 relates to a flexible composite suture having a tandem linkage. The needle is secured to a flexible suture leader manufactured from a readily sterilizable plastic such as nylon, linear polyethylene, isotactic polypropylene, polyester, silk or other proteinaceous material, e.g. by inserting and crimping the leader within an axial bore in the needle shank. The opposite end of the suture leader is crimped within a connector sleeve of a thin walled metal tubing, e.g., stainless steel. The opposite end of the tubing is crimped around a stiff suture, e.g., monofilament stainless steel.

U.S. Pat. No. 3918455 describes a needle-suture attachment wherein a hollow suture portion is secured to the shank end of a needle which is of reduced cross-section as compared to the remainder of the needle.

Additional patents which describe the use of tubing to effect suture-needle attachment include U.S. Pat. Nos. 4672734 (forming needle from U-shaped metal plate around suture), 4359053 (silicone tubing), 3835912 (laser welding of metal tube to needle), 2814296 2802468 (chamfered tubing ends), 2302986 2240330 1981651 (needle and tubing screw threaded), 1960117 and 1591021.

Numerous disadvantages exist with methods used heretofore to effect needle-suture attachment. For example, those methods which involve the formation and use of an axial bore in the shank end of the needle require the use of expensive hole forming equipment. Moreover, it is difficult to maintain the bore concentric with the center-line of the needle and to control the depth (and diameter) of the bore when drilling the needle shank, whether using conventional drilling equipment or laser drilling. Another disadvantage is the possibility that foreign substances may inadvertently or uncontrollably be introduced into the needle bore, e.g., oil used during drilling or silicone from the needle silconization process. Safeguards employed in an attempt to prevent the introduction of such foreign materials, e.g., water blocking during needle silconization, are inconvenient, adding time, effort and cost to the needle production process.

Attachment processes which employ bored needle shanks also limit the range of materials from which needles may be fabricated in a cost effective fashion. For example, it is exceedingly difficult to drill Series 300 stainless steel (laser drilling is required) and, once drilled, it is difficult to swage Series 300 stainless steel in a consistent and reliable manner. For this reason, Series 300 stainless steel is not employed for the vast majority of needled suture products despite its advantageous combination of strength and ductility characteristics as compared to conventionally employed Series 400 stainless steel.

Additional disadvantages associated with needle-suture attachment methods which employ bored needle shanks include the weakness imparted to the bored section of the needle, particularly after swaging, and the attendant increased possibility that the needle will fracture in this region. It is also difficult to provide a specialized surface finish to the needle shank to assist in needle attachment, e.g., a texturized surface and/or a tapered bore. Swaging equipment used in such needle-suture attachment methods is also maintenance intensive.

Needle-suture attachment methods which have employed tubings heretofore also exhibit numerous disadvantages. Methods which employ metal tubings greatly diminish the flexibility of the needle-suture combination in the attachment region. Such diminished flexibility has a deleterious effect in many surgical procedures. Swaging of the tubing to the needle and the suture is also undesirable in that swaging is time-consuming, maintenance intensive, and subject to variability in attachment force.

Moreover, needle-suture attachment methods which have employed tubings heretofore have necessarily required the use of tubing having an inner diameter essentially equal to the outer diameters of the needle shank and suture tip to be attached. Too large a difference between the aforesaid inner and outer diameters inhibits the attachment process, and prevents a tight, secure interface between needle (and/or suture) and tubing. The limited tolerance between the tubing inner diameter and the needle shank/suture outer diameters in such methods make these dimensions critical, thereby making the attachment process more difficult and time-consuming, and increasing the likelihood of attachment failure and/or rejected materials.

With regard to conventional detachable needles, a further disadvantage is that such needles heretofore have been attached by swaging or crimping. It is difficult to sufficiently control the swaging process in day to day manufacture so as to consistently obtain suture-needle devices which consistently detach under the same force with minimal variation in detachment force. Indeed, conventional swaged detachable needles have been observed to fail prematurely under minimal force, e.g. in removing the suture from the package, or to fail to yield under considerable force. Such events can result in unnecessary waste, lost time and, at worst, unavailability of a suture-needle to the surgeon when needed.

Commonly assigned, copending U.S. patent application Ser. No. 413240 filed Sep. 27 1989 describes a combined surgical needle-suture device and surgical needle-suture attachment method which overcomes the aforementioned drawbacks of the previously known needle-suture combinations and needle-suture attachment methods. In accordance with said application, a combined needle-suture device is provided in which a surgical needle having a shank of reduced cross-section is attached to a suture through a shrinkable tubing, or micro-ferrule, which is fitted about the needle shank and a portion of the suture. Application of energy to the shrinkable tubing brings the tubing into engagement with both the needle shank and the suture. The physical and chemical characteristics of the shrinkable tubing material, the relative diameters of the tubing, the needle shank and the suture, and the amount of energy applied to the tubing may be controlled to provide a needle-suture combination having a desired pull-out force. It is thus possible to produce standard needle-suture combinations and removable needle-suture combinations using a single attachment process and a common inventory of materials.

SUMMARY OF THE INVENTION

It has now been found that relationships exist among the area, length and diameter of the tubing and the area, length and diameter of the shank of the needle and suture required to predictably and reliably achieve standard (i.e., ordinarily non-detachable) or selectively reversible (i.e., detachable) attachment of the needle and suture in the combined surgical needle-suture devices of aforementioned U.S. patent application Ser. No. 413240.

In accordance With the present invention, there is provided a combined surgical needle-suture device which comprises:

a) a needle having a shank of reduced cross-section;

b) a suture; and,

c) a shrinkable tubing around said needle shank and a portion of said suture, the ratio of the axial length of the tubing to the effective axial length of the needle shank being at least about 4:1 when the needle is intended to be non-detachable from the suture and no more than about 3.5:1 when the needle is intended to be detachable from the suture.

Further in accordance with this invention, there is provided a method for attaching a surgical needle to a suture to provide a combined surgical needle-suture device which comprises:

a) providing a needle having a shank end of reduced cross-section;

b) placing a shrinkable tubing around the reduced diameter shank and the suture, the ratio of the axial length of the tubing to the effective axial length of the needle shank being at least about 4:1 when the needle is intended to be non-detachable from the suture and no more than about 3.5:1 when the needle is intended to be detachable from the suture; and,

c) applying energy to the shrinkable tubing to bring the tubing into engagement with the needle shank and suture.

It will be noted that for an entire line of surgical needles differing in length, diameter and configuration, attachment of the needles to their sutures in accordance with this invention can be accomplished with as few as two different axial lengths of tubing, the tubing of greater axial length being used for suture-needle devices of the non-detachable variety and the tubing of shorter axial length being used for suture-needle devices of the detachable variety. The use of such tubings makes it possible to minimize the number of different tubings which must be manufactured and inventoried to accommodate the needle-to-suture attachment needs of a comprehensive line of combined surgical needle-suture devices.

In a particularly preferred embodiment of the invention, it has been found that a detachable suture-needle combination can be provided which exhibits more consistent detachment (pull-out) force than known types of detachable needle-suture combinations of comparable size. More specifically, it has been found that a removal interface characterized by optimized suture tip surface characteristics in combination with optimized shrinkable tubing suture contact area results in a detachable suture-needle combination with a more consistent detachment force than the known types of standard detachable suture-needle combinations.

As used herein, the expression "standard needle-suture" refers to permanently attached needle-suture combinations in which the force required to separate the needle from the suture is within the range of pull-out force set forth in the United States Pharmacopeia for permanently attached needle-suture combinations.

As used herein, the expression "standard detachable needle-suture" refers to a detachable needle-suture combination in which the force to separate the needle from the suture is within the range of pull-out forces set forth in the United States Pharmacopeia for removable needle-suture combinations, and includes detachable or removable needle-suture combinations commercially available from Ethicon, Inc. (Johnson & Johnson) and Davis & Geck (American Cyanamid Co.)


System with a surgical needle and a handle
Combined surgical needle-braided suture device
Grindless surgical needle manufacture

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