CA2059746A1 - Method for attaching a surgical needle to a suture - Google Patents

Method for attaching a surgical needle to a suture

Info

Publication number
CA2059746A1
CA2059746A1 CA002059746A CA2059746A CA2059746A1 CA 2059746 A1 CA2059746 A1 CA 2059746A1 CA 002059746 A CA002059746 A CA 002059746A CA 2059746 A CA2059746 A CA 2059746A CA 2059746 A1 CA2059746 A1 CA 2059746A1
Authority
CA
Canada
Prior art keywords
suture
needle
tip portion
heat labile
baffle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002059746A
Other languages
French (fr)
Inventor
Richard N. Granger
Michael S. Kassim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
United States Surgical Corp
Original Assignee
United States Surgical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by United States Surgical Corp filed Critical United States Surgical Corp
Publication of CA2059746A1 publication Critical patent/CA2059746A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06195Apparatus or means for preparing the cut end of the suture thread to be attached to the needle, e.g. tipping to prevent brooming
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse

Abstract

ABSTRACT OF THE DISCLOSURE
A method for needle-suture attachment and needle-suture combinations are provided. A shrinkable tubing is employed to secure the needle to the suture. The tubing shrinks in response to heat. Suture materials which are heat labile are desensitized prior to tubing attachment to preserve the integrity of the suture material. Attachment parameters may be controlled to provide standard needle attachment or removable needle attachment.

Description

2 ~
.
~ METHOD FOR ATTAC~ING A S~GIC~L NE~DL TO A SJT~

BACKGROUND OF THE INVENTION
Ihe pres-n_ inven-ion rela~es to a co~bined surgical needle-suture device, and, more particularly, to 0 s'lch 2 device in which a shrinXable tubing attaches a suture to a surgical needle.
For many years, surgeons have employed needle-suture combinations in which a suture or ligature is attached to the shank end of a needle. Such needle-suture combinations are provided for a wide variety of monofilament and braided suture materials, both absorbable and non-absorbable, e.g., catgut, silk, nylon, polyester, polypropylene, l-nen, cotton, and absorbable synthetic materials such as poly-,ers and copolymers O r slycolic and lactic acids.
Needle-suture combinations fall into two general classes: standard needle attachment and removable or detachable needle attachment. In the case of standard needle attachment, the suture is securely attached to the needle and is not intended to be separable therefrom, except by cutting or severing the suture. Removable needle attachment, by contrast, is such that the needle is separable from the suture in response to a force exerted by the surgeon. Ninimum acceptable forces required to separate a needle from a suture (for various suture sizes) are set 1 forth in the United States Pharmacopeia (USP). The USP
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 refer~nce.
One typical ~ethod 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. Patent No. 1,558,Q37 teaches the addition of a cement material to ~uch a substantially cylindrical recess to secure the suture therein. Additional methods for bonding a suture within a needle bore are described in U.S. Patent Nos. 2,928,395 ladhesives) and 3,394,704 (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. Patent No. 1,250,114. Additional prior art methods for securing a suture within a needle bore include expansion of a catgut suture through the application 20 Of heat (U.S. Patent No. 1,665,216), inclusion of protruding teeth within the axial bore to grasp an inserted suture (U.S. Patent No. 1,678,361) and knotting the end of the suture to be inserted within the bore to secure the suture therein (U.S. Patent No. 1,757,129).
Methods for detachably securing a 6uture to a needle are also well known. For example, U.S. Patent Nos.
3,890,975 and 3,980,177 teach swaging a suture within a needle bore such that the suture has a pull-out value of 3 to 26 ounces. Alternative detachable attachment methods include providing a weakened suture ~egment (U.S. Patent No.
3,949,756), lubricant tipping the end of a suture to be 2~7~

1 inserted in the axial bore of a needle (U.S. Patent No.
3,963,031), and pre-tensioning a suture that is swaged within an axial needle bore (U.S. Patent No. 3,875,946).
See also, U.S. Patent Nos. 3,799,16~; 3,880,167; 3,924,630;
3,926,194; 3,943,933; 3,981,307; 4,124,027; and 4,127,133.
Another method for attaching a 6uture to a needle involves the use o~ tubing which is secured to the shank end of the needle and to the suture. For example, U.S. Patent No. 1,613,206 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. Patent No. 2,240,330 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 relative to the tubing (or vice versa). ~he tubing is manufactured from spring-tempered carbon 6teel or chrome nickel steel and is secured to the suture by heating the tubing and then swaging to the suture.
U.S. Patent No. 3,311,100 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 6uch as nylon, linear 1 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 ~etal tubing, e.g., stainless steel. The opposite end of the tubing is crimped around a stiff suture, e.g., monofilament stainless steel.
U.S. Patent No. 3,918,455 describes a needle-suture attachment wherein a hollow suture portion i8 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.
Patent Nos. 4,672,734 (forming needle from U-shaped metal plate around suture), 4,359,053 (silicone tubing), 3,835,912 (laser welding of metal tube to needle), 2,814,296, 2,802,468 (chamfered tubing ends), 2,302,986, 2,240,330, 1,981,651 (needle and tubing screw threaded), 1,960,117, and 1,591,021.
Numerous disadvantages exist with methods used hereto~ore 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 ~ 7 1 siliconization process. Safeguards employed in an attempt to prevent the introduction of surh foreign materials, e.g., water blocking during needle siliconization, are inconvenient adding time, effort and cost to the needle production process.
Attachment processes which employ bored needle Rhanks 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 3~

2 ~

1 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.
~oreoverl 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.
In an effort to overcome the aforementioned disadvantages of previously known combined surgical needle-suture devices and needle-suture attachment methods, commonly assigned, copending U.S. patent application Serial No. 07/413,240, filed September 27, 1989, the entire contents of which are incorporated herein, discloses a combined needle-suture device in which a shrinkable tubing secures a surgical needle to a suture. According to this method a heat shrinkable tubing is placed around the shank end of a needle and a suture. Energy (for example, heat at a temperature of about 175C or above) is applied to shrink the shrinkable tubing and bring the tubing into engagement with the needle and suture to form a combined needle-suture device.

2~7~

1 While the use of the tubing method disclosed in U.S. patent application Serial No. 07/413,240 for needle-suture attachment has been found to be very effective, in the case of suture materials which are heat labile (i.e., those suture materials which tend to undergo so~e degree of degradation upon application of energy in the form of heat thereto~ it is desirable to take precautions to treat a portion of the heat labile suture to prevent the suture material which is proximate to the energy and possibly exposed to such energy during the shrinkable tubing attachment process from undergoing a degradation of its physical qualities (i.e., tensile strength, etc.~ or blemishing. As used herein the term "heat labile material"
refers to materials which may undergo physical, chemical and/or biological change or breakdown when exposed to energy. A heat labile suture is a suture fabricated from a material that is heat labile and undergoes some degree of breakdown of its components when exposed to sufficient energy, for example, heat energy. Most suture materials arP
sensitive to energy if exposed for an extended period of time; the list of heat labile suture materials affected by heat shrinking processes includes but is not limited to catgut, silk, nylon, polyester, polypropylene, linen, cotton, and/or absorbable synthetic materials for example, copolymers of glycolic and lactic acids.

SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide an improved method for attaching a shrinkable tubing to a needle and suture to provide a combined surgical needle-suture device.
4 ~

1 It is also an object of the present invention to provide a shrinkable tubing attachment method for use with heat labile suture materials.
It is a further object of the present invention to provide an attachment method which prevents degradation of a heat labile suture material when such material is exposed to heat during shrinkable tubing attachment.
An additional object of the present invention is to provide a needle-suture attachment ~eans which eliminates the need for drilling a bore in the needle shank and swaging a suture therein.
An additional object of the invention is to provide an attachment means which reliably secures the suture to the needle in an efficient manner, without close tolerances between elements.
An additional object is to provide a needle-suture attachment which is flexible and atraumatic.
An additional object of the invention is to provide needle-suture attachments having desired pull-out forces.
These and other objects of the invention are accomplished by a method for needle-suture attachment which involve:
a) providing a needle having a needle shank of reduced diameter;
b) placing a shrinkable tubing around the reduced diameter needle shank and a suture to be attached thereto; and, c) applying energy to the shrinkable tubing to bring the tubing into engagement with the needle shank and the suture.

2 ~

1 In the context of this invention, the term energy as referred to in (c) above is not limited to heat energy, but may be in other forms such as ~or example, electric, magnetic, electromagnetic, microwave, radiation, etc.
When the suture to be attached is one fabricated from a heat labile suture material it i6 desirable to take steps to treat the material to prevent ~uch material from undergoing degradation during the application of energv to effect shrinkage of the shrinkable tubing. This is generally accomplished by desensitizing the end of the suture material to be attached to protect the suture from energy related degradation.
Desensitizing the suture material may be accomplished by a wide variety of methods including but not limited to: the application of a vaporizable fluid to a tip portion of a suture such that upon exposure to energy during shrinkable tubing attachment the vaporizable fluid cools the suture material and absorbs excess energy; the application of a cryogenic fluid to a tip portion such that upon exposure to energy during shrinkable tubing attachment the tip portion of the suture is initially in z frozen condition and thus protected from the deleterious effects of the energy; and/or, directing a localized gaseous current such as, for example air, carbon dioxide, etc. to the tip portion of a suture such that upon exposure to energy during shrinkable tubing attachment the gaseous current substantially cools the tip portion and conduct& energy away from the exposed suture material.
The present invention also provides a needle-suture combination in which the needle and fiuture are joinedby a shrinkable tubing. The physical and chemical -lo- 2~9746 1 characteristics of the shrinkable tubing material, the relative diameters of the tubing, the needle shanX 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 i8 thus possible to produce 6tandard needle-suture combinations and removable needle-suture combinations using a single attachment process and a common inventory of materials.

BRIEF pESCRIPTION OF THE DRAWINGS
The present invention will become ~ore apparent from the following detailed description taken in conjunction with the accompanying drawings in which:
Fig. l is a side cross-sectional view of a needle and a suture with a shrinkable tubing positioned therearound (prior to engagement of the shrinkable tubing with the needle and suture);
Fig. 2 is a side cross-sectional view of the tubing of Fig. l in engagement with the needle and suture;
Fig. 3 is a side view of a needle-suture attachment of the present invention;
Fig. 4 is A side cross-sectional view of a needle and a desensitized heat labile suture surrounded by a shrinkable tubing according to the present invention;
Fig. 5 is a side view of an apparatus used to apply a vaporizable fluid to a heat labile suture material prior to insertion into the shrinkable tubing;
FiÇl. 6 i8 a side view of an apparatus in which a vaporizable ~luid is applied to a heat labile suture material after insertion into the shrinkable tubing and simultaneous with the application of energy;

7 ~ ~

1 Fig. 7 is a side view of an apparatus for treating a heat labile suture material with a cryogenic fluid by immersion;
Fig. 8 is a ~ide view of ~n apparatus for treating a heat labile suture with cryoqenic fluid by spraying prior to insertion into the shrinkable tubing;
Fiq. 9 is a ~ide view of an ~pparatu~ for treating a heat labile suture ~aterial with cryogenic fluid by spraying after insertion into the shrinkable tubing and simultaneous with the application of heat energy;
Fig. lOA is a perspective view of the cooling unit and the baffle of a vortex air cycle;
Fig. lOB is a side view illustrating the positioning o~ the baffle and the reflector of the vortex air cycle around the shrinkable tubing;
Fig. lOC is a side view of the shrinkable tubing attachment area illustrating the needle rest and the positioning of the baffle and reflector of the vortex air cycle in relation to the needle rest;
Fig. 11 is a perspective view of the baffle of the vortex air cycle of Fig. lOA illustrating the perforations of the baffle and the placement of a suture inside the baffle;
Fig. 12 is a side cross-sectional view of the positioning of the baffle and reflector of the vortex air cycle around a portion of a heat labile suture during a simultaneous attachment of the shrinkable tubing to the needle and suture;
Fig. 13 is a ~ide cross-6ectional view of the positioning of the baffle and reflector of the vortex air 12- ~59~6 1 cycle around a portion of the shrinkable tubing during the attachment of a needle to a shrinkable tubing;
Fig. 14 is a side view of an alternative embodiment of the needle of the needle-suture attachment of the present invention in which ~he needle shank is scored;
Fig. 15 is a side view of an alternative embodiment of the needle of t~e needle-suture attachment of the present invention in which the needle ~hank is ribbed;
Fig. 16 is a side view of an alternative embodiment of the needle of the needle-suture attachment of the present invention in which the needie shank is threaded;
Fig. 17 is a side view of an alternative embodiment of the needle o~ the needle-~uture attachment of the present invention in which the needle shank is tapered to expand in a direction away from a remainder of the needle; and Fig. 18 is a side view of an alternative embodiment of the needle of the needle-suture attachment of the pre ent invention in which the needle shank i8 tapered to expand in a direction towards the remainder of the needle.

pETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The present invention relates to apparatus and methods for effecting needle-suture attachments and to such needle-suture combinations. The invention has application to any sutur~e material, whether absorbable or non-absorbable, natural or synthetic, braided or monofilament, and to any needle material Pnd configuration, whether straight or curved. The invention may be used to effect standard or detachable needle attachment, as described in -13- 2~97~

1 more detail below. The present invention has specific application to haat labile suture materials which may underqo degradation when exposed to energy.
Referring to Figs. 1-3, needle 10 has a reduced cross-sectional dia~e~er at its shank end 12 relative to the remainder of the needle 14. ~he diameter of shank end 12 may be reduced by any conventional ~eans, e.g., machining on a lathe. Typically, 6hank end 12 has a diameter from 10 to 6S~ smaller than the remainder of the needle 14, and preferably from 25 to 50% smaller. It i~ also possible to provide shank end 12 with a texturized surface to facilitate gripping by shrinkable tubing 20. For example, ~hank end 12 may be scored, ribbed or threaded, in whole or in part (Figs. 14-16 respectively). It may also be desirable to taper shank end 12 such that distal end 16 is of greater cross-sectional diameter than the cross-sectional diameter of shank end 12 in the region of shoulder 18, or vice versa (Figs. 17 and 18 respectively).
Tip portion 31 o~ suture 30 i6 also positioned within shrinkable tubing 20. A gap may exist between shank end 12 and tip portion 31 (as shown in Figs. 1 and 2) or shank end 12 may abut against tip portion 31. As shswn in Fig. 1, suture 30 may initially be of uniform cross-section throughout its length. Alternatively, tip portion 31 of suture 30 may be of reduced cross-section relative to the remainder of suture 30, e.g., by tipping the suture tip with an adhesive or resinous tipping agent while suture 30 is under tension. (See, e.g., Canadian Patent No. 1,009,532 to Messores). Reducing the diameter of the suture tip as by resin tipping may be desirable to prevent brooming of the suture, particularly for multifilament braided ~utures, to -14- 2 ~

1 rigidify the end of the suture to facilitate handling during attachment, and to allow a suture of larger diameter, e.g., a suture diameter eclual to the diameter of the needle to which it is to be attached, to be more efficiently attached to the needle using the shrinkable tubing of the present invention. It is not necessary according to the present invention, however, to reduce the diameter o~ tip portion 31 of suture 30 to efficiently attach needle 10 to suture 30.
Indeed, it may be possible or desirable to apply a tipping agent to prevent brooming without reducing suture diameter.
As shown in Fig. l, shrinkable tubing 20 initially has an inner diameter that is larger than the outer diameter of tip portion 31 of suture 30, thereby reducing the importance of suture tipping.
After shrinkable tubing 20 is placed around shank end 12 of needle lO and tip portion 31 of suture 30, energy is applied to tubing 20. In response to this energy, tubing 20 contracts or shrinks and engages shank end 12 and tip portion 31 of suture 30. The overall length of tubing 20 may also be affected by the application of energy, e.g., the length of tubing 20 may reduce. Thus, the shrinking of tubing 20 brings the inner surface of tubing 20 into engagement with shank end 12 ~nd suture 30, thereby securing suture 30 to needle 10. Suitable ensrgy sources include heat (convec:tive or conductive), radiation, microwave energy, etc.
As shown in Figs. 1-2, shrinkable tubing 20 is simultaneously placed ~round both tip portion 31 of suture 30 and shank end 12 of needle 10 in one embodiment of the present invention. It is preferable, however, to 6ecruentially secure tubing 20 to needle ln and 6uture 30.

-15~

1 Thus, in a preferred embodiment of the present invention, shrinkable tubing 20 is initially secured to shank end 12 through the localized application of energy to tubing 20 in the region surrounding shank end 12. After tubing 20 has been brought into engagement with shanX end 12, tip portion 31 of suture 30 is inserted into tubing 20 and ndditional energy is applied ~hereto. Sequential ~hrinkage of tubing 20 makes it possible to vary the amount of energy used in securing tubing 20 to hank end 12 and tip portion 31 of 10 .suture 30, respectively, and to limit the exposure of suture 30 to energy during the attachment process. In accordance with the present invention, the hPat labile suture tip 31 is desensitized prior to or contemporaneous with attachment to the needle shank 12 by tubing 20. It may also be desirable to cool suture 30 in the region outside tubing 20 to prevent any undesirable degradation thereof, especially if suture 30 is fabricated from a material which is heat labile.
Referring to Figs. 2 and 3, the shrinkage of tubing 20 typically compresses suture 30 to some extent.
This is particularly true where the suture is a braided, multifilament material having void spaces in its structure.
For example, tubing 20 may compress suture 30 by as much as 30 to 35% for a braided, synthetic absorbable suture and by a minimal amount ~or a relatively ~tiff material cuch as a 2~ monofilament surgical gut.
Shrinkable tubing 20 may be manufactured from any material which shrinks, i.e., reduces in diameter, in response to the application of energy. Suitable materials include "memory metals", e.g., nickel-titanium mixtures, nickel-iron-titanium mixtures, or copper based ~aterials, as are well known in the art (see, e.g., U.S. Patent Nos.

-16- 2 ~

1 3,759,552, 3,801,954, 4,198,081 and 4,773,680), and shrinkable plas~ic materials, such as polyvinylidene fluoride materials available from Raychem Corporation, ~enlo Park, California, under the trade name Rynar. In the case of shrinkable plastic ma~erials, the tubing is typically extruded such that the inner diameter i6 less than the final desired inner diameter, i.e., the inner diameter of the ~hrinkable tubing after enersy application in the attachment method of the present invention. Thereafter, the extruded shrinkable tubing is expanded radially outward through radial expansion means to provide a tubing of expanded inner diameter as shown, for example, by tubing 20 in Figure 1. Such plastic tubing i~ thus adapted to shrink or "recover" to its original extruded inner diameter in response to the application of a predetermined amount of energy.
The amount of energy applied to the 6hrinkable tubing to effect the desired attachment, i.e., diameter reduction, depends upon the chemical characteristics of the tubing material, the relative dimensione of the tubing, the treatment used to desensitize a heat labile suture, the shank end of the needle and the suture, the desired pull-out force for the needle-suture combination. For example, one polyvinylidene fluoride material available from Raychem Corporation (RT-850) shrinks at temperatures greater than 175C, and ils adapted to recover to about 50S of its radially expanded inner diameter. In such case, tubing 20 may be brought into engagement with shank end 12 of needle 10 and suture 30, either simultaneously or sequentially, by heatinq tubing 20 to a temperature above 175C. Tubing 20 may be heated through contact with a hot gas stream or with -17- 2B~9746 1 heated dies, or by other heating means. Preferably the shrink tubing is attached to the needle shank by conductive heating of the needle shank, thereby heating the shrinkable tubing only in the region around the shank. Typically, the outer diameters of shank end 12 and suture 30 (in the region inserted into tubing 20) are greater than the fully recovered diameter of tubing 20, e.g., greater than 50% of the initial inner diameter of tubing 20 for the RT-850 material, such that tubing 20 engages ehank end 12 and suture 30. This engagement provides the needle-suture combination of the present invention.
Machining of the needle to provide a reduced diameter needle shank is much easier and more controllable than the drilling processes, and p rmits the use of needle alloys w~ich have previously been impractical, e.g., Series 300 stainless teel and MP35N (available form SPS
Technologies). These heretofore impractical alloys have advantageous ~trength and ductility characteristics as compared to conventionally used Series 400 6tainless steels.
Moreover, an unreliable, expensive and maintenance intensive swaging process is replaced by a sterile, controllable and relatively inexpensive energy ~upply. The tubing used in the present invention may be color coded to designate suture material, standard versus detachable attachment, etc., particularly where a plastic tubing is employed.
The attachment method of the present invention is also much more efficient from a processing and inven-tory control etandpoint. For example, the tubing may be removed from a needle and the needle attached to a resh 6uture, e.g., in instances where the suture and/or attachment properties of the initial suture-needle combination are -18- 23~9746 1 outside specification~. In many instances, the suture may also be recovered and reused, thereby greatly reducing processing waste. ~he range of acceptable suture diameters is greatly expanded due to the ability of the tubing to recover or shrink to varying degrees, thereby minimizing the likelihood that suture production will be rejected for inability to ~ttach needles thereto. A single tubing size may be used to attach several needle ~izes with the same shank diameter because the 6hrinkable tubing i6 capable of recovering or shrinking to varying degrees. Thio ~reatly simplifies inventory considerations.
Needle-suture combinations produced according to the present invention are atraumatic and advantageously exhibit flexibility in the attachment region. Both standard needle attachment and detachable needle attachment products may be produced with great processing ease.
As noted above, the attachment method of the present invention ~ay be easily used to effect both standard needle attachment and detachable needle attachment.
Preferably, the pull-out force of a given needle-cuture combination is controlled through control of the energy source and the length of the tubing. Thus, using the identical inventories of needles, sutures and tubings, it is possible to produce either standard or detachable needle products through simple energy variations. In the case of detachable needle attachment, it iB preferred that the attachment conditions be controlled such that the tubing remains secured to the needle once the suture is detached.
Where a ~urgical needle-suture device i~ formed in accordance with the afore-described attachment methods with a suture which i6 heat labile, precautionary measures may be 2~7'~

1 taken to preserve the suture ma~erial to prevent or minimize its degradation. Such measures include desensitizing a heat labile suture material such that when energy i6 applied during shrinkable tubing attachment, the heat labile suture material i6 protected from degradation.
Accordingly, one ~ethod for desensitizing a heat labile suture material to prot2ct it from degradation is to apply a vaporizable fluid to the tip portion of the suture su~ficiently such that during the attachment of the shrinkable tubing to the needle and ~uture, the energy used to effect the attachment does not have a deleterious effect on the suture material (i.e., 108s of tensile strength, etc.~. The vaporizable fluid absorbs energy and vaporizes thereby directing excess energy away from the suture material to avoid degradation thereof. The vaporizable fluid may be reduced in temperature when applied to cool the suture material.
A primary criteria for the selection of a vaporizable fluid is that it be compatible with and not have a deleterious effect on the suture material being used. A
broad range of vaporizable fluids is contemplated including water, liquid nitrogen, liquid h~lium, hydrocarbons such as Freon or fluorocarbons. One skilled in the art, given the known properties of the suture material to be used, will appreciate that other vaporizable fluids not deleterious to the suture material can be used.
Referring to Fig. 4, a desensitizing method using a vaporizable fluid to saturate a suture portion is illustrated. Tip portion 31 of suture 33 is saturated with a vaporizable fluid as indicated by the cross marks.
Shrinkable tubing 20 is placed around needle shank 12 of 1 needle 10 and tip portion 31 of suture 30. Thereafter energy is applied for example, by heat source 47 to effectuate the needle-suture attachment and provide a co~bined needle-suture device. Tip portion 31 which i~ saturated with the S vaporizable fluid is unblemished due to the cooling qualities and/or vaporization of the fluid.
The amount of vaporiznble fluid applied to a suture portion is a func~ion of the suture material's sensitivity to energy, ~he Æuture's 6ize and the heat transfer characteristics of the vaporizable fluid selected.
Preferably, a portion of the suture is coated sufficiently to minimize or eliminate damage. Furthermore, in certain attachment methods to be explained herein it may also be necessary to extend the saturation to an area past the tip portion 31 of suture 30 to adequately protect this area when exposed to energy either directly or indirectly.
The vaporizable fluid may be applied prior to or during the suture's exposure to energy in the attachment process. Suitable methods for the former include either brushing or spraying fluid on the suture sr immersing the suture into vaporizable fluid prior to insertion into shrinkable tubing 20. Referring to Fig. 5, a mechanized spraying method for 6aturating tip portion 31 of suture 30 prior to exposure to energy is illustrated. Suture 30 is fed off a reel 40 of suture threadO The tip portion 31 of suture 30 is directed by retaining means 50 of linear motion device 55 whieh maneuver6 the ~uture 30 towards the attachment area B. When tip portion 31 is aligned with the spraying ~echanism 51 at position A, adjacent the attachment area, the spraying mechanism 51 is activated and 6upplies a stream of fluid 53 or mist onto tip portion 31 (as indicated -21- 2~7~

1 by the cross marks). Thereafter the suture 30 is maneuvered towards the tubing attac~ment area B in which tip portion 31 is inserted into shrinkable tubing 20. The needle-suture attachment is completed by the application of energy by heat source 47 as described above. The flow of vaporizable fluid from the spraying mechanis~ may be adju6ted for dif~erent suture sizes, absorption qualities, etc.
Although coating tip portion 31 prior to exposure to energy is highly effective in protecting the ~uture material, it is sometimes desirable to apply vaporizable fluid to tip region 31 during or simultaneous with its exposure to energy in the attachment process. Referring to Fig. 6, the ~praying mechanism 51 is positioned proximate to the attachment area B. Tip portion 31 of suture 30 is inserted into shrinkable tubing 20 which is positioned over needle shank 12. Simultaneous with the application of energy, the spraying mechanism is activated and directs a stream or mist of vaporizable fluid 53 over adjacent portion 32 which is now exposed to energy, and continues until the attachment process is complete and the energy is deactivated.
The s~rinkable tubing material which encloses tip portion 31 absorbs energy during the attachment and permits only minimal heat energy to communicate to the suture material of tip portion 31. Thus, it is sufficient to apply the vaporizable fluid directly to adjacent portion 32 which is exposed to heat energy.
Sirlultaneously attaching a needle and a suture to a shrinkable tubing wherein tip portion 31 is inserted into shrinkable tubing 20 prior to saturation of the 6uture portion is particularly applicable to ~utures fabricated 22- 2~7~

1 from catgut. Catgut sutures, when damp or wet, exhibit a tendency to broom, thus creating difficulties in the tubing insertion procPss. By maintaining the portion of the suture to be inserted in a dry ~tate, manufacturing difficulties are avoided.
A second method for desensitizing a heat labile 6uture material which ie exposed to energy during a shrinkable tubing attachment proce6~ involves applying a cryogenic fluid, (i.e., liquid nitrogen, liquid helium, etc.) prior to the attachment process to substantially freeze the material of tip portion 31 of suture 30 thereby preventing substantial movement of the suture material at a ~olecular level. The cryogenic fluid is applied in much the same manner as the previously described method regarding the vaporizable fluid (i.e., immersing, brushing, and spraying) and preferably is distributed to include portions of the suture adjacent the shrinkable tubing attachment referred to as adjacent portion 32.
As illu6trated in Fig. 7, ~pplying cryogenic fluids by immersing or brushing operations may be mechanized if de~ired to include an apparatus to carry out these function As 6hown, 6uture 30 i6 fed into an apparatus having retaining means 60 which secures tip portion 31 of euture 30. The apparatus maneuvers 6uture 30 towards an immersing tray 65 (as shown by the arrows) of cryogenic fluid in which tip portion 31 i5 immersed in the fluid and then removed. Tip portion 31, now in its frozen condition, is conveyed towards attachment area B wherein tip portion 31 ie inserted into shrinkable tubing 20. Heat energy is applied to form the combined needle-suture device.

2~5~

1 Referring to Fig. 8, cryogenic fluid may also be directed to tip portiDn 31 prior to the attachment process by vacuum pump apparatus 77. Discharge outlet 79 of vacuum pump apparatus 77 is positioned to direct a spray 71 of cryogenic fluid or cooling air on tip portion 31 of suture 30 immediately prior to in~erting tip portion 31 into 6hrinkable tubing 20. As tip portion 31 i6 ~oved towards 6hrinkable tubing 20 in the attachment area B, the vacuum pump apparatus 77 is activated at po~ition A wherein cryogenic fluid is released from t~e control valve 73 to blanket tip portion 31 including ~djacent portion 32.
Suture 30 is continually maneuvered by linear motion device 76 towards attachment area B wherein frozen tip portion 31 is inserted in~o shrinkable tubing 20. Heat energy is applied by heat source 47 to attach shrinkable tubing 20 to needle shank 12 and the tip portion 31. It is envisioned that this operation may be continuous with linear motion device 76 continuously maneuvering suture 30 directly towards the attachment area at a predetermined rate.
Thus, combined needle-suture devices are manufactured at a continuous and relatively rapid rate.
Fig. 9 shows another alternative in accordance with the afore-described cryogenic vacuum pumping technique, wherein a means is provided in which cryogenic fluid may be directed at attachment area ~ onto a 6uture portion simultaneous with the application of energy during a ~hrinkable tubing attachment. Tip portion 31 i~ first inserted into shrinkable tubing 20. Subsequent to suture insertion, discharge outlet 79 of vacuum pump 77 directs a flow of cryogenic fluid or cooling air 71 over adjacent portion 32 of suture 30 while heat energy is applied by heat -24- ~a~

1 source 47 to effect tubing attachment. Adjacent portion 32, in a cooled condition, remains substantially unblemished while the combined needle-suture device i~ attached. It is contemplated that alternative cryogenic cooling arrangements, such as a ~cold finger~, might also be used.
Desensitizing of a ~eat labile suture ~aterial which iB exposed to heat during a ~hrinkable tubing zttachment process may al60 be acco~pli6hed by directing a gaseous current over the attachment ~rea thus cooling the 6uture portion exposed to energy. The gaseou~ current (for example, an air current or a current of CO2j may be produced by an apparatus such as, for example, a vortex air cycle.
The use of gaseous currents is both economical and effective and is applicable to simultaneous and sequential needle-suture attachment methods.
Referring to Figs. lOA-C, the schematic illustrates an apparatus for applying a gaseous current to a ~uture portion, the apparatus forming a vortex cycle. The vortex cycle comprises an enclosed unit including a cooling cha~ber 95 (for example an industrial air conditioner) connected to a substantially U-shaped baffle 90 adapted to enclose at least a portion of the suture or a needle-suture device. U-shaped baffle 90 contains a plurality of perforation 92 on the interior ~urface thereof which allow cool air or gas to flow therethrough to cool ~ 6uture.
Perforations 92 are dispersed throughout the inside ~urface 93 of the baffle to effectively cool the ~uture as illustrated in Fig. ll. One 6killed in the art will readily appreciate that baffle 90 need not be shaped primarily like -25- 20~97~

1 a V but may be formed in other shapes including but not limited to ~quare, circular, rectangular, etc.
Referring again to Figs. 10 A-C, baffle 90 includes a slot 97 which defines an inner surface 93 of baffle 90. The portion of baffle 90 containing the upper open end of the Rlot 97 i5 received wi~hin reflector 80, the slot 97 and the inner gurface 9g of the reflector 80 forming an enclosure. In operation, gas i6 released from baffle 90 through perforations 92 and ~reflected" off inner surface 99 of reflector 80. The released And reflected motion of gas from perforations 32 and inner surface 99 of reflector 80, respectively, as illustrated in Fig. lOB by the arrows, provides a "vortex" effect of gas, which in turn, establishes a curtain and an even greater disbursement of gas over the suture.
Referring to Fig. lOC, the gaseous curtain generated by the movement of the gas due to U-shaped baffle 90 and inner surface 9g of reflector 80 is situated adjacent needle rest 100 proximate the attachment area. Needle rest 100 secures a needle 10 to enable a shrinkable tubing to be inserted on the shank end of the needle prior to attachment.
Referring now to Fig. 12, the vortex cycle operates as follows. In a 6imultaneous attachment, tubing 20 i6 placed over 6hank end 1~ of needle 10 and the tip portion 31 of ~uture 30. U-shaped baffle 90 is positioned to 6urround adjacent portion 32 of suture 30. Reflector 80 is positioned over the baffle 90. The vortex cycle is activated to supply an air curtain which c0016 the entire circumference of the adjacent portion 32. Energy is applied to ~hrinkable tubinq 20 by heat source 47 to attach shrinkable tubing 20 and form a combined needle- uture 2~7~

1 device. The adjacent suture portion 32 remains unblemished due to the cooling effect of the air curtain generated by the baffle 90 and reflector ~hield 80.
The vortex air cycle ~ay be continuous. In this case another needle i~ placed on the needle rest~ the baffle and reflector are placed in their proper position around adjacent ~uture portion 32 and energy is applied to form another combined needle-suture device. The approximate cycle time for 6imultaneously attaching a tubing to a needle and suture ranges from 2 to 10 6econds. The air pressure generated at the baffle 90, measured at the point of disbursement (at perforations 92) ranges from about 5 to 40 psi .
It may be preferable in some instances to sequentially attach the needle and ~uture. Sequential attachment is a two-step process involving fir6t the attachment of tbe shrinkable tubing to the needle and thereafter the attachment of the shrinkable tubing (with the attached needle) to the heat labile suture.
Referring to Fig. 13, the positioning of the vortex air cycle components for the attachment of shrinkable tubing 20 to needle 10, is illustrated. Specifically, U-shaped baffle 90 and reflector 80 are positioned to cover the distal portion of shrinkable tubing 20 which will be subsequently shrunk to attach suture 30 in the second 6tep of sequential attachment. The vortex cycle i6 activated and an air curtain is formed inside of U-shaped baffle 90 and inner ~urface 99 of reflector 80. This curtain of cool air is disbursed over the distal portion of shrinkable tubing 20. When energy i6 applied by heat ~ource 47 to form the needle attachment to 6hrinkable tubing 20, the portion of 1 shrinkable tubing 20 enclosing needle shank 12 shrinks and forms a needle-shrinkable tubing attachment while the distal portion of shrinkable tubing 20 positioned in the air curtain and enclosed by baffle 90 ~nd reflector shield 80 remains unblemished. The att~chment parameters for this - needle-shrinkable tubing attachment ~re air pressure of about 35 to 45 psi and preferably about 42 psi and cycle time from 1 to 20 seconds and preferably about 3 to 12 seconds .
10To complete the second step of the se~uential attachment and to attach suture 30 to the now existing needle-shrinkable tubing attachment, U-shaped baffle 90 and reflector 80 are positioned as illustrated in Fig. 12 over adjacent portion 32 of suture 30. Energy is applied locally to the remaining portion of the shrinkable tubing (the portion needed to attach Qhrinkable tubing 20 to tip portion 31) while the air curtain is generated to protect adjacent portion 32 of suture 30 to complete the attachment and form ~ combined needle-suture device. The attachment parameters for the suture-shrinkable ~ubing attachment process include an air pressure of about 35 to 45 psi and preferably about 42 psi and a cycle time ranging from about 1 to 20 6econds and preferably about 2 to 10 6econds.
For both stages of the attachment, the temperature of the air released by the air conditioner and entering the baffle to cool the suture ranges in value from about 100 ~5 to 280 +5F.
The vortex air cycle i6 a desirable method for attachment because it is relatively inexpensive and is well-suited for sequential as well ~s 6imultaneous needle-suture attachment. In accordance with the first step of a -28~ 2~5~7~

1 sequential needle-suture attachment (attaching a needle to a shrinkable tubing) a whole inventory of needle-shrinkable tubing attachments can be manufactured at one time and then subsequently the suture attachment can be completed at a later date thereby facilitating inventory control.
Additionally, the vortex air cycle i~ a clean operation.
The needle-suture attachment method of the present invention has many advan-~ages over previous attachment ~ethods. Desensitizing a h~at labile suture ~aterial according to one of the ~fore-descri~ed methods herein will preserve the integrity of the material as well ~s the physical characteristics (i.e., tensile strength) and will provide a combined needle-suture device which is unblemished, flexible, and inexpensive to manufacture.
While the above description contains many specifics, these specifics should not be construed as limitations on the scope of the invention, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision ~any other possible variations that are within the scope and spirit of the invention as defined by the claims appended hereto.

Claims (51)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A method for attaching a needle to a heat labile suture comprising:
providing a needle having a shank of reduced cross section;
desensitizing a tip portion of said heat labile suture material proximate an end to be attached to said needle shank;
positioning shinkable tubing around the reduced diameter needle shank and the tip portion of said suture;
and applying sufficient energy to the shrinkable tubing to bring the tubing into engagement with the needle shark and suture.
2. The method of Claim 1 wherein said shrinkable tubing is sequentially positioned around said needle shank and said tip portion of said suture, and wherein energy is applied to said shrinkable tubing after each sequential placement.
3. The method of claim 1 wherein. said tip portion of said heat labile suture material is desensitized by applying a vaporizable fluid to said tip portion of said suture.
4. The method of Claim 1 wherein said tip portion of said heat labile suture material is desensitized by applying a cryogenic fluid to said tip portion of said suture.
5. The method of Claim 1 wherein said tip portion of said heat labile suture material is desensitized by directing a gaseous current to said tip portion of said suture.
6. The method of Claim 2, wherein said shrinkable tubing is first positioned around said needle shank.
7. The method of Claim 3 wherein said tip portion is saturated with said vaporizable fluid.
8. The method of Claim 3 wherein said vaporizable fluid is water.
9. The method of Claim 3 wherein said vaporiable fluid is compatible with the heat labile suture material.
10. The method of Claim 3 wherein said vaporizable fluid is applied to said tip portion by spraying.
11. The method of Claim 3 wherein said vaporizable fluid is applied to said tip portion of said suture prior to positioning said shrinkable tubing around said tip portion.
12. The method of Claim 3 wherein said vaporizable fluid is applied to said tip portion of said suture during engagement with said shrinkable tubing.
13. The method of Claim 4 wherein said cryogenic fluid is selected from the group consisting of liquid helium and liquid nitrogen.
14. The method of Claim 4 wherein said cryogenic fluid is applied to said tip portion by vacuum pumping.
15. The method of Claim 4 wherein said cryogenic fluid is applied to said tip portion of said suture prior to positioning said shrinkable tubing around said tip portion.
16. The method of Claim 4 wherein said cryogenic fluid is applied to said tip portion of said suture during engagement with said shrinkable tubing.
l7. The method of claim 5 wherein said gaseous current is selected from the group consisting of carbon dioxide and air.
18. The method of Claim 5 wherein said gaseous current is directed to said tip portion of said suture during engagement with said shrinkable tubing.
19. A needle-heat labile suture attachment comprising:
(a) a needle having a shank of reduced cross-section;
(b) a heat labile suture; and (c) a shrinkable tubing around said needle shank and a desensitized tip portion of said heat labile suture.
20. The needle-heat labile suture combination o' Claim 19 wherein the heat labile suture is fabricated from a nonabsorbable heat labile material selected from the group consisting of silk, nylon, polyester, polypropylene, linen and cotton.
21. The needle-heat labile suture combination of Claim 19 wherein the heat labile suture is fabricated from an absorbable heat labile material selected from the group consisting of catgut and synthetic materials including polymers and copolymers of glycolic and lactic acids.
22. An apparatus for attaching a shrinkable tubing to a surgical needle and a heat labile suture comprising:
means for desensitizing at least a tip portion of said heat labile suture;
means for approximating a shank portion of the surgical needle and said tip portion of said heat labile suture;

means for applying said shiinlable tubing arourd said shank portion or said needle and said tip portion of said suture; and means for applying energy to said heat shrinkable tubing in an amount sufficient to effect attachment of said shank portion of said needle and said tip portion of said suture by said shrinkable tubing.
23. The apparatus of Claim 22 wherein said means for desensitiziing at least said tip portion of said heat labile suture comprises means for reducing the temperature of said tip portion of said heat labile suture.
24. The apparatus of Claim 23 wherein said means for reducing the temperature or said tip portion of said heat labile suture comprises structure for directing a gaseous current to said tip portion of said heat labile suture.
25. The apparatus of Claim 23 wherein said means for reducing the temperature of said tip portion of said neat labile suture comprises structure for applying a cryogenic fluid to said tip portion of said heat labile suture.
26. The apparatus of Claim 23 wherein said means for reducing the temperature of said tip portion of said heat labile suture comprises structure for applying a vaporizable fluid to said tip portion of said heat labile suture.
27. The apparatus of Claim 24 wherein said means for directing a gaseous current for reducing the temperature of said tip portion of said heat labile suture comprises:
means for cooling a flow of gas;

baffle means connected to said cooling means, said baffle means having an outer surface and an inner surface, said inner surface adapted to receive at least a portion of said heat labile suture and including a plurality of perforations therein and reflector means providing an inward surface to receive said baffle means.
28. The apparatus of Claim 24 wherein said gaseous current is selected from the group consisting of carbon dioxide and air.
29. The apparatus of Claim 27 wherein said baffle means includes a generally vertically oriented slot, said slot defining said inner surface of said baffle means and having a lower closed portion and an open upper portion.
30. The apparatus of Claim 29 wherein a portion of said baffle means including said open upper portion of said slot is positioned within said inward surface of said reflector means, said slot and said inward surface of said reflector means forming an enclosure.
31. The apparatus of Claim 30 wherein said baffle and reflector means are oriented such that said gaseous current from said baffle means reflects off said inward surface of said reflector means at various directions forming a vortex gaseous curtain in said enclosure.
32. An apparatus for attaching a shrinkable tubing to a surgical needle and a heat labile suture comprising:
an air supply connected to a nozzle device disposed proximate said surgical needle and said heat labile suture for supplying a flow of air thereto;

means for approxmating a shank portion of the surgical needle and said tip portion of said heat labile suture;
means for applying said shrinkable tubing around said shank portion of said needle and said tip portion of said suture; and means for applying energy to said heat shrinkable tubing in an amount sufficient to effect the attachment of said shank portion of said needle and said tip portion of said suture.
33. The apparatus of Claim 32 wherein said nozzle device is a baffle having a plurality of perforations therein, said perforations adapted to release air therethrough
34. The apparatus of Claim 32 wherein said air supply further comprises means for reducing the temperature of the air.
35. The apparatus of Claim 33 further comprising a reflector having a formed inward surface to receive said baffle.
36. The apparatus of Claim 33 wherein said baffle is U-shaped.
37. The apparatus of Claim 34 wherein said means for reducing the temperature of said air is an air conditioner.
38. The apparatus of Claim 36 wherein said U-shaped baffle includes a generally vertically oriented slot, said slot defining an inner surface of said baffle and having a closed lower portion and an open upper portion.
39. The apparatus of Claim 38 wherein said perforations are disposed throughout said inner surface of said U-shaped baffle.
The apparatus of Claim 38 wherein a portion of said U-shaped baffle including said open upper portion of said slot is positioned within said inward surface of said reflector said slot and said inward surface of said reflector forming an enclosure.
41. The apparatus of Claim 40 wherein said air released at a reduced temperature from said U-shaped baffle reflects off said inward surface of said reflector at various directions forming a vortex air curtain in said enclosure.
42. An apparatus for desensitizing at least a tip portion of a heat labile suture comprising an air supply connected to a nozzle device for supplying a flow of air therethrough, said nozzle device disposed proximate to said tip portion of said heat labile suture and a shank of a needle.
43. The apparatus of Claim 42 wherein said air supply further includes means for reducing the temperature of said air.
44. The apparatus of Claim 42 wherein said nozzle device is a baffle having a plurality of perforations therein, said perforations adapted to release air therethrough.
45. The apparatus of Claim 43 wherein said means for reducing the temperature of said air is an air conditioner.
46. The apparatus of Claim 44 further comprising a reflector having an inward surface to receive said baffle.
47. The apparatus of Claim 44 wherein said baffle is U-shaped.
48. The apparatus of Claim 47 wherein said U-shaped baffle includes a generally vertically oriented slot, said slot defining an inner surface of said baffle and having a closed lower portion and an open upper portion.
49. The apparatus of Claim 48 wherein said perforations are disposed throughout said inner surface of said U-shaped baffle.
50. The apparatus of Claim 48 wherein a portion of said U-shaped baffle including said open upper portion of said slot is positioned within said inward surface of said reflector means, said slot and said inward surface of said reflector means forming an enclosure.
51. The apparatus of Claim 50 wherein said U-shaped baffle is configured such that said air released at a reduced temperature from said U-shaped baffle reflects off said inward surface of said reflector at various directions forming a vortex air curtain in said enclosure.
CA002059746A 1991-02-27 1992-01-21 Method for attaching a surgical needle to a suture Abandoned CA2059746A1 (en)

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US07/661,693 1991-02-27
US07/661,693 US5102418A (en) 1989-09-27 1991-02-27 Method for attaching a surgical needle to a suture

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US5102418A (en) 1992-04-07
EP0501225A1 (en) 1992-09-02

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