A kit comprising a stiffened suture and associated method of reloading

Abstract: A suture for use in a laparoscopic suturing device comprising a suture having a first and second end. The first end being attached to a surgical needle and the second end being attached to a retainer wherein the adjacent to the retainer there is a stiffened segment of the suture.

Description: Field of Invention This invention relates to an improved suture and endoscopic instrument particularly, to a suture with a surgical needle on one end, a retainer attached to the other end and a stiffened segment of suture adjacent thereto. Background of the Invention For surgeons, suturing has long been the standard method for tissue fastening and repair. But, with the advent of laparoscopic surgery, surgeons were removed from the immediacy of contact with the surgical site that facilitated suturing. The complicating aspects of laparoscopic suturing are the handling of the needle, the accurate placement of a stitch and the tying of a knot in the laparoscopic environment. The current techniques are complicated, take many hours to master, and are easily forgotten. As a result, many surgeons avoid laparoscopic suturing, preferring instead to either use alternative tissue fastening method (clips, staples, endo-loops or loop-sutures), or to avoid those laparoscopic procedures which could require suturing. Nevertheless, developments in sutures for assisting with laparoscopic procedures include the provision of gripping and/or stiffening means on the sutures. See, for example, US-A- 5 312 436 and US-A- 5 383 904. However, neither of these documents mentions an associated endoscopic instrument to form a kit which would allow for a rapid reloading. Summary of the Invention According to a first aspect of the present invention there is provided a kit as defined in claim 1. The invention described herein is for use in laparoscopic suturing. A second aspect of the present invention provides a method for rapidly reloading an endoscopic suturing device with as defined in claim 11. The first end of the suture is attached to a surgical needle an the second end is attached to a retainer wherein adjacent to said retainer is a stiffened segment of suture. Description of the Drawings FIG. 1 is a perspective view of the stiffened suture with a needle attached to the suture on one end (armed). On the other end of the suture is a retainer adjacent to the retainer is a stiffened segment. FIG. 2 is a perspective view of the armed stiffened suture loaded in a knot-tying mechanism. Detailed Description of the Invention Referring to FIG. 1 in which the preferred embodiment a suture as comprised in the kit of the present invention is illustrated, the stiffened suture 1 is composed of a suture 160 having a first and second end. Attached to the first end for most surgical procedures is a surgical needle 100. Attached to the second end of the suture is a retainer 151 which in the preferred embodiment is a ferrule 161. The retainer could also be a knot or other device which increased the suture diameter so that it will not pass through passage 122 of the endoscopic suturing device 3 illustrated in FIG. 2. Adjacent to the retainer 151 toward the first end of the suture is a stiffened segment 114. The stiffened segment 114 should be in the range of from about 12 to 75 mm (1/2 inch to about 3 inches) in length and preferably 50 mm (2 inches). The stiffened segment 114 facilities the rapid reloading of new stiffened sutures into the endoscopic suturing device 3. The stiffened segment allows the surgeon to quickly place the stiffened segment 114 into the notch 123 of the endoscopic suturing device. A complete description of the endoscopic suturing device is provided in application serial number 08/319,182, filed October 6, 1994, entitled, "Needle Driving Device" by Measamer et al. published as US-A- 5 601 575 after the filing of the present application. Suture 1 can be fabricated of either bioabsorbable polymeric resins or of non-bioabsorbable biocompatible materials. Suitable bioabsorbable polymeric resins include, for example, homopolymers and copolymers derived from monomers selected from the group consisting of glycolic acid, glycolide, lactide, lactic acid, 1,4-dioxepan-2-one, p-dioxanone, ε-caprolactone, trimethylene carbonate and mixtures thereof. Polymers and copolymers of the foregoing kind and absorbable surgical devices made therefrom are well known. Examples of suitable non-bioabsorbable biocompatible materials include homopolymers and copolymers of polypropylenes, silks, polyamides, polyesters, polyvinyl chlorides, polytetrafluoroethylenes and polysulfones. Materials of the foregoing kind are well known. The suture may include suitable dyes, coatings, plasticizers, fillers, etc., as desired or appropriate to improve the visibility and/or handling characteristics of the suture. The stiffening agent preferably is applied after the coated or dyed suture is attached to the retainer. Suitable stiffening agents are biocompatible materials capable of stiffening the suture sufficiently to allow the quick insertion of the stiffened suture and eyelet (or knot) into the suturing device. Such stiffening agents are preferably liquids, soluble in common solvents, or low melting solids for ease of application to the suture and may be either bioabsorbable or non-bioabsorbable. Examples of such stiffening agents include homopolymers and copolymers of epoxies, vinyl alcohols, hydroxy alkyl methacrylates, acrylamides, n-vinyl pyrrolidones, alkylene oxides, cyanoacrylates, low melting polylactone polymers and copolymers (melting at less than about 100°C) and mixtures thereof. other suitable stiffening agents include waxes, shellacs, carboxyalkyl celluloses, alginic acid, poly-n-acetyl glucose amines, gelatins, collagens, hyaluronic acids and mixtures and copolymers thereof. These stiffening agents may be water soluble. Stiffening agents should have no appreciable toxicity to the body when present at the levels present sufficient to obtain the desired degree of stiffening. To be suitable, for applying a stiffening agent to the suture, a solvent must (1) be miscible with the stiffening agent at a suitable concentration of stiffening agent, (2) have a sufficiently high vapor pressure to be readily removed by evaporation, (3) not appreciably affect the integrity of the retainer and/or suture and (4) capable, in combination with the stiffening agent, of wetting the surface of the suture. Application of the stiffening agent to the suture can be carried out in any number of ways. Thus, for example, the region of the suture adjacent to the ferrule can be submerged in the stiffening agent, or solution thereof, until a suitable quantity of stiffening agent sufficient to obtain the desired stiffening is acquired or otherwise retained by the sutures after removal of any excess agent and/or accompanying solvent, if any. The excess stiffening agent or solvent may be removed by drainage, wiping, evaporation, etc. In many cases, contact times on the order of from just a few seconds, e.g. about 2 to about 50 seconds to several minutes or hours, e.g. about 2 to about 50 minutes or about 1 to about 2 hours and even longer, as long as the contact time is sufficient to impart an amount of stiffening agent to the suture to provide the desired degree of stiffness to the stiffened segment of the suture, as compared with the same type of surgical article which has not been treated with the stiffening agent. Preferably the stiffness of the stiffened segment will be in the range of 0.2 to 1.0 kgf.cm 2 as measured on a Kawabata Bending Rigidity Tester. Alternatively, the stiffening agent and solutions thereof can be applied by coating, spraying, brushing, etc., on the surfaces of the surgical device such that the latter receives and retains a sufficient quantity of the stiffening agent to decrease the probability of tangling or twisting thereof. It may be advantageous to perform one or more applications of the stiffening agent where particular functional properties are desired. The surgical kit and method of reloading of the present invention are generally useful in endoscopic suturing devices for the closing of wounds of living tissue therewith.

Claims: A kit comprising an endoscopic suturing device (3) in the form of an endoscopic knot tying device having a passage (122) and a surgical suture (160) having a first end and a second end, the first end being attached to a needle (100) and the second end being attached to a retainer (151) adapted not to pass through the passage(122), wherein adjacent to the retainer (151) is a stiffened segment of the suture (160) suitable for use in the suturing device (3). The kit of claim 1, wherein the stiffened segment (114) is in the range of from about 12 to 75mm (1/2 to about 3 inches) in length. The kit of claim 1 or 2, wherein the suture (160) is a multifilament suture. The kit of claim 1, 2 or 3, wherein the retainer (151) is a ferrule (161). The kit of any of claims 1 to 4, wherein the suture (160) is bioabsorbable. The kit of any of claims 1 to 4, wherein the suture (160) is non-bioabsorbable. The kit of any of claims 1 to 5, wherein the suture (160) is made from a polymer composed of monomers selected from the group consisting of glycolic acid, glycolide, lactide, lactic acid, 1,4-dioxepan-2-one, p-dioxanone, ε-caprolactone, trimethylene carbonate and mixtures thereof. The kit of any of claims 1 to 4, or 6, wherein the suture (160) is a non-bioabsorbable polymer selected from the group consisting of polypropylenes, silks, polyamides, polyesters, polyvinyl chlorides, polytetrafluoroethylenes and polysulfones. The kit of any preceding claim, wherein the stiffened segment (114) is formed by applying a stiffening agent which is a polymer selected from the group consisting of epoxies, vinyl alcohols, hydroxy alkyl methacrylates, acrylamides, n-vinyl pyrrolidones, alkylene oxide, cyanoacrylates, low melting polylactone polymers and low melting polylactone copolymers, and mixtures thereof. The kit of any of claims 1 to 8, wherein the stiffened segment (114) is formed by applying a stiffening agent selected from the group consisting of waxes, shellacs, carboxyalkyl celluloses, alginic acid, poly-n-acetyl glucose amines, gelatins, collagens, hyaluronic acids and mixtures thereof. A method for rapidly reloading an endoscopic suturing device (3) comprising providing a surgical suture (160) comprising a first end and a second end, the first end being attached to a needle (100) and the second end being attached to a retainer (151) a stiffened segment (114) being provided adjacent to the retainer (151) of the suture (160); providing an endoscopic suturing device having a notch (123) and a passage (122); the method further comprising the steps of placing the stiffened segment into the notch (123) and inserting it into the passage (122), the retainer (151) being adapted not to pass through the passage (122) of the endoscopic suturing device (3).

Inventors: BREGEN MICHAEL F, MEASAMER JOHN PAUL, BREGEN, MICHAEL F., MEASAMER, JOHN PAUL
Applicants: ETHICON INC, ETHICON, INC.
Application year: 1997
Main classification: A61B17
IPC codes: A61B17, A61L17