Suture anchoring and tensioning device and method for using same

#The present invention relates to a suture anchoring and tensioning device for use with sutures in surgical procedures.

#In surgical procedures sutures are commonly used to close incisions and to reunite damaged tissue. Typically, the sutures are maneuvered and passed through the affected tissue and the free ends of the sutures are individually tied together by the surgeon. In most surgical incisions, the surgical site area is sufficiently exposed to permit the surgeon to access and quickly tie the suture manually with a surgical knot. However, in other surgical procedures, such as endoscopic procedures, laparoscopic procedures, arthroscopic procedures and the like, or when robotic surgical procedures occur, the suturing site is inaccessible to the surgeon's hands. As a result, the surgeon must tie each of the suture ends into a knot at location remote from the suturing site, and then manipulate suitably configured instruments for sliding the surgical knot to the suturing site of the incision. Further, surgeons may tie surgical knots intracorporeally (inside of the body) using surgical tools to tie the knot down to the tissue. Conventionally, most surgical sutures are secured with surgical knots that are somewhat cumbersome and slow to tie. As a result, knot tying is one of the more time-consuming steps in the suturing process of the surgical procedure. Also, it is noted that knots are weak points in a suture. That is to say, when a knotted suture is broken from applied tension (assuming the suture is otherwise free from imperfections), the suture will break at the knot.

#In the foregoing circumstances, there remains a need for the elimination of knot tying from surgical procedures in order to significantly reduce the time duration of surgical operations. This is especially true with regard to minimally invasive surgical procedures where the tying of surgical knots within confined spaces is extremely difficult and time consuming. The present invention pertains to a helical suture anchoring device that would be applied quickly and would apply sufficient tension to the sewn sutures (including monofilament sutures) in order to restrict movement of the sutures at the surgical site.

#Further objects, features and advantages of the present invention will become apparent upon consideration of the following detailed description of various exemplary embodiments considered in connection with the accompanying drawings, in which:

#FIG. 1 is a perspective view of a helical suture anchoring device constructed in accordance with a first exemplary embodiment of the present invention, the device being shown in a coiled configuration and without a suture;

#FIGS. 2a to 2c are schematic representations which illustrate the steps involved in the attachment of two suture ends to the helical suture anchoring device of FIG. 1 for suturing an incision by a surgeon;

#Referring to FIGS. 1 through 5b, there is shown a helical suture and anchoring tensioning device 10 for use in surgical procedures. The device 10, as shown in FIG. 1, includes a coiled, circularly-shaped, thin rod or member 12 having a distal end 14, a proximal end 16, a center point 18 between the distal and proximal ends 14, 16 and an outer wall surface 20. As shown in FIG. 1, device 10 is in its normally coiled helical configuration 22, wherein its coiled helical rod or member 12 includes a plurality of helically-configured coiled turns 28. As used herein, the term “coiled helical configuration” shall define any spiral configuration having a plurality of descending turns, regardless of its geometrical or non-geometrical shape. A geometrical shape is any shape which is conducive to a description using conventional geometry nomenclature. Examples of suitable geometrical shapes include, but are not limited to, the following: circular, oval, elliptical, conical, rectangular, square, triangular, pyramidal and any other polygonal shape. A non-geometrical shape is any shape which is not conducive to a description using conventional geometry nomenclature. Examples of suitable non-geometrical shapes include, but are not limited to, the following: U-shaped, V-shaped, parabolically-shaped and the like.

#The helical suture anchoring device (helical suture lock) 10 can be used in combination with multiple sutures 30A, 30B (see FIG. 2c) or with a single suture 30 (see FIG. 3) for various types of surgical procedures by surgeons (to be discussed hereinafter in the “in operation” sections). The single suture 30 or the multiple sutures 30A, 30B may wind down the helical path P in either a clockwise or counterclockwise rotation depending upon the orientation of the helically-configured coiled turns 28 and the lashing methods employed, as described hereinafter. The coiled member 12 may be fabricated and coiled, preferably, from any biocompatible medical material, such as a polymeric, metallic or superelastic (e.g., a nickel-titanium alloy having a memory shape, such as NITINOL®) material that can be coiled into a tight spiral and helical configuration having an inherent resiliency, as depicted in FIGS. 1, 2a and 3. The polymeric material may be absorbable within a mammalian body, or it may be non-absorbable.

#If the helical suture anchoring and tensioning device 10 is made from a nickel-titanium alloy having memory shape capabilities (such as NITINOL® ALLOYS-SESO8 ), one method of manufacturing the device 10 starts with the provision of a thin elongated rod having a thickness in a range of from about 0.15 mm to about 4.0 mm and a length in a range of from about 10.0 mm to about 50.0 mm. The rod is then coiled into a tight spiral having a helical diameter in a range of from about 1.0 mm to about 5.0 mm. A fixturing/clamping device and/or mandril (not shown) is used to maintain the coiled configuration of the rod. The coiled rod and clamping device are then placed in a heat treatment apparatus (e.g., a furnace or salt bath) and heated to a temperature in a range of from about 450° C. to about 600° C., but preferably to a temperature in a range of from about 500° C. to about 550° C. Upon reaching the proper shape-setting temperature (i.e., approximately 500° C.), the rod will become set in its coiled helical state. Typically, the heat treatment process lasts for a period of time in a range of from about 2 minutes to about 30 minutes, but more preferably for a period of time in a range of from about 2 minutes to about 15 minutes. The heat-treated rod and clamping device are then removed from the heat treating equipment. After removal from the clamping device, the coiled helical rod is quenched in water or cooled down rapidly with chilled air.