Surgery – Instruments – Suture retaining means
Reexamination Certificate
1999-08-13
2001-09-18
Jackson, Gary (Department: 3731)
Surgery
Instruments
Suture retaining means
C606S075000
Reexamination Certificate
active
06290711
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a surgical connector and method for the tightening, joining, and securing of flexible members without tying knots.
RELATED ART
With the advent of endoscopic surgical techniques such as arthroscopy, laparoscopy, gastroentroscopy, and laryngoscopy, surgeons are able to access, visualize, and operate on surgical sites from new perspectives. Endoscopic, laparoscopic, and arthroscopic surgery relies on small-diameter cannulas that extend through small incisions made through the skin into a surgical site. In an endoscopic procedure, a video camera having a small-diameter lens is inserted through a trocar tube that is passed through an incision and permits visual inspection and magnification of the surgical site. Small-diameter flexible instruments can then be manipulated to the repair site through additional cannulas. These instruments permit the surgeon to precisely prepare the tissue that is to be repaired or joined together. However, with few exceptions, such as tissue staples or laser fusion tissue is still repaired by stitching with suture.
Currently, an effective and often-used method of surgically tightening and joining suture or other flexible tissue repair members together is by tying knots. Various devices have been developed to assist the surgeon in tying knots during surgical procedures, including suture and surgical clip-type devices that may, however, be too large to use in the confined space available in an endoscopic procedure. Such suture clip and surgical clip devices generally include one-piece bendable arrangements having hinged mechanisms where two ends thereof are brought together to enclose the suture and are locked thereto. Examples of such devices are shown in U.S. Pat. Nos. 5,474,572 to Hayhurst; 5,409,499 to Yo; 5,330,442 to Green et al.; 5,234,449 to Bruker et al.; 5,171,251 to Bregen et al.; 5,160,339 to Chen et al.; 5,078,731 to Hayhurst; and 5,062,846 to Oh. Additional, a number of nonhinged suture locking devices have been developed, such as U.S. Pat. Nos. 5,531,763 to Mastri et al.; 5,413,585 to Pagedas; 5,282,832 to Toso et al.; 5,376,101 to Green et al.; 4,505,274 to Speelman; and 3,910,281 to Kletschka et al. Golds et al. (U.S. Pat. No. 5,383,905) describes a suture loop securing device having relatively slidable members for securing ends of a suture loop in a generally collinear fashion.
In-line tensioning and the joining of a flexible member, with the flexible member describing a nonlinear path through the device, is provided by Caspari et al. (U.S. Pat. Nos. 5,899,921 and 5,902,321).
For use in endoscopy and like procedures, devices such as knot pushers have been designed to assist in tying knots endoscopically. Examples of such devices designed to assist with arthroscopic knot tying include commercially available knot pushers such as disclosed in U.S. Pat. Nos. 5,217,471 to Burkhart and 5,562,684 to Kammerer.
In endoscopic surgery, even with these devices, knot tying is time consuming, difficult, and may produce a knot or knots that lack adequate holding strength or tightness. Accordingly, although conventional knot-tying methods may be adequate for open surgical procedures where the suture can be pulled, as with direct in-line access and visualization, and even where the flexible members or both ends of the same member can be joined with tightly applied knots, it is not necessarily optimal to join flexible members together with knots during endoscopic procedures. Due to the dimensional constraints of endoscopy, knots tied through cannulas tend not to be as tight as knots tied through open surgical techniques. Also, because the surgical sites tend to be smaller in endoscopic procedures than in open procedures, multiple knot throws are often needed to secure the knots. Accordingly, endoscopic knots tend to be significantly proportionately larger than knots tied during open procedures with respect to a small surgical site. This combination of a formation of a relatively large, loose knot in a small hard-to-access surgical site introduces potential surgical difficulties that may affect the procedure outcome. Additionally, such knot-tying procedures can be time consuming and may require advanced endoscopic technical experience to effectively join the tissue together tightly. Also, it is desirable to provide a knot having a verifiable hold. Thus a device that securely, efficiently, and effectively joins together two or more ends of flexible tissue repair members as used in soft tissue repair, such as a suture, is needed during both open and endoscopic procedures.
In addition to the above, the issue of joining suture together endoscopically without the use of knots has been addressed, for example, by Hart (U.S. Pat. No. 5,630,824), Sauer et al. (U.S. Pat. No. 5,520,702), Matula et al. (U.S. Pat. No. 5,514,159), and Golds et al. ('905).
The above examples relate mainly to the joining of sutures endoscopically, although it should be understood that it would be desirable to provide a device that surgically joins together other flexible members such as cable, wire, bands, or other flexible members used to join tissue together. A number of such devices are currently available, with an example disclosed in U.S. Pat. No. 4,050,464 to Hall.
Heretofore, surgeons have lacked the ability to join together two or more dissimilar flexible members where a use of knots for such joining has not been possible due to different mechanical and physical properties of the flexible members, or where space has not been available, or where needed crimps or clips have not been available to join flexible members having different properties. A device that is specifically designed to join together different types of flexible members could therefore potentially open new areas of surgical procedures. With such a device, a surgeon could then repair a soft tissue, such as ligament, with suture and repair a harder tissue, such as bone, with a more rigid band. Accordingly, it is recognized that a device that could then join together the two flexible members of different properties would be an asset to the surgical community.
Additionally, it is further recognized that it would be desirable directly to join together flexible tissue, such as ligaments. Earlier surgical staples and clips have been developed for such purposes, as, for example, the devices shown in U.S. Pat. Nos. 4,505,273 to Braun and 5,222,975 to Crainich. Alternatives to suture for joining tissue are shown in U.S. Pat. Nos. 4,955,913 to Robinson and U.S. Pat. Nos. 5,222,976 to Yoon and 5,123,913 to Wilk et al. Heretofore, as needed, ends of ruptured long flexible tissue, such as ligaments, have been temporarily joined together, typically by a mechanical means, until the tissue heals biologically.
Heretofore, various devices have been developed that have attempted to overcome the disadvantages of conventional suture and knots. Such have included staples, clips, clamps, or other fasteners. Additionally, it has been attempted to join tissue using suture during endoscopic surgery, such as by cinching or crimping suture ends or segments together. No device or method has been known that combines the following three functions: in-line tightening of the flexible member prior to joining; a change in the direction of the flexible member during and after joining; and a capability for additional tightening of the flexible member during joining.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a device for use in an endoscopic procedure that will allow for an in-line joining and tightening of one or more flexible members.
It is another object to provide such a device that permits the flexible member(s) to be additionally tightened, as needed, as the device is engaged.
Another object of the present invention is to provide a device that is capable of joining sections of tissue to be noncollinear with a tension on a flexible member, providing for a mechanically stable engagement.
A further object of the present invention is to provide a device comprising
Caspari Richard B.
Justin Daniel F.
Allen Dyer Doppelt Milbrath & Gilchrist, P.A.
Innovasive Devices, Inc.
Jackson Gary
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