Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
1999-09-14
2001-01-09
Jackson, Gary (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S114000, C289S017000
Reexamination Certificate
active
06171317
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical apparatus and methods. More particularly, the present invention relates to methods, devices, and kits for tying knots in suture used in surgical procedures.
At present, most suture knots used in surgical procedures are tied completely by hand, particularly in open surgical procedures where a surgeon has free access to the tissue site to be surgically closed. A variety of knot tying apparatus have been proposed for use in instances where the surgeon does not have direct access, such as laparoscopic and other minimally invasive procedures. Most prior knot tying devices, however, are useful only for tying relatively simple knots and are often combined with a needle driver or other suturing device, rendering the design of the primary suturing instrument more complicated.
For these reasons, it would be desirable to provide improved knot tying devices, kits, and methods which are useful for tying free suture ends which have been deployed by virtually any known suturing technique. The devices will preferably be capable of imparting both simple and complex knot structures in the suture ends in a repeatable and reliable manner. The devices and methods should be easy to use, even in a surgical environment where the suture to be tied may be covered with blood, tissue debris, and other substances which would render tying difficult. In addition, the devices and kits should be of simple construction, be economical to produce, and be capable of being packaged in small, sterile kits for convenient maintenance in a hospital inventory and subsequent use in the operating room environment. At least some of these objectives will be met by the invention described hereinafter.
2. Description of the Background Art
U.S. Pat. No. 5,217,470, describes a device for forming a “protoknot” in suture by direct passage of one end of the suture through a pre-formed partial knot in another end of the suture. Other suture knotting and tying apparatus are described in U.S. Pat. Nos. 5,814,069; 5,776,150; 5,769,862; 5,728,109; 5,454,821; 5,454,820; 5,163,946; and 5,087,956.
SUMMARY OF THE INVENTION
The present invention provides devices, kits, and methods for transferring a pre-formed or pre-tied knot into a pair of free suture ends. The free suture ends will usually be opposite ends of a single length of suture that has been previously surgically placed by conventional techniques, including both direct manual suturing where the surgeon manipulates a needle and suture directly by hand and remote suturing techniques where a specialized suturing instrument is employed. A particularly preferred use of the present invention will be to tie the free ends of a length of suture which has been placed to close a penetration in a blood vessel located at the end of a tissue tract. Such blood vessel penetrations are formed, for example, to provide access to the femoral artery in the groin by the Seldinger technique.
The devices of the present invention comprise a pair of snare cords, each having a capture end and a pull end. The snare cords are disposed in a knotting guide in a loose knot pattern, typically being held over a number of guide pins or other path-defining structure in the knotting guide. Usually, a first snare cord will be formed in a partial knot pattern and a second snare cord will be formed in a complementary knot pattern so that the two cords together are configured as a full knot, although in a loose fashion so that each of the snare cords can be pulled through the knotting guide. Thus, by capturing the first and second suture ends with the capture ends of the first and second snare cords, respectively, the snare cords may be pulled through the knotting guide sequentially or simultaneously to exchange the suture ends for the snare cords. In this way, the knot pattern which was initially embodied in the snare cords is transferred to the suture ends. After detaching the snare cords and removing the suture knot from the knotting guide, the suture knot can be advanced and tightened over the tissue site which is being sutured in an otherwise conventional manner.
In an exemplary embodiment, the knotting guide comprises a base and a removable cover. Usually, the removable cover is hinged so that it can be selectively opened and closed over the base. A plurality of pins are provided on the base to form paths which can define the partial knot pattern and the complementary knot pattern. A particular embodiment which is illustrated comprises a cluster of pins at one end of the guide and a line of pins extending axially down the guide. A variety of other patterns will also be possible. Additionally, the use of channels, cleats, eye holes, and a variety of other mechanical structures for defining the cord paths could also be employed. The purpose of the knotting guide is to permit the snare cords to be interlaced in a desired knot pattern and to be held in a loose condition so that the cords can subsequently be exchanged with the suture. Any structure which meets these objectives will be useful in the knotting guide of the present invention.
The snare cord can be any filament, multi-filament bundle, wire, or the like, which is capable of being configured into the knot pattern and subsequently pulled or drawn through the knotting guide to effect the suture exchange. Preferred cord materials include polyester, nylon, and polypropylene. The capture end of the snare cord may simply be a loop tied or otherwise formed into the capture end permitting the suture to be threaded through the loop to provide capture. Other more complex structures, including wire eyelets, clips, and the like, could also be used. Whatever the specific structure, the capture end should have a profile and a flexibility which permits it to be drawn through the knotting guide during the suture exchange. The pull end of the snare cord can be unmodified, i.e., simply a free end of the snare cord which is cut off to determine its length. Usually, however, some structure, such as a handle, grip, or the like, will be provided on the pull end to facilitate manual pulling and exchange. It will also be possible to provide automatic mechanisms for pulling the snare cords through the knotting guide, in which cases the pull ends may be fastened or coupled to an automatic pulling mechanism. No such automatic pulling mechanisms, however, are illustrated in the present application.
The snare cords will usually (but not necessarily) be identical in construction and appearance, although they may vary in length depending on the particular knotting pattern. Often, however, it will be desirable to be able to distinguish between the two snare cords (or between multiple pairs of snare cords in certain embodiments as described in detail below). The ability to distinguish among the snare cords can be provided by using different colors, different handle shapes, or the like, as part of the snare cord itself. More usually, however, the snare cords will be distinguished based on indicia present on the device itself. In the exemplary embodiment, one snare cord exits from a proximal portion of the knotting guide while a second cord exits from a side of the knotting guide. Instructions are provided to pull the two snare cords in the desired sequence to effect the knot transfer into the suture.
The devices and methods of the present invention can be used to form a wide variety of surgical knots into suture, including sliding surgeon's knots, a square knot, a capstan knot, a cinch knot, and a reef knot.
The knotting devices of the present invention may optionally be configured to include a “break-away” knot pusher. Most simply, a handle or other shaft structure may be attached to the knotting guide in such a way that it can be selectively detached, usually by simply breaking the shaft at a pre-defined, usually weakened, location. The break-away point of the shaft is positioned so that the loose knot formed by the knotting guide will lie adjacent to a pushing end of the shaft aft
Franco Justina A.
Jackson Jasper
Walberg Erik K.
Jackson Gary
Perclose, Inc.
Townsend and Townsend / and Crew LLP
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