Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2000-09-15
2003-04-29
Hale, Gloria M. (Department: 3765)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S139000
Reexamination Certificate
active
06554845
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of minimally-invasive internal surgery, and more particularly, to methods and apparatus for suturing within a patient body via the manipulation of devices external to a patient body.
BACKGROUND OF THE INVENTION
Minimally invasive internal surgery procedures are ever-increasing. Such procedures typically entail the insertion of a tubular member into a patient body and the passage of various devices through the tubular member to access a tissue site of interest. In laparoscopic procedures, a plurality of tubular members, e.g., trocars, may be inserted through offset incisions and advanced proximal to the tissue site of interest. The tubular members utilized are relatively rigid and of a diameter sufficient to facilitate the passage of a wide variety of devices therethrough, including for example the passage of gas inflation conduits, electrosurgical devices, imaging apparatus and suturing devices. As may be appreciated, laparoscopic surgical procedures include those directed to fundoplications, myomectomies, splenectomies, herniorrhaphies and cholecystectomies.
In endoscopic procedures, a single tubular member is typically inserted through a bodily orifice to provide instrumentation access therethrough to an internal tissue site, e.g., through the mouth or anus to access a hollow organ. Given such access points and associated bodily canals, the tubular members utilized in endoscopic applications are necessarily of flexible construction and may be of significant length. Such considerations present particular challenges in the design and development of endoscopic surgical apparatus and techniques. To date, endoscopic procedures have been largely limited to gasdroesophergeal (GERD) and biopsy applications. However, it is believed that new surgical devices and procedures may be developed that facilitate increased endoscopic applications involving the ligating, proximating and suturing of tissue in the stomach and colon.
Common to both laparoscopic and endoscopic surgical procedures is the need to effectively suture an internal tissue site of interest. Such suturing entails the passage of a suture material into and back out of the tissue at least once, and most typically a plurality of times, followed by the provision and tightening of a knot adjacent to the sutured tissue. As may be appreciated, the completion of suturing procedures in laparoscopic and endoscopic applications can present a challenging and sometimes tedious task for surgical personnel. For example, such suturing procedures may involve difficult manipulation of an external device to cause an internally located needle to pass entirely through tissue at a surgical site to effect suture stitching. Further, in some approaches, the provision of a suture knot at a sutured site may require the time-consuming removal and reinsertion of the entire suturing apparatus and access tubing therefor.
SUMMARY OF THE INVENTION
In view of the foregoing, a broad objective of the present invention is to provide methods and apparatus for internal suturing that are relatively simple to employ yet highly effective.
An additional objective of the present invention is to provide for internal suturing in a manner that reduces componentry cost and complexity.
Another objective of the present invention is to provide for internal suturing in a manner that reduces the overall time required for suturing in a given procedure.
Yet a further objective of the present invention is to provide for internal suturing in a manner that accommodates a wide variety of applications.
An additional objective of the present invention is to provide for internal suturing in a manner that allows for substantially continuous imaging of the entire suturing process.
One or more of the above-noted objectives and additional advantages are realized in a suturing apparatus that comprises a needle member having a distal end portion and a suture material having a pre-tied knot (e.g., a Roeder knot) initially disposed about the distal end of the needle member. As will be appreciated, the needle member may be of a length sufficient to permit external manipulation of a proximal end so as to “thread” the suture material through tissue at a surgical site.
In one aspect of the invention, the apparatus further includes a first member disposed for selective relative movement between the first member and the needle member. Upon such relative movement, the first member is positionable to engage the suture material and thereby position the pre-tied knot beyond the distal end of the needle member, e.g., for subsequent tightening at a surgical site. By virtue of this arrangement, the provision of a suture knot at a sutured site may be accurately and readily accomplished.
The distal end of the needle member may comprise piercing tip. By way of example, such piercing tip may be of a straight or arcuate configuration. Correspondingly, the needle member may be provided so that rotation of a proximal end portion thereof effects substantially co-rotational movement of the piercing tip through a corresponding arc. As will be appreciated, such co-rotational movement facilitates the desired passage, or stitching, of the piercing tip of the member needle into and back out of tissue at a surgical site during suturing procedures. In this regard, it may be preferable to provide a needle member having a torsional strength of at least about 0.02 in. lb. and having buckle strength of at least about 0.2 psi from the distal end to a proximal end thereof.
To facilitate use in endoscopic applications, the needle member may be elongated, with a maximum cross-sectional width, or diameter, of about 0.10 inches. Additionally, for such applications the elongated needle member may preferably comprise a resilient material that permits a degree of flexural curvature along the length thereof. By way of example, the elongated needle member may comprise a material selected from a group consisting of nickel, titanium or nickel titanium alloys, stainless, spring or surgical steel, or flexible plastic.
The inventive apparatus may further comprise a second member having a distal end adapted for cutting the suture material, wherein the second member and at least one of the first member and the needle member are disposed to permit selective relative movement therebetween. More particularly, the second member may be disposed for selective advancement/retraction relative to each of the first member and the needle member. Such an arrangement facilities selective positioning of the second member in a forward position for cutting the suture material, e.g., after tissue has been stitched and a pre-tied knot has been placed/tightened at a given surgical site.
In another aspect of the present invention, a suturing apparatus is provided comprising a needle and suture material having one end anchored near a distal end of the suture needle. Again, the apparatus may be designed so that the needle may be externally manipulated to thread the suture material through tissue at an internal surgical site. The suturing apparatus also includes a grasping member, wherein the needle and grasping member are disposed to permit selective relative movement therebetween. Upon such selective relative movement the grasping member is positionable beyond a distal end of the needle for selectively grasping and/or releasing the suture material, e.g., after threading of the suture material through tissue at a surgical site.
In conjunction with this aspect of the invention, the grasping member may be positioned through at least a portion of the needle, e.g. a hollow piercing tip at the distal end of the needle, and adapted to telescope therebeyond upon selective relative movement therebetween. Further, the grasping member may comprise a spring-loaded portion, (e.g., the grasping member may be shaped to exhibit a spring-loaded behavior), wherein the spring-loaded portion collapses to a non-deployed state upon positioning within a hollow piercing tip of the needle and automatically springs open to
Bromley Robert L.
Fleenor Richard P.
Hale Gloria M.
Marsh & Fischmann & Breyfogle LLP
PARÉ Surgical, Inc.
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