Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2002-03-01
2004-06-01
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S139000
Reexamination Certificate
active
06743241
ABSTRACT:
BACKGROUND OF THE INVENTION
Laparoscopic surgery is a well-known, widely utilized surgical technique that advantageously reduces patient recovery time due to its minimal tissue damage, which consequently permits the patient to return to normal activity in a shorter period of time. Generally, laparoscopic surgery relies upon the formation of one or more trocar puncture wounds through which are deployed surgical instruments and a rod-like telescope with a light source to enable the surgeon to view the organs and conduct the surgery.
Notwithstanding the tremendous advantages afforded by laparoscopic surgery, such technique still presents substantial clinical problems. More specifically, the puncture wounds created within the body by the surgeon to gain access to the surgical site are often difficult and time-consuming to close, and can place great demands on the surgeon. Such task is made even more difficult when laparoscopic surgery is performed upon obese patients where there is a relatively deep puncture wound formed through a relatively small puncture site or incision. Indeed, the puncture site frequently needs to be enlarged following the laparoscopic procedure to ensure that the site is closed at the interior abdominal wall. Ironically, the need to enlarge the puncture site in order to adequately close the same partially negates the primary advantages of laparoscopic surgery; however, such practice is essential insofar as failure to properly close the puncture wound can lead to serious medical complications.
To address such shortcomings, numerous attempts have been made to develop instruments capable of quickly and effectively forming a closure of a laparoscopic fascial defect or puncture site. Exemplary of such attempts include those devices disclosed in U.S. Pat. No. 5,741,279, issued to Gordon et al., on Apr. 21, 1998, entitled ENDOSCOPIC SUTURE SYSTEM; U.S. Pat. No. 5,374,275, issued to Bradley et al., on Dec. 20, 1994, entitled SURGICAL SUTURING DEVICE AND METHOD OF USE; U.S. Pat. No. 5,964,773, issued to Greenstein on Oct. 12, 1999, entitled LAPAROSCOPIC SUTURING DEVICE AND SUTURE NEEDLES; U.S. Pat. No. 5,403,329, issued to Hinchcliffe on Apr. 4, 1995; and U.S. Pat. No. 5,507,757, issued to Sauer et al. on Apr. 16, 1996, entitled METHOD OF CLOSING PUNCTURE WOUNDS, the teachings of all of which are expressly incorporated herein by reference.
Such attempts, however, have proven less than satisfactory and fail to provide a practical solution to the foregoing problems. In this regard, substantially all such devices allegedly designed to facilitate the closure of a laparoscopic puncture site are incapable of deploying a suture a sufficient distance about the puncture site to fashion an appropriate closure. In this respect, prior art devices, such as those referenced above, are operative to stitch a suture into position at points diametrically across the puncture site; however, such suture typically only extends thereacross by a limited distance, which is less than 1.0 cm. Such limited distance fails to sufficiently approximate the peritoneum and fascia surrounding the puncture site sufficiently to form an adequate closure. While it is recognized that a suture extending a greater distance across the puncture site would be more advantageous, the capability of prior art devices position such a suture have not heretofore been available insofar as any laparoscopic fascial closure device must necessarily be insertable through a 10 mm laparoscopic port, which places considerable spacial constraints on the design of such devices.
Additionally disadvantageous with such prior art closure devices include the failure of such devices to selectively deploy needles for positioning and stitching a suture across the puncture site that can ultimately be withdrawn from the puncture wound without the need to enlarge the incision or puncture site. Among those devices possessing such defect include those disclosed in U.S. Pat. Nos. 5,964,733 and 5,403,329, referenced above, which deploy needles that, after having been deployed to fix a suture in position across an intra-abdominal puncture site, are inoperative to become repositioned within the device deployed thereby to thus atraumatically withdraw such needles from the patient.
Accordingly, there is a substantial need in the art for a laparoscopic fascial closure device that overcomes the aforementioned shortcomings in the art. Specifically, there is a need for such a device that is capable of being deployed through a 10 mm or larger laparoscopic port or puncture site that is further capable of deploying a suture at least 1.0 cm across from the periphery thereof. There is additionally a need for such a device that is capable of deploying a suture across a laparoscopic puncture site that provides for the retraction and capture of needles utilized to secure such suture in position back within the device deployed thereby to thus enable the needles to be easily and atraumatically withdrawn from the laparoscopic puncture wound.
BRIEF SUMMARY OF THE INVENTION
The present invention specifically addresses and alleviates the above-identified deficiencies in the art. More specifically, the present invention is directed to a laparoscopic fascial closure device that is operative to fashion a secure closure of laparoscopic puncture wounds, and in particular, in abdominal tissues. According to a preferred embodiment, the device comprises an elongate cannula or other hollow tubular member having proximal and distal ends, the latter being configured to be inserted within the body via the laparoscopic trocar-created punctures used to perform the laparoscopic procedure. To that end, the cannula is sized to be inserted through a puncture site of at least 10 mm or greater.
Disposed within the cannula, and more particularly the distal end thereof, is a needle/suture complex consisting of two diametrically-opposed needle members having an elongate suture extending therebetween that are operatively transitional from a first insertion configuration, whereby the needles are confined within the distal-most end of the cannula for insertion through the abdomen to the puncture site; a second operative configuration whereby the needle members extend outwardly from the distal-most end of the cannula such that each respective needle is oriented toward the fascia surrounding the puncture site in a generally perpendicular orientation. Such needle members, according to said second configuration, are further oriented to extend outwardly from the distal-most end of the cannula by a distance of at least 1.0 cm or greater and pierce through the peritoneum and fascia at diametrically opposed points across the puncture site. To facilitate the ability of the needle/suture complex to gather tissue about a puncture site to form the desired closure, the needle/suture complex will preferably be positioned upon a tapered mount having a generally hourglass shape to thus enable tissue to gather thereabout.
The needle members are further operative to assume a third retraction configuration whereby each respective tip of the two diametrically-opposed needles are brought into and contained within the distal end of the cannula. To facilitate the ability of the device to assume the third configuration, a grasping mechanism is disposed within the cannula that is operative to grasp each respective needle tip and draw the same back into the cannula. The needle/suture complex is mounted upon a connecting rod disposed within the cannula, which is operative to be advanced downwardly into the cannula such that the needles of the needle/suture complex are deployed through and ultimately retracted back within the lumen of the cannula. When in such third configuration, the device is then withdrawn from the body.
In use, the suture connected across the respective needles is caused to extend across the puncture site with the free ends thereof being drawn upwardly from the puncture wound as the device is withdrawn from the body, which thus leaves the two ends of the sutures free to be cut away from the needl
Intellimed Surgical Solutions LLC
Milano Michael J.
Miller Raymond A.
Pantuck Bradford C
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