Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
1999-09-03
2002-10-22
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
Reexamination Certificate
active
06468285
ABSTRACT:
FIELD OF THE INVENTION
The present invention pertains generally to surgical instruments and procedures. More particularly, the invention relates to instruments and procedures that are specifically designed for laparoscopic vascular surgery, but have important applications in other surgical procedures.
BACKGROUND
Vascular surgery has traditionally been performed by making an open incision, or incisions, in the patient large enough for the surgical team to gain access and perform the procedure with hand instruments. These conventional open vascular bypass procedures are well known for their significant post-operative morbidity and recovery time and may be unavailable to certain patients of advanced age or preexisting medical conditions.
Laparoscopic (or endoscopic, thoracoscopic, etc., hereinafter collectively referred to as “laparoscopic”) surgical methods, first introduced in 1991 when Schuessler et al reported the initial results of pelvic lymphadenectomy (W. W. Schuessler, T. G. Vancaillie, H. Reich and D. P. Griffith, Transperitoneal Endosurgical Lymphadenectomy in Patients with Localized Prostate Cancer, J. Urol 1991:145:988-991), have gained an increasingly important role in modern surgery. Tremendous advances have been made and laparoscopic technology, in which access to the abdominal cavity and its enclosed anatomy is by small trocars or ports in the abdominal wall, has been applied to many abdominal and pelvic urological procedures (I. S. Gill, R. V. Clayman and E. M. McDougall, Advances in Urological Laparoscopy, J. Urol 1995:154:1275-1294). Laparascopy is far less invasive, which reduces postoperative morbidity, recovery periods, hospital stays, healthcare costs and unsightly scars. However, the role of laparoscopy in vascular surgery has been virtually nonexistent.
In 1993 Dion et al reported the first laparoscopic vascular procedure—a laparoscopically assisted aorto-bifemoral bypass procedure (Y. M. Dion, N. Katkhouda, C. Rouleau and A. Aucoin, Laparoscopic-assisted Aortobifemoral Bypass, Surg. Laparosc Endosc. 1993:5:425-429). In this report, laparoscopy was only used to perform dissection and mobilization of the vessels, after which minilaparotomy and conventional hand-sewn vascular anastomoses were performed. Since then, only a handful of laparoscopic vascular procedures have been reported. In these cases, again, a minilaparotomy was often made, and vascular anastomosis was performed using conventional surgical techniques and instruments. Up to this time, we are only aware of one report of laparoscopic vascular anastomosis (S. S. Ahn, M. F. Clem, B. D. Braithwaite et al, Laparoscopic Aortofemoral Bypass —Initial Experience in an Animal Model, Annals of Surgery (1995) Vol. 222, No. 5, at 677-683) which reports an aortofemoral artery bypass performed with needle suturing in a porcine model. Other laparoscopic vascular surgical techniques are described in: Laparoscopic-assisted Abdominal Aortic Aneurysm Repair, Surgical Endoscopy (1995) 9:905-907; Laparoscopic vascular surgery: Four case reports, Journal of Vascular Surgery (1995) Vol. 22, No. 1, pages 73-79; Endovascular repair of two abdominal aortic aneurysms, Journal of Vascular Surgery (August 1995) Vol. 22, No. 2, pages 201-202; Video-assisted, Retroperitoneal Approach for Abdominal Aortic Aneurysm Exclusion, The American Journal of Surgery, Vol. 172 (October 1996), pages 363-365; Experimental Laparoscopic Aortic Aneurysm Resection and Aortobifemoral Bypass, Surgical Laparoscopy & Endoscopy, Vol. 6, No. 3, pp. 184-190; and in U.S. Pat. Nos. 5,211,683; 5,304,220; 5,330,490; 5,452,733 and 5,634,941.
Many difficulties with and drawbacks of current techniques for vascular surgery are attributable to the properties of blood vessels. Their walls are elastic, and the two ends of a transected vessel retract in opposite directions. The distance between the retracted vessel ends frequently becomes too great for anamostosis. Thus, there is a need for instruments and procedures with which the surgeon can approximate the vessel ends, i.e. bring them close to each other and align them properly for surgery.
Eversion of the edges of blood vessels prior to suturing, vessel clipping or other reconstructive surgical procedures to achieve intima-intima approximation is critical to a successful clinical outcome. This, in fact, is a fundamental step in all types of vascular anastomotic procedures, including all types of conventional open surgeries. Failure to achieve intima-intima approximation by eversion may result in anastomotic site narrowing, stricture formation, aneurysms and other undesirable surgical sequelae. In open surgeries, eversion may be performed with vascular forceps, but forceps which will perform this function effectively in laparoscopic surgery do not exist. There is, in fact, no laparoscopic instrument that will effectively and reliably evert vessel or tissue edges. The lack of instruments that will perform this function effectively and reliably is a major obstacle to the development of laparoscopic vascular surgery.
SUMMARY OF THE INVENTION
The paired vascular clamps disclosed herein greatly simplify laparoscopic vascular reconstruction surgery by providing an instrument for bringing vessel ends together to a reasonable working distance under a controlled fashion. The size of the clamps can be varied to suit various procedures, and the clamps can be preassembled before insertion or assembled intracorporeally, either before or after attachment to vessels to be anastomosed. Thus, these clamps provide an effective, flexible and reliable instrument which the laparoscopic surgeon can use in the reconnection of severed blood vessels, the repair or reconstruction of vessels or other tissue or other laparoscopic surgical procedures, such as ureteral reconstruction in urologic surgery and fallopian tube reconstruction in gynecologic surgery. Other applications include orthopedic procedures such as tendon and ligament repair. Surgeons who perform reconstruction of any tubular or other elongated tissue may benefit from this device.
This invention also provides a laparoscopic approximator-everter that approximates and everts two blood vessel edges for laparoscopic clip application or suturing with precision and ease. The same instrument can be used to approximate and evert other tissue edges to facilitate other forms of laparoscopic suturing in other types of surgery such as urologic surgery, gynecology, cardiovascular surgery, general surgery and the like. The instrument can be used with tubular structures such as blood vessels and the like, and with non-tubular tissues. Like the paired vascular clamps, this approximate-everter is an effective, flexible and reliable instrument for the laparoscopic surgeon.
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Byermann Bryan P.
Gill Inderbir S
Goodin Mark S.
Hsu Thomas H. S.
Kotschi Helmuth
Ho Tan-Uyen T.
Recla Henry J.
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