Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-09-24
2003-04-01
Fonda, Kathleen K. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C536S053000
Reexamination Certificate
active
06541460
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method of expediting surgical procedures, and more specifically to a method of decreasing or shortening the length of time required to complete a surgical procedure by the application of hyaluronic acid to the surgical site, as well as to a method of wound management (whether a surgical wound or otherwise) by the use of a hyaluronic acid composition for decreased healing time and improved wound healing.
2. Description of Related Art
The expression “time is of the essence” has no more greater meaning or impact than when applied to a surgical procedure. Every second saved in reducing the length of time required to complete a surgical procedure can make the difference between life or death for the patient. Therefore, the length or duration of time required by a surgeon to finish a surgical procedure is a critical factor in determining the successful outcome of a surgical procedure. If a surgeon can shorten the length of time required to complete a surgical procedure, and thereby shorten the length of time a patient must be under anesthesia, in particular general anesthesia, the more likely the surgical procedure will attain the desired successful end result.
Various attempts have been made in the field of surgical medicine to develop ways to decrease or shorten the duration or length of time required to a complete surgical procedure. One such development pertains to the use of laparoscopy, or similar methods, that are less invasive, generally require less time to accomplish the same surgical goals when compared to standard nonlaparoscopy based surgical procedures, and promote a faster rate of recovery for the patient. However, laparoscopy or similar methods generally require equipment that can be very expensive; are not always readily available; often require special training and experience to become proficient in its use; and can not be used or modified in all surgical procedures. Therefore, what is needed is a method that decreases or shortens the duration or length of time required to complete any surgical procedure and that is relatively inexpensive and easy to use; does not require additional training or equipment to use; and is applicable to wide variety of surgical procedures, including laparoscopy or similar such methods.
The present inventor has unexpectedly found a way of accomplishing the above goals by decreasing or shortening the duration or length of time required to complete surgical procedures by the application of hyaluronic acid, or any pharmaceutically acceptable salt thereof such as sodium hyaluronate, into a surgical site in order to coat tissue exposed by the surgical procedure.
Hyaluronic acid (hereinafter referred to as HA) is a naturally occurring high viscosity glycosaminoglycan (GAG) having alternating &bgr;1-3 glucouronidic and &bgr;1-4 glucosaminidic bonds. HA has a broad ranging molecular weight, which is generally accepted to range between about 50,000 and 8,000,000 (or greater) depending upon its source and method of isolation. HA is found in animal tissue (i.e., umbilical cord, skin, vitreous humor, synovial fluid, and rooster combs) and it also can be obtained through fermentation by hemolytic streptococci groups A and C.
Numerous therapeutic uses for HA have been developed for the treatment of a wide range of problems, none of which pertain to methods of decreasing the duration or length of time required to complete a surgical procedure. U.S. Pat. No. 4,920,104, which issued to Dale P. Devore, David A. Swann and Bernard P. Sullivan on Apr. 24, 1990, teaches the use of a sodium hyaluronate solution as an aid in ophthalmological surgery to minimize the increase in post-operative intra-ocular pressure (P.I.O.), particularly where there is loss of the vitreous during surgery. The solutions used therein preferably have a viscosity between about 45-64,000 centistoke, and the HA has an average molecular weight within the range of 1-2 million Daltons.
European Patent Application No. 781 547 issued to Bunter on Jul. 2, 1997 teaches the use of sodium hyaluronate based ophthalmic formulations for use in eye surgery in order to reduce the toxic effects owing to the operation. The sodium hyaluronate based ophthalmic formulation can also be left “in situ” in the eye, without causing any significant elevation in intra-ocular pressure (P.I.O.).
U.S. Pat. No. 4,801,619, which issued to Gert T. Linblad on Jan. 31, 1989, teaches the use of a HA solution by intra-articular injection for controlling joint inflammation and reducing proteoglycan degradation. The solution used therein contains <2.0% HA, with an average molecular weight between about 3-7 million Daltons.
Macromolecular solutions containing HA, for example, have been popular substances in the effort to prevent tissue adhesion and aid in wound healing. It is well known that undesired tissue damage results from most surgical procedures, where cutting, desiccation, ischemic, and manipulative abrasions occur. Suture lines at closed incisions, as well as areas of abrasive contacts that occur between tissue surfaces and the many devices used in surgery (i.e., clamps, gloves, sponges, etc.) are known to be problematic, and often painful sites, which result from damaged cell membrane surfaces. Raftery, A. J.,
Effect of Peritoneal Trauma on Peritoneal Fibrinolytic Activity and Intraperitoneal Adhesion Formation, Eur. Surg. Res
. 13:397-401 (1981); Buckman, R.F., et al.,
A Physiologic Basis for the Adhesion-free Healing of Deperitonealized Surfaces, J. Surg. Res
. 21:67-76 (1976).
Furthermore, research has shown that the viscous HA macromolecule mechanically stops the oozing from disrupted microvasculi, and preliminary studies indicate that HA coats the peritoneum to suppress post-surgical bleeding. Abe, H., et al.,
The Effect of Intraperitoneal Administration of Sodium Tolmetin-Hyaluronic Acid on the Postsurgical Cell Infiltration in Vivo, F. Surg. Res
. 49:322-27 (1990).
U.S. Pat. No. 4,141,973, which issued to Endre A. Balazs on Feb. 27, 1979, discloses an ultra-pure HA fraction that has, among its many uses, the prevention of scar tissue formation and adhesion following surgery by introducing an HA solution into the surgical site, either during surgery or postoperatively. In addition, Balazs contends that HA solutions serve as a mechanical protector of the tissue during surgical manipulation and postoperatively.
U.S. Pat. No. 5,234,914, which issued to Damian Gallina on Aug. 10, 1993, teaches the use of an HA solution for the treatment of hemorrhoids and anorectal diseases which are accompanied by traumatized tissue. The HA solution may contain between 0.01-25.0% HA, which is applied topically to the effected tissues. By adhering to the anorectal epithelium and rectal mucosa, the HA solution provides a reduction in the pain, burning, inflammation, itching, and swelling associated with the above causes.
U.S. Pat. No. 5,190,759, which issued to Gert Linblad and Peter Buckley on Mar. 2, 1993, teaches the use of an HA solution, alone or in combination with dextran, for preventing adhesions between body tissues following surgical procedures. The HA solutions used therein contained between 0.5-6% HA and have a molecular weight within the range of 500,000 and 6,000,000 Daltons.
U.S. Pat. No. 5,409,904, which issued to Gerald Hecht and Ole J. Lorenzetti on Apr. 25, 1995, teaches the use of an HA solution, either alone or in combination with other viscoelastic substances, for preventing post-operative adhesions between healing tissues by introducing the solution into a surgical site during surgery or postoperatively. No mention is made, however, as to the timing of HA solution introduction during the surgical process.
U.S. Pat. No. 5,681,825, which issued to Lindqvist et al. on Oct. 28, 1997 teaches the use of an HA solution into the site of the surgical operation, for facilitating surgical operations that involve the eye or eye area.
U.S. Pat. No. 5,140,016, issued to Goldberg on Aug. 18, 1992 teaches the use of HA based co
Fonda Kathleen K.
Litman Richard C.
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