Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
1999-12-01
2003-03-11
Jackson, Gary (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S142000, C606S143000, C606S075000, C606S078000, C128S898000
Reexamination Certificate
active
06530933
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to methods and devices for fastening bulging or herniated discs. More particularly, the invention relates to devices for compressing the bulge or herniation of a damage intervertebral disc.
BACKGROUND, TRADITIONAL SURGICAL PRACTICES AND PRIOR INVENTIONS
In recent years, much attention has been given to controlling surgical costs. One of the cost-effective approaches is to accelerate the speed of recovery and shorten post-surgical hospital stays. In addition to lowering costs, for the comfort and safety of patients, minimally invasive or endoscopic surgeries are becoming more and more popular. The term “endoscopic” used in this invention encompasses arthroscopic, laparoscopic, hysteroscopic and other instrument viewing procedures. Endoscopy is a surgical procedure, which allows surgeons to manipulate instruments to view and operate the surgical sites through small incisions in the bodies of patients.
(A) Meniscal Tear
In order to minimize both the patients' trauma and potential damage to nerves, blood vessels and other tissues, it is clearly desirable to minimize the size and number of holes puncturing the patients. Take meniscal repair in the knee for example, the current arthroscopic procedure requires one hole for the arthroscope, one hole for a needle to deliver a suture and another hole for a suture-retrieving instrument to complete one suture stitch (Arthroscopic Surgery by L. Johnson, M.D.; Knee Surgery by F. Fu, MD, et al.; Traumatic Disorders of the Knee by J. Siliski, MD; and Knee Surgery Current Practice by P. Aichroth, FRCS et al.). A minimum of three holes is made for the arthroscopic repair. In some cases, surgeons also require a distractor, an external fixation device that is screwed in through skin to the bones, separating the femur from the tibia. This expands the knee joint and makes room to manipulate both the suture and the suture-retrieving instrument. Due to the tightness of joint space, often a needle or instrument can accidentally scrape and damage the smooth surface of the joint cartilage, which given time, can potentially lead to osteoarthritis years after the surgery.
Recently, instead of delivering, manipulating and retrieving a suture, often in a very tight surgical site, delivery of tacks with barbs (U.S. Pat. No. 5,702,462 to Oberlander, 1997; U.S. Pat. No. 5,398,861 to Green, 1995; U.S. Pat. No. 5,059,206 to Winters, 1991; U.S. Pat. No. 4,895,148 to Bays et. al., 1990; U.S. Pat. No. 4,884,572 to Bays et. al., 1989), staples (U.S. Pat. No. 5,643,319 to Green et. al., 1997) and fasteners (U.S. Pat. No. 5,843,084 to Hart et. al., 1998; U.S. Pat. No. 5,374,268 to Sander, 1994; U.S. Pat. No. 5,154,189 to Oberlander et. al., 1992) through a small opening to hold torn tissue, such as the meniscus, in place have been implemented. Unfortunately, very few, if any, of these tacks, staples and fasteners have the holding strength to meet the standard set by sutures.
During the insertion of these devices into tissues, the barbs carve their way into their final holding position. Unavoidably, the carving damages the tissue, and thus weakens it thereby decreasing the holding strength of the freshly inserted devices. As tension is applied to the fastened tissue, it is not surprising that the barbs can lose their grip, slip and creep along the carved paths created during insertion, leaving gaps in the supposed closure sites. The creeping problem of fastening devices is particularly evident in slow healing tissues, such as menisci, and also in tissues providing high tensile strength, such as ligaments and tendons. Since gaps are present, the torn tissue does not reattach and heal, even with the passage of time.
Non-biodegrdable fasteners often have the problem of device migration, which can be devastating, especially into nerves, joints or vessels, after numerous cycles of tissue remodeling.
In summary, currently most of the tacks or fasteners have one or more of the following drawbacks: (1) weak holding strength, (2) creeping and leaving gaps in the repair site, and (3) potential migration into sensitive tissues.
Numerous staples (U.S. Pat. No. 5,829,662 to Allen et. al., 1998; U.S. Pat. No. 5,826,777 to Green et. al., 1998; U.S. Pat. No. 5,817,109 to McGarry et. al., 1998; U.S. Pat. No. 5,794,834 to Hamblin et. al., 1998; U.S. Pat. No. 5,715,987 to Kelley et. al., 1998; U.S. Pat. No. 5,662,662 to Bishop et. al., 1997; U.S. Pat. No. 5,413,584 to Schulze, 1995; U.S. Pat. No. 5,333,772 to Rothfuss et. al., 1994; U.S. Pat. No. 5,304,204 to Bregen, 1994; U.S. Pat. No. 5,257,713 to Green et. al., 1993; U.S. Pat. No. 5,089,009 to Green, 1992; U.S. Pat. No. 5,002,563 to Pyka et. al., 1991; U.S. Pat. No. 4,944,295 to Gwathmey, 1990; U.S. Pat. No. 4,671,279 to Hill, 1987; U.S. Pat. No. 4,485,816 to Krumme, 1984; U.S. Pat. No. 4,396,139 to Hall et. al., 1983) are designed and used for shallow penetration of the staple, mostly to fasten superficial tissues only.
The term “fastener” used in this invention encompasses tacks, staples, screws, clamps and other tissue holding devices.
(B) Anterior Cruciate Ligament Tear
Meniscal damage often accompanies a torn anterior cruciate ligament, ACL, which stabilizes the femoro-tibial joint. Due to the linear orientation of the collagen fibers and the enormous tensile strength required of the ACL, it is often difficult to reattach the ligament by suture. When tensile forces are applied, the suture cuts and tears the collagen fibers along their linear orientation. Therefore, the traditional ACL repair is to abandon the torn ACL altogether. To replace the ACL, a strip of patellar ligament is harvested from the patient. Two bone holes are drilled, one through the tibia and another through the femur. The strip of patellar ligament is threaded through the bone holes. Both ends of the patellar ligaments are then stapled to the anterior surfaces of femur and tibia through incisions of skin covering each bone. The traditional ACL repair is an invasive surgery. To minimize the degree of invasiveness and eliminate opening the skin for ligament stapling, bone fixation devices (U.S. Pat. No. 5,147,362 to Goble, 1992, U.S. Pat. No. 5,129,902 to Goble, et. al. 1992) are designed to grip the ligament replacement inside the drilled hole of the bone.
(C) Bulging or Herniated Disc
Low-back pain is one of the most prevalent and debilitating ailments of mankind. For many people, no position can ease the pain or numbness, not even bed rest. It is often the reason for decreased productivity due to loss of work hours, addiction to pain-killing drugs, emotional distress, prolonged hospital stays, loss of independent living, unplanned early retirements, and even financial ruin. Some may experience it occasionally; others suffer from it for years. One common reason for this chronic pain is the bulging or hemiation of an intervertebral disc, which can cause sciatica
The traditional surgical treatment for a bulging or herniated disc is a series of tissue removing, filling and supporting procedures: (1) laminectomy, removal of the lamina from the vertebra which covers part of the herniated disc, (2) discectomy, removal of the disc, (3) bone harvesting usually from the patient's iliac crest, (4) bone cement filling of the donor site, (5) donor bone packing into the vacant disc space, (6) adjacent vertebra supporting with rods, connectors, wire and screws, and finally, (7) surgical site closing.
After a discectomy, numerous postoperative complications can occur. The major ones are lumbar scarring and vertebral instability. The scar tissue extends and encroaches upon the laminectomy site and intervertebral foramen, then once again, pain returns, which leads to more surgery. In fact, re-operation is very common. Unfortunately, the success rate of re-operation is often less, in some cases, far less than the first. More operations lead to more scarring and more pain. Current emphasis to the patients is to avoid surgical procedures, unless the pain and inconveniences are absolutely unbearable.
Even for the fortunate pa
Yeung Jeffrey E.
Yeung Teresa T.
Gregory Smith & Associates
Jackson Gary
Titus Carol
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