Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2000-10-19
2002-09-10
Vanatta, A. (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S075000, C606S139000, C606S144000, C606S232000
Reexamination Certificate
active
06447524
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates, in general, to a surgical fastener and, more particularly, to a surgical fastener for attaching a prosthetic in the repair of a defect in tissue such as an inguinal hernia.
BACKGROUND OF THE INVENTION
An inguinal hernia is a condition where a small loop of bowel or intestine protrudes through a weak place or defect within the lower abdominal muscle wall or groin of a patient. This condition commonly occurs in humans, particularly males. Hernias of this type can be a congenital defect wherein the patient is born with this problem, or can be caused by straining or lifting heavy objects. Heavy lifting is known to create a large amount of stress upon the abdominal wall and can cause a rupture or tearing at a weak point of the abdominal muscle to create the defect or opening. In any case, the patient can be left with an unsightly bulge of intestinal tissue protruding through the defect, pain, reduced lifting abilities, and in some cases, impaction of the bowel, or possibly other complications if the flow of blood is cut off to the protruding tissue.
A common solution to this problem is surgery. In the surgical procedure, the defect is accessed and carefully examined, either through an open incision or endoscopically through an access port such as a trocar. In either case, the careful examination can be well appreciated, as a network of vessels and nerves exist in the area of a typical defect, which requires a surgeon to conduct a hernia repair with great skill and caution. Within this area are found vascular structures such as gastric vessels, the external iliac vessels, and the inferior epigastric vessels, and reproductive vessels such as the vas deferens extending through the inguinal floor.
Once the surgeon is familiar with the anatomy of a patient, the surgeon carefully pushes the bowel back into the patient's abdomen through the defect. Repairing the defect can involve closure of the defect with sutures or fasteners but generally involves placing a surgical prosthetic such as a mesh patch over the open defect, and attaching the mesh patch to the inguinal floor with conventional suture or with surgical fasteners. The mesh patch acts as a barrier and prevents expulsion of bowel through the defect. Suturing of the mesh patch to the inguinal floor is well suited to open procedures but much more difficult and time consuming with endoscopic procedures. With the adoption of endoscopic surgery, endoscopic surgical instruments that apply surgical fasteners are falling more and more into use. However, the tissue of the inguinal floor offers special challenges to the surgeon when a needle or fastener is used to penetrate structures such as Cooper's ligament.
At present, there are a variety of surgical instruments and fasteners available for the surgeon to use in an endoscopic or open procedure to attach the mesh patch to the inguinal floor. One of the earliest types of endoscopic surgical instruments used is a surgical stapler. These surgical instruments apply a plurality of elongated “U” shaped staples, one at a time, into the mesh patch and the inguinal wall. The “U” shaped staples are formed into a box that digs into tissue as it is formed and tightly holds the mesh patch onto tissue. A plurality of these unformed staples are generally contained within a stapling cartridge in a serial fashion, and are sequentially advanced or fed from the instrument with a spring mechanism. Surgical fasteners of these types are found in U.S. Pat. No. 5,470,010 by Robert Rothfuss et al. and in U.S. Pat. No. 5,582,616, also by Robert Rothfuss et al.
Whereas these surgical stapling instruments did indeed adequately fasten the mesh patch to the inguinal wall, their usage has declined due to a surgeon perception that a smaller diameter instrument was needed for endoscopic procedures. Surgeons have begun to use smaller 5 mm devices that offer a smaller access incision in the abdomen than a 10 mm diameter stapler does. Some of these smaller devices use a different type of fastener, such as a helical wire fastener that resembles a small section of spring. Multiple helical wire fasteners are stored serially within the 5 mm shaft, and are corkscrewed or rotated into tissue. A drive bar extends across the proximal end of the helical fastener and holds the mesh patch against tissue. As the instrument is fired, a load spring is used to bias or feed the remaining helical fasteners distally. Instruments and fasteners of these types are found in U.S. Pat. No. 5,582,616 by Lee Bolduc et al., U.S. Pat. No. 5,810,882 by Lee Bolduc et al., and in U.S. Pat. No. 5,830,221 by Jeffrey Stein et al.
Other surgical fasteners and surgical application instruments have been tried, for example dart fasteners that utilizes a single shot plunger type applicator, and “H” shaped clothes tie type fastener that also uses a plunger type applicator. The dart fastener has a pointed distal end with retaining barbs, and a large disk at the distal end. The fastener is described as being formed of polypropelene, stainless steel or polydioxanone suture. To apply, the surgeon drives the pointed end into the mesh patch and into tissue. The barbs retain the pointed end within tissue and the large disk retains the mesh patch against the inguinal floor. For multiple fastener firings, a rotary feeding magazine is employed. The “H” shaped clothing tag fastener is also described in the prior art. A first vertical leg of the “H” mounts within a needle of an applier with the horizontal bar of the “H” and the second or remaining vertical leg of the “H” sticking out. The needle is plunged into the mesh patch and into tissue, and the first vertical leg is then ejected to lock into tissue, bringing the second vertical leg into contact with the mesh patch. The “H” fasteners are also made of polypropelene, stainless steel or polydioxanone suture. Both of these types of fasteners and surgical fastening instruments can be found in U.S. Pat. No. 5,203,864 and U.S. Pat. No. 5,290,297, Both by Edward Phillips. These instruments have not gained acceptance by the surgical community, possibly due to their single shot capabilities and the large size of the rotary magazine.
Whereas the above fasteners are utilized to attach a prosthetic within the body for the repair of a hernia, none of the fasteners disclosed are formed from a superelastic or pseudoelastic shape memory alloys. These alloys exhibit characteristics that can be used to advantage in the fastener. The prior art makes reference to the use of alloys such as Nitinol (Ni—Ti alloy) which have shape memory and/or superelastic characteristics in medical devices which are designed to be inserted into a patient's body. The shape memory characteristics allow the devices to be deformed to facilitate their insertion into a body lumen or cavity and then be heated within the body so that the device returns to its original shape. Superelastic characteristics on the other hand generally allow the metal to be deformed and restrained in the deformed condition to facilitate the insertion of the medical device containing the metal into a patient's body, with such deformation causing the phase transformation. Once within the body lumen the restraint on the superelastic member can be removed, thereby reducing the stress therein so that the superelastic member can return to its original un-deformed shape by the transformation back to the original phase. Alloys having shape memory/superelastic characteristics generally have at least two phases. These phases are a martensite phase, which has a relatively low tensile strength and which is stable at relatively low temperatures, and an austenite phase, which has a relatively high tensile strength and which is stable at temperatures higher than the martensite phase.
Shape memory characteristics are imparted to the alloy by heating the metal at a temperature above which the transformation from the martensite phase to the austenite phase is complete, i.e. a temperature above which the austenite phase is stable (th
Fuchs Richard P.
Knodel Bryan D.
Ludzack Michael R.
Ethicon Endo-Surgery Inc.
Garner Dean
Muromoto Jr. Robert H.
Vanatta A.
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