Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2000-05-19
2002-11-12
Nerbun, Peter (Department: 3739)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
Reexamination Certificate
active
06478803
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an apparatus and methods for application of a surgical material to a target site within a body cavity. The apparatus and methods of the present invention are suitable for use in laparoscopic and endoscopic surgical procedures, as well as open-incision type procedures.
2. Background
Surgical prosthetic materials are used with a wide variety of surgical procedures. For example, prosthetic materials are often associated with hernia repair. Hernias are abnormal protrusions of an organ or other body structure through a defect or natural opening in a covering membrane, muscle or bone. Hernia repair typically involves replacement of the protruding tissue and repair or reconfiguration of the opening from which it protruded.
Surgical prostheses used in hernia repair and other procedures may include meshor gauze-like materials, which support the repaired hernia or other body structures, and/or anti-adhesion barriers, which are often placed between organs or tissues having different structures. Anti-adhesion barrier products are known to prevent the formation of adhesions between internal organs and/or the abdominal wall. Proper placement of such surgical prostheses is sometimes difficult, particularly where laparoscopic and endoscopic surgical procedures are utilized.
Laparoscopic and endoscopic surgical procedures offer significant advantages relative to conventional surgical procedures, and can often avoid the risks associated with such conventional procedures, e.g., bleeding, infection, and damage to organs, nerves and blood vessels.
In laparoscopic procedures, surgery is performed in the interior of the abdomen through narrow tubes inserted therein. Similarly, in endoscopic procedures, surgery is performed in any hollow cavity of the body through narrow endoscopic tubes inserted through small entrance wounds in the skin.
Since only small diameter incisions are required in laparoscopic and endoscopic procedures, trauma to the body (e.g., to the abdominal wall) is minimized, and the time required for healing and post-operative care is significantly shortened.
A number of devices have been developed for use in laparoscopic, endoscopic and open-incision delivery of surgical materials.
One such device is described in U.S. Pat. No. 5,503,623. The methods disclosed in this patent generally comprise grasping and furling a sheet of surgical material into a roll about a delivery tube, back-loading the delivery tube into an inserter sheath, then inserting the device into the abdomen for deploying and articulating the sheet within the abdomen. Placement of the sheet is facilitated by mechanical articulation of a grasping element.
Another device is described in U.S. Pat. No. 5,350,387. This device also is reported as being suitable for application of an adhesion prophylaxis, particularly a film-like material for use in endoscopic surgery. The apparatus disclosed includes a cylindrical application sleeve and a rod-like film carrier. An elongated reception area, e.g., a slot or clamping device, is provided at the forward end of the instrument for receiving the film. The film is frictionally engaged or grasped within the slot by roughened, opposing bearing surfaces and the adhesion prophylaxis is then wound about the film carrier for subsequent application within the body cavity. Other instruments, introduced by one or more separate trocars or cannulas, facilitate unwinding of the film.
These types of devices present certain limitations, particularly when they are used in laparoscopic and endoscopic procedures. For example, these devices are not suitable for use with most hygroscopic surgical materials; that is, those materials which absorb moisture from the air. Once hygroscopic materials become dampened (which is inevitable upon entry into a body cavity), they tend to become difficult to handle. Additionally, when folded, furled or wound about some type of inserter instrument (which is necessary in laparoscopic and endoscopic procedures), the surgical material may adhere to itself. In this case, unfolding or unwinding of the surgical material is very difficult, if not impossible. Thus, application of the particular surgical material to the target body tissue also becomes very difficult.
Another device for the endoscopic delivery of surgical elements is described in U.S. Pat. No. 5,304,187. The device described in that patent is reported as being particularly useful in the repair of herniated body tissue. Using that device, the surgical element is received through a longitudinal slot in an outer wall of a tubular member described as a housing means. Within the housing means, the element is grasped by a retainer means, then wound into a roll about the retainer means and maintained within the housing means. In preferred embodiments, the retainer means is described as a rod having two opposing convex members at its distal end. Upon entry into the body cavity, the device is positioned adjacent to the target body tissue, and the rolled surgical element is deployed, positioned and secured (e.g., with sutures, clips, staples, etc.) to the body tissue.
That device also is unsuitable for delivery of many hygroscopic surgical materials for the same reasons noted previously. Additionally, the device disclosed in that patent is particularly suited for delivery of a relatively stiff hernia repair material. Delivery of a thin, limp sheet of surgical material, e.g., a hygroscopic anti-adhesion product, would be very difficult, if not impossible, using such a device.
There remains a need for an improved apparatus for laparoscopic and endoscopic delivery of a wide variety of surgical materials to target sites within the body cavity. It would be highly desirable to develop an apparatus for laparoscopic, endoscopic, as well as open-incision delivery of such materials that could be used even for application of thin, limp, hygroscopic surgical materials. Further, it would be highly desirable to develop an apparatus for laparoscopic, endoscopic and open incision application of such materials that would not require the use of mechanical articulation in order to effectively position the surgical material at the target site, and that would not require insertion of additional instruments into the abdomen for articulation and securement of the material with respect to the target sites within the body cavity.
SUMMARY OF THE INVENTION
A central object of the present invention is to provide an apparatus suitable for use in a variety of surgical procedures, including laparoscopic, endoscopic and open incision surgical procedures, for application of a surgical material (e.g., a sheet, film, mesh or gauze) to a target site within a body cavity.
Though the apparatus of the present invention may be used for a wide variety of surgical materials, it is particularly well suited for the application of hygroscopic anti-adhesion products. Examples of such products include Seprafilm® manufactured by Genzyme Corporation and Interceed® manufactured by Johnson and Johnson.
Preferred anti-adhesion products have surfaces with very low coefficients of friction, especially when wetted, so that placement of the material between adjacent tissues will prevent adhesions from forming between the tissues and will allow some relative movement between the tissues without causing substantial tissue damage.
Such materials are typically in the form of dimensionally stable films that are easy to handle when in dry form. Further, such materials are non-adhesive, and preferred materials, such as Seprafilm®, will not cling to themselves or to adjacent surfaces when in dry form. However, preferred materials also are hygroscopic; that is, they absorb moisture from the air. Once hygroscopic material becomes damp or wet, it becomes difficult to handle. More specifically, when the surface of such material becomes wetted, the film has a tendency to cling to itself, to tissue, anatomical structures and various other materials, e.g., metal and plastics.
Because of these distinctive
Chochinov Allan
Kapec Jeffrey
McKenzie Sara
Naoi Yukiko
Tanaka Kazuna
Allison Richard D.
DesRosier Thomas J.
Genzyme Corporation
Moran Katherine
Nerbun Peter
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