Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Hollow or tubular part or organ
Reexamination Certificate
2002-03-22
2004-06-29
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Hollow or tubular part or organ
C606S151000
Reexamination Certificate
active
06755868
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a hernia repair device and, more particularly, to a hernia repair device adapted to be implanted in a patient.
BACKGROUND OF THE INVENTION
Various prosthetic mesh devices have been proposed for use in repairing hernia defects (e.g., an opening in or the thinning of the tranversalis fascia through which the abdominal viscera can extrude). Some of these mesh devices are adapted for anterior-side hernia repair (i.e., repairing a hernia defect from an anterior side of the fascia proximate to the surgeon). For instance, a hernia defect can be repaired exclusively from the anterior side of the fascia by dissecting the sac from the surrounding structures, inverting the sac into an abdominal cavity and then closing the defect with the use of an overlay patch or with the use of a space-filling prosthesis having an overlay patch.
One type of prosthesis adapted for anterior-side hernia repair is made from a sheet of surgical mesh fabric folded into a multi-layered cone. In order to repair a hernia defect, the prosthesis is inserted into the defect to occlude the void. Because the prosthesis is stiff, it does not readily conform to the contour of the defect, forming gaps between the prosthesis and the interior wall of the defect and hence potentially causing recurrent herniation. The stiff, multi-layered prosthesis is also susceptible to kinking and buckling during its placement into the defect.
Additional examples of prostheses adapted for anterior-side hernia repair include the “PERFIX® Plug” and “MARLEX® Mesh Dart” devices marketed by C. R. Bard, Inc., Murray Hill, N.J. The “MARLEX® Mesh Dart” devices are implantable mesh prostheses which are hot-molded into a conical, non-compressible configuration and hence are not readily compliant to irregularities in muscle or tissue walls of hernia defects.
An implantable prosthesis similar to the “PERFIX® Plug” devices is disclosed in U.S. Pat. No. 5,356,432. More particularly, the implantable prosthesis is in the form of a conical plug made from a polypropylene mesh. Longitudinally extending pleats are hot-molded into the mesh to enhance the flexibility of the conical plug for the purpose of allowing the prosthesis to conform more readily to the contour of a herniated opening. Because of its conical shape, the prosthesis has a relatively large vertical length or profile. As a result, when the prosthesis is implanted into a hernia defect, its tip tends to press into and/or against a visceral sac, causing discomfort to the patient and/or impeding proper hernia repair. In one embodiment, the prosthesis is provided with filler layers incorporated into the interior of the prosthesis in order to minimize its contraction while the hernia defect is healed. These layers make the manufacturing of the prosthesis rather complicated.
Hernia defects can also be repaired from the posterior side of the fascia (i.e., the side of the fascia remote from the surgeon) by implanting prostheses in pre-peritoneal spaces to prevent peritonea from passing through the fascia defect. These prostheses are, in some instances, implanted with the use of laparoscopic techniques and, in other instances, require deployment from remote locations within the pre-peritoneal space. Examples of these prostheses are disclosed in U.S. Pat. Nos. 5,116,357, 5,254,133 and 5,916,225. The devices disclosed in these patents will be discussed in greater detail hereinbelow.
U.S. Pat. No. 5,116,357 discloses a hernia repair device having a plug positionable in an opening formed in the abdominal fascia, as well as a patch positionable over weakened portions of the abdominal fascia adjacent to the opening. A central extent of the patch is coupled to a proximal end of the plug. Resilient means is coupled to the patch and provided with memory to assume an extended shape for the proper positioning of the patch with respect to the weakened portions for the abdominal fascia. While this device provides a means of plugging and patching a circular defect, it does not conform to the shape of the naturally occurring defect. Additionally, it requires general anesthesia and additional instrumentation for its deployment at the site of a hernia defect with the use of a laparoscopic surgery.
U.S. Pat. No. 5,254,133 discloses a surgical implantation device for closing an enlarged, generally circular opening in a patient's body. The surgical implantation device includes a pair of generally planar portions interconnected by a connecting segment. While this device can reduce the amount of post-operative discomfort experienced by patients, it requires general anesthesia and additional instrumentation for its deployment at the site of a hernia defect with the use of a laparoscopic surgery.
U.S. Pat. No. 5,916,225 relates to a hernia mesh patch adapted for posterior-side hernia repair. More particularly, the patch includes a first layer sized and shaped so as to extend across and beyond a hernia defect. A second layer overlies the first layer to create a generally planar configuration for the patch. The first and second layers are joined together by a seam defining a periphery of a pouch formed between the first and second layers. An access slit is formed in one of the layers for insertion of a finger of a surgeon into the pouch to allow the surgeon to deform the planar configuration of the patch to facilitate insertion of the patch into the patient and to position the patch across the hernia. A resilient loop is located within the pouch for urging the patch to conform to the generally planar configuration across the hernia defect as the surgeon withdraws his or her finger. Due to the construction and deployment method of the patch, the surgeon needs to have proper dexterity in order to implant the patch at the site of a hernia defect. Moreover, while the resilient loop expands the device into a planar configuration, anatomical structures surrounding a hernia defect are typically non-planar. In such circumstances, the device may not readily conform to such anatomical structures.
Accordingly, there is a need for an implantable hernia repair device that has enhanced compliancy to the irregular shapes of hernia defects, that is simple to install without requiring general anesthesia and that has a reduced length or profile when implanted.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a prosthesis adapted for easy insertion into a hernia defect from an anterior-side thereof and capable of either expanding or collapsing radially so as to occlude and conform to the fascia wall of the hernia defect.
A further object of the present invention is to provide an implantable hernia repair device having a reduced length/profile when deployed in a hernia defect.
Yet another object of the present invention is to provide a prosthesis adapted for use in repairing hernia defects having varying sizes and shapes and adapted to be anchored to surrounding tissues such that it extends beyond the edge of a hernia defect on the anterior-side thereof to prevent migration.
The present invention overcomes the disadvantages and shortcomings of the prior art discussed above and achieves the aforementioned objects by providing a new and improved implantable prosthesis having at least one body made from a biocompatible textile material. The body is provided with a first section and a second section inverted into the first section such that the second section is radially surrounded by the first section. The second section is movably connected to the first section such that the body is expandable or collapsible in a radial direction so as to conform to the size and shape of a hernia defect. In one embodiment, a single, radially collapsible body is provided for use in repairing a hernia defect. In another embodiment, two identical bodies are connected to one another so as to form an implantable plug adapted to be radially expanded into position after its insertion into a hernia defect.
REFERENCES:
patent: 2671444 (1954-03-01), Pease, Jr.
patent: 3054406 (1962-09
Ethicon Inc.
Jackson Suzette J.
Willse David H.
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