Hernia repair device and method

Abstract

An improved abdominal hernia repair system is presented comprised of a silicone layer backed up with a knitted or woven polypropylene fabric layer, the silicone layer possessing a regular pattern of slits that permit equilibration of fluid pressure across the device. A variety of therapeutic substances can be applied to the hernia repair device to promote healing, including aloe and other medicinal preparations. An improved inguinal hernia repair system is presented that is identical to the above except it does not contain the hydrophobic silicone component.

Claims

1. A hernia repair device, the hernia repair device comprised of two layers of material, the first layer of material, an upper layer, comprised of a silicone membrane, the second layer, a lower layer, comprised of a woven polypropylene fiber fabric, the silicone membrane selected in a thickness from 0.001 to 0.005, the upper layer possessing a plurality of slits in its surface, said slits made after the two layers are joined together, said slits in a regular pattern, the regular pattern comprising alternating perpendicular orientation, both horizontal and vertical, the lower layer woven in a regular pattern with weft knitting using a 11 alternating stitch, the slits on the surface either following the weft direction of the lower layer or crossing the weft direction of the lower layer perpendicularly, said upper layer or said lower layer or both the upper and lower layers treated with a plurality of layers of medicinal or therapeutic substances, said slits placed in said upper layer such that the hernia repair device has essentially zero porosity with no stretching tension placed on it, the porosity of said hernia repair device variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the hernia repair device, the direction of stretching tension dependent on the orientation of said slits with the weft orientation of a woven fiber fabric, the hernia repair device designed to place the woven nylon fabric side towards the abdominal wall when in use.

2. The hernia repair device of claim 1 where the plurality of layers of medicinal and therapeutic substances are selected from the list of hypoallergenic Type I porcine collagen peptide , pure aloe, aloesin, and extracellular matrix.

3. The device of claim 1, wherein the upper layer is comprised of a smooth silicone membrane.

4. The device of claim 1, wherein the device is for hernia repair.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1. Weft knitting pattern as used in the device

(2) FIG. 2. Slit pattern on the smooth side of the device

DETAILED DESCRIPTION OF THE INVENTION

(3) The invention (when used as for repair of abdominal hernia repair) is directed to a device comprised of two layers or sheets of material, the first layer of material, an upper layer, comprised of a silicone membrane or sheet and the second layer, a lower layer, comprised of a knitted or woven polypropylene fiber fabric.

(4) In one embodiment, the silicone membrane or sheet is a smooth membrane or sheet. The silicone layer/sheet and the woven fiber fabric are brought together at time of manufacture by implanting the woven fiber fabric into the silicone membrane or sheet while said silicone membrane or sheet is still soft. A portion of the woven fiber fabric implants itself in the material of the silicone membrane or sheet leaving a thickness of the woven material above the level of the silicone membrane or sheet. The resultant material is a 3 dimensional mesh.

(5) In another embodiment, the 3 dimensional mesh is a polypropylene mesh. In one embodiment, the mesh is coated with a mixture of gelatin/Immuno-10 to enhance ingrowth/healing. The invention for non-abdominal hernia repair (inguinal, other) will not have the silicone component but will have the 3 dimensional polypropylene mesh coated with a mixture of gelatin/Immuno-10 to enhance ingrowth/healing.

(6) In one embodiment, the woven fiber fabric is comprised of knitted polypropylene monofilament mesh fabric, the mesh is created using weft knitting using a 11 alternating stitch, the detailed knit pattern shown in FIG. 1.

(7) The woven material above the silicone membrane or sheet, the woven side of the invention, can be impregnated or incorporated with biological and non-biological substances for therapeutic purposes. These substances include but are not limited to hypoallergenic Type I porcine collagen peptide, Immuno-10, and extracellular matrix, or a combination of any of the substances thereof.

(8) The amounts of biological and non-biological substances for therapeutic purposes are as follows for the preferred embodiment: the amount of gelatin is about 20 micrograms/square cm (cm.sup.2); about 40 micrograms of Immuno-10/square cm.

(9) As in FIG. 2, openings are made after the silicone component has been cured, and are in the shape of slits, not holes. The figure shows the hernia repair device silicone layer up with the slits exposed.

(10) The present invention differs from its ancestors in that it has variable porosity; the slit size in the thin silicone will be essentially zero (with no stretch, in relaxed mode) with essentially zero porosity to a higher porosity (proportional to the stretch applied). The stretching will come from buildups of fluid between the smooth side of the invention and the abdominal wall, which would be relieved as the slits are opened by pressure on the membrane. Slightly open slits allow fluid to cross the device and not accumulate (as a seroma) which could become infected.

(11) In this embodiment, designed for hernia repair, the slits made in the silicone are approximately 0.044 long with a space of 0.180 between the centers of the slits; rows of slits are 0.250 apart. The rows of slits are arranged such that the slits alternate orientations, half are parallel to the weft orientation of the knitted polypropylene component, the other half perpendicular to it.

(12) In the preferred embodiment, there is an additional bead of silicone that is added to the smooth side of the invention, on the surface of the silicone sheet, around the edge of the invention. This bead of silicone assists the surgeon implanting the device by giving the surgeon something to grip with forceps. Without the bead of silicone, the edge of the invention could slip out of a forceps during implantation.

(13) This is the preferred embodiment of the invention. The technology to create this invention is listed as the preferred embodiment of this invention, but other methods are possible and are within the contemplation of this patent.