METHOD FOR SHAPING TISSUE MATRICES
Methods for shaping tissue matrices are provided. The methods can be used to produce shaped tissue products that retain desired biologic properties without using chemical crosslinking agents.
1 . A method for shaping a tissue matrix to support a breast implant, comprising:
selecting a collagen-containing tissue matrix;
partially dehydrating the tissue matrix;
applying mechanical forces to the tissue matrix to form a cup shape; and
exposing the tissue matrix while partially dehydrated to ionizing radiation to stabilize at least a portion of the tissue matrix.
2 . The method of claim 1 , wherein the tissue matrix is an acellular tissue matrix.
3 . The method of claim 1 , wherein the tissue matrix comprises a dermal tissue matrix.
4 . The method of claim 1 , wherein the tissue matrix is produced from a tissue selected from fascia, pericardial tissue, dura, umbilical cord tissue, placental tissue, cardiac valve tissue, ligament tissue, tendon tissue, arterial tissue, venous tissue, neural connective tissue, urinary bladder tissue, ureter tissue, or intestinal tissue.
5 . The method of claim 1 , wherein partially dehydrating the tissue matrix includes removing water to produce a tissue matrix containing between 95% (w/w) and 50% (w/w) water content.
6 . The method of claim 5 , wherein the water content is between 80% (w/w) and 65% (w/w).
7 . The method of claim 5 , wherein the water content is between 85% (w/w) and 50% (w/w).
8 . The method of claim 5 , wherein the water content is between 80% (w/w) and 50% (w/w).
9 . The method of claim 5 , wherein the water content is between 90% (w/w) and 50% (w/w).
10 . The method of claim 5 , wherein the water content is between 90% (w/w) and 60% (w/w).
11 . The method of claim 5 , wherein the water content is between 90% (w/w) and 65% (w/w).
12 . The method of claim 1 , further comprising rehydrating the tissue matrix.
13 . The method of claim 1 , wherein the radiation is applied at a dose between 5 Gy and 50 kGy.
14 . The method of claim 1 , wherein the radiation is applied at a dose between 5 Gy and 20 kGy.
15 . The method of claim 1 , wherein the radiation is applied at a dose of less than 10 kGy.
16 . The method of claim 1 , wherein the radiation is applied at a dose of less than 5 kGy.
17 . The method of claim 1 , wherein the radiation is applied at a dose of less than 1 kGy.
18 . The method of claim 1 , wherein the radiation is selected from gamma radiation, e-beam radiation, and X-ray radiation.
19 . The method of claim 1 , the radiation causes cross-linking sufficient to stabilize the tissue matrix to form a stable three-dimensional structure.
20 . The method of claim 1 , wherein selecting a tissue matrix includes selecting a tissue matrix in the form of a flexible sheet.
21 . The method of claim 20 , wherein applying mechanical forces to the tissue matrix to form a cup shape includes:
placing the tissue matrix in a cup shaped mold; and
applying mechanical forces to change the orientation of collagen fibers within the tissue matrix to produce a tissue matrix having a shape corresponding to the mold.
22 . The method of claim 2 , wherein selecting a tissue matrix includes selecting a tissue matrix in the form of a flexible sheet.
23 . The method of claim 22 , wherein applying mechanical forces to the tissue matrix to form a cup shape includes:
placing the tissue matrix in a cup shaped mold; and
applying mechanical forces to change the orientation of collagen fibers within the tissue matrix to produce a tissue matrix having a shape corresponding to the mold.
24 . The method of claim 1 , further comprising:
placing an inner surface of the tissue matrix around a breast implant.
25 . The method of claim 24 , further comprising:
attaching the tissue matrix to surrounding fascia, muscle, or other tissue.
26 . The method of claim 1 , further comprising:
applying mechanical forces to the tissue matrix to change the orientation of collagen fibers within the tissue matrix.
27 . A tissue product for supporting a breast implant, comprising:
a collagen-containing tissue matrix, wherein the collagen-containing tissue matrix has a cup shape formed by a process comprising:
partially dehydrating the collagen-containing tissue matrix;
applying mechanical forces to the collagen-containing tissue matrix to form a cup shape; and
exposing the collagen-containing tissue matrix to radiation to stabilize at least a portion of the matrix.
28 . A tissue product for supporting a breast implant, comprising:
a collagen-containing tissue matrix, wherein the collagen-containing tissue matrix has a mechanically formed cup shape, the cup shape stabilized by radiation without chemical cross-linking agents.