US7815923B2 — Implantable graft material

Claim 1

Independent Claim 146 words

An isolated graft material retaining a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, said isolated graft material prepared by a process comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said graft material to retain said valve cusp shape.

Claim 2

Dependent Claim 146 words

An isolated graft material retaining a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, said isolated graft material prepared by a process comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said graft material to retain said valve cusp shape.

Claim 3

Dependent Claim 27 words

The isolated graft material of claim 1 , wherein said remodelable extracellular matrix material retains bioactive components native to a source tissue for the extracellular matrix material.

Claim 4

Dependent Claim 52 words

The isolated graft material of claim 2 , wherein said remodelable extracellular matrix material comprises at least 80% by weight collagen on a dry weight basis, includes uniaxial or multiaxial oriented fibers, and includes at least about 3% retained non-collagenous solids from the source tissue, the non-collagenous solids including said bioactive components.

Claim 5

Dependent Claim 15 words

The isolated graft material of claim 2 , wherein the bioactive components comprise growth factors.

Claim 6

Dependent Claim 34 words

The isolated graft material of claim 1 , wherein said remodelable extracellular matrix material includes a section that is held in tension against a surface of said implanted shaping element in said body cavity.

Claim 7

Dependent Claim 13 words

The isolated graft material of claim 1 coupled to an implantable valve frame.

Claim 8

Dependent Claim 23 words

The isolated graft material of claim 1 further providing a generally hollow, tubular graft which incorporates said valve cusp within said tubular graft.

Claim 9

Dependent Claim 25 words

The isolated graft material of claim 1 , wherein said remodelable extracellular matrix material is further associated with a frame element in said body cavity.

Claim 10

Independent Claim 167 words

A method of forming an isolated graft material suitable for implantation in the body of a patient, the method comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said tissue material to retain a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, or an elongate generally cylindrical shape having a generally solid cross section for providing a prosthetic ligament or tendon.

Claim 11

Independent Claim 167 words

A method of forming an isolated graft material suitable for implantation in the body of a patient, the method comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said tissue material to retain a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, or an elongate generally cylindrical shape having a generally solid cross section for providing a prosthetic ligament or tendon.

Claim 12

Dependent Claim 24 words

The method of claim 9 , wherein the tissue material is removed from the body cavity at least 15 days after being inserted therein.

Claim 13

Dependent Claim 25 words

The method of claim 9 , wherein the tissue material is removed from the body cavity no later than 45 days after being inserted therein.

Claim 14

Dependent Claim 24 words

The method of claim 9 , wherein the tissue material is removed from the body cavity at least 25 days after being inserted therein.

Claim 15

Dependent Claim 25 words

The method of claim 9 , wherein said remodelable extracellular matrix material retains bioactive components native to a source tissue for the extracellular matrix material.

Claim 16

Dependent Claim 50 words

The method of claim 13 , wherein said remodelable extracellular matrix material comprises at least 80% by weight collagen on a dry weight basis, includes uniaxial or multiaxial oriented fibers, and includes at least about 3% retained non-collagenous solids from the source tissue, the non-collagenous solids including said bioactive components.

Claim 17

Independent Claim 94 words

A method of forming an isolated, decellularized tissue material, the method comprising: removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue; and decellularizing the tissue material following removal from said body cavity.

Claim 18

Independent Claim 94 words

A method of forming an isolated, decellularized tissue material, the method comprising: removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue; and decellularizing the tissue material following removal from said body cavity.

Claim 19

Dependent Claim 17 words

The method of claim 15 , wherein said tissue material is in the form of a sheet.

Claim 20

Dependent Claim 17 words

The method of claim 15 , wherein said tissue material is in the form of a tube.

Claim 21

Dependent Claim 11 words

The method of claim 17 , wherein said tube is hollow.

Claim 22

Dependent Claim 16 words

The method of claim 15 , wherein said tissue material provides one or more valve leaflets.

Claim 23

Dependent Claim 20 words

The method of claim 15 , wherein said tissue material is in the form of a prosthetic ligament or tendon.

Claim 24

Dependent Claim 28 words

The method of claim 15 , wherein said remodelable extracellular matrix material was seeded with one or more cell populations prior to being inserted in said body cavity.

Claim 25

Dependent Claim 22 words

The method of claim 15 , wherein said remodelable extracellular matrix material is associated with a frame element in said body cavity.

Claim 26

Dependent Claim 15 words

The method of claim 22 , wherein said frame element comprises one or more stents.

Claim 27

Dependent Claim 32 words

The method of claim 23 , wherein said one or more stents includes a plurality of discrete, spaced stents which are embedded within and interconnected to one another by said tissue material.

Claim 28

Dependent Claim 19 words

The method of claim 15 , wherein said isolated, decellularized tissue material is adapted for implantation in a joint.

Claim 29

Dependent Claim 15 words

The method of claim 15 , wherein said body cavity is that of a vertebrate.

Claim 30

Dependent Claim 19 words

The method of claim 26 , wherein said body cavity is that of a bovine, equine, ovine, or porcine.

Claim 31

Dependent Claim 15 words

The method of claim 26 , wherein said body cavity is that of a human.

Claim 32

Dependent Claim 14 words

The method of claim 15 , wherein said body cavity is a peritoneal cavity.

Claim 33

Dependent Claim 20 words

The method of claim 15 , wherein said body cavity is a thoracic cavity, scrotum, brain, joint, or pericardial cavity.

Claim 34

Dependent Claim 23 words

The method of claim 15 , wherein said remodelable extracellular matrix material is associated with an implanted shaping element in the body cavity.

Claim 35

Dependent Claim 13 words

The method of claim 31 , wherein said implanted shaping element is biodegradable.

Claim 36

Dependent Claim 25 words

The method of claim 31 further comprising separating said shaping element from said graft material after said graft material is removed from said body cavity.

Claim 37

Dependent Claim 32 words

The method of claim 31 , wherein said isolated, decellularized tissue material retains a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway.

Claim 38

Dependent Claim 22 words

The method of claim 15 , wherein said remodelable extracellular matrix material is located inside a shaping mold in said body cavity.

Claim 39

Dependent Claim 23 words

The graft material of claim 35 , wherein a wall of said shaping mold is perforated to allow fluid access through said wall.

Claim 40

Dependent Claim 15 words

The method of claim 35 , wherein said shaping mold comprises a hollow tubular mold.

Claim 41

Dependent Claim 21 words

The method of claim 37 , wherein said remodelable extracellular matrix material is received within and fills said hollow tubular mold.

Claim 42

Dependent Claim 30 words

The method of claim 15 , wherein said isolated, decellularized graft material provides an elongate graft body having a generally solid cross section for providing a prosthetic ligament or tendon.

Claim 43

Dependent Claim 29 words

The method of claim 15 , wherein said remodelable extracellular matrix material comprises a sheet of remodelable extracellular matrix material obtained in sheet form from a collagenous tissue source.

Claim 44

Dependent Claim 27 words

The method of claim 40 , wherein said remodelable extracellular matrix sheet material retains bioactive components native to a source tissue for the extracellular matrix sheet material.

Claim 45

Dependent Claim 51 words

The method of claim 41 , wherein said remodelable extracellular matrix sheet material comprises at least 80% by weight collagen on a dry weight basis, includes uniaxial or multiaxial oriented fibers, and includes at least about 3% retained non-collagenous solids from the source tissue, the non-collagenous solids including said bioactive components.

Claim 46

Dependent Claim 33 words

The method of claim 40 , wherein said remodelable extracellular matrix sheet material includes a section that is held in tension against a surface of an implanted shaping element in said body cavity.

Claim 47

Dependent Claim 12 words

The method of claim 43 , wherein said surface is generally cylindrical.

Claim 48

Dependent Claim 12 words

The method of claim 43 , wherein said surface is generally planar.

Claim 49

Dependent Claim 28 words

The method of claim 43 , wherein said section, when held in tension against said surface of said implanted shaping element, takes the shape of a valve cusp.

Claim 50

Dependent Claim 39 words

The method of claim 46 , wherein said valve cusp shape is maintained during remodeling of the remodelable extracellular matrix material such that said valve cusp shape is generally retained by said section after removal from the body cavity.

Claim 51

Dependent Claim 169 words

An isolated tissue material suitable for implantation in the body of a patient, said isolated tissue material prepared by a process comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said tissue material to retain a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, or an elongate generally cylindrical shape having a generally solid cross section for providing a prosthetic ligament or tendon.

Claim 52

Dependent Claim 169 words

An isolated tissue material suitable for implantation in the body of a patient, said isolated tissue material prepared by a process comprising removing from a body cavity of a host a tissue material resulting from remodeling of a previously inserted amount of a remodelable extracellular matrix material in the body cavity, the remodelable extracellular matrix material being associated with an implanted shaping element in the body cavity and being effective, upon insertion in said body cavity, to stimulate the ingrowth of native cells into the remodelable extracellular matrix material such that the remodelable extracellular matrix material becomes infiltrated and replaced by newly formed host tissue, wherein said remodeling of said previously inserted amount of remodelable extracellular matrix material in association with said implanted shaping element causes said tissue material to retain a valve cusp shape for providing a valve cusp for contacting and modifying fluid flow in a body passageway, or an elongate generally cylindrical shape having a generally solid cross section for providing a prosthetic ligament or tendon.

Claim 53

Dependent Claim 24 words

The isolated tissue material of claim 48 , wherein said remodelable extracellular matrix material comprises serosa, pericardium, submucosa, dura mater, peritoneum, or dermal collagen.

Claim 54

Dependent Claim 23 words

The isolated tissue material of claim 48 , wherein said tissue material comprises said remodelable extracellular matrix material remodeled in said body cavity.

Claim 55

Dependent Claim 15 words

The isolated tissue material of claim 48 further comprising mesothelial cells from said body cavity.

Claim 56

Dependent Claim 14 words

The isolated tissue material of claim 48 further comprising myofibroblasts from said body cavity.

Claim 57

Dependent Claim 12 words

The isolated tissue material of claim 48 provided in a decellularized state.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2013-10-18	2014-04-19	2014-10-19	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2017-10-18	2018-04-19	2018-10-19	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2021-10-18	2022-04-19	2022-10-19	$7700.00	Window Closed / Lapsed

Implantable graft material

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