US5846828A — Apparatus and method for sterilizing, seeding, cu…

Claim 1

Independent Claim 107 words

An apparatus, comprising: a housing defining a seeding and culturing chamber with first and second ports to permit flow of a medium therethrough; a heart valve substrate disposed within said chamber designed to facilitate three-dimensional tissue growth on said substrate; a heart valve substrate support structure mounted in the chamber, said structure supporting the heart valve substrate such that media flow between said ports is directed through the heart valve substrate and permitted to circulate around exterior surfaces of the heart valve substrate; and means for creating an alternating pressure differential across said heart valve substrate to provide alternating bidirectional flow acting on the heart valve substrate.

Claim 2

Independent Claim 107 words

An apparatus, comprising: a housing defining a seeding and culturing chamber with first and second ports to permit flow of a medium therethrough; a heart valve substrate disposed within said chamber designed to facilitate three-dimensional tissue growth on said substrate; a heart valve substrate support structure mounted in the chamber, said structure supporting the heart valve substrate such that media flow between said ports is directed through the heart valve substrate and permitted to circulate around exterior surfaces of the heart valve substrate; and means for creating an alternating pressure differential across said heart valve substrate to provide alternating bidirectional flow acting on the heart valve substrate.

Claim 3

Dependent Claim 53 words

The apparatus of claim 1, wherein a portion of the support structure seals against the chamber housing to direct substantially all bidirectional flow through the heart valve substrate and a portion of the support structure is spaced away from the housing to permit media circulation around external surfaces of the heart valve substrate.

Claim 4

Dependent Claim 20 words

The apparatus of claim 1, wherein said means comprises a bladder moveable between a first position and a second position.

Claim 5

Dependent Claim 89 words

The apparatus of claim 3, wherein said bladder is disposed within a housing defining a chamber of alternating positive and negative pressure surrounding the bladder; and said bladder communicates with the seeding and culturing chamber and with a media supply, whereby negative pressure in the bladder chamber causes the bladder to expand and draw media from the seeding and culturing chamber and from the media supply and positive pressure in the bladder chamber causes the bladder to contract forcing media from the bladder into the seeding and culturing chamber.

Claim 6

Dependent Claim 18 words

The apparatus of claim 1, wherein said substrate comprises a three-dimensional framework having interstitial spaces bridgeable by cells.

Claim 7

Dependent Claim 24 words

The apparatus of claim 5, further comprising a three-dimensional tissue, said tissue comprising a plurality of cells attached to and substantially enveloping said framework.

Claim 8

Independent Claim 144 words

An apparatus, comprising: a varying pressure source; a bladder cooperating with said varying pressure source, wherein said varying pressure source moves the bladder from a first position to a second position; a supply of fluid in communication with the bladder; chamber having a first port and a second port, said first port in communication with the bladder; a heart valve substrate disposed within said chamber designed to facilitate three-dimensional tissue growth on said substrate; and a support structure mounted within the chamber, said support structure supporting the heart valve substrate within the chamber while permitting flow of the fluid around the heart valve substrate and in contact with the heart valve substrate; wherein the bladder moving between said first and second positions creates an alternating pressure differential across the heart valve substrate to provide a bidirectional fluid flow acting on the heart valve substrate.

Claim 9

Independent Claim 144 words

An apparatus, comprising: a varying pressure source; a bladder cooperating with said varying pressure source, wherein said varying pressure source moves the bladder from a first position to a second position; a supply of fluid in communication with the bladder; chamber having a first port and a second port, said first port in communication with the bladder; a heart valve substrate disposed within said chamber designed to facilitate three-dimensional tissue growth on said substrate; and a support structure mounted within the chamber, said support structure supporting the heart valve substrate within the chamber while permitting flow of the fluid around the heart valve substrate and in contact with the heart valve substrate; wherein the bladder moving between said first and second positions creates an alternating pressure differential across the heart valve substrate to provide a bidirectional fluid flow acting on the heart valve substrate.

Claim 10

Dependent Claim 52 words

The apparatus of claim 7, wherein said chamber is defined by at least on wall; and said support structure defines a central opening through the support structure and is mounted in the chamber in sealing contact with said at least one wall such that fluid flow is forced through said central opening.

Claim 11

Dependent Claim 41 words

The apparatus of claim 8, wherein a portion of the support structure is spaced away from said at least one wall such that fluid is permitted to circulate around the support structure on at least one side of said sealing contact.

Claim 12

Dependent Claim 45 words

The apparatus of claim 9, wherein the heart valve substrate is securable within the support structure central opening and the support structure defines further opening to permit contact of said fluid permitted to circulate around the support structure with surfaces of the heart valve substrate.

Claim 13

Dependent Claim 29 words

The apparatus of claim 7, wherein a closed fluid connection is provided between the second port of the chamber and the fluid supply to provide a completely closed system.

Claim 14

Dependent Claim 30 words

The apparatus of claim 11, wherein said closed fluid connection between the second port of the chamber and the fluid supply allows for the diffusion of gas into the system.

Claim 15

Dependent Claim 13 words

The apparatus of claim 7, wherein said varying pressure source comprises a pump.

Claim 16

Dependent Claim 64 words

The apparatus of claim 7, further comprising: a valve connected to a timer; wherein said valve is connected in between said varying pressure source and said bladder and is controlled by said timer so as to alternatingly provide positive and negative pressure to said bladder from said varying pressure source, said positive and negative pressure moving said bladder between said first and second positions.

Claim 17

Dependent Claim 18 words

The apparatus of claim 7, wherein said substrate comprises a three-dimensional framework having interstitial spaces bridgeable by cells.

Claim 18

Dependent Claim 24 words

The apparatus of claim 15, further comprising a three-dimensional tissue, said tissue comprising a plurality of cells attached to and substantially enveloping, said framework.

Claim 19

Independent Claim 51 words

A method for seeding and culturing a substrate, comprising: exposing a substrate to a fluid media for seeding and culturing, said substrate designed to facilitate three-dimensional tissue growth on said substrate; and altering the pressure differential in said media across the substrate to provide alternating bidirectional flow acting on the substrate.

Claim 20

Independent Claim 51 words

A method for seeding and culturing a substrate, comprising: exposing a substrate to a fluid media for seeding and culturing, said substrate designed to facilitate three-dimensional tissue growth on said substrate; and altering the pressure differential in said media across the substrate to provide alternating bidirectional flow acting on the substrate.

Claim 21

Dependent Claim 57 words

The method of claim 17, wherein said step of altering comprises: creating a cycling pressure drop, in said fluid media to alternatingly provide a low pressure and a high pressure wherein the low pressure draws media across the substrate in a first direction and the high pressure forces media across the substrate in a second, opposite direction.

Claim 22

Dependent Claim 40 words

The method of claim 18, wherein said step of creating a cycling pressure drop comprises expanding and contracting a bladder between a first position and a second position to provide said low pressure and said high pressure across said substrate.

Claim 23

Dependent Claim 13 words

The method of claim 17, wherein said substrate is a heart valve substrate.

Claim 24

Dependent Claim 18 words

The method of claim 20, wherein said substrate comprises a three-dimensional framework having interstitial spaces bridgeable by cells.

Claim 25

Independent Claim 77 words

A method for treating a prosthesis, comprising: holding the prosthesis in a chamber adapted for flow of fluid therethrough from a fluid supply, said prosthesis designed to facilitate three-dimensional tissue growth on said prosthesis; expanding a bladder to draw fluid into the bladder from the fluid supply and from the chamber through the prosthesis in a first direction; and contracting the bladder to force fluid from the bladder to act on the prosthesis in a second direction.

Claim 26

Independent Claim 77 words

A method for treating a prosthesis, comprising: holding the prosthesis in a chamber adapted for flow of fluid therethrough from a fluid supply, said prosthesis designed to facilitate three-dimensional tissue growth on said prosthesis; expanding a bladder to draw fluid into the bladder from the fluid supply and from the chamber through the prosthesis in a first direction; and contracting the bladder to force fluid from the bladder to act on the prosthesis in a second direction.

Claim 27

Dependent Claim 26 words

The method of claim 22, wherein the expanding and contracting of the bladder comprises creating a region of alternating positive and negative pressure surrounding the bladder.

Claim 28

Dependent Claim 25 words

The method of claim 22, further comprising: recycling fluid from the chamber into the fluid supply; and introducing gas into the fluid during said recycling.

Claim 29

Dependent Claim 27 words

The method of claim 22, wherein the expanding and contracting bladder creates an alternating pressure differential across the prosthesis to provide a bidirectional flow through the prosthesis.

Claim 30

Dependent Claim 13 words

The method of claim 22, wherein the prosthesis is a heart valve prosthesis.

Claim 31

Dependent Claim 18 words

The method of claim 26, wherein said prosthesis comprises a three-dimensional framework having interstitial spaces bridgeable by cells.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2001-12-07	2002-06-08	2002-12-08	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2005-12-07	2006-06-08	2006-12-08	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2009-12-07	2010-06-08	2010-12-08	$7700.00	Window Closed / Lapsed

Apparatus and method for sterilizing, seeding, culturing, storing, shipping, and testing tissue, synthetic, or mechanical heart valves orvalve segments

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