Arrangement for preparing natural tissue for implantation

Claim 5

The method as recited in claim 2 in which said pressure is substantially within the range of from about 80 to about 120 mm Hg.

Claim 6

The method as recited in claim 2 in which said tanning fluid is a 4% formaldehyde solution, and in which said tanning fluid is so applied to said valve for around 72 hours.

Claim 7

The method as recited in claim 2 in which said tanning fluid is a 0.2% glutaraldehyde solution, and in which said tanning fluid is so applied to said valve for around 72 hours.

Claim 8

The method as recited in claim 2 in which said tanning fluid under pressure is applied to said valve by maintaining a quantity of said tanning fluid so as to have a predetermined maximum height with respect to said valve, and connecting said quantity of tanning fluid to said valve so that said quantity of tanning fluid produces a pressure head applied to said valve.

Claim 11

The method as recited in claim 7 in which for introducing said pressurized fluid into said chamber a source of said tanning fluid is maintained at a predetermined height relative to said unit, and in which a conduit is extended from said source of said tanning fluid to said chamber to cause said tanning fluid at said source to provide a predetermined pressure head.

Claim 12

The method as recited in claim 8 in which said predetermined height is selected so as to provide a pressure head of around 80 mm Hg.

Claim 15

The method as recited in claim 10 in which, for so applying said tanning fluid to said portion of said tissues with said tanning fluid being under pressure within the physiologic range, a source of said tanning fluid under pressure is provided, and a conduit is extended from said source to said portion of said tissues, for thereby so applying said tanning fluid to said portion of said tissues.

Claim 16

The method as recited in claim 11 in which, for said source of said tanning fluid under pressure, a quantity of said tanning fluid is provided at a predetermined height relative to said portion of said tissues.

Claim 21

The method as recited in claim 14 including the step of engaging said tissues with a guide member of predetermined contour while said tanning fluid under pressure within the physiologic range is so applied to said portion of said tissues for causing said tissues to assume substantially said predetermined contour.

Claim 22

The method as recited in claim 15 in which said tissues constitute a vessel.

Claim 23

The method as recited in claim 16 in which said vessel in its natural state has substantially said predetermined contour.

Claim 24

The method as recited in claim 16 in which said vessel in its natural state has a contour different from said predetermined contour.

Claim 25

The method as recited in claim 28 in which said predetermined contour is substantially U-shaped.

Claim 26

The method as recited in claim 16 in which, for said engaging of said vessel with a guide member, an elongated element having substantially said predetermined contour, and a lateral dimension less than that assumed by said vessel when subjected to pressure within the physiologic range, is inserted into said vessel for thereby maintaining said vessel substantially in said predetermined contour.

Claim 27

The method as recited in claim 16 in which, for said engaging of said vessel with a guide member, said vessel is placed within a tubular element having substantially said predetermined contour and an interior lateral dimension approximately that assumed by said vessel when subjected to pressure within the physiologic range, for thereby maintaining said vessel substantially in said predetermined contour.

Claim 28

The method as recited in claim 16 in which, for applying said pressure to said vessel, the end and any collaterals thereof are ligated, and said tanning fluid under pressure within said physiologic range is introduced into the interior of said vessel.

Claim 29

The method as recited in claim 22 in which, for introducing said tanning fluid under pressure within the physiologic range into said vessel, a source of said tanning fluid is maintained at a predetermined hight relative to said vessel, and a conduit is extended from said source of said tanning fluid to said vessel to cause said tanning fluid at said source to provide a predetermined pressure head.

Claim 30

A natural heart valve for implantation having a generally regular contour, natural shape and size, coaptation of the cusps thereof and relatively high tensile strength prepared by the steps of applying a tanning fluid under pressure in the physiologic range to the downstream end of a natural heart valve so as to cause said valve to assume substantially its natural configuration, and simultaneously applying a tanning fluid to the upstream end of said valve at a pressure less than that at said downstream end, thereby to cause said valve substantially to maintain said configuration during fixation of the tissue thereof.

Claim 31

A natural heart valve for implantation having a generally regular contour, natural shape and size, coaptation of the cusps thereof and relatively high tensile strength prepared by the steps of applying a tanning fluid under pressure in the physiologic range to the downstream end of a natural heart valve so as to cause said valve to assume substantially its natural configuration, and simultaneously applying a tanning fluid to the upstream end of said valve at a pressure less than that at said downstream end, thereby to cause said valve substantially to maintain said configuration during fixation of the tissue thereof.

Claim 32

A natural heart valve for implantation having a generally regular contour, natural shape and size, coaptation of the cusps thereof and relatively high tensile strength prepared by the steps of applying a tanning fluid under pressure within the physiologic range to the downstream end of a natural heart valve so as to cause said valve to assume substantially its natural configuration, applying said tanning fluid to the upstream end of said valve while said tanning fluid under pressure is so applied to said valve at the downstream end thereof so that said valve is at a higher pressure at said downstream end than at said upstream end, and maintaining said tanning fluid so applied to said heart valve for a time sufficient to cause said valve to become fixed so as to substantially maintain said configuration.

Claim 33

A natural heart valve for implantation having a generally regular contour, natural shape and size, coaptation of the cusps thereof and relatively high tensile strength prepared by the steps of applying a tanning fluid under pressure within the physiologic range to the downstream end of a natural heart valve so as to cause said valve to assume substantially its natural configuration, applying said tanning fluid to the upstream end of said valve while said tanning fluid under pressure is so applied to said valve at the downstream end thereof so that said valve is at a higher pressure at said downstream end than at said upstream end, and maintaining said tanning fluid so applied to said heart valve for a time sufficient to cause said valve to become fixed so as to substantially maintain said configuration.

Claim 34

The heart valve as recited in claim 25 in which said pressure is substantially within the range of from about 80 to about 120 mm Hg.

Claim 35

The heart valve as recited in claim 25 in which said tanning fluid is a 4% formaldehyde solution, and in which said tanning fluid is so applied to said valve for around 72 hours.

Claim 36

The heart valve as recited in claim 25 in which said tanning fluid is a 0.2% glutaraldehyde solution, and in which said tanning fluid is so applied to said valve for around 72 hours.

Claim 37

The heart valve as recited in claim 25 in which said tanning fluid under pressure is applied to said valve by maintaining a quantity of said tanning fluid so as to have a predetermined maximum height with respect to said valve, and connecting said quantity of tanning fluid to said valve so that said quantity of tanning fluid produces a pressure head applied to said valve.

Claim 38

A natural heart valve for implantation having a generally regular contour, natural shape and size, coaptation of the cusps thereof and relatively high tensile strength prepared by the steps of inserting a member having an aperture therethrough into the ascending aorta of a unit that includes a natural heart valve and its ascending aorta, attaching said aorta to said member so that said unit and said member define a chamber and said aperture provides access to the interior of said chamber at the downstream end of said valve, ligating the arteries of said unit so as to close said chamber, introducing a tanning fluid which is pressurized to within the physiologic range of pressure for said valve through said aperture into said chamber so as to inflate said valve and cause said valve to assume substantially its natural configuration, applying such tanning fluid to the exterior of said unit while said pressurized tanning fluid is in said chamber with a greater fluid pressure existing in said chamber than on said exterior, and maintaining said pressurized tanning fluid and said tanning fluid so applied to the exterior of said unit for a time sufficient to cause the tissue of said valve to become substantially fixed, thereby to cause said valve to substantially maintain said configuration.

Claim 39

A natural heart valve for implantation having a generally regular contour, natural shape and size, coaptation of the cusps thereof and relatively high tensile strength prepared by the steps of inserting a member having an aperture therethrough into the ascending aorta of a unit that includes a natural heart valve and its ascending aorta, attaching said aorta to said member so that said unit and said member define a chamber and said aperture provides access to the interior of said chamber at the downstream end of said valve, ligating the arteries of said unit so as to close said chamber, introducing a tanning fluid which is pressurized to within the physiologic range of pressure for said valve through said aperture into said chamber so as to inflate said valve and cause said valve to assume substantially its natural configuration, applying such tanning fluid to the exterior of said unit while said pressurized tanning fluid is in said chamber with a greater fluid pressure existing in said chamber than on said exterior, and maintaining said pressurized tanning fluid and said tanning fluid so applied to the exterior of said unit for a time sufficient to cause the tissue of said valve to become substantially fixed, thereby to cause said valve to substantially maintain said configuration.

Claim 40

The heart valve as recited in claim 30 in which for introducing said pressurized fluid into said chamber a source of said tanning fluid is maintained at a predetermined height relative to said unit, and in which a conduit is extended from said source of said tanning fluid to said chamber to cause said tanning fluid at said source to provide a predetermined pressure head.

Claim 41

The heart valve as recited in claim 31 in which said predetermined height is selected so as to provide a pressure head of around 80 mm Hg.

Claim 42

Natural tissues for implantation and in a form in which a portion thereof is subjected to pressure within the physiologic range when implanted and which assumes a predetermined configuration as a result of such pressure, said tissues having full and uniform fixation and a relatively high tensile strength, and prepared by the steps of applying a tanning fluid to said portion of said tissues, said tanning fluid so applied being under pressure in the physiologic range so as to cause said tissues to assume substantially said predetermined configuration, and simultaneously applying a tanning fluid to remaining parts of said tissues at a pressure less than that of said portion of said tissues, thereby to cause said tissues to assume said configuration during fixation of said tissues.

Claim 43

Natural tissues for implantation and in a form in which a portion thereof is subjected to pressure within the physiologic range when implanted and which assumes a predetermined configuration as a result of such pressure, said tissues having full and uniform fixation and a relatively high tensile strength, and prepared by the steps of applying a tanning fluid to said portion of said tissues, said tanning fluid so applied being under pressure in the physiologic range so as to cause said tissues to assume substantially said predetermined configuration, and simultaneously applying a tanning fluid to remaining parts of said tissues at a pressure less than that of said portion of said tissues, thereby to cause said tissues to assume said configuration during fixation of said tissues.

Claim 44

The tissues as recited in claim 33 in which for so applying said tanning fluid to said portion of said tissues with said tanning fluid being under pressure within the physiologic range, a source of said tanning fluid under pressure is provided, and a conduit is extended from said source to said portion of said tissues, for thereby so applying said tanning fluid to said portion of said tissues.

Claim 45

The tissues as recited in claim 34 in which for said source of said tanning fluid under pressure, a quantity of said tanning fluid is provided at a predetermined height relative to said portion of said tissues.

Claim 46

A vessel for implanation having a contour different from the contour thereof in its natural state prepared by the steps of subjecting said vessel to a bath of tanning fluid so as to fix said vessel, and simultaneously engaging said vessel with a guide member of predetermined contour for causing said vessel to assume substantially said predetermined contour upon fixation thereof, said predetermined contour being different from the contour of said vessel in its natural state.

Claim 47

A vessel for implanation having a contour different from the contour thereof in its natural state prepared by the steps of subjecting said vessel to a bath of tanning fluid so as to fix said vessel, and simultaneously engaging said vessel with a guide member of predetermined contour for causing said vessel to assume substantially said predetermined contour upon fixation thereof, said predetermined contour being different from the contour of said vessel in its natural state.

Claim 48

Natural tissues for implantation and in a form in which a portion thereof is subjected to pressure within the physiologic range when implanted and which assumes a predetermined configuration as a result of such pressure, said tissues having full and uniform fixation and a relatively high tensile strength, and prepared by the steps of applying a tanning fluid to said portion of said tissues, said tanning fluid so applied being under pressure within the physiologic range so as to cause said tissues to assume substantially said predetermined configuration, and applying a tanning fluid to remaining parts of said tissues while said tanning fluid under pressure is so applied to said portion of said tissues, so that said tissues experience a higher pressure at said portion thereof than at said remaining parts thereof.

Claim 49

Natural tissues for implantation and in a form in which a portion thereof is subjected to pressure within the physiologic range when implanted and which assumes a predetermined configuration as a result of such pressure, said tissues having full and uniform fixation and a relatively high tensile strength, and prepared by the steps of applying a tanning fluid to said portion of said tissues, said tanning fluid so applied being under pressure within the physiologic range so as to cause said tissues to assume substantially said predetermined configuration, and applying a tanning fluid to remaining parts of said tissues while said tanning fluid under pressure is so applied to said portion of said tissues, so that said tissues experience a higher pressure at said portion thereof than at said remaining parts thereof.

Claim 50

The tissues as recited in claim 37 in which said preparation thereof includes the step of engaging said tissues with a guide member of predetermined contour while said tanning fluid under pressure within the physiologic range is so applied to said portion of said tissues for causing said tissues to assume substantially said predetermined contour.

Claim 51

The tissues as recited in claim 38 in which said tissues constitute a vessel.

Claim 52

The vessel as recited in claim 39 in which said vessel in its natural state has substantially said predetermined contour.

Claim 53

The vessel as recited in claim 39 in which said vessel in its natural state has a contour different from said predetermined contour.

Claim 54

The vessel as recited in claim 41 in which said predetermined contour is substantially U-shaped.

Claim 55

The vessel as recited in claim 39 in which for said engaging of said vessel with a guide member, an elongated element having substantially said predetermined contour, and a lateral dimension less than that assumed by said vessel when subjected to pressure within the physiologic range, is inserted into said vessel for thereby maintaining said vessel substantially in said predetermined contour.

Claim 56

The vessel as recited in claim 39 in which for said engaging of said vessel with a guide member, said vessel is placed within a tubular element having substantially said predetermined contour and an interior lateral dimension approximately that assumed by said vessel when subjected to pressure within the physiologic range, for thereby maintaining said vessel substantially in said predetermined contour.

Claim 57

The vessel as recited in claim 39 in which for applying said pressure to said vessel, the end and any collaterals thereof are ligated, and said tanning fluid under pressure within said physiologic range is introduced into the interior of said vessel.

Claim 58

The vessel as recited in claim 39 in which for introducing said tanning fluid under pressure within the physiologic range into said vessel, a source of said tanning fluid is maintained at a predetermined height relative to said vessel, and a conduit is extended from said source of said tanning fluid to said vessel to cause said tanning fluid at said source to provide a predetermined pressure head.