US5810708A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Ventricular assist conduit with externally supported tissue valve
Assignee: World Heart Corp USA
•
Filing: 1995-06-06
•
Granted: 1998-09-22
•
Expires: 2015-06-06
Abstract
Abstract A ventricular assist device includes a pair of valved conduits and a pumping portion connected by these conduits into the circulatory system of a host patient. The pumping portion and valved conduits are constructed and configured to minimize the number of material-surface transitions which blood must cross in flowing through the device. Also, the valved conduits include porcine xenograft valves, which are externally supported by stenting structure located outside of the blood-contacting flow path of the device. A flexible shape-retaining inner wall member of the valved conduits is impervious to blood, but defines a porous inner surface on which a stable biological interface may form. Also, this inner wall member is shaped with sinuses which do not replicate either the porcine sinuses from which the xenograft valves were taken, or human aortic sinuses. However, the sinuses of the inner wall member are configured to provide effective valve action by the formation of vigorous vortices in the blood flow downstream of these valves, and to avoid the formation of clots on the blood-contacting surfaces of the valved conduits.
Inventors
- 👤 John C. Woodard
- 👤 Ronald A. Ness
- 👤 Richard M. Romley
- 👤 Than Nguyen
- 👤 Herbert Chen
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 14:09
CPC Classifications
A; A61; A61M; A61M1/00; A61M1/36; A61M1/3621; A61M1/3653; A61M1/3659; A61M60/00; A61M60/10; A61M60/122; A61M60/165; A61M60/178; A61M60/40; A61M60/424; A61M60/427; A61M60/80; A61M60/855; A61M60/857; A61M60/89; A61M60/894; A61M60/896; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61M60/126; A61M60/148; A61M60/20; A61M60/247; A61M60/253; A61M60/268; Y; Y10; Y10S; Y10S623/00; Y10S623/90
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
171 words
A tubular conduit for blood flow having a one-way tissue valve therein supported externally by a stent structure which is isolated from blood flowing through the conduit, comprising: a flexible composite tubular member including an inner tube of blood-permeable fabric defining an inner surface of the tubular member, and a blood impermeable polymeric coating on the exterior surface of the inner tube penetrating into the fabric interstices toward but short of the inner surface, a prosthetic tissue valve having multiple leaflets and axially extending commissures positioned within the tubular member and contacting the inner surface of the fabric tube; a stent structure positioned externally of the blood impermeable polymeric coating, the stent structure including a compliant metallic wireform having axially extending commissure supports aligned with the commissures of the tissue valve; and sutures extending through the tubular member securing the stent structure to the tissue valve with the tubular member interposed therebetween, wherein the only blood contacting surfaces within the conduit are the inner surface, the tissue valve, and the sutures.
Claim 2
Dependent Claim
171 words
A tubular conduit for blood flow having a one-way tissue valve therein supported externally by a stent structure which is isolated from blood flowing through the conduit, comprising: a flexible composite tubular member including an inner tube of blood-permeable fabric defining an inner surface of the tubular member, and a blood impermeable polymeric coating on the exterior surface of the inner tube penetrating into the fabric interstices toward but short of the inner surface, a prosthetic tissue valve having multiple leaflets and axially extending commissures positioned within the tubular member and contacting the inner surface of the fabric tube; a stent structure positioned externally of the blood impermeable polymeric coating, the stent structure including a compliant metallic wireform having axially extending commissure supports aligned with the commissures of the tissue valve; and sutures extending through the tubular member securing the stent structure to the tissue valve with the tubular member interposed therebetween, wherein the only blood contacting surfaces within the conduit are the inner surface, the tissue valve, and the sutures.
Claim 3
Dependent Claim
18 words
The conduit of claim 1, the stent structure further including a polymer support member coupled to the wireform.
Claim 4
Dependent Claim
21 words
The conduit of claim 2, the polymer support member and wireform being surrounded by a fabric drape of blood permeable material.
Claim 5
Dependent Claim
32 words
The conduit of claim 1, further including sinuses formed tubular member as outbulges beginning just downstream of the one-way tissue valve, wherein the sinuses have an aspect ratio of at least 1.3.
Claim 6
Dependent Claim
21 words
The conduit of claim 4, wherein the sinuses have an aspect ratio in the range from about 1.3 to about 1.6.
Claim 7
Dependent Claim
58 words
The conduit of claim 1, further including a tubular metallic rigid housing surrounding the tubular member and having a plurality of perforations to allow body fluid to access the internal surfaces of the housing and avoid the formation of cavities or voids which are hidden from the immune system of a host in which the conduit is implanted.
Claim 8
Dependent Claim
27 words
The conduit of claim 1, wherein the inner tube of blood-permeable fabric is a polyethylene terephthalate fabric, and the blood impermeable polymeric coating is a silicon rubber.
Claim 9
Dependent Claim
57 words
An implantable ventricular assist device, comprising: a pumping portion having an inflow port and outflow port; an inflow conduit comprising a tubular conduit as in claim 1 attached to the inflow port of the pumping portion; and an outflow conduit comprising a tubular conduit as in claim 1 attached to the outflow port of the pumping portion.
Claim 10
Dependent Claim
66 words
The ventricular assist device of claim 8, wherein the pumping portion includes a unitary liner extending to the ends of the inflow and outflow ports and in direct and sealing contact with, respectively, the inner surfaces of the conduit tubular members, so that blood contacts only the inner surfaces and the unitary liner across the junctions between the pumping portion and the inflow and outflow conduits.
Claim 11
Dependent Claim
252 words
A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, and increased aspect ratio sinuses downstream of the valve for vigorous vortex flow resulting in improved valve closure and elimination of blood stagnation, comprising; a synthetic tubular wall having an inner surface and a nominal diameter, an inner tube of blood-permeable fabric defining the inner surface, and a blood impermeable polymeric, coating on the exterior surface of the inner tube penetrating into the fabric interstices toward but short of the inner surface; a trifoliate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface; a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve; sutures extending through the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween; and sinuses formed In the tubular wall as outbulges from the nominal diameter beginning just downstream of the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3.
Claim 12
Dependent Claim
252 words
A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, and increased aspect ratio sinuses downstream of the valve for vigorous vortex flow resulting in improved valve closure and elimination of blood stagnation, comprising; a synthetic tubular wall having an inner surface and a nominal diameter, an inner tube of blood-permeable fabric defining the inner surface, and a blood impermeable polymeric, coating on the exterior surface of the inner tube penetrating into the fabric interstices toward but short of the inner surface; a trifoliate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface; a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve; sutures extending through the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween; and sinuses formed In the tubular wall as outbulges from the nominal diameter beginning just downstream of the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3.
Claim 13
Dependent Claim
21 words
The conduit of claim 10, wherein the sinuses have an aspect ratio in the range from about 1.3 to about 1.6.
Claim 14
Dependent Claim
15 words
The conduit of claim 11, wherein the sinuses have an aspect ratio of about 1.45.
Claim 15
Dependent Claim
27 words
The conduit of claim 10, wherein the inner tube of blood-permeable fabric is a polyethylene terephthalate fabric, and the blood impermeable polymeric coating is a silicon rubber.
Claim 16
Dependent Claim
214 words
A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, comprising: a synthetic tubular wall having an inner surface and a nominal diameter: a trifollate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface; a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve, the stent further including a compliant wireform extending along the commissures, and a polymer support member coupled to the wireform; and sutures formed in the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween; and sinuses formed in the tubular wall as outbulges from the nominal diameter beginning just downstream or the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3.
Claim 17
Dependent Claim
214 words
A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, comprising: a synthetic tubular wall having an inner surface and a nominal diameter: a trifollate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface; a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve, the stent further including a compliant wireform extending along the commissures, and a polymer support member coupled to the wireform; and sutures formed in the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween; and sinuses formed in the tubular wall as outbulges from the nominal diameter beginning just downstream or the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3.
Claim 18
Dependent Claim
20 words
The conduit of claim 14, the polymer support and wireform being surrounded by a fabric drape of blood permeable material.
Claim 19
Dependent Claim
21 words
The conduit of claim 14, wherein the sinuses have an aspect ratio in the range from about 1.3 to about 1.6.
Claim 20
Dependent Claim
15 words
The conduit of claim 16, wherein the sinuses have an aspect ratio of about 1.45.
Claim 21
Dependent Claim
246 words
A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, comprising; a synthetic tubular wall having an inner surface and a nominal diameter; a trifollate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface; a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve; sutures extending through the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween; sinuses formed in the tubular wall as outbulges from the nominal diameter beginning just downstream of the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3; and further including a tubular metallic rigid housing surrounding the tubular member and having a plurality of perforations to allow body fluid to access the internal surfaces of the housing and avoid the formation of cavities or voids which are hidden from the immune system of a host in which the conduit is implanted.
Claim 22
Dependent Claim
246 words
A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, comprising; a synthetic tubular wall having an inner surface and a nominal diameter; a trifollate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface; a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve; sutures extending through the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween; sinuses formed in the tubular wall as outbulges from the nominal diameter beginning just downstream of the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3; and further including a tubular metallic rigid housing surrounding the tubular member and having a plurality of perforations to allow body fluid to access the internal surfaces of the housing and avoid the formation of cavities or voids which are hidden from the immune system of a host in which the conduit is implanted.
Claim 23
Dependent Claim
21 words
The conduit of claim 18, wherein the sinuses have an aspect ratio in the range from about 1.3 to about 1.6.
Claim 24
Dependent Claim
15 words
The conduit of claim 19, wherein the sinuses have an aspect ratio of about 1.45.
References Cited (Backward Citations)
US3409914A
Cited
GB1268484A
Cited
GB1315844A
Cited
GB1315845A
Cited
GB1477643A
Cited
DE2619239A1
Cited
US4086665A
Cited
US4195623A
Cited
US4222127A
Cited
US4247292A
Cited
WO1982001647A1
Cited
US4838889A
Cited
US4759759A
Cited
US4581029A
Cited
US4629459A
Cited
EP0170262A2
Cited
US4759758A
Cited
US4925377A
Cited
GB2187535A
Cited
US4902291A
Cited
US5133744A
Cited
WO1990014804A1
Cited
US5609626A
Cited
US5147385A
Cited
US5129789A
Cited
US5139515A
Cited
US5123919A
Cited
WO1993020757A2
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-09-21 | 2002-03-23 | 2002-09-22 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-09-21 | 2006-03-23 | 2006-09-22 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-09-21 | 2010-03-23 | 2010-09-22 | $7700.00 | Window Closed / Lapsed |