US6875231B2
Expired / Lapsed
US
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Percutaneously deliverable heart valve
Assignee: Medtronic 3F Therapeutics Inc
•
Filing: 2002-09-11
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Granted: 2005-04-05
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Expires: 2022-09-11
Abstract
Abstract A percutaneously deliverable heart valve prosthesis and method of delivery, wherein the prosthesis is anchored to a valvular annulus of a patient and used to replace the patient's diseased valve. The prosthesis is supported by a rigid frame that is generally fixed, but capable of being modified between a first collapsed position and a second expanded position. In its first collapsed position, the prosthesis has sufficient flexibility and is of such a low profile that it allows for easy percutaneously delivery. Upon proper delivery, the prosthesis is anchored and modifiable to a generally permanent expanded position sufficiently rigid to resist the strong recoil force exerted by a distorted stenosed valve orifice displaced by the prosthesis.
Inventors
- 👤 James Peter Anduiza
- 👤 Rodolfo C. Quijano
- 👤 Hosheng Tu
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 11:59
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2418; A61F2/2475; A61F2220/00; A61F2220/0008; A61F2220/0016; A61F2220/0025; A61F2220/005; A61F2220/0075; A61F2230/00; A61F2230/0002; A61F2230/0028; A61F2230/0054
Claims Analysis
Total Claims: 57
Claim 1
Independent Claim
119 words
A foldable heart valve prosthesis to replace a diseased valve of a patient comprising: a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars connected at an end of each crossbar; a flexible tissue heart valve with a plurality of valvular leaflets attached to said support structure; and a plurality of slidable ring connectors, wherein at least one slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame, said at least one slidable ring connector configured to coupling the first and the second crossbars.
Claim 2
Dependent Claim
119 words
A foldable heart valve prosthesis to replace a diseased valve of a patient comprising: a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars connected at an end of each crossbar; a flexible tissue heart valve with a plurality of valvular leaflets attached to said support structure; and a plurality of slidable ring connectors, wherein at least one slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame, said at least one slidable ring connector configured to coupling the first and the second crossbars.
Claim 3
Dependent Claim
19 words
The foldable heart valve prosthesis of claim 1 , wherein the flexible tissue heart valve is a porcine valve.
Claim 4
Dependent Claim
31 words
The foldable heart valve prosthesis of claim 1 , wherein the flexible tissue heart valve is made of pericardium tissue selected from a group consisting of equine, bovine, porcine, and ovine.
Claim 5
Dependent Claim
28 words
The foldable heart valve prosthesis of claim 2 or claim 3 , wherein the flexible tissue heart valve is chemically treated to reduce antigenicity of said tissue material.
Claim 6
Dependent Claim
34 words
The foldable heart valve prosthesis of claim 4 , wherein the flexible tissue heart valve is chemically treated with a chemical selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, and polyepoxy compounds.
Claim 7
Dependent Claim
33 words
The foldable heart valve prosthesis of claim 1 , wherein at least one slidable ring connector is slid to adjacent an end of the first crossbar when said heart valve prosthesis is folded.
Claim 8
Dependent Claim
32 words
The foldable heart valve prosthesis of claim 1 , wherein the first crossbar of the first crossbar frame has a recess configured for coupling the second crossbar of the second crossbar frame.
Claim 9
Dependent Claim
29 words
The foldable heart valve prosthesis of claim 7 , wherein the second crossbar comprises a recess, the recess of the first crossbar facing the recess of the second crossbar.
Claim 10
Dependent Claim
26 words
The foldable heart valve prosthesis of claim 7 , wherein the recess of the first crossbar is located close to an end of the first crossbar.
Claim 11
Dependent Claim
20 words
The foldable heart valve prosthesis of claim 1 , wherein the slidable ring connector is made of an elastic material.
Claim 12
Dependent Claim
21 words
The foldable heart valve prosthesis of claim 1 , wherein the slidable ring connector is made of a coil spring material.
Claim 13
Dependent Claim
35 words
The foldable heart valve prosthesis of claim 1 , wherein the at least one slidable ring connector is made of a shape-memory material configured to shrinkably coupling the first crossbar and the second crossbar snugly.
Claim 14
Dependent Claim
24 words
The foldable heart valve prosthesis of claim 12 , wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material.
Claim 15
Dependent Claim
26 words
The foldable heart valve prosthesis of claim 13 , wherein a shape-transition temperature of the shape-memory material is between about 40° C. to about 50° C.
Claim 16
Dependent Claim
19 words
The foldable heart valve prosthesis of claim 1 , wherein the flexible tissue heart valve is an aortic valve.
Claim 17
Dependent Claim
19 words
The foldable heart valve prosthesis of claim 1 , wherein the flexible tissue heart valve is a pulmonary valve.
Claim 18
Dependent Claim
19 words
The foldable heart valve prosthesis of claim 1 , wherein the flexible tissue heart valve is an atrioventricular valve.
Claim 19
Dependent Claim
38 words
The foldable heart valve prosthesis of claim 1 , wherein the flexible tissue heart valve is generally mounted on the support structure at commissural points of said flexible tissue heart valve and is secured to the crossbar frames.
Claim 20
Dependent Claim
41 words
The foldable heart valve prosthesis of claim 1 , wherein the support structure is made of a material selected from a group consisting of polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyurethane, stainless steel, Nitinol, titanium, polyimide, polyester, shape-memory material, and mixture thereof.
Claim 21
Dependent Claim
28 words
The foldable heart valve prosthesis of claim 1 , wherein the slidable ring connector is configured and sized to show minimal circumference after being coupled to the crossbars.
Claim 22
Dependent Claim
29 words
The foldable heart valve prosthesis of claim 20 , wherein an angle of the coupled crossbars after being coupled with said slidable ring connector is at least 15 degrees.
Claim 23
Dependent Claim
15 words
The foldable heart valve prosthesis of claim 1 , wherein the support structure is self-expandable.
Claim 24
Independent Claim
190 words
A method for minimally invasively delivering a foldable heart valve prosthesis into a patient, the foldable heart valve prosthesis comprising a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars; a flexible tissue heart valve with a plurality of valvular leaflets attached to said support structure; and a plurality of slidable ring connectors, wherein at least one slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame, said at least one slidable ring connector configured to coupling the first and the second crossbars; said method comprising: folding said support structure with the attached flexible tissue heart valve inside a lumen of a delivery apparatus; delivering said delivery apparatus to a target valvular annulus of the patient; unfolding said support structure to deploy said foldable heart valve prosthesis in place; and coupling the first and second crossbars by sliding the at least one slidable ring connector to an appropriate location of the first and second crossbars.
Claim 25
Independent Claim
190 words
A method for minimally invasively delivering a foldable heart valve prosthesis into a patient, the foldable heart valve prosthesis comprising a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars; a flexible tissue heart valve with a plurality of valvular leaflets attached to said support structure; and a plurality of slidable ring connectors, wherein at least one slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame, said at least one slidable ring connector configured to coupling the first and the second crossbars; said method comprising: folding said support structure with the attached flexible tissue heart valve inside a lumen of a delivery apparatus; delivering said delivery apparatus to a target valvular annulus of the patient; unfolding said support structure to deploy said foldable heart valve prosthesis in place; and coupling the first and second crossbars by sliding the at least one slidable ring connector to an appropriate location of the first and second crossbars.
Claim 26
Dependent Claim
13 words
The method of claim 23 , wherein the delivery apparatus comprises a catheter.
Claim 27
Dependent Claim
38 words
The method of claim 24 , wherein the delivery step is carried out with said catheter through an opening selected from a group consisting of a carotid artery, a jugular vein, a subclavian vein, and a body vessel.
Claim 28
Dependent Claim
33 words
The method of claim 24 , wherein the catheter is made of a material selected from a group consisting of polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyurethane, stainless steel, Nitinol, titanium, polyimide, and polyester.
Claim 29
Dependent Claim
20 words
The method of claim 23 , wherein the unfolding step is carried out by a support structure that is self-expandable.
Claim 30
Dependent Claim
13 words
The method of claim 23 , wherein the delivery apparatus comprises a cannula.
Claim 31
Dependent Claim
21 words
The method of claim 28 , wherein the delivery step is carried out with said cannula through a percutaneous intercostal penetration.
Claim 32
Dependent Claim
45 words
The method of claim 29 further comprising a step of removing at least a portion of a patient's heart valve by means of a cutting tool introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall before the unfolding step.
Claim 33
Dependent Claim
22 words
The method of claim 30 , wherein the step of removing is carried out by providing radiofrequency energy to the cutting tool.
Claim 34
Dependent Claim
43 words
The method of claim 29 further comprising a step of fastening the unfolded heart valve within the valvular annulus by means of an instrument introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall after the unfolding step.
Claim 35
Dependent Claim
34 words
The method of claim 23 , wherein the folding step is carried out after a step of sliding at least one of the slidable ring connectors to adjacent an end of the first crossbar.
Claim 36
Dependent Claim
27 words
The method of claim 23 further comprising a shrinking step after the coupling step, wherein the shrinking step reduces a circumferential length of the slidable ring connector.
Claim 37
Dependent Claim
43 words
The method of claim 34 , wherein the shrinking step is carried out by raising a temperature of the at least one slidable ring connector above a shape-transition temperature of a shape-memory material, said slidable ring connector being made of said shape-memory material.
Claim 38
Dependent Claim
21 words
The method of claim 35 , wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material.
Claim 39
Dependent Claim
23 words
The method of claim 35 , wherein the shape-transition temperature of the shape-memory material is between about 40° C. to about 50° C.
Claim 40
Dependent Claim
16 words
The method of claim 23 , wherein the flexible tissue heart valve is an aortic valve.
Claim 41
Dependent Claim
16 words
The method of claim 23 , wherein the flexible tissue heart valve is a pulmonary valve.
Claim 42
Dependent Claim
16 words
The method of claim 23 , wherein the flexible tissue heart valve is an atrioventricular valve.
Claim 43
Dependent Claim
16 words
The method of claim 23 , wherein the flexible tissue heart valve is a porcine valve.
Claim 44
Dependent Claim
28 words
The method of claim 23 , wherein the flexible tissue heart valve is made of pericardium tissue selected from a group consisting of equine, bovine, porcine, and ovine.
Claim 45
Dependent Claim
24 words
The method of claim 41 or 42 , wherein the flexible tissue heart valve is chemically treated to reduce antigenicity of said tissue material.
Claim 46
Dependent Claim
31 words
The method of claim 43 , wherein the flexible tissue heart valve is chemically treated with a chemical selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, and polyepoxy compounds.
Claim 47
Dependent Claim
20 words
The method of claim 23 , wherein the unfolding step is carried out by an inflatable balloon on a catheter.
Claim 48
Dependent Claim
24 words
The method of claim 45 , wherein the balloon is selected from a group consisting of compliant material, non-compliant material, and semi compliant material.
Claim 49
Independent Claim
116 words
A method for minimally invasively delivering a foldable heart valve into a patient, the foldable heart valve comprising a support structure having a plurality of crossbars and a plurality of slidable ring connectors; said method comprising: folding said valve within a lumen of a delivery means for delivering said valve to a target valvular annulus of the patient; unfolding said valve in place by a balloon catheter, wherein a differentially expandable balloon of the balloon catheter is configured to expand the folded heart valve into an oval unfolded valve; and coupling the plurality of crossbars by sliding at least one of the plurality of slidable ring connectors to an appropriate location of the plurality of crossbars.
Claim 50
Independent Claim
116 words
A method for minimally invasively delivering a foldable heart valve into a patient, the foldable heart valve comprising a support structure having a plurality of crossbars and a plurality of slidable ring connectors; said method comprising: folding said valve within a lumen of a delivery means for delivering said valve to a target valvular annulus of the patient; unfolding said valve in place by a balloon catheter, wherein a differentially expandable balloon of the balloon catheter is configured to expand the folded heart valve into an oval unfolded valve; and coupling the plurality of crossbars by sliding at least one of the plurality of slidable ring connectors to an appropriate location of the plurality of crossbars.
Claim 51
Dependent Claim
38 words
The method of claim 47 , wherein said differentially expandable balloon comprises a longitudinal axis, a major traverse axis and a minor traverse axis, the major traverse axis being at least 10% longer than the minor traverse axis.
Claim 52
Dependent Claim
21 words
The method of claim 47 , wherein said differentially expandable balloon is delivered through a percutaneous intercostal penetration of the patient.
Claim 53
Dependent Claim
35 words
The method of claim 49 , wherein said differentially expandable balloon is delivered through an opening selected from a group consisting of a carotid artery, a jugular vein, a subclavian vein, and a body vessel.
Claim 54
Dependent Claim
29 words
The method of claim 47 further comprising a shrinking step after the coupling step, wherein the shrinking step reduces a circumferential length of the plurality of slidable ring connectors.
Claim 55
Dependent Claim
44 words
The method of claim 51 , wherein the shrinking step is carried out by raising a temperature of the plurality of slidable ring connectors above a shape-transition temperature of a shape-memory material, said plurality of slidable ring connectors being made of said shape-memory material.
Claim 56
Dependent Claim
21 words
The method of claim 52 , wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material.
Claim 57
Dependent Claim
23 words
The method of claim 52 , wherein the shape-transition temperature of the shape-memory material is between about 40° C. to about 50° C.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2008-04-04 | 2008-10-04 | 2009-04-05 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2012-04-04 | 2012-10-04 | 2013-04-05 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2016-04-04 | 2016-10-04 | 2017-04-05 | $7700.00 | Window Closed / Lapsed |