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US7510572B2
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US
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Implantation system for delivery of a heart valve prosthesis
Assignee: Edwards Lifesciences Cardiaq LLC
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Filing: 2001-10-09
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Granted: 2009-03-31
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Expires: 2021-10-09
Abstract
Abstract A heart valve prosthesis and method of implanting the prosthesis are disclosed. A valve is mounted within a support apparatus that is deformable between a first condition and a second condition. The prosthesis has a cross-sectional dimension in the second condition that is less than a cross-sectional dimension of the supported valve when in first condition. The prosthesis can be implanted into a patient's heart, such as during a direct vision procedure through a tubular implantation apparatus that maintains the prosthesis in its second condition until discharged from the tubular apparatus.
Inventors
- 👤 Shlomo Gabbay
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 22:51
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2427; A61F2/243; A61F2/2433; A61F2/2409; A61F2/2412; A61F2/2418; A61F2/2436; A61F2/2475; A61F2210/00; A61F2210/0014; A61F2220/00; A61F2220/0008; A61F2220/0016; A61F2230/00; A61F2230/0002; A61F2230/0028; A61F2230/005; A61F2230/0054; A61F2230/0063; A61F2230/0067; A61F2230/0073; A61F2230/0078; G; G01; G01N; G01N2800/00; G01N2800/52; Y; Y10; Y10S; Y10S623/00; Y10S623/902; Y10S623/904
Claims Analysis
Total Claims: 22
Claim 1
Independent Claim
216 words
An implantation system, comprising: an elongated cylindrical member having spaced apart ends, at least one of the ends providing an opening; a body portion from which the cylindrical member extends to terminate in the opening that is spaced longitudinally apart from the body portion, the body portion having a greater outer diameter than the cylindrical member, the cylindrical member having an inner diameter in a range from about 5 mm to about 15 mm, the cylindrical member and body portion being substantially coaxial along a linear axis extending through the cylindrical member and the body portion; a heart valve prosthesis including a generally cylindrical support having axially spaced apart ends, a valve mounted within the support at a fixed axial position between the spaced apart ends of the support, the prosthesis being deformable to a first condition in which the prosthesis has a reduced cross-sectional dimension, the support being biased to expand the prosthesis radially outwardly from the first condition to a second condition in which the prosthesis has a cross-sectional dimension that is greater than the reduced cross-sectional dimension, the prosthesis being mounted within the cylindrical member in the first condition; and a plunger operative to traverse at least part of the cylindrical member and urge the prosthesis from the cylindrical member through the opening.
Claim 2
Dependent Claim
216 words
An implantation system, comprising: an elongated cylindrical member having spaced apart ends, at least one of the ends providing an opening; a body portion from which the cylindrical member extends to terminate in the opening that is spaced longitudinally apart from the body portion, the body portion having a greater outer diameter than the cylindrical member, the cylindrical member having an inner diameter in a range from about 5 mm to about 15 mm, the cylindrical member and body portion being substantially coaxial along a linear axis extending through the cylindrical member and the body portion; a heart valve prosthesis including a generally cylindrical support having axially spaced apart ends, a valve mounted within the support at a fixed axial position between the spaced apart ends of the support, the prosthesis being deformable to a first condition in which the prosthesis has a reduced cross-sectional dimension, the support being biased to expand the prosthesis radially outwardly from the first condition to a second condition in which the prosthesis has a cross-sectional dimension that is greater than the reduced cross-sectional dimension, the prosthesis being mounted within the cylindrical member in the first condition; and a plunger operative to traverse at least part of the cylindrical member and urge the prosthesis from the cylindrical member through the opening.
Claim 3
Dependent Claim
24 words
The system of claim 1 , the support being formed of a shape memory alloy operative to urge the prosthesis to the second condition.
Claim 4
Dependent Claim
61 words
The system of claim 1 , the support further comprising a plurality of elongated support features that extend generally axially between ends of the support, biasing elements interconnecting adjacent support features in a circumscribing relationship around the valve, the biasing elements urging the interconnected adjacent support features apart from each other, so as to urge the prosthesis toward the second condition.
Claim 5
Dependent Claim
41 words
The system of claim 3 , further comprising at least one connecting element operative to hold the biasing elements in a generally circular array and to limit the radial outward expansion of the prosthesis at the location of the circular array.
Claim 6
Dependent Claim
25 words
The system of claim 3 , further comprising a plurality of resilient projections that extend radially outwardly from the axially opposed ends of the support.
Claim 7
Dependent Claim
49 words
The system of claim 5 , the projections further comprising a set of triangular projections attached to each of the opposed ends of the support by biasing elements that bias the triangular projections to extend axially and radially outwardly from each of the respective opposed ends of the support.
Claim 8
Dependent Claim
40 words
The system of claim 3 , the support features and the biasing elements being formed of a continuous length of a substantially resilient and elastic material that facilitates expansion of the prosthesis from the first condition to the second condition.
Claim 9
Dependent Claim
23 words
The system of claim 1 , further comprising an outer sheath of a substantially biocompatible material that covers exposed parts of the support.
Claim 10
Dependent Claim
42 words
The system of claim 1 wherein the valve further comprises a pulmonic animal heart valve having leaflets located within a valve wall to permit substantially unidirectional flow of blood through the valve, the support engaging an outer surface of the valve wall.
Claim 11
Dependent Claim
25 words
The system of claim 1 , further comprising indicia along an exterior portion of the cylindrical member to facilitate implantation of the heart valve prosthesis.
Claim 12
Dependent Claim
19 words
The system of claim 1 , wherein the valve comprises a natural tissue heart valve mounted within the support.
Claim 13
Dependent Claim
204 words
An implantation system, comprising: an implanter comprising: an elongated cylindrical member having spaced apart ends and a lumen extending through the cylindrical member, at least one of the ends providing an opening into the lumen; a body portion having a greater outer diameter than the cylindrical member, the cylindrical member extending from the body portion to terminate in the opening spaced longitudinally apart from the body portion, the cylindrical member and body portion being substantially coaxial along a linear axis that extends through the implanter; a plunger operative to traverse at least part of the lumen along the linear axis; and a heart valve prosthesis comprising: a generally cylindrical support having axially spaced apart ends, and a valve mounted within the support, the prosthesis being deformable to a first condition in which the prosthesis has a reduced cross-sectional dimension and being expandable from the first condition to a second condition in which the prosthesis has a cross-sectional dimension that is greater than the reduced cross-sectional dimension, the prosthesis being mounted within the cylindrical member in the first condition, such that the plunger is operative to traverse at least part of the cylindrical member and urge the prosthesis from the cylindrical member through the opening.
Claim 14
Dependent Claim
204 words
An implantation system, comprising: an implanter comprising: an elongated cylindrical member having spaced apart ends and a lumen extending through the cylindrical member, at least one of the ends providing an opening into the lumen; a body portion having a greater outer diameter than the cylindrical member, the cylindrical member extending from the body portion to terminate in the opening spaced longitudinally apart from the body portion, the cylindrical member and body portion being substantially coaxial along a linear axis that extends through the implanter; a plunger operative to traverse at least part of the lumen along the linear axis; and a heart valve prosthesis comprising: a generally cylindrical support having axially spaced apart ends, and a valve mounted within the support, the prosthesis being deformable to a first condition in which the prosthesis has a reduced cross-sectional dimension and being expandable from the first condition to a second condition in which the prosthesis has a cross-sectional dimension that is greater than the reduced cross-sectional dimension, the prosthesis being mounted within the cylindrical member in the first condition, such that the plunger is operative to traverse at least part of the cylindrical member and urge the prosthesis from the cylindrical member through the opening.
Claim 15
Dependent Claim
44 words
The implantation system of claim 12 , the cylindrical member of the implanter having an inner diameter in a range from about 5 mm to about 15 mm, and the body portion having a diameter that is greater than tat of the cylindrical enclosure.
Claim 16
Dependent Claim
39 words
The implantation system of claim 13 , wherein the support of the prosthesis further comprises axially extending support features interconnected by biasing elements that bias the support to expand radially outwardly from the first condition to the second condition.
Claim 17
Dependent Claim
38 words
The implantation system of claim 14 , the biasing elements further comprising springs arranged in a generally circular array at the opposed ends of the support, the springs interconnecting adjacent support features to bias the support radially outwardly.
Claim 18
Dependent Claim
20 words
The implantation system of claim 13 , the prosthesis further comprising projections biased to extend radially outwardly from the support.
Claim 19
Dependent Claim
45 words
The implantation system of claim 12 , the implanter further comprising a handle portion attached to and extending radially outwardly from the body portion at a position that is spaced axially from an end of the body portion from which the cylindrical member enclosure extends.
Claim 20
Dependent Claim
20 words
The implantation system of claim 12 , wherein the valve comprises a natural tissue heart valve mounted within the support.
Claim 21
Dependent Claim
35 words
The implantation system of claim 12 , the prosthesis further comprising a flexible connecting element attached to the support to inhibit radial outward expansion of at least part of the support beyond a predetermined amount.
Claim 22
Dependent Claim
45 words
The implantation system of claim 19 , the prosthesis further comprising a loop of a flexible material connected to the support at each of the axially spaced apart ends to inhibit radial outward expansion of the support at the opposed ends beyond a predetermined amount.
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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) | 2012-03-30 | 2012-09-29 | 2013-03-31 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2016-03-30 | 2016-09-29 | 2017-03-31 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2020-03-30 | 2020-09-29 | 2021-03-31 | $7700.00 | Window Closed / Lapsed |