US7060023B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Pericardium reinforcing devices and methods of using them
Assignee: Foundry LLC
•
Filing: 2001-09-25
•
Granted: 2006-06-13
•
Expires: 2021-09-25
Abstract
Abstract This is a surgical device and a method of using it. In particular, the device is one for reinforcing the pericardial sac surrounding the heart to assist in the treatment of congestive heart failure. The device, generically, is an enclosure having an interior and an exterior. The interior surface is made in such a way that it tends not to or does not form adhesions with or accept ingrowth with the myocardial tissue of the epicardium. The exterior surface of the device, in contrast, is adapted to adhere to or to ingrow with or otherwise attach sufficiently to the pericardium so that it reinforces that membrane or structure. The nature of the device is that it tends not to allow the pericardium to expand further with time. The device, after complete deployment, should envelope some measure of pericardial fluid in its interior separating it from the epicardial surface. This device helps to prevent further declination of the heart during congestive heart failure. The device is preferably introduced into the pericardial space and into the inner surface of the pericardium using transcutaneous or minimally invasive techniques.
Inventors
- 👤 Ronald G. French
- 👤 Sunmi K. Chew
- 👤 Hanson S. Gifford, III
- 👤 Bernard H. Andreas
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 17:54
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2478; A61F2/2481
Claims Analysis
Total Claims: 91
Claim 1
Independent Claim
84 words
A compliant and substantially non-elastic pericardial reinforcement comprising an enclosure generally conforming in shape to at least a portion of the heart, said enclosure consisting essentially of a compliant and substantially non-elastic member having an interior surface for placement adjacent an epicardium, the interior surface tending to inhibit adhesions with the epicardium and having an exterior surface for attachment to the interior of a pericardium, the substantially non-elastic member comprising one or more adjacent layers of material contiguous across the interior and exterior surfaces.
Claim 2
Dependent Claim
84 words
A compliant and substantially non-elastic pericardial reinforcement comprising an enclosure generally conforming in shape to at least a portion of the heart, said enclosure consisting essentially of a compliant and substantially non-elastic member having an interior surface for placement adjacent an epicardium, the interior surface tending to inhibit adhesions with the epicardium and having an exterior surface for attachment to the interior of a pericardium, the substantially non-elastic member comprising one or more adjacent layers of material contiguous across the interior and exterior surfaces.
Claim 3
Dependent Claim
24 words
The pericardial reinforcement of claim 1 where the interior surface comprises at least one material that does not substantially permit ingrowth with said epicardium.
Claim 4
Dependent Claim
21 words
The pericardial reinforcement of claim 1 where the interior surface comprises at least one material that resists ingrowth with the epicardium.
Claim 5
Dependent Claim
22 words
The pericardial reinforcement of claim 1 where the compliant member is conformable in shape to at least a portion of the epicardium.
Claim 6
Dependent Claim
14 words
The pericardial reinforcement of claim 1 where the interior surface comprises a lubricious material.
Claim 7
Dependent Claim
15 words
The pericardial reinforcement of claim 1 where the interior surface comprises a lubricious polymeric material.
Claim 8
Dependent Claim
16 words
The pericardial reinforcement of claim 6 where the interior surface polymeric material comprises a fluorocarbon polymer.
Claim 9
Dependent Claim
26 words
The pericardial reinforcement of claim 7 where the fluorocarbon polymer is selected from the group consisting of polytetrafluoroethylene, ethylene-chiorofluoroethylene, fluorinated ethylene propylene, polychiorotrifluoroethylene, polyvinylfluoride, and polyvinylidenefluoride.
Claim 10
Dependent Claim
12 words
The pericardial reinforcement of claim 7 where the fluorocarbon polymer comprises ePTFE.
Claim 11
Dependent Claim
20 words
The pericardial reinforcement of claim 7 where the fluorocarbon polymer comprises ePTFE having internodal spacing less than about 40 microns.
Claim 12
Dependent Claim
28 words
The pericardial reinforcement of claim 6 where the polymer material comprises a member selected from the group consisting of LLDPE, LDPE, HDPE, polypropylene, polyamides, their mixtures and co-polymers.
Claim 13
Dependent Claim
18 words
The pericardial reinforcement of claim 1 where the exterior surface comprises a material for ingrowth into the pericardium.
Claim 14
Dependent Claim
18 words
The pericardial reinforcement of claim 1 where the exterior surface comprises a material allowing attachment to the pericardium.
Claim 15
Dependent Claim
18 words
The pericardial reinforcement of claim 1 where the exterior surface comprises a material for adherence with the pericardium.
Claim 16
Dependent Claim
16 words
The pericardial reinforcement of claim 1 where the exterior surface further comprises a material promoting endothelization.
Claim 17
Dependent Claim
16 words
The pericardial reinforcement of claim 15 where the material promoting endothelization comprises an effective hyaluronate salt.
Claim 18
Dependent Claim
19 words
The pericardial reinforcement of claim 15 where the material promoting endothelization comprises an effective amount of an angiogenic material.
Claim 19
Dependent Claim
18 words
The pericardial reinforcement of claim 1 where the exterior surface comprises a material enhancing ingrowth with the pericardium.
Claim 20
Dependent Claim
15 words
The pericardial reinforcement of claim 7 where the exterior surface material comprises a polymeric material.
Claim 21
Dependent Claim
47 words
The pericardial reinforcement of claim 19 where the exterior surface polymeric material is selected from the group consisting of polyethylene terephthalate, polyglycolic acid, polylactic acid, reconstituted collagen, poly-p-dioxanone, poly(glycolide-lactide) copolymer, poly(glycolide-trimethylene carbonate) copolymer, poly(glycolide-ε-caprolactone) copolymer, glycolide-trimethylene carbonate triblock copolymer, their block and random copolymers, mixtures, and alloys.
Claim 22
Dependent Claim
14 words
The pericardial reinforcement of claim 19 where the exterior surface polymeric material comprises ePTFE.
Claim 23
Dependent Claim
17 words
The pericardial reinforcement of claim 21 where the ePTFE has internodal spacing greater than about 60 microns.
Claim 24
Dependent Claim
18 words
The pericardial reinforcement of claim 1 where the exterior surface material comprises a woven or non-woven polymeric material.
Claim 25
Dependent Claim
16 words
The pericardial reinforcement of claim 23 where the exterior surface material comprises a woven polymeric material.
Claim 26
Dependent Claim
16 words
The pericardial reinforcement of claim 23 where the exterior surface material comprises a non-woven polymeric material.
Claim 27
Dependent Claim
22 words
The pericardial reinforcement of claim 1 further comprising at least one mechanical linkage configured to attach the exterior surface to the pericardium.
Claim 28
Dependent Claim
18 words
The pericardial reinforcement of claim 26 where the at least one mechanical linkage comprises at least one suture.
Claim 29
Dependent Claim
18 words
The pericardial reinforcement of claim 26 where the at least one mechanical linkage comprises at least one staple.
Claim 30
Dependent Claim
25 words
The pericardial reinforcement of claim 26 where the at least one mechanical linkage comprises a material selected from the group consisting of adhesives and glues.
Claim 31
Dependent Claim
25 words
The pericardial reinforcement of claim 29 where the adhesives and glues are selected from the group consisting of acrylate-based glues, cyanoacrylate-based glues, and fibrin-based glues.
Claim 32
Dependent Claim
17 words
The pericardial reinforcement of claim 30 where the at least one mechanical linkage comprises an acrylate-based glue.
Claim 33
Dependent Claim
17 words
The pericardial reinforcement of claim 30 where the at least one mechanical linkage comprises a cyanoacrylate-based glue.
Claim 34
Dependent Claim
17 words
The pericardial reinforcement of claim 30 where the at least one mechanical linkage comprises a fibrin-based glue.
Claim 35
Dependent Claim
17 words
The pericardial reinforcement of claim 1 where the exterior surface is textured for ingrowth into the pericardium.
Claim 36
Dependent Claim
23 words
The pericardial reinforcement of claim 1 where the compliant and substantially non-elastic member comprises an inner member layer and an outer member layer.
Claim 37
Dependent Claim
22 words
The pericardial reinforcement of claim 35 where at least one of the inner layer and the outer layer comprises a woven fabric.
Claim 38
Dependent Claim
22 words
The pericardial reinforcement of claim 35 where at least one of the inner layer and the outer layer comprises a non-woven fabric.
Claim 39
Dependent Claim
22 words
The pericardial reinforcement of claim 35 where the inner layer and the outer layer comprise separate layers of woven or non-woven fabric.
Claim 40
Dependent Claim
16 words
The pericardial reinforcement of claim 35 where the inner layer is laminated to the outer layer.
Claim 41
Dependent Claim
21 words
The pericardial reinforcement of claim 35 where at least one of the inner layer and the outer layer is substantially non-porous.
Claim 42
Dependent Claim
20 words
The pericardial reinforcement of claim 35 where at least one of the inner layer and the outer layer is non-continuous.
Claim 43
Dependent Claim
31 words
The pericardial reinforcement of claim 1 further comprising an adjuster adapted for changing a compliant and substantially non-elastic member size after attachment of that member to the interior of the pericardium.
Claim 44
Dependent Claim
13 words
The pericardial reinforcement of claim 42 where the adjuster comprises a rotatable roller.
Claim 45
Dependent Claim
12 words
The pericardial reinforcement of claim 42 where the adjuster comprises a drawstring.
Claim 46
Dependent Claim
16 words
The pericardial reinforcement of claim 1 where the compliant and substantially non-elastic member comprises a band.
Claim 47
Dependent Claim
57 words
The pericardial reinforcement of claim 1 where the compliant and substantially non-elastic member comprises a band having an upper end and an apical end and a length extending from the upper end to the apical end and where the length of the band is less than about ⅓ length of a heart to which it is applied.
Claim 48
Dependent Claim
28 words
The pericardial reinforcement of claim 46 where the band has a length substantially matching the width of an A–V groove on a heart to which it is applied.
Claim 49
Dependent Claim
20 words
The pericardial reinforcement of claim 1 where the compliant and substantially non-elastic member comprises a sack having a closed end.
Claim 50
Dependent Claim
44 words
The pericardial reinforcement of claim 48 where the compliant and substantially non-elastic member comprises a sack having a closed end and sized to be positioned only along and less than about ⅓ length of an apical end of heart to which it is applied.
Claim 51
Dependent Claim
40 words
The pericardial reinforcement of claim 1 where the compliant and substantially non-elastic member comprises a substantially elongated member having a distal end and a proximal end and is configured to be helical upon introduction into the region of the pericardium.
Claim 52
Dependent Claim
33 words
The pericardial reinforcement of claim 50 where the compliant and substantially non-elastic member comprises a substantially elongated member having a lumen extending from the proximal end at least partially to the distal end.
Claim 53
Dependent Claim
33 words
The pericardial reinforcement of claim 51 where the substantially elongated member includes at least one orifice open to the exterior surface when the device is helically configured in the region of the pericardium.
Claim 54
Dependent Claim
36 words
The pericardial reinforcement of claim 52 further comprising a source of glue or adhesive flowable through the at least one orifice, the glue or adhesive suitable for causing adherence between the compliant member and the pericardium.
Claim 55
Dependent Claim
23 words
The pericardial reinforcement of claim 53 where the substantially elongated member is expandable upon introduction of the glue or adhesive into the lumen.
Claim 56
Dependent Claim
16 words
The pericardial reinforcement of claim 1 further comprising at least one rib found over the enclosure.
Claim 57
Dependent Claim
45 words
The pericardial reinforcement of claim 1 where the compliant and substantially non-elastic member comprises a band having an upper end and an apical end and a length extending from the upper end to the apical end and having at least two open, generally opposing openings.
Claim 58
Dependent Claim
25 words
The pericardial reinforcement of claim 56 where the band has a length less than about ⅓ length of a heart to which it is applied.
Claim 59
Dependent Claim
26 words
The pericardial reinforcement of claim 55 where the at least one rib has a flexibility different than a flexibility of the compliant and substantially non-elastic member.
Claim 60
Dependent Claim
17 words
The pericardial reinforcement of claim 55 where the at least one rib comprises a generally helical member.
Claim 61
Dependent Claim
15 words
The pericardial reinforcement of claim 59 where the generally helical member comprises a ribbon-like member.
Claim 62
Dependent Claim
16 words
The pericardial reinforcement of claim 55 where each at least one rib comprises a ribbon-like member.
Claim 63
Dependent Claim
18 words
The pericardial reinforcement of claim 61 where each ribbon-like member has a width-thickness ratio greater than about two.
Claim 64
Dependent Claim
18 words
The pericardial reinforcement of claim 62 where each ribbon-like member has a width-thickness ratio greater than about seven.
Claim 65
Dependent Claim
21 words
The pericardial reinforcement of claim 59 where the generally helical member is inflatable over at least a portion of the enclosure.
Claim 66
Dependent Claim
14 words
The pericardial reinforcement of claim 59 where the generally helical member is incrementally inflatable.
Claim 67
Dependent Claim
62 words
The pericardial reinforcement of claim 55 where the compliant and substantially non-elastic member comprises an enclosure generally conforming in shape to at least a portion of an pericardium and having an upper end and an apical end and a length extending from the upper end to the apical end and having multiple ribs extending from the upper end to the apical end.
Claim 68
Dependent Claim
13 words
The pericardial reinforcement of claim 66 where the multiple ribs are each ribbon-like.
Claim 69
Dependent Claim
22 words
The pericardial reinforcement of claim 67 where each ribbon-like member has a cross section with a width-thickness ratio greater than about two.
Claim 70
Dependent Claim
22 words
The pericardial reinforcement of claim 68 where each ribbon-like member has a cross section with a width-thickness ratio greater than about seven.
Claim 71
Dependent Claim
16 words
The pericardial reinforcement of claim 66 where the multiple ribs each have a round cross section.
Claim 72
Dependent Claim
23 words
The pericardial reinforcement of claim 66 where the multiple ribs each have a cross section with a width-thickness ratio of two or less.
Claim 73
Dependent Claim
15 words
The pericardial reinforcement of claim 66 where the multiple ribs are each zigzag in shape.
Claim 74
Dependent Claim
25 words
The pericardial reinforcement of claim 72 where the multiple zigzag ribs have substantially adjacent points and at least some of the adjacent points are connected.
Claim 75
Dependent Claim
20 words
The pericardial reinforcement of claim 66 where at least some of the multiple ribs are joined at the apical end.
Claim 76
Dependent Claim
13 words
The pericardial reinforcement of claim 66 where the enclosure comprises a woven fabric.
Claim 77
Dependent Claim
14 words
The pericardial reinforcement of claim 75 where the fabric comprises an open weave fabric.
Claim 78
Dependent Claim
23 words
The pericardial reinforcement of claim 66 where the enclosure comprises one or more ribbons extending between at least some of the multiple ribs.
Claim 79
Dependent Claim
23 words
The pericardial reinforcement of claim 66 where the enclosure comprises one or more fibers extending between at least some of the multiple ribs.
Claim 80
Dependent Claim
13 words
The pericardial reinforcement of claim 66 where the enclosure comprises an elastic material.
Claim 81
Dependent Claim
14 words
The pericardial reinforcement of claim 66 where the enclosure comprises a substantially inelastic material.
Claim 82
Dependent Claim
42 words
The pericardial reinforcement of claim 66 where the enclosure has a longitudinal opening extending from the upper end towards the apical end and including a plurality of looping members situated on said upper end, said loops deployable over a looping deployment tool.
Claim 83
Dependent Claim
30 words
The pericardial reinforcement of claim 81 further including a looping deployment tool, the tool adapted to be removable after placement of the compliant and substantially non-elastic member adjacent said pericardium.
Claim 84
Dependent Claim
23 words
The pericardial reinforcement of claim 82 where the looping deployment tool further comprises a connector member for separable connection to an installation member.
Claim 85
Dependent Claim
16 words
The pericardial reinforcement of claim 83 where the looping deployment tool further comprises the installation member.
Claim 86
Dependent Claim
25 words
The pericardial reinforcement of claim 66 where the compliant and substantially non-elastic member further comprises a connector member for separable connection to an installation member.
Claim 87
Dependent Claim
18 words
The pericardial reinforcement of claim 85 where the compliant and substantially non-elastic member further comprises the installation member.
Claim 88
Dependent Claim
39 words
A method for reinforcing the pericardium comprising the steps of: a) introducing the pericardial reinforcement of claim 1 proximate a xiphoid process through a pericardium wall into a pericardial space, and b) positioning the pericardial reinforcement adjacent the pericardium.
Claim 89
Dependent Claim
35 words
The method of claim 87 further comprising the steps of puncturing skin beneath the xiphoid process with a needle and an introducer and passing the needle and introducer through the pericardium to the pericardial space.
Claim 90
Dependent Claim
23 words
The method of claim 88 further comprising the steps of withdrawing the needle and introducing a guidewire and a cannula through the introducer.
Claim 91
Dependent Claim
15 words
The method of claim 87 further comprising the subsequent step of tightening the pericardial reinforcement.
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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) | 2009-06-12 | 2009-12-12 | 2010-06-13 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2013-06-12 | 2013-12-12 | 2014-06-13 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2017-06-12 | 2017-12-12 | 2018-06-13 | $7700.00 | Window Closed / Lapsed |