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US6695769B2 Expired / Lapsed US ⏱️ 0.0 years remaining

Passive ventricular support devices and methods of using them

Assignee: Foundry LLC
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Filing: 2001-09-25
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Granted: 2004-02-24
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Expires: 2021-09-25
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Abstract

Abstract This is a surgical device and a method of using it. In particular, the device is one for supporting or constraining at least some part of the epicardial surface of the heart during a portion of the heartbeat, in particular during diastoly. This device may be used 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 preferably 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 device preferably has at least on rib-like structural member. The rib component may extend from end-to end or preferably extends helically around the heart, preferably with at least one revolution. The device may be configured to be self-adherent, i.e., preferably adherent only to itself, and to form a unitary support in the pericardial space after installation. This device helps to prevent further declination of the heart during congestive heart failure. The device is preferably introduced into the pericardial space and onto the surface of the epicardium 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 05:01
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2478; A61F2/2481; A61F2002/2484

Claims Analysis

Total Claims: 60
Claim 1
Independent Claim 69 words
A flexible passive support for constraining epicardial expansion past a predetermined limit comprising a flexible member comprising an enclosure generally conforming in shape to at least a portion of an epicardium and the enclosure comprising at least one rib separated by and spaced by webbing, the webbing being affixed to the at least one rib, and the at least one rib having a flexibility differing than the webbing flexibility.
Claim 2
Dependent Claim 69 words
A flexible passive support for constraining epicardial expansion past a predetermined limit comprising a flexible member comprising an enclosure generally conforming in shape to at least a portion of an epicardium and the enclosure comprising at least one rib separated by and spaced by webbing, the webbing being affixed to the at least one rib, and the at least one rib having a flexibility differing than the webbing flexibility.
Claim 3
Dependent Claim 16 words
The flexible passive support of claim 1 where the generally helical member comprises a ribbon-like member.
Claim 4
Dependent Claim 17 words
The flexible passive support of claim 2 where each at least one rib comprises a ribbon-like member.
Claim 5
Dependent Claim 19 words
The flexible passive support of claim 3 where each ribbon-like member has a width-thickness ratio greater than about two.
Claim 6
Dependent Claim 19 words
The flexible passive support of claim 3 where each ribbon-like member has a width-thickness ratio greater than about seven.
Claim 7
Dependent Claim 22 words
The flexible passive support of claim 1 where the generally helical member is inflatable over at least a portion of the enclosure.
Claim 8
Dependent Claim 15 words
The flexible passive support of claim 1 where the generally helical member is incrementally inflatable.
Claim 9
Dependent Claim 55 words
The flexible passive support of claim 1 where the flexible 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 10
Dependent Claim 60 words
The flexible passive support of claim 1 where the flexible member comprises an enclosure generally conforming in shape to at least a portion of an epicardium 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 11
Dependent Claim 14 words
The flexible passive support of claim 9 where the multiple ribs are each ribbon-like.
Claim 12
Dependent Claim 23 words
The flexible passive support of claim 10 where each ribbon-like member has a cross section with a width-thickness ratio greater than about two.
Claim 13
Dependent Claim 23 words
The flexible passive support of claim 11 where each ribbon-like member has a cross section with a width-thickness ratio greater than about seven.
Claim 14
Dependent Claim 17 words
The flexible passive support of claim 9 where the multiple ribs each have a round cross section.
Claim 15
Dependent Claim 24 words
The flexible passive support of claim 9 where the multiple ribs each have a cross section with a width-thickness ratio of two or less.
Claim 16
Dependent Claim 16 words
The flexible passive support of claim 9 where the multiple ribs are each zigzag in shape.
Claim 17
Dependent Claim 26 words
The flexible passive support of claim 15 where the multiple zigzag ribs have substantially adjacent points and at least some of the adjacent points are connected.
Claim 18
Dependent Claim 21 words
The flexible passive support of claim 9 where at least some of the multiple ribs are joined at the apical end.
Claim 19
Dependent Claim 14 words
The flexible passive support of claim 1 where the webbing comprises a woven fabric.
Claim 20
Dependent Claim 16 words
The flexible passive support of claim 1 where the webbing comprises a woven, open weave fabric.
Claim 21
Dependent Claim 14 words
The flexible passive support of claim 1 where the webbing comprises a non-woven fabric.
Claim 22
Dependent Claim 24 words
The flexible passive support of claim 1 where the webbing comprises one or more ribbons extending between at least some of the multiple ribs.
Claim 23
Dependent Claim 24 words
The flexible passive support of claim 1 where the webbing comprises one or more fibers extending between at least some of the multiple ribs.
Claim 24
Dependent Claim 14 words
The flexible passive support of claim 1 where the webbing comprises an elastic material.
Claim 25
Dependent Claim 15 words
The flexible passive support of claim 1 where the webbing comprises a substantially inelastic material.
Claim 26
Dependent Claim 14 words
The flexible passive support of claim 1 where the flexible member comprises a band.
Claim 27
Dependent Claim 30 words
The flexible passive support of claim 25 where the a band has a length substantially matching the width of an A-V groove on a heart to which it is applied.
Claim 28
Dependent Claim 18 words
The flexible passive support of claim 1 where the flexible member comprises a sack having a closed end.
Claim 29
Dependent Claim 44 words
The flexible passive support of claim 27 where the flexible member comprises a sack having a closed end and sized to be positioned along of an apical end of heart to which it is applied and less than about ⅓ length of that heart.
Claim 30
Dependent Claim 21 words
The flexible passive support of claim 1 where the flexible member comprises a material selected not to adhere to the epicardium.
Claim 31
Dependent Claim 40 words
The flexible passive support of claim 29 where the flexible member has a side selected to be positioned adjacent the epicardium which side has a non-adherent surface comprising a non-adherent material that tends not to form adhesions with the epicardium.
Claim 32
Dependent Claim 26 words
The flexible passive support of claim 30 where the non-adherent material comprises one or more polymers selected from the group consisting of the Nylons and polysulphones.
Claim 33
Dependent Claim 22 words
The flexible passive support of claim 30 where the non-adherent surface has been formed by spraying a non-adherent material onto the side.
Claim 34
Dependent Claim 22 words
The flexible passive support of claim 30 where the non-adherent surface has been formed by infusing a non-adherent material into the side.
Claim 35
Dependent Claim 28 words
The flexible passive support of claim 30 where the non-adherent surface comprises a separate layer of a non-adherent material that tends not to form adhesions with the epicardium.
Claim 36
Dependent Claim 29 words
The flexible passive support of claim 30 where the non-adherent side comprises a separate layer of a non-adherent material is not laminated to other layers in the flexible member.
Claim 37
Dependent Claim 31 words
The flexible passive support of claim 30 where the non-adherent side comprises a separate layer of a non-adherent material is laminated to at least one other layer in the flexible member.
Claim 38
Dependent Claim 25 words
The flexible passive support of claim 30 where the non-adherent material comprises at least one polymer that tends not to form adhesions with the epicardium.
Claim 39
Dependent Claim 24 words
The flexible passive support of claim 30 where the non-adherent material comprises solid lubricious polymers selected from the group consisting of polyfluorocarbons and polyolefins.
Claim 40
Dependent Claim 45 words
The flexible passive support of claim 30 where the non-adherent material comprises one or more polymers selected from the group consisting of polytetrafluoroethylene (PTFE or TFE), ethylene-chlorofluoroethylene (ECTFE), fluorinated ethylene propylene (FEP), polychlorotrifluoroethylene (PCTFE), polyvinylfluoride (PVF), polyvinylidenefluoride (PVDF), polyethylene (LDPE, LLDPE, and HDPE), and polypropylene.
Claim 41
Dependent Claim 51 words
A flexible passive support for constraining epicardial expansion of a heart past a predetermined limit comprising at least one flexible member introducable into a pericardial space and configured to have a generally linear delivery shape and further configured to transform into a generally helical form upon introduction into that pericardial space.
Claim 42
Dependent Claim 51 words
A flexible passive support for constraining epicardial expansion of a heart past a predetermined limit comprising at least one flexible member introducable into a pericardial space and configured to have a generally linear delivery shape and further configured to transform into a generally helical form upon introduction into that pericardial space.
Claim 43
Dependent Claim 18 words
The flexible passive support of claim 40 where the at least one flexible member comprises multiple ribbon-like members.
Claim 44
Dependent Claim 18 words
The flexible passive support of claim 41 where the at least one flexible member comprises a ribbon-like member.
Claim 45
Dependent Claim 19 words
The flexible passive support of claim 42 where each ribbon-like member has a width-thickness ratio greater than about two.
Claim 46
Dependent Claim 19 words
The flexible passive support of claim 43 where each ribbon-like member has a width-thickness ratio greater than about seven.
Claim 47
Dependent Claim 24 words
The flexible passive support of claim 42 where the at least one ribbon-like member has a length and varies in flexibility along that length.
Claim 48
Dependent Claim 24 words
The flexible passive support of claim 42 where the at least one ribbon-like member has a length and varies in width along that length.
Claim 49
Dependent Claim 24 words
The flexible passive support of claim 42 where the at least one ribbon-like member has a length and varies in thickness along that length.
Claim 50
Dependent Claim 17 words
The flexible passive support of claim 42 where the generally helical member is at least partially inflatable.
Claim 51
Dependent Claim 15 words
The flexible passive support of claim 48 where the generally helical member is incrementally inflatable.
Claim 52
Dependent Claim 27 words
The flexible passive support of claim 42 where the generally helical member has a lumen extending from the proximal end at least partially to the distal end.
Claim 53
Dependent Claim 34 words
The flexible passive support of claim 42 where the generally helical member includes at least one orifice situated to open to other surfaces of the generally helical member when the support is helically configured.
Claim 54
Dependent Claim 43 words
The flexible passive support of claim 51 where the generally helical member further comprising a source of glue or adhesive flowable through the at least one orifice, the glue or adhesive suitable for causing adherence only between portions of the generally helical member.
Claim 55
Dependent Claim 16 words
The flexible passive support of claim 52 where the glue or adhesive comprises a modified cyanoacrylate.
Claim 56
Dependent Claim 39 words
A method for supporting the epicardium comprising the steps of: a.) introducing the passive support of claim 1 below a xiphoid process through a pericardium wall into a pericardial space, and b.) positioning the passive support adjacent the epicardium.
Claim 57
Dependent Claim 33 words
The method of claim 54 further comprising the steps of puncturing skin beneath the xiphoid process with a needle and passing the needle and a guidewire through the pericardium into the pericardial space.
Claim 58
Dependent Claim 27 words
The method of claim 55 further comprising the steps of withdrawing the needle and introducing an introducer over the guidewire through the pericardium into the pericardial space.
Claim 59
Dependent Claim 32 words
The method of claim 56 further comprising the step passing a delivery catheter through the introducer over the guidewire through the pericardium into the pericardial space to a site adjacent an epicardium.
Claim 60
Dependent Claim 22 words
The method of claim 56 further comprising the subsequent step of introducing the passive support through the delivery catheter to the epicardium.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2007-02-23 2007-08-25 2008-02-24 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2011-02-23 2011-08-25 2012-02-24 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2015-02-23 2015-08-25 2016-02-24 $7700.00 Window Closed / Lapsed

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