Source: http://www.google.com/patents/US6612978?dq=5537618&ei=urENT6-uEoHegQe698i5Bw
Timestamp: 2016-07-29 22:43:55
Document Index: 690777565

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Patent US6612978 - Expandable cardiac harness for treating congestive heart failure - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA cardiac harness for treating congestive heart failure is disclosed. The harness applies elastic, compressive reinforcement on the left ventricle to reduce deleterious wall tension and to resist shape change of the ventricle during the mechanical cardiac cycle. Rather than imposing a dimension beyond...http://www.google.com/patents/US6612978?utm_source=gb-gplus-sharePatent US6612978 - Expandable cardiac harness for treating congestive heart failureAdvanced Patent SearchPublication numberUS6612978 B2Publication typeGrantApplication numberUS 09/952,074Publication dateSep 2, 2003Filing dateSep 10, 2001Priority dateDec 22, 1999Fee statusLapsedAlso published asUS6702732, US20020045799Publication number09952074, 952074, US 6612978 B2, US 6612978B2, US-B2-6612978, US6612978 B2, US6612978B2InventorsLilip Lau, Bill HartiganOriginal AssigneeParacor Surgical, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (142), Non-Patent Citations (47), Referenced by (76), Classifications (13), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetExpandable cardiac harness for treating congestive heart failure
US 6612978 B2Abstract
providing a cardiac harness sized and configured to fit around at least a ventricle of a patient's heart; providing at least one pad having in a marginal edge; arranging the pad marginal edge in proximity to but not impinging upon a coronary artery; and placing the cardiac harness on the heart so that the harness extends over the pad and coronary artery. 2. The method of claim 1, wherein arranging the pad marginal edge comprises aligning the marginal edge with a substantial portion of the length of the coronary artery.
3. The method of claim 1, wherein the coronary artery is selected from the group consisting of the left anterior descending artery, the right coronary artery, the left circumflex artery, the posterior descending artery, and the obtuse marginal artery.
4. The method of claim 1, wherein the cardiac harness comprises an elastic band configured to impart a compressive force on the heart, and the pad is arranged to reduce compression of said artery by said harness.
5. The method of claim 4, wherein the cardiac harness comprises interconnected strands of material.
6. The method of claim 1, additionally comprising providing a second pad having a marginal edge, and arranging the second pad on an opposite side of the coronary artery from the first pad.
7. The method of claim 6, wherein the first and second pads are arranged so that their marginal edges are generally parallel to the coronary artery.
providing a cardiac harness sized and configured to fit around at least a ventricle of a patient's heart, the harness comprising a slot formed therein; and arranging the cardiac harness on the heart so that the slot is generally aligned with a substantial portion of the length of at least one coronary artery selected from the group consisting of the left anterior descending artery, the right coronary artery, the left circumflex artery, the posterior descending artery, and the obtuse marginal artery. 9. The method of claim 8, wherein the slot is defined by a frame integrated into the harness.
10. The method of claim 9, wherein the frame comprises a wire frame.
11. The method of claim 9, wherein the harness comprises strands of material, and the strands are suspended from the wire frame.
12. The method of claim 11, wherein each of the strands comprises at least one spring element.
13. The method of claim 8, wherein the harness is substantially unitarily formed.
This application is a continuation of copending U.S. application Ser. No. 09/634,043, pending which was filed on Aug. 8, 2000, and which claims priority to U.S. application Ser. No. 60/188,282, which was filed on Mar. 10, 2000, and U.S. application Ser. No. 60/171,792, which was filed on Dec. 22, 1999.
The concept of using a permanently implantable passive, non-contracting wrap around the heart to prevent its further deterioration is not new. Suggestions have been published in the literature. Kass et al. (1995) questioned whether an “artificial elastic sock” could be used in lieu of skeletal muscle. They speculated that in dynamic cardiomyoplasty, the latissimus dorsi wrap provides some of its benefit by acting as an elastic constraint around the epicardial surface. They further suggest that the passive skeletal muscle wrap stiffens gradually with stretch, unlike pericardium, which is highly compliant at low levels of stretch but becomes very stiff when expanded beyond resting dimensions. Throughout the article, the importance of gradually increasing stiffness over the entire range of cardiac operating dimensions is emphasized. Despite the conceptual discussion; however, there is no mention of how a cardiac wrap that is both elastic over the entire range of cardiac dimensions and gradually stiffens with stretch can be designed or built.
In another aspect, the harness of the disclosed embodiments can treat or prevent congestive heart failure in a heart having a ventricle that changes sphericity in response to diastolic filling. The harness comprises a plurality of interconnected spring elements, limiting diastolic distention of the ventricle to a degree of expansion without substantially altering naturally occurring changes in the sphericity of the ventricle through the same degree of expansion caused by diastolic filling of the, heart. Alternatively, the harness can limit diastolic distention of the ventricle to a degree of expansion while substantially decreasing the magnitude of a naturally occurring increase in the sphericity of the ventricle through the same degree of expansion caused by diastolic filling.
FIG. 13 is a graph of the sphericity-versus-volume relationship of a latex bladder: alone, in conjunction with application of the cardiac harness, and in conjunction with application of a polyester knit'sock.
In FIG. 8b another configuration is illustrated. The-central portion of a hinge 6 within a first strip 20 is joined to the central portion of another hinge 6 in a second strip 20, by an interconnecting element 16. As illustrated in FIG. 8c, the interconnecting element 16 can be angled to provide a spring-like mechanism between strips 20. FIG. 8d shows another configuration of the interconnecting element 16, providing firmer support between hinges 6 in different rows 20.
FIG. 9c illustrates a corollary property of the hinges 6, most readily seen when the cardiac harness 4 is applied to a live heart 2: The stretching of the strips 20 of hinges 6 in the transverse (X-axis) direction produces very little or no foreshortening in the longitudinal (Y-axis) direction. In the region of the cardiac base, which is close to the outflow (aortic and pulmonic) valves, it is advantageous to have the rows 20 of hinges 6 expanding and contracting in the circumferential or transverse direction (i.e., along the X axis) while little or no foreshortening in the longitudinal direction (i.e., along the Y axis) occurs. This phenomenon is illustrated in FIG. 9c. Closer to the cardiac apex, it may be more advantageous to have the rows or strips 20 of hinges 6 move apart in the longitudinal direction (i.e., along the Y axis) while there is very little or no foreshortening in the circumferential or transverse direction (i.e., along the X axis). This phenomenon is illustrated in FIG. 9b. An additional way that the longitudinal expansion of the harness can be decoupled from the transverse expansion of the harness is through the use of elastically recoiling interconnecting elements 16, as illustrated in FIGS. 8a and 8 c. Additionally, having interconnecting hinges 18, as illustrated in FIG. 8e, is, an additional way of decoupling longitudinal contraction and expansion of the harness from transverse expansion and contraction of the hinges 6 within the harness 4.
FIGS. 16a and 16 b illustrate a protection mechanism for minimizing compression of one or more coronary arteries 26. To minimize the risk of ischemia, the compression of the harness on an epicardial coronary artery 26 can be alleviated by placement of protecting strips 28 on either side of the coronary artery 26. This mechanism lifts the harness 4 off of the coronary. artery 26. A suitable material for the protecting strip 26 can be expanded polytetrafluoroethylene ePTFE.
Another approach to minimizing compression of the coronary artery 26 is illustrated in FIG. 17. A wire frame 30 that runs parallel to the coronary artery 26 can be integrated into the harness 4. The hinges 6 can be suspended from the wire frame 30 like curtains on a curtain rod. The hinges 6 extend from one arm of the wire frame 30 to 30 the other over the surface of the myocardium, between coronary arteries.
Delivery of the harness 4 can be accomplished through conventional cardiothoracic surgical techniques through a median stemotomy. Alternatively, the harness 4 may be delivered through minimally invasive surgical access to the thoracic cavity, as illustrated in FIG. 19. A delivery device 36 may be inserted into the thoracic cavity 34 between the patient's ribs to gain direct access to the heart 2. Preferably, such a minimally invasive procedure is accomplished on a beating heart, without the use of cardiopulmonary bypass. Access to the heart can be created with conventional surgical approaches. The pericardium may be opened completely, or a small incision can be made in the pericardium (pericardiotomy) to allow the delivery system 36 access to the heart 2. The delivery system 36 of the disclosed embodiments comprises an integrated unit of several components, as illustrated in FIGS. 20a and 20 b. Preferably, there is a releasable suction device, such as a suction cup 38, at the distal tip of the delivery device 36. This negative pressure suction cup 38 is used to hold the apex of the heart 2. Negative pressure can be applied to the cup 38 using a syringe or other vacuum device. A negative pressure lock can be achieved through a one-way valve, stopcock, or a tubing clamp. The suction cup 38, advantageously formed of a biocompatible material, is preferably stiff to prevent any negative pressure loss through heart manipulation, this provides traction by which the harness 4 can be pushed forward onto the heart 2. In addition, the suction cup 38 can be used to lift the heart 2 to facilitate advancement of the harness 4 or allow visualization and surgical manipulation of the posterior side of the heart 2. After secure purchase of the apex of the heart 2 is achieved, the harness 4, which is collapsed within the body 46 of the delivery device 36, is advanced distally toward the heart 2 by actuating fingers 40. The harness 4 can be inverted (i.e., turned inside-out) ahead of time, to allow it to-unroll, or evert as it advances over the surface of the heart 2. In this discussion, the term “evert” means turning right-side-in, i.e., reversing an inverting process. After the harness 4 is advanced into place, the suction is released and the delivery system 36 is released from the harness 4 and heart 2.
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ClassificationA61M2205/8206, A61M2205/3523, A61M1/1003, A61M1/1068, A61M1/122, A61F2002/2484, A61F2/2481, A61M1/1048European ClassificationA61M1/10E50B, A61F2/24W2Legal EventsDateCodeEventDescriptionSep 10, 2001ASAssignmentOwner name: PARACOR SURGICAL, INC., CALIFORNIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LAU, LILIP;HARTIGAN, BILL;REEL/FRAME:012174/0662Effective date: 20001103Mar 2, 2007FPAYFee paymentYear of fee payment: 4Oct 4, 2008ASAssignmentOwner name: PARACOR MEDICAL, INC., CALIFORNIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PARACOR SURGICAL, INC.;REEL/FRAME:021630/0514Effective date: 20080918Apr 11, 2011REMIMaintenance fee reminder mailedSep 2, 2011LAPSLapse for failure to pay maintenance feesOct 25, 2011FPExpired due to failure to pay maintenance feeEffective date: 20110902RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS 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