Source: http://www.google.com/patents/US6663558?dq=calbucci
Timestamp: 2016-07-25 16:07:41
Document Index: 55915627

Matched Legal Cases: ['art.\n5', 'art.\n17', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2']

Patent US6663558 - 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/US6663558?utm_source=gb-gplus-sharePatent US6663558 - Expandable cardiac harness for treating congestive heart failureAdvanced Patent SearchPublication numberUS6663558 B2Publication typeGrantApplication numberUS 09/952,116Publication dateDec 16, 2003Filing dateSep 10, 2001Priority dateDec 23, 1999Fee statusLapsedAlso published asCA2402504A1, DE60124872D1, DE60124872T2, EP1261294A1, EP1261294B1, US6595912, US6602184, US6612979, US6682474, US7077802, US7081086, US7097611, US7124493, US7189202, US7238152, US7276022, US7410461, US20020019580, US20020028981, US20020032364, US20020045798, US20020045800, US20020052538, US20030065248, US20040106848, US20040162463, US20040171906, US20040230091, US20050020874, US20050102016, US20050107661, WO2001067985A1Publication number09952116, 952116, US 6663558 B2, US 6663558B2, US-B2-6663558, US6663558 B2, US6663558B2InventorsLilip Lau, Bill HartiganOriginal AssigneeParacor Surgical, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (142), Non-Patent Citations (46), Referenced by (74), Classifications (26), Legal Events (11) External Links: USPTO, USPTO Assignment, EspacenetExpandable cardiac harness for treating congestive heart failure
US 6663558 B2Abstract
a cardiac harness having first and second transversely extending series of spring elements, said first and second series of spring elements mechanically longitudinally coupled to each other by a longitudinally expandable member, said harness adapted to be placed about at least a cardiac base region defined generally adjacent and below an atrioventricular groove of a heart; wherein said spring elements are configured to interact such that said harness expands and contracts in a substantially transverse dimension of said harness in the region of the cardiac base in response to the mechanical cardiac cycle, wherein any longitudinal foreshortening of said harness in the region of the cardiac base is substantially decoupled from expansion of the harness in the transverse dimension. 2. The apparatus of claim 1, wherein said spring elements comprise Nitinol.
3. The apparatus of claim 1, wherein the cardiac harness comprises a strip comprising a plurality of spring elements.
4. The apparatus of claim 3, wherein the strip is sized and configured to fit circumferentially around the base portion of the heart.
5. The apparatus of claim 3, wherein the harness comprises a plurality of strips, each strip comprising a plurality of spring elements, and the strips are arranged substantially adjacent to one another.
6. The apparatus of claim 1, wherein the interconnecting element is substantially elastic.
7. The apparatus of claim 6, wherein the interconnecting element comprises a spring element.
a cardiac harness having first and second longitudinally extending series of spring elements, said first and second series of spring elements mechanically transversely coupled to each other by a transversely expandable member, said harness adapted to be placed on or adjacent an epicardium of a heart at a region adjacent at least a cardiac apex; wherein said spring elements interact such that said harness expands and contracts in a substantially longitudinal dimension of said harness in the region of the cardiac apex in response to the mechanical cardiac cycle, wherein any transverse foreshortening of said harness in the region of the cardiac apex is substantially decoupled from expansion of the harness in the longitudinal dimension. 9. The apparatus of claim 8, wherein said spring elements comprise Nitinol.
10. The apparatus of claim 8, wherein at least one of the spring elements comprises a pair of arm members connected at a center portion, the spring elements configured so that moving the arms relative to each other creates a bending moment in the center portion.
11. The apparatus of claim 10, wherein the spring elements comprise metal.
12. The apparatus of claim 11, wherein the plurality of spring elements are connected to one another, and wherein the spring elements are unitarily formed.
13. The apparatus of claim 10, comprising a plurality of elongate strips disposed in the apex region and extending generally longitudinally, each of the strips comprising at least one spring element.
14. The apparatus of claim 13, wherein the strips are connected to one another.
plural elongate strips sized to fit around at least a base of a ventricle of a head, such that said strips extend substantially transverse to the longitudinal axis of the heart, said strips longitudinally mechanically coupled to each other by a longitudinally expandable member and comprising respective spring elements, said spring elements elongating in the transverse direction in response to expansion of the ventricle without applying substantial longitudinal forces between adjacent strips. 16. The apparatus of claim 15, wherein at least one of said strips surrounds the heart.
17. The apparatus of claim 15, wherein said strips surround the left ventricle.
18. The apparatus of claim 15, wherein said strips surround the right ventricle.
19. The apparatus of claim 15, wherein said strips comprise at least one undulating strand.
20. The apparatus of claim 15, wherein said at least one spring element comprises a central portion and two arm portions.
21. The apparatus of claim 15, wherein said at least one spring element comprises Nitinol.
22. An apparatus for treating or preventing congestive heart failure, comprising:
a cardiac harness comprising a plurality of interconnected spring elements, the harness having a base portion and an apex portion, the base and apex portions being sized and configured to be fitted to a base region and an apex region, respectively, of a patient's heart; an array of spring elements in the base portion, the array comprising at least one strip comprising a plurality of spring elements configured to elastically extend in a direction substantially transverse to a longitudinal axis of the heart; and an array of spring elements in the apex portion, the array comprising at least one strip comprising a plurality of spring elements configured to elastically extend in a direction substantially parallel to the longitudinal axis. 23. The apparatus of claim 22, wherein the base portion comprises a plurality of strips, each of the strips comprising a plurality of spring elements.
24. The apparatus of claim 23, wherein the base portion strips are movable relative to one another.
25. The apparatus of claim 24, additionally comprising interconnecting elements extending between adjacent strips, wherein the interconnecting elements are substantially elastic.
26. The apparatus of claim 22, wherein the apex portion comprises a plurality of strips, each of the strips comprising a plurality of spring elements.
27. The apparatus of claim 26, wherein the apex portion strips are movable relative to one another.
28. The apparatus of claim 27 additionally comprising interconnecting elements extending between adjacent strips, wherein the interconnecting elements are substantially elastic.
29. The apparatus of claim 22, wherein the harness is substantially unitarily formed.
30. The apparatus of claim 22, wherein the spring elements in the harness do not overlap each other.
This application is a continuation of copending U.S. application Ser. No. 09/634,043, 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 first reported clinical case of dynamic cardiomyoplasty using a latissimus dorsi wrap was published in 1985. Since then, over 1,000 patients have been treated with this experimental procedure. Numerous published studies have shown that the procedure produces significant improvement in clinical status, as graded by the New York Heart Association (“NYHA”) classification scale, a slight but significant hemodynamic or systolic function improvement, and a reduction in the number of patient hospital visits after the procedure. However, an improvement in survival has yet to be consistently demonstrated. Furthermore, perhaps due to their frail condition, NYHA class IV patients have not fared well with the procedure. This has limited its use to NYHA class III patients. It appears that the skeletal muscle wrap, probably because of its deterioration over time, does not provide sustained squeezing of the heart over time Yet, the clinical benefits of the procedure appear to persist. This paradox has led to considerable research into the underlying mechanisms of dynamic latissimus dorsi cardiomyoplasty.
An important difference between the decoupled hinge harness construction of the preferred embodiment and a knitted fabric harness, or cardiac “sock,” is the hinge harness's ability to closely track changes in sphericity of the underlying heart, whether the heart is healthy or diseased. This has been demonstrated experimentally by using an inflated latex bladder, which simulates a heart in its expansion and contraction. First, relative changes in sphericity of the bladder were measured. Note that sphericity is defined as diameter (D) divided by length (L): sphericity = diameter length  This relationship is illustrated in FIG. 12, which shows the diameter (D) of the heart in the transverse dimension and the length (L) of the heart in the longitudinal direction. The results of this experiment are illustrated in FIG. 13. When the bladder was inflated alone (i.e., without the presence of a harness), it generated a sphericity-versus-volume curve that is illustrated as the middle curve in FIG. 13. When a polyester knit “sock” was applied to the bladder, there was a great increase in sphericity as the volume of the bladder increased, as illustrated by the top curve of FIG. 13. In contrast, when the elastic hinge harness 4 of the preferred embodiment was applied to the bladder, the sphericity-versus-volume curve more closely matched that of the unencumbered bladder alone. The elastic hinge harness sphericity curve is illustrated as the bottom curve in FIG. 13. Thus, the elastic hinge harness of the preferred embodiment closely tracks changes in sphericity over a range of volumes of the underlying structure, in this case a latex bladder. The nonforeshortening elastic hinge harness 4 had little impact on the sphericity index as bladder volume increased. In fact, the sphericity index values were slightly lower than for the bladder alone. In contrast, the presence of the knitted sock significantly increased the sphericity of the bladder as its volume was increased. This demonstrates the potential importance of the nonforeshortening elastic feature of the harness with respect to its application to the human heart. The harness has the ability either (1) to “track” (i.e., minimally alter) changes in sphericity of one or both ventricles throughout systole and diastole; or (2) to progressively decrease the sphericity index of the heart, relative to an unencumbered heart (i.e., without the harness), as diastole proceeds, whether the heart is healthy or in congestive failure.
Delivery of the harness 4 can be accomplished through conventional cardiothoracic surgical techniques through a median sternotomy. 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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ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LAU, LILIP;HARTIGAN, BILL;REEL/FRAME:012175/0471Effective date: 20001103Nov 17, 2003ASAssignmentOwner name: PARACOR MEDICAL, INC., CALIFORNIAFree format text: CHANGE OF NAME;ASSIGNOR:PARACOR SURGICAL, INC.;REEL/FRAME:014697/0952Effective date: 20030613Jan 10, 2006CCCertificate of correctionJun 18, 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:021630/0508Effective date: 20080918Jul 25, 2011REMIMaintenance fee reminder mailedNov 14, 2011SULPSurcharge for late paymentYear of fee payment: 7Nov 14, 2011FPAYFee paymentYear of fee payment: 8Jul 24, 2015REMIMaintenance fee reminder mailedDec 16, 2015LAPSLapse for failure to pay maintenance feesFeb 2, 2016FPExpired due to failure to pay maintenance feeEffective date: 20151216RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy 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