Source: http://www.google.com/patents/US6045497?dq=7,321,221
Timestamp: 2017-08-24 11:11:34
Document Index: 200617964

Matched Legal Cases: ['art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14']

Patent US6045497 - Heart wall tension reduction apparatus and method - Google Patents
An apparatus for treatment of a failing heart by reducing the wall tension therein. In one embodiment, the apparatus includes a tension member for drawing at least two walls of a heart chamber toward each other. Methods for placing the apparatus on the heart are also provided....http://www.google.com/patents/US6045497?utm_source=gb-gplus-sharePatent US6045497 - Heart wall tension reduction apparatus and method
Publication number US6045497 A
Application number US 09/124,286
Also published as DE69942183D1, EP1143858A2, EP1143858A3, EP1520519A1, EP1520519B1, US6261222, US6629921, WO2000006026A2, WO2000006026A3, WO2000006026A9
Publication number 09124286, 124286, US 6045497 A, US 6045497A, US-A-6045497, US6045497 A, US6045497A
Inventors Cyril J. Schweich, Jr., Todd J. Mortier, Robert M. Vidlund, Peter T. Keith, Thomas M. Paulson
Patent Citations (38), Non-Patent Citations (106), Referenced by (669), Classifications (37), Legal Events (8)
US 6045497 A
1. A transventricular splint, comprising:
an elongate tension member having two axially disposed ends; and
a substantially atraumatic anchor having a disc-like shape disposed at each end, such that the length of the tension member between the anchors is about 1 to 4 inches.
2. The transventricular splint in accordance with claim 1, wherein the tension member comprises a multi-filament elongate member.
3. The transventricular splint in accordance with claim 1, wherein the tension member is substantially radiopaque.
4. The transventricular splint in accordance with claim 1, further comprising a radiopaque marker disposed on the tension member.
5. The transventricular splint in accordance with claim 1, wherein the tension member is echo cardiograph compatible.
6. The transventricular splint in accordance with claim 1, further comprising an echogenic marker disposed on the tension member.
7. The transventricular splint in accordance with claim 1, wherein the tension member has a substantially antithrombogenic surface.
8. The transventricular splint in accordance with claim 7, wherein the tension member has a substantially antithrombogenic coating.
9. The transventricular splint in accordance with claim 1, wherein the tension member has a length of between about 0.6 and 2.0 inches.
10. The transventricular splint in accordance with claim 1, wherein the tension member has a diameter of between about 0.01 and 0.02 inches.
11. An apparatus for placement in a heart, the apparatus comprising:
an elongate, multifilament member having opposite ends; and
an anchor having a disc-like shape disposed at each end to engage a wall of the heart so that the engaged walls remain in a non-contacting relationship.
12. The apparatus of claim 11, wherein the member is formed essentially of stainless steel.
13. The apparatus of claim 11, wherein the member is formed essentially of a titanium alloy.
14. The apparatus of claim 11, wherein the member is formed essentially of a nickel titanium alloy.
15. The apparatus of claim 11, wherein the member is formed essentially of a shape memory alloy.
16. The apparatus of claim 11, wherein the member has a diameter in the range of approximately 0.005 inches to 0.035 inches.
17. The apparatus of claim 11, wherein the member has a length in the range of approximately 0.6 inches to 4 inches.
18. The apparatus of claim 11, wherein the member is braided wire.
19. The apparatus of claim 11, wherein the member is twisted wire.
20. The apparatus of claim 11, wherein the member is formed essentially of polymeric fiber.
21. The apparatus of claim 11, wherein the member is formed essentially of carbon fiber.
22. The apparatus of claim 11, wherein the member includes a coating.
23. The apparatus of claim 22, wherein the coating is formed essentially of silicone.
24. The apparatus of claim 22, wherein the coating is formed essentially of urethane.
25. The apparatus of claim 22, wherein the coating is formed essentially of PTFE.
26. The apparatus of claim 22, wherein the coating is formed essentially of carbon.
27. The apparatus of claim 22, wherein the coating includes a drug.
28. The apparatus of claim 22, wherein the coating is ingrowth inducing.
29. The apparatus of claim 28, wherein the coating is formed essentially of collagen.
30. The apparatus of claim 11, wherein the member includes a core fiber extending along an axis of the member.
31. The apparatus of claim 11, wherein the member is radiopaque.
32. The apparatus of claim 11, wherein the member is echo cardiograph compatible.
33. The apparatus of claim 11, wherein the member is MRI compatible.
34. The apparatus of claim 11, wherein the member includes a radiopaque marker.
35. The apparatus of claim 11, wherein the member includes an echo cardiograph compatible marker.
36. The apparatus of claim 11, wherein the member includes an MRI compatible marker.
37. The apparatus of claim 11, wherein the member is configured to extend transverse the left ventricle of the heart and avoid papillary muscles and arteries.
38. An apparatus for placement in a heart, the apparatus comprising:
an elongate member having opposite ends; and
an anchor disposed at each end to engage a wall of the heart, the anchor being capable of articulating relative to the member.
39. The apparatus of claim 38, wherein each anchor includes a recess for receiving a corresponding end of the member.
40. The apparatus of claim 39, wherein the corresponding end of the member includes a ball.
41. The apparatus of claim 38, wherein the member is a multifilament member.
42. The apparatus of claim 38, wherein each anchor includes a socket for receiving a ball at a corresponding end of the member.
43. An apparatus for placement in a heart, the apparatus comprising:
an anchor disposed at each end to engage a wall of the heart so that the engaged walls remain in a non-contacting relationship, the anchor including a mechanism capable of securing the member to the anchor.
44. The apparatus of claim 43, wherein the mechanism includes a collet disposed within an orifice of the anchor to receive the member.
45. The apparatus of claim 44, wherein the collet is threaded to receive a nut.
46. The apparatus of claim 43, wherein the anchor includes an aperture having sloping sides.
47. The apparatus of claim 43, wherein the mechanism includes a set screw disposed within a passage of the anchor.
48. The apparatus of claim 43, wherein the mechanism includes a pair of cantilever members capable of clamping the member.
49. The apparatus of claim 43, wherein the anchor is formed essentially of a stainless steel alloy.
50. The apparatus of claim 43, wherein the anchor is formed essentially of a titanium alloy.
51. An apparatus for placement in a heart, the apparatus comprising:
an anchor having a disc-like shape disposed at each end to engage a wall of the heart so that the engaged walls remain in a noncontacting relationship, the anchor including a mechanism capable of securing the anchor to the wall.
52. The apparatus of claim 43, wherein the anchor is capable of articulating relative to the member to reduce bending of the member.
53. The apparatus of claim 43, wherein the member is configured to extend transverse the left ventricle of the heart and avoid papillary muscles and arteries.
54. An apparatus for placement in a heart, the apparatus comprising:
an anchor disposed at each end to engage a wall of the heart so that the engaged walls remain in a non-contacting relationship, the anchor including a mechanism capable of securing the anchor to the wall.
55. The apparatus of claim 54, wherein the mechanism includes a biocompatible adhesive.
56. The apparatus of claim 54, wherein the mechanism includes an aperture extending through the anchor, the aperture configured to receive a suture for securing the anchor to the wall.
57. The apparatus of claim 54, wherein the mechanism includes an aperture extending through the anchor, the aperture being threaded to receive a screw for securing the anchor to the wall.
58. The apparatus of claim 54, wherein the mechanism includes a layer of material capable of promoting tissue ingrowth.
59. The apparatus of claim 58, wherein the material is a mesh material.
60. The apparatus of claim 58, wherein the material is formed essentially of PTFE.
61. The apparatus of claim 58, wherein the anchor includes a top layer of material connected to the layer of tissue ingrowth material.
62. The apparatus of claim 61, wherein the top layer is formed essentially of PTFE.
63. The apparatus of claim 54, wherein the member is a multifilament member.
64. The apparatus of claim 54, wherein the anchor is capable of articulating relative to the member to reduce bending of the member.
65. The apparatus of claim 54, wherein the member is configured to extend transverse the left ventricle of the heart and avoid papillary muscles and arteries.
66. The apparatus of claim 54, wherein the anchor includes a second mechanism capable of securing the member to the anchor.
This application is a continuation-in-part of U.S. patent application Ser. No. 08/933,456, filed Sep. 18, 1997, which in turn is a continuation-in-part of U.S. application Ser. No. 08/778,277, filed Jan. 2, 1997. This application is related to U.S. application Ser. No. 09/123,977, filed on Jul. 29, 1998 and entitled "Transventricular Implant Tools and Devices" and U.S. application Ser. No. 09/124,321, filed on Jul. 29, 1998 and entitled "Stress Reduction Apparatus and Method", both of which are incorporated herein by reference.
The syndrome of heart failure is a common course for the progression of many forms of heart disease. Heart failure may be considered to be the condition in which an abnormality of cardiac function is responsible for the inability of the heart to pump blood at a rate commensurate with the requirements of the metabolizing tissues, or can do so only at an abnormally elevated filling pressure. There are many specific disease processes that can lead to heart failure. Typically resulting in dilatation of the left ventricular chamber. Etiologies that can lead to this form of failure include idiopathic cardiomyopathy, viral cardiomyopathy, and ischemic cardiomyopathy.
The present invention pertains to a non-pharmacological, passive apparatus and method for the treatment of a failing heart. The device is configured to reduce the tension in the heart wall. It is believed to reverse, stop or slow the disease process of a failing heart as it reduces the energy consumption of the failing heart, decreases isovolumetric contraction, increases isotonic contraction (sarcomere shortening), which in turn increases stroke volume. The device reduces wall tension during diastole and systole.
Those apparatus of the present invention which reduce heart wall stress by changing chamber wall geometry can be referred to as "splints". Splints can be grouped as either "full cycle splints" which engage the heart to produce a chamber shape change throughout the cardiac cycle, or "restrictive splints" which do not engage the heart wall at end systole to produce a chamber shape change.
FIG. 18 is a vertical cross-section of the heart of FIG. 17 showing the splint of FIG. 1 drawing the scar tissue toward the opposite wall of the left ventricle;
Those apparatus of the present invention which reduce heart wall stress by changing chamber wall geometry can be referred to as "splints". "Full cycle splints" engage the heart to produce a chamber shape change throughout the cardiac cycle. "Restrictive splints" do not engage the heart wall at end systole to produce a chamber shape change.
FIG. 13 is a vertical cross sectional view of left ventricle 10 of heart 14. A splint 50 is shown disposed on heart 14. Splint 50 includes a compression member 52 shown extending through left ventricle 10. Opposite ends of compression member 52 are disposed exterior to left ventricle 10. Lever members 54 extend from each end of compression member 52 upwardly along the exterior surface of ventricle 10. A tension member 56 extends between lever members 54 to bias lever members 54 toward heart 14 to compress chamber 10. Compression member 52 should be substantially rigid, but lever members 54 and to some degree compression member 52 should be flexible enough to allow tension member 56 to bias lever members 54 toward heart 14. Alternately, lever members 54 could be hinged to compression member 52 such that lever members 54 could pivot about the hinge when biased toward heart 14 by tension member 56.
FIG. 15 is a vertical cross sectional view of left ventricle 10 of heart 14. An alternate embodiment 250 of the splint is shown on heart 14. A preferably relatively rigid frame member 256 extends through ventricle 10. Disposed on opposite ends of frame 256 are cantilever member 254. Disposed on cantilever members 254 are atraumatic pads 258. Cantilever members 254 can be positioned along frame member 256 such that atraumatic pads 258 press against heart 14 to compress chamber 10. FIG. 16 is an end view of frame member 256 showing cantilever members 254 and pads 258.
FIG. 19 is a vertical cross-sectional view of left ventricle 10 and left atrium 22 of heart 14 in which a splint 16 has been placed. As shown in FIG. 9, splint 16 includes an alternative anchor 26. The anchor 20 is preferably an elongate member having a length as shown in FIG. 9 substantially greater than its width (not shown). Anchor bar 26 might be used to reduce the radius or cross-sectional area of the left ventricle in an instance where there is generalized enlargement of left ventricle 10 such as in idiopathic dilated cardiomyopathy. In such an instance, bar anchor 26 can distribute forces more widely than anchor 20.
FIG. 24 is a cross sectional view of an alternate embodiment of anchor pad 340 in accordance with the present invention. Anchor pad 340 preferably includes a disc shaped pad portion 342. Disc shape pad portion 342 includes side 343, which in use is disposed toward the heart. A conical aperture 348 having sloping sides 346 extends through pad 342. Collet 344 is disposed within orifice 348. A threaded portion 350 of collet 344 extends from orifice 348 opposite side 343, nut 352 is threaded over threaded portion 350. Lumen 345 extends through collet 344. A tension member 354 is shown extending through lumen 345. Lumen 345 has a diameter such that when nut 352 is not tightened on threaded portion 350, tension member 354 can slide freely through lumen 345. When nut 352 is tightened, it draws collet 344 away from side 343. Collet 344 is then pinched between walls 346 of orifice 348. When collet 344 is pinched, the size of lumen 345 is reduced such that tension member 354 can no longer move freely within lumen 345, fixing the position of pad 340 on tension member 354.
FIG. 25 is a cross sectional view of an alternate embodiment an anchor pad 360 in accordance with the present invention. Anchor pad 360 includes a generally disc-shaped pad portion 362. Pad 362 includes a side 363 which when the pad is in use, is disposed toward the heart. A tension member lumen 364 extends through pad 362. Lumen 364 preferably has a generally conical shaped portion 365 disposed toward side 363. Tension member 370 is shown disposed through lumen 364 in FIG. 25. Pad 362 includes a threaded passage 366 extending from an edge of pad 362 to lumen 364. A set screw 368 is threaded into passage 366. Set screw 368 can be tightened to engage tension member 370 to fix the position of anchor pad 360. When set screw 368 is not tightened, the size of lumen 364 is preferably large enough that anchor pad 360 can slide relatively freely over tension member 370.
As shown in FIG. 26, tension member 392 is clamped between cantilever members 387 such that the location of pad 382 is fixed along tension member 392. Pad 382 can be released by using a spreading device 396 to spread cantilever members 387 apart. Spreading device 396 includes handle 398 to spreading arms 400 each having a finger 402. Fingers 402 can be placed within aperture 394 then arms 400 and fingers 402 can be spread apart by pivoting them around a pin 404 such that cantilevers 387 are spread apart and pad 382 can move freely along tension member 392. It can be appreciated that although spreader 396 is shown extending transversely from tension member 392, it could also be configured such that fingers 402 do not curve transversely from arms 400 and thus spreader 396 could be disposed parallel to tension member 392. This would be particularly desirable in a situation where anchor pad 380 was being placed through a port or window during a less invasive splint implantation procedure. It can be appreciated that cantilever members 387 can be held apart such that pad 380 can be moved along tension member 392 by placement of a temporary wedge or pin in groove 388. For example, grooves 388 may include an additional small aperture disposed between aperture 390 and aperture 394 into which a pin could be placed to hold open members 387. When it is desired to fix the position of anchor pad 380 on tension member 392, device 396 could be used to spread cantilever members 387 to remove the pin. The cantilever members could then be released to engage tension member 392. Aperture 390 of pad 380 can also include a conical portion disposed toward side 383 such as conical portion 365 of pad 360.
FIG. 28 is a cross sectional view of an alternate embodiment 420 of a tension member cutter. Device 420 includes an elongate outer tube 422 having a distal end 424. Tube 422 defines a lumen 423 through which extends a second tube 430 having a distal end 428. Extending distally from distal end 428 are two cutting arms 422 and 426 which are shown partially withdrawn into lumen 423 and transversely restrained by distal end 422 of outer tube 422. When unrestrained by distal end 424, arms 424 and 426 are biased apart. Each arm 426 and 426 has a cutting element 425 and 427, respectively. Elements 425 and 427 are shown in contact with each other in FIG. 28. A tension member 370 extends between arms 426 and through lumen 432 of inner tube 430. A representative anchor pad 360 is disposed adjacent elements 425 and 427. Device 420 of FIG. 28 is particularly useful when trimming excess tension member using less invasive techniques as it can be readily advanced over a tension member through a port or window trocar.
FIG. 30 illustrates yet another alternative approach to securing the anchors or anchor pads to the heart surface. FIG. 30 is a cross sectional view of an anchor pad 340 disposed on heart A. Anchor pad 340 is disposed within an envelope 446. Envelope 446 includes a bottom layer 447 disposed between anchor pad 340 and heart A and a top layer 448 disposed on the opposite side of anchor pad 340. Layers 447 and 448 are held together by sutures 449. Bottom layer 447 is preferably a mesh or expanded PTFE which has a pore size or intranodial dimension sufficient to promote tissue ingrowth. The pore size is preferably between about 10 and about 100 microns and more preferably, between about 20 and about 40 microns. With respect to expanded PTFE, the intranodial dimension is preferably between about 10 to about 100 microns and more preferably between about 20 to about 40 microns. The top material could also be expanded PTFE or the like having a pore size which preferably does not promote ingrowth and thus resists adhesion to surrounding tissue. As an alternative embodiment, the pores could be formed directly in the pad surface.
The tension member, in a preferred embodiment, articulates with respect to the anchor pad to reduce bending of the tension member at the pad. This can be accomplished by a ball and socket joint shown in FIG. 22, for example. The tension member itself can be made more flexible or bendable by providing a multi-filament tension member such as a braided or twisted wire cable tension member. A multifiber filament structure of numerous smaller wires can bend easily, while reducing the stress level on any individual wire as compared to a solid wire of the same diameter as the multifilament bundle. Such a multi-filament tension member can be made from biocompatible materials such as, but not limited to, stainless steel, Nitinol, titanium alloys, LCP (liquid crystal polymer), Spectra™ fiber, kevlar fiber, or carbon fiber. In a preferred embodiment, the multi-filament structure is coated or covered to substantially seal the multi-filament structure. Coatings such as silicone, urethane or PTFE are preferred.
The tension member is preferably flexible enough to allow for changing interface conditions between the heart and the splint, and alternating pad orientation throughout the cardiac cycle. The flexibility should be sufficient enough to avoid injury to the heart or bleeding. It is also preferable that if the heart were to contract sufficiently enough to put the tension member in compression that it would readily buckle. Buckling could be promoted by providing a ribbon shaped tension member, chain link tension member, thin wire tension member, bent tension member or multi-filament tension.
The tension member is preferably radiopaque, echo cardiographic compatible, or MRI compatible or includes a marker which is radiopaque, echo compatible, or MRI compatible. The preferred locations for markers would include the center of the tension member and at the ends of the tension member disposed at the heart walls. The radiopaque markers could be gold or platinum or other biocompatible metal or heavy metal filled polymeric sleeves. With respect to echo compatible or MRJ compatible tension members or markers, the tension or marker are preferably non-interfering or visible. Having radiopaque echo compatible or MRI compatible tension members or markers is particularly desirable for follow-up, non-invasive monitoring of the tension member after implantation. The presence of the tension member can be visualized and the distance between two or more markers measured. Integrity of the tension member can be confirmed as well.
In use, the various embodiments of the present invention are placed in or adjacent the human heart to reduce the radius or cross-section area of at least one chamber of the heart. This is done to reduce wall stress or tension in the heart or chamber wall to slow, stop or reverse failure of the heart. In the case of the splint 16 shown in FIG. 1, a cannula can be used to pierce both walls of the heart and one end of the splint can be advanced through the cannula from one side of the heart to the opposite side where an anchor can be affixed or deployed. Likewise, an anchor is affixed or deployed at the opposite end of splint 16. Additional methods for splint placement are described in more detail in U.S. application Ser. No. 09/123,977, filed on date even herewith and entitled "Transventricular Implant Tools and Devices" and incorporated herein by reference.
It can be appreciated that the methods described above to advance the tension members through the ventricles can be repeated to advance the desired number of tension members through the ventricle for a particular configuration. The length of the tension members can be determined based upon the size and condition of the patients heart. It should also be noted that although the left ventricle has been referred to here for illustrative purposes, that the apparatus and methods of this invention can also be used to splint multiple chambers of a patients heart as well as the right ventricle or either atrium.
FIG. 35 is a schematic view of generally horizontal cross section of heart A including left ventricle B and right ventricle C. Also shown are left anterior descending artery E, posterior descending artery F, obtuse marginal artery G, postero-medial papillary muscle H and antero-lateral papillary muscle I. Shown in FIG. 35 are three generally horizontal preferred alignments for tension member placement for the splints of the present invention. These alignments generally met three goals of splint positioning including good bisection of the left ventricle, avoidance of major coronary vessels and avoidance of valve apparatus including chordae leaflets and papillary muscles. Alignment 420 can be referred to as the anterior/posterior (AP) position. Alignment 422 can be referred as the posterior septal/lateral wall (PSL) position. Alignment 424 can be referred to as the anterior septal/lateral wall (ASL) position.
It can be appreciated that the alignments shown illustrative only and that the alignments may be shifted or rotated about a vertical axis generally disposed through the left ventricle and still avoid the major coronary vessels and papillary muscles. When the alignment passes through a substantial portion of right ventricle C, it may be desirable to dispose not only two pads on the exterior of the heart at opposite ends of a tension member, but also a third pad within right ventricle C on septum J. The spacing between the third pad and the pad disposed outside the heart proximate left ventricle B preferably defines the shape change of left ventricle B. This will allow the spacing of the third pad relative to the pad disposed outside the heart proximate right ventricle C to define a shape change if any of right ventricle C in view of the spacing between those pads. With the alignments as shown in FIG. 35, the third pad will be unnecessary. It is likely, however, that with alignments 422 and 424 in order to achieve the desired shape change of left ventricle B, the exterior pad of the wall proximate the right ventricle C will be drawn into contact with septum J. This will consequently somewhat reduce the volume of right ventricle C.
A2 =2π(R2)2 (l-θ-/2π)+hl
Where chamber 48 is unsplinted as shown in FIG. 36 A1, the original cross-sectional area of the cylinder is equal to A2 where 0=180°, h=0 and l=2R2. Volume equals A2 times length L and circumferential wall tension equals pressure within the chamber times R2 times the length L of the chamber.
When a splint is actually placed on the heart, along an alignment such as those shown in FIG. 35, the length l between the two pads as measured along the tension member is preferably 0.4 to about 0.8 and more preferably between about 0.5 to about 0.7 and most preferably about 0.6 times the distance along the length of the tension member at end diastole if the pads were not secured to the tension member and provided no resistance to expansion of the heart. A more detailed discussion of tension member length can be found in U.S. application Ser. No. 09/123,977, filed on date even herewith and entitled "Transventricular Implant Tools and Devices" which is incorporated herein by reference.
1 "Congestive Heart Failure in the United States: A New Epidemic" Data Fact Sheet, National Heart, Lung, and Blood Institute, National Institutes of Health, Dec. 09, 1996, pp. 1-6.
2 "Reversible Cardiomyopathy", Thoratec's Heartbeat, vol. 10.2, Aug. 1996, 4 pages.
3 A. Boyd et al., "Tricuspid Annulopathy", The Journal of Thoracic and Cardiovascular Surgery, vol. 68, No. 3, Sep. 1974, 8 pages.
4 * A. Boyd et al., Tricuspid Annulopathy , The Journal of Thoracic and Cardiovascular Surgery, vol. 68, No. 3, Sep. 1974, 8 pages.
5 A. Carpentier and J.C. Chachques, "Myocardial Substitution with a Stimulated Skeletal Muscle: First Successful Clinical Case", Letter to the Editor, p. 1267, Sep. 25, 1996.
6 * A. Carpentier and J.C. Chachques, Myocardial Substitution with a Stimulated Skeletal Muscle: First Successful Clinical Case , Letter to the Editor, p. 1267, Sep. 25, 1996.
7 * ABIOMED, Inc. Annual Report 1996, 32 pages.
8 Brochure entitled "Thoracic Ventricular Assist Device System-Because Heart Patients Come in All Sizes", date even with or prior to Jan. 2, 1997, 5 pages.
9 * Brochure entitled Thoracic Ventricular Assist Device System Because Heart Patients Come in All Sizes , date even with or prior to Jan. 2, 1997, 5 pages.
10 C. Burnett et al., "Improved Survival After Hemopump Insertion in Patients Experience Postcardiotomy Cardiogenic Shock During Cardiopulmonary Bypass", From the Section of Transplantation, Division of Cardiovascular Surgery, Texas Heart Institute and St. Luke's Episcopal Hospital, Houston, Texas, date even with or prior to Jan. 2, 1997, pp. 626-628.
11 * C. Burnett et al., Improved Survival After Hemopump Insertion in Patients Experience Postcardiotomy Cardiogenic Shock During Cardiopulmonary Bypass , From the Section of Transplantation, Division of Cardiovascular Surgery, Texas Heart Institute and St. Luke s Episcopal Hospital, Houston, Texas, date even with or prior to Jan. 2, 1997, pp. 626 628.
12 C. David Ianuzzo et al., "Preconditioning of Skeletal Muscle: Application to Dynamic Cardiomyoplasty", Invited Commentary, J. Card. Surg., 1996:109-110.
13 C. David Ianuzzo et al., "Preservation of the Latissimus Dorsi Muscle During Cardiomyoplasty Surgery", J. Card. Surg., 1996:11:99-108.
14 * C. David Ianuzzo et al., Preconditioning of Skeletal Muscle: Application to Dynamic Cardiomyoplasty , Invited Commentary, J. Card. Surg., 1996:109 110.
15 * C. David Ianuzzo et al., Preservation of the Latissimus Dorsi Muscle During Cardiomyoplasty Surgery , J. Card. Surg., 1996:11:99 108.
16 C. Lucas et al., "Long-Term Follow-Up (12 to 35 Weeks) After Dynamic Cardiomyoplasty", JACC, vol. 22, No. 3, Sep. 1993: 758-67.
17 * C. Lucas et al., Long Term Follow Up (12 to 35 Weeks) After Dynamic Cardiomyoplasty , JACC, vol. 22, No. 3, Sep. 1993: 758 67.
18 C. Pitarys II et al., "Long-Term Effects of Excision of the Mitral Apparatus . . . ", JACC, vol. 15, No. 3, Mar. 1, 1990:557-63.
19 * C. Pitarys II et al., Long Term Effects of Excision of the Mitral Apparatus . . . , JACC, vol. 15, No. 3, Mar. 1, 1990:557 63.
20 C. Tsai et al., "Surface Modifying Additives for Improved Device-Blood Compatibility", ASAIO Journal, 1994, pp. 619-624.
21 * C. Tsai et al., Surface Modifying Additives for Improved Device Blood Compatibility , ASAIO Journal, 1994, pp. 619 624.
22 * Congestive Heart Failure in the United States: A New Epidemic Data Fact Sheet, National Heart, Lung, and Blood Institute, National Institutes of Health, Dec. 09, 1996, pp. 1 6.
23 Cox, "Left Ventricular Aneurysms: Pathophysiologic Observations and Standard Resection," Seminars in Thoracic and Cardiovascular Surgery, vol. 9, No. 2, Apr. 1997, pp. 113-122.
24 * Cox, Left Ventricular Aneurysms: Pathophysiologic Observations and Standard Resection, Seminars in Thoracic and Cardiovascular Surgery, vol. 9, No. 2, Apr. 1997, pp. 113 122.
25 D. Bach et al., "Early Improvement in Congestive Heart Failure After Correction of Secondary Mitral Regurgitation in End-Stage Cardiomyopathy", American Heart Journal, vol. 129, No. 6, Jun. 1995, 6 pages.
26 * D. Bach et al., Early Improvement in Congestive Heart Failure After Correction of Secondary Mitral Regurgitation in End Stage Cardiomyopathy , American Heart Journal, vol. 129, No. 6, Jun. 1995, 6 pages.
27 D. Farrar et al., "A New Skeletal Muscle Linear-Pull Energy Convertor as a Power Source for Prosthetic Support Devices", The Journal of Heart & Lung Transplantation, vol. 11, No. 5, Sep., 1992, pp. 341-349.
28 * D. Farrar et al., A New Skeletal Muscle Linear Pull Energy Convertor as a Power Source for Prosthetic Support Devices , The Journal of Heart & Lung Transplantation, vol. 11, No. 5, Sep., 1992, pp. 341 349.
29 Doty, M.D. et al., "Septation of the univentricular heart," The Journal of Thoracic and Cardiovascular Surgery, vol. 78, No. 3, Sep. 1979, pp. 423-430.
30 * Doty, M.D. et al., Septation of the univentricular heart, The Journal of Thoracic and Cardiovascular Surgery, vol. 78, No. 3, Sep. 1979, pp. 423 430.
31 E. Bocchi et al., "Clinical Outcome after Surgical Remodeling of Left Ventricle in Candidates to Heart Transplantation with Idiopathic Dilated Cardiomyopathy-Short Term Results", date even with or prior to Jan. 2, 1997, 1 page.
32 * E. Bocchi et al., Clinical Outcome after Surgical Remodeling of Left Ventricle in Candidates to Heart Transplantation with Idiopathic Dilated Cardiomyopathy Short Term Results , date even with or prior to Jan. 2, 1997, 1 page.
33 Edie, M.D. et al., "Surgical repair of single ventricle," The Journal of Thoracic and Cardiovascular Surgery, vol. 66, No. 3, Sep. 1973, pp. 350-360.
34 * Edie, M.D. et al., Surgical repair of single ventricle, The Journal of Thoracic and Cardiovascular Surgery, vol. 66, No. 3, Sep. 1973, pp. 350 360.
35 Feldt, M.D. et al., "Current status of the septation procedure for univentricular heart," The Journal of Thoracic and Cardiovascular Surgery, vol. 82, No. 1, Jul. 1981, pp. 93-97.
36 * Feldt, M.D. et al., Current status of the septation procedure for univentricular heart, The Journal of Thoracic and Cardiovascular Surgery, vol. 82, No. 1, Jul. 1981, pp. 93 97.
37 G. Bearnson et al., "Development of a Prototype Magnetically Suspended Rotor Ventricular Assist Device", ASAIO Journal, 1996, pp. 275-280.
38 * G. Bearnson et al., Development of a Prototype Magnetically Suspended Rotor Ventricular Assist Device , ASAIO Journal, 1996, pp. 275 280.
39 G. Deeb et al., "Clinical Experience with the Nimbus Pump", From the University of Michigan Medical Center Section of Thoracic Surgery and Division of Cardiology, Ann Arbor, Michigan, date even with or prior to Jan. 2, 1997, pp. 632-636.
40 * G. Deeb et al., Clinical Experience with the Nimbus Pump , From the University of Michigan Medical Center Section of Thoracic Surgery and Division of Cardiology, Ann Arbor, Michigan, date even with or prior to Jan. 2, 1997, pp. 632 636.
41 G. Schuler et al., "Temporal Response of Left Ventricular Performance to Mitral Valve Surgery", Circulation, vol. 59, No. 6, Jun. 1979, 1218-1231.
42 * G. Schuler et al., Temporal Response of Left Ventricular Performance to Mitral Valve Surgery , Circulation, vol. 59, No. 6, Jun. 1979, 1218 1231.
43 H. Huikuri, "Effect of Mitral Valve Replacement on Left Ventricular Function in Mitral Regurgitation", Br. Heart Journal, 1983; 49;328-33.
44 * H. Huikuri, Effect of Mitral Valve Replacement on Left Ventricular Function in Mitral Regurgitation , Br. Heart Journal, 1983; 49;328 33.
45 J. Chapman et al., "Adjustable Annuloplasty for Tricuspid Insufficiency", The Annals of Thoracic Surgery, vol. 46, No. 3, Sep. 1988, 2 pages.
46 * J. Chapman et al., Adjustable Annuloplasty for Tricuspid Insufficiency , The Annals of Thoracic Surgery, vol. 46, No. 3, Sep. 1988, 2 pages.
47 J.C. Chachques et al., "Latissimus Dorsi Dynamic Cardiomyoplasty", Ann. Thorae. Surg., 1989:47:600-604.
48 * J.C. Chachques et al., Latissimus Dorsi Dynamic Cardiomyoplasty , Ann. Thorae. Surg., 1989:47:600 604.
49 L. Moreira et al., "Latissimus Dorsi Cardiomyoplasty in the Treatment of Patients with Dilated Cardiomyopathy", Supplement IV Circulation, Sep. 25, 1996, 7 pgs.
50 * L. Moreira et al., Latissimus Dorsi Cardiomyoplasty in the Treatment of Patients with Dilated Cardiomyopathy , Supplement IV Circulation, Sep. 25, 1996, 7 pgs.
51 Lev M.D. et al., "Single (Primitive) Ventricle," Circulation, vol. 39, May 1969, pp. 577-591.
52 * Lev M.D. et al., Single (Primitive) Ventricle, Circulation, vol. 39, May 1969, pp. 577 591.
53 M. Dickstein et al., "Heart Reduction Surgery: An Analysis of the Impact on Cardiac Function", The Journal of Thoracic and Cardiovascular Surgery, vol. 113, No. 6, Jun. 1997, 9 pages.
54 * M. Dickstein et al., Heart Reduction Surgery: An Analysis of the Impact on Cardiac Function , The Journal of Thoracic and Cardiovascular Surgery, vol. 113, No. 6, Jun. 1997, 9 pages.
55 M. Oe et al., "Effects of Preserving Mitral Apparatus on Ventricular Systolic Function in Mitral Valve Operations in Dogs", The Journal of Thoracic and Cardiovascular Surgery, vol. 106, No. 6, Dec. 1993, 9 pages.
56 * M. Oe et al., Effects of Preserving Mitral Apparatus on Ventricular Systolic Function in Mitral Valve Operations in Dogs , The Journal of Thoracic and Cardiovascular Surgery, vol. 106, No. 6, Dec. 1993, 9 pages.
57 McGoon, M.D. et al., "Correction of the univentricular heart having two atrioventricular valves," The Journal of Thoracic and Cardiovascular Surgery, vol. 74, No. 2, Aug. 1977, pp. 218-226.
58 * McGoon, M.D. et al., Correction of the univentricular heart having two atrioventricular valves, The Journal of Thoracic and Cardiovascular Surgery, vol. 74, No. 2, Aug. 1977, pp. 218 226.
59 * Medtronic, Inc. 1996 Annual Shareholders Report, 79 pages.
60 Melvin, "Ventricular Radius Reduction Without Resection: A Computational Analysis," ASAIO Journal, 45:160-165, 1999.
61 * Melvin, Ventricular Radius Reduction Without Resection: A Computational Analysis, ASAIO Journal, 45:160 165, 1999.
62 N. Sakakibara et al., "A Muscle Powered Cardiac Assist Device for Right Ventricular Support: Total Assist or Partial Assist?", Trans Am Soc Antif Intern Organs, vol. XXXVI, 1990, pp. 372-375.
63 * N. Sakakibara et al., A Muscle Powered Cardiac Assist Device for Right Ventricular Support: Total Assist or Partial Assist , Trans Am Soc Antif Intern Organs, vol. XXXVI, 1990, pp. 372 375.
64 P. Kurlansky et al., "Adjustable Annuloplasty for Tricuspid Insufficiency", The Annals of Thorac. Surg., 44:404-406, Oct. 1987, 3 pages.
65 * P. Kurlansky et al., Adjustable Annuloplasty for Tricuspid Insufficiency , The Annals of Thorac. Surg., 44:404 406, Oct. 1987, 3 pages.
66 P. McCarthy et al., "Clinical Experience with the Novacor Ventricular Assist System", J. Thorac. Cardiovasc Surg., 1991:102:578-87.
67 P. McCarthy et al., "Early Results with Partial Left Ventriculectomy", From the Dept. of Thoracic and Cardiovascular Cardiology Surgery, and Transplant Center, Cleveland Clinic Foundation, Presented at the 77th Annual Meeting of the American Association of Thoracic Surgeons, May 1997, 33 pages.
68 * P. McCarthy et al., Clinical Experience with the Novacor Ventricular Assist System , J. Thorac. Cardiovasc Surg., 1991:102:578 87.
69 * P. McCarthy et al., Early Results with Partial Left Ventriculectomy , From the Dept. of Thoracic and Cardiovascular Cardiology Surgery, and Transplant Center, Cleveland Clinic Foundation, Presented at the 77 th Annual Meeting of the American Association of Thoracic Surgeons, May 1997, 33 pages.
70 Press Release dated Apr. 27, 1995, "ABIOMED Temporary Artificial Heart System Reaches 1,000 Patient Milestones, BVS-5000 in More Than 100 U.S. Medical Centers", 1 page.
71 * Press Release dated Apr. 27, 1995, ABIOMED Temporary Artificial Heart System Reaches 1,000 Patient Milestones, BVS 5000 in More Than 100 U.S. Medical Centers , 1 page.
72 Press Release dated Aug. 11, 1995, "ABIOMED Receives Grant from NIH to Develop Disposable Bearingless Centrifugal Blood Pump", 1 page.
73 * Press Release dated Aug. 11, 1995, ABIOMED Receives Grant from NIH to Develop Disposable Bearingless Centrifugal Blood Pump , 1 page.
74 Press Release dated Aug. 25, 1996, "ABIOMED Wins Research Grant from NIH to Develop Suturing Instrument for Abdominal Surgery", 1 page.
75 * Press Release dated Aug. 25, 1996, ABIOMED Wins Research Grant from NIH to Develop Suturing Instrument for Abdominal Surgery , 1 page.
76 Press Release dated Jun. 9, 1995, "ABIOMED Receives Grant from National Institutes of Health to Develop a Laser Welding Technique for Tissue Repair", 1 page.
77 * Press Release dated Jun. 9, 1995, ABIOMED Receives Grant from National Institutes of Health to Develop a Laser Welding Technique for Tissue Repair , 1 page.
78 Press Release dated May 17, 1996, "ABIOMED Receives FDA Approval to Expand Indications for Use of Cardiac Assist System", 1 page.
79 * Press Release dated May 17, 1996, ABIOMED Receives FDA Approval to Expand Indications for Use of Cardiac Assist System , 1 page.
80 Press Release dated Oct. 3, 1994, "Heartmate System Becomes First Implantable Cardiac-Assist Device to be Approved for Commercial Sale in the U.S.", 2 pages.
81 * Press Release dated Oct. 3, 1994, Heartmate System Becomes First Implantable Cardiac Assist Device to be Approved for Commercial Sale in the U.S. , 2 pages.
82 Press Release dated Oct. 3, 1995, "ABIOMED Wins $4.35 Million Contract from the National Heart, Lung and Blood Institutes to Develop Implantable Heart Booster", 1 page.
83 * Press Release dated Oct. 3, 1995, ABIOMED Wins $4.35 Million Contract from the National Heart, Lung and Blood Institutes to Develop Implantable Heart Booster , 1 page.
84 Press Release dated Sep. 16, 1996, "ABIOMED Wins $8.5 Million Federal Contract to Qualify its Artificial Heart for Human Trials", 5 pages.
85 * Press Release dated Sep. 16, 1996, ABIOMED Wins $8.5 Million Federal Contract to Qualify its Artificial Heart for Human Trials , 5 pages.
86 Press Release dated Sep. 26, 1996, "ABIOMED's Temporary Artificial Heart System Reaches 200 U.S. Medical Center Milestone", 1 page.
87 * Press Release dated Sep. 26, 1996, ABIOMED s Temporary Artificial Heart System Reaches 200 U.S. Medical Center Milestone , 1 page.
88 Press Release dated Sep. 29, 1995, "ABIOMED Wins NIH Grant to Develop Calcification-Resistant Plastic Heart Valve", 1 page.
89 * Press Release dated Sep. 29, 1995, ABIOMED Wins NIH Grant to Develop Calcification Resistant Plastic Heart Valve , 1 page.
90 R. Batista et al., "Partial Left Ventriculectomy to Improve Left Ventricular Function in Eng-Stage Heart Disease", J. Card. Surg., 1996:11:96-98.
91 * R. Batista et al., Partial Left Ventriculectomy to Improve Left Ventricular Function in Eng Stage Heart Disease , J. Card. Surg., 1996:11:96 98.
92 R. Kormos et al., "Experience with Univentricular Support in Mortally III Cardiac Transplant Candidates", Ann. Thorac. Surg., 1990:49:261-71.
93 * R. Kormos et al., Experience with Univentricular Support in Mortally III Cardiac Transplant Candidates , Ann. Thorac. Surg., 1990:49:261 71.
94 R. Wampler et al., "Treatment of Cardiogenic Shock with the Hemopump Left Ventricular Assist Device", Ann. Thorac. Surg., 1991:52-506-13.
95 * R. Wampler et al., Treatment of Cardiogenic Shock with the Hemopump Left Ventricular Assist Device , Ann. Thorac. Surg., 1991:52 506 13.
96 * Reversible Cardiomyopathy , Thoratec s Heartbeat, vol. 10.2, Aug. 1996, 4 pages.
97 S. Bolling et al., "Surgery for Acquired Heart Disease", The Journal of Thoracic and Cardiovascular Surgery, vol. 109, No. 4, Apr. 1995, 8 pages.
98 * S. Bolling et al., Surgery for Acquired Heart Disease , The Journal of Thoracic and Cardiovascular Surgery, vol. 109, No. 4, Apr. 1995, 8 pages.
99 S. Phillips et al., "Hemopump Support for the Failing Heart", From the Department of Cardiovascular Medicine and Surgery, Mercy Hospital Medical Center, Des Moines, Iowa, date even with or prior to Jan. 2, 1997, pp. 629-631.
100 * S. Phillips et al., Hemopump Support for the Failing Heart , From the Department of Cardiovascular Medicine and Surgery, Mercy Hospital Medical Center, Des Moines, Iowa, date even with or prior to Jan. 2, 1997, pp. 629 631.
101 Savage, M.D. et al., "Repair of left ventricular aneurysm," The Journal of Thoracic and Cardiovascular Surgery, vol. 104, No. 3, Sep. 1992, pp. 752-762.
102 * Savage, M.D. et al., Repair of left ventricular aneurysm, The Journal of Thoracic and Cardiovascular Surgery, vol. 104, No. 3, Sep. 1992, pp. 752 762.
103 Schumacker, Jr., "Cardiac Aneurysms," The Evolution of Cardiac Surgery, 1992, pp. 159-165.
104 * Schumacker, Jr., Cardiac Aneurysms, The Evolution of Cardiac Surgery, 1992, pp. 159 165.
105 Westaby, "Landmarks in Cardiac Surgery," Surgery of left ventricular aneurysm, 1997, pp. 198-199.
106 * Westaby, Landmarks in Cardiac Surgery, Surgery of left ventricular aneurysm, 1997, pp. 198 199.
US6475169 * Jan 2, 2001 Nov 5, 2002 Micrus Corporation Micro-strand cable with enhanced radiopacity
US7374546 * Jan 29, 2004 May 20, 2008 Roche Diagnostics Operations, Inc. Integrated lancing test strip
US7771482 * May 9, 2000 Aug 10, 2010 Ben-Zion Karmon Method for tissue expansion and regeneration using bioresorbable inflatable devices
US7877142 * Jul 3, 2007 Jan 25, 2011 Micardia Corporation Methods and systems for cardiac remodeling via resynchronization
US7883538 * Sep 20, 2005 Feb 8, 2011 Guided Delivery Systems Inc. Methods and devices for termination
US8007514 * Oct 17, 2003 Aug 30, 2011 St. Jude Medical Puerto Rico Llc Automatic suture locking device
US8226654 * Dec 4, 2008 Jul 24, 2012 Aeton Medical Llc Trocar-tipped drill bit
US8506474 * Aug 21, 2006 Aug 13, 2013 Bioventrix, Inc. Method and device for treating dysfunctional cardiac tissue
US8777949 Jun 25, 2012 Jul 15, 2014 Aeton Medical, LLC Trocar-tipped drill bit
US9173711 * Sep 30, 2012 Nov 3, 2015 Bioventrix, Inc. Cardiac implant migration inhibiting systems
US9277994 * May 4, 2010 Mar 8, 2016 Valtech Cardio, Ltd. Implantation of repair chords in the heart
US20040122503 * Dec 20, 2002 Jun 24, 2004 Campbell Carey V. Implantable medical device assembly
US20050085855 * Oct 17, 2003 Apr 21, 2005 Forsberg Andrew T. Automatic suture locking device
US20090177266 * Mar 5, 2009 Jul 9, 2009 Powell Ferolyn T Methods, systems and devices for cardiac valve repair
US20100145341 * Dec 4, 2008 Jun 10, 2010 Ranck Roger S Trocar-tipped drill bit
US20130090672 * Sep 30, 2012 Apr 11, 2013 Bioventrix, Inc. Cardiac implant migration inhibiting systems
US20140094903 * May 4, 2010 Apr 3, 2014 Valtech Cardio, Ltd. Implantation of repair chords in the heart
US20150011821 * Dec 21, 2012 Jan 8, 2015 The Trustees Of The University Of Pennsylania Mechanical myocardial restraint device
US20170156865 * Nov 2, 2016 Jun 8, 2017 Bioventrix, Inc. Treating dysfunctional cardiac tissue
WO2003026483A2 * Sep 25, 2002 Apr 3, 2003 The Foundry, Inc. Ventricular infarct assist device and methods for using it
WO2003026483A3 * Sep 25, 2002 Jul 10, 2003 Bernard H Andreas Ventricular infarct assist device and methods for using it
WO2004058047A2 * Dec 16, 2003 Jul 15, 2004 Gore Enterprise Holdings, Inc. Implantable medical device assembly
WO2004058047A3 * Dec 16, 2003 Feb 17, 2005 Gore Enterprise Holdings Inc Implantable medical device assembly
U.S. Classification 600/16, 600/37, 128/898
International Classification A61N1/362, A61F2/02, A61M31/00, A61B17/06, A61B17/00, A61B17/12, A61B17/04, A61B19/00, A61B17/122, A61F2/00
Cooperative Classification A61F2/2487, A61B2017/0445, A61B2017/0454, A61B2017/0496, A61B2017/0435, A61B2017/0417, A61B2017/0464, A61B2017/0404, A61B2017/0446, A61F2/2481, A61B17/06166, A61B17/1227, A61B17/0487, A61B17/00234, A61B2017/0461, A61B2017/00243, A61B17/0401, A61B17/00491, A61B2017/048, A61B2017/0458, A61B90/39
European Classification A61F2/24W4, A61B17/06S, A61B17/00E
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SCHWEICH, CYRIL J.;MORTIER, TODD J.;VIDLUND, ROBERT M.;AND OTHERS;REEL/FRAME:009656/0937