Lau, Lilip (Los Altos, CA, US)
Hong, James (Palo Alto, CA, US)
Fishler, Matthew (Sunnyvale, CA, US)
Mar, Craig (Fremont, CA, US)
Meyer, Steven (Oakland, CA, US)

Plaque It! Sponsored by: Flash of Genius

10/888806

11/06/2007

07/08/2004

Images are available in PDF form when logged in. To view PDFs, Login  or  Create Account (Free!)

View patents that cite this patent

Click for automatic bibliography generation

Paracor Medical, Inc. (Sunnyvale, CA, US)

600/37

600/16

A61F13/00

602/75-76, 601/148, 600/37, 600/16-18, 623/3.16-3.17, 623/3.26, 623/3.1, 602/36-37, 601/151-153, 623/3.11-3.12

2826193	Cardiac resuscitation device	March, 1958	Vineberg
3464322	DEFORMABLE DIAPHRAGM	September, 1969	Pequignot
3513836	PROSTHESIS FOR CARDIAC ASSISTANCE	May, 1970	Sausse
3587567		June, 1971	Schiff
3613672	MECHANICAL VENTRICULAR ASSISTANCE CUP	October, 1971	Schiff
3966401	Preparing natural tissue for implantation so as to provide improved flexibility	June, 1976	Hancock et al.
3983863	Heart support for coronary artery surgery	October, 1976	Janke et al.
3988782	Non-antigenic, non-thrombogenic infection-resistant grafts from umbilical cord vessels and process for preparing and using same	November, 1976	Dardik et al.
4011947	Packaged prosthetic device	March, 1977	Sawyer
4048990	Heart massage apparatus	September, 1977	Goetz
4065816	Surgical method of using a sterile packaged prosthesis	January, 1978	Sawyer
4108161	Graft forming device	August, 1978	Samuels et al.
4192293	Cardiac assist device	March, 1980	Asrican
4211325	Heart valve holder	July, 1980	Wright
4261342	Process for installing mitral valves in their anatomical space by attaching cords to an artificial stent	April, 1981	Aranguren Duo
4306318	Tubular organic prosthesis	December, 1981	Mano et al.
4372293	Apparatus and method for surgical correction of ptotic breasts	February, 1983	Vijil-Rosales
4403604	Gastric pouch	September, 1983	Wilkinson et al.
4428375	Surgical bag for splenorrhaphy	January, 1984	Ellman
4512471	Storage unit	April, 1985	Kaster et al.
4536893	Implant device for substaining the activity of the myocardium	August, 1985	Parravicini
4545783	Rigid medical solution container	October, 1985	Vaughan
4628937	Mapping electrode assembly	December, 1986	Hess et al.
4630597	Dynamic aortic patch for thoracic or abdominal implantation	December, 1986	Kantrowitz et al.
4665906	Medical devices incorporating sim alloy elements	May, 1987	Jervis
4690134	Ventricular assist device	September, 1987	Snyders
4697703	Joint prosthesis package	October, 1987	Will
4750619	Package with tray for securing and presenting a sterile prosthetic implant element	June, 1988	Cohen et al.
4821723	Biphasic waveforms for defibrillation	April, 1989	Baker, Jr. et al.
4827932	Implantable defibrillation electrodes	May, 1989	Ideker et al.
4834707	Venting apparatus and method for cardiovascular pumping application	May, 1989	Evans
4838288	Heart valve and xenograft washing system	June, 1989	Wright et al.
4840626	Heparin-containing adhesion prevention barrier and process	June, 1989	Linsky et al.
4863016	Packaging for a sterilizable calibratable medical device	September, 1989	Fong et al.
4878890	Perihepatic prosthesis	November, 1989	Bilweis
4936857	Prosthetic pericardium	June, 1990	Kulik
4957477	Heart assist jacket and method of using it	September, 1990	Lundbäck
4960424	Method of replacing a defective atrio-ventricular valve with a total atrio-ventricular valve bioprosthesis	October, 1990	Grooters
4973300	Cardiac sling for circumflex coronary artery surgery	November, 1990	Wright
4976730	Artificial pericardium	December, 1990	Kwan-Gett
5031762	Three envelope package for sterile specimens	July, 1991	Heacox
5057117	Method and apparatus for hemostasis and compartmentalization of a bleeding internal bodily organ	October, 1991	Atweh
5067957	Method of inserting medical devices incorporating SIM alloy elements	November, 1991	Jervis
5087243	Myocardial iontophoresis	February, 1992	Avitall
5098369	Biocompatible ventricular assist and arrhythmia control device including cardiac compression pad and compression assembly	March, 1992	Heilman et al.
5106386	Catheter	April, 1992	Isner et al.
5119804	Heart massage apparatus	June, 1992	Anstadt
5131905	External cardiac assist device	July, 1992	Grooters
5150706	Cooling net for cardiac or transplant surgery	September, 1992	Cox et al.
5169381	Ventricular assist device	December, 1992	Snyders
5186711	Hemostasis apparatus and method	February, 1993	Epstein
5190546	Medical devices incorporating SIM alloy elements	March, 1993	Jervis
5192314	Synthetic intraventricular implants and method of inserting	March, 1993	Daskalakis
5197978	Removable heat-recoverable tissue supporting device	March, 1993	Hess
5256132	Cardiac assist envelope for endoscopic application	October, 1993	Snyders
5279539	Drawstring surgical pouch and method of use for preventing ovarian adhesions	January, 1994	Bohan et al.
5290217	Method and apparatus for hernia repair	March, 1994	Campos
5336254	Defibrillation lead employing electrodes fabricated from woven carbon fibers	August, 1994	Brennen et al.
5344442	Cardiac valve	September, 1994	Deac
5352184	Reservoir for enclosing and retrieving body specimens	October, 1994	Goldberg et al.
5356432	Implantable mesh prosthesis and method for repairing muscle or tissue wall defects	October, 1994	Rutkow et al.
5366460	Apparatus and method for laparoscope hernia repair	November, 1994	Eberbach
5383840	Biocompatible ventricular assist and arrhythmia control device including cardiac compression band-stay-pad assembly	January, 1995	Heilman et al.
5385156	Diagnostic and treatment method for cardiac rupture and apparatus for performing the same	January, 1995	Oliva
5385229	Container for the packaging of a hollow endoprosthesis	January, 1995	Bittmann et al.
5385528	Intrapericardial assist device and associated method	January, 1995	Wilk
5405360	Resilient arm mesh deployer	April, 1995	Tovey
5429584	Cardiac assist method and apparatus	July, 1995	Chiu
5433727	Centering buttoned device for the occlusion of large defects for occluding	July, 1995	Sideris
5456711	Warp knitted carotid patch having finished selvedged edges	October, 1995	Hudson
5460962	Peracetic acid sterilization of collagen or collagenous tissue	October, 1995	Kemp
5500015	Cardiac valve	March, 1996	Deac
5507779	Cardiac insulation for defibrillation	April, 1996	Altman
5509428	Method and apparatus for the creation of tricuspid regurgitation	April, 1996	Dunlop
5524633	Self-deploying isolation bag	June, 1996	Heaven et al.
5533958	Intrapericardial assist device and associated method	July, 1996	Wilk
5534024	Intraluminal stenting graft	July, 1996	Rogers et al.
5545210	Method of implanting a permanent shape memory alloy stent	August, 1996	Hess et al.
5558617	Cardiac compression band-stay-pad assembly and method of replacing the same	September, 1996	Heilman et al.
5571215	Devices and methods for intracardiac procedures	November, 1996	Sterman et al.
5582616	Surgical helical fastener with applicator	December, 1996	Bolduc et al.
5584803	System for cardiac procedures	December, 1996	Stevens et al.
5593424	Apparatus and method for reducing and stabilizing the circumference of a vascular structure	January, 1997	Northrup III
5593441	Method for limiting the incidence of postoperative adhesions	January, 1997	Lichtenstein et al.
5597378	Medical devices incorporating SIM alloy elements	January, 1997	Jervis
5603337	Two-stage cardiomyoplasty	February, 1997	Jarvik
5607477	Soft tissue augmentation apparatus	March, 1997	Schindler et al.
5647372	Specimen retrieval pouch and method for use	July, 1997	Tovey et al.
5647380	Method of making a left ventricular assist device	July, 1997	Campbell et al.
5695525	Implantable prosthesis and method and apparatus for loading and delivering an implantable prosthesis	December, 1997	Mulhauser et al.
5702343	Cardiac reinforcement device	December, 1997	Alferness
5713954	Extra cardiac ventricular assist device	February, 1998	Rosenberg et al.
5727569	Surgical devices for imposing a negative pressure to fix the position of cardiac tissue during surgery	March, 1998	Benetti et al.
5749839	Direct mechanical bi-ventricular cardiac assist device	May, 1998	Kovacs
5782746	Local cardiac immobilization surgical device	July, 1998	Wright
5799661	Devices and methods for port-access multivessel coronary artery bypass surgery	September, 1998	Boyd et al.	128/898
5800334	Intrapericardial assist device and associated method	September, 1998	Wilk
5800528	Passive girdle for heart ventricle for therapeutic aid to patients having ventricular dilatation	September, 1998	Lederman et al.
5814097	Devices and methods for intracardiac procedures	September, 1998	Sterman et al.
5824028	Line electrode oriented relative to fiber direction	October, 1998	Knisley
5836311	Method and apparatus for temporarily immobilizing a local area of tissue	November, 1998	Borst et al.
5848962	Device for assisting cardiac function	December, 1998	Feindt et al.
5849005	Method and apparatus for minimizing the risk of air embolism when performing a procedure in a patient's thoracic cavity	December, 1998	Garrison et al.
5853422	Apparatus and method for closing a septal defect	December, 1998	Huebsch et al.
5865791	Atrial appendage stasis reduction procedure and devices	February, 1999	Whayne et al.
5904690	Device or apparatus for manipulating matter	May, 1999	Middleman et al.
5910124	Ventricular assist device and method	June, 1999	Rubin
5927284	Method and apparatus for temporarily immobilizing a local area of tissue	July, 1999	Borst et al.
5948019	Heart valve suturing ring with surface coating to inhibit tissue ingrowth	September, 1999	Shu et al.
5957977	Activation device for the natural heart including internal and external support structures	September, 1999	Melvin
5961440	Heart wall tension reduction apparatus and method	October, 1999	Schweich, Jr. et al.
5976069	Epicardial immobilization device	November, 1999	Navia et al.
5979456	Apparatus and method for reversibly reshaping a body part	November, 1999	Magovern
5984857	Step-down skeletal muscle energy conversion system	November, 1999	Buck et al.
5990378	Textile surgical implants	November, 1999	Ellis
6007486	Tissue stabilization device for use during surgery having a segmented shaft	December, 1999	Hunt et al.
6015378	Method and apparatus for temporarily immobilizing a local area tissue	January, 2000	Borst et al.
6024096	Anterior segment ventricular restoration apparatus and method	February, 2000	Buckberg
6045497	Heart wall tension reduction apparatus and method	April, 2000	Schweich, Jr. et al.
6050936	Heart wall tension reduction apparatus	April, 2000	Schweich, Jr. et al.
6059715	Heart wall tension reduction apparatus	May, 2000	Schweich, Jr. et al.
6071303	Device for the treatment of infarcted tissue and method of treating infarcted tissue	June, 2000	Laufer
6076013	Apparatus and methods for treating congestive heart failure	June, 2000	Brennan et al.
6077214	Stress reduction apparatus and method	June, 2000	Mortier et al.
6077218	Cardiac reinforcement device	June, 2000	Alferness
6079414	Method for thoracoscopic intracardiac procedures including septal defect	June, 2000	Roth
6085754	Cardiac disease treatment method	July, 2000	Alferness et al.
6095968	Reinforcement device	August, 2000	Snyders
6110100	System for stress relieving the heart muscle and for controlling heart function	August, 2000	Talpade
6117159	Apparatus and method for closing a septal defect	September, 2000	Huebsch et al.
6117979	Process for making a bioprosthetic device and implants produced therefrom	September, 2000	Hendriks et al.
6123662	Cardiac disease treatment and device	September, 2000	Alferness et al.
6125852	Minimally-invasive devices and methods for treatment of congestive heart failure	October, 2000	Stevens et al.
6126590	Cardiac reinforcement device	October, 2000	Alferness
6155968	Method and device for improving cardiac function	December, 2000	Wilk
6155972	Cardiac constraint jacket construction	December, 2000	Nauertz et al.
6162168	Heart wall tension reduction apparatus	December, 2000	Schweich, Jr. et al.
6165119	Heart wall tension reduction apparatus and method	December, 2000	Schweich, Jr. et al.
6165120	Heart wall tension reduction apparatus and method	December, 2000	Schweich, Jr. et al.
6165121	Cardiac reinforcement device	December, 2000	Alferness
6165122	Cardiac reinforcement device	December, 2000	Alferness
6166184	Process for making a bioprosthetic device	December, 2000	Hendriks et al.
6169922	Defibrillating cardiac jacket with interwoven electrode grids	January, 2001	Alferness et al.
6174279	Cardiac constraint with tension indicator	January, 2001	Girard
6179791	Device for heart measurement	January, 2001	Krueger
6183411	External stress reduction device and method	February, 2001	Mortier et al.
6190408	Device and method for restructuring the heart chamber geometry	February, 2001	Melvin
6193648	Cardiac constraint with draw string tensioning	February, 2001	Krueger
6206820	Device for supporting cardiac function having elastic filling chambers	March, 2001	Kazi et al.
6214047	Article and method for coupling muscle to a prosthetic device	April, 2001	Melvin
6217894	Compliant tissue sealants	April, 2001	Sawhney et al.
6221103	Device and method for restructuring heart chamber geometry	April, 2001	Melvin
6224540	Passive girdle for heart ventricle for therapeutic aid to patients having ventricular dilatation	May, 2001	Ledermann et al.
6230714	Cardiac constraint with prior venus occlusion methods	May, 2001	Alferness et al.
6258023	Device and method for isolating a surface of a beating heart during surgery	July, 2001	Rogers et al.	600/37
6260552	Transventricular implant tools and devices	July, 2001	Mortier et al.
6261222	Heart wall tension reduction apparatus and method	July, 2001	Schweich, Jr. et al.
6264602	Stress reduction apparatus and method	July, 2001	Mortier et al.
6282445	Passive defibrillation electrodes for use with cardiac assist device	August, 2001	Reinhardt et al.
6287250	Method and apparatus for cardiac lifting during beating heart surgery using pericardial clips	September, 2001	Peng et al.
6293906	Delivery of cardiac constraint jacket	September, 2001	Vanden Hoek et al.
6306141	Medical devices incorporating SIM alloy elements	October, 2001	Jervis
6312725	Rapid gelling biocompatible polymer composition	November, 2001	Wallace et al.
6346077	Surgical instrument for stabilizing the beating heart during coronary artery bypass graft surgery	February, 2002	Taylor et al.	600/204
6352710	Compliant tissue sealants	March, 2002	Sawhney et al.
6360749	Modification of properties and geometry of heart tissue to influence heart function	March, 2002	Jayaraman
6375608	Cardiac reinforcement device	April, 2002	Alferness
6390976	System to permit offpump beating heart coronary bypass surgery	May, 2002	Spence et al.
6402679	External stress reduction device and method	June, 2002	Mortier et al.
6402680	Stress reduction apparatus and method	June, 2002	Mortier et al.
6406420	Methods and devices for improving cardiac function in hearts	June, 2002	McCarthy et al.
6409760	Device and method for restructuring heart chamber geometry	June, 2002	Melvin
6416459	Bag for at least partially enveloping a heart	July, 2002	Haindl
6425856	Cardiac disease treatment and device	July, 2002	Shapland et al.
6432039	Methods and apparatus for reinforcement of the heart ventricles	August, 2002	Wardle
6451025	Prosthesis and method for deployment within a body lumen	September, 2002	Jervis
6482146	Cardiac disease treatment and device	November, 2002	Alferness et al.
6537203	Cardiac disease treatment and device	March, 2003	Alferness et al.
6544168	Cardiac reinforcement device	April, 2003	Alferness
6547821	Surgical procedures and devices for increasing cardiac output of the heart	April, 2003	Taylor et al.
6564094	Cardiac disease treatment and device	May, 2003	Alferness et al.
6567699	Defibrillating cardiac constraint	May, 2003	Alferness et al.
6569082	Apparatus and methods for cardiac restraint	May, 2003	Chin
6572533	Cardiac disease treatment and device	June, 2003	Shapland et al.
6575921	Device for heart measurement	June, 2003	Vanden Hoek et al.
6582355	Cardiac disease treatment method	June, 2003	Alferness et al.
6587734	Cardio therapeutic heart sack	July, 2003	Okuzumi
6595912	Expandable cardiac harness for treating congestive heart failure	July, 2003	Lau et al.
6602184	Expandable cardiac harness for treating congestive heart failure	August, 2003	Lau et al.
6612978	Expandable cardiac harness for treating congestive heart failure	September, 2003	Lau et al.
6612979	Expandable cardiac harness for treating congestive heart failure	September, 2003	Lau et al.
6633780	Cardiac shock electrode system and corresponding implantable defibrillator system	October, 2003	Berger
6645139	Bag for at least partially enveloping a heart	November, 2003	Haindl
6663558	Expandable cardiac harness for treating congestive heart failure	December, 2003	Lau et al.
6673009	Adjustment clamp	January, 2004	Vanden Hoek et al.
6682474	Expandable cardiac harness for treating congestive heart failure	January, 2004	Lau et al.
6682475	Tension indicator for cardiac support device and method therefore	January, 2004	Cox et al.
6682476	Cardiac disease treatment and device	January, 2004	Alferness et al.
6685620	Ventricular infarct assist device and methods for using it	February, 2004	Gifford, III et al.
6685627	Modification of properties and geometry of heart tissue to influence heart function	February, 2004	Jayaraman
6689048	Delivery of cardiac constraint jacket	February, 2004	Vanden Hoek et al.
6695769	Passive ventricular support devices and methods of using them	February, 2004	French et al.
6699259	Minimally invasive direct cardiac massage device and method	March, 2004	Fogarty et al.
6701929	Device and method for treatment of congestive heart failure	March, 2004	Hussein
6702732	Expandable cardiac harness for treating congestive heart failure	March, 2004	Lau et al.
6723041	Device for treating heart failure	April, 2004	Lau et al.
6730016	Cardiac disease treatment and device	May, 2004	Cox et al.
6755779	Apparatus and method for delivery of cardiac constraint jacket	June, 2004	Vanden Hoek et al.
6759431	Compositions and methods for treating or preventing diseases of body passageways	July, 2004	Hunter et al.
6818018	In situ polymerizable hydrogels	November, 2004	Sawhney
6833408	Methods for tissue repair using adhesive materials	December, 2004	Sehl et al.
6846296	Apparatus and method for detachably securing a device to a natural heart	January, 2005	Milbocker et al.	601/153
6876887	Cardio therapeutic heart sack	April, 2005	Okuzumi
7022063	Cardiac harness	April, 2006	Lau et al.
7155295	Cardiac harness for treating congestive heart failure and for defibrillating and/or pacing/sensing	December, 2006	Lau et al.
7189203	Cardiac harness delivery device and method	March, 2007	Lau et al.
20010029314	Cardiac disease treatment and device	October, 2001	Alferness et al.
20010047122	Delivery of cardiac constraint jacket	November, 2001	Vanden Hoek et al.
20020007216	Heart wall actuation device for the natural heart	January, 2002	Melvin
20020019580	Expandable cardiac harness for treating congestive heart failure	February, 2002	Lau et al.
20020022880	Device and method for restructuring heart chamber geometry	February, 2002	Melvin
20020068849	Heart wall tension reduction apparatus	June, 2002	Schweich, Jr. et al.
20020077524	Heart wall tension reduction apparatus	June, 2002	Schweich, Jr. et al.
20020082647	Cardiac disease treatment and device	June, 2002	Alferness et al.
20020091296	Cardiac reinforcement device	July, 2002	Alferness
20020103511	Defibrillating cardiac constraint	August, 2002	Alferness et al.
20020151950	Cardio therapeutic heart sack	October, 2002	Okuzumi
20030060674	Ventricular infarct assist device and methods for using it	March, 2003	Gifford, III et al.
20030060677	Passive ventricular support devices and methods of using them	March, 2003	French et al.
20030060895	Pericardium reinforcing devices and methods of using them	March, 2003	French et al.
20030065248	Cardiac treatment apparatus	April, 2003	Lau et al.
20030199733	Cardiac disease treatment and device	October, 2003	Shapland et al.
20030199955	Cardiac restraint with electrode attachment sites	October, 2003	Struble et al.
20030229265	Cardiac support device	December, 2003	Girard et al.
20040064014	Devices and methods for assisting natural heart function	April, 2004	Melvin et al.	600/37
20040133069	Cardiac disease treatment and device	July, 2004	Shapland et al.
20040171907	Cardiac disease treatment and device	September, 2004	Alferness et al.
20040171908	Cardiac disease treatment and device	September, 2004	Alferness et al.
20040267086	Sensor-equipped and algorithm-controlled direct mechanical ventricular assist device	December, 2004	Anstadt et al.	600/17

DE3831540	April, 1989
DE29517393	March, 1996
EP0370931	May, 1990			Apparatus for the directional and periodical massage of part of a human body.
EP0280564	June, 1993			Implantable defribrillation electrodes.
EP0583012	July, 1996			Ventricular assist device.
EP0791330	August, 1997			Surgical instruments and procedures for stabilizing the beating heart during coronary artery bypass graft surgery
EP0919193	June, 1999			A tissue stabilization device for use during surgery
FR2527435	December, 1983
FR2645739	October, 1990
GB2115287	September, 1983
GB2209678	May, 1989
JP60203250	October, 1985
JP1145066	June, 1989
JP1271829	October, 1989
SU331620628-13	April, 1983
SU1734767	May, 1992
WO/1991/019465	December, 1991			MITRAL HEART VALVE REPLACEMENTS
WO/1995/006447	March, 1995			IMPROVED DEVICE FOR TISSUE REPAIR AND METHOD FOR EMPLOYING SAME
WO/1996/004852	February, 1996			APPARATUS FOR REDUCING CIRCUMFERENCE OF VASCULAR STRUCTURE
WO/1996/040356	December, 1996			ATRIAL APPENDAGE STASIS REDUCTION PROCEDURES AND DEVICES
WO/1997/020505	June, 1997			VASCULAR WOUND CLOSURE DEVICE
WO/1997/024101	July, 1997			ACTIVATION DEVICE FOR THE NATURAL HEART AND METHOD OF DOING THE SAME
WO/1998/003213	January, 1998			MINIMALLY-INVASIVE DEVICES AND METHODS FOR TREATMENT OF CONGESTIVE HEART FAILURE
WO/1998/014136	April, 1998			HEART VOLUME LIMITING DEVICE
WO/1998/026738	June, 1998			DEVICE FOR THE TREATMENT OF INFARCTED TISSUE AND METHOD OF USING THE DEVICE
WO/1998/029041	July, 1998			HEART WALL TENSION REDUCTION APPARATUS AND METHOD
WO/1998/058598	December, 1998			BAG FOR AT LEAST PARTIALLY ENVELOPING A HEART
WO/1999/011201	March, 1999			ARTIFICIAL CHORDAE REPLACEMENT
WO/1999/030647	June, 1999			VALVE TO MYOCARDIUM TENSION MEMBERS DEVICE AND METHOD
WO/1999/044534	September, 1999			DEVICE AND METHOD FOR RESTRUCTURING HEART CHAMBER GEOMETRY
WO/1999/044680	September, 1999			CONTROLLING CONGESTIVE HEART FAILURE
WO/1999/053977	October, 1999			SYSTEM FOR STRESS RELIEVING THE HEART MUSCLE AND FOR CONTROLLING HEART FUNCTION
WO/1999/056655	November, 1999			ANTERIOR SEGMENT CORONARY RESTORATION APPARATUS AND METHOD
WO/2000/002500	January, 2000			CARDIAC DISEASE TREATMENT DEVICE AND METHOD
WO/2000/006026	February, 2000			HEART WALL TENSION REDUCTION APPARATUS AND METHOD
WO/2000/006027	February, 2000			HEART STRESS REDUCTION APPARATUS AND METHOD
WO/2000/006028	February, 2000			TRANSVENTRICULAR IMPLANT TOOLS AND DEVICES
WO/2000/013722	March, 2000			CARDIAC ASSIST DEVICE USING FLUID
WO/2000/016700	March, 2000			EXTERNAL STRESS REDUCTION DEVICE AND METHOD
WO/2000/018320	April, 2000			DEVICE AND METHOD FOR RESTRUCTURING HEART CHAMBER GEOMETRY
WO/2000/028912	May, 2000			CARDIAC CONSTRAINT WITH PRIOR VENUS OCCLUSION
WO/2000/028918	May, 2000			DEFIBRILLATING CARDIAC CONSTRAINT
WO/2000/043919	July, 2000			LINK PRESENTATION AND DATA TRANSFER
WO/2000/045735	August, 2000			CARDIAC CONSTRAINT JACKET CONSTRUCTION
WO/2000/048795	August, 2000			INTERCHANGEABLE OR FIXED CUTTING INSERT SYSTEM FOR CLIPPING HEAD IN AN ELECTRIC CLIPPER FOR TRIMMING HAIRS OR HAIR
WO/2000/062727	October, 2000			DEVICE FOR SHAPING INFARCTED HEART TISSUE AND METHOD OF USING THE DEVICE
WO/2000/074769	December, 2000			CARDIAC SHOCK ELECTRODE SYSTEM AND CORRESPONDING IMPLANTABLE DEFIBRILLATOR SYSTEM
WO/2001/017437	March, 2001			ORGAN MANIPULATOR
WO/2001/021098	March, 2001			CARDIAC CONSTRAINT WITH DRAW STRING TENSIONING
WO/2001/050981	July, 2001			DELIVERY OF CARDIAC CONSTRAINT JACKET
WO/2001/067985	September, 2001			EXPANDABLE CARDIAC HARNESS FOR TREATING CONGESTIVE HEART FAILURE
WO/2001/085061	November, 2001			CARDIAC DISEASE TREATMENT AND DEVICE
WO/2001/091667	December, 2001			DEVICES AND METHODS FOR ASSISTING NATURAL HEART FUNCTION
WO/2001/095830	December, 2001			CARDIAC DISEASE TREATMENT AND DEVICE
WO/2001/095831	December, 2001			CARDIAC DISEASE TREATMENT AND DEVICE
WO/2001/095832	December, 2001			CARDIAC DISEASE TREATMENT AND DEVICE
WO/2002/013726	February, 2002			CARDIAC DISEASE TREATMENT AND DEVICE
WO/2002/019917	March, 2002			HEART SUPPORT TO PREVENT VENTRICULAR REMODELING
WO/2003/026483	April, 2003			VENTRICULAR INFARCT ASSIST DEVICE AND METHODS FOR USING IT
WO/2003/026484	April, 2003			PASSIVE VENTRICULAR SUPPORT DEVICES AND METHODS OF USING THEM
WO/2003/026485	April, 2003			PERICARDIUM REINFORCING DEVICES AND METHODS OF USING THEM

Wharton, J. Marcus, et al., Electrophysiological Effects of Monophasic and Biphasic Stimuli in Normal and Infarcted Dogs, PACE, vol. 13, pp. 1158-1172, Sep. 1990.
Shabetai, Ralph, The Role of the Pericardium in the Pathophysiology of Heart Failure, Congestive Heart Failure, Second Edition, Chapter 9, pp. 157-187, 2000.
Cohn, Jay N., M.D., The Management of Chronic Heart Failure, The New England Journal of Medicine, vol. 335, No. 7, pp. 490-498, Aug. 15, 1996.
Bencini, Adriano, M.D., The “Pneumomassage” of the Heart, Surgery, vol. 39, No. 3, Mar. 1956.
Anstadt, George L., et al., A New Instrument for Prolonged Mechanical Cardiac Massage, Abstracts of the 38th Scientific Sessions, Supplement II to Circulation, vols. 31 and 32, pp. 375-384, Oct. 1965.
Lev, Maurice, M.D., et al., Single (Primitive) Ventricle, Circulation, vol. 39, pp. 577-591.
Paling, D.F., Warp Knitting Technology, 1970.
Edie, Richard N., M.D., et al., Surgical Repair of Single Ventricle, The Journal of Thoracic and Cardiovascular Surgery, vol. 66, No. 3, pp. 350-360, Sep. 1972.
McGoon, Dwight C., M.D., et al., Correction of the Univentricular Heart Having Two Atriovantricular Valves, The Journal of Thoracic and Cardiovascular Surgery, vol. 74, No. 2, pp. 218-226, Aug. 1977.
Doty, Donald B., et al., Septation of the Univentricular Heart: Transatrial Approach, The Journal of Thoracic and Cardiovascular Surgery, vol. 78, No. 3, pp. 424-430, Sep. 1979.
Melton, K.N., et al., Alloys With Two-Shape Memory Effect, Mechanical Engineering, pp. 42-43, Mar. 1980.
Feldt, Robert H., M.D., et al., Current Status of the Septation Procedure for Univentricular Heart, The Journal of Thoracic and Cardiovascular Surgery, vol. 82, No. 1, pp. 93-97, Jul. 1981.
Carpentier, A., et al., Myocardial Substitution With Stimulated Skeletal Muscle: First Successful Clinical Case. The Lancet, Jun. 1, 1985.
Anstadt, George L. et al., Direct Mechanical Ventricular Actuation: A Review, Resuscitation, pp. 7-23, 1991.
Anstadt, Mark P., M.D., et al., Pulsatile Reperfusion After Cardiac Arrest Improves Neurologic Outcome, American Surgery, vol. 214, No. 4, pp. 478-490, Oct. 1991.
Schumacker, Harris B., Jr., Chapter 21: Cardiac Aneurysms, The Evolution of Cardiac Surgery, pp. 159-165, 1992.
Savage, Edward B., M.D., et al., Repair of Left Ventricular Aneurysm, The Journal of Thoracic and Cardiovascular Surgery, vol. 104, No. 3, pp. 752-762, Sep. 1992.
Carpentier, Alain, M.D., Ph.D., et al., Dynamic Cardiomyoplasty at Seven Years, The Journal of Thoracic and Cardiovascular Surgery, vol. 106, No. 1, pp. 42-54, Jul. 1993.
Capouya, Eli R., M.D., et al., Girdling Effect of Nonstimulated Cardiomyoplasty on Left Ventricular Function, Annals of Thoracic Surgeons, vol. 56, pp. 867-871, 1993.
Chekanov, Valeri, M.D., Ph.D., Nonstimulated Cardiomyoplasty Wrap Attenuated the Degree of Left Ventricular Enlargement, Annals of Thoracic Surgeons, vol. 57, pp. 1684-1690, 1997.
Chiu, Ray C.-J, Using Skeletal Muscle for Cardiac Assistance, Scientific American, pp. 68-77, Nov./Dec. 1994.
Kass, David A., M.D., et al., Reverse Remodeling From Cardiomyoplasty in Human Heart Failure: External Constraint Versus Active Assist, Circulation, vol. 91, No. 9, pp. 2314-2318, May 1, 1995.
Vaynblat, Mikhail, M.D., et al., Cardiac Binding in Experimental Heart Failure, Annals of Thoracic Surgery (Abstract), Supplement to Circulation, vol. 92, Suppl. 1, 1995.
Levin, Howard R., M.D., et al., Reversal of Chronic Ventricular Dilation in Patients With End-Stage Cardiomyopathy by Prolonged Mechanical Unloading, Circulation, vol. 91, No. 11, pp. 2717-2720, 1995.
Chaudhry, Pervaiz A., M.D., et al., Acute Ventricular Reduction with Acorn's Cardiac Support Device Prevents Progressive Left Ventricular Dysfunction and Remodeling in Dogs With Advanced Heart Failure, Cardiothoracic Surgery, pp. 146-148, 1996.
Oh, Joong Hwan, M.D., et al., Mechanisms of Dynamic Cardiomyoplasty: Current Concepts, Journal of Cardiac Surgery, vol. 11, pp. 194-199, 1996.
Badhwar, Vinay, Power Generation From Four Skeletal Muscle Configurations Design Implications for a Muscle Powered Cardiac Assist Device, ASAIO Journal, vol. 43, pp. M651-M657, 1997.
Westaby, Stephen, et al., Landmarks in Cardiac Surgery, pp. 198-199, 1997.
Cox, James L., Left Ventricular Aneurysms: Pathophysiologic Observations and Standard Resection, Seminars in Thoracic and Cardiovascular Surgery, vol. 9, No. 2, pp. 113-122, Apr. 1997.
Coletta, C., et al., Prognostic Value of Left Ventricular Volume Response During Dobutamine Stress Echocardiography, European Heart Journal, vol. 18, pp. 1599-1603, Oct. 1997.
Capomolla, Soccorso, M.D., et al., Dobutamine and Nitroprusside Infusion in Patients With Severe Congestive Heart Failure: Hemodynamic Improvement by Discordant Effects on Mitral Regurgitation, Left Atrial Function, and Ventricular Function, American Heart Journal, 1089-1098, Dec. 1997.
Oh, Joong Hwan, The Effects of Prosthetic Cardiac Binding and Adynamic Cardiomyoplasty in a Model of Dilated Cardiomyopathy, The Journal of Thoracic and Cardiovascular Surgery, vol. 116, No. 1, pp. 148-153, 1998.
Cohn, Jay N., M.D., Preventing Congestive Heart Failure, American Family Physician, 6 pages, Apr. 15, 1998.
Cohn, Jay N., M.D., Structural Basis for Heart Failure: Ventricular Remodeling and Its Pharmacological Inhibition, Circulation, vol. 91, No. 10, pp. 2504-2507, May 15, 1995.
Gaudron, Peter, M.D., et al., Progressive Left Ventricular Dysfunction and Remodeling After Myocardial Infarction, Circulation, vol. 87, pp. 755-763, Mar. 1993.
Pfeiffer, Marc A., M.D., et al., Ventricular Remodeling After Myocardial Infarction: Experimental Observations and Clinical Implications, Circulation, vol. 81, No. 4, pp. 1161-1172, Apr. 1990.
Guasp, Francisco Torrent, Una protesis contentiva para el tratamiento de le microcardiopatia dilatads, Revista Española de Cardiologia, vol. 51, No. 7, Jul. 1998.
Power, J.M., et al., Passive Ventricular Constraint Amends the Course of Heart Failure: A Study in an Ovine Model of Dilated Cardiomyopathy, Cardiovascular Research, vol. 44, pp. 549-555, 1999.
Frazier, O.H., M.D., et al., Left Ventricular Assist System as a Bridge to Myocardial Recovery, Annals of Thoracic Surgery, vol. 68, pp. 734-741, 1999.
Melvin, David B., Ventricular Radium Reduction Without Resection: A Computational Analysis, ASAIO Journal, pp. 160-165, 1999.
ABSTRACTS—Heart Failure, JACC Feb. 1999.
Raman, Jai S., Fracs, et al., Ventricular Containment as an Adjunctive Procedure in Ischemic Cardiomyopathy: Early Results, Annals of Thoracic Surgery, vol. 70, pp. 1124-1126, Jan. 2000.
McCarthy, Patrick M., et al., Device Based Left Ventricular Shape Change Immediately Reduces Left Ventricular Volume and Increases Ejection Fraction in a Pacing Induced Cardiomyopathy Model in Dogs, JACC, Feb. 2000.
Chaudhry, Pervaiz A., M.D., et al., Passive Epicardial Containment Prevents Ventricular Remodeling in Heart Failure, Annals of Thoracic Surgeons, vol. 70, pp. 1275-1280, 2000.
Acorn Cardiovascular, Inc., CSD Specifications Acorn Cardiac Support Device, 2000.
Heart “jacket” could help stop heart failure progression, Clinicia, No. 916, Jul. 2000.
Acorn Cardiovascular, Inc., CorCap™ Cardiac Support Device Pamphlet, Jun. 2001.
Medtronic's InSync Cardiac Resynchronization Therapy Device Approved by FDA, (Press Release) Aug. 28, 2001.
Oz, Mehmet C., M.D., Passive Ventricular Constraint for the Treatment of Congestive Heart Failure, Annals of Thoracic Surgery, vol. 71, pp. 5185-5187, 2001.
Abstract Supplement, European Heart Journal, vol. 22, Sep. 2001.
Gorman, J., Self-Sutures: New Material Knots Up On Its Own, Science News, vol. 161, p. 262, Apr. 27, 2002.
Teckell-Taylor, Leah A., et al., Passive Ventricular Restraint With Nitinol Mesh Attenuates Remodeling Following Acute Myocardial Infarction, Abstract, American College of Cardiology (Undated).
Mann, Douglas L., M.D., Basic Mechanisms of Remodeling and Reverse Remodeling, presented at 6th Annual Scientific Meeting of the Heart Failure Society of America, Sep. 24, 2002.
Bocchi, Edimar a., M.D., Arrhythmias and Sudden Death After Dynamic Cardiomyoplasty, Circulation, vol. 90, No. 5, Part 2, pp. 11-107 thru 11-111, Nov. 1994.
Chachques, Juan C., M.D., Study of Muscular and Ventricular Function in Dynamic Cardiomyoplasty: A Ten-Year Follow-Up, The Journal of Heart and Lung Transplantation, vol. 16, No. 8, pp. 854-868, Aug. 1997.
Dullum, Mercedes K.C., M.D., et al., Less Invasive Surgical Management of Heart Failure by Cardiac Support Device Implantation on the Beating Heart, The Heart Surgery Forum, #2001-1818, pp. 361-363, Jan. 4-7, 2001.
Macris, Michael P. M.D., et al., Minimally Invasive Access of the Normal Preicardium: Initial Clinical Experience with a Novel Device, Clinical Cardiology, vol. 22 (Suppl. 1), pp. 1-36 thru 1-39, 1999.
Thakur, Ranjan K., M.D., et al., Latissimus dorsi Dynamic Cardiomyoplasty: Role of Combined ICD Implantation, Journal of Cardiac Surgery, vol. 10, pp. 295-297, 1995.
Wharton, J. Marcus, et al., Electrophysiological Effects of Monophasic and Biphasic Stimuli in Normal and Infarcted Dogs, PACE, vol. 13, pp. 1158-1172, Sep. 1990.

Lacyk, John P.

Fulwider Patton LLP

CROSS-REFERENCE TO RELATED APPLICATION

This application depends for priority upon U.S. Provisional Patent Application No. 60/486,062, filed Jul. 10, 2003, which is incorporated herein in its entirety by reference.

We claim:

1. A self-anchoring cardiac harness, comprising: a plurality of circumferential rings of elastic undulating elements, the majority of the rings being sized to circumferentially surround an outer surface of the heart in conformity with the general anatomy of a portion of the patient's heart; and a plurality of connecting members having a friction enhancing surface adapted for restricting migration of the harness in relation to the outer surface of the heart without substantially penetrating the heart wall, wherein a portion of the adjacent rings extend through the connecting members.

2. The self-anchoring cardiac harness of claim 1, wherein the friction enhancing surface includes a grit.

3. The self-anchoring cardiac harness of claim 1, wherein the friction enhancing surface includes a suction cup.

4. The self-anchoring cardiac harness of claim 1, wherein the friction enhancing surface includes a plurality of protuberances, the protuberances having a configuration including at least two planar sides extending from a substrate.

5. The self-anchoring cardiac harness of claim 4, wherein the protuberances are spaced apart on the connecting member.

6. The self-anchoring cardiac harness of claim 4, wherein the protuberances cover the entire substrate.

7. The self-anchoring cardiac harness of claim 1, wherein the friction enhancing surface includes a plurality of protuberances, the protuberances having a pyramidal configuration.

8. The self-anchoring cardiac harness of claim 1, wherein the protuberances are conical.

9. The self-anchoring cardiac harness of claim 1, wherein the friction enhancing surface is formed from a semi-compliant material.

10. The self-anchoring cardiac harness of claim 9, wherein the semi-compliant material is silicone.

11. The self-anchoring cardiac harness of claim 9, wherein the semi-compliant material is a polymer.

12. The self-anchoring cardiac harness of claim 1, wherein the friction enhancing surface includes a plurality of protuberances disposed on a substrate, and the protuberances extend between about 10-500 μm above the substrate.

13. The self-anchoring cardiac harness of claim 1, wherein the friction enhancing surface is configured to not penetrate the epicardium.

14. The self-anchoring cardiac harness of claim 1, wherein the friction enhancing surface is molded into the connecting members.

15. A self-anchoring cardiac harness, comprising: a plurality of rows formed from elastic undulating elements, the majority of the rows being joined at their opposite ends to form rings of various sized circumferences such that each ring is adapted to circumferentially surround an outer surface of the heart in conformity with the general anatomy of a portion of the patient's heart; a plurality of connecting members linking adjacent circumferential rings; and a plurality of tubular friction enhancing members disposed on the harness and adapted for restricting migration of the harness in relation to the outer surface of the heart, the tubular friction enhancing members having a lumen which receives at least one elastic undulating element therein.

16. The self-anchoring cardiac harness of claim 15, wherein the tubular friction enhancing members are formed from a semi-compliant material.

17. The self-anchoring cardiac harness of claim 15, wherein the tubular friction enhancing members are configured with an irregular non-piercing surface.

18. The self-anchoring cardiac harness of claim 17, wherein the non-piercing surface is molded into the surface of the tubular friction enhancing surface.

19. The self-anchoring cardiac harness of claim 15, wherein the opposite ends of the rings are joined by connective junctions.

20. The self-anchoring cardiac harness of claim 15, wherein the cardiac harness is configured to be delivered minimally invasively.

21. The self-anchoring cardiac harness of claim 15, wherein the tubular friction enhancing members includes a plurality of protuberances, the protuberances having a configuration including at least two planar sides extending from a substrate.

22. The self-anchoring cardiac harness of claim 21, wherein the protuberances are spaced apart on the connecting member.

23. The self-anchoring cardiac harness of claim 21, wherein the protuberances cover the entire substrate.

24. The self-anchoring cardiac harness of claim 15, wherein the tubular friction enhancing members include a grit.

25. The self-anchoring cardiac harness of claim 15, wherein the tubular friction enhancing members include a suction cup.

26. The self-anchoring cardiac harness of claim 15, wherein the tubular friction enhancing members are configured to not substantially penetrate the heart wall.

BACKGROUND OF THE INVENTION

The present invention relates to a device for treating heart failure. More specifically, the invention relates to a self-anchoring cardiac harness configured to be fit around at least a portion of a patient's heart. The cardiac harness includes an engaging element that provides a force to hold the harness onto the cardiac surface. In combination, the engaging elements hold the harness on the heart and resist migration of the harness relative to the heart during the cardiac cycle, without the need to substantially penetrate the heart.

Congestive heart failure (“CHF”) is characterized by the failure of the heart to pump blood at sufficient flow rates to meet the metabolic demand of tissues, especially the demand for oxygen. One characteristic of CHF is remodeling of at least portions of a patient's heart. Remodeling involves physical change to the size, shape and thickness of the heart wall. For example, a damaged left ventricle may have some localized thinning and stretching of a portion of the myocardium. The thinned portion of the myocardium often is functionally impaired, and other portions of the myocardium attempt to compensate. As a result, the other portions of the myocardium may expand so that the stroke volume of the ventricle is maintained notwithstanding the impaired zone of the myocardium. Such expansion may cause the left ventricle to assume a somewhat spherical shape.

Cardiac remodeling often subjects the heart wall to increased wall tension or stress, which further impairs the heart's functional performance. Often, the heart wall will dilate further in order to compensate for the impairment caused by such increased stress. Thus, a cycle can result, in which dilation leads to further dilation and greater functional impairment.

Historically, congestive heart failure has been managed with a variety of drugs. Devices have also been used to improve cardiac output. For example, left ventricular assist pumps help the heart to pump blood. Multi-chamber pacing has also been employed to optimally synchronize the beating of the heart chambers to improve cardiac output. Various skeletal muscles, such as the latissimus dorsi, have been used to assist ventricular pumping. Researchers and cardiac surgeons have also experimented with prosthetic “girdles” disposed around the heart. One such design is a prosthetic “sock” or “jacket” that is wrapped around the heart.

What has been needed, and is at this time unavailable, is a cardiac harness that resists migration off of the heart without the need to apply a suture to the heart or substantially penetrate the surface of the heart.

SUMMARY OF THE INVENTION

Accordingly the present invention includes a self-anchoring cardiac harness that is configured to fit at least a portion of a patient's heart and has an engaging element for frictionally engaging an outer surface of a heart. The engaging element includes at least a surface, and may include surface relief protuberances which provide a plurality of tissue engaging elements that apply respective localized forces against the heart without substantially penetrating the heart wall. Collectively, the engaging elements produce sufficient friction relative to the outer surface so that the harness does not migrate substantially relative to the outer surface. The engaging element is formed of a material that is less compliant than the heart wall.

In one embodiment, the engaging element of a self-anchoring cardiac harness includes at least one suction cup configured to engage the heart so as to hold the harness in position on the heart. It is preferred that the harness has a plurality of spaced apart suction cups that are formed of a compliant material, such as silicone rubber.

In another embodiment of the present invention, a cardiac harness has a surface configured to engage a patient's epicardium, wherein the engaging element is at least a portion of the inner surface of the harness that has a grip portion formed of a grit. In this embodiment, the grit is a particle that can have a size between about 10-500 μm, and preferably between about 10-100 μm. The particles forming the grit can be silica or aluminum oxide particles. With a cardiac harness having a plurality of elastic rows, and wherein adjacent rows are connected by row connectors, the grit can be applied to the row connectors. In other embodiments, the grit can be applied to any portion of the harness, including the elastic rows.

In yet another embodiment, the self-anchoring harness can have an inner surface from which at least one grip protuberance extends. The grip protuberance includes a first surface portion lying generally in a first plane, a second surface portion lying generally in a second plane, and a peak along which the first and second surface portions meet, the peak defining an angle between the first and second planes. The peak is configured to engage a surface of the heart without substantially penetrating the heart surface. In one embodiment, the harness includes at least one engagement element having a plurality of grip protuberances. The engagement element can be disposed along any portion of the cardiac harness, including along elastic rows or connectors that connect adjacent rows of the harness together. In these embodiments, the grip protuberance is a polymer, such as a urethane, and the grip protuberance can be formed by injection molding.

In another embodiment, the self-anchoring cardiac harness can have at least one grip element. The grip element extends inwardly toward the heart and has a point that engages a surface of the heart without substantially penetrating the heart surface. In one embodiment, the grip element extends inwardly about 10-500 μm, and is generally conical in shape. However, the grip element may be formed into a variety of shapes, including among others, a generally pyramid-shape. A plurality of grip protuberances may be disposed on an engagement element, and the harness of the present invention may include a plurality of spaced apart engagement elements.

The present invention produces a friction by pressing an engaging element disposed on the cardiac harness against an outer surface of the heart. There is enough force created by the engaging element that there is no need to apply a suture to the heart to retain the cardiac harness. Further, the engaging elements or surface relief protuberances are adapted to engage the heart surface without substantially penetrating the heart surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a schematic view of a heart with a prior art cardiac harness placed thereon.

FIGS. 2A-2B depict a spring hinge of a prior art cardiac harness in a relaxed position and under tension.

FIG. 3 depicts a perspective view of one embodiment of a cardiac harness having a plurality of rings, and tissue engaging elements disposed along the rings.

FIG. 4 depicts an unattached elongated strand or series of spring elements that are coated with a dielectric material.

FIG. 5 depicts a partial cross-sectional view of opposite ends of a ring attached to one another by a connective junction.

FIG. 6 depicts a perspective view of another embodiment of a cardiac harness having a plurality of rings, and suction cups disposed along the inner surface of the harness.

FIG. 7 depicts an enlarged partial plan view of a cardiac harness having grit disposed on the entire inner surface of the harness, including the rings of the harness and a connector that joins adjacent rings together.

FIG. 8 depicts an enlarged partial plan view of a cardiac harness having grit disposed only on a connector that joins adjacent rings together, and not on the rings of the harness.

FIG. 9 depicts an enlarged partial plan view of a cardiac harness wherein the connector is a tissue engaging element having surface relief protuberances disposed thereon.

FIG. 10 depicts an enlarged view of another embodiment of a tissue engaging element having surface relief protuberances.

FIG. 11 depicts a partial cross-sectional view of opposite ends of a ring attached to one another by a connective junction and a tissue engaging element disposed on the connective junction.

FIG. 12 depicts an enlarged view of another embodiment of a tissue engaging element disposed on a tube segment that is attached to a spring member of the cardiac harness.

FIG. 13 depicts a partial cross-section taken along line 13 - 13 of FIG. 10, showing the engagement element having a surface relief formed by several rows of elongated protuberances extending from a substrate.

FIG. 14 depicts an enlarged view of another embodiment of a tissue engaging element having surface relief protuberances.

FIG. 14A depicts a partial cross-section of the tissue engaging element taken along line 14 A- 14 A of FIG. 14.

FIG. 15 depicts an enlarged view of yet another embodiment of a tissue engaging element having surface relief protuberances.

FIG. 15A depicts a partial cross-section of the tissue engaging element taken along line 15 A- 15 A of FIG. 15.

FIG. 16 depicts an enlarged view of another embodiment of a tissue engaging element having surface relief protuberances.

FIG. 16A depicts a partial cross-section of the tissue engaging element taken along line 16 A- 16 A of FIG. 16.

FIG. 17 depicts an enlarged view of yet another embodiment of a tissue engaging element having surface relief protuberances.

FIG. 17A depicts a partial cross-section of the tissue engaging element taken along line 17 A- 17 A of FIG. 17.

FIG. 18 depicts a plan view of one embodiment of a tissue engaging element having a surface formed by several rows of protuberances that do not extend all the way across the engagement element.

FIG. 18A depicts a perspective view of the tissue engaging element of FIG. 18.

FIG. 19 depicts a plan view of another embodiment of a tissue engaging element having a surface formed by several rows of protuberances that are spaced apart from adjacent rows of protuberances.

FIG. 19A depicts a perspective view of the tissue engaging element of FIG. 19.

FIG. 20 depicts a plan view of an embodiment of a tissue engaging element having pyramid-shaped surface relief protuberances arranged into a row/column structure.

FIG. 20A depicts a partial cross-section of the tissue engaging element taken along ling 20 A- 20 A of FIG. 20.

FIG. 20B depicts a partial cross-section of the tissue engaging element taken along ling 20 B- 20 B of FIG. 20.

FIG. 21 depicts a plan view of an embodiment of a tissue engaging element having surface relief protuberances arranged into a row/column structure.

FIG. 21A depicts a partial cross-section of the tissue engaging element taken along ling 21 A- 21 A of FIG. 21.

FIG. 21B depicts a partial cross-section of the tissue engaging element taken along ling 21 B- 21 B of FIG. 21.

FIG. 22 depicts a perspective view of another embodiment of a tissue engaging element having surface relief protuberances with conical-shaped surfaces.

FIG. 23A depicts a plan view of an embodiment of a tissue engaging element having conical protuberances spaced apart from one another.

FIG. 23B depicts a cross-sectional view of the tissue engaging element taken along line 23 B- 23 B of FIG. 23A.

FIG. 24 depicts a plan view of a mold for forming an array of conical protuberances.

FIG. 24A depicts a cross-sectional view of the mold taken along line 24 A- 24 A of FIG. 24.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

This invention relates to a method and apparatus for treating heart failure. As discussed in Applicants' co-pending application entitled “Expandable Cardiac Harness For Treating Congestive Heart Failure”, Ser. No. 09/634,043, which was filed on Aug. 8, 2000, the entirety of which is hereby expressly incorporated by reference herein, it is anticipated that remodeling of a diseased heart can be resisted or even reversed by alleviating the wall stresses in such a heart. The present application discusses certain embodiments and methods for supporting the cardiac wall. Additional embodiments and aspects are also discussed in Applicants' co-pending applications entitled “Device for Treating Heart Failure,” Ser. No. 10/242,016, filed Sep. 10, 2002; “Heart Failure Treatment Device and Method”, Ser. No. 10/287,723, filed Oct. 31, 2002; “Method and Apparatus for Supporting a Heart”, Ser. No. 10/338,934, filed Jan. 7, 2003; and “Method and Apparatus for Treating Heart Failure,” Ser. No. 60/409,113, filed Sep. 5, 2002; “Cardiac Harness Delivery Device and Method,” Ser. No. 60/427,079, filed Nov. 15, 2002; and “Multi-panel Cardiac Harness, Ser. No. 60/458,991, filed Mar. 28, 2003, the entirety of each of which is hereby expressly incorporated by reference.

FIG. 1 illustrates a mammalian heart 30 having a prior art cardiac wall stress reduction device in the form of a harness 32 applied to it. The cardiac harness has rows 34 of elastic members 36 that circumscribe the heart and, collectively, apply a mild compressive force on the heart so as to alleviate wall stresses.

The term “cardiac harness” as used herein is a broad term that refers to a device fit onto a patient's heart to apply a compressive force on the heart during at least a portion of the cardiac cycle. A device that is intended to be fit onto and reinforce a heart and which may be referred to in the art as a “girdle,” “sock,” “jacket,” “cardiac reinforcement device,” or the like is included within the meaning of “cardiac harness.”

The cardiac harness 32 illustrated in FIG. 1 has several rows 34 of elastic members 36 . Each row includes a series of spring elements, referred to as hinges, or spring hinges, that are configured to deform as the heart 30 expands during filling. For example, FIG. 2A shows a prior art hinge member 36 at rest. The hinge member has a central portion 40 and a pair of arms 42 . As the arms are pulled, as shown in FIG. 2B, a bending moment 44 is imposed on the central portion. The bending moment urges the hinge member back to its relaxed condition. Note that a typical row or strand comprises a series of such hinges, and that the hinges are adapted to elastically expand and retract in the direction of the strand.

In the harness illustrated in FIG. 1, the elastic rows 34 are constructed of drawn wire that is deformed to form the spring elements 36 .

In one embodiment of the invention, as shown in FIG. 3, a cardiac harness 50 has several adjacent elastic rows 52 of spring members 54 is illustrated. In this embodiment, adjacent rows preferably are connected to one another by one or more connectors 56 . The connectors help maintain the position of the elastic rows relative to one another. Preferably, the connectors have a length oriented longitudinally relative to the elastic rows so as to create a space between adjacent rows. The illustrated harness is configured to circumferentially surround at least a portion of the heart between an apex portion 58 and a base portion 60 . Preferably, the connectors allow some relative movement between adjacent rows.

The connectors 56 preferably are formed of a semi-compliant material such as silicone rubber. Most preferably the connectors are formed of the same material used for coating the rings with a dielectric coating, if applicable. Some materials that can be used for the connectors include, for example, medical grade polymers such as, but not limited to, polyethylene, polypropylene, polyurethane and nylon.

As discussed above, and as discussed in more detail in the applications that are incorporated herein by reference, the elastic rows 52 exert a force in resistance to expansion of the heart. Collectively, the force exerted by the elastic rows tends toward compressing the heart, thus alleviating wall stresses in the heart as the heart expands. Accordingly, the harness helps to decrease the workload of the heart, enabling the heart to more effectively pump blood through the patient's body and enabling the heart an opportunity to heal itself. It should be understood that several arrangements and configurations of elastic rows can be used to create a mildly compressive force on the heart so as to reduce wall stresses. For example, elastic members 54 can be disposed over only a portion of the circumference of the heart or harness.

With next reference to FIG. 4, a close-up of a portion of one embodiment of an elastic row 52 is shown. In the illustrated embodiment, the row has an undulating strand of drawn wire formed into a series of successive spring elements 54 . A dielectric coating 55 is disposed over the spring elements to electrically insulate the strand of drawn wire. In the illustrated embodiment, the dielectric coating includes silicone rubber. Other acceptable materials include urethanes as well as various polymers, elastomers and the like. In the illustrated embodiment, the silicone rubber coating is a tubing that has been pulled over the wire. It is to be understood that other methods for applying a coating, such as dip coating and spraying, can also be used to apply a coating to the elastic row. Further, it should be understood that in other embodiments no coating is applied over the elastic row.

In one embodiment, each elastic row 52 initially includes an elongate strand. During manufacturing of the cardiac harness 50 , each elongate strand is cut to a length such that when opposite ends of the elongate strand are bonded together, the elongate strand assumes a ring-shaped configuration. The rings form the adjacent elastic rows. The lengths of the elongate strands are selected such that the resulting rings/rows are sized in conformity with the general anatomy of the patient's heart. More specifically, strands used to form the apex portion 58 of the harness are not as long as strands used to form the base portion 60 . As such, the harness generally tapers from the base toward the apex in order to generally follow the shape of the patient's heart.

In another embodiment, the diameter of a ring at the base of the harness is smaller than the diameter of the adjacent ring. In this embodiment, the harness has a greatest diameter at a point between the base and apex ends, and tapers from that point to both the base and apex ends. Preferably, the point of greatest diameter is closer to the base end than to the apex end. It is contemplated that the lengths of the strands, as well as the sizes of the spring members, may be selected according to the intended size of the cardiac harness and/or the amount of compressive force the harness is intended to impart to the patient's heart.

With continued reference to FIG. 3, the opposite ends of each circumferentially extending ring 52 are attached to one another by a connective junction 62 . In one embodiment, illustrated in FIG. 5, each connective junction includes a small tube segment 64 into which opposite ends 66 of the ring are inserted. The tube segment serves to prevent the opposite ends of the ring from tearing loose from one another after the harness is placed on the heart. Preferably, each tube segment is filled with a dielectric material such as silicone rubber or another similar material after the ring-ends are placed therein. It is to be understood that additional methods and structure can be used to form the connective junctures. For example, the ends of the strands can be welded together or intertwined. Also, in other embodiments, each ring can be unitarily formed, such as by molding, without requiring cutting and joining of the ends.

In a human heart the right ventricle extends further from the apex of the heart than does the left ventricle. The cardiac harness 50 illustrated in FIG. 3 has a right ventricle engagement portion 68 configured to fit about the uppermost portion of the right ventricle where the ventricle begins to curve inwardly. With continued reference to FIG. 3, the right ventricle engagement portion of the harness has elastic rows that form only a partial circle. Preferably, these partial rings 70 are connected to the adjacent full ring in a manner so that the partial rings are at least mildly stretched when the rest of the harness is at rest. As such, the partial strands are biased inwardly. When placed on the heart, the partial rings “cup” the upper portion of the right ventricle. As such, the harness fits better and is held more securely on the heart than if the right side of the harness were configured the same as the left side.

In yet another embodiment, a cardiac harness has a basal-most ring 72 that is less compliant than rings elsewhere in the harness. In one embodiment, the basal-most ring has a larger diameter wire than the wire comprising the other rings of the harness. In another embodiment, the basal-most ring has a shorter length of wire than the other rings of the harness. As such, once the cardiac harness is appropriately positioned on the heart, the basal-most ring tightly engages the heart and resists apical migration of the harness. The basal-most region of the ventricles adjacent to the AV groove undergoes less circumferential change during a cardiac cycle than does the remaining bulk of the ventricles. As such, it is contemplated that the basal-most ring will have minimal or no adverse impact on cardiac performance, or cardiac cycle dynamics. It is also to be understood that, in other embodiments, multiple rings, or a basal-most portion of the harness, may have the reduced compliance. Such reduced compliance may be obtained in any manner. For example, in one embodiment, the basal-most portion is pre-stretched relative to the rest of the harness. In another embodiment, the basal-most portion is formed of a thicker or different material than other portions of the harness.

It is to be understood that several embodiments of cardiac harnesses can be constructed and that such embodiments may have varying configurations, sizes, flexibilities, etc. As discussed in the above-referenced applications, such harnesses can be constructed from many suitable materials including various metals, woven or knitted fabrics, polymers, plastics and braided filaments, and may or may not include elastic rows. Suitable harness materials also include superelastic materials and materials that exhibit shape memory. For example, a preferred embodiment is constructed of Nitinol. Shape memory polymers can also be employed. Such shape memory polymers can include shape memory polyurethanes or other polymers such as those containing oligo(e-caprolactone) dimethacrylate and/or poly(e-caprolactone), which are available from mnemoScience. Further, harness materials can be elastic or substantially non-elastic.

With next reference to FIG. 6, another embodiment of a cardiac harness 50 is illustrated. The illustrated harness has several inwardly-directed suction cups 74 extending from an inner surface of the harness. As shown in the illustrated embodiment, the suction cups are spaced apart from each other. Each cup is configured to engage the outer surface of the heart to create a local engagement force holding the harness onto the cardiac surface. The combined action of the several local engagement forces combine to hold the harness on the heart so as to resist migration of the harness relative to the heart during the cardiac cycle. As such, the illustrated harness embodiment anchors itself to the heart. Other embodiments of tissue engagement elements as will be described below, may also be used in conjunction with the suction cups to anchor the harness onto the heart.

In the illustrated embodiment shown in FIG. 6, the suction cups 74 may be disposed on the connectors 56 between elastic rows 52 . It is to be understood, however, that in additional embodiments, suction cups can extend inwardly from any portion of the harness. In one embodiment, the suction cups are co-formed with the harness. In another embodiment, the suction cups are formed separately from the harness and are attached to the harness.

In accordance with another embodiment, a cardiac harness 50 having a structure similar to the embodiment shown and described in connection with FIG. 3 further includes a textured coating including particles or grit 76 having sizes measurable on the order of microns. As such, when the harness is disposed on the heart, and the harness gently squeezes the heart, the grit engages the heart surface so as to resist migration of the harness relative to the heart surface during the cardiac cycle.

FIG. 7 is a close up view of a portion of the inner surface of a cardiac harness embodiment having a structure in accordance with this aspect. As depicted in FIG. 7, grit 76 is distributed generally around the entire inner surface of the harness. The grit may be applied to the harness in accordance with various methods such as spray coating, dipping, or the like. In the illustrated embodiment, the grit is attached to the dielectric coating 55 of the undulating wire. It is to be understood that in additional embodiments grit can be adhered directly to any structure on the inner surface of the harness.

In a preferred embodiment, a grit 76 having a size between about 10 to 500 micrometers is used. Each particle of grit, when engaged with the heart surface, creates a localized friction force that resists migration of the grit and associated harness relative to the heart surface. The several localized forces generated by each grit particle interacting with the heart surface collectively comprise a harness friction force which resists migration of the harness relative to the heart surface.

Although the grit 76 engages the heart surface and/or tissue adjacent the heart surface, it does not substantially penetrate the heart surface due to the small size of the grit particles. This should be taken to mean that the grit engaging the heart surface does not penetrate the heart surface sufficiently to cause any debilitating injury to the heart. Further, the grit does not penetrate the tissue enough to puncture any coronary vessel wall.

As discussed above, the grit 76 preferably extends from the inner wall of the cardiac harness. As such, each particle of grit includes a protuberance extending from the harness. Collectively, several particles of grit create a three-dimensional surface relief that is relatively rough and which, when engaged with the heart surface, creates a friction force that resists migration of the harness relative to the heart.

Multiple particles of grit 76 , taken together, make up a tissue engagement element 78 . In the embodiment illustrated in FIG. 7, since the grit is disposed generally evenly throughout the inner surface of the harness, the entire inner surface can be considered a tissue engaging element, or a certain zone or portion of the grit-covered inner surface can be defined as a tissue engagement element.

In accordance with another embodiment, a cardiac harness has a plurality of tissue engaging elements 78 . Each tissue engaging element includes a surface relief made up of a plurality of protuberances. In this embodiment, surface relief protuberances are collected in tissue engaging elements, and substantially no surface relief protuberances are provided on the inner surface of the harness between tissue engagement elements, which are spaced apart from one another.

FIG. 8 shows a portion of a harness having a structure similar to the harness shown and discussed in connection with FIG. 3, wherein a plurality of tissue engagement elements 78 , each having surface relief protuberances, are disposed on the inner surface of the harness and spaced apart from one another. In the illustrated embodiment, the tissue engagement elements have grit particles 76 having sizes of about 50 to 500 micrometers. More preferably the grit particles are between about 50 to 250 micrometers, still more preferably between about 60 to 200 micrometers, and most preferably between about 50 to 100 micrometers. In another embodiment, the particles are between about 200 to 400 micrometers. In a still further embodiment the grit has a medium grit of about 220 mesh. As discussed above, the grit particles have protuberances that collectively create a surface relief so that each tissue engaging element applies a localized frictional force between the heart surface and the harness in order to resist migration of the harness relative to the surface.

In the embodiments discussed above, the particles of grit preferably are sufficiently hard to engage the heart wall without bending. As such, the surface relief protuberances will firmly engage the heart wall. In a preferred embodiment, such surface relief protuberances are less compliant than the heart wall in order to ensure a thorough and firm engagement.

The grit particles 76 in the above embodiments can include any of several materials. In accordance with one embodiment, the grit particles comprise 66 μm aluminum oxide. It is to be understood that several other materials can be used. Preferably such materials include a bio-compatible material such as silica or other similarly textured materials. In another embodiment, the grit particles are biodegradable materials such as, for example, calcium sulfate, hydroxyapatite, polymethlmethacrylate (PMMA), polylactic acid (PLA), polyglycolic acid (PGA), or the like.

With next reference to FIG. 9, another embodiment of a cardiac harness 50 has tissue engagement elements 78 that include surface relief protuberances 80 . In the illustrated embodiment, the tissue engagement element is disposed on a connector 56 between elastic rows 52 . As discussed above, such connectors preferably are formed of a semi-compliant material such as, for example, silicone or urethane. In the illustrated embodiment, the inner surface of the silicone rubber connector is treated chemically in order to alter its properties, and to create surface relief protuberances that will increase the frictional force resisting relative movement between the connector and the heart surface. In accordance with one embodiment, plasma modification is used to change the cross-linking properties of the surface of the connector in order to form the tissue engaging element having surface relief protuberances. In another embodiment, other chemical processes are used to harden the surface. In another embodiment, the surface of the connector is coated with a ceramic deposition to create surface relief protuberances. In yet another embodiment, the connector is mechanically roughened such as by sanding, machining or the like in order to create surface relief protuberances. In a still further embodiment, after surface relief protuberances are formed on a connector, the surface of the connector is chemically or mechanically treated to harden the surface of the connector so that the surface relief protuberances are sufficiently rigid to engage the heart surface.

With reference next to FIG. 10, a close-up view is provided of another embodiment wherein a tissue engaging element 78 has surface relief protuberances 80 that are manufactured according to a prescribed pattern. In the illustrated embodiment, the tissue-engaging element is located on a connector 56 disposed between adjacent elastic rows 52 in an embodiment of a harness having a structure similar to that shown and described in connection with FIG. 3. With reference next to FIG. 11, in accordance with another embodiment, a tissue-engaging element 78 is disposed on a connective junction 62 of a harness. With reference next to FIG. 12, in accordance with still another embodiment, a tissue-engaging element 78 is disposed on a tube segment 82 at a basal-most ring 72 and at an upper-most portion of a harness. Each of the embodiments shown in FIGS. 10 through 12 show different arrangements of tissue-engaging elements that can be used for a harness having structure similar to that shown and described in connection with FIG. 3. It is to be understood, however, that tissue-engaging elements can be used with any cardiac harness having any type of structure.

As just discussed, an embodiment of a tissue engaging element 78 has a manufactured pattern that defines surface relief protuberances 80 . It should be appreciated that several such patterns, as well as several methods and apparatus for constructing such patterns, can be employed. The discussion below presents some additional examples of tissue engaging elements.

With reference again to FIG. 10 and also to FIG. 13, which is a partial cross-section of FIG. 10 taken along line 13 - 13 , the engagement element 78 has a surface relief 80 formed by several rows of elongate protuberances 84 . The protuberances extend from a substrate 86 of the engagement element. Each protuberance has a first planar surface 88 and a second planar surface 90 that intersect along an edge 91 . In the illustrated embodiment, the edge also has a peak 92 , which is the furthest-most point from the substrate of the engagement element. As there are several rows of protuberances, there is a space 94 between adjacent protuberance peaks.

The first planar surface 88 is disposed at a first angle α relative to a tangent or plane of the substrate 86 . The first angle is measured from the open face of the first surface to the substrate. The second planar surface 90 is disposed at a second angle β. An edge or peak angle γ is defined by the intersection of the first and second planar surfaces. In the illustrated embodiment, the first and second angles are generally the same, about 135°, and the peak angle is about 90°. Of course, in other embodiments, the first and second angles are not necessarily the same, and one of the angles can be acute. Further, in other embodiments the peak angle can be acute or obtuse.

In accordance with this embodiment, the tissue engagement element 78 is configured so that the protuberances 84 engage the heart surface. Preferably, the size and peak angles γ of the protuberances are configured so that they engage heart tissue without substantially penetrating the heart surface, but also create a friction force that will resist migration of the engagement element relative to the heart surface in at least a direction generally transverse to the edge of the protuberances.

In accordance with one embodiment, material is drawn in the shape of the tissue engagement element embodiment discussed above. The drawn material is then cut to the size and shape of the engagement element 78 shown in FIG. 10. The engagement element is then bonded or otherwise attached to the harness. In the illustrated embodiment, the engagement element is bonded to a connector 56 disposed between adjacent elastic rows 52 . It is to be understood that, in other embodiments, the engagement element can be adhered or otherwise attached to any portion of a cardiac harness. Additionally, in accordance with other embodiments, an engagement element can be molded, machined or otherwise formed. Further, an engagement element can be attached to a connector, or an engagement element can be co-formed as part of a connector.

With reference to FIG. 14, a close-up view is provided of another embodiment wherein a tissue engaging element 78 has surface relief protuberances 80 that are manufactured according to a prescribed pattern. As illustrated in FIG. 14A, which is a cross-section of FIG. 14 taken along line 14 A- 14 A, the tissue engaging element has several rows of elongate protuberances 84 . The protuberances extend from a substrate 86 of the engaging element. Each protuberance has a first planar surface 88 and a second planar surface 90 that intersect along an edge 91 . In the illustrated embodiment, the edge also has a peak 92 , which is the furthest point from the substrate of the engaging element. There is a space 94 between adjacent protuberance peaks. When the engaging element is placed in contact with the tissue of the heart, the protuberances produce a friction force which is greatest in a direction generally transverse to the edges of the protuberances. The tissue engaging element is configured so that the protuberances engage the surface tissue of the heart without substantially penetrating the heart surface and so as to create a friction force that will resist migration of the tissue engaging element.

With continued reference to FIGS. 14 and 14A, each of the protuberances 84 may be viewed as defined by an first angle α, a second angle β, and an edge or peak angle γ. The first angle is formed by the intersection of the first planar surface 88 and a plane defined by the extent of the substrate 86 . The second angle is formed by the intersection of the second planar surface 90 and the plane of the substrate. The edge angle is defined by the intersection of the first and second surfaces. In the embodiment illustrated in FIGS. 14 and 14A, the first angle is about 135 degrees, the second angle is about 90 degrees and the edge angle is about 45°. It should be understood that, in other embodiments, the first and second angles may be different. It will be appreciated that changing the size, angles and/or the spacing of the protuberances changes the level and behavior of the friction forces between the engaging element and the heart surface, and thus affects the behavior of the tissue engaging element in suppressing migration of the harness on the heart surface.

With continued references to FIGS. 14 and 14A, the first plane angle α is greater than the second plane angle β. In this arrangement, a frictional force resisting migration of the engagement element in direction B is greater than a frictional force resisting migration of the engagement element in direction A. Thus, the engagement element of FIGS. 14 and 14A exhibits preferential migration resistance in direction B.

In accordance with one embodiment, several such preferentially directional engagement elements are installed on a cardiac harness so that the harness preferentially resists migration in a direction that is generally downwardly relative to a longitudinal axis of the heart. As such, the harness will preferentially migrate upwardly toward the base of the heart. Preferably, the structure of the harness at and around the apex is configured to prevent the harness from moving too far upwardly. Simultaneously, the directional engagement elements prevent the harness from working itself downwardly over the apex and off of the heart. Thus, the harness is held snugly in place.

In another embodiment, a plurality of directional engagement elements are disposed in various orientations around the harness. Although each engagement element exhibits preferential migration resistance, the combined effect of the plurality of variously-arranged elements holds the harness in place on the heart without substantial preferential migration in any direction. In still another embodiment, directional engagement elements are disposed on the harness so that certain zones of the harness have a preferential migration resistance. Thus, certain portions of the harness will tend to migrate in a preferred direction. For example, a right side of the harness may be configured to preferentially migrate upwardly so that the harness covers a greater proportion of the right ventricle which, as discussed above, extends farther from the apex than does the left ventricle.

With reference next to FIGS. 15 and 15A, a close-up view is provided of another embodiment wherein a tissue engaging element 78 has surface relief protuberances 80 that are manufactured according to a prescribed pattern. The tissue engaging element shown in FIG. 15 is similar to the tissue engaging element shown in FIG. 14, except as described below. As best illustrated in FIG. 15A, which is a cross-section of FIG. 15, taken along line 15 A- 15 A, on a first side 96 of a dividing line of the tissue engaging element, the protuberances 84 are oriented in a first arrangement that preferentially resists movement in direction A. On a second side 98 of the dividing line of the tissue engaging element, the protuberances are oriented in a second arrangement that preferentially resists movement in direction B. It will be appreciated that because the directions A and B are opposite to one another, the engaging element produces oppositely directed friction forces on the heart surface. Thus, the tissue engaging element resists migration in both directions A and B.

In the embodiment illustrated in FIGS. 15 and 15A, the first angle α is about 90 degrees and the second angle β is about 135 degrees in the first arrangement, but the first angle is about 135° and the second angle is about 90° in the second arrangement. It is to be understood that plane angles need not be uniform throughout an engagement element and, in some embodiments adjacent protuberances may have different plane angles.

FIGS. 16 and 16A illustrate another embodiment of a tissue engaging element 78 which is capable of gripping the surface tissue of the heart. The tissue engaging element illustrated in FIGS. 16-16A, is substantially similar to the engaging element illustrated in FIGS. 15-15A. However, the plane angles α and β in FIGS. 16-16A differ from those of FIGS. 15-15A. For example, on the first side 96 , the first angle is acute and the second angle is an obtuse angle of more than about 135°. A similar embodiment of a tissue engaging element 78 is illustrated in FIGS. 17 and 17A. The tissue engaging element illustrated in FIGS. 17-17A has a space 94 between adjacent protuberances 84 . It will be appreciated that changing the size, angles and/or the spacing of the protuberances changes the level of the friction force which the engaging element can exert on the heart surface, and thus affects the level to which the tissue engaging element suppresses migration of the harness on the heart surface.

FIGS. 18 and 18A illustrate one embodiment of a tissue engaging element 78 which has a surface relief formed by several rows of protuberances 84 . The protuberances illustrated in FIGS. 18-18A are substantially similar to the elongate protuberances illustrated in FIGS. 14-14A. However, the protuberances illustrated in FIGS. 18-18A do not extend all the way across the engagement element. Instead, a plurality of rows 100 of protuberances are disposed adjacent one another. As best shown in FIG. 18A, each protuberance terminates with an upper-most edge which also has a peak 92 . As there are several protuberances in each row, there is a space 94 between adjacent protuberance peaks. The protuberances in each row preferably have a peak-to-peak spacing of about 10 μm to 500 μm. Each row is arranged to preferentially frictionally resist movement in one direction. Adjacent rows preferably have opposite preferred resistance directions. In other embodiments, the adjacent rows may be spaced apart from one another. For example, in the embodiment illustrated in FIGS. 19 and 19A, adjacent rows are separated by a space 94 . With reference to FIGS. 18 through 19A, it will be appreciated that because adjacent rows are capable of producing friction forces in opposite directions on the heart surface, the totality of the rows forming the tissue engaging element are capable of producing friction forces which grip the surface tissue of the heart.

With reference next to FIG. 20, one embodiment of a tissue engaging element 78 has surface relief protuberances 102 that are arranged into a row/column structure. As shown in FIG. 20A, which is a cross-section of FIG. 20 taken along line 20 A- 20 A, the tissue engaging element has a surface relief formed by several rows of protuberances 104 . The protuberances extend from a substrate 106 of the engaging element. Each protuberance has a first planar surface 108 and a second planar surface 110 that intersect along an edge 112 . Similarly, as shown in FIG. 20B, which is a cross-section of FIG. 20 taken along line 20 B- 20 B, the surface relief protuberances of the engaging element are divided into several columns. Each protuberance comprises a third planar surface 114 and a fourth planar surface 116 that intersect along an edge. As illustrated in FIG. 20 the edges formed by the planar surfaces intersect at a peak 118 , which is the furthest point from the substrate of the engaging element. In the illustrated embodiment, the peak is generally pointed, and the edges at which the planes intersect are not elongate.

With continued reference to FIG. 20, each of the planar surfaces 108 , 110 , 114 and 116 has an inclination angle δ. The inclination angle is formed by the intersection of the planar surface and a plane defined by the surface of the substrate. In the illustrated embodiment, the four planar surfaces have equal inclination angles, thus giving the protuberances a pyramid shape. As there are several rows and columns of protuberances, there is a space 120 between adjacent protuberance peaks. When the tissue engaging element is placed in contact with the heart surface, the protuberances engage the surface tissue without substantially penetrating the heart surface so as to create a friction force that will resist migration of the tissue engaging element relative to the heart surface.

With continued reference to FIG. 20, because the planar surfaces 108 , 110 , 114 and 116 have the same inclination angles δ, the peaks 118 are centrally positioned within the pyramid-shaped protuberances. Thus, the tissue engaging element produces friction forces that resist migration of the harness generally equally in directions facing each plane. In another embodiment, the peaks are advantageously positioned off-center so that frictional forces resisting migration in a first direction are greater than frictional forces resisting migration is a second direction. FIG. 21 illustrates one embodiment of a tissue engaging element that has pyramid-shaped protuberances with off-center peaks.

As shown in FIG. 21A, which is a cross-section of FIG. 21 taken along line 21 A- 21 A, the tissue engaging element 78 has a surface relief formed by several rows and columns of protuberances 104 . The protuberances extend from a substrate 106 of the engaging element. Each protuberance has a first planar surface 108 and a second planar surface 110 that intersect along an edge 112 . Similarly, as shown in FIG. 21B, which is a cross section of FIG. 21 taken along line 21 B- 21 B, the surface relief protuberances are arranged into several columns that extend from the substrate of the engaging element. Each protuberance has a third planar surface 114 and a fourth planar surface 116 that intersect along an edge 117 . As illustrated in FIG. 21 the edges formed by the planar surfaces intersect at a peak 118 , which is the furthest point from the substrate of the engaging element. In one embodiment, the protuberances extend to a height of about 0.005 inches or less above the substrate. The peaks are separated from adjacent peaks within the same row/column by a distance of about 0.007 inches.

With continued reference to FIG. 21, each of the planar surfaces 108 , 110 , 114 and 116 of the protuberances 104 can be viewed as defined by an inclination angle δ. The inclination angle is formed by the intersection of the planar surface and a plane defined by the surface of the substrate 106 . In the illustrated embodiment, the inclination and third planar surfaces have equal inclination angles of about 135 degrees, while the second and fourth planar surfaces have equal inclination angles of about 90 degrees. Because of the difference in inclination angles, the peaks 118 are not centrally positioned on the protuberances. Instead, the peaks are off center as shown in FIG. 21. When the tissue engaging element is placed in contact with the tissue of the heart, the off-center peaks of the protuberances engage the surface tissue of the heart so as to create friction forces that provide greater resistance to migration of the tissue engaging element in a first direction than in a second direction.

It is to be noted that in other embodiments, the inclination angles of the second and fourth planar surfaces may be greater than or lesser than about 90 degrees. Likewise, in other embodiments the inclination angles of the first and third plan