Lau, Lilip (Los Altos, CA, US)
Fishler, Matthew (Sunnyvale, CA, US)
Mar, Craig (Fremont, CA, US)
Meyer, Steven (Oakland, CA, US)
Patel, Anuja (Sunnyvale, CA, US)

Plaque It! Sponsored by: Flash of Genius

11/033409

10/16/2007

01/10/2005

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

600/37

623/3.100, 600/16

A61F2/00

600/37, 623/3.16, 623/3.1, 600/16, 623/3.17

2278926	Knitted metallic fabric for belting and other uses	April, 1942	Hartwell
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	Vaughn
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
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.
5876432	Self-expandable helical intravascular stent and stent-graft	March, 1999	Lau 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.	600/16
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	Lederman et al.
6230714	Cardiac constraint with prior venus occlusion methods	May, 2001	Alferness et al.
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.
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.
6517570	Exterior supported self-expanding stent-graft	February, 2003	Lau 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.
6876887	Cardio therapeutic heart sack	April, 2005	Okuzumi
6881185	Delivery of cardiac constraint jacket	April, 2005	Vanden Hock et al.
6887192	Heart support to prevent ventricular remodeling	May, 2005	Whayne et al.
6893392	Cardiac reinforcement device	May, 2005	Alferness
6896652	Cardiac disease treatment and device	May, 2005	Alferness et al.
6902522	Cardiac disease treatment and device	June, 2005	Walsh et al.
6902524	Cardiac disease treatment and device	June, 2005	Alferness et al.
6908426	Cardiac disease treatment and device	June, 2005	Shapland et al.
7181272	Cardiac restraint with electrode attachment sites	February, 2007	Struble et al.	607/4
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
20020022880	Device and method for restructuring heart chamber geometry	February, 2002	Melvin
20020045798	Expandable cardiac harness for treating congestive heart failure	April, 2002	Lau et al.	600/37
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.
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.
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.
20050059854	Apparatus and method for applying cardiac support device	March, 2005	Hoek et al.
20050085688	Cardiac support device	April, 2005	Girard et al.

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
SU1009457	April, 1983
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/2000/002500	January, 1999			CARDIAC DISEASE TREATMENT DEVICE AND METHOD
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/2000/006026	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/2000/036995	June, 2000			METHOD AND APPARATUS FOR REINFORCEMENT OF THE HEART VENTRICLES
WO/2000/042919	July, 2000			ANTERIOR AND INFERIOR SEGMENT CARDIAC RESTORATION APPARATUS AND METHOD
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

Cohn, Jay N., M.D., The Management of Chronic Heart Failure, The New England Journal of Medicine, vol. 335, No. 7, pp. 490-498, August 15, 1996.
Zhou, Xiaohong, et al., Epicardial Mapping of Ventricular Defibrillation With Monophasic and Biphasic Shocks in Dogs, Circulation Research, vol. 72, No. 1, pp. 145-160, Jan. 1993.
Shorofsky, Stephen R., et al., Comparison of Step-Down and Binary Search Algorithms for Determination of Defibrillation Threshold in Humans, PACE, vol. 27, pp. 218-220, Feb. 2004.
Gold, Michael R., M.D., et al., Comparison of Single- and Dual-Coil Active Pectoral Defibrillation Lead Systems, Journal of the American College of Cardiology, vol. 31, No. 6, pp. 1391-1394, May 1998.
Rinaldi, C. Aldo, A Randomized Prospective Study of Single Coil Versus Dual Coil Defibrillation in Patients With Ventricular Arrhythmias Undergoing Implantable Cardioverter Defibrillator Therapy, PACE, vol. 26, pp. 1684 1690, Aug. 2003.
Schwartzman, David, M.D., et al., Serial Defibrillation Lead Impedance in Patients with Epicardial and Nonthoracotomy Lead Systems, Journal of Cardiovascular Electrophysiology, vol. 7, No. 8, pp. 697-703, Aug. 1996.
Sandstedt, Bengt, et al., Bidirectional Defibrillation Using Implantable Defibrillators: A Prospective Randomized Comparison Between Pectoral and Abdominal Active Generators, PACE, vol. 24, Part I, pp. 1343-1353, Sep. 2001.
Schulte, B., et al., Dual-Coil vs. Single-Coil Active Pectoral Implantable Defibrillator Lead Systems: Defibrillation Lead Requirements and Probability of Defibrillation Success at Multiples of the Defibrillation Energy Requirements, Europace, vol. 3, pp. 177-180, Jul. 2001.
U.S. Appl. No. 09/952,145, filed Sep. 10, 2001 published on Feb. 14, 2003 as Pub. No. 02-0019580-A1; Inventors: Lau et al.
U.S. Appl. No. 10/314,696, filed Dec. 9, 2002 published on Apr. 3, 2003 as Pub. No. 03-0065248-A1; Inventors: Lau et al.
U.S. Appl. No. 60/486,062, filed Jul. 10, 2003; Inventors: Hong et al.
U.S. Appl. No. 10/698,237, filed Oct. 31, 2003 published on Jul. 29, 2004 as Pub. No. 04-0147805-A1; Inventor: Lau.
U.S. Appl. No. 10/704,376, filed Nov. 7, 2003; Inventor: Lau.
U.S. Appl. No. 10/715,150, filed Nov. 17, 2003 published on Mar. 10, 2005 as Pub. No. 05-0055032; Inventor: Lau.
U.S. Appl. No. 60/535,888, filed Jan. 12, 2004; Inventors: Fishler et al.
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.
Schetky, L. McDonald, Shap- Memory Alloys, Scientific American, vol. 241, No. 5, pp. 74-82, Nov. 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. 1559-1603, 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 Adyanmic 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.
Guadron, 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 traiamiento de le microcardiopatia dilatads, Revista Españo la 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.
ABSTRACT—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 Norman Preicardium: Initial Clinical Experience with a Novel Device, Clinical Cardiology, vol. 22 (Suppl. I), pp. I-36 thru I-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.
Shabetai, Ralph, The Role of the Pericardium in the Pathophysiology of Heart Failure, Congestive Heart Failure, Second Edition, Chapter 9, pp. 157-187, 2000.
U.S. Appl. No. 09/952,145, filed Sep. 10, 2001 published on Feb. 14, 2003 as Pub. No. 02-0019580-A1.
U.S. Appl. No. 10/314,696, filed Dec. 9, 2002 published on Apr. 3, 2003 as Pub. No. 03-0065248-A1.
U.S. Appl. No. 60/486,062, filed Jul. 10, 2003.
U.S. Appl. No. 10/698,237, filed Oct. 31, 2003 published on Jul. 29, 2004 as Pub. No. 04-0147805-A1.
U.S. Appl. No. 10/704,376, filed Nov. 7, 2003.
U.S. Appl. No. 10/715,150, filed Nov. 17, 2003.
U.S. Appl. No. 60/535,888, filed Jan. 12, 2004.

Evanisko, George R.

Stoklosa, Joseph

Fulwider Patton LLP

CROSS-REFERENCE TO RELATED APPLICATIONS

This application depends for priority upon U.S. Provisional Application No. 60/535,888 filed Jan. 12, 2004, which is incorporated herein in its entirety by reference.

We claim:

1. A cardiac harness for mounting on a heart, comprising: a plurality of undulating rows having a plurality of apices, each of the rows connected to an adjacent row by at least one connector; a plurality of the connectors arranged in a connector assembly, wherein a transverse spacing between connectors of adjacent rows within the connector assembly is no greater than one apex, and wherein the at least one connector connects to only one apex of a first row and more than one apex of a second row.

2. The cardiac harness of claim 1, wherein the at least one connector is generally Y-shaped.

3. The cardiac harness of claim 1, wherein at least some of the rows are arranged into 360° circumferential rows.

4. The cardiac harness of claim 1, further comprising a first connector assembly and a second connector assembly, the first connector assembly being arranged in a different pattern than the second connector assembly.

5. The cardiac harness of claim 1, wherein the rows have proximal apices and distal apices, the at least one connector between adjacent rows connects a proximal apex of a first row to a distal apex of a second row.

6. The cardiac harness of claim 1, wherein the connector is formed from an elastomer.

7. The cardiac harness of claim 1, wherein the connector is formed from silicone rubber.

8. The cardiac harness of claim 1, wherein longitudinal elasticity of the harness generally correlates to the elasticity of the connectors.

9. The cardiac harness of claim 1, wherein the connector member is formed from a flexible material.

10. The cardiac harness of claim 1, wherein the cardiac harness is configured for mounting on a beating heart.

FIELD OF THE INVENTION

The present invention relates to a device for treating heart failure. More specifically, the invention relates to a cardiac harness configured to be fit around at least a portion of a patient's heart. The cardiac harness includes multiple elastic rows or undulating strands extending circumferentially around the heart and connected together by a connector assembly.

BACKGROUND OF THE INVENTION

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 currently unavailable, is a cardiac harness having multiple elastic strands or rows interconnected by a connector assembly that prevents the longitudinal migration of the rows after the cardiac harness is mounted on the patient's heart.

SUMMARY OF THE INVENTION

The present invention relates generally to a cardiac harness that is configured to fit at least a portion of a patient's heart. The cardiac harness includes adjacent rows that are connected to one another by one or more connectors. The connectors help to maintain the position of the elastic rows relative to one another. In one embodiment, the connectors form a connector assembly between the adjacent rows of the cardiac harness. The connector assembly has a pattern that provides longitudinal stability between the adjacent rows so that the rows do not expand or shift longitudinally while mounting the harness on the heart or during use after the harness is mounted on the heart.

In another embodiment, an elongated connector is woven through the apices of adjacent rows to again maintain the spacing between the rows during delivery and use of the cardiac harness. Typically, the connectors are formed from an elastomeric material, preferably silicone rubber.

The connectors are formed by placing the undulating strands or rows in a mold and injecting the elastomeric material through the gates in the mold to form the connectors. Typically, the connectors extend between the apices of adjacent rows so that the elastomeric material formed in the mold flows around the apices of adjacent rows. Preferably, the elastomer is a silicone rubber or similar material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a schematic view of the 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 an unattached elongated strand or row, or series of spring elements that are coated with a dielectric material.

FIG. 4 depicts a perspective view of an embodiment of a cardiac harness having a plurality of rows connected by a connector assembly.

FIG. 5 depicts a portion of a elastic row showing the ends of the row being connected by a connector.

FIG. 5A depicts a portion of a row showing the ends of the row being connected by a connector.

FIG. 6 depicts an enlarged partial plan view of a cardiac harness wherein the connectors provide uniform spacing between adjacent rows.

FIG. 6A depicts an enlarged partial plan view of a cardiac harness wherein the connectors form a pattern that permits distended spacing between adjacent rows.

FIG. 7 depicts an enlarge partial plan view of a cardiac harness wherein the connectors form a connector assembly.

FIG. 8 depicts an enlarged partial plan view of a cardiac harness wherein the connectors form a connector assembly.

FIG. 9 depicts an enlarged partial plan view of a cardiac harness wherein Y-shaped connectors connect adjacent rows of the cardiac harness.

FIG. 10 depicts an enlarged partial plan view of a cardiac harness wherein a single elongated connector is woven between apices of adjacent rows.

FIG. 11 depicts an enlarged partial plan view of a cardiac harness wherein a single connector is woven between all of the apices of adjacent rows.

FIG. 12 depicts an enlarged partial plan view of a cardiac harness wherein a single connector is attached to the apices of adjacent rows.

FIG. 12A depicts a cross-sectional view taken along lines 12 A- 12 A showing attachment of the connector to an apex of one of the rows.

FIG. 13A depicts a plan view of a sheet of material used to form a connector.

FIG. 13B depicts a plan view of a sheet of material having cuts that form an elongated connector.

FIG. 13C depicts a plan view of an elongated connector.

FIG. 14 depicts a plan view of a mold for forming connectors between adjacent rows of a cardiac harness.

FIG. 15 depicts a plan view of a mold for forming connectors between adjacent rows of a cardiac harness.

FIG. 16 depicts an enlarged partial plan view of a cardiac harness wherein connectors extend longitudinally along the rows of the cardiac harness attaching distal apices.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present 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, now U.S. Pat. No. 6,702,732 issued Mar. 9, 2004, 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, now U.S. Pat. No. 6,723,041 issued Apr. 20, 2004; “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; “Cardiac Harness,” Ser. No. 10/656,722, filed Sep. 5, 2003; “Cardiac Harness Delivery Device and Method,” Ser. No. 10/715,150, filed Nov. 17, 2003; “Multi-Panel Cardiac Harness,” Ser. No. 60/458,991, filed Mar. 28, 2003; “Self Anchoring Cardiac Harness,” Ser. No. 60/486,052, filed Jul. 10, 2003; and “Cardiac Harness,” Ser. No. 10/698,237, filed Oct. 31, 2003, the entirety of each of which is hereby expressly incorporate by reference.

FIG. 1 illustrates a mammalian heart 30 having a cardiac wall stress reduction device in the form of a harness 32 applied to it. The cardiac harness 32 includes rows of elastic members that circumscribe the heart 30 and, collectively, apply a mild compressive force on the heart 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, includes several rows or strands 36 of elastic members. Each row has a series of spring elements 34 , also referred to as hinges or spring hinges, that are configured to deform as the heart 30 expands during filling. For example, FIG. 2A shows one embodiment of a hinge member 34 at rest. The hinge member 34 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 40 . The bending moment 44 urges the hinge member 34 back to its relaxed condition. Note that a typical row or strand has a series of such hinges, and that the hinges 34 are adapted to elastically expand and retract in the direction of the strand 36 .

In the embodiment illustrated in FIG. 1, the elastic rows 36 are constructed of pulled or extruded wire that is deformed to form the spring elements. Although FIG. 1 shows adjacent rows interwoven one with another, it is to be understood that, in additional embodiments, adjacent rows may not overlay or touch one another.

With next reference to FIG. 3, a close-up of a portion of one embodiment of an elastic row 36 is shown. In the illustrated embodiment, the row comprises an undulating strand of wire 46 formed into a series of successive spring elements 34 . A dielectric coating 48 is disposed over the spring elements. In the illustrated embodiment, the dielectric coating comprises silicone or more precisely silicone rubber. Other acceptable materials include urethanes as well as various polymers, elastomers and the like. In the illustrated embodiment, the silicone rubber coating comprises tubing 50 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.

With reference next to FIG. 4, an embodiment of a cardiac harness 32 having several adjacent elastic rows 36 is illustrated. In this embodiment, adjacent rows preferably are connected to one another by one or more connectors 52 . 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 to create a space between adjacent rows. The illustrated harness is configured to circumferentially surround at least a portion of the heart between the heart apex and base portions. Preferably, the connectors allow some relative movement between adjacent rows.

The connectors 52 preferably are formed of a semi-compliant material such as silicone rubber. Most preferably the connectors are formed of the same material used for the dielectric coating 48 , if applicable. Some additional materials that can be used for the conductors 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 36 exert a force in resistance to expansion of the heart 30 . 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 to reduce wall stresses. For example, elastic members can be disposed over only a portion of the circumference of the heart or harness.

In one embodiment, each elastic row 36 initially includes an undulating elongate strand 46 . During manufacturing of the cardiac harness 32 , 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 comprise 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 54 of the harness are not as long as strands used to form the base portion 56 . As such, and as shown in FIG. 4, the harness generally tapers from the base 56 toward the apex 54 in order to generally follow the shape of the patient's heart.

In another embodiment, the diameter of a base ring or row 58 at the base 56 of the harness 32 is smaller than the diameter of the adjacent row. In this embodiment, the harness has a greatest diameter at a point 60 between the base and apex ends 54 , 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 rows, as well as the sizes of the spring members 34 , 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 reference to FIG. 5, the opposite ends 62 , 63 of each circumferentially extending row are attached to one another by a connective junction 64 . In one embodiment, illustrated in FIG. 5, each connective junction 64 includes a small tube segment 66 into which the opposite ends 62 , 63 of the row are inserted. The tube segment serves to prevent the opposite ends of the row from tearing loose from one another after the harness is placed on the heart. Preferably, each tube segment is filled with a dielectric material 68 such as silicone rubber, or other similar material after the row ends are placed therein. It is to be understood that additional methods and structure can be used to form the connective junction. For example, in another embodiment, illustrated in FIG. 5A, each connective junction 64 includes a small tube segment 66 into which the spring members 34 at the opposite ends 62 , 63 of the row 36 are inserted. The connective junction is then back-filled with a liquid silicone rubber 68 or other similar material. In still another embodiment, the ends of the strands can be welded together or intertwined. Also, in other embodiments, each ring can be unitarily formed without requiring cutting and joining of the ends.

In a still further embodiment, a cardiac harness 32 is formed by arranging one or more undulating strands 46 in a helix (not shown). In such an embodiment, portions of the helically-arranged strand are disposed adjacent one another. As with the rows/rings 36 shown in FIG. 4, connectors 52 may connect the adjacent portions. In keeping with the invention, certain aspects and principles are discussed for connecting adjacent rows/rings of a harness. It is to be understood that the same principles can be applied to a helically-arranged harness embodiment, and that adjacent portions of such a harness may be treated like adjacent rows or rings.

Due to the anatomy of the human heart, the right ventricle extends further from the apex of the heart than does the left ventricle. The cardiac harness 32 illustrated in FIG. 4 includes a right ventricle engagement portion 70 configured to fit about the uppermost portion of the right ventricle where the ventricle begins to curve inwardly. With continued reference to FIG. 4, the right ventricle engagement portion of the harness has elastic rows 36 that form only a partial row 72 . Preferably, the partial rows are connected to the adjacent full row 36 in a manner so that the partial rows are at least partially stretched when the rest of the harness is at rest. As such, the partial rows are biased inwardly. When placed on the heart, the partial rows “cup” the upper portion of the right ventricle. 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 row (not shown) that is less compliant than rows elsewhere in the harness. In one embodiment, the basal-most row has a larger diameter wire (not shown) than the wire of the other rows of the harness. In another embodiment, the basal-most row has a shorter length of wire (not shown) than the other rows of the harness. As such, once the cardiac harness is appropriately positioned on the heart, the basal-most row 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. Accordingly, it is contemplated that the basal-most row 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 rows, 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 he 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, 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 he elastic or substantially non-elastic.

With reference to FIG. 6, a representative portion of a cardiac harness embodiment is illustrated. The illustrated portion presents a connector assembly having connectors as discussed in connection with FIG. 4. As discussed herein, the connectors interconnect adjacent rings of the cardiac harness and thus provide longitudinal structure to the harness. The connectors have a length oriented longitudinally relative to the rings so that adjacent rings are spaced apart a short distance.

As shown in FIG. 6, each of the rows 36 includes an undulating spring member 74 . For purposes of this discussion, each undulating spring member includes a proximal portion 75 having a proximal apex 76 and a distal portion 78 having a distal apex 80 . The connectors 52 connect adjacent rows by aligning the proximal apex of one row with the distal apex of an adjacent row, and a connector extends therebetween. The connectors define the spacing 82 between the distal apex of one row and the proximal apex of an adjacent row. The connector assembly illustrated in FIG. 6 illustrates an arrangement of connectors that is used as a pattern generally through all or a portion of one cardiac harness embodiment. In connection with this embodiment, and at least the embodiments discussed below in connection with FIGS. 6-9, the term “connector assembly” refers to at least the pattern and spacing of connectors between rows.

One way to describe the arrangement of connectors in a connector 52 in a connector assembly is by a transverse spacing T between connectors of adjacent rings or rows 36 . The transverse spacing T is measured as the number of apices between a connector disposed on a proximal apex 76 of the row and the nearest connector that is disposed on the distal apex 80 of the row, when counting in a transverse direction (circumferentially). For example, in the embodiment illustrated in FIG. 6, the connectors have a transverse spacing T of 5. In other words, in the disclosed embodiment, there are three proximal apices and two distal apices, totaling five apices between the connectors. Of course, in other embodiments, the transverse spacing can be greater or less than 5. Further, the transverse spacing can vary through the harness. In the illustrated embodiment, however, the connector assembly is arranged such that there is a transverse spacing T of more than one apex between adjacent rows.

With reference to FIG. 6A, it has been found that when a longitudinal force is applied to a harness 32 with a connector assembly having a transverse spacing T of more than one apex between adjacent rows 36 , portions of the adjacent rows between the connectors 52 have a tendency to move longitudinally, while the distance between adjacent rows at the connector remains the same. As such, distended spaces 84 are formed between adjacent rows. As shown in FIG. 6A, the result of such distended spaces is that the rows of spring hinges 34 are somewhat deformed. In fact, the geometry of the undulating rows 46 can become significantly distorted and inconsistent. When mounting the cardiac harness onto the heart and during operation, the spring members are exposed to varying longitudinal and transverse stresses. Since the design of at least some embodiments of undulating rows are optimized for transverse stresses, distended spaces can result in inconsistent and irregular loading of the cardiac harness embodiment. This can reduce the efficacy of the harness and reduce the lifetime of the undulating rings.

With reference to FIG. 7, a portion of another embodiment of a cardiac harness 32 is illustrated. The illustrated portion employs another embodiment of a connector assembly. In the illustrated embodiment, each connector 52 extends between a distal apex 80 of one row 36 A and a proximal apex 76 of a spring member 34 on the adjacent row 36 B. As shown in FIG. 7, a second row 36 B is connected to a first row 36 A by a connector 52 extending from a proximal apex of the first row connected to a distal apex of the second row. The second row is then connected to a third row 36 C by a connector extending from a proximal apex of the second row to a distal apex of the third row. As shown, the connector between the second and third rows is arranged immediately adjacent the connector between the first and second rows so that the transverse spacing T between the connectors is only one apex. A similar disposition exists between the third row 36 C and fourth row 36 D and, preferably. through all or a portion of the harness. This arrangement is labeled and referred to as a “1-1-1” longitudinal structure. The transverse spacing T of the “1-1-1” longitudinal structure minimizes the number of spring member apices between adjacent connectors, and thus minimizes distended stretching of spring members between adjacent connectors. Thus, the longitudinal stretching of the cardiac harness when the harness is installed on the heart is substantially reduced.

In the embodiment illustrated in FIG. 7, two “1-1-1” connector assemblies (A, B) are shown. In one embodiment, several such connector assemblies extend from the apex 54 to the base 56 of the harness. It is to be understood that such connector assemblies can also extend only part way from the base to the apex. It is also to be understood that a cardiac harness may have two or more connector assemblies having different patterns of connectors.

FIG. 8 illustrates a portion of another embodiment of a cardiac harness 32 connector assembly. In the illustrated embodiment, the connector assemblies are arranged in a “1-2-1” longitudinal structure. More specifically, the connector assemble is comprised of a single connector 52 interconnecting a proximal apex 76 of a first row 36 A and a distal apex 80 of a second row 36 B, followed by two connectors 52 connecting the adjacent proximal apices of the second row with two adjacent distal apices of a third row 36 C, followed by a single connector interconnecting a proximal apex of the third row and a distal apex of a fourth row 36 D. As shown in FIG. 8, the two connectors interconnecting the second and third rows are disposed on the apices immediately adjacent the apices supporting the single connector between each of the first and second and the third and fourth rows. The transverse spacing T between adjacent connectors of the rows in this connector assembly embodiment is one apex.

The illustrated arrangement lends further longitudinal rigidity to the cardiac harness, as longitudinal forces acting upon the harness are generally distributed through the connectors rather than the bending portions of the spring members. This is because there are no spring apices between connectors to allow the creation of distended spaces as illustrated in FIG. 6A. Additionally, the longitudinal stretching of the cardiac harness when the harness illustrated in FIG. 8 is installed on the heart is substantially reduced. Due to the longitudinal rigidity of the cardiac harness, it can be repositioned or moved on the heart by using forceps (or the physician's hand) to pull on the apex of the harness or to grasp and push on the base of the harness.

It is to be noted that although FIGS. 6-8 illustrate connector assemblies comprised of specific numbers of connectors 52 , each connector assembly may advantageously be comprised of more than or less than the number of the connectors illustrated in FIGS. 6-8, depending on the particular harness 32 and/or utilization thereof contemplated. It is also to he understood that although just a few adjacent rows have been illustrated, the illustrated connector assembly arrangements are simply for illustration, and it is anticipated that such arrangements will extend longitudinally through all or at least a portion of the cardiac harness.

FIG. 9 illustrates another embodiment of a connector assembly for interconnecting rows of a cardiac harness. The connector assembly is formed of several Y-shaped connectors 85 , each of which includes a first attachment portion 86 , a second attachment portion 87 , and a third attachment portion 88 . The attachment portions give the connector a generally “Y-shaped” geometry. Preferably, the connector is formed of a semi-compliant material, such as silicone rubber or other similar material. In the embodiment illustrated in FIG. 9, the first and second attachment portions of each connector are attached to proximal apices 76 of a first row 36 A, while the third attachment portion of each connector is attached to the distal apex 80 of an adjacent second row. In another embodiment, the proximal/distal arrangement is reversed.

As illustrated. the transverse spacing T between the first attachment portion 86 or second attachment portion 87 and the third attachment portion 88 is one apex. As such, when the harness is subjected to longitudinal forces, most or all of the longitudinal forces will be communicated through the Y-shaped connectors 85 and the bending portions of the undulating spring members 34 will encounter little or none of the longitudinal force.

It is to be understood that in other embodiments, the specific form and shape of a connector assembly may be different. Yet, the assembly may similarly be adapted to connect adjacent undulating rows so that a proximal portion of a first row is attached to a distal portion of an adjacent row in a manner that communicates longitudinal forces through the connectors and minimizes longitudinal distention of spring members due to such longitudinal forces.

FIG. 10 illustrates another embodiment of a connector assembly which is utilized for interconnecting rings of a cardiac harness. The connector assembly is comprised of a long, thin connector 90 which is interwoven between apices 92 (reference number 92 points to the apex region since the connector covers the apex) of adjacent undulating rows 36 of a cardiac harness 32 . As shown in FIG. 11, the connector has a length sufficient to pass through every apex 92 of the adjacent rows and thus interconnects all of the undulations forming the adjacent rows. The connector preferably is formed of a semi-compliant dielectric material, such as silicone rubber or other similar material. In the embodiment illustrated in FIG. 11, the connector is formed from silicone tubing substantially similar to the silicone tubing discussed with reference to FIG. 3.

In another embodiment, illustrated in FIG. 12, a row connector is comprised of a long, thin strip 94 of dielectric material which is formed into numerous elongate portions 96 and attachment portions 98 . The attachment portions are disposed at opposite ends of each elongate portion. The elongate portions interconnect all of the apices of adjacent undulating rows 36 of the harness. The attachment portions facilitate fastening the elongate portions of the apices 93 . One embodiment of an attachment portion is illustrated in FIG. 12A, which is cross-sectional view of FIG. 12, taken along line 12 A- 12 A. As shown, the attachment portion 98 is passed over the spring member apex 92 (apex region) and adhered to the underside of the elongate portion 96 , thereby locking the spring member within the attachment portion. The wire 100 forming the cardiac harness has a dielectric coating 102 , which is covered by the attachment portion in the area of the apex of the row. Preferably, an adhesive 104 is used to adhere the attachment portion to the elongate portion.

With continued reference to FIGS. 10 through 12A, because all of the apices participate in connecting the rows of the harness, distended spaces such as those shown in FIG. 6A are substantially eliminated. Additionally, the connectors shown in FIGS. 10 and 12 prevent the rows from becoming overturned, flipped over, or tangled with one another during installation of the harness on the heart.

It has been found that cardiac harnesses comprised of connector assemblies of the forms shown in FIGS. 10 and 12 exhibit low compliance in longitudinal tension, yet provide relatively high compliance in longitudinal compression. This facilitates normal longitudinal strain of the heart during the cardiac cycle. It has also been found that the connector assemblies of FIGS. 10 and 12 provide harnesses exhibiting relatively high compliance in shear. This allows adjacent rows to twist with respect to one another, and thereby allows for normal epicardial shear (i.e., torsion) during the cardiac cycle. Moreover, the connectors shown in FIGS. 10 and 12 generally uniformly distribute the compressive forces of the rows on the surface of the heart, thereby reducing the possibility that myocardial aneurysms may form between adjacent rows.

With reference to FIGS. 13A through 13C, one embodiment of a method for making the connector 94 of FIG. 12 is shown. Initially, the connector is formed from a sheet 106 of material having properties and/or characteristics desired for the connector. Preferably, the sheet material is a dielectric, semi-compliant material such as silicone rubber or other similar material. As shown in FIG. 13A, the sheet has a length which is generally longer than its width. As shown in FIG. 13B, a series of cuts 108 are applied to the sheet on opposite sides. The cuts preferably are generally linear along a direction transverse to the length of the sheet. The cuts alternate from one side of the sheet to the other side to form a series of elongate portions 96 which are endwise attached to one another. An undulating connector 94 is thus provided upon stretching the sheet lengthwise, as shown in FIG. 13C.

In another embodiment, a row connector includes an elongate tube or wire formed of an elastomeric material such as silicone rubber wound between adjacent apices of adjacent undulating rows. In still another embodiment, the connecting member is not wound between every single adjacent apex. In still another embodiment, a connecting member is formed by molding a row connection member substantially in the shape of the cut connector shown in FIG. 13C.

With reference to FIG. 14, another example of a method and apparatus for interconnecting the elastic rows 36 of a harness 32 is provided. FIG. 14 discloses one embodiment of a mold 110 for making the connectors 52 shown and discussed in connection with FIG. 4, and for assembling a cardiac harness having adjacent undulating rows. The mold includes a base portion 112 and a connector portion 114 . The connector portion includes a gate 116 for injecting a liquid material into the connector portion. The connector portion has a shape and size optimal for allowing the liquid material to solidify into a connector. Preferably, the liquid material used for the connectors is silicone rubber or other material suitable for making the connectors. The shape and size of the connectors can vary and the connectors can be formed with ridges or protrusions on the side facing the heart to increase frictional engagement between the connectors and the heart to hold secure the harness on the heart. The base portion is configured to receive at least two rows 36 . The two rows are releaseably attached to the mold so that at least one apex 118 from each row passes within the connector portion. In one embodiment, the rows are fastened to the mold in a stretched state. This facilitates adjusting the positions of the rows on the mold. The mold preferably is made of Teflon or other similar material.

In operation, the connector portion 114 of the mold 110 is partially filled with liquid silicone rubber or another material selected for the connector 52 . The liquid silicone rubber is injected into the connector portion through the gate 116 . As discussed above, the two rows 36 are positioned on the mold so that one apex member 118 from each ring is positioned within the connector portion, as shown in FIG. 14. Once the apices are suitably positioned, the connector portion is filled to capacity with the liquid silicone rubber. The liquid silicone is then cured in the connector portion. In one embodiment, the liquid silicone rubber is baked in the connector portion at a temperature of about 150° C. for a period of about five minutes. The solidified connector is then removed from the mold along with the two rows.

In other embodiments, the connector portion 114 can have shapes and sizes different than those shown in FIG. 14, depending on the type of connectors desired. For example, in another embodiment, the connector portion may have a “Y-shape” as illustrated and discussed above in connection with FIG. 9. Moreover, the mold 110 may include several connector portions to facilitate assembling most or all of a harness.

FIG. 15 discloses one embodiment of a mold 110 for making a connector assembly comprising multiple connectors 52 . The mold shown in FIG. 15 is configured for making connector assemblies of the form illustrated and discussed in connection with FIG. 8. Several rows 36 can be disposed in the mold shown in FIG. 15 and the multiple connector portions 114 can be filled with the liquid material simultaneously. It will be appreciated that in other embodiments, the positions of the connector portions on the mold may be changed to facilitate making other connector assemblies, such as any of the connector assemblies illustrated in FIGS. 6-9.

Molds of the type illustrated in FIG. 15 are particularly suitable for one method embodiment of making a cardiac harness 32 , in which a totality of the elastic rows 36 (FIG. 3) comprising the harness are positioned in a mold 110 having multiple connector portions 114 positioned at locations suitable for forming connectors 52 between the elastic rows of the harness 32 . The elastic rows are positioned in the mold in an arrangement which facilitates simultaneously forming all of the connectors between all of the elastic rows of the harness. Operation of the mold is substantially identical in all respects to the operation of the mold illustrated and discussed in connection with FIG. 14. Once the connectors are formed, the elastic rows are folded so that the opposite ends of each strand meet one another, thereby forming the rows of the harness. The opposite ends are secured to one another as illustrated and discussed in connection with FIGS. 5-5A.

With reference to FIG. 16, a portion of another embodiment of a cardiac harness 32 is illustrated. The illustrated portion employs another embodiment of a connector assembly, in which a single elongate connector 120 spans several rows 36 . More specifically, the elongate connector attaches to the distal apices 80 of several adjacent rows. In this embodiment, the spring elements 34 are in phase in that all of the distal apices 80 are in line. In a preferred embodiment, one elongate connector extends from a base portion 56 of the harness to an apex portion 54 of the harness. As such, longitudinal expansion of the harness at or near the connector is substantially entirely controlled by the connector. In another embodiment, an elongate connector spans three or more adjacent rows, and extends at least a portion of the distance between the apex and the base.

In the embodiment illustrated in FIG. 16, the elongate connectors 120 connect to the distal apices 80 of rows 36 spanned by the connector. It is to be understood that other arrangements may also be acceptable. For example, an elongate connector may connect only to proximal apices 76 of adjacent rows 36 , or may connect to one or both of the proximal and distal apices 76 , 80 of adjacent rows.

Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiment to other alternative embodiments an/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of the invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims.