Source: http://www.google.com/patents/US6645139?dq=patent:4807115
Timestamp: 2013-12-13 13:36:46
Document Index: 761530004

Matched Legal Cases: ['art.\n6', 'art.\n7', 'application No. 197', 'art 1', 'art 1', 'art 1', 'art 1']

Patent US6645139 - Bag for at least partially enveloping a heart - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA pouch to at least partly enclose a heart (1), the wall of the pouch (2) being elastic. The purpose of the pouch is to enclose at least part of a heart (1) and to oppose excessive dilation of the heart (1) that might be due to infectious disease of the heart muscle, for instance a viral infection or...http://www.google.com/patents/US6645139?utm_source=gb-gplus-sharePatent US6645139 - Bag for at least partially enveloping a heartAdvanced Patent SearchPublication numberUS6645139 B2Publication typeGrantApplication numberUS 10/140,225Publication dateNov 11, 2003Filing dateMay 7, 2002Priority dateJun 21, 1997Fee statusPaidAlso published asDE19826675A1, EP0991373A1, EP0991373B1, US6416459, US20020133055, US20040102678, WO1998058598A1Publication number10140225, 140225, US 6645139 B2, US 6645139B2, US-B2-6645139, US6645139 B2, US6645139B2InventorsHans HaindlOriginal AssigneeAcorn Cardiovascular Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (50), Non-Patent Citations (14), Referenced by (11), Classifications (7), Legal Events (5) External Links: USPTO, USPTO Assignment, EspacenetBag for at least partially enveloping a heartUS 6645139 B2Abstract A pouch to at least partly enclose a heart (1), the wall of the pouch (2) being elastic. The purpose of the pouch is to enclose at least part of a heart (1) and to oppose excessive dilation of the heart (1) that might be due to infectious disease of the heart muscle, for instance a viral infection or an autoimmune process. In many cases the use of such a pouch (2) may circumvent the need for a heart transplant.
What is claimed is: 1. A pouch adapted to at least partly enclose and oppose distention of a heart having a first volume at minimum filling and a second volume at maximum diastolic filling the pouch comprising a knit material that is adapted to be stretched and exert stress on the heart, wherein said pouch has a volume that is less than the volume of said heart at minimum filling when in an unstretched state, and wherein said pouch has a volume that corresponds to the volume of the heart at maximum diastolic filling in a stretched state.
2. The pouch according to claim 1, wherein the heart has a shape and a volume at maximum diastolic filling and the pouch is adapted to be tensioned following application to the heart to match the shape and volume of the heart at maximum diastolic filling.
3. The pouch according to claim 1, wherein said knit material comprises an elastic material.
4. The pouch according to claim 1, wherein said knit material comprises an inelastic material.
5. The pouch according to claim 1, wherein the heart includes a valve plane and an apex, and the pouch is adapted to extend from the valve plane to the apex of the heart.
6. The pouch according to claim 1, wherein said pouch is adapted to be affixed to the heart.
7. The pouch according to claim 1, wherein said knit material comprises threads.
8. The pouch according to claim 7, wherein said threads run substantially circumferentially in relation to said pouch.
9. The pouch according to claim 7, wherein said threads are connected to each other where they cross.
10. The pouch according to claim 9, wherein said threads are connected by being fused, by being bonded, or by dipping the entire pouch into a body of material which subsequently solidifies.
CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of application Ser. No. 09/453,722, filed Dec. 3, 1999, now U.S. Pat. No. 6,416,459, issued Jul. 9, 2002, which is a continuation of application Ser. No. PCT/EP98/03619, filed Jun. 16, 1998, which application claims the priority of German application No. 197 26 389.5, filed Jun. 21, 1997, which applications are incorporated herein by reference.
FIELD OF THE INVENTION The invention relates to a bag, hereafter called pouch, with which to at least partly enclose a heart.
BACKGROUND OF THE INVENTION Infectious disease of the heart muscle both by viral infection and by autoimmune processes may lead to enlarged heart volume. If such an enlargement exceeds a critical value, the result will be progressive heart dilation which can be explained by Laplace's law. As the volume subtended by the left heart chamber increases, the stresses in the walls of this cavity will increase. Consequently the muscle fibrils are overloaded and their ideal range of elongation is exceeded. When this excessive elongation takes place, there is, as a rule, a residual volume in the heart. Then the muscle fibrils must operate against a primarily high wall strain, and are further extended thereby. A vicious cycle arises, leading to increasing distension of the heart and consequent heart insufficiency.
It is basically feasible to treat such a development in its early stages by medicinally lowering the initial load by ACE inhibitors, however such treatment is not always successful. Moreover, on account of initially slight clinical effects, the status will be noticed many times only when a critical point already has been passed. In that case only a heart transplant can be resorted to.
The German patent document U1 295 17 393 discloses a pouch defined in the preamble of claim 1; this pouch however is inelastic and serves to prevent myocardial dilation by the end-diastolic pressure. While this known pouch does prevent cardiac wall distention, it delivers this effect impulsively once the heart volume equals the volume enclosed by the pouch. This impulsive effect adversely affects the heart. Moreover pleats may form in the pouch when the heart volume is less than that subtended by the size of the pouch.
OBJECTS AND SUMMARY OF THE INVENTION The objective of the invention is to create a pouch with which to at least partly enclose a heart and opposing heart distention without thereby degrading heart function.
The problem basic to the invention is resolved by the disclosure of the characterizing part of claim 1.
The basic concept of the invention is to absorb in part the strains in the wall of the hollow body foremost constituted by the left heart chamber and to relieve thereby the myofibrils. This general effect alone already may prevent enlarging the heart volume beyond a critical value. Accordingly the pouch of the invention offers a support role.
The elasticity function of the invention may be implemented in a number of ways. A very simple implementation calls for the pouch always exerting the same force on the heart regardless of the pouch's elongation, as a result of which the heart, regardless of its volume, shall always be relieved at substantially the same strain. In another appropriate embodiment of the invention, the pouch wall is elastic, whereby the stress it exerts and hence the relief of the heart increases with volume. The characteristics of elongation may be altered depending on the desired relief. Appropriately for instance the pouch wall elasticity decreases with increasing stretching in order to account for the specific strain in the heart wall. Advantageously too, said stretching shall be bounded by a limit value at which the heart no longer can enlarge. Contrary to the known pouch, this limit value cannot be reached impulsively, but because of the elasticity of the pouch of the invention, can be reached only gradually, as a result of which impulsive pouch actions are precluded. The pouch limit value appropriately shall be at a pouch volume corresponding to the heart volume at maximum diastolic filling. On the whole, therefore, the kind of elasticity and the shape of the stretching curve of the pouch allows determining and adapting the myofibril relief implemented by this pouch.
To mount the pouch in place, it can be thorascopically opened and then be drawn over the heart muscle. This motion illustratively proceeds to the anulus fibrosus, that is, the valve plane, where the pouch shall be fixed in place.
In a further embodiment of the invention, the volume of the pouch in its unstretched state is less than the volume of the heart in the stage of minimum filling. As a result, the pouch shall reliably rest against the heart in all stretching phases.
If, as in one embodiment of the invention, the pouch wall is elastic and the stretching is bounded by a limit value, then advantageously the pouch shall be made of an elastic and of an inelastic material. In this case the elastic material determines the stretching function, whereas the inelastic material determines the stretching limit value. Appropriately in practice, the elastic material is made of a threaded sheet or fabric or knit into which are integrated threads made of a substantially inelastic material. The substantially spatially inelastic threads appropriately are longitudinally displaceable in the sheet or fabric or knit.
In this embodiment it is especially advantageous that the substantially inelastic threads be guided segment-wise out of the pouch and in this manner are adapted at maximum diastolic filling by being segment-wise knotted in length and volume to the shape and/or volume of the pouch. In this process the substantially inelastic threads run appropriately from the edge of the pouch aperture to a substantially opposite tip of the pouch. The threads then can be guided out of the pouch in the zone of its tip.
As regards the embodiment wherein the pouch dilation is subject to a limit value, the pouch appropriately consists of a fabric or knit made of inelastic threads while however allowing bending and being crimped transversely to their longitudinal direction. This kind of shaping allows determining the stretching function and the limit value.
Appropriately the pouch wall is a thermoplastic allowing simple shaping of the pouch and adapting it to the shape of the heart, or it may be made of a biological material, denatured bovine pericardium being especially suitable.
To implement permeability to gases, in particular oxygen, and to liquids, the wall of the pouch of the invention appropriately shall be a netting. Such netting appropriately may be made of an open-pore foam, for instance silicone foam. Such a foam assures highly uniform and gentle application of pressure to the heart muscle. Moreover such a foam is able to absorb a lubricant, for instance a serous liquid, thus providing good slippage between pouch and pericardium. Appropriately the lubricant is biological and genetically engineered, hyaluronic acid being especially suitable. By introducing a lubricant beforehand into the foam, good slipping properties are provided from the beginning and as a result primary, self-reinforcing irritation of the pericardium shall be avoided.
If the wall of the pouch of the invention is a netting, then such may be formed as a perforated sheet. Such a sheet is able to transmit the pouch pressure through a large surface to the heart.
The wall of the pouch of the invention also may be a fabric or a knit. In this manner the pouch's stretching behavior can be matched to any particulars within wide limits.
Regardless of the pouch wall netting being constituted by a sheet, fabric or knit, appropriately an additional coating of open-pore foam shall be provided to assure uniform force transmission and also holding any lubricants.
If the elasticity of the pouch wall decreases as stretching increases, or if there is a limit value on stretching, then a special embodiment of the invention provides that the pouch be composed of two kinds of plastic threads or fibers, one kind of higher, and preferably much higher shaping temperature than the other, one kind being elastic and the other kind relatively less, preferably much less elastic than the other. By using such differing fibers, it is possible to thermoplastically shape the pouch at a temperature at which the less elastic or inelastic material remains permanently shaped at a given shaping temperature, though not the more elastic material. The less elastic or inelastic material in this manner determines the maximum pouch stretching whereas the elastic material, which shall return to its initial shape, applies constricting forces on the heart, below the shape determined by the less or inelastic material.
In another embodiment of the invention, the plastic used in manufacturing the pouch is thermoplastic. This feature offers the advantage that not only can the pouch be prefinished in simple manner into a given shape, but also that the pouch can be shaped during surgery, or its shape may be altered during surgery, in order to adapt the dimensions so found to the parts of the heart to be enclosed.
In a further embodiment of the invention the foam is made of silicone.
The objective of the invention furthermore is to propose a method for manufacturing a pouch as defined in claim 1. This problem is resolved by making a mold in the shape of the heart part to be enclosed and in that a gas- and/or liquid-permeable sheet or a netting of knit consisting of a thermoplastic is pulled over the mold while heated.
The structure of the mold appropriately is entailed or determined by imaging the shape of the heart to be enclosed and in that the mold is produced from this image. The image can be produced in arbitrary manner, for instance by x-rays or computer tomography.
BRIEF DESCRIPTION OF THE DRAWINGS The invention is elucidated further in relation to the drawings.
FIG. 2 is a second embodiment of the invention, and
FIG. 3 is a third embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION The drawing schematically shows a heart 1 partly enclosed by a pouch 2 of which the wall consists of a netting 3. The pouch 2 reaches as far as into the zone of the anulus fibrosus, that is as far as the valve plane, where it is affixed (omitted from the drawing) to the heart muscle along a selvage 4. The netting 3 consists of elastic threads. In the unstretched state, the volume of the pouch 2 is less than the volume of the heart 1 in the stage of minimum filling. As a result, the netting shall rest against the heart 1 in all stretching stages.
FIG. 2 shows a second embodiment of the invention which is a variant of that of FIG. 1. Identical or corresponding components are denoted by identical references. The difference is that threads 5 converge from the selvage 4 into a central point 6, whereas threads 7 run substantially circumferentially. Where they cross at points 8, the threads 5 and 7 are connected to each other, either by being fused, bonded or by dipping the entire pouch 2 into a body of material, for instance foam which shall subsequently solidify.
FIG. 3 shows an embodiment of a pouch 9 consisting of a knit of threads 10 running from a selvage 11 to a central point 12 where they are bundled away at their ends 13 which, following application of the pouch 9, then can be tensioned or be knotted to one another in order to match thereby the pouch 9 to the shape and volume of the heart 1.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS3983863Jun 2, 1975Oct 5, 1976American Hospital Supply CorporationHeart support for coronary artery surgeryUS4048990Sep 17, 1976Sep 20, 1977Goetz Robert HHeart massage apparatusUS4428375Feb 16, 1982Jan 31, 1984Ellman Barry RSurgical bag for splenorrhaphyUS4630597Apr 30, 1984Dec 23, 1986Adrian KantrowitzDynamic aortic patch for thoracic or abdominal implantationUS4690134Jul 1, 1985Sep 1, 1987Snyders Robert VVentricular assist deviceUS4821723Feb 27, 1987Apr 18, 1989Intermedics Inc.Biphasic waveforms for defibrillationUS4878890Oct 13, 1987Nov 7, 1989Ethicon, Inc.Perihepatic prosthesisUS4936857Feb 15, 1988Jun 26, 1990Kulik Yaroslav PProsthetic pericardiumUS4957477May 9, 1989Sep 18, 1990Astra Tech AbHeart assist jacket and method of using itUS4973300Sep 22, 1989Nov 27, 1990Pioneering Technologies, Inc.Cardiac sling for circumflex coronary artery surgeryUS4976730Oct 11, 1988Dec 11, 1990Kwan Gett Clifford SArtificial pericardiumUS5057117Apr 27, 1989Oct 15, 1991The Research Foundation Of State University Of New YorkMethod and apparatus for hemostasis and compartmentalization of a bleeding internal bodily organUS5087243Jun 18, 1990Feb 11, 1992Boaz AvitallMyocardial iontophoresisUS5131905Jul 16, 1990Jul 21, 1992Grooters Ronald KExternal cardiac assist deviceUS5150706Aug 15, 1991Sep 29, 1992Cox James LCooling net for cardiac or transplant surgeryUS5186711May 28, 1991Feb 16, 1993Albert Einstein College Of Medicine Of Yeshiva UniversityHemostasis apparatus and methodUS5192314Dec 12, 1991Mar 9, 1993Daskalakis Michael KSynthetic intraventricular implants and method of insertingUS5256132Aug 17, 1992Oct 26, 1993Snyders Robert VCardiac assist envelope for endoscopic applicationUS5290217Oct 10, 1991Mar 1, 1994Earl K. SipesMethod and apparatus for hernia repairUS5356432Feb 5, 1993Oct 18, 1994C. R. Bard, Inc.Implantable mesh prosthesis and method for repairing muscle or tissue wall defectsUS5383840Jul 28, 1992Jan 24, 1995Vascor, Inc.Biocompatible ventricular assist and arrhythmia control device including cardiac compression band-stay-pad assemblyUS5385156Aug 27, 1993Jan 31, 1995Rose Health Care SystemsDiagnostic and treatment method for cardiac rupture and apparatus for performing the sameUS5429584Nov 9, 1990Jul 4, 1995Mcgill UniversityCardiac assist method and apparatusUS5507779Apr 12, 1994Apr 16, 1996Ventritex, Inc.Cardiac insulation for defibrillationUS5524633Oct 1, 1993Jun 11, 1996Advanced Surgical, Inc.Self-deploying isolation bagUS5603337Dec 5, 1994Feb 18, 1997Jarvik; RobertTwo-stage cardiomyoplastyUS5647380Jun 7, 1995Jul 15, 1997W. L. Gore & Associates, Inc.Method of making a left ventricular assist deviceUS5702343Oct 2, 1996Dec 30, 1997Acorn Medical, Inc.Cardiac reinforcement deviceUS5713954Jun 13, 1995Feb 3, 1998Abiomed R&D, Inc.Extra cardiac ventricular assist deviceUS5800528Dec 29, 1995Sep 1, 1998Abiomed R & D, Inc.Passive girdle for heart ventricle for therapeutic aid to patients having ventricular dilatationUS5961440Sep 18, 1997Oct 5, 1999Myocor, Inc.Heart wall tension reduction apparatus and methodUS5990378May 23, 1996Nov 23, 1999Bridport Gundry (Uk) LimitedTextile surgical implantsUS6045497Jul 29, 1998Apr 4, 2000Myocor, Inc.Heart wall tension reduction apparatus and methodUS6050936Jan 2, 1997Apr 18, 2000Myocor, Inc.Heart wall tension reduction apparatusUS6059715Jan 4, 1999May 9, 2000Myocor, Inc.Heart wall tension reduction apparatusUS6416459 *Dec 3, 1999Jul 9, 2002Acorn Cardiovascular Inc.Bag for at least partially enveloping a heartDE29517393U1Nov 3, 1995Feb 1, 1996Hohmann Claas Dr MedHerzbeutelprotheseEP0280564A2Feb 26, 1988Aug 31, 1988Intermedics, Inc.Implantable defribrillation electrodesFR2737106A1 Title not availableJPH01145066A Title not availableJPS60203250A Title not availableSU1009457A1 Title not availableWO1996016601A1Feb 22, 1995Jun 6, 1996Gore & AssSurgical device for protecting organs from formation of adhesionsWO1998029041A1Dec 31, 1997Jul 9, 1998Myocor IncHeart wall tension reduction apparatus and methodWO1998058598A1Jun 16, 1998Dec 30, 1998Hans HaindlBag for at least partially enveloping a heartWO1999044534A1Mar 5, 1999Sep 10, 1999Univ CincinnatiDevice and method for restructuring heart chamber geometryWO2000006026A2Jul 27, 1999Feb 10, 2000Peter T KeithHeart wall tension reduction apparatus and methodWO2000006027A2Jul 27, 1999Feb 10, 2000Todd J MortierHeart stress reduction apparatus and methodWO2000006028A1Jul 27, 1999Feb 10, 2000Peter T KeithTransventricular implant tools and devicesWO2000016700A1Sep 17, 1999Mar 30, 2000Myocor IncExternal stress reduction device and method* Cited by examinerNon-Patent CitationsReference1"Supplement to Circulation", Abstracts from the 68th Scientific Sessions, vol. 92, No. 8, 2 pages (Oct. 15, 1995).2Capomolla, S. 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, pp. 1089-1098 (Dec. 1997).3Capouya, E. et al., "Girding Effect of Nonstimulated Cardiomyoplasty on Left Ventricular Function", Ann Thorac. Surg., vol. 56, pp. 867-871 (1993).4Cohn, J., "The Management of Chronic Heart Failure", The New England Journal of Medicine, vol. 335, No. 7, pp. 490-498 (Aug. 15, 1996).5Coletta, C. et al., Prognostic value of left ventricular volume response during dobutamine stress echocardiography:, European Heart Journal, vol. 18, pp. 1599-1605 (Oct. 1997).6Guasp, F., "Una pr�tesis contentiva para el tratamiento de la miocardiopat�a dilatada", Revista Espa�ola de Cardiolog�a, vol. 51, No. 7, pp. 521-528 (Jul. 1998).7International Preliminary Examination Report (8 pages) dated Sep. 22, 1999 (English) for PCT/EP98/03619, filed Jun. 16, 1998.8Internationaler Recherchenbericht dated Oct. 27, 1998 (3 pgs.).9Kass, 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).10Levin, H. et al., "Reversal of Chronic Ventricular Dilation in Patients With End-State Cardiomyopathy by Prolonged Mechanical Unloading", Circulation, vol. 91, No. 11, pp. 2717-2720 (Jun. 1, 1995).11Oh, J. et al., "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 (Jul. 1998).12Paling, D., "Warp Knitting Technology", Columbine Press, p. 111 (1965).13PCT Schrifticher Bescheid dated Mar. 26, 1999 (6 pgs.).14Vaynblat, M. et al., "Cardiac Binding in Experimental Heart Failure", Ann. Thorac. Surg., vol. 64, 11 pages, (1997).Referenced byCiting PatentFiling datePublication dateApplicantTitleUS6951534 *Jun 7, 2002Oct 4, 2005Acorn Cardiovascular, Inc.Cardiac support deviceUS7077802 *Nov 13, 2003Jul 18, 2006Paracor Medical, Inc.Expandable cardiac harness for treating congestive heart failureUS7238152Jun 9, 2004Jul 3, 2007Paracor Medical, Inc.Self-adjusting expandable cardiac harness for treating congestive heart failureUS7276022Dec 14, 2004Oct 2, 2007Paracor Medical, Inc.Expandable cardiac harness for treating congestive heart failureUS7285087May 31, 2005Oct 23, 2007Micardia CorporationShape memory devices and methods for reshaping heart anatomyUS7402134May 31, 2005Jul 22, 2008Micardia CorporationMagnetic devices and methods for reshaping heart anatomyUS7594887Oct 22, 2007Sep 29, 2009Micardia CorporationShape memory devices and methods for reshaping heart anatomyUS7621866May 31, 2005Nov 24, 2009Ethicon, Inc.Method and device for deployment of a sub-pericardial sackUS7877142Jul 3, 2007Jan 25, 2011Micardia CorporationMethods and systems for cardiac remodeling via resynchronizationUS7959555Oct 13, 2009Jun 14, 2011Ethicon, Inc.Method and device for deployment of a sub-pericardial sackUS8109868Jul 6, 2010Feb 7, 2012Mardil, Inc.Cardiac support device* Cited by examinerClassifications U.S. Classification600/37International ClassificationA61F2/24, A61F2/00Cooperative ClassificationA61F2002/0068, A61F2250/0018, A61F2/2481European ClassificationA61F2/24W2Legal EventsDateCodeEventDescriptionJul 19, 2011ASAssignmentOwner name: MARDIL, INC., MINNESOTAFree format text: CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNMENT DOCUMENT A COPY OF WHICH WAS INCOMPLETE WHEN SUBMITTED PREVIOUSLY RECORDED ON REEL 026558 FRAME 0507. ASSIGNOR(S) HEREBY CONFIRMS THE COMPLETENESS OF THE ATTACHED ASSIGNMENT DOCUMENT;ASSIGNOR:ACORN CARDIOVASCULAR, INC.;REEL/FRAME:026616/0655Effective date: 20101210Jul 7, 2011ASAssignmentFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ACORN CARDIOVASCULAR, INC.;REEL/FRAME:026558/0507Owner name: MARDIL, INC., MINNESOTAEffective date: 20101210Jul 6, 2011ASAssignmentOwner name: ACORN CARDIOVASCULAR, INC., MINNESOTAEffective date: 20010201Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:HAINDL, HANS;REEL/FRAME:026551/0422Mar 23, 2011FPAYFee paymentYear of fee payment: 8May 7, 2007FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google