Source: http://www.google.com/patents/US6494825?dq=4740761
Timestamp: 2014-07-13 20:04:09
Document Index: 668307984

Matched Legal Cases: ['art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10']

Patent US6494825 - System for stress relieving the heart muscle and for controlling heart function - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsAn apparatus and method for relieving stress on a heart muscle tissue in a wall of a heart having a chamber. A plurality of biocompatible and implantable elongate strips are configured to be connected to the heart wall and disposed about the chamber such that the elongate strips are arranged in spaced...http://www.google.com/patents/US6494825?utm_source=gb-gplus-sharePatent US6494825 - System for stress relieving the heart muscle and for controlling heart functionAdvanced Patent SearchPublication numberUS6494825 B1Publication typeGrantApplication numberUS 09/415,638Publication dateDec 17, 2002Filing dateOct 12, 1999Priority dateApr 22, 1998Fee statusPaidAlso published asCA2329735A1, EP1073488A1, US6110100, WO1999053977A1Publication number09415638, 415638, US 6494825 B1, US 6494825B1, US-B1-6494825, US6494825 B1, US6494825B1InventorsDnyanesh TalpadeOriginal AssigneeScimed Life Systems, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (8), Referenced by (12), Classifications (15), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetSystem for stress relieving the heart muscle and for controlling heart functionUS 6494825 B1Abstract An apparatus and method for relieving stress on a heart muscle tissue in a wall of a heart having a chamber. A plurality of biocompatible and implantable elongate strips are configured to be connected to the heart wall and disposed about the chamber such that the elongate strips are arranged in spaced relation to one another. The elongate strips are bendable and are sufficiently resistant to elongation such that natural stretching of the heart wall does not cause elongation of the plurality of strips.
What is claimed is: 1. An apparatus for relieving stress of heart muscle tissue in a wall of a heart having a chamber, the muscle tissue having an epicardium layer, an endocardium layer and a midwall portion between the epicardium and endocardium layers, the epicardium layer, the endocardium layer and the midwall portion extending generally longitudinally to form the wall of the heart, the apparatus comprising:
a first biocompatible and implantable elongate member, elongate in a longitudinal direction, configured to be connected to the heart wall, the elongate member being bendable and being sufficiently resistant to elongation that natural stretching of the heart wall does not cause elongation of the elongate member, wherein the elongate member comprises: a longitudinal strut; and a first plurality of protrusions extending from the longitudinal strut in a first direction, the first protrusions being sufficiently resistant to elongation in the first direction such that natural stretching of the heart wall does not cause elongation of the first protrusions in the first direction. 2. The apparatus of claim 1 and further comprising:
at least one additional biocompatible and implantable elongate member, elongate in a longitudinal direction, configured to be connected to the heart wall in spaced relation to the first elongate member, the additional elongate member being bendable and being sufficiently resistant to elongation that natural stretching of the heart wall does not cause elongation of the elongate member. 3. The apparatus of claim 2 wherein the elongate members are resistant to elongation in the longitudinal direction.
4. The apparatus of claim 2 wherein the elongate members are connected to one another, in spaced relation to one another to form a cage structure sized to be disposed about the chamber.
5. The apparatus of claim 4 wherein the elongate members carry a plurality of sensors configured to sense physiological parameters in the wall of the heart and provide sensor signals indicative of the sensed parameters.
6. The apparatus of claim 5 wherein the plurality of sensors are configured to sense stretching of the wall of the heart and provide the sensor signals indicative of the sensed stretching.
a monitor coupled to the plurality of sensors to receive the sensor signals and provide a monitor signal based on the sensor signals; and an input/output device, coupled to the monitor, to receive the monitor signal and provide user observable indicia, indicative of the sensed stretching based on the monitor signal. 8. The apparatus of claim 7 and further comprising:
a plurality of electrodes carried by the elongate members; and wherein the monitor includes a controller coupled to the electrodes to control application of excitation signals to the electrodes, the electrodes stimulating the heart muscle in response to the excitation signals. 9. The apparatus of claim 8 wherein the controller is coupled to the sensors and is configured to apply the excitation signals based on the sensor signals.
10. The apparatus of claim 9 wherein the controller is configured to apply the excitation signals to all electrodes substantially simultaneously.
11. The apparatus of claim 9 wherein the controller is configured to apply the excitation signals to the electrodes sequentially.
12. The apparatus of claim 11 wherein the controller is configured to apply the excitation signals to sets of electrodes sequentially, wherein at least one set contains a plurality of electrodes.
13. The apparatus of claim 5 wherein the elongate members define a plurality of apertures therein sized to receive sutures.
14. The apparatus of claim 1 wherein the elongate member comprises:
a second plurality of protrusions extending from the longitudinal strut in a second direction, generally opposite the first direction, the second protrusions being sufficiently resistant to elongation in the second direction such that natural stretching of the heart wall does not cause elongation of the second protrusions in the second direction. 15. The apparatus of claim 14 wherein the longitudinal strut and the first and second protrusions are arranged such that when the longitudinal strut is positioned longitudinally in the midwall portion, the first protrusions extend into the epicardium layer and the second protrusions extend into the endocardium layer.
16. The apparatus of claim 15 wherein the first protrusions have a generally linear conformation.
17. The apparatus of claim 15 wherein the second protrusions have a generally T-shaped conformation.
18. The apparatus of claim 15 wherein the longitudinal strut and the first and second protrusions define a plurality of apertures suitable for receiving sutures.
19. The apparatus of claim 1 wherein the elongate member is adapted to be connected to the epicardium layer.
20. The apparatus of claim 1 wherein the elongate member includes a drug releasably coupled thereto.
21. A method of restricting elongation of heart muscle tissue in a wall of a heart having a chamber, the muscle tissue having an epicardium layer, an endocardium layer and a midwall portion between the epicardium and endocardium layers, the epicardium layer, the endocardium layer and the midwall portion extending generally longitudinally to form the wall of the heart, the method comprising:
providing a biocompatible and implantable elongate member, elongate in a longitudinal direction, the elongate member being bendable under normal heart pumping action and being sufficiently resistant to elongation in the longitudinal direction such that natural stretching of the heart wall does not cause elongation of the elongate member; and connecting the elongate member to the heart wall to inhibit elongation of the heart muscle tissue adjacent the elongate member.
REFERENCE TO CO-PENDING APPLICATION The present application is a continuation application of U.S. patent application Ser. No. 09/064,370, filed Apr. 22, 1998 entitled �SYSTEM FOR STRESS RELIEVING THE HEART MUSCLE AND FOR CONTROLLING HEART FUNCTION� and assigned to the same assignee as the present application now U.S. Pat. No. 6,110,100.
BACKGROUND OF THE INVENTION The present invention deals with treatment of heart disease. More particularly, the present invention deals with a system and method for treating heart disease by regulating blood flow in the vasculature.
For instance, if the heart muscle is stressed, the heart works harder and begins to stretch. This reduces the efficiency of the heart in the following way. Muscles are thought of as being composed of many fibers which contract and lengthen to accomplish muscular action. Each fiber includes many densely packed subunits referred to as myofibrils which are on the order of 1 μm in diameter and extend in parallel from one end of the muscle fiber to the other. Each myofibril has spaced regions of thick filaments (about 110 Å thick) and thin filaments (about 50-60 Å thick) The thick filaments are formed of a protein, myosin, and the thin filaments are formed of a protein, actin. The actin and myosin filaments overlap in regions periodically spaced along the myofibrils. The units in the repeated overlapping pattern are referred to as sarcomeres.
This inefficient or impaired heart function causes blood pressure in the areas of both the kidneys and the baroreceptors to decrease. The feedback response generated by the kidneys causes further overload and stress on the heart. The feedback response generated by the baroreceptors causes increased heart rate. Both of these feedback responses cause the heart to work harder, causing further stretching of the heart muscle and thus leading to greater inefficiencies. In response, the feedback responses become even more acute�and the cascade continues.
This cascade effect, which is a natural progression of congestive heart failure, leads to increased muscle mass and stretching of the heart muscle fibers which, in turn, leads to muscular hypertrophy,of the left ventricle. The hypertrophy is a compensatory mechanism which, if maintained at a given level such that muscle fibers maintain inherent contractile properties (i.e., actin-myosin overlap), can be beneficial for maintaining proper heart function. However, prolonged and continuous stretching causes muscular fatigue and reduced muscle performance as explained by the known Frank-Starling mechanism.
SUMMARY OF THE INVENTION An apparatus and method restrict elongation of heart muscle tissue in a wall of a heart having a chamber. A plurality of biocompatible and implantable elongate strips are configured to be connected to the heart wall and disposed about the chamber such that the elongate strips are arranged in spaced relation to one another. The elongate strips are bendable and are sufficiently resistant to elongation such that natural stretching of the heart wall does not cause elongation of the plurality of strips.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A is a side sectional view of a heart.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1A illustrates a portion of a heart 10. FIG. 1A illustrates a plurality of chambers in heart 10 including right ventricle 12 and left ventricle 14. FIG. 1A also illustrates heart wall 16 which extends around chambers 12 and 14, and separates chambers 12 and 14. As discussed in the background portion above, congestive heart failure can lead to hypertrophy of the muscle fibers in heart 10, particularly those surrounding left ventricle 14.
Also, while only three protrusions 28, 30, and 32 are shown and two protrusions 34 and 36 are shown, any suitable number of protrusions can be used on either side of retention strip 24. Strut 26 and protrusions 28-36 are preferably formed of a material which allows repeated bending cycles, without permanent deformation or breakage. However, strut 26 and protrusions 28-36 are also preferably formed of a material which exhibits high resistance to elongation in the longitudinal direction. Suitable materials include collagen, or biocompatable and implantable polymer strips, as well as biocompatable and implantable metals, cartilage, or composite materials, Nitinol and bovine and porcine byproducts, as examples.
FIG. 3 illustrates a portion of wall 16 with retention strip 24 implanted therein. In a preferred embodiment, longitudinal strut 26 is implanted. in the mid-wall region 22 of wall 16. Protrusions 28, 30 and 32 (and any other number of protrusions) extend into the endocardium layer 18, while protrusions 34 and 36 (and any other suitable number of protrusions) extend into the epicardium layer 20. Retention strip 24 is then sutured in place by an appropriate suturing technique using apertures 38 in retention strip 24. Retention strip 24 preferably extends throughout substantially the entire longitudinal length of the ventricular cavity wall, such as from the base to the apex of the ventricular cavity wall.
Placement of retention strips 24 in the positions illustrated in FIG. 4 thus restrict the progression of congestive heart failure of the muscle due to the pressure overload on left ventricle 14. The muscle is supported in such a way that it is not allowed to progressively increase its mass, and also such that uncontrolled stretching is limited by physically restricting its growth and stretch. Thus, heart failure scan be controlled. Further, since the recruitable muscle mass can still perform a satisfactory job due to the limited constraint on its contraction, no additional or compensatory muscle mass is generated, which also restricts growth of new muscle tissue in wall 16. This aspect of the present invention thus reduces fatigue of the heart muscle and allows for natural regeneration of healthy cardiac tissue. Also, it is believed that supporting the cardiac muscle tissue relives tension on the chordae tendinae which, in turn, helps prevent mitral valve regurgitation which prevents higher mean atrial pressures and thus pulmonary edema.
Retention device 40 includes a first generally circular strap 42 and a second generally circular strap 44. Straps 42 and 44 are connected to one another by a plurality of generally longitudinal straps 46, 48, 50, 52 and 54. Straps 46-54 are preferably attached to circular strips 42 and 44 by a suitable adhesive, by welding, or by another suitable mechanism, or are formed integrally with circular straps 42. Straps 42-54 are preferably formed of collagen, polymer or metal fibers which exhibit the capability of undergoing many bending cycles, without permanent deformation of damage. Straps 42-54 are also formed to exhibit high resistance to elongation in the generally longitudinal directions. In addition, straps 42-54 have a plurality of apertures 56 therein which are used to attach retention device 40 to the heart wall 16 with an appropriate suturing technique. Of course, as with the embodiment illustrated in FIGS. 2-4, any suitable number of straps 42-54 can be used. The arrangement of straps 42-54 can also be changed as desired. Further, the number and placement of suture apertures 56 can be changed to any suitable number and location on straps 42-54.
FIG. 6A illustrates retention device 40 deployed on wall 16 of left ventricle 14. FIG. 6A illustrates that, in one preferred embodiment, straps 42-54 are periodically, and alternately, sutured to the outer surface of epicardium 20, and embedded within wall 16. FIG. 6A also illustrates that more longitudinal straps can be used than are illustrated in FIG. 5. This simply illustrates that any desired number of longitudinal straps can be used. In the preferred embodiment, in the areas where straps 42-54 are embedded in wall 16, they are embedded only in the epicardium layer 20 such that extensive incisions into wall 16 need not be made.
FIG. 6B better illustrates embedding of straps 42-54 in the wall 16 of heart 10. FIG. 6B is a greatly enlarged cross-section of wall 16 taken in the region labeled 6B in FIG. 6A. FIG. 6B illustrates that strap 46, at alternate portions 58 is simply sutured to the exterior of epicardium layer 20, while at other portions 60 is embedded within the epicardium layer 20. Of course, straps 42-54 could be embedded more deeply in the wall 16. However, embedding in epicardial layer 20 is preferred.
FIG. 7 illustrates another embodiment of retention device 40 in accordance with one aspect of the present invention. Retention device 40, shown in FIG. 7, is similar to that shown in FIG. 5, and similar items are similarly numbered. However, the longitudinal straps 46-54 (only four of which are shown in FIG. 7) are each provided with a plurality of sensors 62 which are configured to sense stretching, and/or other physiologic parameters, such as electrical activity, acceleration or physicochemical activity, of the cardiac muscle wall 16. In the illustration of FIG. 7, sensors 62 are only provided on longitudinal strap 48, it will be appreciated that, in a preferred embodiment, sensors 62 are similarly disposed on each of the straps 42-54.
In the embodiment illustrated in FIG. 8, differential amplifiers 72-76 are provided for amplifying the signals received from strain sensors 62. In one preferred embodiment, each strain sensor 62 has a corresponding differential amplifier. Alternatively, of course, multiplexing circuity can be used to switch the signals from sensors 62 into a single, or into one or more of the differential amplifiers. In any case, the output signals from differential amplifiers 72-76 are provided to circuit 78. In the embodiment in which circuit 78 is a summing amplifier, the signals are summed in a desired manner to obtain the total stretch response of the myocardium of heart 10. The signal from amplifier 78 is provided to microprocessor 80 where it is preferably corrected for any non-linearities and temperature affects, in a known manner. Microprocessor 80 then generates a suitable output signal to user I/O device 70.
In another embodiment in which circuit 78 is a multiplexer, each of the signals from amplifiers 72-76 are switched into microprocessor 80 under the control of microprocessor 80. Alternatively, circuit 78 can also be eliminated. In that embodiment, the outputs from amplifiers 72-76 are provided as discrete inputs to microprocessor 80. It should also be noted that other inputs can be provided to microprocessor 80 as well, such as EKG information, blood pressure information, or other sources of information. In any case, microprocessor 80 generates a signal to user I/O device 70 based on the signals from amplifiers 72-76.
FIG. 9 illustrates another embodiment of a monitoring and control system 82 in accordance with one aspect of the present invention. Some items in system 82 are similar to those shown in FIGS. 7 and 8 and are similarly numbered. In system 82, each sensor 62 is provided with a strain sensing element 84, as discussed above, and an excitation electrode 86. Excitation electrodes 86 are preferably conventional pacing electrodes capable of delivering pacing voltages to the myocardium of heart 10. While the sensing elements 84 and pacing electrodes 86 are shown attached to one another in FIG. 9, it should be noted that they can be separated from one another, but are preferably closely proximate one another when deployed on one of straps 42-54.
The present invention reduces fatigue of the heart and allows for natural regeneration of healthy cardiac tissue, or increases the efficiency of pharmacologically administered treatments. It is also believed that supporting the cardiac muscle in this way relieves tension on the chordae tendinae which in turn prevents mitral. valve regurgitation thus preventing higher mean atrial pressures and pulmonary edema. All of these factors contribute to the cascade of failures in organs and systems associated with congestive heart failure. Once the relaxed heart muscle has regained many of its own contractile properties, it can be weaned from the pacing routine.
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2014Bioventrix, Inc.Signal transmitting and lesion excluding heart implants for pacing, defibrillating, and/or sensing of heart beatUS20080294251 *May 21, 2007Nov 27, 2008Bioventrix (A Chf Technologies' Company)Location, time, and/or pressure determining devices, systems, and methods for deployment of lesion-excluding heart implants for treatment of cardiac heart failure and other disease statesWO2005099374A2 *Apr 5, 2005Oct 27, 2005J Kern BucknerMethod and apparatus for the surgical treatment of congestive heart failure* Cited by examinerClassifications U.S. Classification600/16, 600/37, 600/375, 600/393, 623/3.28, 607/119International ClassificationA61M1/10, A61F2/08, A61F2/02, A61F2/00, A61F2/24Cooperative ClassificationA61F2/2481, A61M1/1068European ClassificationA61F2/24W2, A61M1/10E50BLegal EventsDateCodeEventDescriptionMay 21, 2010FPAYFee paymentYear of fee payment: 8Nov 6, 2006ASAssignmentOwner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTAFree format text: CHANGE OF 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