Cardiac treatment system

Abstract

A cardiac device for implantation proximate an exterior of a heart, the cardiac device including an inflatable bladder including an inner wall and an outer wall, wherein the inner wall itself is more expandable than the outer wall itself such that the inflatable bladder itself is configured to deform substantially inwardly to exert localized pressure against a region of the heart when the inflatable bladder is positioned adjacent the region of the heart and inflated.

Claims

1. A cardiac device for implantation adjacent an exterior of a heart, the cardiac device comprising: a jacket configured for implantation circumferentially around ventricles of the heart; an inflatable bladder comprising an inner wall and an outer wall, wherein the inner wall itself is more expandable than the outer wall itself such that the inflatable bladder itself, without any effect to the outer wall from the jacket, deforms substantially inwardly to exert localized pressure against a region of the heart when the inflatable bladder is positioned adjacent the region of the heart and inflated.

2. The cardiac device of claim 1, wherein the region of the heart comprises a mitral valve of the heart.

3. The cardiac device of claim 1, wherein: the inflatable bladder comprises a first inflatable bladder; the region comprises a first region; and the cardiac device further comprises a second inflatable bladder configured to exert localized pressure against a second region of the heart when the second inflatable bladder is positioned adjacent the second region of the heart and inflated.

4. The cardiac device of claim 3, wherein the second region comprises a papillary muscle of the heart.

5. The cardiac device of claim 3, further comprising a third inflatable bladder configured to exert localized pressure against a third region of the heart when the third inflatable bladder is positioned adjacent the third region of the heart and inflated.

6. The cardiac device of claim 5, wherein the third region of the heart comprises a tricuspid valve of the heart.

7. The cardiac device of claim 1, wherein the jacket defines an open top end configured to be positioned in an atrial-ventricular (A-V) groove of the heart, and wherein the inflatable bladder is positioned adjacent the jacket.

8. The cardiac device of claim 7, wherein the inflatable bladder is located such that, when the top end of the jacket is in the A-V groove, the inflatable bladder is positionable adjacent to a mitral valve of the heart.

9. The cardiac device of claim 7, wherein the inflatable bladder is attached to the jacket.

10. The cardiac device of claim 1, further comprising a fluid supply line configured to be coupled to the inflatable bladder and provide fluid to the inflatable bladder.

11. The cardiac device of claim 1, wherein the inflatable bladder is unattached to the jacket.

12. A method of providing localized pressure to one or more regions of a heart to improve heart functioning, the method comprising: a) positioning a cardiac device adjacent the heart, wherein the cardiac device comprises: a jacket configured for implantation circumferentially around ventricles of the heart; an inflatable bladder comprising an inner wall and an outer wall, wherein the inner wall itself is more expandable than the outer wall itself such that the inflatable bladder itself, without any effect to the outer wall from the jacket, deforms substantially inwardly to exert localized pressure against a region of the heart when the inflatable bladder is positioned adjacent the region of the heart and inflated; and (b) inflating the inflatable bladder such that the inflatable bladder exerts localized pressure to the region of the heart.

13. The method of claim 12, wherein: the inflatable bladder comprises a first inflatable bladder; the region comprises a first region; and the method further comprises inflating a second inflatable bladder of the cardiac device to exert a localized pressure against a second region of the heart.

14. The method of claim 13, wherein: the first region comprises a mitral valve of the heart; the second region comprises a papillary muscle of the heart; and wherein inflating the first inflatable bladder reshapes the mitral valve and inflating the second inflatable bladder repositions the papillary muscle to relieve tension on chordae of the mitral valve.

15. The method of claim 14, further comprising inflating a third inflatable bladder of the cardiac device to exert a localized pressure on a third region of the heart.

16. The method of claim 15, wherein the third region comprises a tricuspid valve of the heart.

17. The method of claim 12, wherein said inflating the inflatable bladder occurs after fibrotic encapsulation.

18. The method of claim 12, wherein the jacket defines an open top end configured to be positioned in an atrial-ventricular (A-V) groove of the heart, and wherein the inflatable bladder is positioned adjacent the jacket.

19. The method of claim 12, wherein inflating the inflatable bladder comprises filling the inflatable bladder with a fluid via a fluid supply line coupled to the inflatable bladder.

20. The method of claim 12, wherein inflating the inflatable bladder comprises filling the inflatable bladder with at least one of a group consisting of: air, inert gas, silicone gel, saline, and contrast agents.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 A is a perspective view of the present assembly positioned on a patient's heart, showing an inflatable bladder positioned adjacent to the mitral valve.

(2) FIG. 1 B is a view similar to FIG. 1 A, but showing three optional bladder locations at the mitral valve, papillary muscle and tricuspid valve.

(3) FIG. 2 is a sectional elevation view through one of the inflatable bladders.

DETAILED DESCRIPTION

(4) Particular embodiments of the present invention provide an assembly for providing localized pressure to a region of a patient's heart. As will be described below, some embodiments described herein provide a jacket with one or more inflatable bladders received therein. Thus, the bladder(s) are positioned between the patient's heart and the jacket when the jacket is slipped over the heart.

(5) FIGS. 1A and 1B show embodiments having one or more inflatable bladders, as follows. In FIG. 1A, the inflatable bladder is positioned adjacent to the patient's mitral valve. FIG. 1B shows additional placement locations of bladders adjacent to the papillary muscle and tricuspid valve. It is to be understood that the description herein encompasses embodiments with only one or with more than one inflatable bladder. Thus, FIGS. 1A and 1B simply show preferred locations for the bladder placement(s).

(6) As seen in FIGS. 1A-B and 2, the depicted embodiment provides an assembly comprising: a jacket 10 and at least one inflatable bladder 20. Jacket 10 is made of a flexible biocompatible material and has an open top end 12 that is received around the heart H and a bottom portion 14 that is received around the apex A of the heart. In optional aspects, jacket 10 may be made of a knit mesh. This knit mesh may optionally be made of a polymer, including but not limited to high-density polyethylene. Alternatively, jacket 10 may be made of metal.

(7) In one preferred embodiment, jacket 10 is made of a suitable knit material. An example of such a knit material may be the well known “Atlas Knit” material, being a knit structure formed from generally inelastic fibers. In an Atlas Knit, the fibers are interwoven into sets of parallel spaced-apart strands. In response to the low pressures of the heart during diastole, the fibers are generally non-elastic. Alternatively, jacket 10 may be elastic. Optionally, the fibers may be made of Denier polyester. However, other suitable materials, including but not limited to, PTFE, ePTFE, polypropylene and stainless steel may also be used. Advantages of using a knit material include flexibility, fluid permeability and minimizing the amount of heart surface area in direct contact with the jacket (thereby minimizing the potential of scar tissue development).

(8) Inflatable bladder 20 is disposed on an interior surface of jacket 10. Bladder 20 may or may not be attached to jacket 10. FIG. 1B illustrates three separate inflatable bladders 20, being positioned at the mitral valve (bladder 20A), the papillary muscle (bladder 20B) and the tricuspid valve (bladder 20C). When bladder 20 is positioned adjacent to the mitral valve, it is preferably positioned at the P2 area of the valve (in the center of the posterior leaflet) to reduce the distance across the valve, thereby reducing the gap in the valve responsible for the regurgitation. When bladder 20 is positioned adjacent to the tricuspid valve, it performs a similar function, reducing regurgitation through the tricuspid valve. When bladder 20 is positioned adjacent to the papillary muscle, it gently corrects papillary muscle position and relieves tension on the chordae (which otherwise prohibits normal valve functioning).

(9) As seen in FIG. 2, inflatable bladder 20 has an inelastic outer surface 22 positioned adjacent to jacket 10 and an elastic inner surface 24 positioned adjacent to the heart. Bladder 20 may optionally be made of silicon. In preferred aspects, jacket 10 is inelastic, the outer surface 22 of bladder 20 positioned adjacent to the bladder is inelastic and the inner surface 24 of bladder 10 is elastic. As a result, when inflated through fluid supply line 25, inflation of bladder 20 causes the bladder to deform substantially inwardly (i.e.: towards the heart). This then exerts localized pressure against a region of the heart. As can be seen, supply line(s) 25 are preferably positioned inside jacket 10 and extend out of an open bottom end 13 of the jacket adjacent to the apex of the heart. Bottom end 13 may be cinched closed after the jacket 10 has been positioned around the heart.

(10) In preferred aspects, bladder 20 may be is inflated with fluids including air, inert gasses (such as fluorocarbons), silicone gel, saline and contrast agents. Supply lines 25 may optionally be inflated through a blunt needle port, a Luer port fitting, a subcutaneous port 26, etc. Supply lines 25 are made of a suitable bio-compatible material, including but not limited to silicone. The present invention preferably includes mechanisms for inflating and deflating bladders 20 post-implementation. For example, in one approach the device is first received onto the heart. After a period of time (e.g.: 30 days) fibrotic encapsulation of mesh jacket 10 will have occurred. At this time, the bladder(s) 20 can then be inflated (through supply line 25 using a needle to percutaneously access filling reservoir 26. Thus, subcutaneous ports 26 are useful for percutaneous inflation and deflation for therapy optimization or abandonment. Alternatively, the fluid path tube may stay in the intercostal space and be accessed by a small “cut-down” procedure to access the tube.

(11) In optional embodiments, jacket 10 has an elastic band 14 passing around its top end 12. In addition, radiopaque markers 15 can also be provided around top end 12.

(12) The present jacket and bladder system can be placed around the patient's heart in a variety of different approaches. In a preferred method of use, the present system further includes a delivery device for positioning the jacket onto the heart. Exemplary jacket designs and methods of placement are illustrated in US Published Patent Application 2010/0160721, incorporated herein by reference in its entirety. In one preferred aspect of the method, the assembly is implanted into the patient in a left intercostal mini-thoracotomy using contrast pericardiography and fluoroscopic visualization. After opening the parietal pericardium, the lower portion of the heart is free for applying the jacket over the apex. An example system for positioning the jacket is found in U.S. Pat. No. 5,702,343, incorporated herein by reference.

(13) Particular embodiments described herein also include a preferred method of providing localized pressure to a region of a patient's heart H to improve heart functioning, by: (a) positioning an assembly around a patient's heart, wherein the assembly comprises: a jacket 10 and at least one inflatable bladder 20, wherein jacket 10 is made of a flexible biocompatible material having an open top end 12 that is received around the heart and a bottom portion 14 that is received around the apex of the heart, and the inflatable bladder 20 is disposed on an interior surface of the jacket, and the inflatable bladder 20 has an inelastic outer surface positioned adjacent to the jacket and an elastic inner surface. Next, bladder 20 is inflated causing it to expand such that the bladder deforms substantially inwardly to exert localized pressure against a region of the heart.

(14) In another method of use, Pericardial Edge Management Strips (PEMS) are used. PEMS are sheets having one “peel and stick” side, and may be made of Teflon. These sheets can be used to keep the opening into the pericardium open to facilitate insertion of the device without damage to the pericardium (i.e.: the insertion tool getting hung up on the edges of the opening). In addition, Epicardial Management Strips (EMS) can be used to initially separate the heart from the mesh fabric. After the EMS are pulled out, the jacket fabric can then engage the heart.

(15) An example of a suitable system for measuring the size of the heart is illustrated in International Patent Publication WO 2010/111592, entitled Intra-Operative Heart Size Measuring Tool. This device has a flexible measuring cord with length indicia that is placed around the heart. The distal end of the tool can be inserted through an opening in the patient's chest and pericardium and then positioned at a measurement position at the apex of the patient's heart. Circumference measurements can be made at the A-V groove or at other heart locations, as desired.