Sensor-equipped and algorithm controlled direct mechanical ventricular assist device
An apparatus for assisting the function of a heart disposed within a body. The apparatus can apply a compressive force and an expansive force to a portion of the outer wall of the heart. The apparatus can comprise a cup-shaped shell having an exterior wall, an interior wall, an apex, and an upper edge; a liner having an outer surface and an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell, thereby forming a cavity between the outer surface thereof and the interior wall of the shell; and a drive fluid within the cavity. The drive fluid can apply a force on a portion of the outer wall of the heart.
1 . An apparatus for assisting the function of a heart disposed within a body, the apparatus comprising:
a cup-shaped shell including an interior wall and an exterior wall;
a liner including an outer surface, portions of the outer surface joined to portions of the interior wall of the cup-shaped shell such that a cavity is formed between the outer surface and the interior wall; and
a seal including a base, a tapered midsection and a tip, the tip adapted to be deployed contiguously with the heart.
2 . The apparatus of claim 1 , wherein the liner and the seal are unitary.
3 . The apparatus of claim 2 , wherein the liner and the seal are formed by a molding process.
4 . The apparatus of claim 2 , wherein the liner and the seal are of heat cured liquid silicone rubber.
5 . The apparatus of claim 1 , wherein the seal further comprises a ring disposed proximate to the tip, and a mating groove formed in the exterior wall of the shell proximate to the seal.
6 . The apparatus of claim 5 , further comprising:
a cavity disposed within the tapered midsection of the seal; and
a lumen connected to the cavity disposed within the tapered midsection and to a fluid source.
7 . The apparatus of claim 1 , wherein the seal is biocompatible.
8 . The apparatus of claim 1 , wherein the seal is biodegradable.
9 . The apparatus of claim 1 , wherein the seal is detachable from the upper edge of the cup-shaped shell.
10 . The apparatus of claim 1 , wherein the seal comprises a first therapeutic agent.
11 . The apparatus of claim 10 , wherein the first therapeutic agent is diffused throughout the seal.
12 . The apparatus of claim 10 , wherein the first therapeutic agent comprises a coating on the outer surface of the seal.
13 . The apparatus of claim 10 , wherein a cavity is disposed within the seal, and the first therapeutic agent is disposed within the cavity disposed within the seal.
14 . The apparatus of claim 10 , wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.
15 . The apparatus of claim 10 , wherein the seal further comprises a second therapeutic agent.
16 . The apparatus of claim 1 , wherein the seal has a textured outer surface.
17 . The apparatus of claim 1 , wherein the liner is an elastic liner.
18 . The apparatus of claim 17 , wherein the elastic liner is of silicone polymer.
19 . The apparatus of claim 1 , wherein the liner is detachable from the interior wall of the cup-shaped shell.
20 . The apparatus of claim 1 , wherein the liner comprises a first therapeutic agent.
21 . The apparatus of claim 20 , wherein the first therapeutic agent is diffused throughout the liner.
22 . The apparatus of claim 20 , wherein the first therapeutic agent comprises a coating on an inner surface of the liner.
23 . The apparatus of claim 20 , wherein the liner comprises a first membrane and a second membrane, and the first therapeutic agent is disposed between the first and second membranes.
24 . The apparatus of claim 20 , wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.
25 . The apparatus of in claim 20 , wherein the liner further comprises a second therapeutic agent.
26 . The apparatus of claim 1 , wherein the liner has a textured inner surface.
27 . The apparatus of claim 1 , wherein the liner comprises:
a first membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell; and
a second membrane including an outer surface and an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell;
wherein the inner surface of the first membrane is contiguous with the outer surface of the second membrane.
28 . The apparatus of claim 1 , wherein the liner is a rolling diaphragm liner.
29 . An apparatus for assisting the function of a heart disposed within a body, the apparatus comprising:
a cup-shaped shell including an interior wall, an exterior wall and an upper edge;
a liner including an outer surface, portions of the outer surface joined to the interior wall such that a cavity is defined between the outer surface and the interior wall; and
a seal joined to the upper edge, the seal unitary with the liner.
30 . The apparatus of claim 29 , wherein the seal further comprises a base joined to the upper edge of the cup-shaped shell, a tapered midsection, and a tip, the tip adapted to be deployed contiguously against the heart.
31 . The apparatus of claim 29 , wherein the liner and the seal are formed by a molding process.
32 . The apparatus of claim 30 , wherein the liner and the seal are of heat cured liquid silicone rubber.
33 . The apparatus of claim 30 , wherein the seal further comprises a ring disposed proximate to the tip and a mating groove formed in the exterior wall of the shell proximate to the seal.
34 . The apparatus of claim 30 , further comprising a cavity disposed within the tapered midsection of the seal and a lumen connected to the cavity and to a fluid source.
35 . The apparatus of claim 29 , wherein the seal is biocompatible.
36 . The apparatus of claim 29 , wherein the seal is biodegradable.
37 . The apparatus of claim 29 , wherein the seal is detachable from the upper edge of the cup-shaped shell.
38 . The apparatus of claim 29 , wherein the seal comprises a first therapeutic agent.
39 . The apparatus of claim 38 , wherein the first therapeutic agent is diffused throughout the seal.
40 . The apparatus of claim 38 , wherein the first therapeutic agent comprises a coating on the outer surface of the seal.
41 . The apparatus of claim 38 , wherein a cavity is disposed within the seal, and the first therapeutic agent is disposed within the cavity disposed within the seal.
42 . The apparatus of claim 38 , wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.
43 . The apparatus of claim 38 , wherein the seal further comprises a second therapeutic agent.
44 . The apparatus of claim 29 , wherein the seal has a textured outer surface.
45 . The apparatus of claim 29 , wherein the liner is an elastic liner.
46 . The apparatus of claim 45 , wherein the elastic liner is of silicone polymer.
47 . The apparatus of claim 29 , wherein the liner is detachable from the interior wall of the cup-shaped shell.
48 . The apparatus of claim 29 , wherein the liner comprises a first therapeutic agent.
49 . The apparatus of claim 48 , wherein the first therapeutic agent is diffused throughout the liner.
50 . The apparatus of claim 48 , wherein the first therapeutic agent comprises a coating on an inner surface of the liner.
51 . The apparatus of claim 48 , wherein the liner comprises a first membrane and a second membrane, and the first therapeutic agent is disposed between the first and the second membranes.
52 . The apparatus of claim 48 , wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.
53 . The apparatus of claim 48 , wherein the liner further comprises a second therapeutic agent.
54 . The apparatus of claim 29 , wherein the liner has a textured inner surface.
55 . The apparatus of claim 29 , wherein the liner comprises:
a first membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell; and
a second membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell;
wherein the inner surface of the first membrane is contiguous with the outer surface of the second membrane.
56 . The apparatus of claim 29 , wherein the liner is a rolling diaphragm liner.