Source: https://patents.google.com/patent/US20020065449A1/en
Timestamp: 2018-03-22 06:22:34
Document Index: 625387264

Matched Legal Cases: ['art.\n3', 'art.\n15', 'art.\n24', 'art.\n25', 'art.\n29', 'art;\n36']

US20020065449A1 - Cardiac reinforcement device - Google Patents
US20020065449A1
US20020065449A1 US10058475 US5847502A US2002065449A1 US 20020065449 A1 US20020065449 A1 US 20020065449A1 US 10058475 US10058475 US 10058475 US 5847502 A US5847502 A US 5847502A US 2002065449 A1 US2002065449 A1 US 2002065449A1
US10058475
A unique device is provided for treating heart disorders, and particularly cardiomyopathy. The inventive device is comprised of a compliant containment structure shaped in a configuration such that it surrounds and encases the heart. Within this containment structure are housed two or more inflation pockets that are fabricated from a non-elastic compliant material. These pockets are disposed on the interior surface of the containment structure and are configured to oppose and support the external wall of at least one of the ventricles of the heart. In the preferred embodiment, there are a plurality of relatively small, spaced inflation pockets disposed to act against each ventricle which is to be contained.
[0010]FIG. 1 is a schematic, perspective view of a first embodiment of the present invention;
[0011]FIG. 2 is a schematic exploded view of the embodiment illustrated in FIG. 1;
[0012]FIG. 2a is a schematic exploded view similar to that of FIG. 2, illustrating a somewhat modified version of the embodiment illustrated in FIG. 1;
[0013]FIG. 3 is a schematic perspective view of a second embodiment of the present invention;
[0014]FIG. 4 is a schematic exploded view of the embodiment illustrated in FIG. 3;
[0015]FIG. 5 is a cross-sectional view of a portion of the device illustrated in FIGS. 1 and 2, wherein the inflation pocket which forms a part of the invention is in an inflated state;
[0016]FIG. 6 is a cross-sectional view similar to FIG. 5, illustrating a portion of the device shown in FIGS. 1 and 2, during the fluid exchange phase;
[0017]FIG. 7 is a cross-sectional view similar to FIG. 6, illustrating a portion of the device shown in FIGS. 3 and 4, wherein the inflation pocket and secondary recoil balloon are in a filled state;
[0018]FIG. 8 is a cross-sectional view similar to FIG. 7, illustrating a portion of the device shown in FIGS. 3 and 4, during the fluid exchange phase;
[0019]FIG. 9 is a perspective view of the containment structure which forms a part of the inventive device;
[0020]FIGS. 10A and 10B are plan views, in isolation, of the inflation pockets which form a part of the inventive device;
[0021]FIG. 11 is a plan view, in isolation, of the recoil plate which forms a part of the second configuration of the inventive device illustrated in FIGS. 3 and 4;
[0022]FIG. 12 is a schematic view illustrating the placement of the fluid access port which forms a part of the present invention;
[0023]FIG. 13 is a schematic view illustrating yet a third embodiment of the inventive device;
[0024]FIG. 14 is a perspective view illustrating a fourth preferred embodiment of the invention;
[0025]FIG. 14a is a perspective view illustrating a modified version of the fourth embodiment shown in FIG. 14;
[0026]FIG. 14b is a cross-sectional view of a portion of the embodiment illustrated in FIG. 14a;
[0027]FIG. 15 is a front elevational view showing the embodiment of FIG. 14 after it has been placed about a heart, with a bypass graft in place;
[0028]FIG. 16 is a cross-sectional view of the embodiment illustrated in FIG. 14, showing in detail the inflation pockets of the invention;
[0029]FIG. 17 is a conceptual graphical plot of the cyclical pressure measured by an external pressure monitor for the device illustrated in FIG. 14 when it is installed on a heart and working full time (i.e. in contact with the heart full time);
[0030]FIG. 18 is a conceptual graphical plot similar to that of FIG. 17 of the cyclical pressure measured by an external pressure monitor for the device illustrated in FIG. 14 when it is installed on a heart but not in contact with the external surface of the heart full time (i.e. it needs to be re-sized by addition of fluid); and
[0031]FIG. 19 is a schematic view illustrating a system for monitoring pressure and/or providing counter-pulsating assist for any one of the embodiments illustrated in FIGS. 1-18.
1. A device for treating a heart disorder, comprising:
a first structure for placement over a patient's heart;
a second structure for applying pressure against a first portion of said heart during a portion of the pumping cycle of said heart; and
a third structure for applying pressure against a second portion of said heart during a portion of the pumping cycle of said heart;
wherein the pressure applied by said second and third structures may be independently controllable so that the different pressures may be selectively applied against said first and second heart portions.
2. The device as recited in claim 1, wherein said first structure comprises a containment structure for enclosing a substantial portion of said heart.
3. The device as recited in claim 1, wherein said second structure comprises a first inflation pocket.
4. The device as recited in claim 3, wherein said third structure comprises a second inflation pocket disposed in a spaced relationship from said first inflation pocket.
5. The device as recited in claim 3, and further comprising a recoil balloon disposed outwardly of said inflation pocket and a fluid passage disposed between said inflation pocket and said recoil balloon to permit fluid to be exchanged therebetween.
6. The device as recited in claim 5, wherein said inflation pocket is filled with fluid, and said first portion of said heart is the left ventricle, wherein when the heart enters a diastolic state, the left ventricle expands against said inflation pocket, thereby forcing fluid from said inflation pocket through said fluid passage and into said recoil balloon.
7. The device as recited in claim 6, wherein when said heart enters a systolic state, said fluid returns through said fluid passage from the recoil balloon into the inflation pocket, so that the inflation pocket becomes pressurized and exerts pressure against said left ventricle.
8. The device as recited in claim 4, and further comprising a fluid injection port for injecting fluid into each of said first and second inflation pockets, wherein differing amounts of fluid may be injected into each of the inflation pockets independently, thereby permitting different pressures to be selectively applied against said first and second heart portions.
9. The device as recited in claim 8, wherein said fluid injection port comprises two septums disposed just beneath the skin of said patient, each of which is fluidly connected through a separate fluid passage to a corresponding one of said inflation pockets.
10. The device as recited in claim 8, wherein said fluid injection port comprises a pressurized fluid reservoir and a one-way valve, so that fluid may be automatically injected into each of the first and second inflation pockets independently, responsive to pressure in each pocket.
11. The device as recited in claim 2, wherein the containment structure is comprised substantially entirely of a flexible, biocompatible open mesh material, having a plurality of access openings disposed therein which are distributed about an outer surface of said containment structure.
12. The device as recited in claim 3, wherein said first inflation pocket comprises a plurality of relatively small, spaced inflation pockets.
a second structure disposed within said first structure for supporting a portion of said heart during at least a period of time when the heart is in a diastolic state;
14. The device as recited in claim 13, wherein said first structure comprises a containment structure for enclosing a substantial portion of said heart.
15. The device as recited in claim 13, wherein said second structure comprises an inflation pocket comprised of a substantially non-elastic biocompatible material.
16. The device as recited in claim 14, wherein said third structure comprises a recoil balloon.
17. The device as recited in claim 16, and further comprising a fluid passage disposed between said inflation pocket and said recoil balloon to permit fluid to be exchanged therebetween.
18. The device as recited in claim 17, and further comprising a fluid injection port for injecting fluid into said inflation pocket, wherein the amount of fluid being injected into said inflation pocket may be increased responsive to the size of the heart, in order to ensure that pressure is applied by said inflation pocket against said heart at least when said heart is in a diastolic state.
19. The device as recited in claim 14, wherein said third structure is spaced from said first structure.
20. The device as recited in claim 14, and further comprising a drug delivery line for selectively delivering drugs to said heart through said first structure.
a first inflation pocket for applying pressure against the left heart ventricle during at least a period of time when the heart is in a diastolic state;
a second inflation pocket for applying pressure against the right heart ventricle during at least a period of time when the heart is in a diastolic state; and
a fluid injection port comprising a fluid line for independently delivering pressurized fluid to each of said first and second inflation pockets, so that different pressures may be selectively applied against each of said left and right heart ventricles.
an inflation pocket disposed within said containment structure for supporting a portion of the heart during at least a period of time when the heart is in a diastolic state; and
applying a first level of pressure against a first portion of a patient's heart; and
applying a second level of pressure against a second portion of said heart.
24. The method as recited in claim 23, and further comprising the step of placing a containment structure over said heart.
25. The method as recited in claim 23, wherein the step of applying a first level of pressure is accomplished by inflating a first inflation pocket which is disposed to lie adjacent to said first heart portion within said containment structure to said first level of pressure.
26. The method as recited in claim 25, wherein the step of applying a second level of pressure is accomplished by inflating a second inflation pocket which is disposed to lie adjacent to said second heart portion within said containment structure to said second level of pressure.
27. A method for treating a heart disorder, comprising the steps of:
applying a first level of pressure against a first portion of a patient's heart;
monitoring the size of said heart over time; and
increasing said first level of pressure to a second higher level of pressure when a reduction in size of said heart is detected.
28. A device for treating a heart disorder, comprising:
a containment structure for placement over a patient's heart; and
a plurality of inflation pockets for applying pressure against a portion of said heart during at least a portion of the pumping cycle of said heart.
29. The device as recited in claim 28, wherein said containment structure has an outer surface and comprises an open mesh material having a plurality of openings distributed about said outer surface, said plurality of openings providing access for visualizing coronary arteries and performing bypass procedures on said heart without removing said device.
30. The device as recited in claim 28, wherein said plurality of inflation pockets comprise a plurality of inflation pockets which are each substantially smaller than a ventricle of said heart, and which are spaced with respect to one another, said plurality of inflation pockets together having sufficient size and being capable of applying sufficient force to restrain a heart ventricle.
31. The device as recited in claim 30, and further comprising a fluid injection port and a fluid passage connected between said fluid injection port and each of said plurality of inflation pockets, for injecting fluid into each of said plurality of inflation pockets.
32. The device as recited in claim 31, and further comprising a recoil balloon which is fluidly connected to each of said plurality of inflation pockets, said recoil balloon receiving fluid from said inflation pockets during a portion of the heart pumping cycle and delivering fluid to said inflation pockets during another portion of the heart pumping cycle.
33. The device as recited in claim 32, wherein said recoil balloon is disposed at a location remote from said containment structure.
34. The device as recited in claim 33, wherein said recoil balloon is disposed in said fluid passage, said fluid passage comprising a fluid line, said recoil balloon being connected to said fluid line using detachable fittings so that it is readily replaceable.
35. A device for treating a heart disorder, comprising:
a containment structure for placement over a patient's heart;
36. A dual function device for treating a heart disorder, comprising:
at least one inflation pocket for applying pressure against a portion of said heart during at least a portion of the pumping cycle of said heart;
a fluid passage connected between said fluid injection port and said at least one inflation pocket;
said device being operable to inject fluid into said at least one inflation pocket during any portion of the pumping cycle of the heart, so that it may operate either passively to restrain the size of the heart during the diastolic portion of the pumping cycle, or actively to provide a rapid pressure pulse to assist the heart during the systolic portion of the pumping cycle.
US10058475 1998-12-21 2002-01-28 Cardiac reinforcement device Abandoned US20020065449A1 (en)
US09346643 Continuation US6432039B1 (en) 1998-12-21 1999-07-01 Methods and apparatus for reinforcement of the heart ventricles
US20020065449A1 true true US20020065449A1 (en) 2002-05-30
EP2482865B1 (en) * 2009-09-30 2015-05-06 AdjuCor GmbH Cardiac assistance device
US6432039B1 (en) 2002-08-13 grant