Synthetic intraventricular implants and method of inserting

• US 5,192,314 A
• Filed: 12/12/1991
• Issued: 03/09/1993
• Est. Priority Date: 12/12/1991
• Status: Expired due to Term

• Current Assignee: Michael K. Daskalakis
• Original Assignee: Michael K. Daskalakis
• Inventors: Daskalakis, Michael K.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Nguyen, Dinh X.
• Application Number:
  US07/806,696
• Time in Patent Office: 453 Days
• Field of Search: 623/2, 623/11, 623/3, 623/1, 623/66, 604/96, 604/97, 604/98, 604/99
• US Class Current: 623/3.21
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/17 inside a ventricle, e.g. intraventricular balloon pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/882 Devices powered by the patient, e.g. skeletal muscle powered devices

Abstract

A synthetic intraventricular implant device adapted to be surgically secured in a ventricle of the heart of a patient. The shape, size and volume of the device so inserted will depend on the size of the ventricle of the patient, and how much of the end-diastolic volume thereof it is desired to reduce. The device is surgically inserted into and secured in place in the ventricle by suturing it onto a preselected segment of the interior wall of the ventricle to reduce end-diastolic volume, pressure and wall stress, and to subsequently increase ejection fraction and cardiac output. The device may include a fluid, liquid, semi-liquid, semi-solid, solid or viscous core and/or an inflatable balloon-like portion for use in assisting in the elimination of blood from the "dead volume" within the ventricle. Additionally, the inflatable implant, when used as a ventricular assist device, will increase the ejection fraction and contractility of the myocardium, as well as cardiac output, either permanently or temporarily, in some patients with specific cardimoypathies.

An implant device is inserted during open heart surgery on a patient, by forming an opening in a portion of the distal end wall of a ventricle of the patient'"'"'s heart, inserting the selected implant into the interior chamber of the ventricle, suturing the implant in a predetermined position against a segment of the interior wall within the patient'"'"'s ventricle and suturing the opening made in the distal end wall of the ventricle. Revascularization or associated procedures may follow or proceed insertion of the implant.

Claims

1. A synthetic intraventricular implant device capable of being surgically secured within a ventricle of a human heart, said ventricle having a wall with exterior and interior surfaces and an interior cavity with a distal end, comprising:

a generally oblong, shaped and contoured body having an inner wall adapted to face said interior cavity of said ventricle and an outer wall adapted to be snugly secured against said interior surface of said ventricle;

said inner and outer walls of said contoured body being sealingly fixed together; and

a cuff formed from a portion of one of said inner and outer walls of said contoured body so as to completely surround said inner and outer walls of said contoured body for securing said implant in position within said wall of said ventricle, with said cuff capable of being fixed to said interior surface of said ventricle wall, within said interior cavity.

2. The synthetic intraventricular implant device of claim 1 wherein said ventricle is a left ventricle and said implant is inserted into a resected segment of said ventricle wall with said outer wall of said implant snugly secured against a surface of skeletal muscle whereby said implant may be displaced into said interior cavity of said left ventricle upon contraction of said skeletal muscle.

3. The synthetic intraventricular implant device of claim 1, further including a hollow, internal chamber formed between said inner and outer walls of said contoured body and a core of material held within said internal chamber.

4. The synthetic intraventricular implant device of claim 3 wherein said inner and outer walls are made from a material selected from the group consisting of Dacron, Polytetrafluroethylene and other synthetic, non-allergenic, bio-acceptable materials for use within a human body.

5. The synthetic intraventricular implant device of claim 3 wherein said core of material is selected from a group consisting of synthetic, non-allergenic, bio-acceptable fluids, liquids, semi-liquids, semi-solids and solids.

6. The synthetic intraventricular implant device of claim 3, further including an expandable balloon fixed to said inner wall, and a tube fluidly connected to said expandable balloon.

7. The synthetic intraventricular implant device of claim 1, further including an expandable balloon fixed to said inner wall of said contoured body, and a tube fluidly connected to said expandable balloon.

8. The synthetic intraventricular implant device of claim 1 wherein said inner wall of said contoured body is expandable and a tube is fluidly connected thereto.

9. The synthetic intraventricular implant device of claim 1 wherein said cuff is formed from a portion of said outer wall of said contoured body extending beyond said inner wall thereof and said inner wall thereof is capable of being covered with pericardium.

10. The synthetic intraventricular implant device of claim 1 wherein said inner and outer walls of said contoured body are made from a material selected from the group consisting of Dacron, Polytetrafluroethylene and other synthetic, non-allergenic, bio-acceptable materials for use within a human body.

11. A synthetic intraventricular implant device capable of being surgically secured in a ventricle of a human heart, which ventricle has a wall with exterior and interior surfaces and an interior cavity formed therein having a distal end, comprising:

a generally oblong, shaped and contoured body having an inner wall adapted to face said interior cavity of said ventricle and an outer wall adapted to be snugly secured against a predetermined segment of said interior wall of said ventricle interior cavity;

said inner and outer walls of said contoured body being sealingly fixed together around a periphery;

a hollow, internal chamber formed within said periphery between said inner and outer walls of said contoured body;

a core of material held within said internal chamber of said contoured body; and

a cuff formed from a portion of one of said inner and outer walls of said contoured body so as to completely surround said periphery and said inner and outer walls of said contoured body for securing said implant in position within said interior cavity of said ventricle, with said cuff capable of being fixed to said interior wall of said ventricle.

12. The synthetic intraventricular implant device of claim 11 wherein said inner and outer walls of said contoured body are made from a material selected from the group consisting of Dacron, Polytetrafluroethylene and other synthetic, non-allergenic, bio-acceptable materials for use within a human body.

13. The synthetic intraventricular implant device of claim 11 wherein said core of material held within said internal chamber of said contoured body is selected from a group consisting of synthetic, non-allergenic bio-acceptable fluids, liquids, semi-liquids, semi-solids and solids.

14. The synthetic intraventricular implant device of claim 13 wherein said inner wall of said contoured body is expandable.

15. The synthetic intraventricular implant device of claim 11, further including an expandable balloon fixed to said inner wall of said contoured body, and a tube fluidly connected to said expandable balloon.

16. The synthetic intraventricular implant device of claim 11 wherein said inner wall of said contoured body is expandable and a tube is fluidly connected thereto.

17. The synthetic intraventricular implant device of claim 11 wherein said cuff is formed from a portion of said outer wall of said contoured body extending beyond said inner wall thereof and said inner wall thereof is covered with pericardium.