Tool and method for installation of a ventricular cannulation device

• US 5,843,088 A
• Filed: 06/06/1995
• Issued: 12/01/1998
• Est. Priority Date: 12/23/1991
• Status: Expired due to Fees

• Current Assignee: Institut National De La Sante Et De La Recherche Medicale (Inserm) (Allianz Global Investors GmbH), Ela Medical S.A. (LivaNova Plc)
• Original Assignee: Institut National De La Sante Et De La Recherche Medicale (Inserm) (Allianz Global Investors GmbH), Ela Medical S.A. (LivaNova Plc)
• Inventors: Barra, Jean-Aubert, Paillot, Rene
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US08/468,553
• Time in Patent Office: 1,274 Days
• Field of Search: 606/1, 606/108, 600/16, 600/17, 601/153, 623/3, 604/49, 604/8
• US Class Current: 606/108
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/253 including a displacement member directly acting on the blood
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/859 Connections therefor
• 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 60/863 Apex rings
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/878 Electrical connections within the patient's body
• CPC Class Codes: A61M 60/882 Devices powered by the patient, e.g. skeletal muscle powered devices
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A ventricular cannulation device. An inner part is placed in the cardiac chamber and an outer part is placed outside the cardiac wall. Each of the inner and outer parts is equipped with means for catching onto the cardiac wall. The inner part bears a means for guiding and attaching the outer part thereto. A tube corresponding to the opening of the cardiac wall serves as a support for an outer tube or a vascular prosthesis. A blood circulatory assistance system is provided using a bio-pump, made from the patient'"'"'s muscle, and a pulse generator to stimulate the bio-pump under program control, to pump blood from the ventricle. Vascular prosthesis are used to connect the cannulation device and the bio-pump with the aorta for blood flow therethrough.

Claims

1. A method for installing a cannulation device in an aperture formed in cardiac tissue comprising:

(a) providing an inner part having a central opening and an outer perimeter dimension, for placement in the cardiac chamber;

(b) providing the inner part with a first means for catching onto the cardiac wall having a normal position for catching tissue and a deformed position in which the first catching means is confined within the perimeter dimension of the inner part;

(c) providing an outer part having a central opening, for placement on the cardiac tissue opposite the inner part;

(d) providing the outer part with a second means for catching the cardiac tissue;

(e) placing a sleeve over the inner part so that the first catching means is in its deformed position confined within the sleeve;

(f) inserting the sleeve through the cardiac tissue aperture so that the inner part passes inside the cardiac chamber;

(g) removing the sleeve while maintaining the inner part inside the cardiac chamber so that the first catching means returns to its normal position; and

(h) urging the inner and outer parts together so that the first catching means catches the cardiac tissue from the inside and the second catching means catches the cardiac tissue from the outside and securing the inner and outer parts together to provide the cannulation device.

2. The method of claim 1 wherein step (b) further comprising providing the first catching means as a plurality of claws having tissue penetrating tips.

3. The method of claim 2 wherein the plurality of claws extend radially around the perimeter of the inner part and further comprising providing each claw with a pad for resting against the cardiac wall.

4. The method of claim 2 in which step (b) further comprises providing a netting of a biocompatible material secured to the plurality of claws.

5. The method of claim 1 wherein step (c) further comprises providing the outer part with a disk structure and (d) further comprises providing the second catching means as a plurality of needles extending from the disk structure for passing into the cardiac tissue.

6. The method of claim 1 further comprising (i) providing a tube for supporting a vascular prosthesis and securing the tube to the central aperture of one of the inner and outer parts.

7. The method of claim 1 further comprising occluding the central opening of the inner part during insertion of the inner part.

8. The method of claim 7 in which the occluding step further comprises providing a removable plug in the central opening during insertion and removing the plug after the first and second parts have been secured.

9. The method of claim 7 in which the occluding step further comprises providing an inflatable stopper in the central opening during insertion, and, after the first and second parts have been secured, deflating the inflatable stopper and removing the deflated stopper.

10. The method of claim 1 wherein step (h) further comprises:

providing a guide means secured to the inner part;

mounting the outer part on the guide means for movement therealong towards the inner part; and

moving the outer part along the guide means towards the inner part.

11. The method of claim 10 wherein providing a guide means further comprises providing a plurality of rods secured to the inner part and wherein mounting the outer part further comprises providing the outer part with a like plurality of apertures for sliding engagement with the guide rods.

12. The method of claim 11 further comprising blocking or crimping the guide rods after the inner and outer parts have been urged together to hold the inner and outer parts in place.

13. The method of claim 12 further comprising removing the length of the guide rods distal to the blocked or crimped area.

14. The method of claim 11 wherein step (h) further comprises securing a bearing ring to the plurality of guide rods and inserting a tool between the outer part and the bearing ring for urging the outer part toward the inner part along the plurality of guide rods.

15. The method of claim 14 wherein inserting a tool further comprises providing a tool having a first lever and first contacting surface for contacting the outer part, a second lever and second contacting surface for contacting the bearing ring, and a guide ring, providing the guide ring with a plurality of apertures, mounting the first and second levers to move about a pivot, and passing the plurality of guide rods through the plurality of guide ring apertures so that the first and second contacting surfaces are between the outer part and the bearing ring, and moving the first and second levers to separate the first and second contacting surfaces for urging the outer part towards the inner part.

16. The method of claim 15 further comprising securing the guide ring to the second lever for movement therewith.

17. The method of claim 1 wherein step (e) further comprises placing a sleeve having a perforated wall over the inner part and wherein step (g) further comprises tearing the sleeve along the perforated wall prior to removing the sleeve.

18. The method of claim 2 wherein the plurality of claws extend spirally or helically from the perimeter of the inner part.

20. The tool of claim 15 in which the cannulation device has an inner part and an outer part, a plurality of guide rods connected to the inner part, and a bearing ring secured to the end of the plurality of guide rods, wherein the guide ring further comprises a plurality of apertures for receiving the guide rods so that the first and second contacting surfaces, when separated by said second distance, fit between the bearing ring and the ventricular cannulation device and, when moved from the second distance to the first distance, urge the inner and outer parts together.

21. The tool of claim 20 wherein the first and second contacting surfaces further comprise first and second forks, respectively.

19. An insertion tool for installing a ventricular cannulation device on opposite sides of a cardiac wall comprising:

a first lever having a first contacting surface;

a second lever having a second contacting surface;

a pivot, wherein at least one of the first and second levers is pivotably connected to said pivot, the first and second contacting surfaces being movable in a range of motion between a first distance of separation and a second distance of separation, the second distance being greater than the first distance; and

a ring supporting member having a guide ring at one end, the ring supporting member being connected to said pivot and the guide ring being interposed between said first and second contacting surfaces in said range of motion.

22. The tool of claim 19 wherein each of the first and second levers is pivotably connected to said pivot.

23. The tool of claim 22 wherein the ring supporting member is integral with said pivot.