Intrapericardial assist device and associated method

• US 5,533,958 A
• Filed: 08/05/1994
• Issued: 07/09/1996
• Est. Priority Date: 06/17/1993
• Status: Expired due to Term

• Current Assignee: WILK Patent and Development Corporation
• Original Assignee: WILK Patent and Development Corporation
• Inventors: Wilk, Peter J.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/286,817
• Time in Patent Office: 704 Days
• Field of Search: 601/151, 601/152, 601/153, 607/5, 607/129, 607/130, 607/116, 607/119, 600/16, 600/17, 600/18, 128/639, 128/644, 604/96, 604/97, 604/98, 604/99
• US Class Current: 600/18
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2090/0815 Implantable devices for insertion in between organs or other soft tissues
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 60/191 mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/435 with diastole or systole switching by valve means located between the blood pump and the hydraulic or pneumatic energy source
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• 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

Abstract

An intrapericardial assist device and method comprises an electrode carrier in the form of an inflatable cuff-shaped balloon adapted for juxtaposition to a patient'"'"'s heart in an intrapericardial space. An electrical contact or electrode is disposed on the contact surface of the carrier for conducting electrical energy to the heart upon an insertion of the electrode carrier into the intrapericardial space and upon inflation of the balloon so that the electrode engages cardiac tissues.

Claims

1. An intrapericardial assist device comprising:

an electrode carrier having a surface for contacting a patient'"'"'s heart in an intrapericardial space;

electrical contact means disposed on said surface for conducting electrical energy to the heart upon an insertion of said electrode carrier into the intrapericardial space;

means operatively connected to said contact means for supplying electrical energy to said contact means; and

means connected to said electrode carrier for maintaining said surface in contact with the patient'"'"'s heart,

said electrode carrier being a collapsible member which has a configuration of a slotted cuff in an expanded configuration, said electrode carrier having a predetermined size and shape in said expanded configuration so that said electrode carrier is disposable in the intrapericardial space in juxtaposition to the patient'"'"'s heart.

2. The device defined in claim 1, further comprising spring means connected to said electrode carrier for automatically unfurling said carrier from a folded collapsed configuration to said expanded configuration.

3. The device defined in claim 2 wherein said spring means includes an elongate rib element.

4. The device defined in claim 1, further comprising sensing means disposed in part on said carrier for generating an electrocardiograph of the patient'"'"'s heart activity.

5. An intrapericardial assist device comprising:

an electrode carrier having a surface for contacting a patient'"'"'s heart in an intrapericardial space;

electrical contact means disposed on said surface for conducting electrical energy to the heart upon an insertion of said electrode carrier into the intrapericardial space;

means operatively connected to said contact means for supplying electrical energy to said contact means; and

means connected to said electrode carrier for maintaining said surface in contact with the patient'"'"'s heart;

said electrode carrier having the form of a balloon, said means for maintaining including inflation means operatively connected to said electrode carrier for inflating said electrode carrier from a folded collapsed configuration to an unfolded expanded configuration.

6. The device defined in claim 5, further comprising spring means connected to said electrode carrier for automatically unfurling said carrier from said folded collapsed configuration to said unfolded expanded configuration.

7. The device defined in claim 6 wherein said spring means includes an elongate rib element.

8. The device defined in claim 5 wherein said inflation means includes means for automatically and periodically inflating and alternately deflating said balloon upon a disposition thereof into said intrapericardial space.

9. The device defined in claim 5, further comprising sensing means disposed in part on said carrier for generating an electrocardiograph of the patient'"'"'s heart activity.

10. A surgical method for reactivating a malfunctioning heart, comprising the steps of:

providing an inflatable balloon in a collapsed configuration, said balloon being provided with an electrode on a surface adapted for contact with a patient'"'"'s heart;

inserting said balloon into an intrapericardial space about the patient'"'"'s heart;

upon insertion of said balloon into the intrapericardial space, inflating said balloon to place said electrode in electrically conductive contact with the heart of the patient; and

upon inflation of said balloon, conducting a voltage through the electrode to the patient'"'"'s heart.

11. The method defined in claim 10 wherein said voltage is a defibrillating voltage, further comprising the steps of:

upon completion of said step of conducting, monitoring heart action via an EKG device for a predetermined period; and

upon a determination that the heart has started with an inadequate strength, inflating said balloon in synchronism with a heart contraction to place a compressive pressure on the heart to thereby increase pumping action.

12. The method defined in claim 11, further comprising the step of at least partially deflating said balloon upon completion of said step of conducting and prior to said step of monitoring.

13. The method defined in claim 11, further comprising the steps of:

generating a pacemaker type periodic voltage;

applying said periodic voltage to the heart via said electrode upon completion of said step of inflating said balloon in synchronism with a heart contraction to place a compressive pressure on the heart; and

maintaining said balloon in an inflated state during said step of applying to maintain said electrode in electrically conductive contact with the heart of the patient.

14. The method defined in claim 10, further comprising the steps of generating a pacemaker type periodic voltage, said step of conducting including the step of applying said periodic voltage to the heart via said electrode;

and

maintaining said balloon in an inflated state during said step of applying to maintain said electrode in electrically conductive contact with the heart of the patient.

15. The method defined in claim 10 wherein said step of inserting includes the steps of providing a hypodermic type needle, inserting said needle through a skin surface and into said intrapericardial space, and injecting said balloon in said collapsed configuration into said intrapericardial space.

16. The method defined in claim 10, further comprising the step of deflating said balloon upon completion of said step of inflating, also comprising the step of again inflating said balloon upon deflation thereof.

17. The method defined in claim 10, further comprising the step of periodically inflating said balloon upon completion of said step of conducting.

18. The method defined in claim 10 wherein said balloon has an arcuate cuff configuration in an inflated configuration, further comprising the step of placing said balloon at least partially around the heart in said intrapericardial space upon completion of said step of inserting.

19. The method defined in claim 10, further comprising the steps of providing a hypodermic type needle and a dilating device, said step of inserting including the steps of partially inserting said needle through a skin surface and into said intrapericardial space and placing a distal end portion of said dilating device into said intrapericardial space via said needle upon the partial insertion thereof into said intrapericardial space, also comprising the step of expanding said dilating device upon the insertion of the distal end portion thereof into said intrapericardial space, said balloon being inserted into said intrapericardial space through the expanded dilating device.