Intrapericardial assist device and associated method

• US 5,800,334 A
• Filed: 07/09/1996
• Issued: 09/01/1998
• 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): Getzow, Scott M.
• Application Number:
  US08/678,479
• Time in Patent Office: 784 Days
• Field of Search: 601/151, 601/152, 601/153, 607/3, 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 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• 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 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/585 User interfaces
• CPC Class Codes: A61M 60/857 Implantable blood tubes

Abstract

A surgical method for assisting a malfunctioning heart comprises inserting a balloon into an intrapericardial space and inflating the balloon in the intrapericardial space to place a compressive pressure on a heart in the intrapericardial space sufficient to force blood from the heart. A lubricant is fed to the intrapericardial space after insertion of the balloon into the space.

Claims

1. A surgical method for aiding a malfunctioning heart, comprising:

providing an inflatable balloon in a collapsed configuration;

inserting said balloon into an intrapericardial space about a heart disposed in said space;

inflating said balloon in said intrapericardial space to place a compressive pressure on the heart sufficient to force blood from the heart; and

feeding a lubricant to the intrapericardial space after insertion of said balloon into said space.

2. The method defined in claim 1 wherein said the feeding of said lubricant comprises dripping said lubricant into said intrapericardial space by a gravity flow.

3. The method defined in claim 1 wherein said lubricant is a saline solution with cortico-steroids to at least reduce adhesion formation.

4. The method defined in claim 1 wherein said balloon is made of a flexible material and has an external surface with a low coefficient of friction.

5. The method defined in claim 1 wherein a first tube and a second tube are operatively connected to said balloon, the inflating of said ballooon including guiding a fluid under pressure to said balloon via said first tube, the feeding of said lubricant to said intrapericardial space comprising guiding said lubricant to said intrapericardial space via said second tube.

6. The method defined in claim 1 wherein the inserting of said balloon includes inserting a hypodermic type needle through a skin surface and into said intrapericardial space, and injecting said balloon in said collapsed configuration into said intrapericardial space.

7. The method defined in claim 6, 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.

8. The method defined in claim 1, further comprising the step of periodically inflating said balloon upon completion of said step of inserting.

9. The method defined in claim 1 wherein said balloon is provided with an electrode on a surface adapted for contact with the heart, further comprising conducting a voltage through the electrode to the heart after inflation of said balloon.

10. The method defined in claim 9 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.

11. The method defined in claim 1, 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.

12. An intrapericardial assist device comprising;

a balloon having a predetermined size and shape in an expanded configuration so that said balloon is capable of being disposed in an intrapericardial space about a heart;

inflation means operatively connected to said balloon for inflating said balloon from an unfolded collapsed configuration to the expanded configuration; and

lubricating means operatively connected to said balloon for delivering a lubricant to an external surface of said balloon upon disposition of said balloon in the intrapericardial space.

13. The device defined in claim 12 wherein said lubricating means includes a tube extending to a source of lubricating fluid.

14. The device defined in claim 12, further comprising spring means connected to said balloon for automatically unfurling said balloon from a folded collapsed configuration to an unfolded collapsed configuration, said spring means being different from said inflation means, said spring means includes an elongate rib element.

15. The device defined in claim 12 wherein said inflation means includes means for automatically and periodically inflating and alternately deflating said balloon upon a disposition thereof into said intrapericardial space.

16. The device defined in claim 12 wherein electrical contact means are disposed on a surface of said balloon for conducting electrical energy to the heart upon an insertion of said balloon into the intrapericardial space, also comprising means operatively connected to said contact means for supplying electrical energy to said contact means.

17. A surgical method for assisting a malfunctioning heart, comprising the steps of:

inserting a balloon into an intrapericardial space; and

inflating the balloon in said intrapericardial space to place a compressive pressure on a heart in said intrapericardial space sufficient to force blood from the heart.

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

19. The method defined in claim 17, further comprising the step of unfolding said balloon in said intrapericardial space upon insertion of said balloon into said intrapericardial space.

20. The method defined in claim 17 wherein the inserting of said balloon includes inserting a hypodermic type needle through a skin surface and into said intrapericardial space, and injecting said balloon in a collapsed configuration into said intrapericardial space.