Implantable medical device with a reduced volumetric configuration and improved shock stabilization

• US 5,741,313 A
• Filed: 09/09/1996
• Issued: 04/21/1998
• Est. Priority Date: 09/09/1996
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Truex, Buehl E., Stutz, William H. Jr., Nason, Clyde K., Davis, Dion Frank
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/711,012
• Time in Patent Office: 589 Days
• Field of Search: 607/36, 607/37
• US Class Current: 607/36
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing

Abstract

A cardiac stimulation device having a reduced volumetric configuration contains a pair of high-voltage cylindrical discharge capacitors positioned at rounded edges within a device container. The capacitors have electrical contact tabs at one end which are inserted directly through apertures formed within an associated electronic module. The capacitor tabs are connected directly to the electronic module eliminating the need for secondary connectors or point to point wiring, thus reducing the number of connections. Direct connection of the capacitors to the electronic module allows for optimal positioning of the module within the container. Specifically, the generally planar module is oriented perpendicular to planar cover surfaces of the container. Irregularly shaped components attached to the surface of the module advantageously extend away from the surface into remaining voids within the container. Adhesive compressible foam is placed around and between the internal components of the stimulation device to stabilize the device against shock and vibration.

Claims

1. An implantable cardiac stimulation device having internal components optimally configured to reduce the overall volumetric displacement of the device comprising:

a container defining an interior region for holding an assembly of electronic components, the electronic components operating to deliver an electric shock to a patient in response to a cardiac arrhythmia, the assembly of electronic components comprising;

a voltage discharge module generating a high-voltage electric charge for delivering the electric shock to the patient, the voltage discharge module having an electrical substrate formed with an aperture therethrough;

a battery connected to the voltage discharge module for supplying electrical energy to generate the high-voltage electric charge; and

a cardiac discharge capacitor assembly connected to the voltage discharge module for temporarily storing the high-voltage electric charge, the cardiac discharge capacitor assembly having an electrical connector lead directly inserted through the substrate aperture for establishing electrical communication with the voltage discharge module and achieving a reduced volumetric configuration for the stimulation device; and

adhesive tape means for joining the voltage discharge module, the battery, and the capacitor assembly into a single, rigid assembly, thereby stabilizing the assembly against shock movement within the housing.

2. The cardiac stimulation device of claim 1, wherein the device is a cardioverter-defibrillator and the cardiac discharge capacitor assembly comprises first and second cylindrical capacitors, each of the first and second capacitors having a pair of electrical tabs formed at a first end of the first and second capacitors, and wherein each pair of electrical tabs is inserted through a respective mating aperture formed within the electrical substrate.

3. The cardiac stimulation device of claim 1, wherein:

the container is physiologically shaped comprising front and back substantially flat cover surfaces, and rounded peripheral edges for facilitating implantation;

the first and second capacitors are positioned at opposite edges of the interior region so that a longitudinal axis of the first capacitor is parallel to a longitudinal axis of the second capacitor;

the battery is positioned at a central portion of the interior region; and

the adhesive means is applied between at least one of the container cover surfaces and at least one of the first capacitor, the second capacitor, or the battery, thereby stabilizing the single, rigid assembly to the container.

4. The cardiac stimulation device of claim 3, wherein the electrical substrate of the voltage discharge module has a substantially planar surface oriented perpendicular to the flat cover surfaces of the container.

5. The cardiac stimulation device of claim 4, wherein the voltage discharge module comprises electrical components mounted to the substrate of the voltage discharge module, and wherein the electrical components extend away from the planar surface of the substrate towards the battery to achieve an optimal reduced volumetric configuration.

6. The cardiac stimulation device of claim 3, wherein the cardioverter-defibrillator further comprises a control module for monitoring cardiac functions of the patient and communicating with the voltage discharge module, the control module positioned at a second end of the first and second capacitors, and the control module comprising a substantially planar substrate surface oriented perpendicular to the flat cover surfaces of the container.

7. The cardiac stimulation device of claim 6, wherein the control module comprises a first electronic component mounted to a top surface of the control module substrate, and a second electronic component mounted to a bottom surface of the control module substrate, the first electronic component extending away from the top surface towards the battery and the second electronic component extending away from the bottom surface towards an edge of the container.

8. The cardiac stimulation device of claim 1, wherein the adhesive means comprises adhesive foam tape placed between the cardiac discharge capacitor assembly and the voltage discharge module, between the cardiac discharge capacitor assembly and the battery, and between the cardiac discharge capacitor assembly and the container for providing stabilization of the assembly of internal components in response to movement of the cardiac stimulation device.

9. An implantable cardioverter-defibrillator comprising:

a container constructed of a biocompatible material for subcutaneous positioning within a human patient;

electronic circuit means disposed within an interior region of the container for monitoring the cardiac activity of a patient and delivering a high voltage charge to the patient in response to a cardiac arrhythmia;

a battery within the interior region of the container for supplying electrical energy to the electronic circuit means; and

energy storage means disposed within the interior region of the container for storing the high voltage electrical charge, the energy storage means comprising electrical connection means for transferring the high voltage charge to the electronic circuit means;

compressible tape adhesive means for protecting the energy storage means and the electronic circuit means against shock and vibration; and

wherein the electronic circuit means is formed with at least one aperture for receiving the electrical connection means of the energy storage means.

10. The implantable cardioverter-defibrillator of claim 9, wherein the container comprises flat cover surfaces terminating at a plurality of edges about a periphery, the energy storage means comprising a pair of high-voltage capacitors positioned at opposite edges of the container within the interior region, the electronic circuit means comprising a first module having a substantially planar substrate formed with the at least one aperture, and wherein the substantially planar substrate is placed perpendicular to the flat cover surfaces of the container.

11. The implantable cardioverter-defibrillator of claim 10, wherein the high-voltage capacitors are cylindrically shaped and the electrical connection means is a pair of contact tabs formed on a flat top surface of each capacitor, the flat top surfaces of the capacitors positioned adjacent to the first module and the contact tabs directly inserted into the at least one aperture.

12. The implantable cardioverter-defibrillator of claim 10, wherein the electronic circuit means further comprises a second module for performing cardiac monitoring functions of the patient, the second module having a substantially planar substrate with individual circuit components mounted thereon, and wherein the substantially planar substrate of the second module is placed perpendicular to the flat cover surfaces of the container.

13. The implantable cardioverter-defibrillator of claim 12, wherein the high-voltage capacitors each comprise a flat bottom surface positioned in substantially the same plane and wherein the second module is placed adjacent to the flat bottom surfaces of the capacitors.

14. The implantable cardioverter-defibrillator of claim 9, wherein the compressible adhesive means comprises adhesive foam sections for damping the physical shock and vibration placed between (1) the energy storage means and the electronic circuit means;

(2) between the energy storage means and the container; and

(3) between the energy storage means and the battery.

15. An implantable cardioverter-defibrillator having a reduced volumetric displacement comprising:

a container constructed of a biocompatible material for subcutaneous positioning within a human patient, the container formed with substantially planar top and bottom surfaces merging at a rounded periphery;

a battery housed at a substantially central region within the container for providing electrical power to the cardioverter-defibrillator;

first energy storage means housed within the container for storing a high voltage electric charge, the first energy storage means in electrical communication with the battery and positioned at a first edge of the rounded periphery;

second energy storage means housed within the container for storing a high voltage electric charge, the second energy storage means in electrical communication with the battery and positioned at a second edge of the rounded periphery opposite the first edge;

electronic circuit means housed within the container for monitoring and regulating cardiac activity of the patient, the electronic circuit means attached to the first and second energy storage means for delivering the high voltage electric charge to the patient in response to a cardiac arrhythmia;

wherein the electronic circuit means comprises (1) a first circuit module having a first substantially planar substrate and individual circuit components mounted thereon, the first planar substrate positioned perpendicular to the planar top and bottom surfaces of the container at a third edge of the rounded periphery, and (2) a second circuit module having a second substantially planar substrate for mounting electrical components thereto, the second planar substrate of the second circuit module positioned perpendicular to the planar top and bottom surfaces of the container at a fourth edge of the rounded periphery;

compressible tape adhesive means for protecting the electronic circuit means and the first and second energy storage means against shock and vibration.

16. The implantable cardioverter-defibrillator of claim 15, wherein the first and second energy storage means each comprise a high-voltage capacitor having electrical contact means attached to a respective top surface of the high-voltage capacitors, the first circuit module of the electronic circuit means having a first aperture formed thereon for receiving the electrical contact means of the first energy storage device and a second aperture formed thereon for receiving the electrical contact means of the second energy storage device.

17. The implantable cardioverter-defibrillator of claim 15, wherein the first and second energy storage means comprise electrical contact means inserted through the first planar substrate for establishing a direct electrical connection to the first circuit module.

18. The implantable cardioverter-defibrillator of claim 15, wherein individual circuit components are mounted to the second substrate of the second circuit module, the individual circuit components extending away from the second substrate towards the fourth edge of the rounded periphery.

19. The implantable cardioverter-defibrillator of claim 15, further comprising compressible support means for protecting the implantable cardioverter-defibrillator against physical shock and vibration, the compressible support means comprising adhesive foam pieces for damping the physical shock and vibration, wherein the adhesive foam pieces are placed between (1) the electronic circuit means and first energy storage means;

(2) the electronic circuit means and second energy storage means;

(3) the first energy storage means and the first edge of the container; and

(4) the second energy storage means and the second edge of the container.

20. An implantable cardiac stimulation device for subcutaneous positioning within a human patient comprising:

a container defining an interior region for housing electrical components of the stimulation device;

a battery housed within the container for providing electrical power to the stimulation device;

energy storage means housed within the container for storing an electric charge received from the battery;

electronic circuit means housed within the container for monitoring and regulating cardiac activity of the patient, the electronic circuit means connected to the battery and energy storage means and delivering electric pulses to the patient in response to detected cardiac activity of the patient; and

compressible tape support means positioned within the container for providing stabilization of the energy storage means and electronic circuit means in response to movement of the cardiac stimulation device, the compressible tape support means positioned between the electronic circuit means and the energy storage means, and the compressible support means positioned between the energy storage means and an interior surface of the container.

21. The implantable cardiac stimulation device of claim 20, wherein the stimulation device is a pacemaker for monitoring the heartbeat of the patient and providing an electronic stimulus to the heart of the patient to regulate the heartbeat.

22. The implantable cardiac stimulation device of claim 20 wherein the compressible support means comprises adhesive foam.

23. The implantable cardiac stimulation device of claim 22, wherein the adhesive foam is a double-sided adhesive acrylic tape.

24. The implantable cardiac stimulation device of claim 20, wherein the stimulation device is a defibrillator and the energy storage means comprises a pair of high voltage discharge capacitors.

25. The implantable cardiac stimulation device of claim 24, wherein the container comprises flat cover surfaces terminating at a plurality of edges about a periphery, the pair of high-voltage capacitors positioned at opposite edges of the container within the interior region, the electronic circuit means comprising a first module having a substantially planar substrate formed with a plurality of apertures for receiving electrical leads attached to the pair of high-voltage capacitors, and wherein the substantially planar substrate is placed perpendicular to the flat cover surfaces of the container.

26. A method of constructing an implantable cardioverter-defibrillator to achieve a reduced volumetric displacement wherein the cardioverter-defibrillator comprises a container having substantially planar top and bottom covering surfaces for housing a battery, a cylindrical charge capacitor having electrical contact tabs, and an electronic module having a substantially planar substrate surface, all for delivering a high-voltage charge to a patient, the method of constructing comprising the following steps:

forming at least one opening within the electronic module for receiving at least one of the electrical contact tabs of the charge capacitor;

inserting the at least one electrical contact tab into the at least one opening formed within the electronic module;

securing the at least one electrical contact tab to the electronic module to establish electrical connection between the electronic module and the charge capacitor;

placing the charge capacitor and electronic module combination within the container so that the longitudinal axis of the capacitor is parallel to the planar top and bottom surfaces of the container and so that the planar substrate surface of the electronic module is perpendicular to the planar top and bottom surfaces of the container;

attaching a first piece of compressible tape adhesive material to the electronic module wherein the first piece of adhesive material is secured between the electronic module and the charge capacitor to damp movement of the charge capacitor relative to movement of the electronic module; and

attaching a second piece of compressible tape adhesive material to the charge capacitor wherein the second piece of adhesive material as secured between the charge capacitor and an interior surface of the container to damp movement of the charge capacitor relative to movement of the container.

27. The method of claim 26, wherein the step of securing comprises the step of soldering the at least one electrical contact tab to the electronic module.

28. The method of claim 26, wherein the implantable cardioverter-defibrillator further comprises a second charge capacitor having a pair of electrical contact tabs, the method of constructing an implantable cardioverter-defibrillator further comprising the step of inserting the electrical contact tabs of the second charge capacitor through the at least one opening formed in the electronic module.

29. The method of claim 26 wherein the first and second pieces of compressible adhesive material are tape.

30. A method of constructing an implantable cardiac stimulation device to achieve a high degree of stabilization and protection from shock and vibration wherein the cardiac stimulation device comprises a container for housing a battery, a capacitor placed within the container for discharging an electrical stimulus delivered to a host patient, and an electrical control module connected to the capacitor and to the battery for monitoring the cardiac activity of a patient and delivering the electrical stimulus in response to irregular cardiac activity of the patient, the method of constructing comprising the following steps:

securing a first section of compressible adhesive tape between the electrical control module and the capacitor to damp movement of the capacitor relative to the electrical control module;

securing a second section of compressible adhesive tape between the capacitor and an interior surface of the container to damp movement of the capacitor relative to the container; and

securing a third section of compressible adhesive tape between the capacitor and the battery to damp movement of the capacitor relative to the battery.

31. The method of claim 30, wherein the device is a cardioverter-defibrillator and the capacitor is a high voltage discharge capacitor having contact tabs directly connected to the electrical control module.

32. The method of claim 31, further comprising the additional step of attaching a fourth section of adhesive tape between the battery and the interior surface of the container to damp movement of the battery relative to the container.

33. An implantable cardiac stimulation device having internal components optimally configured to reduce the overall volumetric displacement of the device comprising:

a hermetically-sealed, physiologically-shaped housing for holding a single, rigid sub-assembly of electronic components, the electronic components including means for delivering an electric shock to a patient in response to a cardiac arrhythmia, the rigid sub-assembly of electronic components comprising;

a non-hermetic electronic module generating a high-voltage electric charge for delivering the electric shock to the patient, the electronic module having an electrical substrate formed with apertures therethrough;

a pair of capacitors, connected to the electronic module, for temporarily storing the high-voltage electric charge, each capacitor having terminals which are directly inserted through the substrate apertures for establishing electrical communication with the electronic module;

a battery, electrically connected to the electronic module, located at a substantially central region between the pair of capacitors for supplying electrical energy to generate the high-voltage electric charge; and

adhesive means for joining the non-hermetic electronic tape module, the battery, and the pair of capacitors into a single, rigid sub-assembly, thereby stabilizing the sub-assembly against shock movement within the housing and achieving a reduced volumetric configuration for the stimulation device.

34. The cardiac stimulation device of claim 33, wherein:

the adhesive means is applied between the housing and at least one of the pair of capacitors and the battery, thereby stabilizing the single, rigid assembly to the housing.