Self-expanding endovascular pacemaker system

• US 10,549,092 B1
• Filed: 06/08/2018
• Issued: 02/04/2020
• Est. Priority Date: 10/11/2011
• Status: Active Grant

• Current Assignee: A-Hamid Hakki
• Original Assignee: A-Hamid Hakki
• Inventors: Hakki, A-Hamid
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US16/003,604
• Time in Patent Office: 606 Days
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37516 Intravascular implants
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 2/004 specially adapted for a specific therapy
• CPC Class Codes: A61N 2007/0004 Applications of ultrasound therapy
• CPC Class Codes: A61N 2007/0026 Stimulation of nerve tissue
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A system applies and senses electrical energy to and from tissue within a patient'"'"'s body. The system includes a steerable delivery catheter, housing a flexible shaft and an electrical generator disposed on or embedded within the flexible shaft. Electrodes coupled to the shaft self-expand radially from a compressed position to an expanded position once the delivery catheter is withdrawn, thereby contacting a wall of the tissue of the patient'"'"'s body to conduct electrical or other signals. The system may be inserted into the coronary sinus and tributary vein to provide physiological pacing to the His bundle and left ventricle. Further, the system provides for controlled passive transmission of normal electric impulses from the atria to the His bundle and ventricles without the need for an embedded generator.

Claims

1. A system for applying and sensing electrical energy to and from tissue within a patient'"'"'s body, the system comprising:

a flexible shaft having a proximal end and a distal end, and insertable within the patient'"'"'s body, said shaft defining a shaft axis line;

a plurality of self-expanding electrodes electrically coupled to an electrical source, each self-expanding electrode of said plurality thereof having a first end coupled to said shaft and a second end extending towards said distal end of said flexible shaft and separated from said first end a length of said each self-expanding electrode,

wherein an angular displacement of said each self-expanding electrode at said first end thereof from said shaft is less than 90°

,

wherein said each self-expanding electrode extends helically along and around said flexible shaft in an antegrade dispositional relation therewith, and

wherein said each self-expanding electrode is radially expandable with respect to the shaft axis line from a compressed position to an expanded position into a contiguous contact with a wall of a tissue of the patient'"'"'s body substantially along said length of said each self-expanding electrode, said each self-expanding electrode being configured to conduct electrical signals from said electrical source into the wall of the tissue of the patient'"'"'s body when in contact with the wall; and

a steerable delivery catheter for insertion into a vascular system of the patient, said delivery catheter surrounding said electrodes and said flexible shaft and applying a pressure to said electrodes to thereby restrain said electrodes in the compressed position while within said delivery catheter, wherein said electrodes and said flexible shaft are removable from said delivery catheter,

wherein said electrodes are elastically self-expanded to the expanded position when removed from said delivery catheter.

2. The system as recited in claim 1, wherein said shaft is formed of an electrically conductive composition for electrical communication with said electrodes.

3. The system as recited in claim 1, wherein said electrodes are disposed in substantially curvilinear planes each with respect to the other, and said electrodes overlap with respect to the other while in the compressed position.

4. The system as recited in claim 1, wherein said electrodes are disposed on at least opposing sides of said shaft.

5. The system as recited in claim 1, wherein said electrical source is an electrical generator embedded within said shaft.

6. The system as recited in claim 1, wherein said electrical source is an element with a piezoelectric composition embedded within said shaft.

7. The system as recited in claim 1, wherein the flexible shaft includes a constriction point, at least one distal electrode disposed between said distal end of said shaft and said constriction point, and at least one proximal electrode disposed between said proximal end of said shaft and said constriction point.

8. The system as recited in claim 7, wherein

said flexible shaft is configured to be inserted within a vessel of the patient'"'"'s body so as to contact a coronary sinus with the at least one proximal electrode and to contact coronary veins with the at least one distal electrode, and

wherein, when said electrical source is a patient'"'"'s atria, the system thereby acting as a controlled passive conduit of normal electric impulses generated by the atria for transmission to a His bundle.

9. The system as recited in claim 1, wherein each of said electrodes is selected from the group consisting of high voltage pacing electrodes, low voltage pacing electrodes, and parameter sensing electrodes.

10. The system as recited in claim 1, wherein said each electrode has embedded therein elements having a piezoelectric composition.

11. The system as recited in claim 1, wherein said each electrode is at least partially formed of a piezoelectric composition.

12. The system as recited in claim 1, wherein said electrical source includes an ultrasound and Doppler source for pacing in proximity to said electrically conductive electrode.

13. A system for applying and sensing electrical energy to and from tissue within a patient'"'"'s body, the system comprising:

a flexible shaft having a proximal end and a distal end insertable within the patient'"'"'s body, said flexible shaft defining a shaft axis line;

an electrical source embedded within said shaft; and

,

a plurality of self-expanding electrodes electrically coupled to said electrical source, each self-expanding electrode of said plurality thereof having a first end coupled to said shaft and a second end extending towards said distal end of said flexible shaft and separated from said first end a length of said each self-expanding electrode,

wherein an angular displacement of said each self-expanding electrode at said first end thereof from said shaft is less than 90°

,

wherein said each self-expanding electrode extends helically along and around said flexible shaft in an ante grade dispositional relation therewith, and

wherein said each self-expanding electrode is radially expandable with respect to the shaft axis line from a compressed position to an expanded position into a contact with a wall of a tissue of the patient'"'"'s body substantially along said length of said each self-expanding electrode in multiple radial planes, said each self-expanding electrode being configured to conduct electrical signals from said electrical source into the wall of the tissue of the patient'"'"'s body when in contact with the wall.

14. The system as recited in claim 13, wherein said shaft is formed of an electrically conductive composition for electrical communication with said electrodes.

15. The system as recited in claim 13, wherein said electrodes are disposed in substantially curvilinear planes each with respect to the other, and said electrodes overlap with respect to the other while in the compressed position.

16. The system as recited in claim 13, wherein said electrodes are disposed on at least opposing sides of said shaft.

17. The system as recited in claim 13, wherein said electrical source is an electrical generator embedded within said shaft.

18. The system as recited in claim 13, wherein said electrical source is an element with a piezoelectric composition embedded within said shaft.

19. The system as recited in claim 13 further comprising:

a microprocessor operatively coupled to said self-expanding electrodes, and

non-electrical sensors operatively coupled to said microprocessor and configured to detect at least the patient'"'"'s body position and body activity,

wherein said electrodes are operated by said microprocessor executing a defibrillation algorithm, the defibrillation algorithm receiving input from said non-electrical sensors and selecting a therapy routine based on at least the detected body activity and the detected body position.

20. A system for generating and applying ultrasound energy to tissue within a patient'"'"'s body, the system comprising:

a flexible shaft having a proximal end and a distal end, and insertable within the patient'"'"'s body, said shaft defining a shaft axis line;

an ultrasound energy source embedded within said shaft; and

,

a plurality of self-expanding electrodes electrically coupled to said ultrasound energy source, each self-expanding electrode of said plurality thereof having a first end coupled to said shaft and a second end extending towards said distal end of said flexible shaft and separated from said first end a length of said each self-expanding electrode,

wherein an angular displacement of said each self-expanding electrode at said first end thereof is less than 90°

,

wherein said each self-expanding electrode extends helically along and around said flexible shaft in an antegrade dispositional relation therewith, and

wherein said each self-expanding electrode is radially expandable with respect to the shaft axis line from a compressed position into a contiguous contact with a wall of a tissue of the patient'"'"'s body substantially along said length of said each self-expanding electrode in multiple radial planes, said each self-expanding electrode being configured to conduct ultrasound energy signals from said ultrasound energy source into the wall of the tissue of the patient'"'"'s body when in contact with the wall.