Trans-septal intra-cardiac lead system

• US 7,450,999 B1
• Filed: 02/07/2005
• Issued: 11/11/2008
• Est. Priority Date: 02/07/2005
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Karicherla, Annapurna, Morgan, Kevin L., Bornzin, Gene A., Williams, Sheldon
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Oropeza; Frances P
• Application Number:
  US11/053,566
• Time in Patent Office: 1,373 Days
• Field of Search: 607125-128, 607/115, 607/116, 607/119, 607/122, 607/123, 600372-375, 600/377, 600/381, 600/485, 600/486, 600/488, 600/508
• US Class Current: 607/126
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

An apparatus for and method of measuring pressure through a septum in a patient'"'"'s heart is disclosed. A lead inserted into the right side of a heart is routed through the septum to gain access to the left side of the heart. The lead includes an attachment structure that secures the lead to one or both of the septal walls. The attachment structure may include at least one protruding tine, membrane, inflatable balloon, involuted spiral or J-lead that engage one or more sides of the septum. The lead also includes one or more sensors for measuring cardiac pressure on the left side of the heart and, as necessary, the right side of the heart.

Claims

1. A lead configured for measuring pressure in a heart comprising:

a lead body;

at least one involuted spiral tine attached to a distal portion of the lead body and adapted to attach the lead body to a wall in a heart; and

at least one pressure sensor attached to the distal portion of the lead body and adapted to measure pressure at a distal side of the wall in the heart;

wherein the at least one pressure sensor is attached to an end of one of the at least one involuted spiral tine; and

wherein before implantation, the at least one involuted spiral tine is maintained in a relatively straight configuration within the distal portion of the lead body.

2. The lead of claim 1 wherein the wall in the heart is a septal wall, and wherein the at least one involuted spiral tine comprises a first involuted spiral tine adapted to be disposed relatively flat against a first side of the septal wall and a second involuted spiral is adapted to be disposed relatively flat against a second side of the septal wall.

3. The lead of claim 2 wherein the first involuted spiral tine is adapted to be disposed within the right atrium and the second involuted spiral tine is adapted to be disposed within the left atrium, and wherein the at least one pressure sensor is attached to an end of the second involuted spiral tine.

4. The lead of claim 2 wherein the first involuted spiral tine is adapted to abut against the first side of the septal wall and the second involuted spiral tine is adapted to be abut against the second side of the septal wall.

5. The lead of claim 1 comprising a stylet, wherein the at least one involuted spiral tine is held in a relatively straight configuration by the stylet, and wherein the at least one involuted spiral tine is allowed to unwind on a septal wall by retraction of the stylet.

6. The lead of claim 1 wherein the at least one pressure sensor comprises a chip and a flexible diaphragm, and wherein the chip and flexible diaphragm are attached to the end of one of the at least one involuted spiral tine.

7. A lead configured for measuring pressure in a heart comprising:

a lead body;

at least one involuted spiral tine attached to a distal portion of the lead body and adapted to attach the lead body to a wall in a heart; and

at least one pressure sensor attached to the distal portion of the lead body and adapted to measure pressure at a distal side of the wall in the heart;

wherein before implantation, the at least one involuted spiral tine is maintained in a relatively straight configuration within the distal portion of the lead body;

wherein the at least one involuted spiral tine comprises involuted spiral tines spaced longitudinally along the lead body; and

wherein the wall in the heart is a septal wall, and wherein the at least one involuted spiral tine comprises a first involuted spiral tine adapted to be disposed relatively flat against a first side of the septal wall and a second involuted spiral tine is adapted to be disposed relatively flat against a second side of the septal wall.

8. The lead of claim 7 wherein the first involuted spiral tine is adapted to be disposed within the right atrium and the second involuted spiral tine is adapted to be disposed within the left atrium.

9. The lead of claim 7 wherein the first involuted spiral tine is adapted to abut against the first side of the septal wall and the second involuted spiral tine is adapted to be abut against the second side of the septal wall.

10. The lead of claim 7 comprising a stylet, wherein the at least one involuted spiral tine is held in a relatively straight configuration by the stylet, and wherein the at least one involuted spiral tine is allowed to unwind on the septal wall of the heart by retraction of the stylet.

11. A lead configured for measuring pressure in a heart comprising:

a lead body;

at least one involuted spiral tine attached to a distal portion of the lead body and adapted to attach the lead body to a wall in a heart; and

at least one pressure sensor attached to the distal portion of the lead body and adapted to measure pressure at a distal side of the wall in the heart;

wherein before implantation, the at least one involuted spiral tine is maintained in a relatively straight configuration within the distal portion of the lead body;

wherein the at least one involuted spiral tine comprises a first involuted spiral tine having a first orientation and a second involuted spiral tine having a second orientation, and wherein the first orientation is different than the second orientation; and

wherein the wall in the heart is a septal wall, and wherein the first involuted spiral tine is adapted to be disposed relatively flat against a first side of the septal wall and the second involuted spiral tine is adapted to be disposed relatively flat against a second side of the septal wall.

12. The lead of claim 11 wherein the first orientation is clockwise and the second orientation is counterclockwise.

13. The lead of claim 11 comprising at least one stylet for straightening the at least one involuted spiral tine.

14. The lead of claim 11 wherein the first involuted spiral tine is adapted to abut against the first side of the septal wall and the second involuted spiral tine is adapted to be abut against the second side of the septal wall.

15. The lead of claim 11 wherein the at least one involuted spiral tine is allowed to unwind on the septal wall of the heart by retraction of the stylet.

16. A lead configured for measuring pressure in a heart comprising:

a lead body;

at least one involuted spiral tine attached to a distal portion of the lead body and adapted to attach the lead body to a wall in a heart; and

at least one pressure sensor attached to the distal portion of the lead body and adapted to measure pressure at a distal side of the wall in the heart;

wherein before implantation, the at least one involuted spiral tine is maintained in a relatively straight configuration within the distal portion of the lead body;

wherein the at least one involuted spiral tine comprises a first involuted spiral tine having a first orientation and a second involuted spiral tine having a second orientation, and wherein the first orientation is different than the second orientation; and

wherein the first involuted spiral tine is adapted to be disposed within the right atrium and the second involuted spiral tine is adapted to be disposed within the left atrium.

17. The lead of claim 16 comprising at least one electrode at the distal portion of the lead body.

18. The lead of claim 17 wherein the at least one electrode is adapted to be configured to pace the heart or sense signals in the heart.

19. The lead of claim 16 wherein the first involuted spiral tine is adapted to abut against a first side of a septal wall and the second involuted spiral tine is adapted to abut against a second side of a septal wall.

20. The lead of claim 16 comprising a stylet, wherein the at least one involuted spiral tine is held in a relatively straight configuration by the stylet, and wherein the at least one involuted spiral tine is allowed to unwind on a septal wall by retraction of the stylet.