Transcoronary Sinus Pacing System, LV Summit Pacing, Early Mitral Closure Pacing, and Methods Therefor

• US 20080082136A1
• Filed: 06/28/2007
• Published: 04/03/2008
• Est. Priority Date: 10/03/2006
• Status: Active Grant

• Current Assignee: Vincent Gaudiani
• Original Assignee: Vincent Gaudiani
• Inventors: Gaudiani, Vincent
• Granted Patent: US 8,068,920 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• CPC Class Codes: A61B 8/5292 using additional data, e.g. patient information, image labeling, acquisition parameters
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A transcoronary sinus pacing system comprising a sheath having a lumen, a pacing catheter having a pacing needle, wherein the catheter can be advanced within the lumen and placed in the LV summit, and a right ventricular pacing device. A LV summit pacing device. An early mitral valve closure pacing device configured to operate with a right ventricular apex pacing device. A method for implanting a pacing device at a target coronary sinus tissue location, wherein the target can be the posterior LV summit. A method for achieving early closure of a mitral valve. A method for using visualization devices such as fluoroscopy or ultrasound and/or catheter features such as a radiopaque marker to locate a target location for LV pacing and to avoid piercing an artery or the pericardium when anchoring the LV pacing electrode.

Claims

1. A transcoronary sinus pacing system, comprising:

a. an elongate sheath having a distal end, a proximal end, a first lumen and a second lumen wherein the first lumen has a first lumen exit port distal to a second lumen exit port;

b. a pacing catheter having a tip that perforates a coronary sinus; and

c. a right ventricular pacing device.

2. The system of claim 1, wherein the elongate sheath is steerable by a guidewire.

3. The system of claim 1, wherein the elongate sheath further provides a radiopaque marker.

4. The system of claim 1, wherein the elongate sheath has a teardrop cross-section.

5. The system of claim 1, wherein the pacing catheter optimizes early closure of the mitral valve when anatomically positioned within a heart.

6. The system of claim 1, wherein the pacing catheter reduces the time required to activate the left ventricle when anatomically positioned within a heart.

7. The system of claim 1, wherein placement of the pacing catheter occurs irrespective of an anatomical position of a coronary sinus.

8. The system of claim 1, wherein the sheath is removable.

9. The system of claim 1, further comprising an imaging system.

10. The system of claim 9, wherein the imaging system correlates a recorded angoigraphic image and live fluoroscopic image.

11. The system of claim 9, wherein the imaging system correlates a recorded angoigraphic image and a live intravascular ultrasound image.

12. A left ventricular summit pacing system, comprising:

a. an elongate sheath having a distal end and a proximal end and two lumen;

b. a pacing catheter having a tip that perforates a coronary sinus and lodges in an LV summit; and

c. a left ventricular summit pacing device engages the pacing needle.

13. The system of claim 12, wherein the elongate sheath is steerable by a guidewire.

14. The system of claim 12, wherein the elongate sheath further provides a radiopaque marker.

15. The system of claim 12, wherein the elongate sheath has a teardrop cross-section.

16. The system of claim 12, wherein the pacing catheter optimizes early closure of the mitral valve when anatomically positioned within a heart.

17. The system of claim 12, wherein the pacing catheter reduces a time required to activate the left ventricle when anatomically positioned within a heart.

18. The system of claim 12, wherein placement of the pacing catheter is irrespective of an anatomical position of the veins of a coronary sinus.

19. The system of claim 12, wherein the sheath is removable.

20. An early mitral valve closure pacing system, comprising:

a. an elongate sheath having a distal end and a proximal end and two lumen;

b. a pacing catheter having a tip that perforates a coronary sinus and lodges in an LV summit to activate early mitral valve closure; and

c. a pacing device configured to engage the pacing needle, wherein the pacing device operates in conjunction with a right ventricular apex pacing device.

21. The system of claim 20, wherein the elongate sheath is steerable by a guidewire.

22. The system of claim 20, wherein the elongate sheath further provides a radiopaque marker.

23. The system of claim 20, wherein the elongate sheath has a teardrop cross-section.

24. The system of claim 20, wherein the pacing catheter optimizes early closure of the mitral valve when anatomically positioned within a heart.

25. The system of claim 20, wherein the pacing catheter reduces the time required to activate the left ventricle when anatomically positioned within a heart.

26. The system of claim 20, wherein the pacing catheter is configured for placement irrespective of the anatomical position of a coronary sinus.

27. The system of claim 20, wherein the sheath is removable.

28. A method for implanting a pacing device, comprising the steps of:

a. introducing a sheath;

b. steering the sheath to a target location within a coronary sinus;

c. lodging a distal end of the sheath beyond a posterior summit of a left ventricle;

d. advancing a pacing lead through a lumen of the sheath to the target location within the coronary sinus;

e. perforating the coronary sinus with the pacing lead;

f. coupling the pacing lead to cardiac tissue at the posterior summit of the left ventricular at a first end; and

g. removing the sheath.

29. The method of claim 28, further comprising the steps of:

h. advancing a right ventricular pacing catheter to a target location within a right ventricle.

i. positioning the electrode at the target location within the right ventricle.

30. The method of claim 28, further comprising the steps of

obtaining an angiogram,

obtaining a live fluoroscopic image,

correlating the angiogram with live fluoroscopic image, and

analyzing the correlated images to identify anatomical structures.

31. The method of claim 28, further comprising the steps of:

obtaining an angiogram;

obtaining a live intravascular ultrasound;

correlating an angiogram with live intravascular ultrasound; and

analyzing the correlated images to identify anatomical structures.

32. The method of claim 28, wherein the target location within the coronary sinus is a left ventricular summit.

33. The method of claim 32, comprising the step of:

a. activating a left ventricular summit to achieve early closure of a mitral valve during systole.

34. The method of claim 28, comprising the step of using the cross-sectional shape of the device to facilitate steering and perforating.

35. A method for achieving early closure of a mitral valve, comprising the steps of:

a. introducing a sheath;

b. steering the sheath to a target location within a coronary sinus;

c. advancing a left ventricular pacing lead through a lumen of the sheath to the target location within the coronary sinus;

d. perforating the coronary sinus with the left ventricular pacing lead;

e. coupling the left ventricular pacing lead to a cardiac stimulation device;

f. coupling a right ventricular pacing lead from a right ventricle to the cardiac stimulation device;

g. removing the sheath; and

h. activating the cardiac stimulation device to deliver energy to the pacing leads to achieve early closure of the mitral valve during systole.

36. The method of claim 35, wherein the step of coupling the right ventricular pacing lead further comprises the step of advancing a right ventricular pacing catheter to a first target location within the heart.

37. The method of claim 36, comprising the step of positioning a right ventricular pacing lead at the first target location within the heart.

38. The method of claim 37, comprising the step of correlating an angiogram with live fluoroscopy.

39. The method of claim 35, comprising the step of correlating an angiogram with live intravascular ultrasound.

40. The method of claim 35, wherein the target location within the coronary sinus is a left ventricular pacing summit.

41. The method of claim 35, comprising the step of using the cross-sectional shape of the device to facilitate the steering and perforating.

42. A guiding catheter comprising an elongate sheath having a distal end, a proximal end, a first lumen and a second lumen wherein the first lumen has a first lumen exit port distal to a second lumen exit port and the distal end is configured to lodge within a coronary sinus of a heart distal to a summit of a left ventricle.

43. The system of claim 42, wherein the elongate sheath is steerable by a guidewire.

44. The system of claim 42, wherein the elongate sheath further provides one or more radiopaque markers.

45. The system of claim 42, wherein the elongate sheath has a teardrop cross-section.