Coronary Sinus Cannula With Left Ventricle Lead And Pressure Tent

• US 20120097174A1
• Filed: 07/07/2010
• Published: 04/26/2012
• Est. Priority Date: 07/07/2009
• Status: Active Grant

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Spotnitz, Henry M., Wang, Daniel Y., Cabreriza, Santos
• Granted Patent: US 8,938,310 B2
• Time in Patent Office: Days
• US Class Current: 128/853
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

Techniques for biventricular pacing include a rigid shaped stylet approximating curves of a coronary sinus and branch vein. Some techniques include a parasternal coronary sinus cannula comprising an outer sheath and an obturator. The obturator is removeably disposed inside the outer sheath from a device end of the hollow shaft. The obturator includes a flexible stem that fits snugly inside the hollow shaft, a malleable core disposed inside the flexible stem, a tapered tip that extends beyond a cardiac end of the shaft when the obturator is disposed inside the outer sheath, and a sensor for determining properties of the subject in a vicinity of the tapered tip. An optional pressure-seal, such as a tent, connected to suction maintains negative intrepleural pressure for insertion under local anesthesia.

Claims

1. A lead for a pacing electrode comprising:

a hollow tube of flexible material open at a device end;

a first electrode at a cardiac end of the hollow tube;

a first electrical conductor that electrically connects the first electrode to the device end and that is positioned within the flexible material; and

a shaped stylet of rigid material inside the hollow tube at the cardiac end and removable through the open device end,

wherein the shaped stylet is curved in a first plane to match a curve of a left ventricle portion of coronary sinus and curved in a different second plane to match a curve of a branch vein of the coronary sinus.

2. A lead as recited in claim 1, further comprising:

a second electrode at the cardiac end of the hollow tube and spaced apart from the first electrode; and

a second electrical conductor that electrically connects the second electrode to the device end and that is positioned within the flexible material apart from the first electrical conductor.

3. A lead as recited in claim 1, wherein the device end is configured to be releasably connected physically and electrically to a pacing signal generator.

4. A lead as recited in claim 1, wherein the cardiac end is configured to hook into a wall of the branch vein when the shaped stylet is retracted through the open device end.

5. A lead as recited in claim 1, wherein the hollow tube and first electrode have a diameter less than an inner diameter of a coronary sinus cardioplegia cannula catheter.

6. A lead as recited in claim 1, wherein the hollow tube and first electrode and the second electrode have a diameter less than an inner diameter of a cardioplegia cannula catheter.

7. A lead as recited in claim 1, further comprising at the cardiac end a probe for a guidance system for at least one of an X-ray fluoroscope guidance system, an echocardiography guidance system, an electrical guidance system, a thermography guidance system, or a radio frequency identification (RFID) guidance system.

8. A lead for a pacing electrode comprising:

a hollow tube of flexible material open at a device end;

a first electrode at a cardiac end of the hollow tube; and

a first electrical conductor that electrically connects the first electrode to the device end and that is positioned within the flexible material,

wherein the device end is configured to be releasably connected physically and electrically to a pacing signal generator.

9. A lead for a pacing electrode comprising:

a hollow tube of flexible material open at a device end;

a first electrode at a cardiac end of the hollow tube; and

a first electrical conductor that electrically connects the first electrode to the device end and that is positioned within the flexible material,

wherein the cardiac end is configured to hook into a wall of a branch vein when a rigid stylet is retracted through the open device end.

10. A lead for a pacing electrode comprising:

a hollow tube of flexible material open at a device end;

a first electrode at a cardiac end of the hollow tube; and

a first electrical conductor that electrically connects the first electrode to the device end and that is positioned within the flexible material,

wherein the hollow tube and first electrode have a diameter less than an inner diameter of a cardioplegia cannula catheter.

11. A kit for a lead for a pacing electrode comprising:

a hollow tube of flexible material open at a device end;

a first electrode at a cardiac end of the hollow tube;

a first electrical conductor that electrically connects the first electrode to the device end; and

a shaped stylet of rigid material for insertion and removal through the hollow device end to position in the hollow tube at the cardiac end,

wherein the shaped stylet is curved in a first plane to match a curve of a left ventricle portion of coronary sinus and curved in a different second plane to match a curve of a branch vein of the coronary sinus.

12. A method for placing a left ventricle pacing electrode, comprising:

inserting a coronary sinus cannula catheter through an orifice from a right atrium to a coronary sinus;

feeding a cardiac end of a left ventricle lead that includes a shaped stylet in a hollow tube through the coronary sinus cannula catheter into the coronary sinus and a branch vein of the coronary sinus;

removing the coronary sinus cannula catheter; and

retracting the shaped stylus,

wherein the left ventricle lead comprises;

the hollow tube made of flexible material and open at a device end,

a first electrode at a cardiac end of the hollow tube;

a first electrical conductor that electrically connects the first electrode to the device end and that is positioned within the flexible material; and

the shaped stylet of rigid material inside the hollow tube at the cardiac end and removable through the open device end.

13. A method as recited in claim 12, wherein inserting the coronary sinus cannula catheter further comprises first performing a parasternal medial sternotomy to gain access to the chest cavity and then inserting the coronary sinus cannula catheter into the right atrium.

14. A method as recited in claim 12, wherein inserting the coronary sinus cannula catheter comprises inserting a cardioplegia cannula catheter during open heart surgery.

15. A method as recited in claim 12, further comprising physically and electrically connecting the device end of the lead to a biventricular pacing (BiVP) signal source after removing the coronary sinus cannula catheter.

16. A method as recited in claim 15, further comprising performing biventricular pacing.

17. A method as recited in claim 16, further comprising retracting the LV lead after performing temporary biventricular pacing.

18. A method as recited in claim 12, wherein the shaped stylet is curved in a first plane to match a curve of a left ventricle portion of coronary sinus and curved in a different second plane to match a curve of a branch vein of the coronary sinus.

19. A cannula comprising:

an outer sheath comprising a flexible hollow shaft of sufficient length to extend from outside a subject'"'"'s body through a right parasternal mediastinotomy incision to a coronary sinus orifice in a right atrium of a heart of the subject; and

an obturator removeably disposed inside the outer sheath from a device end of the hollow shaft, wherein the obturator comprises;

a flexible stem that fits snugly inside the hollow shaft,

a malleable core disposed inside the flexible stem,

a tapered tip that extends beyond a cardiac end of the shaft when the obturator is disposed inside the outer sheath, and

a sensor for determining properties of the subject in a vicinity of the tapered tip.

20. A cannula as recited in claim 19, wherein the outer sheath is a tear-away outer sheath.

21. A cannula as recited in claim 19, wherein the sensor is at least one member of a group comprising:

a temperature sensor;

an ultrasound sensor;

a pressure sensor;

an oxygen sensor; and

a flow velocity sensor.

22. A cannula as recited in claim 19, wherein the malleable core and flexible stem and hollow shaft are shaped in a curve suited to extend through the right parasternal mediastinotomy incision to the coronary sinus orifice.

23. A cannula as recited in claim 19, further comprising a skin level pressure seal collar forming an air tight seal around the outer sheath for maintaining a pressure difference between a pressure in a right pleural space adjacent to a pericardium of a subject and ambient pressure outside the subject.

24. A cannula as recited in claim 23, wherein the pressure seal collar further comprises a vacuum port for connection to a pump that provides negative pressure.

25. A cannula as recited in claim 19, further comprising a self-sealing system disposed on the outer sheath for forming a pressure seal at a right atrium wall around a lead deposited by the cannula.

26. A kit for a cannula comprising:

an outer sheath comprising a flexible hollow shaft of sufficient length to extend from outside a subject'"'"'s body through a right parasternal mediastinotomy incision to a coronary sinus orifice in a right atrium of a heart of the subject;

an obturator reversibly insertable inside the outer sheath from a device end of the hollow shaft, wherein the obturator comprises

a flexible stem that fits snugly inside the hollow shaft,

a malleable core disposed inside the flexible stem,

a tapered tip that extends beyond a cardiac end of the shaft when the obturator is disposed inside the outer sheath, and

a sensor for determining properties of the subject in a vicinity of the tapered tip; and

a lead insertable inside the outer sheath from a device end of the hollow shaft, wherein the lead comprises

a hollow tube of flexible material open at a device end,

a first electrode at a cardiac end of the hollow tube,

a first electrical conductor that electrically connects the first electrode to the device end and that is positioned within the flexible material, and

a shaped stylet of rigid material inside the hollow tube at the cardiac end and removable through the open device end.

27. A kit as recited in claim 26, the lead further comprises:

a second electrode at a cardiac end of the hollow tube; and

a second electrical conductor that electrically connects the second electrode to the device end and that is positioned within the flexible material.

28. A kit as recited in claim 26, further comprising a skin level pressure seal collar for allowing access to a pericardial space of a subject while maintaining a pressure difference between a pressure in the space and ambient pressure outside the subject.

29. A kit as recited in claim 26, further comprising a self-sealing system disposed on the outer sheath for forming a pressure seal at a right atrium wall around a lead deposited by the cannula.

30. A method for operating a cannula, comprising:

shaping a malleable core of an obturator to reach a coronary sinus orifice in a right atrium from an entry point in the right atrium;

inserting a cannula through a right parasternal mediastinotomy incision to a coronary sinus, wherein the cannula comprises;

an outer sheath comprising a flexible hollow shaft; and

the obturator removeably disposed inside the outer sheath from a device end of the hollow shaft, wherein the obturator comprises;

a flexible stem that fits snugly inside the hollow shaft,

the malleable core disposed inside the flexible stem, and

a tapered tip that extends beyond a cardiac end of the shaft when the obturator is disposed inside the outer sheath;

removing the obturator;

feeding a cardiac end of a left ventricle lead through the outer sheath into the coronary sinus and a branch vein of the coronary sinus; and

removing the outer sheath.

31. A method as recited in claim 30, wherein:

the left ventricle lead comprises a shaped stylet in a hollow tube; and

the method further comprises retracting the shaped stylus after feeding the cardiac end of the left ventricle lead through the outer sheath.

32. A method as recited in claim 30, further comprising physically and electrically connecting the device end of the lead to a biventricular pacing (BiVP) signal source after removing the outer sheath.

33. A method as recited in claim 32, further comprising performing biventricular pacing.

34. A method as recited in claim 31, wherein the shaped stylet is curved in a first plane to match a curve of a left ventricle portion of coronary sinus and curved in a different second plane to match a curve of a branch vein of the coronary sinus.

35. A method as recited in claim 30, wherein:

the obturator further comprises a sensor for measuring properties of a subject in a vicinity of the tapered tip; and

inserting the cannula further comprises guiding the cannula based on signals received from the sensor.

36. A method as recited in claim 30, wherein.

the cannula further comprises a self-sealing system for forming a pressure seal at a right atrium wall around a lead deposited by the cannula;

and

the method further comprises administering only local anesthesia to a subject into which the cannula is inserted.

37. A method as recited in claim 30, wherein.

the cannula further comprises a skin level pressure seal collar for allowing access to a pericardial space of a subject while maintaining a pressure difference between a pressure in the space and ambient pressure outside the subject;

and

inserting the cannula further comprises inserting the cannula without positive pressure ventilation.

38. A method as recited in claim 37, wherein.

the skin level pressure seal collar further comprises a vacuum port;

and

the method further comprises operating a pump connected by pressure hose to the vacuum port to maintain a negative intrapleural pressure of seven centimeters of water.

39. A surgical pressure tent comprising:

a rigid framework circumscribing a volume sufficient to accommodate manipulators to perform a surgery;

a sheet of flexible material impervious to airflow and having a surgical opening;

a sealing material along a perimeter of the surgical opening; and

a pressure hose fitting;

wherein the sheet of flexible material is attached to the framework to prevent airflow into the circumscribed volume except through the surgical opening,

the sealing material forms a seal against a skin surface of a patient sufficient to withstand pressure differences up to about 5 centimeters of water (cm H2O), and

the pressure hose fitting is configured to allow the circumscribed volume to be connected to an air pump to establish a target pressure inside the circumscribed volume.

40. A surgical pressure tent of claim 39, wherein the rigid framework includes a top panel comprising a transparent portion that permits a view of the surgical opening.

41. A surgical pressure tent of claim 40, wherein the top panel further comprises an outer door that, when open, permits access to at least a portion of the circumscribed volume and, when closed, seals sufficiently to withstand pressure differences of about 5 cm H2O.

42. A surgical pressure tent of claim 41, further comprising within the circumscribed volume a chamber with an inner door that when open permits access to an operative portion of the circumscribed volume that includes the surgical opening and, when closed, blocks access to the operative portion of the circumscribed volume and seals sufficiently to withstand pressure differences of about 5 cm H2O, wherein the outer door, when open, permits access to the chamber.

43. A surgical pressure tent of claim 39, the sheet of flexible material further comprising a plurality of sealed arm access ports to allow access for hands of one or more surgeons while maintaining the pressure differences of about 5 cm H2O.

44. A surgical pressure tent of claim 39, wherein the rigid framework is collapsible.