Method of surgical perforation via the delivery of energy

• US 7,947,040 B2
• Filed: 11/03/2005
• Issued: 05/24/2011
• Est. Priority Date: 01/21/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Baylis Medical Company Inc. (Boston Scientific Corporation)
• Inventors: Davies, Gareth, Baylis, Frank, Shah, Krishan, Hartley, Amanda April, Visram, Naheed
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US11/265,304
• Publication Number:
  US 20060142756A1
• Time in Patent Office: 2,028 Days
• Field of Search: 606 41- 50, 600/433, 604/22, 604/264
• US Class Current: 606/45
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/00351 Heart

Abstract

A method of surgical perforation via the delivery of electrical, radiant or thermal energy comprising the steps of: introducing an apparatus comprising an energy delivery device into a patient'"'"'s heart via the patient'"'"'s superior vena cava; positioning the energy delivery device at a first location adjacent material to be perforated; and perforating the material by delivering energy via the energy delivery device; wherein the energy is selected from the group consisting of electrical energy, radiant energy and thermal energy.

Claims

1. A method of surgical perforation via the delivery of electrical, radiant or thermal energy comprising the steps of:

(i) introducing an apparatus comprising an energy delivery device into a patient'"'"'s heart via said patient'"'"'s superior vena cava, said apparatus further comprising at least one pressure sensing mechanism selected from the group consisting of a pressure-transmitting lumen and a pressure transducer;

(ii) positioning said energy delivery device at a first location adjacent material to be perforated;

(iii) perforating said material by delivering energy via said energy delivery device;

(iv) advancing said energy delivery device to a second location through the perforation, said second location being a left atrium of said patient'"'"'s heart; and

(v) measuring pressure at said second location;

wherein said energy is selected from the group consisting of electrical energy, radiant energy and thermal energy.

2. The method as claimed in claim 1, wherein step (ii) comprises positioning said energy delivery device at an angle of about 80 degrees to about 100 degrees relative to said material to be perforated.

3. The method as claimed in claim 2, wherein step (ii) comprises positioning said energy delivery device substantially perpendicularly relative to said material to be perforated.

4. The method as claimed in claim 1 wherein said apparatus further comprises a distal region capable of adopting a curved shape and wherein step (iv) further comprises directing a distal tip of said apparatus in a desired direction.

5. The method as claimed in claim 4, wherein said distal tip is directed away from cardiac structures in order to decrease risk of unwanted injury.

6. The method as claimed in claim 4 wherein said apparatus further comprises an orientation indicator for determining a direction of said distal tip and wherein said method comprises monitoring said orientation indicator.

7. The method as claimed in claim 1 wherein step (ii) comprises staining at least a portion of said first location with a radiopaque dye.

8. The method as claimed in claim 1 wherein the step of introducing an apparatus comprises the steps of:

(a) introducing said apparatus into said patient'"'"'s vasculature; and

(b) advancing said apparatus through said patient'"'"'s vasculature into said patient'"'"'s heart.

9. The method as claimed in claim 8 wherein step (a) comprises inserting said apparatus into a vein selected from the group consisting of a jugular vein, a subclavian vein, a brachial vein and an axillary vein.

10. The method as claimed in claim 1, wherein step (i) further comprises inserting a dilator and a sheath into said patient'"'"'s heart.

11. The method as claimed in claim 10, wherein step (ii) comprises positioning said dilator such that a distal end of said dilator is oriented at an angle of about 80 degrees to about 100 degrees relative to said material to be perforated.

12. The method as claimed in claim 11, wherein step (ii) comprises positioning said dilator such that a distal end of said dilator is oriented substantially perpendicularly relative to said material to be perforated.

13. The method as claimed in claim 10, further comprising advancing said energy delivery device, said dilator and said sheath to a second location through the perforation.

14. The method as claimed in claim 13, wherein said dilator is shaped such that a distal end of said dilator will be advanced through said perforation upon an application of a longitudinal force onto a proximal end of said dilator.

15. The method as claimed in claim 1 wherein said material to be perforated is tissue of an atrial septum of said patient'"'"'s heart.

16. The method as claimed in claim 15, wherein said material comprises a fossa ovalis of said patient'"'"'s heart.

17. The method as claimed in claim 1, further comprising a step of delivering one or more of a treatment device, a diagnostic device and a treatment composition through said perforation.

18. A method of surgical perforation via the delivery of electrical, radiant or thermal energy comprising the steps of:

(i) introducing an apparatus comprising an energy delivery device into a patient'"'"'s heart via said patient'"'"'s superior vena cava;

(ii) positioning said energy delivery device at a first location adjacent material to be perforated;

(iii) perforating said material by delivering energy via said energy delivery device; and

(iv) monitoring ECG in said patient'"'"'s heart using said apparatus;

wherein said energy is selected from the group consisting of electrical energy, radiant energy and thermal energy.

19. The method as claimed in claim 18, wherein step (ii) comprises dragging said energy delivery device about a surface of said patient'"'"'s heart while monitoring ECG in order to determine said first location.

20. The method as claimed in claim 19, wherein said ECG at said first location comprises a damped signal in comparison with ECG monitored otherwise on said surface of said patient'"'"'s heart.

21. A method of surgical perforation comprising the steps of:

(i) introducing an apparatus into a patient'"'"'s heart via said patient'"'"'s superior vena cava, said apparatus comprising an energy delivery device and a means for determining the position of said energy delivery device, said means for determining position comprising at least one pressure sensing mechanism selected from the group consisting of a pressure transmitting lumen and a pressure transducer; and

(ii) positioning said energy delivery device adjacent material to be perforated in response to the means for determining position.

22. The method as claimed in claim 21 further comprising the step of:

(iii) perforating said material by delivering energy via said energy delivery device.

23. The method as claimed in claim 22, wherein said energy comprises radiant energy.

24. The method as claimed in claim 22, wherein said energy comprises electrical energy.

25. The method as claimed in claim 22, wherein said energy comprises thermal energy.

26. A method of surgical perforation comprising the steps of:

(i) introducing an apparatus into a patient'"'"'s heart via said patient'"'"'s superior vena cava, said apparatus comprising an energy delivery device and a means for determining the position of said energy delivery device, said means for determining position comprising an ECG measuring device; and

(ii) positioning said energy delivery device adjacent material to be perforated in response to the means for determining position.

27. The method as claimed in claim 26 further comprising the step of:

(iii) perforating said material by delivering energy via said energy delivery device.

28. The method as claimed in claim 27, wherein said energy comprises radiant energy.

29. The method as claimed in claim 27, wherein said energy comprises electrical energy.

30. The method as claimed in claim 27, wherein said energy comprises thermal energy.