METHOD OF SURGICAL PERFORATION VIA THE DELIVERY OF ENERGY

• US 20110224666A1
• Filed: 05/23/2011
• Published: 09/15/2011
• 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: Visram, Naheed, Baylls, Frank, Hartley, Amanda, Davies, Gareth, Shah, Krishan
• Granted Patent: US 9,597,146 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image

Abstract

Apparatuses and methods for the perforation of heart tissue of a patient when an inferior approach to the heart is contraindicated are disclosed. The method includes using a superior approach to introduce the apparatus, positioning the apparatus at a tissue location and delivering a controlled amount of non-mechanical energy to the tissue to create a perforation. For example, a method of surgical perforation via the delivery of electrical, radiant or thermal energy may include: 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 delivery of energy delivered by an energy delivery device, said method comprising the steps of:

(i) introducing an apparatus comprising said 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; and

(iii) delivering said energy via said energy delivery device to create a perforation;

wherein said energy includes energy 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 staining at least a portion of said first location with a radiopaque dye.

3. 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 a surface of said material to be perforated.

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

5. The method as claimed in claim 1, further comprising a step of:

(iv) advancing said energy delivery device to a second location through said perforation.

6. The method as claimed in claim 5, wherein said second location is a left atrium of said patient'"'"'s heart.

7. The method as claimed in claim 5, wherein said apparatus further comprises at least one pressure sensor selected from the group consisting of a pressure-transmitting lumen and a pressure transducer and wherein said method comprises measuring pressure with said pressure sensor.

8. The method as claimed in claim 1, wherein introducing said 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 said dilator is articulated and wherein the step of positioning said energy delivery device comprises adjusting a shape of said dilator to position said energy delivery device at said first location.

12. The method as claimed in claim 10, wherein said sheath is articulated and wherein the step of positioning said energy delivery device comprises adjusting a shape of said sheath to position said energy delivery device at said first location.

13. The method as claimed in claim 10, further comprising a step of applying a longitudinal force onto a proximal end of said dilator to advance a distal end of said dilator through said perforation.

14. The method as claimed in claim 10, wherein said apparatus further comprises an elongated support, and wherein said dilator defines a lumen, said method further comprising inserting said elongated support into said lumen defined by said dilator prior to step (i) and removing said elongated support after creating said perforation .

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, step (iii) comprising perforating said atrial septum by delivering said energy via said energy delivery device.

16. The method as claimed in claim 15, wherein said material comprises a fossa ovalis of said patient'"'"'s heart, step (iii) comprising perforating said fossa ovalis by delivering said energy via said energy delivery device.

17. The method as claimed in claim 1, wherein said energy comprises pulsed radio frequency energy.

18. The method as claimed in claim 17, wherein said pulsed radio frequency energy comprises radio frequency energy of about 60 watts or less, a voltage from about 200 Vrms to about 400 Vrms and a duty cycle of about 5% to about 50% at about 0 Hz to about 10 Hz.

19. The method as claimed in claim 18, wherein said pulsed radio frequency energy is delivered for about 10 seconds or less.

20. The method as claimed in claim 1, wherein a length of said energy delivery device is about 0.10 cm to about 0.20 cm and wherein an outer diameter of said energy delivery device is about 0.02 cm to about 0.06 cm.

21. The method as claimed in claim 20, wherein said energy is delivered as a continuous wave at a frequency between about 400 kHz and about 550 kHz and a voltage of between about 100 Vrms to about 200 Vrms.

22. A method of surgical perforation via delivery of energy delivered by an energy delivery device, said method comprising the steps of:

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

(ii) delivering energy via said energy delivery device to perforate a septum of said heart;

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

23. A method of surgical perforation via delivery of energy delivered by an energy delivery device, said method comprising the steps of:

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

(ii) perforating material of said heart by delivering non-mechanical energy via said energy delivery device.