Method of surgical perforation via the delivery of energy

• US 9,597,146 B2
• Filed: 05/23/2011
• Issued: 03/21/2017
• 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, Hartley, Amanda, Visram, Naheed, Shah, Krishan, Baylls, Frank
• Primary Examiner(s): DELLA, JAYMI E
• Application Number:
  US13/113,326
• Publication Number:
  US 20110224666A1
• Time in Patent Office: 2,129 Days
• Field of Search: 606/41, 606/45
• US Class Current: 1/1
• 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, the method utilizing an apparatus having an energy delivery device at a distal end thereof and a delivery system comprising a sheath and a dilator, said method comprising the steps of:

(i) inserting the delivery system into a patient'"'"'s vasculature at a location superior to a patient'"'"'s heart;

(ii) advancing the delivery system into the patient'"'"'s heart through a superior vena cava;

(iii) adjusting a shape of a distal portion of the delivery system to define a first configuration such that a distal end of the delivery system is oriented substantially perpendicularly relative to a surface of a septum of the patient'"'"'s heart;

(iv) inserting the apparatus through the delivery system to position the energy delivery device about the distal end of the delivery system;

(v) positioning the delivery system such that it is braced against a free wall of a right atrium of the patient'"'"'s heart and positioning said energy delivery device at a first location against the septum; and

(vi) delivering energy via said energy delivery device to create a perforation through the septum.

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

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

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

(vii) adjusting the shape of the distal portion of the delivery system to define a second configuration to facilitate advancement of the delivery system through the perforation.

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

(vii) advancing said energy delivery device to a second location through the 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.

8. The method as claimed in claim 1 wherein the step of (iv) inserting the apparatus is performed prior to the step of adjusting the shape of the distal portion of the delivery system.

9. The method as claimed in claim 1, wherein said patient'"'"'s vasculature comprises a vein and wherein step (i) comprises inserting said apparatus into said vein, wherein said vein is 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 said dilator is articulated and wherein the step of positioning said energy delivery device comprises adjusting a shape of the dilator to position the energy delivery device at said first location.

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

12. The method as claimed in claim 1, 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.

13. The method as claimed in claim 1 wherein said septum is an atrial septum of said patient'"'"'s heart, wherein step (vi) further comprises perforating said atrial septum by delivering said energy via said energy delivery device.

14. The method as claimed in claim 13, wherein said atrial septum comprises a fossa ovalis of said patient'"'"'s heart, wherein step (vi) further comprises perforating said fossa ovalis by delivering said energy via said energy delivery device.

15. The method as claimed in claim 1, wherein said energy comprises radio frequency electrical energy delivered in a pulsed manner.

16. The method as claimed in claim 15, wherein said radio frequency electrical 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 up to about 10 Hz.

17. The method as claimed in claim 16, wherein said radio frequency electrical energy is delivered for about 10 seconds or less.

18. 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.

19. The method as claimed in claim 18, 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 to about 200 Vrms.