Surgical perforation device with curve

• US 7,048,733 B2
• Filed: 09/19/2003
• Issued: 05/23/2006
• Est. Priority Date: 09/19/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Baylis Medical Company Inc. (Boston Scientific Corporation)
• Inventors: Baylis, Frank, Shah, Krishan, Hartley, Amanda April, Visram, Naheed
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/666,301
• Publication Number:
  US 20050065507A1
• Time in Patent Office: 977 Days
• Field of Search: 606 1- 50, 607 96-101, 607/122, 600485-488
• US Class Current: 606/41
• 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 2018/00351 Heart
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/00702 Power or energy
• 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 2218/002 Irrigation

Abstract

A device for creating a surgical perforation with a functional distal tip for creating a controlled perforation. The functional tip may comprise at least one active electrode for creating the perforation through the application of Radio Frequency (RF) energy. The device is curved in order to decrease the likelihood of injury to structures of a patient such as inadvertent cardiac perforation when used in transseptal perforation procedures. The device is introduced into the right atrium, and the functional tip is then positioned against the atrial septum. Energy is applied to create the perforation. The tip is advanced toward the left atrium to create the perforation and as it advances into the left atrium, the device takes on its curved shape to direct the tip away from cardiac structures. The position of the tip of the device can be determined in response to pressure sensed at the tip and determined by a monitor.

Claims

1. A method of creating a perforation in a heart septum comprising the steps of:

applying a form of energy to a perforation device positioned at a desired location of a heart septum to create a perforation at said desired location, wherein said perforation device comprises an elongate member having a proximal region and a distal region and wherein said distal region comprises a portion fixed in a desired curve shape; and

advancing a distal tip of the device through the septum, such that said distal tip is automatically directed away from cardiac structures while being advanced, due to the shape of the curved portion;

whereby said distal tip is directed away from said cardiac structures in order to decrease risk of unwanted injury.

2. The method of claim 1 wherein said perforation device comprises a pressure sensing mechanism for sensing pressure at said distal tip and wherein the method comprises monitoring said pressure to indicate a location of said distal tip.

3. The method of claim 1 wherein said perforation device comprises an orientation indicator for determining a direction of said distal tip and wherein the method comprises monitoring said orientation indicator to advance said distal tip through said septum in a desired direction.

4. The method as claimed in claim 1, further comprising the steps of inserting said perforation device into a guiding catheter and advancing said perforation device through said guiding catheter within a patient'"'"'s vasculature, wherein said distal region conforms to a shape of said guiding catheter when inserted into said guiding catheter.

5. The method as claimed in claim 4, wherein said distal region further comprises a substantially straight portion distal to said curved portion and wherein the method comprises a further step of advancing said substantially straight portion of said distal region out of a tip of said guiding catheter in order to position said device at said desired location for creating a perforation.

6. The method as claimed in claim 1 wherein the energy is in the form of electrical current energy in the radio frequency range and wherein the energy is applied to ionize a conductive medium on top of a target tissue resulting in a low temperature molecular disintegration.

7. The method as claimed in claim 1, wherein the energy is in the form of mechanical energy and wherein said perforation device comprises a sharp distal tip.

8. The method as claimed in claim 1 wherein said desired location comprises cellular tissue and wherein sufficient energy is delivered to the tissue so as to cause cell lysis to occur.