Assessment of lesion transmurality

• US 7,232,437 B2
• Filed: 05/19/2005
• Issued: 06/19/2007
• Est. Priority Date: 10/30/2003
• Status: Expired due to Fees

• Current Assignee: Endophotonix, Inc.
• Original Assignee: Medical CV, Inc.
• Inventors: Brucker, Gregory G., Svenson, Robert H., Berman, Adam L.
• Primary Examiner(s): FARAH, AHMED M
• Application Number:
  US11/133,900
• Publication Number:
  US 20050209589A1
• Time in Patent Office: 761 Days
• Field of Search: 606/7, 606 13- 16, 606 32- 35, 606 41- 52, 607/88, 607/89, 607/101, 607/102, 607/104, 607/122, 600372-374, 128/898
• US Class Current: 606/34
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy

Abstract

A method and apparatus for treating a body tissue in situ (e.g., an atrial tissue of a heart to treat) atrial fibrillation include a lesion formation tool is positioned against the heart surface. The lesion formation tool includes a guide member having a tissue-opposing surface for placement against a heart surface. An ablation member is coupled to the guide member to move in a longitudinal path relative to the guide member. The ablation member has an ablation element for directing ablation energy in an emitting direction away from the tissue-opposing surface. The guide member may be flexible to adjust a shape of the guide member for the longitudinal path to approximate the desired ablation path while maintaining the tissue-opposing surface against the heart surface. In one embodiment, the ablation member includes at least one radiation-emitting member disposed to travel in the longitudinal pathway. Transmurality can be assessed to approximate a location of non-transmurality in a formed lesion.

Claims

1. A method for assessing efficacy of a lesion formed on a human heart where said lesion is intended to be formed as a transmural lesion through a wall thickness of myocardial tissue and with said lesion having a depth dimension of penetration into said tissue, an elongated dimension on a surface of said tissue and a narrow width dimension transverse to said elongated dimension, said method comprising:

(a) placing a first electrode at said tissue on a first side of said lesion;

(b) placing a second electrode at a said tissue on a second side of said lesion with said lesion between said first and second sides;

(c) applying an electrical signal to said first electrode;

(d) noting a received response to said electrical signal at said second electrode; and

(e) processing said received response to both determine (i) an existence of a discontinuity of said lesion and (ii) approximating a position of a location of said discontinuity along said elongated dimension.

2. A method according to claim 1 wherein said received response is a time delay between an application of said electrical signal to said first electrode and a receipt of said response at said second electrode.

3. A method according to claim 1 wherein said received response is a measure of conductance between said first electrode and said second electrode.

4. A method according to claim 1 wherein said received response is an alteration of a waveform of said electrical signal between said first electrode and said second electrode.

5. A method according to claim 1 wherein said lesion is formed as an intended complete lesion surrounding a pulmonary vein and defining a bounded area within said lesion, said method further comprising:

(a) placing multiple pairs of said first and second electrodes on said first and second sides;

(b) applying separate ones of said electrical signal to said first electrodes of said pairs;

(c) noting separate ones of said received response to said separate ones of said electrical signal at said second electrodes; and

(d) comparing said separate ones of said received response to approximate a location of a discontinuity of said lesion based on said received response.

6. A method according to claim 5 wherein said received response is a time delay between an application of said electrical signal to said first electrode and a receipt of said response at said second electrode.

7. A method according to claim 5 wherein said received response is a measure of conductance between said first electrode and said second electrode.

8. A method according to claim 5 wherein said received response is an alteration of a waveform of said electrical signal between said first electrode and said second electrode.

9. A method for forming a lesion in a heart tissue, said method comprising:

(a) forming at least a segment of a lesion on a human heart where said lesion is intended to be formed as a transmural lesion through a wall thickness of myocardial tissue and with said lesion having a depth dimension of penetration into said tissue, an elongated dimension on a surface of said tissue and a narrow width dimension transverse to said elongated dimension;

(b) assessing a rransmurality of said lesion by;

(ii) placing a first electrode at said tissue on a first side of said lesion;

(ii) placing a second electrode at a said tissue on a second side of said lesion with said lesion between said first and second sides;

(iii) applying an electrical signal to said first electrode;

(iv) noting a received response to said electrical signal at said second electrode;

(v) processing said received response to both determine (i) an existence of a discontinuity of said lesion and (ii) approximating a position of a location of said discontinuity along said elongated dimension and

(c) repeating a formation of said lesion at said location.

10. An apparatus for forming a lesion in tissue along a desired ablation path, said apparatus comprising:

a guide member having a tissue-opposing surface for placement against a heart surface;

an ablation member having an ablation element for directing ablation energy in an emitting direction;

said ablation member coupled to said guide member to move in a longitudinal path relative to said guide member and with said ablation member oriented relative to said guide member for said emitting direction to be directed away from said tissue opposing surface;

a transmurality assessor for assessing efficacy of a lesion formed by said ablation member wherein said transmurality assessor includes;

(a) a first electrode for placement at said tissue on a first side of said lesion;

(b) a second electrode for placement at a said tissue on a second side of said lesion with said lesion between said first and second sides;

(c) said electrodes adapted for connection to a source of an electrical signal for applying said electrical signal to said first electrode;

(d) said electrodes adapted for connection to a monitoring equipment for processing a received response to both determine (i) an existence of a discontinuity of said lesion and (ii) approximating a position of a location of said discontinuity along

said elongated dimension.

11. An apparatus according to claim 10 wherein said electrodes are attached to said guide member.

12. An apparatus according to claim 11 wherein said electrodes are attached to said ablation member for movement therewith.