Expandable catheter and related methods of manufacture and use

• US 10,478,247 B2
• Filed: 08/07/2014
• Issued: 11/19/2019
• Est. Priority Date: 08/09/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Litscher, Eric Karl, Levendusky, Joseph A., Nguyen, Man Minh, Mannion, Paul, Byrne, T J
• Primary Examiner(s): Hupczey, Jr., Ronald
• Application Number:
  US14/454,383
• Publication Number:
  US 20150045788A1
• Time in Patent Office: 1,930 Days
• CPC Class Codes: A61B 17/12104 in an air passage
• 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 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00136 with polymer
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe

Abstract

A medical device may include an expandable energy delivery array reciprocally movable between a first configuration and a second configuration. The expandable energy delivery array may include a first assembly having a first proximal end piece, a first distal end piece, and one or more first energy transfer elements extending between the first proximal and first distal end pieces, and a second assembly having a second proximal end piece, a second distal end piece, and one or more second energy transfer elements extending between the second proximal and second distal end pieces. The second proximal end piece may be proximal to the first proximal end piece and the second distal end piece may be distal to the first distal end piece.

Claims

1. A medical device, comprising:

an expandable energy delivery array reciprocally movable between a first configuration and a second configuration, the expandable energy delivery array comprising;

a first assembly having a unitary first proximal end piece, a unitary first distal end piece, and a plurality of first energy transfer elements each directly coupled to and extending between the unitary first proximal and unitary first distal end pieces; and

a second assembly having a unitary second proximal end piece, a unitary second distal end piece, and a plurality of second energy transfer elements each directly coupled to and extending between the unitary second proximal and unitary second distal end pieces, wherein the unitary second proximal end piece is proximal to the unitary first proximal end piece, and a proximalmost portion of the unitary second distal end piece is distal to a distalmost portion of the unitary first distal end piece, wherein the first and second energy transfer elements circumferentially alternate with one another relative to a longitudinal axis of the medical device such that each first energy transfer element is circumferentially between two second energy transfer elements, and each second energy transfer element is circumferentially between two first energy transfer elements;

wherein;

the first and second assemblies are electrically insulated from one another;

the first and second proximal end pieces are separated by a first insulating element contained longitudinally between the first and second proximal end pieces; and

the first and second distal end pieces are longitudinally separated by a second insulating element contained longitudinally between the first and second distal end pieces.

2. The medical device of claim 1, wherein a distalmost portion of the unitary second proximal end piece is proximal to a proximalmost portion of the unitary first distal end piece, and the first insulating element is an insulating washer.

3. The medical device of claim 1, wherein the second insulating element is an insulating washer.

4. The medical device of claim 1, wherein distalmost ends of the second energy transfer elements extend through one or more notches disposed in an outer radial surface of the unitary second distal end piece.

5. The medical device of claim 1, wherein the first energy transfer elements are disposed further from a longitudinal axis of the energy delivery array than the second energy transfer elements.

6. The medical device of claim 1, further including an activation element that extends from a proximal end of the medical device through the first and second assemblies, the activation element being coupled to the unitary second distal end piece, wherein longitudinal movement of the activation element is configured to reciprocally move the energy delivery array between the first and second configurations, wherein the first configuration is a collapsed configuration and the second configuration is a radially expanded configuration, wherein the activation element is configured to deliver RF energy to the second assembly.

7. The medical device of claim 1, wherein each of the first and second energy transfer elements includes an active region defined at proximal and distal portions by insulating regions, wherein the active region is configured to deliver RF energy to body tissues when in contact with the body tissues, and the insulating regions are not configured to deliver RF energy to body tissues at any time, and the active region of at least one first or second energy transfer element includes at least one temperature sensing element configured to sense a temperature of the active region or of body tissue.

8. The medical device of claim 1, wherein the energy delivery array is configured to deliver energy to body tissues in a bipolar configuration.

9. A medical device, comprising:

an expandable energy delivery array reciprocally movable between a first configuration and a second configuration, the expandable energy delivery array comprising;

a plurality of first energy transfer elements, a first proximal end piece, and a first distal end piece, wherein each of the plurality of first energy transfer elements is coupled at a proximal end to the first proximal end piece, and is coupled at a distal end to the first distal end piece, and the first proximal end piece and the first distal end piece are hollow cylinders; and

a plurality of second energy transfer elements, a second proximal end piece, and a second distal end piece, wherein the plurality of first energy transfer elements alternate with the plurality of second energy transfer elements circumferentially about a longitudinal axis of the energy delivery array such that each first energy transfer element is circumferentially between two second energy transfer elements, and each second energy transfer element is circumferentially between two first energy transfer elements, wherein radially outermost portions of each of the plurality of first energy transfer elements are spaced further from the longitudinal axis of the energy delivery array than radially outermost portions of each of the plurality of second energy transfer elements, wherein each of the plurality of second energy transfer elements is coupled at a proximal end to the second proximal end piece, and is coupled at a distal end to the second distal end piece, and the second proximal end piece and the second distal end piece are hollow cylinders;

wherein;

the plurality of first energy transfer elements and the plurality of second energy transfer elements are electrically insulated from one another;

the first and second proximal end pieces are separated by a first insulating element contained longitudinally between the first and second proximal end pieces; and

the first and second distal end pieces are separated by a second insulating element contained longitudinally between the first and second distal end pieces.

10. The medical device of claim 9, further including an activation element that extends from a proximal end towards a distal end of the medical device, the activation element configured to deliver energy to the plurality of second energy transfer elements.

11. The medical device of claim 9, wherein each first energy transfer element is circumferentially offset from each other first energy transfer element, and each second energy transfer element is circumferentially offset from each other second energy transfer element.

12. A medical device, comprising:

an expandable energy delivery array reciprocally movable between a first configuration and a second configuration, the expandable energy delivery array comprising;

a first assembly having a first proximal end piece, a first distal end piece, and a plurality of first electrodes extending between the first proximal and first distal end pieces, each of the plurality of first electrodes being circumferentially offset from each other of the plurality of first electrodes; and

a second assembly having a second proximal end piece, a second distal end piece, and a plurality of second electrodes extending between the second proximal and second distal end pieces, each of the plurality of second electrodes being circumferentially offset from each other of the plurality of second electrodes, wherein a distalmost portion of the second proximal end piece is proximal to both i) a proximalmost portion of the first proximal end piece and ii) proximalmost ends of each of the plurality of first electrodes, and a proximalmost portion of the second distal end piece is distal to i) a distalmost portion of the first distal end piece and ii) distalmost ends of each of the plurality of first electrodes, wherein;

the first and second assemblies are electrically insulated from one another;

the first and second proximal end pieces are separated by a first insulating element contained longitudinally between the first and second proximal end pieces;

the first insulating element directly contacts a proximally-facing surface of the first proximal end piece and directly contacts a distally-facing surface of the second proximal end piece;

the first and second distal end pieces are separated by a second insulating element contained longitudinally between the first and second distal end pieces; and

the second insulating element directly contacts a distally-facing surface of the first distal end piece and directly contacts a proximally-facing surface of the second distal end piece; and

an activation element configured to reciprocally move the expandable energy delivery array between the first configuration and the second configuration, wherein when the expandable energy delivery array is in the first configuration, proximal movement of the activation element is configured to move both the first and second distal end pieces proximally to cause each of the first electrodes and the second electrodes to buckle and expand radially outward.

13. The medical device of claim 12, wherein each first electrode is disposed circumferentially between two second electrodes, and each second electrode is disposed circumferentially between two first electrodes.

14. The medical device of claim 12, wherein each first electrode is circumferentially adjacent to only second electrodes, and each second electrode is circumferentially adjacent to only first electrodes.

15. The medical device of claim 12, wherein each of the first proximal end piece, the second proximal end piece, the first distal end piece, and the second distal end piece is unitary in construction, each first electrode is directly coupled to both the first proximal end piece and the first distal end piece, and each second electrode is directly coupled to both the second proximal end piece and the second distal end piece.

16. The medical device of claim 15, wherein each of the first proximal end piece, the second proximal end piece, the first distal end piece, and the second distal end piece is a hollow cylinder.

17. The medical device of claim 16, wherein distalmost ends of the second electrodes each extend through a respective notch disposed in an outer radial surface of the second distal end piece.

18. The medical device of claim 17, wherein proximalmost ends of the second electrodes each extend through a respective notch disposed in an outer radial surface of the second proximal end piece.