Apparatus and method for targeting a body tissue

• US 9,498,585 B2
• Filed: 10/22/2013
• Issued: 11/22/2016
• Est. Priority Date: 10/06/2006
• Status: Active Grant

• Current Assignee: Bavaria Medizin Technologie GmbH (Berkshire Hathaway Incorporated), Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Kapadia, Samir, Berrada, Marwane, Fuentes-Ortega, Cesar, Mok, Daniel Wing Fai
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): FREHE, WILLIAM R
• Application Number:
  US14/060,274
• Publication Number:
  US 20140114246A1
• Time in Patent Office: 1,127 Days
• Field of Search: 600/424, 600433-435
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• 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 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3411 with a plurality of holes, e.g. holes in matrix arrangement
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/0038 Foramen ovale
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

An apparatus for targeting a desired target site on a body tissue comprising a wall of a first body cavity of a patient includes a target catheter. The framing member, when deployed into an expanded condition, has a framing member body which includes a three-dimensionally bulbous portion defining a maximum body footprint in a lateral dimension and has longitudinally spaced proximal and distal body ends which are both longitudinally spaced from the maximum body footprint. The proximal body end is attached to the target catheter. A protrusion has a diameter which is smaller than the maximum body footprint diameter. At least one target point is carried by the framing member and is adapted for placement adjacent the desired target site. At least one target pathway is attached to at least one target point. At least a portion of the target pathway is substantially spaced apart from the framing member body.

Claims

1. An apparatus for targeting a desired target site on a body tissue comprising a wall of a first body cavity of a patient, the apparatus comprising:

a target catheter having a longitudinally extending target catheter lumen surrounded by a tubular target catheter wall having an outer surface;

a framing member having a collapsed condition in which the framing member is adapted for insertion into the first body cavity and an expanded condition in which the framing member is adapted for placement within the first body cavity, the framing member, when deployed into the expanded condition, having;

a framing member body which includes a three-dimensionally bulbous portion defining a maximum body footprint in a lateral dimension and having longitudinally spaced proximal and distal body ends which are both longitudinally spaced from the maximum body footprint, a diameter of the bulbous portion being significantly smaller at the proximal and distal body ends than at the maximum body footprint, the proximal body end being attached to the outer surface of the target catheter wall, and

a protrusion located at the distal body end, the protrusion having a diameter which is smaller than the diameter of the maximum body footprint, the protrusion extending longitudinally distally from the distal body end of the bulbous portion;

at least one target point carried by the framing member and adapted for placement adjacent the desired target site; and

at least one target pathway attached to at least one target point, at least a portion of the target pathway extending through the target catheter lumen, and the target pathway being substantially spaced apart from the framing member body.

2. The apparatus of claim 1, including a puncture needle guided by the target pathway and adapted for insertion through the target catheter lumen and into the first body cavity, the puncture needle having a first needle end operative to puncture the body tissue responsive to guidance by the target pathway.

3. The apparatus of claim 2, wherein the target pathway is moved in the longitudinal direction to guide the first needle end to puncture the body tissue at a predetermined insertion trajectory.

4. The apparatus of claim 3, wherein movement of the target pathway in the longitudinal direction causes pivotal movement of a tissue-contacting distal end of the target pathway in relation to an attached framing member, the pivotal movement causing the tissue-contacting distal target pathway end to exert pressure on an adjacent body tissue, the tissue-contacting distal target pathway end moving substantially within a plane which is perpendicular and transverse to the attached framing member.

5. The apparatus of claim 1, wherein the framing member is substantially rotationally symmetrical.

6. The apparatus of claim 1, wherein a plurality of target points are arranged in a target array carried by the framing member.

7. The apparatus of claim 1, including a delivery catheter having a delivery catheter lumen extending longitudinally between proximal and distal delivery catheter ends, the delivery catheter lumen being configured to substantially laterally surround the framing member in the collapsed condition, at least one target point, and at least one target wire to carry the collapsed framing member, at least one target point, and at least one target wire to the first body cavity of the patient, and the framing member, at least one target point, and at least one target wire exiting distally from the distal delivery catheter end for deployment in the first body cavity of the patient.

8. The apparatus of claim 1, wherein the first body cavity has an interior first body cavity surface including a portion of the body tissue, the framing member body, when in the expanded condition, exerting positive pressure at a plurality of locations on the interior first body cavity surface to maintain a position of the at least one target point adjacent the body tissue.

9. The apparatus of claim 1, wherein at least one target point has an associated radiopaque marker to indicate a position of the target point relative to the body tissue in cooperation with an external imaging system.

10. The apparatus of claim 1 wherein the first body cavity is a right atrium and when the framing member is in the expanded condition, the protrusion at least partially enters, and exerts an anchoring force upon, a chosen one of the superior vena cava and the inferior vena cava to resist displacement of the framing member within the right atrium.

11. The apparatus of claim 1, wherein the proximal body end of the framing member substantially mates with the outer surface of the target catheter wall, a bonding sleeve laterally surrounds both the proximal body end of the framing member and at least a portion of the outer surface of the target catheter wall and the proximal body end is attached to the outer surface at least partially through direct adhesion of the bonding sleeve to the outer surface of the target catheter wall laterally through at least one fenestration in the proximal body end of the framing member.

12. The apparatus of claim 1, wherein the framing member is shaped to substantially mimic an interior volume shape of the first body cavity.

13. An apparatus for targeting a desired target site on a body tissue comprising a wall of a first body cavity of a patient, the apparatus comprising:

a target catheter having a longitudinally extending target catheter lumen surrounded by a tubular target catheter wall having an outer surface;

a framing member defining a longitudinally oriented central framing member axis and having a collapsed condition in which the framing member is adapted for insertion into the first body cavity and an expanded condition in which the framing member is adapted for placement within the first body cavity, the framing member, when deployed into the expanded condition, having;

a framing member body which includes a three-dimensionally bulbous portion defining a maximum body footprint in a lateral dimension and having longitudinally spaced proximal and distal body ends which are both longitudinally spaced from the maximum body footprint, a diameter of the bulbous portion being significantly smaller at the proximal and distal body ends than at the maximum body footprint, the proximal body end being attached to the outer surface of the target catheter wall, and

a protrusion located at the distal body end, the protrusion having a maximum protrusion diameter which is significantly smaller than the diameter of the maximum body footprint, the protrusion including a plurality of protrusion body beams extending longitudinally distally from the distal body end of the bulbous portion, each protrusion body beam extending in a plane substantially parallel to, and laterally spaced from, the central framing member axis, each protrusion body beam having a distal body beam end which is laterally spaced from each other distal body beam end to define a protrusion aperture substantially concentric to the central framing member axis, the protrusion aperture permitting unobstructed access longitudinally therethrough to an interior of the bulbous portion via the distal body end;

at least one target point carried by the framing member and adapted for placement adjacent the desired target site; and

at least one target pathway attached to at least one target point, at least a portion of the target pathway extending through the target catheter lumen, and the target pathway being substantially spaced apart from the framing member body.

14. The apparatus of claim 13, wherein the framing member is substantially rotationally symmetrical.

15. The apparatus of claim 13, wherein a plurality of target points are arranged in a target array carried by the framing member.

16. The apparatus of claim 13, including a delivery catheter having a delivery catheter lumen extending longitudinally between proximal and distal delivery catheter ends, the delivery catheter lumen being configured to substantially laterally surround the framing member in the collapsed condition, at least one target point, and at least one target wire to carry the collapsed framing member, at least one target point, and at least one target wire to the first body cavity of the patient, and the framing member, at least one target point, and at least one target wire exiting distally from the distal delivery catheter end for deployment in the first body cavity of the patient.

17. The apparatus of claim 13, including a puncture needle adapted for insertion through the target catheter lumen and into the first body cavity, the puncture needle having a first needle end operative to puncture the body tissue at the target site.

18. An apparatus for targeting a desired target site on a body tissue comprising a wall of a first body cavity of a patient, the apparatus comprising:

a target catheter having a longitudinally extending target catheter lumen surrounded by a tubular target catheter wall having an outer surface;

a framing member defining a longitudinally oriented central framing member axis and having a collapsed condition in which the framing member is adapted for insertion into the first body cavity and an expanded condition in which the framing member is adapted for placement within the first body cavity, the framing member, when deployed into the expanded condition, having;

a framing member body which includes a three-dimensionally bulbous portion defining a maximum body footprint in a lateral dimension and having longitudinally spaced proximal and distal body ends which are both longitudinally spaced from the maximum body footprint, a diameter of the bulbous portion being significantly smaller at the proximal and distal body ends than at the maximum body footprint, the proximal body end being attached to the outer surface of the target catheter wall, and

a protrusion located at the distal body end, the protrusion having a maximum protrusion diameter which is significantly smaller than the diameter of the maximum body footprint, the protrusion including

a plurality of protrusion body beams extending longitudinally distally from the distal body end of the bulbous portion, each protrusion body beam extending along a plane substantially parallel to, and laterally spaced from, the central framing member axis,

a hub located at a distalmost end of the protrusion, longitudinally spaced distally from each of the protrusion body beams, and substantially co-located with the central framing member axis, and

a plurality of protrusion cap beams, each protrusion cap beam extending at an angle relative to the central framing member axis to both laterally and longitudinally connect the hub with the distalmost ends of each of the protrusion body beams;

at least one target point carried by the framing member and adapted for placement adjacent the desired target site; and

at least one target pathway attached to at least one target point, at least a portion of the target pathway extending through the target catheter lumen, and the target pathway being substantially spaced apart from the framing member body.

19. The apparatus of claim 18, including a puncture needle adapted for insertion through the target catheter lumen and into the first body cavity, the puncture needle having a first needle end operative to puncture the body tissue at the target site.

20. The apparatus of claim 19, wherein the target pathway is moved in the longitudinal direction to guide the first needle end to puncture the body tissue at a predetermined insertion trajectory.

21. The apparatus of claim 19, wherein movement of the target pathway in the longitudinal direction causes pivotal movement of a tissue-contacting distal end of the target pathway in relation to an attached framing member, the pivotal movement causing the tissue-contacting distal target pathway end to exert pressure on an adjacent body tissue, the tissue-contacting distal target pathway end moving substantially within a plane which is perpendicular and transverse to the attached framing member.

22. The apparatus of claim 18, wherein the framing member is substantially rotationally symmetrical.

23. The apparatus of claim 18, wherein a plurality of target points are arranged in a target array carried by the framing member.

24. The apparatus of claim 18, including a delivery catheter having a delivery catheter lumen extending longitudinally between proximal and distal delivery catheter ends, the delivery catheter lumen being configured to substantially laterally surround the framing member in the collapsed condition, at least one target point, and at least one target wire to carry the collapsed framing member, at least one target point, and at least one target wire to the first body cavity of the patient, and the framing member, at least one target point, and at least one target wire exiting distally from the distal delivery catheter end for deployment in the first body cavity of the patient.