APPARATUS, SYSTEMS, AND METHODS FOR EPICARDIAL IMAGING AND INJECTION

• US 20150173592A1
• Filed: 11/15/2014
• Published: 06/25/2015
• Est. Priority Date: 11/14/2013
• Status: Active Grant

• Current Assignee: CLPH, LLC
• Original Assignee: CLPH, LLC
• Inventors: Leeflang, Stephen A., Eversull, Christian S.
• Granted Patent: US 10,653,297 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/00098 Deflecting means for inserted tools
• CPC Class Codes: A61B 1/00133 Drive units for endoscopic tools inserted through or with the endoscope
• CPC Class Codes: A61B 1/0125 Endoscope within endoscope
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/313 for introducing through surgical openings, e.g. laparoscopes
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/0034 adapted to be inserted through a working channel of an endoscope
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives

Abstract

Systems and methods are provided for injecting one or more agents into tissue within a patient'"'"'s body that includes a catheter. A needle guide extends from a distal end of the catheter and terminates at a distal tip, e.g., including a foot with an atraumatic contact surface, the needle guide having a cross-section smaller than the distal end and being biased to a curved shape. The needle guide includes a passage communicating from a lumen of the catheter to an outlet at the distal tip, and a needle device is disposed within the passage that may be deployed from the outlet to inject one or more agents into tissue. The catheter also includes an imaging assembly on the distal end configured to acquire images of tissue adjacent the needle guide distal tip.

Claims

1. An apparatus for imaging tissue during a medical procedure, comprising:

a tubular member comprising a proximal end, a distal end sized for introduction into a patient'"'"'s body, and one or more lumens extending between the proximal and distal ends;

a tubular extension extending distally beyond the distal end to a distal tip, the tubular extension having a cross-section smaller than the distal end and being biased to a curved shape, the tubular extension including a passage communicating from a first lumen of the tubular member to an outlet at the distal tip;

a foot on the distal tip comprising a substantially atraumatic contact surface having an area larger than the cross-section of the tubular extension for contacting tissue; and

an imaging assembly on the distal end configured to acquire images of tissue adjacent the foot.

2. The apparatus of claim 1, wherein the tubular member comprises a central longitudinal axis extending between the proximal and distal ends, and wherein the tubular extension is biased to the curved shape wherein the foot is offset from the longitudinal axis and is flexibly movable to a substantially straightened shape to facilitate introduction into a patient'"'"'s body.

3. The apparatus of claim 2, wherein the imaging assembly comprises an imaging element having a field of view that is offset from the longitudinal axis such that the field of view is substantially centered on the foot when the tubular extension is in the curved shape.

4. The apparatus of claim 2, wherein the distal end terminates at a distal surface defining a non-perpendicular angle with respect to the longitudinal axis and wherein the imaging assembly comprises an imaging element mounted on the distal surface such that a field of view of the imaging element is offset from the longitudinal axis.

5. The apparatus of claim 1, further comprising a substantially transparent expandable member comprising a proximal end attached to the tubular member distal end and a distal end attached to one of the distal tip and the foot such the imaging assembly is disposed within an interior of the expandable member.

6. The apparatus of claim 5, wherein the expandable member is expandable from a contracted condition to an enlarged condition when fluid is introduced through an inflation lumen of the tubular member into the interior of the expandable member.

7. The apparatus of claim 1, further comprising:

a needle device disposed within the passage of the tubular extension; and

an actuator on the proximal end of the tubular member for directing the needle device from a retracted position wherein a tip of the needle device is disposed within the passage and an advanced position wherein the tip is deployed from the outlet.

8. The apparatus of claim 7, wherein the needle device comprises a tubular body that extends through the first lumen in the tubular member from the tubular member proximal end into the tubular member distal end and a tip portion that extends from the tubular body into the passage and terminates in the tip.

9. The apparatus of claim 8, wherein the needle device is removable entirely from the tubular member from the tubular member proximal end.

10. The apparatus of claim 8, wherein:

the first lumen has a first region defining a first inner diameter extending from the tubular member proximal end to a location within the tubular member distal end and a second region defining a second inner diameter smaller than the first inner diameter communicating with the passage in the tubular extension; and

the tubular body has a first portion extending from the tubular member proximal end into the tubular member distal end and sized to be slidably received in the first region of the first lumen, and a second portion sized to be slidably received in the second region of the first lumen and the passage,

wherein a transition from the first region to the second region provides a stop that engages a transition from the first portion to the second portion to limit advancement of the needle tip in the advanced position.

11. (canceled)

12. A system for injecting one or more agents into tissue within a patient'"'"'s body, comprising:

a. a catheter comprising;

i. a tubular member comprising a proximal end, a distal end sized for introduction into a patient'"'"'s body, and one or more lumens extending between the proximal and distal ends;

ii. a needle guide extending distally beyond the distal end to a distal tip, the needle guide having a cross-section smaller than the distal end and being biased to a curved shape, the needle guide including a passage communicating from a first lumen of the tubular member to an outlet at the distal tip;

iii. an imaging assembly on the distal end configured to acquire images of tissue adjacent the needle guide distal tip; and

b. a needle device disposed within the passage of the needle guide and movable from a retracted position wherein a needle tip of the needle device is disposed within the passage and an advanced position wherein the needle tip is deployed from the outlet.

13. The system of claim 12, wherein the tubular member comprises a central longitudinal axis extending between the proximal and distal ends, and wherein the needle guide is biased to the curved shape and is flexibly movable to a substantially straightened shape to facilitate introduction into a patient'"'"'s body.

14. The system of claim 13, wherein the imaging assembly comprises an imaging element having a field of view that is offset from the longitudinal axis such that the field of view is substantially centered on needle guide distal tip in the curved shape.

15. The system of claim 13, wherein the distal end terminates at a distal surface defining a non-perpendicular angle with respect to the longitudinal axis and wherein the imaging assembly comprises an imaging element mounted on the distal surface such that a field of view of the imaging element is offset from the longitudinal axis.

16. The system of claim 12, further comprising a substantially transparent expandable member comprising a proximal end attached to the tubular member distal end and a distal end attached to the distal tip such the imaging assembly is disposed within an interior of the expandable member.

17. The system of claim 12, wherein the needle device comprises a tubular body that extends through the first lumen in the tubular member from the tubular member proximal end into the tubular member distal end.

18. The system of claim 17, wherein the needle device is removable entirely from the tubular member from the tubular member proximal end.

19. The system of claim 17, wherein:

the first lumen has a first region defining a first inner diameter extending from the tubular member proximal end to a location within the tubular member distal end and a second region defining a second inner diameter smaller than the first inner diameter communicating with the passage in the needle guide; and

the tubular body has a first portion extending from the tubular member proximal end into the tubular member distal end and sized to be slidably received in the first region of the first lumen, and a second portion sized to be slidably received in the second region of the first lumen and the passage,

wherein a transition from the first region to the second region provides a stop that engages a transition from the first portion to the second portion to limit advancement of the needle tip in the advanced position.

20. The system of claim 12, wherein the catheter further comprises a foot on the distal tip comprising a substantially atraumatic contact surface having an area larger than the cross-section of the needle guide.

21. A method for imaging tissue structures within a patient'"'"'s body,

comprising:

introducing a distal end of a catheter into a pericardial space adjacent the patient'"'"'s heart;

deploying a curved delivery guide extending from the distal end of the catheter such that a foot on the delivery guide is oriented transversely relative to the distal end;

manipulating the catheter such a substantially atraumatic surface of the foot contacts the heart wall; and

acquiring one or more images of the foot and adjacent tissue to identify a target location on the heart wall.

22-27. -27. (canceled)