Devices, systems, and methods for obtaining biopsy tissue samples

• US 8,147,424 B2
• Filed: 04/16/2008
• Issued: 04/03/2012
• Est. Priority Date: 06/30/2006
• Status: Expired due to Fees

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Jose A. Sr.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Stout, Michael C
• Application Number:
  US12/597,852
• Publication Number:
  US 20100228221A1
• Time in Patent Office: 1,448 Days
• Field of Search: 600564-568
• US Class Current: 600/564
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00628 T-shaped occluders
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 1/0587 : Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

Devices, systems, and methods for accessing tissue in a minimally invasive manner and taking a biopsy tissue sample therefrom are disclosed. At least some of the embodiments disclosed herein enable a tissue sample to be taken from the external surface of the heart in a non-invasive manner. In addition, various disclosed embodiments provide devices, systems and methods for accessing the pericardial space through the interior of the heart and engaging the epicardial surface and removing a tissue sample therefrom for diagnostic purposes through the use of suction.

Claims

1. A system for obtaining a tissue sample from a targeted tissue, the system comprising:

a first catheter having a proximal end, distal end, and an interior, the distal end of the first catheter comprising a cutting portion adapted to cut a targeted biological tissue;

a second catheter slidably received within the interior of the first catheter, the second catheter having a proximal end, an interior, a distal end adapted to puncture the targeted tissue, and an opening disposed proximal to the distal end of the second catheter and in communication with the interior of the second catheter;

a torque mechanism comprising at least one dial coupled with at least one shaft, the at least one dial configured for rotational movement and the at least one shaft adapted to convert the rotational movement of the at least one dial into linear movement of the at least one shaft, the at least one shaft coupled with the first catheter such that the at least one shaft is adapted to advance and retract the first catheter, and the at least one shaft coupled with the second catheter such that the at least one shaft is adapted to advance and retract the second catheter; and

a deliver catheter comprising an elongated tube having a proximal end, a distal end, a wall, and a first lumen and a second lumen, the delivery catheter adapted for at least partial intravascular insertion into a mammalian body, and the at least one lumen of the delivery catheter extending from approximately the proximal end of the tube to or near the distal end of the tube and comprising a bend relative to the tube at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube, the first and second lumens each extending from approximately the proximal end of the tube to or near the distal end of the tube, each positioned longitudinally adjacent to each other, and each comprising a bend relative to the tube at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube, the first lumen of the delivery catheter having the catheter slidably disposed therein, and the second lumen of the delivery catheter having a navigational tool disposed therein, the navigational tool configured to be advanceable through the outlet of the second lumen.

2. The system of claim 1, further comprising at least one limiter device coupled with the at least one shaft of the torque mechanism and adapted to prevent the second catheter from advancing farther than a specified distance.

3. The system of claim 1, wherein the torque mechanism comprises a first shaft coupled with the proximal end of the first catheter and a second shaft coupled with the proximal end of the second catheter.

4. The system of claim 3, further comprising:

a first limiter device coupled with the first shaft and adapted to prevent the first catheter from advancing farther than a first distance; and

a second limiter device coupled with the second shaft and capable of adapted to prevent the second catheter from advancing farther than a second distance.

5. The system of claim 1, wherein the distal end of the second catheter comprises a hollow needle.

6. The system of claim 1, wherein the first and second catheters comprise a semi-rigid material.

7. The system of claim 1, wherein the cutting portion of the first catheter comprises a metallic cylinder having a cutting edge.

8. The system of claim 1, wherein the at least one shaft comprises a leadscrew.

9. The system of claim 1, wherein the at least one dial is adapted for segmented rotational movement and the at least one shaft is configured to convert the segmented rotational movement of the at least one dial into a defined amount of linear movement of the second catheter.

10. The system of claim 9, wherein the defined amount of linear movement comprises about 1 mm.

11. The system of claim 3, wherein a first dial is coupled with the first shaft and a second dial is coupled with the second shaft, the first dial and the second dial each adapted for segmented rotational movement, the first shaft configured to convert the segmented rotational movement of the first dial into a defined amount of linear movement of the first catheter, and the second shaft of configured to convert the segmented rotational movement of the second dial into a defined amount of linear movement of the second catheter.

12. The system of claim 1, wherein the targeted tissue is a mammalian heart.

13. The system of claim 1, wherein the system is capable of intravascular insertion.

14. The system of claim 1, wherein the distal end of the second catheter comprises a tapered configuration.

15. The system of claim 1, wherein the proximal end of the first catheter is coupled with a handle.

16. The system of claim 1, further comprising at least one suction port in communication with either the interior of the first catheter, the interior of the second catheter, or both, the at least one suction port adapted for operative connection to a vacuum source.

17. A system for accessing a targeted tissue and obtaining a tissue sample therefrom, the system comprising:

a delivery catheter comprising an elongated tube having a proximal end, a distal end, a wall, and a first lumen and a second lumen, the delivery catheter adapted for at least partial intravascular insertion into a mammalian body, and the at least one lumen of the deliver catheter extending from approximately the proximal end of the tube to or near the distal end of the tube and comprising a bend relative to the tube at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube, the first and second lumens each extending from approximately the proximal end of the tube to or near the distal end of the tube, each positioned longitudinally adjacent to each other, and each comprising a bend relative to the tube at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube; and

a biopsy system slidably disposed within the at least one lumen of the delivery catheter, the biopsy system comprising;

a first catheter having a proximal end, a distal end, and an interior extending between the proximal end and the distal end, and the distal end of the first catheter comprising a cutting portion adapted biological tissue,

a second catheter slidably received within the interior of the first catheter, the second catheter having a proximal end, a distal end, and an interior extending between the proximal end and the distal end, and the distal end of the second catheter comprising a tapered configuration configured to puncture the targeted tissue and an opening in communication with the interior of the second catheter, and

a torque mechanism comprising at least one dial coupled with a first shaft and at least one dial coupled with a second shaft, each of the at least one dials configured for rotational movement and the respective shaft adapted to convert the rotational movement of the at least one dial into linear movement of the respective shaft, the first shaft of the torque mechanism coupled with the first catheter such that the first shaft of the torque mechanism is adapted to advance and retract the first catheter, and the second shaft coupled with the second catheter such that the second shaft is adapted to advance and retract the second catheter;

the first lumen of the delivery catheter having the biopsy system slidably disposed therein, and the second lumen of the delivery catheter having a navigational tool disposed therein, the navigational tool configured to be advanceable through the outlet of the second lumen.

18. The system of claim 17, wherein the at least one lumen of the delivery catheter further comprises a third lumen, the third lumen extending from approximately the proximal end of the tube to or near the distal end of the tube, positioned longitudinally adjacent to the first and second lumens, and comprising a steering wire system disposed therein, the steering wire system configured to facilitate the navigation of the delivery catheter through vasculature of the body.

19. The system of claim 18, wherein a guide wire is disposed within the third lumen of the delivery catheter.

20. The system of claim 18, wherein each of the steering wire system, the navigational tool and the biopsy system may be independently controlled by a user.

21. The system of claim 17, wherein the targeted tissue is an epicardial surface of a mammalian heart.

22. The system of claim 17, wherein the navigational tool is selected from the group consisting of a laser Doppler tip, an endo-camera, and a micro-camera.

23. A method of engaging a tissue and retrieving a tissue sample therefrom, the method comprising the steps of:

inserting into a blood vessel an elongated tube having a proximal end, a distal end, and a first lumen, such that the distal end of the tube is in contact with a first targeted biological tissue on an interior wall of a mammalian heart;

accessing the pericardial space through the first targeted tissue;

inserting at least a distal end of a delivery catheter into the first lumen of the tube, the delivery catheter comprising at least a first lumen comprising a bend at or near the distal end of the delivery catheter and an outlet at or near the distal end of the delivery catheter;

advancing at least the distal end of the delivery catheter through the first targeted tissue and into the pericardial space such that the distal end of the delivery catheter is positioned at or near a second targeted biological tissue;

inserting at least a portion of a biopsy system into the at least one lumen of the delivery catheter, the biopsy system comprising a first catheter and a second catheter, the first catheter of the biopsy system comprising a distal end having a cutting portion, an outlet disposed at or near the distal end, and an interior in communication with the outlet, the second catheter of the biopsy system slidably disposed within the interior of the first catheter and comprising an interior, a distal end adapted to puncture the second targeted tissue and an opening disposed at or near the distal end of the second catheter and in communication with the interior of the second catheter;

advancing the first and second catheters of the biopsy system through the outlet of the first lumen of the delivery catheter such that the distal ends of the first and second catheters are positioned at or near the second targeted tissue;

piercing the second targeted tissue with the second catheter of the biopsy system; and

collecting a sample of the second targeted tissue into the opening of the second catheter of the biopsy system.

24. The method of claim 23, wherein the second targeted tissue comprises an epicardial surface of a mammalian heart.

25. The method of claim 24, wherein the delivery catheter further comprises a second lumen, the second lumen of the delivery catheter comprising a bend at or near the distal end of the delivery catheter and an outlet at or near the distal end of the delivery catheter, and further comprising the steps of inserting at least a distal end of a navigational tool into the second lumen of the delivery catheter and locating the second targeted tissue.

26. The method of claim 24, further comprising the step of aspirating the second targeted tissue such that the distal end of the first catheter is reversibly coupled therewith.

27. The method of claim 23, wherein the biopsy system further comprises a torque mechanism comprising at least one dial coupled with at least one shaft, the at least one dial configured for rotational movement about the at least one shaft and the at least one shaft adapted to convert the rotational movement of the at least one dial into linear movement of the first catheter of the biopsy system, the second catheter of the biopsy system or both, and the step of piercing the second targeted tissue with the second catheter of the biopsy system further comprises operating the torque mechanism of the biopsy system to advance the distal end of the second catheter a first distance into the second targeted tissue.

28. The method of claim 27, further comprising the step of advancing the first catheter through operation of the torque mechanism such that the cutting portion of the first catheter cuts a sample of the second targeted tissue.

29. The method of claim 28, further comprising the step of aspirating the second targeted tissue such that the sample of the second targeted tissue is pulled into the interior of the second catheter through the opening of the second catheter and detached from the remaining second targeted tissue.

30. The method of claim 29, further comprising the step of withdrawing the first catheter and the second catheter containing the sample of the second targeted tissue.

31. The method of claim 27, further comprising the step of advancing the first catheter a second distance through operation of the torque mechanism such that the cutting portion of the first catheter cuts the second targeted tissue, and wherein the first distance and the second distance are substantially equal.

32. A system for obtaining a tissue sample from a targeted tissue, the system comprising:

a catheter having a proximal end, distal end, and an interior extending between the proximal and distal ends, the distal end comprising a tapered configuration, a cutting edge capable of slicing a targeted biological tissue, and an opening in communication with the interior of the catheter;

a torque mechanism coupled with the proximal end of the catheter, the torque mechanism comprising at least one dial coupled with at least one shaft, the at least one dial being configured for rotational movement and the at least one shaft adapted to convert the rotational movement of the at least one dial into either linear movement of the catheter or rotational movement of the catheter, and rotation of the catheter in a first direction causes the cutting edge of the catheter to slice a sample of a targeted tissue and wherein the cutting edge and the opening are configured to allow the sample to be drawn through the opening and into the interior of the catheter; and

a delivery catheter comprising an elongated tube having a proximal end, a distal end, a wall, and a first lumen and a second lumen, the delivery catheter adapted for at least partial intravascular insertion into a mammalian body, and the at least one lumen of the delivery catheter extending from approximately the proximal end of the tube to or near the distal end of the tube and comprising a bend relative to the tube at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube, the first and second lumens each extending from approximately the proximal end of the tube to or near the distal end of the tube, each positioned longitudinally adjacent to each other, and each comprising a bend relative to the tube at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube, the first lumen of the delivery catheter having the catheter slidably disposed therein, and the second lumen of the delivery catheter having a navigational tool disposed therein, the navigational tool configured to be advanceable through the outlet of the second lumen.

33. The system of claim 32, wherein the at least one lumen of the delivery catheter further comprises a third lumen, the third lumen extending from approximately the proximal end of the tube to or near the distal end of the tube and comprising a steering wire system disposed therein, the steering wire system configured to facilitate the navigation of the delivery catheter through vasculature of the body.

34. The system of claim 33, wherein a guide wire is disposed within the third lumen of the delivery catheter.

35. The system of claim 33, wherein each of the steering wire system, the navigational tool and the biopsy system may be independently controlled by a user.

36. The system of claim 32, further comprising a suction port in communication with the interior of the catheter, the suction port adapted for operative connection to a vacuum source.

37. The system of claim 32, wherein the distal end of the catheter further comprises a first edge and a second edge, the first edge and the second edge configured in a tapered configuration such that the first edge overlaps the second edge and the opening is formed therebetween.

38. The system of claim 32, wherein the distal end of the catheter is comprised of a metallic material.

39. The system of claim 32, further comprising at least one limiter device coupled with the at least one shaft of the torque mechanism and adapted to prevent the catheter from advancing farther than a specified distance.

40. The system of claim 32, wherein the proximal end of the catheter is coupled with a handle.

41. The system of claim 32, wherein the targeted tissue is an epicardial surface of a mammalian heart.

42. The system of claim 32, wherein the navigational tool is selected from the group consisting of a laser Doppler tip, an endo-camera, and a micro-camera.

43. A method of retrieving a tissue sample from a body, the method comprising the steps of:

inserting into a blood vessel an elongated tube having a proximal end, a distal end, and a first lumen, such that the distal end of the tube is in contact with a first targeted biological tissue on an interior wall of a mammalian heart;

accessing a pericardial space of the heart through the first targeted tissue;

inserting at least a distal end of a delivery catheter into the first lumen of the tube, the delivery catheter comprising at least one lumen comprising a bend at or near the distal end of the delivery catheter and an outlet at or near the distal end of the delivery catheter;

advancing at least the distal end of the delivery catheter through the first targeted tissue and into the pericardial space such that the distal end of the delivery catheter is positioned at or near a second targeted biological tissue;

inserting at least a portion of a biopsy system into the at least one lumen of the delivery catheter, the biopsy system comprising a catheter comprising a distal end having a tapered configuration, a cutting edge configured to slice the second targeted tissue and an opening in communication with the interior of the catheter;

advancing the catheter of the biopsy system through the outlet of the first lumen of the delivery catheter such that the distal end of the catheter is positioned at or near the second targeted tissue;

piercing the second targeted tissue with distal end of the catheter; and

rotating the distal end of the catheter such that the cutting edge slices the second targeted tissue, detaches a sample thereof and draws the sample into the interior of the catheter.

44. The method of claim 43, wherein the biopsy system further comprises a torque mechanism coupled with the catheter and comprising at least one dial coupled with at least one shaft, the at least one dial configured for rotational movement relative to the respective shaft and each of the at least one shafts adapted to convert the rotational movement of the respective dial into either linear movement of the catheter or rotational movement of the catheter, and wherein the step of piercing the second targeted tissue with the distal end of the catheter further comprises rotating the a first dial of a torque mechanism to advance the distal end of the catheter a first distance into the second targeted tissue.

45. The method of claim 44, wherein the step of rotating the distal end of the catheter further comprises rotating a second dial of the torque mechanism.

46. The method of claim 43, wherein:

the at least one lumen of the delivery catheter comprises a first lumen and a second lumen, the first and second lumens each extending from approximately the proximal end of the delivery catheter to or near the distal end of the delivery catheter, each positioned longitudinally adjacent to each other, and each comprising a bend at or near the distal end of the delivery catheter, the first lumen of the delivery catheter having a biopsy system slidably disposed therein, and the second lumen of the delivery catheter having a navigational tool disposed therein, the navigational tool adapted to be advanceable through the outlet of the second lumen; and

the method further comprising the step of operating the navigational tool to locate the second targeted tissue on the epicardial surface of the heart.

47. The method of claim 43, further comprising the step of aspirating the second targeted tissue such that the distal end of the catheter is reversibly coupled with the second targeted tissue.

48. The method of claim 43, further comprising the step of operating a vacuum source operatively coupled with the interior of the catheter to facilitate retention of the sample within the interior of the catheter.

49. The method of claim 43, further comprising the step of withdrawing the catheter containing the sample.