OBTAINING A TISSUE SAMPLE

• US 20080015466A1
• Filed: 07/09/2007
• Published: 01/17/2008
• Est. Priority Date: 07/13/2006
• Status: Active Grant

• Current Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Lerman, Amir
• Granted Patent: US 9,033,896 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

Some embodiments of a biopsy system are configured to obtain a sample of tissue from an internal body site, such as a portion of myocardial tissue from a heart chamber wall. The biopsy system may include a catheter device having tissue collection jaws and an inflatable balloon disposed along a distal portion. Also, the biopsy system may include a pressure sensor device to detect the pressure within the heart chamber in which the tissue collection jaws are disposed.

Claims

1. A biopsy system, comprising:

a catheter device having an elongate body that extends from a proximal portion to a distal portion, the distal portion being deliverable to a targeted heart chamber, the catheter device including;

a fluid delivery lumen, a pressure sensor channel, and a working channel;

tissue collection jaws disposed along the distal portion to obtain a sample of body tissue from the targeted heart chamber, the tissue collection jaws being adjustable from an opened position to a closed position in response to movement of an actuation rod within the working channel;

an inflatable balloon device to maintain position of the distal portion in the targeted heart chamber when the balloon device is expanded to an inflated condition, the balloon device being disposed along the distal portion and in fluid communication with the fluid delivery lumen; and

a pressure sensor device to detect a blood pressure proximate to the tissue collection jaws, the pressure sensor device in communication with the pressure sensor channel, the pressure sensor device outputting data signals to external monitoring equipment that indicates pressure readings viewable to a practitioner while catheter device is being delivered to the targeted heart chamber.

2. The system of claim 1, the balloon device anchors the distal portion of the catheter device in the targeted chamber while the tissue collection jaws obtain the sample of bodily tissue.

3. The system of claim 1, wherein the pressure data signals are transmitted via an electrical line arranged in the pressure sensor channel.

4. A biopsy system for collecting a sample of heart tissue, comprising:

a catheter device having an elongate body that extends from a proximal portion to a distal portion, the distal portion being deliverable to a targeted heart chamber;

tissue collection jaws to obtain a sample of body tissue, the tissue collection jaws being disposed along the distal portion;

an inflatable balloon device to maintain position of the distal portion in the targeted heart chamber when the balloon device is expanded to an inflated condition, the balloon device being disposed along the distal portion.

5. The system of claim 4, further comprising a pressure sensor device to detect a blood pressure proximate to the tissue collection jaws, the pressure sensor device being coupled to the catheter device.

6. The system of claim 5, wherein the catheter device includes:

a fluid delivery lumen in communication with the inflatable balloon device, a pressure sensor channel in communication with the pressure sensor device, and a working channel that at least partially surrounds an actuation rod for adjusting the tissue collection jaws.

7. The system of claim 5, wherein the pressure sensor device comprises a pressure transducer disposed along an outer portion of the catheter device.

8. The system of claim 7, wherein the pressure sensor device comprises a micromanometer device that, when delivered to the targeted heart chamber, is exposed to blood pressure on one side and a reference pressure on the opposite side.

9. The system of claim 7, wherein the pressure transducer is arranged along the outer portion of the catheter device distally of the inflatable balloon device.

10. The system of claim 7, wherein the pressure transducer is arranged along the outer portion of the catheter device and within the inflatable balloon device.

11. The system of claim 5, wherein the pressure sensor device operates in conjunction with fluid in the inflatable balloon device, further comprising a pressure sensor port and a pressure sensor channel in fluid communication with the balloon device.

12. The system of claim 11, wherein pressure fluctuations acting upon an outer surface of the balloon device are transmitted through the pressure sensor channel for detection by the pressure sensor device.

13. The system of claim 5, wherein the pressure sensor device comprises a fiber optic sensor.

14. The system of claim 5, wherein data signals from the pressure sensor device are transmitted to external monitoring equipment to indicate pressure readings that are viewable to a practitioner while catheter device is being delivered to the targeted heart chamber.

15. The system of claim 14, wherein the external monitoring equipment includes a screen that displays pressure readings to indicate that the tissue collection jaws are disposed within the targeted heart chamber.

16. The system of claim 15, wherein the pressure readings in the targeted heart chamber indicate a blood pressure of about 20 mmHg to about 40 mmHg, the blood pressure in the targeted heart chamber being greater than blood pressure in an adjacent heart chamber.

17. The system of claim 4, wherein the tissue collection jaws comprise opposing concave members that are movable relative to a pivot axis so as to adjust from an opened position to a closed position, the opposing concave members at least partially defining a tissue collection space therebetween when arranged in the closed position.

18. The system of claim 17, wherein the concave members are about 1 mm to about 6 mm in diameter.

19. The system of claim 17, wherein the concave members include tissue cutting surfaces having a plurality of serrated teeth, the serrated teeth of one concave member being matable with the serrated teeth of the opposing concave member when the concave members are in the closed position.

20. The system of claim 4, the balloon device anchors the distal portion of the catheter device in the targeted chamber while the tissue collection jaws obtain the sample of bodily tissue.

21. The system of claim 20, wherein the balloon device is biased by blood flow to anchor the distal portion of the catheter device in the targeted chamber when expanded to the inflated condition.

22. The system of claim 20, wherein the balloon device abuts again at least one of a heart wall or a heart valve to anchor the distal portion of the catheter device in the targeted chamber when expanded to the inflated condition.

23. The system of claim 4, wherein when the balloon device is pressurized, the balloon device expands to a predetermined shape of the inflated condition without elastic deformation substantially beyond the predetermined shape.

24. The system of claim 23, wherein the balloon device comprises a polymer material selected from the group consisting of a polyolefin copolymer, polyester, polyethylene teraphthalate, polyethylene, polyether-block-amide, polyamide, polyimide, nylon, latex, and urethane.

25. The system of claim 23, wherein the balloon device expands to the predetermined shape selected from the group consisting of a cylindrical shape a conical shape, a frusto-conical shape, a hyperbolic shape, a spherical shape, and a rectangular prism shape.

26. A method for obtaining a myocardial tissue sample, comprising:

advancing a distal portion of a catheter device through a right atrium and into a right ventricle;

inflating a balloon device disposed along the distal portion so as to maintain position of the distal portion in the right ventricle;

actuating tissue collection jaws to remove myocardial tissue from a chamber wall of the right ventricle.

27. The method of claim 26, further comprising monitoring blood pressure proximate the tissue collection jaws of the catheter device using a pressure sensor device coupled to the catheter device, and viewing blood pressure readings as the distal portion advances from the right atrium to the right ventricle so as to verify that the distal portion is located in the right ventricle.