Image guided catheters and methods of use

• US 8,403,858 B2
• Filed: 07/25/2007
• Issued: 03/26/2013
• Est. Priority Date: 10/12/2006
• Status: Active Grant

• Current Assignee: Perceptive Navigation LLC
• Original Assignee: Perceptive Navigation LLC
• Inventors: Abraham, Theodore P.
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): Brutus, Joel F
• Application Number:
  US11/782,991
• Publication Number:
  US 20080091109A1
• Time in Patent Office: 2,071 Days
• Field of Search: 600/461, 600/462, 600/463, 600/464, 600/466, 600/467, 600/470
• US Class Current: 600/466
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/54 Control of the diagnostic device
• CPC Class Codes: A61B 8/565 involving data transmission via a network
• CPC Class Codes: A61B 8/582 Remote testing of the device

Abstract

An interventional medical device that incorporates an imaging system may be minimally invasive and equipped with an anchoring portion at a proximal end for securing the device to a human body. A luer lock may be utilized at the proximal end, for example, for introducing a syringe. The medical device can be in the form of sheaths, catheters, and interventional devices, particularly those suitable for minimally invasive procedures in the pericardium. The imaging system comprises one or more ultrasound transducers and can be used to guide the device to a target area and to perform a procedure and/or provide access to a target area for performing a procedure via a plurality of lumen. In one embodiment, a micro-electro-mechanical system may be utilized to monitor pressure within a human body.

Claims

1. An interventional medical device for pericardial access configured to perform minimally invasive surgical procedures comprising at least one ultrasound transducer, the device comprising

an elongate body having no exterior delivery catheter or sheath configured to facilitate entry of a catheter through skin tissue of a human body, the elongate body configured to be introduced directly through a chest of the human body to the pericardium after a small stab incision on the skin during use of the device, the elongate body having proximal and distal ends, the elongate body having a tapered tip at the distal end, the elongate body configured to be a conduit from a skin surface of the chest to a target site proximate the pericardium during use of the device;

an insertable needle configured to puncture an internal wall of the human body proximate the target site during use of the device;

a plurality of lumen extending through the elongate body, one lumen extending through the elongate body having an end aperture at a distal tip of the tapered tip of the elongate body, the one lumen adapted to receive the insertable needle during use of the device, the insertable needle configured to puncture the target site as the needle extends from the end aperture during use of the device;

said at least one ultrasound transducer being located at an outer periphery of the tapered tip of the elongate body and proximally located near the distal end in relation to the end aperture and oriented and configured to provide images for guidance of movement of the elongate body from the chest to the target site proximate the pericardium of the human body and images of said needle puncture of the human body wall during use of the device; and

an anchoring portion near the proximal end of the elongate body for maintaining a proper position during use of the device.

2. The interventional medical device as recited in claim 1, said anchoring portion having at least one suture hole.

3. The interventional medical device as recited in claim 1, further comprising a luer lock at the proximal end of the elongate body for coupling a syringe to the insertable needle configured to puncture a pericardial lining of the pericardium during use of the device, the insertable needle extending through the one lumen having the end aperture at the distal tip to the distal end during use of the device.

4. The interventional medical device as recited in claim 1, further comprising a micro-electro-mechanical system mounted on the device configured to monitor pressure within a human body during use of the device.

5. The interventional medical device as recited in claim 1, the elongate body further comprising first and second inflatable balloons configured to provide, when inflated, a stationary grasp of an inner wall of a human body during use of the device, the balloons configured to sandwich said inner wall during use of the device.

6. The interventional medical device as recited in claim 1, comprising first and second imaging lumen, a first imaging lumen for ultrasonic imaging and a second imaging lumen for fiber optic imaging.

7. The interventional medical device as recited in claim 1, further comprising at least one side aperture of the elongate body corresponding to a lumen configured for delivery to a human body during use of the device in the vicinity of said side aperture.

8. The interventional medical device as recited in claim 7, comprising two side apertures sharing a common delivery lumen.

9. The interventional medical device as recited in claim 7, comprising a second side aperture and associated imaging lumen proximate said side delivery aperture and lumen.

10. The interventional medical device as recited in claim 1, further comprising at least one side aperture of the elongate body corresponding to an imaging lumen configured to image a human body in the vicinity of said side aperture during use of the device.

11. The interventional medical device as recited in claim 10, comprising two side apertures sharing a common imaging lumen.

12. The interventional medical device of claim 1 configured for intracardiac treatment via pericardial access without entry of the device through a blood vessel during use of the device.

13. An interventional medical device for pericardial access configured to perform minimally invasive surgical procedures comprising at least one ultrasound transducer, the device comprising

an elongate body having no exterior delivery catheter or sheath configured to facilitate entry of a catheter through skin tissue of a human body, the elongate body configured to be introduced directly through a chest of the human body to the pericardium after a small stab incision on the skin during use of the device, the elongate body having proximal and distal ends and being tapered at the distal end to a distal tip having an end aperture, the distal tip of the elongate body having an outer diameter of a minimum of approximately 1 F, the tapered tip of the elongate body configured to form a conduit for the elongate body from a skin surface of the chest to a target site proximate the pericardium during use of the device;

an insertable needle configured to puncture a pericardial lining of the pericardium during use of the device;

a plurality of lumen extending through the elongate body, the plurality of lumen including one lumen for needle insertion and an imaging lumen, said one lumen for needle insertion extending through the elongate body to the end aperture at the distal tip of the elongate body;

said at least one ultrasound transducer being located at an outer periphery of the tapered tip of the elongate body near the distal end configured to provide images for guidance of movement of the elongate body from the chest to the target site proximate the pericardium of the human body and images of said puncture of the pericardial lining by said needle inserted in said one lumen for needle insertion as said insertable needle extends from said end aperture at said distal tip of the tapered tip of the elongate body during use of the device; and

a luer lock near the proximal end of the elongate body for permitting a coupling of said one lumen for needle insertion to a syringe during use of the device.

14. The interventional medical device as recited in claim 13, the syringe for one of fluid removal and fluid delivery.

15. The interventional medical device as recited in claim 14, wherein the fluid comprises saline solution.

16. The interventional medical device as recited in claim 13 comprising first and second imaging lumen, a first imaging lumen for ultrasonic imaging and a second imaging lumen for fiber optic imaging.

17. The interventional medical device as recited in claim 13 further comprising at least one side aperture of the elongate body corresponding to a lumen configured for delivery to a human body in the vicinity of said side aperture during use of the device.

18. The interventional medical device as recited in claim 17 comprising two side apertures sharing a common lumen.

19. The interventional medical device as recited in claim 17 further comprising at least one side aperture of the elongate body corresponding to an imaging lumen configured to image a human body in the vicinity of said delivery side aperture.

20. An interventional medical device for pericardial access configured to perform minimally invasive surgical procedures comprising at least one ultrasound transducer, the device being a catheter configured for pericardial access during use of the device, the catheter comprising

an elongate body having no exterior delivery catheter or sheath configured to facilitate entry of a catheter through skin tissue of a human body, the elongate body configured to he introduced directly through a chest of the human body to the pericardium after a small stab incision on the skin during use of the device, the elongate body having proximal and distal ends, the distal end of the catheter being tapered to form a distal tip of the distal end, the distal tip having an end aperture and having a minimal outer diameter of 1 F, the elongate body configured to be a conduit from a skin surface to a target site proximate the pericardium during use of the device;

an insertable needle configured to puncture a pericardial lining of the pericardium during use of the device;

a plurality of lumen extending through the elongate body, the plurality of lumen including one lumen for needle insertion, said one lumen for needle insertion having the end aperture at the distal tip of the elongate body for needle extension from the end aperture during use of the device, and a lumen for imaging during use of the device;

a plurality of apertures at the distal end corresponding to the plurality of lumen extending through the elongate body, the plurality of apertures comprising an aperture for imaging and the end aperture at the distal tip for needle extension from the end aperture configured to puncture the pericardial lining during use of the device, and

said at least one ultrasound transducer being located at an outer periphery of the tapered tip of the elongate body near the distal end coupled to said imaging lumen and corresponding aperture, the at least one ultrasound transducer configured for providing images for guidance of movement of the elongate body from the chest to the target site proximate the pericardium of the human body and for providing images of said insertable needle extending from said end aperture, said insertable needle configured to puncture said pericardial lining during use of the device,

the catheter configured for advancement to the pericardial lining and the insertable needle configured to be removed after said pericardial lining puncture during use of the device.

21. The interventional medical device as recited in claim 20, comprising first and second imaging lumen, a first imaging lumen for ultrasonic imaging and a second imaging lumen for fiber optic imaging.

22. The interventional medical device as recited in claim 20, further comprising at least one side aperture of the elongate body corresponding to a lumen configured for delivery to a human body in the vicinity of said side aperture during use of the device.

23. The interventional medical device as recited in claim 22, comprising two side apertures sharing a common lumen.

24. The interventional medical device as recited in claim 22, further comprising at least one side aperture of the elongate body corresponding to an imaging lumen configured for imaging a human body in the vicinity of said side delivery aperture during use of the device.

25. The interventional medical device of claim 20, wherein the elongate body is fabricated of a material selected from silicone, TEFLON, polyurethane, PVC, and elastomeric hydrogel.

26. The interventional medical device of claim 20, wherein the elongate body is substantially cylindrical in shape and has a maximum outer diameter of approximately 15 F.

27. The interventional medical device of claim 20, configured for performance of one of an epicardial mapping, lead placement and an intracardiac intervention via the catheter during use of the device.

28. The interventional medical device of claim 20, the tapered distal end configured for accessing the heart through the chest through the pericardium during use of the device.