System and method for endoluminal and translumenal therapy

• US 20120191079A1
• Filed: 01/20/2012
• Published: 07/26/2012
• Est. Priority Date: 01/20/2011
• Status: Abandoned Application

• Current Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Original Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Inventors: MOLL, Frederic H., Soleimani, Farzad, Lundmark, David C.
• Application Number:
  US13/355,304
• Publication Number:
  US 20120191079A1
• Time in Patent Office: Days
• US Class Current: 606/14
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00256 Creating an electrical block
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1405 Electrodes having a specific shape
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/2046 Tracking techniques
• CPC Class Codes: A61B 2034/2061 : using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• CPC Class Codes: A61B 2034/301 : for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2034/302 : specifically adapted for manipulations within body cavities, e.g. within abdominal or thoracic cavities
• CPC Class Codes: A61B 2034/303 : specifically adapted for manipulations within body lumens, e.g. within lumen of gut, spine, or blood vessels
• CPC Class Codes: A61B 2090/364 : Correlation of different images or relation of image positions in respect to the body
• CPC Class Codes: A61B 34/10 : Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/30 : Surgical robots
• CPC Class Codes: A61B 5/0066 : Optical coherence imaging
• CPC Class Codes: A61B 5/0084 : for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/02007 : Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/062 : using magnetic field
• CPC Class Codes: A61B 5/065 : Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/14546 : for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/201 : Assessing renal or kidney functions
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A system for conducting a denervation of the neural plexus adjacent the renal artery of a patient comprises a first elongate member operatively coupled to a testing element, a second elongate member having a distal portion coupled to an ablative element, and a controller configured to: activate an ablative element to selectively denervate a portion of the neural plexus which is positioned adjacent the ablative element; monitor a level of a compound in blood sampled from the testing element of the first elongate member; and modulate the activation of the ablative element based at least in part upon the level of renin monitored using the testing element.

Claims

1. A system for conducting a denervation of the neural plexus adjacent the renal artery of a patient, comprising:

a. a first elongate member operatively coupled to a testing element;

b. a second elongate member having a distal portion coupled to an ablative element; and

c. a controller configured to;

1) activate an ablative element to selectively denervate a portion of the neural plexus which is positioned adjacent the ablative element;

2) monitor a level of a compound in blood sampled from the testing element of the first elongate member; and

3) modulate the activation of the ablative element based at least in part upon the level of renin monitored using the testing element.

2. The system of claim 1, wherein the ablative element is selected from the group consisting of:

an RF ablation element, a cryo-ablation element, a laser ablation element, a microwave ablation element and an ultrasound ablation element.

3. The system of claim 1, wherein modulate the activation comprises modulating the energy passed through the ablative element.

4. The system of claim 1, wherein the compound comprises renin.

5. The system of claim 1, wherein the testing element comprises a lumen defined through the first elongate member.

6. The system of claim 1, wherein the first elongate member comprises a distal portion sized to be inserted into the renal vein of the patient.

7. The system of claim 1, wherein the second elongate member comprises an electromechanically steerable catheter having at least one pitch/yaw degree of freedom using one or more motors operatively coupled to the distal portion.

8. The system of claim 1, further comprising an imaging device configured to capture and relay image information to the controller.

9. The system of claim 8, wherein the imaging device is selected from the group consisting of:

an ultrasound device, a fluoroscopy device, a radiography device, and an OCT interferometry device.

10. The system of claim 8, wherein the imaging information is used either to identify ablative loci or modulate the activation of the ablative element.

11. A method for conducting a denervation process upon the neural plexus adjacent the renal artery, comprising:

a. navigating an ablative element adjacent to a portion of the neural plexus;

b. navigating a testing element into the renal vein;

c. controllably denervating the portion of the neural plexus;

d. utilizing the testing element to detect a compound secreted by a kidney into the renal vein; and

e. determining whether further denervation of the portion of the neural plexus is required based at least in part upon the detection of the compound.

12. The method of claim 11, wherein the ablative element is selected from the group consisting of:

an RF ablation element, a cryo-ablation element, a laser ablation element, a microwave ablation element and an ultrasound ablation element.

13. The method of claim 11, wherein the compound comprises renin.

14. The method of claim 11, wherein navigating an ablative element comprises inserting a steerable elongate member coupled to the ablative element relative to the renal artery.

15. The method of claim 11, wherein the testing element comprises a blood sampling lumen, and wherein navigating the testing element comprises inserting an elongate member comprising the testing element relative to the renal vein.

16. The method of claim 11, further comprising imaging targeted portions of the neural plexus to create an anatomic map of the targeted portions.

17. The method of claim 16, wherein imaging utilizes a modality selected from the group consisting of:

ultrasound, fluoroscopy, radiography, and OCT interferometry.

18. The method of claim 14, wherein inserting comprises electromechanically inserting the steerable elongate member in response to a command created by an operator with a master input device.

19. A method for conducting a denervation of the neural plexus adjacent the renal artery, comprising:

a. creating a neural plexus anatomical map by repeatedly moving, capturing, and assembling image data from an OCT fiber adjacent various portions of the renal artery adjacent the neural plexus;

b. navigating an ablative element adjacent to a targeted portion of the neural plexus that is targeted, at least in part, based upon the neural plexus anatomical map; and

c. controllably denervating the targeted portion of the neural plexus by activating the ablative element.

20. The method of claim 19, wherein the ablative element is selected from the group consisting of:

an RF ablation element, a cryo-ablation element, a laser ablation element, a microwave ablation element and an ultrasound ablation element.

21. The method of claim 19, wherein creating a neural plexus anatomical map further comprises conducting interferometry on the captured image data to create one or more images.

22. The method of claim 19, wherein creating a neural plexus anatomical map further comprises placing a distal portion of the OCT fiber immediately adjacent a portion of a wall of the artery.

23. The method of claim 19, wherein assembling image data comprises creating an image based upon image data from various smaller captures of image data.

24. The method of claim 19, wherein repeatedly moving comprises operating an electromechanically steerable elongate member coupled to the OCT fiber.

25. The method of claim 19, wherein navigating an ablative element comprises operating an electromechanically steerable elongate member coupled to the ablative element.

26. The method of claim 25, wherein operating an electromechanically steerable elongate member comprises electromechanically inserting the steerable elongate member in response to a command created by an operator with a master input device.

27. A system for conducting a denervation of the neural plexus adjacent the renal artery, comprising:

a. an OCT imaging fiber having a proximal end coupled to an interferometer and a distal end configured to capture image information pertinent to nearby tissue structures;

b. an elongate member configured to be navigated into the renal artery, the elongate member having a distal portion that is coupled to both the distal end of the OCT imaging fiber and an ablative element configured to controllably ablate nearby tissue structures when activated by an operator;

wherein the interferometer is configured to receive signals from the OCT imaging fiber and present images to an operator based at least in part upon the signals, the images being indicative of location and depth of the nearby tissue structures relative to the distal end of the OCT imaging fiber.

28. The system of claim 27, further comprising a lens interposed between the distal end of the OCT imaging fiber and the nearby tissue structures.

29. The system of claim 27, wherein the elongate member is controllably steerable by an operator.

30. The system of claim 29, wherein the elongate member is steerable by an operator in response to operator commands through a master input device.

31. The system of claim 30, wherein the elongate member is operatively coupled to one or more motors configured to controllably induce at least one pitch/yaw degree of freedom.

32. The system of claim 27, further comprising a controller configured to aggregate one or more images from the interferometer into a larger aggregation image.

33. The system of claim 27, further comprising an illumination light source configured to send light through the OCT imaging fiber that may be scattered and received by the OCT imaging fiber to create the image information pertinent to nearby tissue structures.