Method and apparatus for remodeling/profiling a tissue lumen, particularly in the urethral lumen in the prostate gland

• US 9,204,922 B2
• Filed: 11/30/2011
• Issued: 12/08/2015
• Est. Priority Date: 12/01/2010
• Status: Active Grant

• Current Assignee: Enable Urology, LLC
• Original Assignee: Enable Urology, LLC
• Inventors: Hooven, Michael D.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Giuliani, Thomas
• Application Number:
  US13/991,023
• Publication Number:
  US 20130253622A1
• Time in Patent Office: 1,469 Days
• Field of Search: 606/48, 606/47, 607/99, 607/126, 607/143
• US Class Current: 1/1
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00892 Voltage
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2210/166 Prostate
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

Apparatus for tissue lumen (such as urethra) remodeling includes an elongated shaft and at least one expandable structure on a distal end of the shaft. At least one desiccator or energy emitter is carried by the structure and operable to define a support structure in lumen tissue that resists lumen closure. Apparatus is also disclosed for identifying tissue or developing a profile of tissue along the lumen based at least in part on an electrical characteristic of the tissue. Methods of remodeling and profiling are also disclosed.

Claims

1. Apparatus for remodeling a tissue lumen comprising:

an elongated shaft having proximal and distal end portions;

at least one expandable structure located at the distal end portion and being movable between a retracted position for insertion into and withdrawal from the lumen and an expanded position for enlarging a selected portion of the lumen;

at least one tissue desiccator carried on the expandable structure in a preselected configuration for contacting lumen tissue when the expandable structure is expanded;

the preselected configuration being operable for defining in the lumen tissue a support structure of desiccated tissue that resists closure of the lumen; and

an elongated hollow sheath having a lumen for slidably receiving the elongated shaft and at least one sensing station on the sheath for contacting lumen tissue and sensing an electrical characteristic of tissue therearound prior to desiccation, the sheath being relatively movable along and over the shaft to shield at least one dessicator from lumen tissue,

the at least one tissue desiccator comprising a plurality of electrode pairs at spaced apart locations on the expandable structure, each pair comprising two spaced electrode rings configured to contact tissue upon expansion of the expandable structure, the electrodes of each pair being connectable to opposite poles of an rf generator to form, when energized, an annular ring or hoop of desiccated tissue in the lumen, whereby a plurality of spaced apart annular desiccation tissue rings may be formed in the lumen to support it in an open condition.

2. The apparatus of claim 1 in which the expandable structure includes at least one balloon, basket, cage or open framework.

3. The apparatus of claim 1 in which the expandable structure has a plurality of regions that expand to different cross-sectional sizes.

4. The apparatus of claim 3 wherein the expandable structure includes at least a proximal region, a distal region and an intermediate region therebetween, and when expanded, the intermediate region has a larger cross-sectional size than the proximal and distal regions.

5. The apparatus of claim 1 wherein the expandable structure comprises an inflatable balloon that has a proximal end portion, a distal end portion and an intermediate portion;

the balloon having a length sufficient to extend through a male urinary tract substantially between the urinary sphincter and bladder neck such that the proximal portion is located in the vicinity of the sphincter and the distal portion is located in the vicinity of the bladder neck and the intermediate portion is located within the prostate gland, the intermediate portion of the balloon when expanded having a cross-sectional size sufficiently large to enlarge the cross-sectional size of the urethra and the proximal and distal portions having a smaller expanded cross-sectional size than the intermediate portion.

6. The apparatus of claim 1 further including a monitor that senses before desiccation the electrical characteristic of lumen tissue surrounding at least one of the desiccators.

7. The apparatus of claim 6 wherein the monitor generates information based at least in part on the electrical characteristic sensed for determining different types of tissue surrounding the desiccator.

8. The apparatus of claim 1 further comprising a plurality of sensing stations disposed along the sheath.

9. The apparatus of claim 1, the sheath including a plurality of sensing stations spaced apart along the sheath, the sensing stations being respectively spaced apart substantially the same distance that the dessicator pairs are spaced apart.

10. A method for remodeling a tissue lumen comprising:

advancing an elongated hollow sheath into the tissue lumen, the sheath including a lumen and at least one sensing station on the sheath for contacting lumen tissue before desiccation,

advancing an elongated shaft through the lumen of the sheath, the shaft including at least one expandable structure located at a distal end structure of the shaft, the expandable structure being movable between a retracted position for movement through the sheath or tissue lumen and an expanded position for enlarging a selected portion of the lumen, and at least one tissue desiccator carried on the expandable structure in a preselected configuration for contacting lumen tissue when the expandable structure is expanded, the preselected configuration defining a tissue support structure in the lumen tissue that resists closure of the lumen;

sensing an electrical characteristic of lumen tissue with the sheath sensing station before desiccation, identifying prostate tissue based on the sensed electrical characteristic and relatively positioning the sheath and shaft to shield lumen tissue from a portion of the shaft;

enlarging a selected length of the tissue lumen by expanding the expandable structure; and

desiccating tissue of and surrounding the tissue lumen with the at least one desiccator while the expandable structure is enlarged, in a predetermined pattern that resists closure of the tissue lumen.

11. The method of claim 10 including distinguishing prostate tissue from urinary sphincter tissue or bladder neck tissue based on sensed electrical characteristic before desiccation.

12. A method for remodeling a tissue lumen of a human urinary tract comprising:

advancing an elongated hollow sheath into the tissue lumen, the sheath including a lumen and at least one sensing station on the sheath,

advancing an elongated shaft through the lumen of the sheath, the shaft including at least one expandable structure located at a distal end structure of the shaft, the expandable structure being movable between a retracted position for movement through the sheath or tissue lumen and an expanded position for enlarging a selected portion of the lumen, and at least one tissue desiccator carried on the expandable structure in a preselected configuration for contacting lumen tissue when the expandable structure is expanded, the preselected configuration defining a tissue support structure in the lumen tissue that resists closure of the lumen;

sensing an electrical characteristic of lumen tissue with the sheath sensing station at spaced locations along the urinary tract before desiccation, creating a profile of the sensed electrical characteristic of tissue along the tissue lumen before desiccation; and

relatively positioning the sheath and shaft to shield lumen tissue from a portion of the shaft;

enlarging a selected length of the tissue lumen by expanding the expandable structure; and

desiccating tissue of and surrounding the tissue lumen with the at least one desiccator while the expandable structure is enlarged, in a predetermined pattern that resists closure of the tissue lumen.

13. The method of claim 12 in which the profile is generated before the enlarging step.

14. The method of claim 12 including distinguishing prostate tissue from urinary sphincter tissue or bladder neck tissue based on sensed electrical characteristic before desiccation.

15. Apparatus for remodeling a tissue lumen comprising:

an elongated shaft having proximal and distal end portions;

a plurality of tissue desiccators spaced apart along the shaft;

at least one expandable structure located at the distal end portion and being movable between a retracted position for insertion into and withdrawal from the lumen and an expanded position for enlarging a selected portion of the lumen;

at least one tissue desiccator carried on the expandable structure in a preselected configuration for contacting lumen tissue when the expandable structure is expanded;

the preselected configuration being operable to defining in the lumen tissue a support structure of desiccated tissue that resists closure of the lumen and;

an elongated hollow sheath having a lumen for slidably receiving the elongated shaft and a plurality of sensing stations spaced apart along the sheath for contacting lumen tissue and sensing an electrical characteristic of tissue therearound prior to desiccation, the sensing stations being respectively spaced apart substantially the same distance that the tissue desiccators are spaced apart, the sheath being relatively movable along and over shaft to shield at least one desiccator from lumen tissue.

16. The apparatus of claim 15 further comprising a monitor that monitors the electrical characteristic of tissue surrounding each of the sensing stations.

17. The apparatus of claim 16 wherein the monitor provides user information to distinguish tissue types based at least in part on the sensed electrical characteristic.