Incontinence treatment with urethral guide

• US 7,179,219 B2
• Filed: 03/10/2004
• Issued: 02/20/2007
• Est. Priority Date: 11/20/2001
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Matlock, George L.
• Primary Examiner(s): Gilbert; Samuel G.
• Application Number:
  US10/798,717
• Publication Number:
  US 20040236177A1
• Time in Patent Office: 1,077 Days
• Field of Search: 600 28- 31, 607/105, 607/113, 607/138, 606/27, 606/32, 606/1, 128/DIG.25, 128897-898
• US Class Current: 600/29
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints

Abstract

Devices and methods for aligning a probe body and a treatment surface adjacent a target tissue. A guide shaft can be positioned in a urethra. The probe body can be positioned in a vagina and registered relative to the guide so as to position the treatment surface in alignment with the target tissue.

Claims

1. An incontinence treatment system for directing treatment to a target tissue of a patient, the system comprising:

a urethral guide having a proximal guide portion and a distal guide portion, the distal guide portion configured to be inserted into a urethra of a patient and having at least one urethral positioning surface, said urethral guide including at least one urethral guide palpation member thereon;

a probe body having a proximal probe portion and a distal probe portion, the distal probe portion configured to be inserted into a vagina of the patient and having a treatment delivery surface;

the least one urethral guide palpation member registering with the proximal probe portion so as to register the treatment delivery surface of the probe with the target support tissue of the patient when the at least one urethral positioning surface engages tissue adjacent the urethra.

2. The system of claim 1, wherein the at least one urethral positioning surface of the urethral guide comprises a meatus engaging surface and an expandable body, the meatus-engaging surface disposed near the proximal guide portion and oriented distally, the expandable body disposed near the distal guide portion and insertable transurethrally so that the meatus and expandable body can receive the urethra axially therebetween.

3. The system of claim 2, wherein at least one of the meatus engaging surface and the expandable body is movable axially relative to the other so as to accommodate variations in urethral length, and wherein the at least one urethral guide palpation member and proximal probe portion register so as to align the treatment surface axially with the target support tissue and away from a meatus and bladder of the patient.

4. The system of claim 3, further comprising a threaded mechanism for registering the at least one urethral guide palpation with the proximal probe portion, the threaded mechanism having a first thread pitch and a second thread pitch that is less than the first thread pitch, rotation of the threaded mechanism effecting movement of the meatus engaging surface relative to the expandable body via the first thread pitch and effecting registration of the treatment delivery surface via the second thread pitch so that the treatment delivery surface remains oriented toward the target tissue between and safely separated from the meatus engaging surface and the expandable body when the urethra if fittingly received therebetween.

5. The system of claim 4, further comprising an electromagnetic source and an electromagnetic receiver mounted to the probe body and the urethral guide body, the receiver generating a signal indicating axial registration when the source is registered therewith, the source or the receiver being mounted to the threaded mechanism.

6. The system of claim 5, wherein the treatment delivery surface comprises a cooled electrode array, wherein the source and receiver comprise a Hall effect system, wherein a magnet of the Hall effect system is mounted to the threaded mechanism and at least one Hall Effect receiver is used to generate the signal when disposed axially along or between the at least one receiver so as to indicate that the electrode array is aligned with a midpoint of the urethra.

7. The system of claim 4, further comprising a first visual alignment indicator mounted to the proximal guide portion and a second visual alignment indicator mounted to the proximal probe portion, the first and second visual alignment indicators providing visual indicia of alignment when the treatment delivery surface is oriented toward the target tissue between and safely separated from the meatus engaging surface and the expandable body.

8. The system of claim 7 wherein the first alignment indicator or the second alignment indicator comprises a window, the other alignment indicator visible within the window when the probe body is axially aligned with the urethral guide body.

9. An incontinence treatment system for directing treatment to a target tissue of a patient, the system comprising:

a urethral guide having a proximal guide portion with a distally oriented meatus engaging surface and a distal guide portion, the distal guide portion configured to be inserted into a urethra of a patient and having an expandable body insertable transurethrally so that the meatus and expandable body can receive the urethra therebetween, the urethral guide including at least one urethral guide palpation member thereon;

a probe body movable relative to the urethral guide and having a proximal probe portion and a distal probe portion, the distal probe portion configured to be inserted into a vagina of the patient and having a treatment delivery surface, the probe body including at least one probe body palpation member thereon; and

the least one urethral guide palpation member registering with the least one probe body palpation member so as to register the treatment delivery surface of the probe with the target support tissue of the patient when the at least one urethral positioning surface engages tissue adjacent the urethra.

10. An incontinence treatment method comprising:

introducing a distal portion of a urethral guide into a urethra of a patient, said urethral guide including at least one urethral guide registration member thereon;

engaging at least one of a bladder neck of the patient and a urethral meatus of the patient with a surface of the urethral guide;

introducing a distal portion of a probe body into a vagina of the patient; and

registering a treatment delivery surface of the probe body by movement of the probe body relative to the urethral guide registration member and to a target support tissue of the patient, the target support tissue offset laterally from the urethra and disposed axially between and separated from the bladder neck and the urethral meatus, registration being effected by registering the urethral registration member with the proximal end of the probe body; and

altering support of the urethra by the support tissue with the treatment delivery surface of the probe.

11. The method of claim 10 wherein the registration step comprises rotating a threaded mechanism having a first pitch so as to axially move a meatus-engaging surface relative to an expandable body within the bladder to fittingly receive the urethra axially therebetween, the threaded mechanism having a second pitch less than the first pitch so as to move the urethral body registration member a portion of the urethral receiving movement, and at least one of:

electromagnetically axially registering the probe body with the urethral guide with reference to the at least one urethral body registration member; and

visually axially registering the probe body with the urethral guide with reference to the urethral body registration member.