Claims
- 1. An apparatus for evaluating urinary incontinence of a patient, the patient having a urethra extending from a bladder to a urethral opening with a maximum urethral pressure disposed therebetween, the system comprising:
a pressure-sensing system comprising an elongate body having a proximal end and a distal end, a vesicle pressure sensor disposed adjacent the distal end for measuring fluid pressure within the bladder, and at least one urethral pressure sensor disposed proximally of the vesicle pressure sensor for measuring urethral pressure; an anchoring structure disposed along the elongate body, the anchoring structure adapted to engage a tissue surface comprising or adjacent the urethra so as to maintain alignment between the urethral pressure sensor and the maximum urethral pressure when a pressure pulse moves the urethra; and a processor coupled to the pressure-sensing system, the processor calculating a relationship between the urethral pressure and the vesicle pressure.
- 2. The apparatus of claim 1, wherein the relationship comprises a pressuregram, and further comprising a display showing the pressuregram in real time to a system operator disposed adjacent the patient, the pressuregram comprising a slope defined by an increase of the measured vesicle pressure relative to an increase of the measured urethral pressure.
- 3. The apparatus of claim 1, wherein the relationship is calculated from a plurality of pressure pulses.
- 4. The apparatus of claim 1, wherein the relationship is independent of time.
- 5. The apparatus of claim 1, wherein the anchoring structure comprises a radially expandable structure.
- 6. The apparatus of claim 5, wherein the anchoring structure is disposed proximally of the vesicle pressure sensor and has at least one axial channel, the channel allowing free transmission of urine through the urethra when the expandable structure is expanded to inhibit movement of the sensor system relative to the urethra.
- 7. The apparatus of claim 6, wherein the expandable structure comprises a balloon having an inflated cross-section defining the at least one channel.
- 8. The apparatus of claim 5, wherein the expandable structure is disposed distally of the at least one urethral pressure sensor and has a proximally oriented surface for engaging the bladder adjacent the urethra, the at least one pressure sensor capable of measuring the maximum urethral pressure at a variable distance from the expandable structure, the anchoring structure further comprising a distally oriented tissue-engaging surface positionable along the elongate body for engaging an external meatus adjacent the urethral opening so as to axially affix the urethral pressure sensor relative to the maximum urethral pressure between the distally oriented surface and the proximally oriented surface.
- 9. The apparatus of claim 1, wherein the anchoring structure comprises a distally oriented surface adapted for engaging an external meatus adjacent the urethral opening, the distally oriented surface variably positionable relative to the urethral pressure sensor for alignment of the urethral pressure sensor with the maximum urethral pressure.
- 10. The apparatus of claim 9, further comprising a support longitudinally movable relative to the distally oriented surface, and a biasing device coupling the support relative the distally oriented surface to urge the distally oriented surface distally against the external meatus.
- 11. The apparatus of claim 1, wherein the anchoring structure comprises at least one vacuum port oriented to engage a tissue along the urethra so as to inhibit movement of the urethral pressure sensor relative to the maximum urethral pressure.
- 12. The apparatus of claim 11, wherein the anchoring structure further comprises a vacuum system coupled to the vacuum port.
- 13. The apparatus of claim 1, wherein at least one of the sensors comprises a port coupled to a transducer by a fluid lumen.
- 14. The apparatus of claim 1, wherein at least one of the sensors comprises a piezo-resistive transducer or an optical pressure sensor.
- 15. The apparatus of claim 1, wherein the at least one urethral pressure sensor comprises a plurality of axially separated sensors exposed to a plurality of differing urethral pressures, the processor selectively couplable to each sensor so as to calculate the relationship when the maximum urethral pressure moves between the plurality of urethral pressure sensors.
- 16. A urethral catheter holder, comprising:
a supporting base; a suspension housing mounted to the supporting base; a catheter securement device adapted to hold a catheter passing longitudinally therethrough, the catheter securement device being adapted to slide longitudinally within the suspension housing; and a biasing device adapted to push the catheter securement device against the external meatus of a patient's urethra.
- 17. The catheter holder of claim 16, wherein the catheter securement device comprises:
a torroidal balloon; a generally ring-shaped balloon support mount surrounding the torroidal balloon; and a pneumatic or hydraulic pressure tube for inflating and deflating the torroidal balloon, the pressure tube passing through the balloon support mount.
- 18. The catheter holder of claim 17, wherein,
the pressure tube extends from the torroidal balloon to a position external to the suspension housing.
- 19. The catheter holder of claim 18, wherein the pressure tube moves longitudinally in a groove in the suspension housing as the balloon support mount slides longitudinally within the suspension housing.
- 20. The catheter holder of claim 16, wherein the catheter is received longitudinally through the supporting base and the suspension housing.
- 21. The catheter holder of claim 20, further comprising:
a longitudinally extending catheter guide mounted to the catheter securement device.
- 22. The catheter holder of claim 21, wherein the catheter securement device is adapted to move in response to an abdominal pressure pulse.
- 23. The catheter holder of claim 22, wherein the catheter securement device remains in generally the same position relative to a surrounding urethra when the patient coughs.
- 24. The catheter holder of claim 22, wherein longitudinal displacement of the catheter securement device is approximately equal to longitudinal displacement of the urethra of a patient during the pelvic pressure pulse.
- 25. The catheter holder of claim 16, wherein the biasing device is a spring.
- 26. The catheter holder of claim 17, wherein the torroidal balloon is made of silicone rubber.
- 27. The catheter holder of claim 16, wherein the support housing is fabricated of aluminum or a polycarbonate material.
- 28. The catheter holder of claim 16, wherein the supporting base is adapted to register against the labia of the patient.
- 29. The catheter holder of claim 21, wherein the catheter guide is adapted to contact the urethral external meatus of the patient.
- 30. The catheter holder of claim 16, further comprising:
a pair of leg straps, with opposite ends of each leg strap fastened to the supporting frame, such that each leg strap is adapted to be wrapped around one of the patient's thighs.
- 31. The catheter holder of claim 16, further comprising:
a stretchable undergarment; and a plurality of leg straps, each leg strap being attachable to the supporting frame at one end and to the stretchable undergarment at an opposite end.
- 32. The catheter holder of claim 31, wherein each leg strap is attachable to the stretchable undergarment by a Velcro-type fastener.
- 33. The catheter holder of claim 16, further comprising:
a catheter retraction device for withdrawing the catheter from the patient at a controlled speed.
- 34. The urethral catheter of claim 16, wherein the catheter securement device comprises:
a mechanical clamp adapted to be longitudinally movable within the suspension housing.
- 35. The urethral catheter of claim 34, wherein the mechanical clamp is secured to a longitudinally movable backing.
- 36. A system for evaluating female urinary incontinence, comprising:
a catheter having at least one pressure sensor positioned thereon; and a catheter holder adapted to support the catheter and to allow movement of the catheter in response to a pelvic pressure pulse, wherein the movement of the catheter tracks movement of the urethra of a patient during a pelvic pressure pulse.
- 37. The system of claim 36, further comprising:
a computer system in communication with the pressure sensor of the catheter, the computer system being adapted to generate a pressuregram of the relationship between urethral pressure and vesicle pressure in response to changes in pelvic pressure as the pressure sensor on the catheter is moved through the urethra of a patient.
- 38. The system of claim 37, further comprising:
a display terminal adapted to display the pressuregram.
- 39. The system of claim 36, wherein the pressure-sensing catheter comprises:
a catheter positioning surface positioned to engage soft tissues of the urethra so as to inhibit movement of the catheter within the urethra.
- 40. The system of claim 40, wherein the catheter positioning surface comprises:
a high friction surface of the catheter for engaging the surrounding urethra.
- 41. The system of claim 41, further comprising:
a removable sheath positioned over the high friction surface of the catheter.
- 42. The system of claim 36, wherein the pressure-sensing catheter comprises:
a balloon positioned to engage soft tissues of the urethra so as to inhibit movement of the catheter within the urethra when the balloon is inflated.
- 43. The system of claim 36, wherein the at least one pressure sensor comprises an array with a plurality of pressure sensors separated axially relative to an axis of the catheter.
- 44. A method for evaluating urinary incontinence comprising:
introducing a pressure sensor system into a urethra of the patient; aligning at least one urethral pressure sensor of the pressure sensor with a maximum urethral pressure; affixing the aligned urethral pressure sensor of the pressure sensor system relative to a urethra of the patient with an anchoring structure of the pressure sensor system; inducing a pressure pulse in a patient, the urethra moving with the pressure pulse; monitoring a fluid pressure of a bladder during the pressure pulse; monitoring the maximum urethral pressure during the pressure pulse with the pressure sensor by moving the pressure sensor with the urethra via the anchoring structure during the pressure pulse; and comparing the monitored bladder and urethral pressures.
- 45. A data system for use with a mechanism for diagnosing urinary incontinence of a patient, the mechanism producing a pressuregram indicating a pressuregram slope defined by a change of vesicle pressure of the patient relative to a change of urethral pressure of the patient, the vesicle and urethral pressures being measured with a catheter system having a distal end and a proximal end, the data system comprising:
a processor coupled to the catheter for receiving a vesicle pressure signal and a urethral pressure signal, the processor generating a pressuregram dataset in real time at least in part from the vesicle and urethral pressure signals; and a display coupled to the processor so as to generate a real time image of the pressuregram from the pressuregram dataset, the display visible from adjacent the proximal end of the catheter.
- 46. The data system of claim 45, wherein a soft tissue of the patient moves with the urethra during a pelvic pressure pulse, and further comprising a catheter positioning surface attached to the catheter, the catheter positioning surface adapted to engage the soft tissue so as to inhibit movement of the catheter within the urethra.
- 47. The data system of claim 46, wherein the positioning surface is insertable along at least a portion of the urethra, the soft tissue being disposed along the urethra.
- 48. The data system of claim 46, wherein the positioning surface comprises a high friction surface of the catheter oriented for engaging the surrounding urethra, and further comprising a removable low friction interface disposable between the positioning surface and the urethra for insertion, the interface comprising a fluid.
- 49. The data system of claim 46, wherein the positioning surface has a cross-section larger than a cross-section of the catheter so as to engage the soft tissue adjacent an external meatus.
- 50. The data system of claim 49, wherein the positioning surface is adjustably affixable along an axis of the catheter.
- 51. The data system of claim 49, further comprising a reaction support and a biasing mechanism supporting the positioning surface relative to the support, the biasing mechanism oriented to urge the positioning surface against the external meatus.
- 52. The data system of claim 51, wherein the biasing mechanism movably supports the positioning surface so that the positioning surface can move at least about 2 cm with the external meatus.
- 53. The data system of claim 51, wherein the positioning mechanism comprises a clear material having a cross-sectional dimension of at least ½ inch and at least one passage for monitoring of voiding.
- 54. The data system of claim 45, wherein the processor selectably displays one or more pressure pulses, the program capable of refreshing the display between pressure pulses.
- 55. The data system of claim 45, wherein the display further shows
a continence margin defined by a difference between the urethral pressure and the vesicle pressure.
- 56. The data system of claim 45, wherein the display further shows an equilibrium pressure above which the vesicle pressure will exceed the urethral pressure.
- 57. The data system of claim 56, wherein the processor extrapolates the equilibrium pressure using a curve approximation of the pressuregram.
- 58. The data system of claim 45, wherein the processor generates the pressuregram dataset using a windows-based program.
- 59. A system for treatment of urinary stress incontinence of a patient, the patient having a tissue comprising or support the urethra, the bladder neck, or the bladder, the system comprising:
a diagnostic system including a urethral pressure sensor, a bladder pressure sensor, and a processor coupled to the sensors, the processor generating an output indicating a desired remodeling of the tissue of the patient; and a probe having an energy transmitting element that controllably delivers energy to the tissue so as to effect the desired remodeling such that the incontinence is inhibited.
- 60. The system of claim 59, wherein the energy transmitting element of the probe controllably delivers the energy in response to the output of the processor.
- 61. The system of claim 59, wherein the processor is coupled to the probe, the processor generating an energy signal, the energy varying with the energy signal.
- 62. A method for treatment of urinary stress incontinence of a patient, the method comprising:
sensing a bladder pressure and a urethral pressure; determining a desired remodeling of a tissue comprising or supporting a urethra, a bladder neck, and/or a bladder of the patient from the bladder pressure and the urethral pressure; effecting the desired remodeling of the tissue so that the incontinence is inhibited.
- 63. The incontinence treatment method of claim 62, further comprising generating a pressure pulse in the tissue during the sensing step.
- 64. The incontinence treatment method of claim 63, wherein the pressure pulse is the result of a cough.
- 65. The incontinence treatment method of claim 62, wherein the pressure pulse is generated after effecting partial remodeling of the tissue for use as feedback in the remodeling step.
- 66. A method for treatment of urinary stress incontinence of a patient, wherein a pressuregram of the patient indicates urethral pressure of the patient differs from a vesicle pressure of the patient by a continence margin, the pressuregram having a pressuregram slope defined by change of the vesicle pressure relative to change of the urethral pressure, the pressuregram slope being such that the vesicle pressure will exceed the urethral pressure of the patient above an equilibrium pressure, the method comprising:
determining a desired change in a support tissue comprising or supporting the urethra based at least in part on at least one parameter selected from the group comprising the equilibrium pressure, the continence margin, and the pressuregram slope; and remodeling the support tissue by the desired change from the determining step.
- 67. The method of claim 66, wherein the remodeling step comprises directing energy into the support tissue so as to contract the support tissue.
- 68. The method of claim 66, wherein a plurality of pressuregrams are taken with the patient in a plurality of positions selected from the group consisting of standing, sitting, and supine, and wherein the determining step is based on the plurality of pressuregrams.
- 69. A system for evaluating urinary incontinence, the system comprising:
a body having a proximal end, a distal end, and a cross-section suitable for insertion into a urethra; a pressure sensor disposed along the body for measuring urethral pressure; and a position sensing system couplable to the body to measure an axial position of the pressure sensor within the urethra.
- 70. The system of claim 69, wherein the pressure sensor generates pressure signals and the position sensing system generates position signals.
- 71. The system of claim 70, further comprising a processor coupled to the pressure sensor and to the positioning system, and a display coupled to the processor, the display showing a plot of associated urethral pressures and axial positions, the plot being independent of rate of movement of the body relative to the urethra.
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application claims the benefit and priority of U.S. Provisional Patent Application Nos. 60/153,332 filed Sep. 10,1999, and 60/104,818 filed Oct. 9, 1998, and of U.S. patent application Ser. No. 09/288,865 filed Apr. 9, 1999, the full disclosures of which are incorporated herein by reference for all purposes. The subject matter of this application is related to that of U.S. Provisional Patent Application 60/153,330 filed Sep. 10, 1999, the disclosure of which is also incorporated herein by reference. COPYRIGHT NOTICE
[0002] A portion of the disclosure of this patent document may contain material which is subject to copyright protection. The copyright owner has no objection to the xerographic reproduction by anyone of the patent document or the patent disclosure in exactly the form it appears in the Patent & Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.
Provisional Applications (3)
|
Number |
Date |
Country |
|
60153332 |
Sep 1999 |
US |
|
60104818 |
Oct 1998 |
US |
|
60153330 |
Sep 1999 |
US |
Divisions (1)
|
Number |
Date |
Country |
Parent |
09413657 |
Oct 1999 |
US |
Child |
09851662 |
May 2001 |
US |