Surgical monitor

• US 6,302,840 B1
• Filed: 02/24/2000
• Issued: 10/16/2001
• Est. Priority Date: 09/21/1998
• Status: Expired due to Term

• Current Assignee: Basin Medical, LLC
• Original Assignee: Theodore V. Benderev
• Inventors: Benderev, Theodore V.
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/511,822
• Time in Patent Office: 600 Days
• Field of Search: 600/37, 600/30, 600/561, 600/29, 600/547, 600/31, 600/485-488, 600/587, 600/591, 128/855, 128/898, 607/105
• US Class Current: 600/37
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence

Abstract

A system and method for measuring and indicating the degree of tension and/or positioning of a surgical sling, in particular, a suburethral sling, during surgery. In a first embodiment, the invention comprises a sensor interposable between a suburethral sling and the urethra supported thereby for measuring either relative spatial positioning and/or pressure. A monitor is provided for providing an indication when such tension/pressure/spacing attains optimal levels that correlate with ideal surgical outcomes. In a second embodiment, the invention comprises a tension monitor that may be connected, via a suture, to either respect one or both ends of a suburethral sling. The device may be utilized to manipulate the tension in or positioning of such sling to enable the surgeon to secure such sling in a manner that causes the sling to maintain a desired tension and/or imparted desired urethral support.

Claims

1. A device for determining the spatial relationship between a suburethral sling and the urethra of a patient comprising:

a) a sensor interposable between said sling and said urethra, said sensor being designed to produce a signal corresponding to the position of said sling relative said urethra; and

b) a monitor coupled to said sensor for receiving said signal generated thereby, said monitor being designed to provide a quantifiable indication of the relative positioning between said sling and said urethra.

2. The device of claim 1 further comprising:

a) a signal processor coupled to said sensor and said monitor, said signal processor be designed to compare the signals generated from said sensor corresponding to the distance separating said sling from said urethra and compare said distance to establish spatial parameters such that a comparative indication of the distance between said sling and said urethra relative said established parameters is provided via said monitor.

3. The device of claim 2 wherein said established spatial parameters consist of a database of spatial settings that correspond to fixed distances between said sling and said urethra that have been ascertained from a determined patient population having undergone suburethral surgery.

4. The device of claim 1 wherein said sensor comprises a balloon member interposable between said urethra and said sling, said balloon being fluidly coupled to a volume indicating device such that in use, as said balloon expands and contracts, a signal is caused to be generated corresponding to the distance separating said urethra from said sling.

5. The device of claim 1 wherein said sensor comprises a balloon member having a sensor for determining the internal pressure thereof, said balloon member being interposable between said urethra and said sling such that in use, as said sling is caused to compress against said balloon, a signal indicative of internal pressure within the balloon is generated corresponding to the distance separating said urethra from said sling.

6. The device of claim 1 wherein said sensor comprises a shim member interposable between said urethra and said sling, said shim member being operative to generate a signal corresponding to the distance separating said urethra from said sling as said shim is extended therebetween.

7. A method for measuring and monitoring the amount of tension placed on a suburethral sling during the surgical or postoperative fixation thereof comprising the steps:

a) providing a pressure sensor positionable upon said sling, said sensor being designed to produce a signal corresponding to the degree of tension placed on said sling during the surgical or postoperative fixation thereof;

b) positioning said pressure sensor on said sling; and

c) monitoring said signal generated by said pressure sensor on said sling.

8. The method of claim 7 wherein step a) further comprises providing a monitor, said monitor being coupled to said pressure sensor and operative to provide a quantifiable indication of the degree of tension placed upon said sling as indicated by said signal generated thereby.

9. The method of claim 7 wherein said method further comprises:

a) comparing said tension monitored in step c) with established tension parameters such that a comparative indication of the tension in said sling and the tension of said established parameters may be determined.

10. The method of claim 7 wherein in step a), said sensor is interposable between said sling and urethra supported thereby.

11. The method of claim 10 wherein in step a), said sensor comprises a balloon member interposable between said urethra and said sling, said balloon being fluidly coupled to a pressure indicating device such that in use, when an increase in tension is placed upon said sling, said balloon is correspondingly caused to incrementally increase the internal pressure therein such that a signal is caused to be generated corresponding to the degree of pressure exerted upon the urethra by said sling.

14. The method of claim 11 wherein in step a), said sensor comprises a shim member indisposable between said urethra and said sling, said shim member being operative to produce a signal indicative of the distance separating said sling from said urethra as such shim member is interposed therebetween.

12. A method for measuring and monitoring the distance between a suburethral sling and the urethra of a patient during the surgical or postoperative fixation thereof comprising:

a) providing a sensor positionable upon said sling, said sensor being designed to produce a signal corresponding to the spatial relationship between said sling and said urethra during the surgical or postoperative fixation of said sling;

b) positioning said sensor upon said sling; and

c) monitoring said signal generated by said sensor.

13. The method of claim 12 wherein in step a) further comprises providing a signal processor coupled to said sensor and said monitor, said signal processor be designed to compare the signals generated from said sensor corresponding to the distance separating said sling from said urethra and comparing said distance to establish spatial parameters such that a comparative indication of the spacing between said sling and said urethra relative said established parameters is provided via said monitor.

15. The method of claim 12 wherein in step a), said sensor comprises a balloon member interposable between said urethra and said sling, said balloon having an internal pressure sensor such that in use, when an increase in tension is placed upon said sling, said balloon is correspondingly caused to incrementally increase the internal pressure therein such that a signal is caused to be generated corresponding to the spatial relationship between said sling and said urethra.