Surgical tension/pressure monitor

• US 6,050,937 A
• Filed: 09/21/1998
• Issued: 04/18/2000
• Est. Priority Date: 09/21/1998
• Status: Expired due to Term

• Current Assignee: Basin Medical, LLC
• Original Assignee: Springboard Medical Ventures LLC
• Inventors: Benderev, Theodore V.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/157,466
• Time in Patent Office: 575 Days
• Field of Search: 600/29, 600/30, 600/37
• 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 surgical tension/pressure monitor for measuring and indicating the degree of tension of a surgical sling, and in particular, a suburethral sling, as well as the pressure exerted thereby upon the urethra. In a first embodiment, the invention comprises a pressure sensor interposable between a suburethral sling and the urethra supported thereby. The pressure sensor is coupled to a meter that provides an indication as to the degree of tension in the sling and/or pressure exerted on the urethra, as well as provides an indication when such tension/pressure 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 a respective one or both ends of a suburethral sling. The device may be utilized to manipulate the tension in such sling and 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. There is further provided devices and methods for measuring the positioning of the urethra, as well as intra-urethral pressure during urologic/gynecologic surgery.

Claims

1. A surgical tension measuring and monitoring device for determining the amount of tension placed on a suburethral sling comprising:

(a) 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 implantation thereof; and

(b) a monitor coupled to said pressure sensor for receiving said signal generated thereby, said monitor being designed to provide a quantifiable indication of the degree of tension placed upon said sling during the surgical implantation thereof.

2. The device of claim 1 further comprising:

(a) a signal processor coupled to said pressure sensor and said monitor, said signal processor being designed to compare the signal generated from said sensor corresponding to the degree of tension placed on said sling and compare the same to established tension parameters such that a comparative indication of the tension in said sling and the tension of said established parameters is provided via said monitor.

3. The device of claim 2 wherein said established tension parameters consist of a database of tension settings that correspond to sling tension levels that have been ascertained from a determined patient population having undergone suburethral sling surgery.

4. The device of claim 1 wherein said pressure sensor comprises a sensor interposable between said sling and the urethra supported thereby.

5. 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 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.

6. A surgical tension measuring and monitoring device for determining the amount of tension placed on a suburethral sling comprising:

a) a tension sensing device attachable to a free respective one of an opposed end of said sling, said tension sensing device being designed to measure and identify the degree of tension in said sling when the respective other opposed end of said sling is fixed in position within the patient and the elongate portion of said sling is extended around and compresses against the urethra of the patient, said tension monitor further being designed to produce a signal corresponding to the degree of tension placed on said sling during the surgical implantation thereof; and

b) a monitor coupled to said tension sensing device for receiving said signal generated thereby, said monitor being designed to provide a quantifiable indication of degree of tension placed upon said sling during the surgical implantation thereof.

7. The tension measuring and monitoring device of claim 6 wherein said tension sensing device further provides a comparison of the tension placed upon said sling and established suburethral sling tension parameters and generates a signal corresponding to said comparative tension levels.

8. The tension measuring and monitoring device of claim 7 wherein said established tension parameters consist of a database of tension settings that correspond to sling tension levels that have been ascertained from a determined patient population having undergone suburethral sling surgery.

9. The tension measuring and monitoring device of claim 6 wherein said tension sensing device further includes a self-actuating locking device designed and configured to prevent further tension from being placed upon said sling once a predetermined tension in the sling has been attained.

10. The tension measuring and monitoring device of claim 6 wherein said tension sensing device further includes a self-actuating member that causes the free-end of said sling to be secured to the patient when the tension in said sling attains a predetermined threshold.

11. The tension measuring and monitoring device of claim 10 wherein said self-actuating member causes the free-end of said sling to be secured to the respective other opposed end of said sling.

12. The tension monitoring device of claim 10 wherein said self-actuating member causes the free-end of said sling to be secured to the patient at a point selected from the group consisting of the abdominal facia, pubic bone and Cooper'"'"'s Ligament.

13. The tension measuring and monitoring device of claim 10 wherein said self-actuating member secures said free-ends of said sling to the patient at a point such that when said patient maintains a supine position, said sling exerts substantially zero pressure upon said urethra.

14. A surgical tension measuring and monitoring device for determining the amount of tension placed on a suburethral sling comprising:

a) a tension sensing device attachable to the respective ones of the opposed ends of said sling, said tension sensing device being designed to measure and identify the degree of tension in said sling when the elongate portion of said sling is extended around and compresses the urethra of the patient and the respective ones of the opposed ends are respectively caused to extend through the abdomen of said patient, said tension monitor further being designed to produce a signal corresponding to the degree of tension placed on said sling during the surgical manipulation thereof; and

b) a monitor coupled to said tension sensing device for receiving said signal generated thereby, said monitor being designed to provide a quantifiable indication of degree of tension placed upon said sling during the surgical implantation thereof.

15. The tension monitoring device of claim 14, wherein said tension sensing device is attached to the opposed ends of said sling via dedicated suture lines.

16. The tension monitoring device of claim 14, wherein said tension sensing device further provides a comparison of the tension placed upon said sling and established suburethral sling tension parameters and generates a signal corresponding to said comparative tension levels.

17. The tension monitoring device of claim 14, wherein said established tension parameters consist of a database of tension settings that correspond to sling tension levels that have been ascertained from a determined patient population having undergone suburethral sling surgery.

18. The tension monitoring device of claim 14, wherein said tension sensing device further includes a self-actuating locking device designed and configured to prevent further tension from being placed upon said sling once a predetermined tension in the sling has been attained.

19. The tension monitoring device of claim 14, wherein said tension sensing device further includes a self-actuating member that causes the respective opposed free-ends of said sling to be secured to one another within the patient when the tension in said sling attains a pre-determined threshold.

20. The tension measuring and monitoring device of claim 18 wherein said self-actuating member secures said opposed free-ends of said sling to the patient at a point such that when said patient maintains a supine position, said sling exerts substantially zero pressure upon said urethra.