Smart surgical spacer for tissue-implant interface

Abstract

A surgical spacer equipped to measure important parameters for determining the optimal placement of a surgically-implanted sling.

What is claimed is: 
     
         1 . A method relating to a surgical procedure comprising:
 establishing a target value for a parameter relating to a surgical procedure in dependence upon patient specific data and a model;   performing the surgical procedure in combination with a medical device which provides a medical professional associated with the surgical procedure with a current value of the parameter relating to the surgical procedure; and   adjusting an aspect of the surgical procedure such that the current value of the parameter relating to the surgical procedure is the target value.   
     
     
         2 . The method according to  claim 1 , wherein
 the model is established by a process comprising:
 performing one or more pre-operative evaluations upon a plurality of patients to establish pre-operative data; 
 performing the surgical procedure upon the plurality of patients; 
 establishing surgical data comprising values for the parameter relating to the surgical procedure using a medical device employed within the surgical procedure; 
 performing one or more post-operative evaluations upon the plurality of patients to establish post-operative data; and 
 performing one or more statistical analyses in dependence upon the pre-operative data, the post-operative data and the surgical data. 
   
     
     
         3 . The method according to  claim 2 , wherein
 at least one of a pre-operative evaluation of the one or more pre-operative evaluations and post-operative evaluation of the one or more post-operative evaluations is selected from the group comprising:
 urethral hypermobility assessment; 
 evaluation for pelvic organ prolapse; 
 a pad test; 
 a bladder diary; 
 force-of-stream evaluation; and 
 one or more urodynamic observations. 
   
     
     
         4 . The method according to  claim 2 , wherein
 at least one of a pre-operative evaluation of the one or more pre-operative evaluations and post-operative evaluation of the one or more post-operative evaluations is a urodynamic observation; and   the urodynamic observation is selected from the group comprising:
 a measure of bladder sensation during filling cystometry; 
 a measure of detrusor function during filling cystometry; 
 a measure of bladder compliance during filling cystometry; 
 a measure of bladder capacity during filling cystometry; 
 a measure of urethral function during filling cystometry; 
 a measure obtained during a pressure-flow study. 
   
     
     
         5 . The method according to  claim 1 , wherein
 the medical device is a spacer;   the surgical procedure is the implantation of a sling;   the surgical procedure includes the steps of:
 inserting a first end of a spacer into a patient where the spacer has a second distal end external to the patient when the first end of the spacer is inserted into the patient; 
 attaching a first portion of the sling to a predetermined portion of the first end of the spacer containing a sensor for determining a load applied from the sling to the first end of the spacer; 
 attaching a second portion of the sling to a predetermined portion of body tissue of the patient; 
 displaying to an operator of the spacer upon a display forming another part of spacer the load applied from the sling to the first end of the spacer; and 
   the spacer allows the operator to simultaneously quantify the load and adjust a tension of the sling whilst employing the spacer as a spacing tool between the predetermined portion of the bodily tissue of the patient and the sling.   
     
     
         6 . The method according to  claim 5 , wherein
 the sensor comprises at least one mechanical load transducer; and   the at least one mechanical load transducer is selected from the group consisting of a strain gauge, a standard load transducer, a pressure-sensitive-conductive rubbers and a piezoelectric force transducer.   
     
     
         7 . A method relating to a surgical procedure comprising:
 establishing a target value for a parameter measured with a medical device relating to a surgical procedure in dependence upon patient specific data and a model.   
     
     
         8 . The method according to  claim 7 , wherein
 the model is established by a process comprising:
 performing one or more pre-operative evaluations upon a plurality of patients to establish pre-operative data; 
 performing the surgical procedure upon the plurality of patients; 
 establishing surgical data comprising values for the parameter relating to the surgical procedure using the medical device employed within the surgical procedure; 
 performing one or more post-operative evaluations upon the plurality of patients to establish post-operative data; and 
 performing one or more statistical analyses in dependence upon the pre-operative data, the post-operative data and the surgical data. 
   
     
     
         9 . The method according to  claim 8 , wherein
 at least one of an evaluation generating part of the patient specific data, a pre-operative evaluation of the one or more pre-operative evaluations is selected from the group, and post-operative evaluation of the one or more post-operative evaluations comprises:
 urethral hypermobility assessment; 
 evaluation for pelvic organ prolapse; 
 a pad test; 
 a bladder diary; 
 force-of-stream evaluation; and 
 one or more urodynamic observations. 
   
     
     
         10 . The method according to  claim 8 , wherein
 at least one of an evaluation generating part of the patient specific data, a pre-operative evaluation of the one or more pre-operative evaluations and post-operative evaluation of the one or more post-operative evaluations is a urodynamic observation; and   the urodynamic observation is selected from the group comprising:
 a measure of bladder sensation during filling cystometry; 
 a measure of detrusor function during filling cystometry; 
 a measure of bladder compliance during filling cystometry; 
 a measure of bladder capacity during filling cystometry; 
 a measure of urethral function during filling cystometry; 
 a measure obtained during a pressure-flow study. 
   
     
     
         11 . The method according to  claim 7 , wherein
 the medical device is a spacer;   the surgical procedure is the implantation of a sling;   the surgical procedure includes the steps of:
 inserting a first end of a spacer into a patient where the spacer has a second distal end external to the patient when the first end of the spacer is inserted into the patient; 
 attaching a first portion of the sling to a predetermined portion of the first end of the spacer containing a sensor for determining a load applied from the sling to the first end of the spacer; 
 attaching a second portion of the sling to a predetermined portion of body tissue of the patient; 
 displaying to an operator of the spacer upon a display forming another part of spacer the load applied from the sling to the first end of the spacer; and 
   the spacer allows the operator to simultaneously quantify the load and adjust a tension of the sling whilst employing the spacer as a spacing tool between the predetermined portion of the bodily tissue of the patient and the sling.   
     
     
         12 . The method according to  claim 7 , wherein
 the model is established by a process comprising performing one or more statistical analyses in dependence upon pre-operative data, post-operative data and surgical data for a plurality of patients; wherein   the surgical data comprises values for the parameter relating to the surgical procedure obtained using a medical device employed within the surgical procedure for the plurality of patients.   
     
     
         13 . The method according to  claim 7 , wherein
 at least one of:
 the pre-operative data is obtained by performing one or more pre-operative evaluations upon a plurality of patients to establish pre-operative data; and 
 the post-operative data is obtained by performing one or more post-operative evaluations upon the plurality of patients to establish post-operative data. 
   
     
     
         14 . A method relating to a surgical procedure comprising:
 establishing a model to establish a parameter to be measured with a medical device relating to a surgical procedure.   
     
     
         15 . The method according to  claim 14 , wherein
 the model is established by a process comprising:
 performing one or more pre-operative evaluations upon a plurality of patients to establish pre-operative data; 
 performing the surgical procedure upon the plurality of patients; 
 establishing surgical data comprising values for the parameter relating to the surgical procedure using the medical device employed within the surgical procedure; 
 performing one or more post-operative evaluations upon the plurality of patients to establish post-operative data; and 
 performing one or more statistical analyses in dependence upon the pre-operative data, the post-operative data and the surgical data. 
   
     
     
         16 . The method according to  claim 15 , wherein
 at least one of an evaluation generating part of the patient specific data, a pre-operative evaluation of the one or more pre-operative evaluations is selected from the group, and post-operative evaluation of the one or more post-operative evaluations comprises:
 urethral hypermobility assessment; 
 evaluation for pelvic organ prolapse; 
 a pad test; 
 a bladder diary; 
 force-of-stream evaluation; and 
 one or more urodynamic observations. 
   
     
     
         17 . The method according to  claim 15 , wherein
 at least one of an evaluation generating part of the patient specific data, a pre-operative evaluation of the one or more pre-operative evaluations and post-operative evaluation of the one or more post-operative evaluations is a urodynamic observation; and   the urodynamic observation is selected from the group comprising:
 a measure of bladder sensation during filling cystometry; 
 a measure of detrusor function during filling cystometry; 
 a measure of bladder compliance during filling cystometry; 
 a measure of bladder capacity during filling cystometry; 
 a measure of urethral function during filling cystometry; 
 a measure obtained during a pressure-flow study. 
   
     
     
         18 . The method according to  claim 14 , wherein
 the medical device is a spacer;   the surgical procedure is the implantation of a sling;   the surgical procedure includes the steps of:
 inserting a first end of a spacer into a patient where the spacer has a second distal end external to the patient when the first end of the spacer is inserted into the patient; 
 attaching a first portion of the sling to a predetermined portion of the first end of the spacer containing a sensor for determining a load applied from the sling to the first end of the spacer; 
 attaching a second portion of the sling to a predetermined portion of body tissue of the patient; 
 displaying to an operator of the spacer upon a display forming another part of spacer the load applied from the sling to the first end of the spacer; and 
   the spacer allows the operator to simultaneously quantify the load and adjust a tension of the sling whilst employing the spacer as a spacing tool between the predetermined portion of the bodily tissue of the patient and the sling.   
     
     
         19 . The method according to  claim 14 , wherein
 the model is established by a process comprising performing one or more statistical analyses in dependence upon pre-operative data, post-operative data and surgical data for a plurality of patients; wherein   the surgical data comprises values for the parameter relating to the surgical procedure obtained using the medical device employed within the surgical procedure for the plurality of patients.   
     
     
         20 . The method according to  claim 14 , further comprising employing the model to establish a patient specific value to be measured with the medical device to guide a medical professional during the surgical procedure.