SMART SURGICAL SPACER FOR TISSUE-IMPLANT INTERFACE
A surgical spacer equipped to measure important parameters for determining the optimal placement of a surgically-implanted sling.
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.