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.
This application claims the benefit of priority as a continuation of U.S. patent application Ser. No. 15/503,670 filed Feb. 13, 2017 entitled “Smart Surgical Spacer for Tissue-Implant Interface” which itself claims the benefit of priority as a 371 national phase application of PCT/US2015/045131 filed on Aug. 13, 2015 entitled “Sensor for Tissue-Implant Interface” which claims the benefit of priority to U.S. provisional application 62/036,986 filed Aug. 13, 2014 entitled “Sensor for Tissue-Implant Interface,” the entire contents of each being incorporated herein by reference.
FIELD OF THE INVENTIONThis patent application relates to the tensioning of sub-urethral slings used to treat female or male stress urinary incontinence (SUI) or any other implantable sling of device.
BACKGROUND OF THE INVENTIONSub-urethral slings are effective at alleviating stress urinary incontinence (SUI) symptoms and are one of the least invasive surgical treatments available to the pelvic surgeon. Nonetheless, these procedures are affected by complications including urinary retention, pelvic pain, and vaginal extrusion/erosion and urethral extrusion/erosion; and some patients may not see a large enough reduction in SUI symptoms to improve their quality of life. Proper tensioning of the sling is crucial in avoiding complications and surgical revisions, as well as ensuring the patient sees symptomatic improvement commensurate with a surgical intervention.
A device and method are provided to enable surgeons to measure and adjust mechanical loads on a sling for relieving SUI, or on an implanted device of any kind. As used throughout this specification, a “sling” includes not only a sling for SUI, but also any other implanted device.
During sub-urethral sling surgery, a graft (synthetic, autologous, cadaveric, or biological xenograft) is positioned below the urethra to provide additional support. Excessive urethral movements, or hypermobility, may lead to SUI. Therefore, it is important that the implanted sling provide adequate support by being placed against the posterior of the urethra. If too much tension is applied to the sling during placement, complications including urinary outlet obstruction may follow. However, if the sling is too loose, then the patient may suffer persistent SUI. Typically, once the sling is guided through the suprapubic, retropubic, or obturator tissues and appropriately positioned, the surgeon will use a blunt instrument which is readily available in the surgical field as a spacer between the sling and urethra while applying tension to the distal ends of the sling. Tension is applied until the surgeon feels the sling will provide the needed support to the urethra without causing obstruction or other complications. The spacer comprises a self-contained, standalone tool for use for spacing and for measuring the mechanical load applied by the sling to the spacer and displaying the load in real time on a small display, such as a liquid crystal display (LCD), a multi-colored light emitting diode, an array of light emitting diodes, or a light emitting diode display. Moreover, since the tool functions as both a spacer and a load sensor, there is no need to remove the tool to adjust the sling and then re-measure the tension. Instead, the tool can be used as a lever to assist with sling adjustment while simultaneously measuring loads. In addition to measuring the load imparted by the sling onto the spacer, the spacer is capable of detecting changes in the angle of the urethra as well. Using the data regarding the load on the display, the surgeon can observe and adjust the sling accordingly.
Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.
SUMMARY OF THE INVENTIONIt is an object of the present invention to mitigate limitations within the prior art relating to implantable slings or other surgical devices.
A device and method are provided to enable surgeons to measure and adjust mechanical loads on a sling for relieving SUI, or on an implanted device of any kind. As used throughout this specification, a “sling” includes not only a sling for SUI, but also any other implanted device.
Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.
Embodiments of the present invention will now be described, by way of example only, with reference to the attached Figures, wherein:
The present description is directed to implantable slings or other surgical devices and the methods of use of such implantable slings or other surgical devices.
The present invention comprises a smart surgical spacer 1 which is placed between the sling and bodily tissue during surgery. The surgical spacer is used as a lever to adjust the sling and to ensure there is some slack or decreased tension within the sling once the spacer is removed. If the surgeon desires a low tension or tension-free placement of the sling, then it is preferred that, once the spacer is removed, the sling barely touches the urethra and does not impart significant force on it. The present invention also comprises a method for measuring the load the sling exerts on the spacer rather than directly measuring the load on the bodily tissue itself. As such, the load that the sling will exert on the bodily tissue will be less than the load measured when the spacer is between the body tissue and the sling.
Without limitation and by way of illustration only, the spacer and method disclosed herein are useful in measuring mechanical loads from a sub-urethral sling on the spacer during surgery for the treatment of SUI, particularly mid-urethral sling procedures.
The load from the sling onto the sensing region 6 will result in microscopic expansion and/or contraction of the sensing region. As a result, the strain gauges, which are bonded to the sensing region, will expand and/or contract with the sensing region. The expansion and contraction of the strain gauges results in changes in the electrical properties of the strain gauge which are proportional to the degree of expansion and/or contraction. Once the spacer is removed from between the tissue (e.g., the urethra) and the sling, the load between the sling and the tissue is less than what was initially measured. For example, initially the device is in place above the sling as the sling is being tensioned. Given that, in one embodiment, the device also functions as a spacer with a thickness of 5-7 mm, the load measurements obtained correspond to the load applied on the sling when only when the device is in place above the sling. Once the device is removed, the sling collapses into the 5-7 mm void that was once occupied by the sensing region 6 of the spacer. Therefore, the load measurements obtained during the time of sling placement are only associated with the load between the tissue and the sling once the device is removed. This end load will be significantly smaller than the load measured with the sling in place, and it is not a function of the device to measure directly the end load of the sling on the body tissue. However, the measurements obtained with the spacer in place (i.e. between the sling and urethra) may be correlated to the end load that the sling places on the urethra following removal of the spacer.
A strain gauge is one of several types of mechanical load transducers which detect bending loads. The mechanical load transducers which may be used in the present invention may be selected from the group consisting of strain gauges, standard load transducers, pressure-sensitive-conductive rubbers, piezoelectric force transducers and the like.
As seen in
The spacer 1 allows for the sensing region 6 to interface with patient tissues 13 and sling 14 to measure loading, and the shaft 2 and handle 3 allow the surgeon to hold and position the flex-beam. Additionally, the materials used for the shaft, in one embodiment preferably steel, are strong enough to allow for the device to function as a lever for adjusting the sling. The handle, in one embodiment, includes a display 11 which displays the measurements to inform and assist the surgeon with performing the surgery. Together, the handle and shaft are designed in a way to ergonomically support the thumb and fingers while optimizing device functionality.
Preferably, the sensing region 6 is mechanically isolated from the rounded tip 5 via a gap 9 and the use of a pin (not depicted) at the portion of the flex-beam on the proximal side of the gap 9. The pin allows the sensing region to move perpendicularly to the paddle 10, but not side to side. The proximal end of the flex beam (closest to the shaft) is attached securely to the paddle or the shaft, but the most distal end of the flex-beam (and proximal to the gap 9) is either pinned or is not attached in any way. The flex-beam 4 comprises a sensing region 6 which flexes or bends (microscopically) during the tensioning of the sling. This bending alters the electrical properties of the at least one strain gauge 15, 16, 17, 18 whose output is communicated to the display. The sensing region is one alternative for providing a convenient location for isolating the load from the sling, because the design of the flex-beam at this region creates relative weakness in the probe, and so bending of the probe will be greatest in the sensing region. In one embodiment the sensing region is solid but is narrower than the rest of the flex-beam which helps further isolate the load from the sling because the narrowing creates relative weakness in the sensing region, and so bending of the flex-beam from the sling will be greatest at this region. In one embodiment the sensing region may be further comprised of a curve 12 where the sling is positioned. This curve serves to ensure consistent readings by providing the surgeon with haptic and visual feedback that the sling is located at the location where the strain gauges are mounted. The curve 12 provides a nesting place for the sling and also prevents the sling from contacting the strain gauges 17-18 on the bottom. Similarly, a wall 26 near each side of the top of the sensing region prevents the paddle 10 from contacting the strain gauges 15, 16 directly. In one embodiment with two pairs of strain gauges 15-16, 17-18 are placed near the center of the sensing region 6 to maximize the sensitivity of the measurements they create. In one embodiment with two pairs of strain gauges, the strain gauges 15-16, 17-18 are placed between walls 26 which are adjacent to both sides of the top 7 and bottom 8 of the sensing region and help protect the strain gauges. The strain gauges on the bottom 8 of the sensing region 6 are located between curves 12 on both sides of the sensing region 6. The walls 26 and the curves 12 allow the strain gauges to sense the deformation of the sensing region while being isolated from contact with the sling, surgeon, or tissue; which might alter the measurements or otherwise affect the strain gauges. These walls 26 and curves 12 further include one or more small posts 25 which allow the sensing region to bend upward but prevent excessive bending which could damage the sensing region and the strain gauges. This functions to protect the strain gauges from over-straining and to increase the durability of the instrument.
Strain gauges may be located in any number and any combination in any location in or near the sensing region 6. Generally speaking, in any embodiment of the spacer, the more strain gauges in or near the sensing region 6 the more sensitive the measurements will be.
In one embodiment, the tip region 5 may be about 15 mm in length. In one embodiment, the first 5 cm from the tip may have a clamshell shape, i.e., a concave top part which is a urethral groove 28 and a convex bottom, as shown in
The handle 3 is ergonomically optimized for handling, control, and visibility during sling placement. The angle between the flex-beam and the handle allows for easy visibility of the sling during placement and decreases the effect of bending moment artifact on load measurements.
As shown in
An alternative embodiment for isolating the loads generated from the sling involves the use of one or more additional sensors (strain gauges, pressure transducer, and the like) near the tip. These sensors (not depicted) can then measure the loads imparted onto the device due to Bending Load C and Bending Load C may then be resolved theoretically and subtracted from Bending Load B in the sensing region.
The sensing region may further comprise grooves (not depicted) which allow wires (not depicted) to connect to the strain gauges and pass into the shaft 2 and then to the display 11.
In one embodiment, the shaft 2 is a steel tube or other metal tube which is flattened to a paddle 10 at the distal end and connects to the flex-beam by mechanical means. As shown in
The spacer 1 comprises certain electrical components which allow the bending loads to be converted to voltage changes which are output to a display in one or more units which a surgeon can see and then use in his or her decision on much tension to allow between the sling and the tissue. In one embodiment, the display 11 may be located in the handle, and the display may comprise any of several technologies, such as a light emitting diode (LED) display, liquid crystal display (LCD), organic light emitting diode (OLED) display, or other appropriate display. There are buttons 20, located on the handle or at any other convenient location, which allow for the device functions to be executed. These functions include, without limitation, changing display units (e.g. gram-force to Newtons), storing a particular load value, zeroing or blanking the load, or turning the display on/off.
Compressive and tensile strains accumulate on the top and bottom of the sensing region, as depicted in
In the embodiment shown in
Data can be reported in many units including voltage, strain, stress, pressure, and applied force, depending on the mathematical and digital means for processing the output voltage. Bending strain is relatable to bending force, which is directly related to the tension in the sling while the device is being used as a spacer between the sling and paraurethral tissues. A calibration data set, as described earlier, which correlates voltage to applied load, is provided in one embodiment. This load can be output to the display 11 to indicate the load applied by the sling onto the sensing region 6.
Although a single strain gauge can be used, one embodiment uses two pairs of strain gauges, that is, four. The embodiment with four strain gauges 15, 16, 17, 18 is represented on
When force from the sling is imparted onto the sensing region, R9 on the bottom of the sensing region is in compression so resistance decreases causing a voltage increase at the positive input to the amplifier while R10 is in tension, increasing its resistance causing the voltage to decrease at the negative input of the amplifier, as shown on
In one embodiment, the components comprise a microcontroller (not shown) capable of reading the output voltage and then converting this to load and sending the signal to a display, i.e., a numeric display of any kind (e.g. LCD, LED, etc.) and a power supply sufficient to power all of these circuit components. The display settings (e.g. output units of measurement) may be changed using, for example, various buttons 20.
Bending strains and stresses are directly correlated to mechanical load applied to the spacer. One option for reporting the flexural deformation is to solve for the mechanical load theoretically via a shear/bending moment diagram strategy. Since the circuit measures a change in output voltage due to a change in strain gauge resistance from the strain, it is possible to accurately correlate mechanical load to strain via these equations.
In another embodiment as depicted in
For quantification of urethral angle or mobility during sling placement, the end of the probe 22 is placed approximately 1.5-3 cm into the urethra. The flex-beam is introduced between the urethra and the sling as previously described. The probe is then snapped into the probe holder 23. The sensor, e.g., a potentiometer, is then reset (or set to zero) via the input buttons 20. The patient is asked to Valsalva (bear down or cough) if the patient is conscious, or a Crede maneuver (manual pressing of the bladder) if the patient is unconscious (can still be done on a conscious patient). As the urethra moves up and down during the Valsalva or Crede maneuver, this movement is transferred to the angle sensor 24 via the probe 22 and probe holder 23. This angular change of the movement is quantified by the angle sensor 24, which transduces the angular change directly into changes in the electrical properties of its circuit (e.g., voltage or current). The relationship between this change in electrical output and angular change can be pre-determined using calibration curve similar to previously described. The urethral mobility angle measurement alone can be used by the surgeon to determine ideal sling placement. The load between the sling and the device alone can be used to determine ideal sling placement. Alternatively, the urethral mobility angle along with the load between the sling and the spacer is used by the surgeon to develop a “sling placement index” that utilizes both values to determine ideal sling placement.
There are a number of variables for the design of the sensing region 6. The material properties of the sensing region directly impact the device function. The stiffness of the material properties affect the range of load values that are accurately read by the device (i.e. stiffer materials will read accurately in a higher range of load values, and less stiff materials will read accurately in a lower range of load values). In one embodiment, the material for the flex-beam 4 and the sensing region 6 is a resilient plastic such as polypropylene or polyethylene. The geometry of the sensing region also impacts device function. For a given material, a thicker sensing region will behave as a stiffer structure than a thinner sensing region. As a result, a thicker sensing region will read more accurately in a higher range of load values and a thinner sensing region will read more accurately in a lower range of load values. Alternative geometries may be used for the sensing region such as a cantilevered beams, or different thickness profiles within the sensing region which serve to concentrate stresses near a strain gage (i.e. a thinner area near a strain gage which serves to increase the strain on that strain gage, thereby increasing the strength of the sensor reading for a given load). These geometries may be selected and altered as a means of optimizing the range of values most accurately read by the surgical device.
The material for the sensing region and any nearby region of the device should be mechanically and thermodynamically elastic in nature, with regards to the level loading indicated for the use of the device. This serves to ensure more consistent readings. A material that behaves in a mechanically or thermodynamically viscous or plastic manner within the loading level indicated for the use of the device would be largely undesirable, as repeated loading cycles could ultimately result in different readings for identical loads. If a material that were chosen that behaves in a mechanically or thermodynamically viscous or plastic manner within the loading level indicated for the use of the device, the sensing components and other aspects of configuration would need to account for this.
The strain gauges can measure the load applied to the sensing region 6 when aligned parallel to the direction strain and serve as temperature compensating components of a strain gage bridge when placed perpendicular to the direction of strain. It is important that the material selected for the sensing region be mechanically isotropic so that the strain gages sensing strain and the gages performing temperature compensation are not affected by the unequal effects of mechanical anisotropy. If an anisotropic material is used, it is important that the readings of the sensing region are adjusted to account for the material anisotropy.
The material and geometric properties of the sensing region 6 and flex-beam 4 will dictate the degree of bending at the sensing region and thus the degree of strain experienced by each strain gauge, and the important parameters revolve around how the device responds to loads, more specifically, the stress-to-strain ratio at the loads applied during surgical sling placement. Therefore, the linear region of the strain versus voltage plot can be tuned by altering the material properties of the sensing region. In addition to material properties, the design of the geometry of the sensing region will also influence the quantity of strain felt by the strain gauges. For example, if the sensing region is very long, then there will be more bending at the middle where the strain gauges are placed. If the sensing region is shortened, then there will be less bending at the middle. All of these properties impact the sensitivity and resolution of the load measurements. For example, if the device's sensing region is made of a very stiff material (e.g. steel) and the slot is fairly short, then a significant amount of load must be applied which will correspond only to a fairly small amount of change in resistance within the strain gauges and the electric circuit. Such a design would not be ideal for the measurement of small loads (i.e. +/−5 grams) with high accuracy and precision but may be suitable for measuring loads in the kilogram range.
The invention may further comprise an algorithm designed to determine the ideal loads and/or angles for slings based on each patient's specific needs. In this algorithm, a number of patients undergoing sub-urethral sling surgery for SUI may undergo an evaluation of lower urinary tract prior to surgery that may include at least one of the following: q-tip test for urethral hypermobility assessment, evaluation for pelvic organ prolapse, pad tests, bladder diary, force-of-stream evaluation, and/or urodynamic observations. Said urodynamic observations may include measures of bladder sensation during filling cystometry (e.g. volume at first sensation of filling, volume at first desire to void, volume at strong desire to void), measures of detrusor function during filling cystometry (e.g. evidence of detrusor overactivity, etc.), measures of bladder compliance during filling cystometry, measures of bladder capacity during filling cystometry, measures of urethral function during filling cystometry (e.g. urethral pressure, urethral pressure profile, maximum urethral closure pressure, functional profile length, pressure transmission ratio, abdominal leak point pressure, detrusor leak point pressure), and/or measures obtained during pressure-flow studies (e.g. urine flow rates, voided volumes, time to maximum flow, premicturition pressures, opening pressures, pressure at maximum flow, etc.). During surgery, surgeons would tighten the sub-urethral sling using the spacer. However, surgeons would be blinded to the load they placed on the sling that was measured by the device. Subsequently, patients would undergo follow-up evaluations such as those described previously and/or questionnaires that aim to determine postoperative outcomes. All of these data (including pre-operative lower urinary tract evaluation, sling loads at device interface during surgery, and post-operative outcomes) may then be used to conduct statistical analyses (e.g. logistic regression models, linear regression models, and/or receiver operating characteristic curves, etc.) to develop a model that may be used to inform the surgeon of the ideal sling loads to be used for surgery based on patients' pre-operative evaluations. In this method, sling loads used during surgery will be individualized to patients based on pre-operative evaluations.
As can be seen from the above, the invention further comprises a method comprising the steps of: inserting a measuring device between body tissue and a sling, measuring the loading on the measuring device from the sling, outputting electrical changes from the loading on the measuring device, and reporting the electrical changes such as, for example, voltage changes (or derivatives thereof) to the user.
Also, as seen from the above, the invention further comprises a method comprising the steps of: inserting a probe into a patient's body cavity such as the urethra, inducing movement of the body cavity through the patient's cough or bearing down or manipulation by the surgeon, measuring the movement of the body cavity in response to the previous step, and reporting the electrical changes such as voltage changes (or derivatives thereof) from the previous step.
Claims
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.
Type: Application
Filed: Mar 9, 2020
Publication Date: Jul 2, 2020
Inventors: ALI BORAZJANI (WASHINGTON, DC), BENJAMIN WEED (MOBILE, AL)
Application Number: 16/812,550