CA2344346A1

CA2344346A1 - Surgical tension/pressure monitor

Info

Publication number: CA2344346A1
Application number: CA002344346A
Authority: CA
Inventors: Theodore V. Benderev
Original assignee: Individual
Current assignee: Springboard Medical Ventures LLC
Priority date: 1998-09-21
Filing date: 1999-09-13
Publication date: 2000-03-30
Also published as: AU6496799A; AU763270B2; EP1115351A1; EP1115351A4; WO2000016717A1; US6050937A

Abstract

This invention is a surgical tension/pressure monitor for measuring, and indicating the degree of tension of a surgical sling (30), as well as the pressure exerted thereby upon the urethra (20). In a first embodiment, the invention comprises a pressure sensor (52) interposed between a sub-urethral sling (30), and the urethra (20) supported thereby. The pressure sensor (52) is coupled to a meter that provides an indication as to the degree of tension in the sling (30), and/or pressure exerted on the urethra (20), as well as provides an indication when such tension/pressure attains optimal levels that correlate with ideal surgical outcomes.

Description

SURGICAL TENSION/PRESSURE MONITOR
The present application relies on the disclosure provided for in Disclosure Document No. 437,730, having a date of receipt of June 15,:1998.
Field of the Invention The present invention relates generally to medical devices and methods, and .more particularly to devices and methods for determining and setting the tension or pressure of a suburethral or periurethral sling, as well as identifying, stabilizing and setting the position of the urethra during suburethral sling surgical procedures.
Baekaround of the Invention Urinary incontinence is believed to affect l5% to 300 of non-institutionalized persons over the age of &0, and more than 50% of elderly persons (over the age of 60) who reside in nursing homes. The presently available modes for the treatment of urinary incontinence fall into four general categories, name:Ly: (i) mai~.agement apparatus; (ii) behavioral; (iii) pharmacologic; and (iv) surgical.
With respect to the latter, numerous procedures and devices utilized therewith are available to treat urinary incontinence of a variety of etiologies in men, women and children. Amang the well-recognized procedures include the use of fluid-filled urinary prostheses which typically comprise a cuff pump and pressure regulating balloon. Exemplary of such devices is the AMS Sphincter 800TM, produced by American Medical Systems. Typically, such device is implanted in either the bulbus urethra or bladder neck in men and adolescent males. In females, the cuff portion of such device is placed at the bladder neck.
The cuff of the urinary prostheses, which is filled with fluid, surrounds the urethra and gently squeezes it _2_ closed to keep urine in the bladder. To urinate, the cuff is deflated by squeezing t:he pump several times, which causes the fluid to move from the cuff to the balloon member. Within several minutes after urinating, the fluid atomically flows from the balloon back to the cuff, and as a consequence, causes the latter to become full and squeeze the urethra closed, thus restoring continence once again. While effective in controlling urinary incontinence, such urinary protheses suffer from numerous drawbacks. In this regard, such urinary protheses are difficult to surgically implant, and can be difficult and embarrassing to operate. Moreover, such urinary protheses axe not ideally suited for all types of.
urinary incontinence; are contraindicated in a variety of patients, and are associated with complications, such as excessive cuff pressure.
An alternative and well-recognized surgical procedure available for those suffering urinary incontinence; and particularly women, is suburethral sling surgery. The specifics regarding such surgical procedure are disclosed in greater detail in the following references: Blaivas, Jerry, G. Successful Pubovaginal Sling Surgery Contemporary Uroloav, July, 1993; Blaivas, Jerry G. , Treatment of Female Incontinence Secondary To Urethral Damage Or Loss, Urologic Clinics of North America, Vol. 18,, No. 2, Ma.y, 1991; Raz, Schlomo, Surgical Therapv For Urinary Incontinence Atlas Of Transvaainal Surgery, W.B. Saunders, 1992, Loughlin, K.R., The Endoscopic Fascial Sling Treatment of Female Urinary Stress Incontinence, J. Urol, 199&, A.P.R.; 155 (4): 1265-7; and Staskin, D.R., et al., The Gore-Text Sling Procedure For Female Sphincteric Incontinence:
Indications Technique And Results, J. Urol, 1997; 15 (5) 295-9, the teachings of which are expressly incorporated herein by reference.
Essentially, such surgical procedure involves the formation of a sling, which may comprise a harvested _3_ graft from a donor, of the patient's own tissue or an elongate strip fabricated from synthetic material, that is selectively positioned beneath the urethra and secured above or to the abdominal fascia. Alternatively, the opposed ends of the sling may bes fixed in place, via a suture and anchored to the pubic bone of the patient or in various other ways such as to sutures or tissue adjacent to the urethra.
While suburethral sling surgery, which includes pubovaginal sling surgery, is considered the procedure of choice for women with urinary incontinence resulting from intrinsic sphincter deficiency (ISD), also referenced as type III stress urinary incontinence, to date, however, such procedure has not achieved widespread popularity.
In this regard, although such surgical procedure reportedly has a success rate consistently above over 80%, efforts to popularize this durable technique for all farms of stress incontinence have been hampered by the significant post-operative complications that can arise in those situations where suburethral sling surgery is performed incorrectly. The most common complication of such surgical procedure is caused from placing too much tension on the sling at the time of surgery, which as a consequence causes urinary retention, detrusor instability, or both.
While attempts have been made to provide surgeons with means to properly set the accurate tension within a sling during suburethral sling surgery, such devices have met with limited success. The most well known of such devices include spacers, the latter typically comprising a small spherical body mounted upon the pubic bone of the patient. Spacers typically have a channel formed therein which provides the surgeon with a surface upon which sutures of the free end of the sling may be affixed.
While generally effective in providing the surgeon with readily available means for securing the sutures of a suburethral sling in position, such devices do not WO OO/i6717 PCT/US99J21171 provide the surgeon with any indication as to the degree of tension in the sling, let alone what impact the position of the sling has with respect to anatomical positioning of and pressure within the urethra.
Further prior art systems and procedures, such as ultrasound, lateral cystourethragraphy, and the Q-tip test, while generally effective in measuring the urethral angle, an important factor in evaluating incontinence surgery, are poorly adapted in providing the surgeon with any kind of indication as to the proper position of and pressure within the urethra during the actual suburethral sling surgery. Among the references discussing such systems include Schaer, G.N. et al., Perineal Ultrasound for Evaluating the Bladder Neck and Urinary Stress Incontinence, Obstet. Gynecol., 1995 February; 85(2):
220-4; and Bergman, A., et al., Negative 0-Ti_p Test as a Risk Factor for Failed Incontinence Surgery in Woman, J.
Reprod. Med. I989 March; 34(3): 1.93-7.
Notwithstanding the fact that excessive sling tension has been identified as the major cause for complications in suburethral sling surgery and that crude attempts have been made to address the same, there presently does not exist any system or procedure by which the surgeon performing such operation can quantify during the operation the amount of tension or pressure being imparted by the sling to the urethra. There is further lacking in the art a system and method that, in addition to identifying the amount of tension or pressure imparted by a suburethral sling upon the urethra also provides an indication as to the optimal degree of tension to be imparted by the sling in supporting the urethra, as well as when such optimal amount of tension is attained.
Still further, there exists a need in the art fox systems and methods that enable the surgeon performing a suburethral sling surgery to identify the proper position of and pressure within the urethra of the patient so that the resultant sling imparts an optimal tension, and hence the desired degree of structural stability to the urethra supported thereby.
Suamnarv of the Invention The present invention specifically addresses and alleviates the above-identified deficiencies in the art.
In this regard, the present invention is directed to systems and methods for measuring and identifying the tension of a suburethral sling, as well as measure the pressure exerted thereby upon the urethra during a suburethral sling surgical procedure. The present invention is further directed to systems and methods that provide a surgeon performing a suburethral sling procedure with an indication as t~o the optimal degree of tension including no tension at al.l that should be set by the sling for the particular patient undergoing such procedure, as well as systems and methods that enable the surgeon to secure such sling at such optimal tension/position relative the urethra. Moreover, the present invention is directed towards systems and methods for determining the position of and pressure within the urethra of the patient undergoing suburethral sling surgery and how such sling affects the optimal urethral positioning and the pressure such sling exerts thereabout.
In the first embodiment., the invention comprises the combination of a sensor for measuring tension and pressure and a monitor or meter coupled thereto. The sensor, which is preferably interposable between a suburethral sling and the urethra supported thereby, is specifically designed and configured to detect and quantify the pressure exerted by the sling against the urethra. The monitor or meter coupled to the sensor provides a visual indication of the pressure that is being exerted by the sling upon the urethra to thus enable the surgeon to manipulate and properly position the sling so that the pressure imparted thereby is WO 00116717 PCT/US99/2I17i optimally set (i.e., set at levels that correspond to statistical data indicative of favorable patient outcomes). In a further ref inement, such meter, in addition to providing an indication of the pressure 5 exerted upon the urethra by a sling, further provides the surgeon with an indication as to when such pressure has obtained ideal levels indicative of a favorable patient outcome so as to enable the surgeon to secure the sling in position in such a manner that an ideal pressure or l0 urethral support is maintained.
In an alternative embodiment, the invention comprises a system and method for not only measuring and identifying the degree of tension. in a suburethral sling and the amount of pressure exerted thereby upon the 15 urethra, but further enables the surgeon to secure such sling to the patient at a position; that maintains optimal support of the urethra. In such embodiment, the system comprises a tension monitoring device attached, via a suture line, to either a respective one or both ends of 20 the sling as the sling is being surgically implanted within the patient. As with the first embodiment, the tension monitoring device measures and identifies the degree of tension placed on the sling, as well as when an optimal degree of tension is attained. However, such 25 embodiment may further preferab:Ly be provided with a self-actuating locking member which locks the sutures in position and prevents further tension from being applied to the sling by the surgeon once an amount of sling tension/urethral support reaching a predetermined level 30 that correlates with the best or most desirable results is attained. The device may further be optionally provided with means for detaching the suture connecting the sling with the device and securing the same to the abdominal fascia or pubic bone when a predetermined 35 tension level is attained to thus secure the sling in a position that preserves the optimal post-operative urethral support. The device may further be designed to WO 00/I6717 . PCTNS99I21171 _ include a corrective mechanism that causes the sutures to be secured to the patient at decreased tension levels to ensure that such sling is maintained only in close proximity to the urethra and does not exert any pressure thereupon.
The present invention further comprises systems and methods far accurately determining the position of the urethra, and more particularly,. the urethral angle, of a patient undergoing suburethra.l sling surgery. Such apparatus may further be modified to determine the amount of intra-urethral pressure of .a patient undergoing such surgery. In the preferred embodiment, the invention comprises a probe member insertable within a portion of the urethra coupled to a monitor. The sensor member measures the urethral angle of the patient, as well as how the urethral angle changes as the tension in a suburethral sling is either increased or decreased. The sensor may further be adapted to measure intra-urethral pressure and how such pressure changes with increased or decreased tension in the suburethral sling.
The monitor coupled to t:he sensor provides the surgeon performing the operation with the data regarding the urethral angle and/or intra-urethral pressure so that the sling may be secured to the patient in a manner that optimizes the anatomical position of the urethra. Such embodiment may be used in other types of urologic and/or gynecologic surgical procedures, and further may be used either alone or in combination with the aforementioned tension monitoring devices to thus ensure that proper urethral positioning is attained as a result of such surgical procedure.
It is therefore an object of the present invention to provide a system and method for accurately measuring the tension in a suburethral sling, as well as the urethral support imparted thereby, to a surgeon during the performance of a suburethral sling surgical procedure.

_g_ Another object of the present invention is to provide a system and method far providing a surgeon performing a suburethral sling surgical procedure with an indication as to the degree of tension of the sling, as well as when such sling tension and urethral support imparted thereby have obtained optimal parameters for the patient undergoing such procedure.
Another object of the present invention is to provide a system and method for identifying and za accurately setting the tension of a suburethral sling during the formation thereof in a suburethral sling surgical procedure, enable a surgeon to surgically secure a suburethral sling in a manner such that the sling is maintained at a desired tension that optimally supports I5 the urethra and minimizes post-operative complications following suburethral sling surgery.
Another object of the present invention is to provide a system and method for determining the position of the urethra, and more particularly, the urethral angle 20 of the patient undergoing suburethral sling surgery to thus enable the physician to perform such surgery in a manner such that urethra is optimally positioned and supported by said sling.
Still further objects of the present invention 25 include providing systems and methods for measuring and identifying the degree of tension in a suburethral sling, as well as indicate the support: and position of the urethra that are of simple construction, easy to utilize, provide a high degree of accuracy, are inexpensive to 30 deploy, and substantially minimize post-operative complications associated with suburethral sling surgery.
Brief Description of the Dra~winas These, as well as other features of the present 35 invention will become more apparent upon reference to the drawings wherein:

_g_ Figure 1 is a frontal-perspective view of the labia, vagina and catheterized urethra of a female patient placed in a dorsal lithomy position with the labia being retracted laterally with sutures.
Figure 2 is a perspective view of the anatomical structures depicting in Figure 1, further depicting a sling member being passed through an incision formed upon the vagina and advanced therethrough, and passed around the urethra via a clamp,. the latter having been advanced through an opening formed upon the patient's abdomen.
Figure 3 is a perspective view of the sling depicted in Figure 2 as positioned about the urethra wherein a respective one of the opposed ends of the sling is secured to the abdominal fascia. Figure 3 further depicts a surgical tension/pressure monitor constructed in accordance to the preferred emloodiment of the present invention, a sensor component thereof having been interposed between the sling and the urethra supported thereby.
Figure 4 is a perspective view of the sling depicted in Figure 2 as positioned about the urethra wherein a respective one of the opposed ends of the sling is secured to the abdominal fascia. Figure 4 further depicts a surgical tension/pressure monitor constructed in accordance to a second preferred embodiment of the present invention, the latter of which being connected, via a suture, to the respective other opposed end of the sling to be secured to the abdominal fascia of the patient.
Figure 4a is a perspective view of the device as depicted in Figure 4 as utilized to secure the free end of a suburethral patch abdominal fascia once a particular tension in the patch is attained.
Figure S is a cross-sectional view of a urethra, as supported by a suburethral sling. Figure 5 further depicts a monitoring device for monitoring the urethral angle and/or intro-urethral pressure, of the urethra of a patient-undergoing suburethral sling surgery.
Detailed Descrit~tion of the Preferred Embodiments The detailed description as set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of the invention; and is not intended to represent the only form in which the present invention may be constructed or 30 utilized. The description sets forth the functions and sequences of steps for constructing and operating the invention in connection with the illustrated embodiments.
It is understood, however, that the same or equivalent functions and sequences may be accomplished by different embodiments and that they are also intended to be encompassed within the scope of this invention.
Referring now to the drawings, initially to Figure 2, there is prospectively depicted the pelvic region 10 of a female patient placed in a dorsal lithomy position for purposes of undergoing a suburethral sling surgical procedure. The specifics regarding suburethral sling surgical procedures is described in detail in the references of Blaivas, Jerry G., Successful Pubovaainal Sling Surgery Contemporarv Urology, July, 1993; Blaivas, Jerry, G. Treatment of Female Incontinence Secondary To Urethral Damage Or Loss, Urologic Clinics of North America, Vol. 18, No. 2, May, 1991; Raz, Schloma, Surgical Therapy For Urinary Incontinence Atlas Of Transvaginal Surgery, W.B. Sounders, 1992, Loughlin, K.R., The Endoscopic Fascial Sling Treatment of Female Urinary Stress Incontinence, J. Urol, 1996, A.P.R.; 155 (4): 1265-7; and Staskin, D.R., et al., The Gore-Text Sling Procedure For Female Sph~ncteric Incontinence Tndications Technique And Results,, J. Urol, 1997; 15 (5) 295-9, the teachings of which are expressly incorporated herein by reference.

-lI-As is recognized, such positioning provides the necessary access to the vagina 12 to facilitate such access, the labia 14 is retracted laterally, typically by stay sutures 16. Similarly, a weighted postural vaginal retractor is incorporated to provide the surgeon with intravaginal access. Such surgical procedure further necessitates that a urethral catheter- 18 be inserted within the urethra 20 during such surgical procedure.
With the patient in. the lithotomy position as shown, an inverted U-shape 22 incision, as shown in Figure 2, is made in the interior vaginal wall. The lateral edges of the resultant wound are thereafter retracted laterally to thus enable the surgeon to perform the necessary dissection that must be made to ultimately enable the surgeon to define a tunnel created toward the suprapubic area.
By forming an incision 24 upon the lower abdomen 26 of the patient, and more particularly an incision made just above the pubic bone, as depicted in Figure 2, there is thus caused to be formed a continuous tunnel 28 extending from the suprapubic area. through the retropubic space and out through the vaginal. incision 22. At this stage of the procedure, a sling 30 may be introduced from the vaginal to suprapubic area, typically via a clamp 32, the latter extending through the tunnel 28 defined by the aforementioned surgical procedure. As is well known to those skilled in the art, the sling 30 may be comprised of synthetic materials or, alternatively, rnay comprise an elongate graft of tissue harvested fram the patient or donor.
A respective one 30a of the opposed ends 30a, 30b of the sling 30 is attached to the abdominal fascia, pubic bone , or Cooper ~ s Ligament , as shown in Figure 3 , thus fixing one side of the sling. The respective other free-end 30b of the sling 30 is then placed around all or a portion of the urethra 20, and may thereafter be secured by the surgeon to the other side of the abdominal fascia, pubic bone, or Cooper's Ligament.
However, as further depicted in Figure 3, there is shown a surgical tension/pressure monitoring device 50 that is specifically designed to measure and provide an indication as to the degree of tension placed on the sling, as well as the pressure the sling exerts upon the urethra supported thereby. As is; well known in the art, significant post-operative complications can arise as a IO result of the surgeon having placed toa much tension on the sling at the time of surgery. Such excess tension has been shown to cause urinary retention, detrusor instability, or both. However, there is currently lacking in the art any systems or methods my which the tension of such suburethral slings can be measured, let alone quantified in such a matter enables the surgeon to surgically secure such slings in position at a specific tension that optimizes urethral positioning or support and hence, optimizes the patient's outcome.
According to the first preferred method shown in Figure 3, the surgical tension/pressure monitoring device 50 comprises a- pressure or contact sensor 52 interposable between the sling 30 and the urethra 20 supported thereby. Such sensor 52, which may take the form of any a variety of those well known to those skilled in the art, is designed to measure the compressive force exerted by the sling upon the urethra to generate a signal correspondingly thereto.
Although any of a number of sensors are known in the art and are commercially available that can readily identify and measure the pressure exerted by the sling 30 upon the urethra 20 supported thereby, it is contemplated that one embodiment may simply comprise the combination of a balloon coupled to a fluid-filled syringe (not shown). The balloon may preferably be pre-filled ar, at the time of surgery, filled to a certain volume using the syringe to establish a baseline pressure, before tension WO 08/t6717 PCT/US99/2I171 is applied to the sling. Thereafter, during the surgery when tension in the sling 30 is being set, such sensor device can then measure the compression of the sling upon the urethra as the sling is fixed or tied in place.
It should be understood, however, that the sensor 52 member need not be limited to applications where the same must necessarily be interposed between the urethra 20 and the sling 30, but may be affixed or positioned upon the sling 30 and/or urethra.20 at any point therealong, so l0 long as the tension and/or pressure in such structures can be sufficiently measured and identified by such sensor device 52. It is additionally contemplated that intro-urethral sensor devices for measuring intro-urethral pressure may further be utilized for quantifying ~5 such tension and/or pressure, such as those discussed further herein.
The sensor 52 is coupled, via cord 54, to a meter or monitor 50 that provides an indication as to the degree of tension and/or pressure being exerted by the sling 30 20 based upon signals received from the sensor 52. For purposes of the present invention, it is further contemplated that in addition to indicating the degree of tension exerted by the sling 30, the devices of the present invention may further make a comparative analysis 25 between the tension placed upon a given sling 30 and tension parameters that have been derived from a database of tension settings corresponding to sling tension levels that have been ascertained from a determined patient population having undergone suburethral sling surgery and 30 have had favorable outcomes.
In this regard, it is contemplated that the present invention may further incorporate the use of a microprocessor or signal processor (not shown) that processes the signal received from the pressure sensor 52 35 and makes a comparison to such established tension parameters to thus provide the surgeon with an indication of not only what tension is placed upon the sling 30, but also whether such tension is indicative of a favorable post-operative outcome, namely, that the urethra will be sufficiently supported and that the sling will. not secured to the patien with e:KCessive or inadequate tension.
To derive such tension and/or pressure parameters, it is understood that it may be necessary to accumulate a statistically significant number of tension readings from a sufficiently large population of patients having undergone suburethral sling surgery before such tension parameters can be established. Alternatively, such tension and/or pressure parameters indicative of a favorable post-operative outcome may be determined based upon certain physiological characteristics of the patient undergoing surgery, or may even comprise simple threshold levels estimated to produce the desired post-operative outcome. Notwithstanding, once such tension parameters have been established, it is contemplated that the devices of the present inventicm will be capable of providing the surgeon with a signal when the tension is too high to thus enable the surgeon to take corrective measures by decreasing the tension in the sling prior to fixing the same in position. Referring now to Figure 4, there is shown a second embodiment 50 of a surgical tension/pressure monitoring device constructed in accordance to the present invention. Such embodiment, similar to the first embodiment discussed above, is specifically designed and adapted to measure and identify the tension in a suburethral slang 30 as the same is fixed or tied in place during surgery. As illustrated, the device 60 comprises a tension monitor 62 that is affixed, via a suture, to a respective one of the opposed ends of the graft or sling being implanted to support the urethra.
Tn the particular embodiment shown, it will be recognized that such device 60 is deployed after the respective other end 30a of the graft or sling 30 has been fixed or tied in place. In this regard, it is known to ,those skilled in the art that the opposed ends 30a, 30b of the sling 30 may be either secured to the abdominal fascia or, alternatively, fixed to the pubic bone of the patient.
As the free-end 30b of the sling 30 is placed around all or a portion of the urethra 20, the sutures 64 stitched therethrough are pulled upwardly in the direction A such that measurable tension is created in the sling 30 that can be quantified to thus provide an indication to the surgeon when such tension has reached an optimal level based upon established or predetermined parameters. At such point, the sling 30 may be fixed or tied in place in such a manner that the ideal tension levels in the sling are preserved. In order to more accurately assess the resultant amount of the pressure the sling 30 exerts upon the urethra 20, it is presently contemplated that such tension monitoring device 60 will ideally be utilized in combination with the suburethral surgical tension/pressure monitor 50 depicted in Figure 3 with the sensor member 52 thereof being interposed between the sling and the urethra while the free-end of the sling is pulled upwardly. In this regard, the device 60 affixed to the sutures 64 will be electrically coupled via connection 68 to monitor 56 such that tension/pressure levels measured by both the device 60 and sensor 52 can be concurrently evaluated.
In a further refinement of such embodiment, such tension monitoring device 60 may further be provided with a self-actuating locking member 70 that locks the sutures 64 into position once a predetermined pressure or tension is realized in the sling 30. Such embodiment may further be refined such that the sutures 64 are actually either fixed or tied in place to the abdominal fascia (e.g. , via surgical staple) or fixed into the pubic bone to thus enable the surgeon to perform the suburethral sling surgery in a virtually error-free manner insofar as the surgeon will be prohibited from placing too much tension on the sling 30 at the time of surgery.
Along these lines, it should be recognized that much of the medical literature tends to indicate in a vast majority of patients, the sling 30 should be placed with little to no tension at all. Accordingly, in those patients undergoing suburethral sling surgery that may be optimally treated by forming slings having little or no tension at all, the devices of the: present invention may further operate to provide an indication to the surgeon as to when any appreciable tension is placed on the sling 30, even if the sling 30 just comers into contact with the urethra 20, at the time of surgery. Such an indication may be particularly useful for :inexperienced surgeons unfamiliar with the procedure and, out of concern for the patient, inadvertently form and implant a sling 30. having an excess of tension.
In an alternative embodiment 80 depicted in Figure 4a, there may further be provided a surgical tension/pressure monitor 82 used in suburethral sling surgery that, as opposed to measuring the tension in a sling 30 from free-end 30b of a sling, which may take the form of a patch-type sling 31 as shown, placed around the urethrovesical junction, simultaneously measures the tension from both ends 31a, 31b of the sling 31 prior to when the same are fixed or tied to the abdominal fascia, pubic bone, or possibly to one another (i.e., the opposed ends of the sling themselves?. In such embodiment 80, the device will measure the tension in the sling 31 when the sling 31 is placed around the urethrovesical junction with the opposed ends thereof extending through separate openings through the lower abdomen. The opposed ends of the sling 31a, 31b, which will be connected to the device via dedicated sutures 84, 86, enables the surgeon to place tension on the sling 3l by simply lifting the sutures 84, 86 in an upward direction through the lumen WO 00/16717 PCT/lJS99/21171 88 of a manually operable tubular member 90 formed within the device.
Once the opposed ends of the sling 31a, 31b have been lifted or pulled a sufficient distance to create the 5 desired tension in the sling 31, (i.e., via their dedicated suture connections extending within the device) , the device 82 will then provide an indication to the surgeon that the ideal tension has been attained and to therefore affix the opposed u:rethral support ends of l0 the sling to the patient so that such ideal tension may be maintained (e.g., a tension either selected by the surgeon or a tension corresponding to statistical data indicative of a favorable patient outcome). In this regard, similar to the embodiment depicted in Figure 4, 15 the device 84 will be coupled via a connection 92 to a monitor/display device 56.
In a further refinement (not shown) , such device 82 may further be provided with a self-actuating locking members that lock the respective sutures 84, 86 stitched 20 through the ends of the sling 31a, 31b into position, namely to either the abdominal facia, pubic bone, or even to one another, once the ideal tension in the sling is attained. Such device 82 may even have integrated therein a surgical stapler or other like device to enable 25 the surgeon to surgically affix t:he opposed ends of the sling 31a, 31b in any manner known in the art.
It will further be appreciated by those skilled in the art that either of the tension monitors 62 and 82 depicted in Figures 4 and 4a may further be utilized 30 simply as surgical fixation devices designed to secure the free end or ends of the sling 30, 31 in position when either a signal is received from a sensor, such as 52, or even self-actuate if merely a .given threshold tension level in the sling 30 is achieved. Such devices 62, 82 35 may even be provided with a trigger mechanism (not shown) that enables the surgeon to actuate the self-actuating lacking members on such devices so that the end or ends WO 00/Ib7I7 PCT/US99/21171 _18_ of the sling 30, 31 and/or the sutures affixed thereto, may be selectively fixed in position (or even tied to one another? at a specific site on or within the patient.
In either of the embodiments depicted in Figures 4 and 4a, it will be recognized that either of such devices, particularly when adapted to secure one or more sutures stitched to the ends of the sling into position, may further be designed to fix such sutures in position such that the sling does.not exert any pressure upon the urethra, but is merely maintained in close proximity thereto. In this regard, it is presently contemplated that a certain degree of slack could be maintained in the sutures during the point at which the same are secured to the patient. As a result, such sling, rather than exerting any pressure or deflection upon the urethra, merely enables the same to maintain its normal pre-operative position. When the patient makes provocative gestures, as occurs during coughing for example, the sling serves as a support floor that prevents incontinence occurring during such provocative event.
Referring now to Figure 5, there is shown a urethral support monitoring device 100 that may be utilized alone or in combination with the aforementioned surgical tension/pressure monitoring devices to provide yet a further indication when a suburethral sling 30 provides an optimal degree of support to the urethra 20 supported thereby. As illustrated in the cross-sectional view, there is shown the lumen of a urethra 20 extending from bladder 102, as supported by a suburethral sling 30. As is known in the art, as the tension in the sling 30 increased or decreased, so does the urethral angle ( i . a . , the angle by which the urethra extends from the bladder to the anterior vaginal wall). The device 100 is specifically designed and configured to measure the urethral angle during suburethral sling surgery so that the sling 30 formed by the surgeon results in the urethra 20 attaining an optimal anatomical position. In this regard, it is considered by many that the urethral angle should be supported at approximately O~ in order for the same to function optimally.
The device 100 comprises the combination of a probe 104 insertable within the urethra 20 or a portion thereof, that measures the urethral angle during sling surgery coupled with a monitoring apparatus. As the tension in the sling is adjusted to an optimal level, as may be determined by. any o.f the aforementioned embodiments, the urethral angle farmed as a result of the support provided by the sling 30 may be further determined to confirm that the sling 30 has been set at an optimal tension. In this regard, the probe 100 will produce a signal corresponding to 'the urethral angle that is then sent via connection 106 to the monitor 108, the latter providing the surgeon with a visual indicator or sound, which may take the form of a simple visual indicator that signals that the urethral angle is either being maintained within ideal parameters or, alternatively, that the urethras 20 is suboptimally positioned.
In an alternative embodiment 120 depicted in Figure 5a, the probe 122 may, in addition to or separate from providing a measurement as to the urethral angle assumed by the urethra 20 during sling surgery, be adapted to measure intra-urethral pressure and produce a signal corresponding thereto. The signal is then forwarded via connection 124 to the monitor 126 coupled therewith which thus produces a perceptible signal providing the surgeon with an indication as to the amount of pressure being exerted upon the lumen of the urethra 20, as well as how the intra-urethral pressure changes with the varying degrees of tension applied to the suburethral sling 30 or patch supported thereby.
In either of the embodiments depicted in Figures 5 and 5a, it will be recognized that the same may be adapted to sense the slightest pressure or movement _20_ within the urethra 20 such that a signal may be generated to indicate when there has been the slightest degree of contact between the sling 30 and the urethra 20. As discussed above, it is contemplated that it may be 5 desirable to provide the surgeon with an indication when the sling 30 merely comes in close proximity, but does not exert any direct force upon the urethra 20 except in those instances where the urethra 20 is compressed against the sling when the individual performs a provocative motion.
Moreover, while it is intended that such probes 104, 122 and monitors 108 ,126 respectively coupled therewith may be used in combination with the aforementioned sling tension/pressure monitoring devices depicted in Figures 3 -4a, these specific embodiments 100, 120 may be used separate and independent therefrom. In this regard, such device 100, 120 may be used in connection with conventional suburethral sling surgery to thus provide an indication when the sling 30, as fixed into position by the surgeon, causes the urethra 20 supported thereby to maintain a desired urethral angle or intro-urethral pressure.
Alternatively, such embodiments 100, 120 may be coupled with the respective other tension/pressure monitoring devices of the present invention and the data produced collectively thereby correlated with the tension/pressure data to thus provide the surgeon with a comprehensive indication of not only the tension and pressure that is being exerted by the sling 30 upon the urethra 20, but further indicates the consequential urethral angle and/or intro-urethral pressure that is caused thereby. The surgeon will thus be provided with means for incrementally adjusting the sling tension to a level to thus maintain the urethral angle and/or intra-urethral pressure at optimal positions and/or levels.
For example, to the extent a 10% increase in sling tension corresponds to a 4° deviation in the urethral angle, a urethral angle that deviates by 12° would thus indicate that tension in the sling should be reduced by 30%, which could be easily achieved by the surgeon by adjusting tension in the sling until such 30% decrease in tension is achieved. Similarly, changes in sling tension can be correlated to correspond with incremental changes in intra-urethral pressure . For example , a 10 % change in sling tension can be quantified to correspond to a 10 mm Hg change in intra-urethral pressure.
As discussed above, it will be recognized that certain parameters will be established regarding various levels and ranges of tensions that will provide the optimal degree of urethral support and that further minimize post-operative complications. To establish such parameters, whether such parameters axe expressed in terms of ranges of intra-urethral pressure or radians of the urethral angle, it is contemplated that a sufficient number of suburethral sling surgical procedures might need to be performed upon a sufficient patient pool so that such parameters can be established, and will necessarily have to take into account such factors as age, ethnicity, medical history, prior surgeries, urethral pressure, among other important factors.
However, it is believed that once a sufficient patient population upon which such surgical procedure has been performed there will consequently be derived preferred ranges of sling tension, urethral support and/or peri-operative urethral pressure that can be readily identified for a specific patient, and that the devices disclosed herein can be readily deployed and provide the surgeon with sufficient data to optimally perform such procedure.
Additional modifications and improvements of the present invention may also be apparent to those skilled in the art. Thus, the particular combination of the parts described and illustrated herein is intended to represent only one embodiment of the present invention, and is not intended to serve as , limitations of alternative devices within the spirit and scope of the invention. Moreover, it should be understood that all of the embodiments disclosed herein may find use in a wide 5 variety of urological and gynecologic surgical procedures other than the suburethral sling surgical procedures discussed herein. For example, it will be readily recognized that the specific embodiments depicted in Figures 5 and 5a may find wide spread use in urinary 10 prosthesis implantation procedures. Accordingly, it is to be understood that the present: invention is in no way to be deemed limited thereto.

Claims

WHAT IS CLAIMED IS:

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 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. 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.

14. The tension monitoring device of Claim 13, wherein said tension sensing device is attached to the opposed ends of said sling via dedicated suture lines.

15. The tension monitoring device of Claim 13 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.

16. The tension monitoring device of Claim 13 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.

17. The tension monitoring device of Claim 13 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.

18. The tension monitoring device of Claim 13 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.

19. A device for monitoring the urethral angle of a patient undergoing suburethral sling surgery comprising:

a) a probe member positionable within a portion of the urethra, said probe being designed to measure the angle of the urethra when said sling is compressed thereagainst, said probe being further designed to produce a signal corresponding to the change in the angle of the urethra as tension in said sling is decreased or increased; and b) a monitor coupled to said probe for receiving said signal generated thereby, said monitor being designed to provide a quantifiable indication of the degree of tension placed upon said sling relative to the urethral angle during the surgical implantation thereof.

20. The device of Claim L9 wherein said sensor of further provides a comparative indication of the urethra angle and a predetermined range of angles.

21. The device of Claim 20 wherein said sensor generates a signal that indicates when said urethral angle of said patient falls within said predetermined range of angles, said signal causing said monitor to provide a signal selected from the group consisting of a visual, acoustic and auditory indication when the urethral angle of said patient falls within said predetermined range of angles.

22. A device for monitoring intra-urethral pressure within the urethra of a patient undergoing suburethral sling surgery comprising:
(a) a probe member positionable within a portion of the urethra, said probe being designed to measure intra-urethral pressure within the urethra when said sling is compressed thereagainst, said probe being further designed to produce a signal corresponding to the change in the angle of the urethral pressure within the urethra as tension in said sling is decreased or increased; 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.

23. The device of Claim 22 wherein said sensor of further provides a comparative indication of the urethral angle and a predetermined range of angles.

24. The device of Claim 22 wherein said sensor generates a signal that indicates when said patient falls within said predetermined range of pressures, said signal causing said monitor to provide a signal selected from the group consisting of visual, acoustic and auditory indicators when the intra-urethral pressure of said patient falls within said predetermined range of pressures.

25. A device for measuring the urethral angle of a patient undergoing urologic or gynecologic surgery and monitoring the change in said urethral angle during such surgical procedure comprising:
a) a probe member positionable within a portion of the urethra for measuring the angle of the urethra and the change in the angle of the urethra during said surgical procedure, said probe being further designed to produce a signal corresponding to the measurement of the urethral angle and the change in the angle of the urethra during said surgical procedure; and b) a monitor coupled to said probe for receiving said signal generated thereby, said monitor being designed to produce a perceptible signal indicating the angle of the urethra and the change in said angle during said surgical procedure.

26. A device for measuring the intra-urethral pressure of a patient undergoing urologic or gynecologic surgery and monitoring the change in said intra-urethral pressure during such surgical procedure comprising:
a) a probe member positionable within a portion of the urethra for measuring the intra-urethral pressure of the urethra and the change in the intra-urethral pressure of the urethra during the surgical procedure, said probe being further designed to produce a signal corresponding to the measurement of the intra-urethral pressure and the change in the intra-urethral pressure of the urethra during said surgical procedure; and b) a monitor coupled to said probe for receiving said signal generated thereby, said monitor being designed to produce a perceptible signal indicating the intra-urethral pressure of the urethra and the change in said intra-urethral pressure during said surgical procedure.

27. The device of Claim 25 wherein said device is designed to measure the urethral angle of a patient undergoing surgical implantation of urinary prosthesis.

28. The device of Claim 25 wherein said device is designed to measure the urethral angle of a patient undergoing suburethral sling surgery.

29. The device of Claim 26 wherein said device is designed to measure the urethral angle of a patient undergoing surgical implantation of urinary prosthesis.

30. The device of Claim 26 where in said device is designed to measure the urethral angle of a patient undergoing suburethral sling surgery.

31. 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.

32. 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.

33. The device of Claim 19 wherein said probe member produces a signal once said sling comes into contact with said urethra.

34. The device of Claim 22 wherein said probe member produces a signal once said sling comes into contact with said urethra.

35. A surgical fixation device for securing tissue or synthetic material at a specific site within or upon a living organism comprising:
a) a housing having an opening formed thereon;
b) an attachment mechanism disposed within said housing for engaging with at least one free portion of said tissue or synthetic material, said attachment member being designed to selectively position said free portion of said tissue or synthetic material at said particular site upon or within said living organism;
c) a fixation mechanism formed within said housing and connectible to said free portion of said tissue or synthetic material held by said attachment mechanism, said fixation mechanism being operative to secure at least one free portion of said tissue or synthetic material at said particular site; and d) a switching mechanism coupled to said fixation mechanism for causing said fixation mechanism to secure said tissue or synthetic material at said specific site.

36. The surgical fixation of Claim 35 wherein said attachment mechanism is designed to selectively engage at least two free portions of said tissue or synthetic material and said fixation member is designed and configured to selectively attach said two free portions of said tissue or synthetic material to said specific site.

37. A surgical fixation device for securing a suburethral sling into position within a human being comprising:
a) a housing having an opening formed thereon for receiving a respective one of the opposed ends of said suburethral sling;
b) a fixation device disposed within said housing for attaching said free end of said suburethral sling, said fixation device being operative to selectively attach said free end of said suburethral sling at said particular site; and c) a switching apparatus coupled to said fixation device for actuating said fixation device.

38. The device of Claim 37 wherein said housing fixation member is operative to secure both respected ends of said suburethral sling and affix the same to a particular site when said switch member is actuated.

39. The surgical fixation device of Claim 38 wherein said fixation mechanism disposed within said housing causes said opposed ends of said sling to be secured to one another when said fixation device is actuated by said switch.