Untitled record

ES 2 368 136 T3

DESCRIPTION

System for the evaluation of urinary function

Field of the invention

The present invention relates generally to a system for evaluating urinary function. More particularly, the system is used to check the integrity of the urinary system for diagnostic purposes and for use with therapies to correct urinary incontinence.

Background of the invention

Women account for more than 11 million cases of incontinence. Also, a majority of women with incontinence suffer from stress urinary incontinence (SUI). Women with SUI involuntarily leak urine during normal daily activities and movements, such as laughing, coughing, sneezing, and regular exercise.

SUI can be caused by a functional defect in the tissue or ligaments that connect the vaginal wall to the pelvic muscles and pubic bone. Common causes include repetitive strain on the pelvic muscles, childbirth, loss of pelvic muscle tone, and a loss of estrogen. Such a defect results in a malfunctioning urethra. Unlike other types of incontinence, SUI is not a bladder problem.

Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent inadvertent loss of urine. However, when a woman has the most common form of SUI, weakened pelvic muscles and tissues cannot adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder with the diaphragm, the urethra cannot maintain its closure, allowing urine to escape. Because SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle, avoiding social situations.

SUI is categorized into three types. Type I and type II are directed at urethral hypermobility. Type III is directed at an intrinsic sphincter deficiency (DIE). The diagnosis of DIE requires a urodynamic evaluation. Urodynamic evaluation involves complex and invasive equipment and often requires a referral to a qualified urodynamic evaluation specialist.

All existing diagnostic systems require that a catheter be passed transurethrally to measure pressure, such as Leak Pressure (LPP) or Urethral Pressure Profile (UPP). An exemplary system is disclosed in the publication (WO 0023127). Detection of LPP requires a pressure sensor and catheter to be passed transurethrally. The bladder is filled, and the pressure is recorded. The loss of fluid from the urethral opening (meatus) corresponds to the maximum pressure that the urethral sphincter, or LPP, can withstand. During the PU measurement procedure, a catheter with a pressure sensor at the tip is placed transurethrally into the bladder and then withdrawn at a constant rate. The pressure profile is recorded along the urethra, from the bladder neck to the meatus.

Other parameters, such as abdominal pressure and urinary flow, can also be measured. A cystometry (CMG) is a pressure study that simultaneously measures intra-abdominal, total bladder, and true detrusor pressures. Uroflowmetry measures urine flow visually, electronically, or through a disposable system. There are also videourodynamic systems that simultaneously measure parameters, as described above, with a radiographic visualization of the lower urinary tract.

Existing urodynamic evaluation systems are complex, expensive, and require extensive training. Additionally, existing urodynamic systems often require at least 30 minutes to complete a test. This exceeds the time available for most standard doctor visits and results in a referral to a specialist. There is no urodynamic system that can quickly and inexpensively record useful urodynamic measurements without passing a catheter or instrument transurethrally.

There remains a need for an improved system and procedure to assess urinary function.

DE 196 17 854 discloses a portable medical system to be used in the evaluation of urinary function. The system includes a control device and a humidity detection probe and a pressure detection probe, each removably coupled to the control device. The two probes are coupled separately and differently to the control device.

Summary of the invention

The present invention provides a portable medical system as defined in appended claim 1 for use in the evaluation of urinary function. The medical system includes a monitoring device and a plurality

ES 2 368 136 T3 of independent test modules, each capable of being removably and interchangeably coupled to the control device. For each of the test modules, when removably coupled to the monitoring device, the medical system is capable of carrying out a separate test to assess urinary function.

Additional aspects of the invention are defined in the dependent claims.

These and other features and advantages of the present invention will be apparent from the following more detailed description, when taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.

Brief description of the drawings

Figure 1 is a perspective view of one embodiment of a portable medical system in accordance with the present invention;

Figure 2 is a front perspective view of a control device according to the present invention;

Figure 3 is a rear perspective view of the control device of Figure 2;

Figure 4 is a front elevational view of a control device according to the present invention attached to a post;

Figure 4a is an exploded perspective view of one embodiment of a post attachment mechanism;

Figure 4b is a rear perspective view of the post attachment mechanism of Figure 4a;

Figure 5 is an exploded perspective view illustrating the interaction of a control device identification mechanism and module identification components;

Figure 5a is a schematic cross-sectional view taken through line 5a-5a of Figure 5 prior to coupling of the control device to the test module;

Figure 5b is a schematic cross-sectional view similar to Figure 5a showing engagement of the control device with the test module;

Figure 6 is a front perspective view of a module according to the present invention;

Figure 7 is a schematic illustration of an embodiment of the electronic assembly of the control device;

Figures 8a-8i are flow charts illustrating the operation of the software and graphical user interface components of the control device;

Figure 9 is an alternative embodiment of a medical system in accordance with the present disclosure;

Figure 10 is a schematic representation of a portable medical system that includes a SUI module;

Figure 10a is a partial cross-sectional view of one embodiment of a portable medical system that includes a SUI module;

Figure 11a is a side elevational view and a partial cross section of one embodiment of a hand actuator in an assembled configuration;

Figure 11b is a side elevational view and a partial cross section of the hand actuator of Figure 11a in a disassembled configuration;

Figure 11c is a side elevational view and a partial cross section of the hand actuator of Figure 11a in an operating mode;

Figure 11d is an alternative embodiment of a hand actuator in accordance with the present invention;

Figure 12 is an enlarged perspective view of one embodiment of a meatal plug device;

Figure 13 is a schematic view illustrating one embodiment of a urodynamic system relative to a female urinary / reproductive system;

Figure 14 is a schematic view illustrating the internal components of one embodiment of a system that includes a SCMG module;

ES 2 368 136 T3

<td>Figures 15-16 are female urinary / reproductive views;</td><td>schematic</td><td>of the</td><td>system</td><td>of</td><td>the</td><td>Figure</td><td> 14</td><td>with regard</td><td>to</td><td>a system</td>

<td colspan="7">Figure 17 is a schematic view illustrating an internal component of</td><td>a</td><td>realization of</td><td>a</td><td>system that</td>

<td>includes a CCMG module;</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>Figures 18-19 are views</td><td>schematic</td><td>of the</td><td>system</td><td>of</td><td>the</td><td>Figure</td><td> 17</td><td>with regard</td><td>to</td><td>a system</td>

female urinary / reproductive system;

Figure 20 is a flow chart illustrating the steps for using the system of Figure 10;

Figure 21 is a flow chart illustrating the steps for using the system of Figure 14;

Figure 22 is a flow chart illustrating the steps for using the system of Figure 17;

Figure 23 is a perspective view of one embodiment of an entrance pendant in accordance with the present invention;

Figure 24 is a schematic view illustrating internal components of one embodiment of a system that includes a uroflowmetry module;

Figure 25 is a schematic view illustrating use of the system of Figure 24;

Figure 26 is a perspective view of one embodiment of a vaginal speculum assembly;

Figure 27 is an exploded perspective view of the vaginal speculum assembly of Figure 26;

Figure 28 is a schematic view of one embodiment of a urodynamic system and speculum assembly relative to the female urinary / reproductive system; and Figure 29 is an exploded perspective view of a battery charger module that can be used in conjunction with the control device.

Detailed description of the realizations

Figures 1 through 26 generally illustrate various systems and procedures for evaluating urinary function and / or the components of such systems and procedures. Although the systems and procedures disclosed herein are described in detail with respect to the female urinary system, it should be understood that the present invention can also be readily adapted for use in the evaluation of male urinary function. Furthermore, those skilled in the art will recognize that the inventive principles, apparatus, and procedures disclosed herein may also be applied to assess function in other areas, such as coronary function or lung function. The present invention should only be limited by the claims defined herein.

Referring now to Figures 1 and 2, an embodiment of a portable medical system 100 is illustrated that has a particular application for evaluating urinary function. The system 100 includes a control device 102 that controls the operation of the system, at least one module 104 that may be removably coupled to the control device, at least one input device, such as the input pendant 106 illustrated, and / or or keypad 108, and at least one output device, such as the illustrated display 110. As will be described in more detail below, the monitoring device 102 is designed to be removably coupled to any one of a plurality of test modules 104 at any given time. Since each module is uniquely suited to support a different type of diagnostic test or medical procedure, the resulting diagnostic system is not only easily portable, but is also extremely versatile because the single monitoring device, along with a plurality of small test modules, it is capable of carrying out a set of diagnostic tests or other procedures. The system has a particular useful application for evaluating urinary function because it provides a portable modular system as opposed to the bulky, expensive, and non-portable equipment currently used to evaluate urinary function. Furthermore, as will also be described in greater detail below, the present invention can carry out tests more quickly, and in a way that is less cumbersome and less invasive for a patient.

Control device 102 includes a housing 112 for housing various components, including one or more batteries 114, an electronic assembly 116, a pump device 118 that includes a motor, and various other circuitry. The batteries supply power to the control device 102, and are contained within a battery compartment 120 which can be accessed by removing the battery cover 122 that is part of the housing 112. In addition, the control device includes an entry keypad 108 to allow a user to enter data (such as the patient's name or other identifier, numerical identifiers, patient history, date, etc.) and an entry pendant 106 that includes one or more switches 124 that allow the user to input additional information (i.e., an input of an event based on the reaction of the

ES 2 368 136 T3 patient), and an activation switch 126 to turn the device on and off. The pump device 118 and at least one pressure transducer 128 are also contained within the housing. The pump device is electrically coupled to the battery and electronics, and the pressure transducer is electrically coupled to the electronics. The control device 102 may also include a pole mounting mechanism 400 for mounting the control device to a pole, such as the pole of a rolling stand 402 for IV solutions that includes a hook 404. In Figures 4a and 4b An embodiment of a pole mounting mechanism is illustrated. The device may also include an interface 130 that includes appropriate electrical outlets to allow the monitoring device to communicate for the purposes of recharging batteries or printing patient test data.

As noted above, any one of a plurality of modules 104, such as the diagnostic test modules, may be removably coupled to the monitoring device 102, and the monitoring device is designed to uniquely identify the device. module set, and carry out routines specific to that module. Therefore, the control device includes a module detection mechanism 500 capable of identifying the attached module that is electrically coupled to the electronics assembly (see FIG. 5). This module sensing mechanism includes one or more identification probes 502 that project from the interface side 132 of the control device and are electrically coupled to the electronics assembly. Modules 104 may include one or more openings in module housing 506 that is designed to receive identification probes therein when the module is removably coupled to the control device. When coupled in this manner, the identification probes connect one or more module identification elements or components 504, such as resistors, capacitors, fuses, or other suitable electronic components, present in the module. The identification probes are electrically coupled to the electronic assembly 116 (described in more detail below), which determines a value, such as resistance, associated with the identification element (s) of the module they connect. Each module is designed to have a value, so that the identification of this value by the electronic control assembly allows the control device to uniquely identify the fixed module. In a preferred embodiment, the control device may include one or more sets of identification probes 502 at different locations, and different modules have module identification components 504 at different locations. The location, as detected by the control device, identifies the attached module. In yet another embodiment, the module identification component (s) may be coupled to an outer side of the module housing, so that no openings are required in the module housing.

The module further includes at least one coupling element 600 for removably coupling the module to the control unit (see Figure 6). In the illustrated embodiment, the module includes four coupling elements positioned toward the ends of each of the front and rear faces 602, 604 of the test module. Each coupling element contains a flange element 606 that engages a corresponding flange 607 (best seen in Fig. 5) on an interior surface of the control device when the module is removably coupled to the control device. To couple the module to the control unit, the coupling elements are lightly pressed in the direction indicated by the arrow in Figure 6. The module is then aligned with the control device as shown in Figure 1, and the engagement elements are released to allow engagement with the corresponding ridges described above. Subsequently, the module can be removed from the control unit by pressing the coupling elements again and removing the module from the control device.

Finally, the module housing 506 includes first 608 and possibly second 610 holes in it, as shown in Figure 6. Each of the first and second holes are configured to define a hole capable of receiving a sensor from pressure from the control device, such as a pressure transducer, therein when the module is coupled to the control device. For example, a first pressure transducer 128 from the control device is received within the gap of the first orifice 608 and comes into physical contact with a pressure interface 1024 (see FIG. 10), so that changes in pressure can be transmitted. pressure at the pressure interface to the pressure transducer 128, and be detected by it, and be converted into electrical signals that are sent to the electronic assembly to be interpreted. Similarly, the second port 610 also defines a gap capable of receiving therein a second pressure transducer 1030 from the control device. The first and second holes are further configured to form a seal with the control device when coupled thereto, preferably by incorporating sealing elements such as gaskets or the like. The individual modules and their operations together with the control device will now be described in more detail.

As noted above, within the housing 112 of the control device 102 is contained an electronic assembly 116 (see Figure 7) that is designed to control the operation of the pump device 118, to acquire and format data from the pump device (s). pressure transducers, to drive a display 110 and / or other output device, and to accept and interpret input data, such as from switches 108, 126 and / or 124. Electronic assembly 116 consists of integrated circuit board 702, hardware interfaces to pump device 708, pressure transducers 706, 707, display 709, and switches 703, 704, and 705; and a microprocessor 710. The microprocessor 710 serves as the main controller for the diagnostic system and is supported by the custom integrated circuit 702 and powered by the

ES 2 368 136 T3 batteries. Interface connection elements are also included, including an electronic module identification connection 712 to electronic sensing mechanism 500, and electronic connections 714 that allow data to be downloaded to a printer or other external device.

Microprocessor 710 is programmed with a custom program file. In the illustrated embodiment, this software has multiple functions. First is the acquisition of operator input data. This input data is captured from the input keypad 108, and / or the switches 124, 126, the pressure transducer (s), or other input device, depending on which test module is in use. The software also controls the operation of the pump device 118. The input data is interpreted and appropriate signals are sent to the motor of the pump device via the integrated circuit board 702. Yet another function is to acquire and condition data from the pressure transducer (s). This data is then sent in the appropriate format to the display screen 110, along with the applicable data from the pump device in the form of volume or time information. Finally, as noted above, the software receives input data from the module's detection mechanism 500 and interprets this input data to determine which test module is coupled to the control device.

Figures 8a-8i are flow charts illustrating the operation of the diagnostic system software and features of the graphical user interface system for a preferred embodiment of the invention. When the system is on, the user is first presented with a welcome screen. While this screen is being displayed the system is undergoing a self-test routine 802 to verify the integrity of the system hardware and software components. Upon completion of this routine, information about the amount of available memory 804 on the system is provided to the user. After the user has pressed any key 806 on input device 108, the system identifies fixed module 808 as described above, and after such identification, the processor executes a software subroutine specific to the identified module. However, for each software subroutine a main menu is displayed below, as indicated by reference numeral 810. In the illustrated embodiment, the main menu includes six possible selections. "Utilities" allows the user to access various features of the system, such as setting the date, time, etc., or adjusting the brightness or contrast of the display screen; "Exit" ends the session; "Patients" allows the user to access any previously stored data related to other patients and tests already performed; “Prime” starts the pump priming procedure; "Patient ID" allows the user to enter a patient identification number; and "Test" starts a specific software subroutine to the set module to carry out the desired test procedure. In the embodiment described herein, the software and user interface associated with the selections of "Prime," "Utilities," "Exit", and "Patient ID" are substantially the same for each software subroutine. However, the “Test” and “Patients” selections are different for each test module. Each of these selections will be described in more detail below.

As illustrated in Fig. 8a, the first time the main menu is displayed, both “Test” and “Prime” appear in a color or tone different from the other options, indicating that they are not available at that time. This is to ensure that patient identification information is entered before proceeding with any priming or testing procedure. The user may select the "Patient ID" option by scrolling using the appropriate arrows on the entry keypad 108. After this selection the Patient ID screen 820 appears (Fig. 8b). In the illustrated embodiment, the patient ID consists of a nine digit integer. To enter the patient ID, the user scrolls to a selected blank space using the left and right arrows and / or the left and right arrows on the entry pad 108 (824) to select the desired numbers. Once the desired number is selected, the user presses ENTER; then the selected number will appear in the blank space to the right. Subsequent numbers are selected as described above, and will appear in the rightmost blank space while previously selected numbers are moved to the left. This procedure is completed until all the blanks are filled. In one embodiment, there is a default value for each blank, such as 0, and the user can proceed with the test by accepting the default patient ID number consisting of all 0's. Once all the patient identification information has been entered, the user selects option 832 from "Main Menu", which returns to the main menu display screen. However, at this point, the “Prime” option becomes available 834 (and “Patient ID” is no longer available).

Before conducting any tests that require fluid to be infused into the patient, priming operations must be performed to ensure that the fluid infusion lines (tubes) are filled with fluid and not air. Referring now to Fig. 8c, the user selects the "Prime" option 840 by using the arrow keys to select the option, and then by pressing the enter key. Then the Prime display screen appears. According to one embodiment, the Prime display screen includes two options as indicated at 842: "Prime" or "Main Menu." In another embodiment, the Prime display screen is unique to each module, and may present only one option to initiate the prime. Selecting the Prime option causes the pump to start and run for a predetermined amount of time, such as 20 seconds, and then automatically shuts off. The user is then presented with a display screen 846 in which the user can accept the prime as complete (MAIN), or choose to re-prime (PRIME). When priming is accepted as complete, the main menu appears again, this time with “Test” as an 848 option. In another

In an embodiment, priming operations may be specifically tailored for different test modules. For example, as will be described in more detail below, SUI test modules include a hand-held actuator that includes an activation button 1118 or 1128. The system may be designed so that after visual representation of the Prime screen, priming operations of the pump can be initiated by pressing the activation button.

The test can begin when priming is complete. As indicated above, the test procedures depend on the set test module, and consequently, the software and graphical user interfaces related to each test module will be presented in greater detail below along with the detailed description of each. test module.

In an alternate embodiment of the invention illustrated in Figure 9, the control device 102 is electrically coupled to a laptop / standard computer 900, and the microprocessor and associated software reside on the computer.

As indicated above, the diagnostic system described herein has a particular application to urodynamics because it allows clinicians to diagnose a plurality of urinary incontinence problems when used with specifically designed test modules (to be presented later). . As a miniaturized urodynamic tool, monitoring device 102 along with modules 104 can measure urethral resistance pressure (URP), evacuation flow (uroflowmetry), and bladder dysfunction (cystometry (CMG)). As will be described below, URP is a new and unique approach to urodynamic measurement of stress incontinence that is less invasive for a patient, and faster than known and widely used diagnostic tests. Uroflowmetry is the study of urination over time. CMG is the study of bladder or detrusor instability. A primary advantage of the diagnostic system disclosed herein is that you can accomplish all of the tests described above with a portable unit that can be used in any examination room, eliminating the need for a specialized urodynamic room reservation or planning. , and the need for the complex equipment required today for such tests. The urodynamic system is simple to use and does not require advanced training. Use of the disclosed system makes testing more comfortable for patients by allowing faster setup, shorter testing time, and less invasive procedures.

During actual use, various modules can be removably attached to the monitoring device 102 to perform these various urodynamic tests. Each module carries out a different and differentiated test. These modules include, but are not limited to, a stress urinary incontinence (SUI) module for measurement of urethral resistance pressure (URP); a simple CMG module for measuring bladder instability; a complex CMG module for measuring bladder instability; and a uroflowmetry module to study urination over time. The modules can be suitably adapted for both male and female incontinence diagnosis.

Before proceeding with a presentation of individual test modules, to assist the reader, the female urinary system will be described with reference to Figure 13. The female urinary system 1300 including an elongated urethral canal 1302 having a urethral meatus (inlet) 1304 and having a substantially circular shaped urethral sphincter muscle 1306 attached thereto, and a bladder cavity 1308 surrounded by a detrusor muscle 1310. The detrusor muscle 1310 also surrounds and supports the urethral canal 1302. The bladder cavity 1308 is in close proximity to the abdominal wall 1312, the pubic bone 1314, the pelvic floor 1316 (levator ani muscle), the vaginal canal 1318 , the clitoris 1320, the uterus 1322 and the muscle 1324 of the anal sphincter.

The individual test modules will be described in detail below.

Stress Urinary Incontinence Module

Figures 10-13 illustrate one embodiment of a stress urinary incontinence (SUI) test module 1000 for diagnosing involuntary loss of urine during physical activities such as coughing, sneezing, laughing, or lifting. The SUI test module 1000 includes a SUI module housing 1002 that may be removably coupled to the control device 102 as described above. This module housing may be in the form of a plastic disposable cartridge. Within the module housing is a tube assembly 1004 that includes a fluid inlet 1006, a fluid outlet 1008, and a first fluid conduit 101 extending therebetween. The tube loop 1012 is part of the tube assembly and is positioned so that, when the SUI test module is coupled to the control unit, the stator 1014 of the pump device 118 in the control unit 102 physically cooperates with the tube loop 1012, so that the pump device operates as a peristaltic pump to pump fluid through the first fluid conduit 1010. To assist in this regard, a tubing guide 599 aids in the positioning of a portion of the tubing assembly so that it will properly and effectively couple to the peristaltic pump. According to the illustrated embodiment, tube guide 599 has a substantially U-shaped configuration, however, many other configurations are suitable, since the principles of peristaltic pump operation are well known in the art. Tube member 1050 is also part of the first fluid conduit. The module housing 1002 also includes a pressure chamber 1016 to dampen pressure fluctuations that 7

ES 2 368 136 T3 can be caused by the operation of the pump device. The pressure chamber 1016 is in fluid communication with the first fluid conduit 1010 via the valve openings 1018a-c of the three-way valve member 1020. The pressure chamber is primarily filled with air, but varying amounts of fluid may also be present. Placed at a distal end of pressure chamber 1016 is a filter component 1022 designed to isolate fluid from the electronics of system 100. In this sense, filter 1022 can be a hydrophobic filter that allows air to pass into the system. the pressure contact surface 1024, but not the liquid. When the test module is coupled to control device 102, pressure contact surface 1024 is in physical contact with control device pressure transducer 128 so that pressure fluctuations within pressure chamber 1016 and the surface

1024 Contact pressure signals can be transmitted to and detected by the pressure transducer, and subsequently transmitted to the electronics assembly as indicated above. In this way, the monitoring device measures the pressure within the first fluid conduit of the SUI test module tube assembly, which substantially corresponds to the pressure in the urethral canal as described in more detail below.

The SUI test module tube assembly 1000 also includes a second tube member 1025 having a channel through it that forms a second fluid conduit between a proximal end 1026 and a distal end 1028.

Referring now to Figures 11a-c, the SUI test module may also include a handheld actuator 1100 having an insertion device such as a meatal plug device 1102 attached thereto. The meatal plug device 1102 (see Figure 12) includes a fixation member 1104 at a proximal end 1106 coupled to a plug or insert member 1108 at a distal end 1110, and a channel 1112 extending through thereof allowing fluid to flow through the first fluid conduit to flow through the meatal plug device. The distal end 1114 of the plug member may also include one or more transverse aligned openings or holes 1116 therein, evenly spaced from one another about the outer surface of the distal end. Since the outer diameter of the distal end at the location of the openings is less than the diameter of the inner wall of the urethral canal at that location (described in more detail below), one or more of the openings 1116 can be used to secure the fluid flow into the urethra during the actual operation.

In one embodiment, the hand actuator further includes a hand-sized housing or cover 1102 that includes an initiator element 1118 (Figures 11a-c) that is in fluid communication with the member.

1025 tube. Preferably, the initiator element is an air chamber 1097 coupled to a distal end 1028 of tube member 1025. The proximal end 1026 of the tube member 1025 is coupled to a pressure contact surface 1026a that is positioned so that, when the SUI test module is coupled to the monitoring device, the pressure within the tube member 1025 can be sensed by pressure transducer 1030. As a closed system, the pressure on the activation button 1118 on the pressure contact surface 1026a can be detected by the pressure transducer 1030, and can be interpreted by the control device 102 as a signal to initiate and / or disable the test.

The handheld actuator 1100 further includes a fluid conduit 1050 extending between an outlet 1195 and an inlet 1194 that is coupled (integrally or otherwise) to an external tube conduit leading to a source of fluid. , such as the first fluid conduit 1010 of the SUI test module. Alternatively, the hand-held actuator may be designed to include the fluid source therein. Fluid outlet 1195 is in fluid communication with the channel of the insertion member of the meatal plug device. An activation device 1127 that includes a trigger 1128 extends through an opening 1118a to an exterior of the cover. Activation device 1127 is movable between a first (shown) resting position and a second activated position. In the first position a spring 1130 exerts force on coupling member 1132, causing it to pivot relative to pivot element 953 and pinch the distal ends of at least tube member 1050 to prevent fluid flow through the tube. same. When in the second position, the movement of the trigger causes the coupling member 1132 to pivot to a point where it no longer pinches the tube member 1050. In addition, trigger 1128 may also compress air chamber 1097 to initiate the test as described above in connection with the initiator element.

Plug member 1108 is configured such that, when inserted into a patient's urethral meatus (see Figure 13), it will substantially block or prevent fluid flow out of the urethra, as well as into the urethra at all. rather than through channel 1112 of the meatal plug device. In addition, when inserted, the plug member is positioned distal to the urethral sphincter 1306 (toward the exterior of the body) as shown in Fig. 13. In the embodiment shown in Fig. 12, the distal end or distal portion 1114 of the plug member has a substantially conical shape, and its diameter is reduced toward its distal end 1114. A proximal portion 1199 is configured to engage the wall. internal urethral canal to substantially prevent fluid flow through it. However, other forms are possible, as long as fluid flow into or out of the urethra is substantially blocked (through the channel of the meatal plug device only) and the plug member remains located distal to the sphincter. urethral. The meatal plug device 1102 is

ES 2 368 136 T3 made of a biocompatible material, such as stainless steel or polypropylene. The meatal plug device can be disposable, but it can also be made of a material that can be sterilized so that it can be reused.

The first fluid conduit 1010 of the tube assembly also includes an elongated single lumen tube member 1032 having a first end 1006 and a second end 1034 and a fluid channel extending therethrough. A piercing device 1036 is attached to the first end 1006 of the single lumen tube member for attachment to a fluid bag 1038 (having fluid 1010 therein) in a manner well known in the art. As described above, the meatal plug device and the first fluid conduit are coupled to each other so that fluid from the fluid source traveling through the first fluid conduit can pass through the fluid conduit member. insertion (through the canal) and into the urethral canal distal to the urethral sphincter. Furthermore, since the first pressure interface 1024 is in fluid communication with the first fluid conduit and ultimately the urethral canal, the pressure at the pressure interface substantially corresponds to the pressure within the urethral canal distal to the urethral sphincter.

The use of system 100 that includes a SUI test module 1000 is as follows. First, the SUI test module is removably coupled to the monitoring device 102 in the manner described above. The physical coupling causes the control unit identification probes 502 to couple to the module identification element (s) 504 of the SUI test module, allowing the control device to identify the SUI test module. Physical coupling also brings pressure interface 1024 into physical contact with pressure transducer 128 as described above, so that pressure changes at the pressure interface can be detected by means of the pressure transducer. pressure and can be transmitted to the electronic assembly for interpretation. Pressure contact surface 1026a at the proximal end of tube member 1025 similarly contacts pressure transducer 1030 so that pressure within tube member 1025 can also be sensed. Finally, the tube loop 1012 is brought into physical contact with the pump device 118 so that the pump device can propel fluid through the first fluid conduit by means of a peristaltic movement, as described above.

As shown in FIG. 20, once the SUI test module 1000 is coupled to the control device 102 (2010), the operator enters appropriate input data into the keypad 108 or other input device (2015) to the SUI test (described in more detail below). This data is received and interpreted by the microprocessor 710 and the microprocessor sends the applicable information to the display means 110. Then, priming operations are carried out (2020) to ensure that the first fluid conduit 1010 contains fluid. At this point, the microprocessor is ready to start the test routine.

The meatal plug 1102 is inserted into the urethral meatus (2025) and the test is initiated (2030) by pressing the activation button as described above. This in turn sends instructions to the pump device via the integrated circuit. The pump device then pumps fluid 1040 through the first fluid conduit 1010 and the channel 1112 of the meatal plug device and into the urethral canal distal to the urethral sphincter (2035). As fluid pressure in urethral canal 1302 increases, pressure in pressure chamber 1016 also increases. This pressure is transmitted through filter component 1022 and pressure interface 1024 to pressure transducer 128, which receives the pressure data and transcribes it into an electrical signal. The electrical signal from the pressure transducer is sent to the microprocessor 710 via the integrated circuit 702 where it is acquired and conditioned. The information is then sent to the display means 110 via the integrated circuit. The microprocessor terminates the test after a specified amount of time, or upon receipt of user input by sending a "off" signal to the pump motor driver. Once the test is complete, the operator releases the activation button 1118 (step 2040) and removes the meatus plug member 1304 (2045).

Referring again to Figures 8a-i, and in particular to Fig. 8d, when the "Test" option is selected, the SUI test can be carried out. The SUI test display screen appears 860, and the user initiates the test by pressing trigger 1128 or removable liner 1126 (862) to allow fluid flow into the urethral canal as described above. The motor is then activated and the pump device pumps fluid into the urethral canal for a predetermined period of time, preferably 15 to 20 seconds. During this time, a graph is displayed continuously (see 860) illustrating pressure measured on the vertical axis (preferably in cm of water) versus time on the horizontal axis. As fluid is pumped into the urethral canal, the pressure in the urethral canal distal to the sphincter continues to increase until that point in time when the urethral sphincter yields (opens) under the force of pressure in the urethral canal. . At that point the pressure curve becomes substantially flat, as illustrated in Fig. 8d, since the sphincter is open and fluid is filling the bladder. The value of the flat portion of the curve is considered the "urethral resistance pressure (URP)", and can be obtained from the visually plotted graph. Upon completion of the test (after the expiration of the predetermined period of time, the pump device stops), the graph remains, and the user is preferably given an option to adjust the software-generated URP value ( 860a) before saving the test results. To adjust the

ES 2 368 136 T3 URP value, the user uses the up and down arrows to manipulate the horizontal line that indicates the URP value that appears on the display screen (870). When the dashed line is at the desired value, the user presses enter (872).

Once the final URP value is displayed, a Save / Delete display screen 874 is superimposed on the display screen. If the user selects the "Save" option, the test results are saved to memory. If the user selects "Delete" from the Save / Delete display screen 874, the user is then presented with the Save Test screen 876. Choosing “Delete” clears the test, but selecting “Cancel” returns the user to the Save / Delete display screen.

According to one embodiment, the test results of up to three out of six possible tests can be saved. Once all three tests have been saved or six tests have been performed, whichever comes first, the control unit 102 will disable the module identification component 504 via the identification probes 502. After the test has been completed, the user can return to the main menu by selecting the “Menu” option on the Test Completed screen.

An option available from the Main Menu, as noted above, is "Patients", which allows the user to access previously stored patient and test data. According to an embodiment illustrated in FIG. 8h, when "Patients" is selected from the Main Menu, a Patient display screen 891 appears. On this display screen, the options for each patient and test for which 892 data have been stored are presented and selecting one of these options causes a Patient Test Menu 893 to be displayed (Fig. 8i). Selecting "Clear" 896 will present the user with the option to clear the stored data for that patient / test, and selecting "Print" 895 will allow the user to print the stored data. The Print option will only be available (not grayed out) when the control device is attached to a stand, or otherwise appropriately attached to a printer. Selecting “View Test” will bring up a Patient Test display screen 898 or 899 depending on whether the stored data is a CMG (898) or SUI (899) data set. The Patient Test display screen may vary depending on the test module that is set. For example, for stored SUI data, the Patient Test display screen is the display screen illustrated by 899, while for CMG data (presented below), the Patient Test display screen is the same. display screen illustrated by 898. The Patient Test display screen provides the user with the option of viewing data relevant to the particular form of test performed.

As previously stated, the results obtained from the SUI test is the urethral resistance pressure (URP), which is the back pressure necessary to force the urethral sphincter muscle 1306 to open from the reverse or opposite direction with respect to the normally flowing fluid. A primary advantage of the SUI test module 1000 is that the plug or insert member 1108 of the meatal plug device 1102 only enters the external urethral canal (meatus) and does not cause any discomfort associated with passing a catheter through of the internal urethral sphincter. Therefore, the diagnostic system disclosed herein having a SUI module 1000 is less invasive and more comfortable for patients. In addition, the testing procedure for SUI Module 1000 is simple to implement, quick to perform, and does not require advanced training from the clinician and / or physician.

Simple cystometry (CMG)

The diagnostic system disclosed herein can also be used to perform both simple and complex cystometries. Figures 14-19 show both simple (SCMG) and complex (CCMG) cystometry systems for bladder function testing in which the pressure and volume of fluid in bladder cavity 1308 during filling are measured. , storage and evacuation. Normally, urologists measure the ratio of static pressure in the bladder of patients, this is called cystometry (CMG), to determine the capacity of the bladder as a function of pressure and volume.

Referring now to Figure 14, the SCMG test module 1400 includes a module housing 1020b that may be removably coupled to the control device 102 in the manner described above. The module housing 1020b may be in the form of a plastic disposable cartridge. The SCMG test module contains many items that are similar to those described above in connection with the SUI test module, and similar numbers will therefore be used for these items. There is a tube assembly 1004b contained in the module housing that includes a first fluid conduit 1402 between the fluid inlet 1404 and the fluid outlet 1406. The tube assembly also includes a second conduit 1408 between a distal end 1410 and a proximal end 1412. There is a filter 1022b and a pressure contact surface 1412 coupled to the proximal end that contact pressure transducer 128 to transmit pressure information. pressure to it when the SCMG test module is attached to the control device. Similarly, compatible tube loop 1012 forms part of the first fluid conduit, and engages with pump device 118 in the same manner as previously described in connection with the SUI module. Each of the extremes

ES 2 368 136 T3 distal 1406, 1410 of the first and second conduits are coupled to the respective proximal ends 1414, 1416 of the first and second tube elements 1418, 1420 of a dual-lumen catheter 1422, such that the first conduits and second 1402, 1408 between the proximal end 1414, 1416 and distal 1460, 1462 of the dual lumen catheter are in fluid communication with the channels in the first and second elements 1418, 1420 1422 dual lumen catheter tube. This fixation can be accomplished by an adhesive bond, a solvent bond, an ultrasonic welding, or any other suitable type of fixation that creates a watertight joint. In another embodiment, the dual-lumen catheter is an inflatable balloon catheter, such as a Foley-type catheter, that includes a pressure sensor 1424 positioned at the tip of the catheter (see Figure 16). Any other suitable catheter, such as fiberoptic or air-loaded catheters, can also be used. The pressure sensor can be a micro-tip transducer, an air-loaded sensor, a fluid-loaded sensor, a fiber optic sensor, or any other pressure measurement sensor.

The use of the diagnostic system to perform an SCMG will now be described in detail with reference to Figures 15, 16 and 21. First, the SCMG test module is coupled to the monitoring device in the manner described above ( 2110). The physical connection causes the control unit identification probes 502 to mate with the SCMG test module module identification element (s) 504, allowing the control device to identify the SCMG test module from the way described above. The physical coupling also brings pressure contact surface 1024b into contact with pressure transducer 128, so that pressure changes in the second fluid conduit can be detected by the pressure transducer. This coupling also causes the tube loop 1012 to engage the pump device, so that the pump can propel fluid through the tube loop by peristaltic motion, as also described above.

Once the SCMG test module 1400 is coupled to the control device 102, the operator enters appropriate input data for the SCMG test (2115). This data is received and interpreted by the microprocessor 710 and the microprocessor 710 sends the applicable information to the display means 110. Then, the priming operations are carried out (2120). At this point, the microprocessor is ready to start the test routine.

Then, the dual lumen catheter 1422 is inserted into the bladder 1308 (2125) via the urethra 1304 and the test is initiated by depressing the input pendant switches 124 (2130). The microprocessor 710 receives the signal from the input pendants. Then, instructions are sent to pump device 118 via integrated circuit 702. The pump device then pumps fluid through first fluid conduit 1402 and tube member 1418 into bladder (2135). As the volume of fluid in the bladder increases, the pressure in the bladder also increases. This pressure is transmitted through tube member 1420 and second conduit 1408, filter component 1022b, and pressure contact surface 1024b. The pressure transducer 128 receives the pressure data and transcribes it into an electrical signal. The electrical signal from pressure transducer 128 is sent to microprocessor 710 via integrated circuit board 702 on which it is acquired and conditioned. During the course of a typical SCMG test, the patient provides an input of events, such as feeling the urge to void and / or the intensity of that sensation, which is entered into the control device via pendant switches 124 of input, as will be described in more detail below. The microprocessor terminates the test (2140) after a specified amount of time, or upon receipt of an "off" signal from the input pendant switch 124. Once the test is complete, the operator removes catheter 1422 from the bladder (2145). After the test, the software exits the SCMG test subroutine, and the data storage routine is executed to store and / or display the test results.

Referring again to Figures 8a-i, and in particular Figure 8e, when the "Test" option is selected the SCMG test can be performed. The SCMG Test display screen appears 870a, and the user initiates the test by quickly pressing the input pendant switch 124 (see FIG. 10a). Then, the pump device is activated and pumping 872a begins. In a preferred embodiment, the fluid is infused into the patient's bladder at a rate of about 1 ml / sec. As such, this test can last approximately 16 minutes, instead of the approximately 15-20 seconds that may be required for the SUI test.

As the bladder fills, the patient reports the instant in time when they feel the initial sensation of needing to evacuate, and the user presses the input pendant switch 124 to mark this instant in time 873a. The fluid infusion continues, and the user then marks the instant in time when the patient feels the urge to evacuate 874a, and the instant in which the patient feels an extreme, almost unbearable urge to evacuate 875a, or has evacuated. . After this third mark, the fluid infusion ends and the 876a test is completed. During fluid infusion and after the test is complete, a graph is displayed illustrating pressure versus volume infused. After completion of the test a Save / Delete overlay 877 appears. Selecting "Save" and hitting enter saves the test data. Selecting "Delete" brings up the Save / Delete overlay display 878. Selecting “Delete” on this display screen erases the data, while selecting “Cancel” on this display screen returns to the Save / Delete overlay.

ES 2 368 136 T3

The user can pause the test anytime between the start of pumping and the completion of the SCMG test by pressing and holding, or firmly pressing the input pendant switch 880, causing the pump device to stop pumping fluid to the interior of the patient's bladder, and a Pause display screen 881 (Fig. 8f) appears in the display medium. Selecting “Exit” causes an End Test display screen 885 to appear, and selecting “OK” stops the test 886. If “Cancel” is selected, the Pause display screen reappears. If “Continue” 883 is selected from the Pause display screen 881, the SCMG test continues where it left off (pumping begins again). However, if "LPP" 882 is selected from the Pause display screen 881, the evaluation of the patient's loss pressure (LPP) begins. No pumping of fluid occurs during this test. First, an LPP display screen 887 appears and an empty graph is displayed. Plot the pressure in centimeters of water on the vertical axis with respect to time on the horizontal axis. The patient then proceeds to exert pressure on the bladder as if attempting to evacuate 888. The user marks the point at which a leak occurs 889, and the test is automatically completed after three minutes or three leaks, after which it returns the user to the Pause display screen 881. Then, the LPP results can be saved or deleted, the CMG test can be resumed, or the test can be terminated entirely.

Complex cystometry

Referring to Figures 17-19, the complex CMG test module (CCMG) 1700 is similar to the SCMG test module, but the tube assembly also includes an additional single-lumen tube member 1702 that has one end proximal 1704 and a distal end 1706 and a third conduit extending therethrough. The proximal end 1704 of the single lumen tube member is coupled to another filter component 1022c and to a pressure contact surface 1024c. The pressure contact surface 1024c contacts the pressure transducer 1030 when the CCMG test module is coupled to the control device, allowing the pressure transducer 1030 to detect the pressure within the third fluid conduit.

The use of the diagnostic system to perform a CCMG will now be described in detail with reference to Figures 18, 19 and 22. First, the CCMG module is coupled to the monitoring device (2210). The physical connection causes the identification probes 502 of the control device 102 to couple to the identification elements 504 of the CCMG test module, allowing the control device to identify the CCMG test module. The physical coupling also brings pressure contact surfaces 1024b, 1024c into contact with pressure transducers 128, 1030 so that pressure changes in the second and third conduits can be detected by the pressure transducers. This engagement also causes tube loop 1012 to engage pump device 118 so that the pump can drive fluid through the tube into the CCMG module.

Once the CCMG test module 1700 is coupled to the control device 102, the operator enters appropriate input data for the CCMG test (2215). This data is received and interpreted by the microprocessor 710 and the microprocessor sends the applicable information to the display means 110. Then, the priming operations are carried out (2220).

Dual lumen catheter 1422 is inserted into the bladder via urethra 1302 (2225). Single lumen catheter 1702 is inserted into either the vagina or rectum (2230) and the test (2235) is initiated by depressing the input pendant switches 124. The microprocessor 710 receives the signal from the input pendants. This in turn sends instructions to pump device 118 via integrated circuit 702, and the pump device pumps fluid through first tube conduit 1042 and tube element 1418 into bladder (2240). As the volume of fluid in the bladder increases, the pressure in the bladder also increases. This pressure is transmitted through pressure contact surface 1024b to pressure transducer 128. Similarly, abdominal pressure is transmitted through pressure contact surface 1024c to pressure transducer 1030. Pressure transducers receive pressure data and transcribe it into electrical signals. Electrical signals are sent to microprocessor 710 via integrated circuit board 702 where they are acquired and conditioned. The microprocessor terminates the test after a specified amount of time or upon receipt of an "off" signal from input pendants 124 (2245). Once the test is complete, the operator disengages the inlet pendant switches and removes catheters 1422 and 1702 from the bladder (2250). The stored information is then available to be reviewed on the display screen, or by being printed through a charging cradle (printer assembly), or it can be downloaded to a PC via a software interface on the cradle. loading.

Referring again to Figures 8a-i, the CCMG module software subroutine and graphical user interface are substantially as described in connection with the SCMG module. The system subtracts abdominal pressure from bladder pressure to calculate detrusor (bladder muscle) pressure. The detrusor pressure is then plotted as a function of volume.

Both the SCMG and CCMG 1400 and 1700 test modules provide a simple and relatively low cost procedure for recording a cystometry (CMG). The SCMG and CCMG Test Modules are sterile disposable kits that eliminate the need to disinfect equipment prior to use. This, along with a

ES 2 368 136 T3 relatively simple setup and operative procedure by the physician greatly reduces the time required to obtain urodynamic data. The SCMG and CCMG test modules are more comfortable for the patient and cost-effective for the clinician. The simplicity of the SCMG and CCMG test modules and control device 102 allow for operation with minimal training. Additionally, when combined in operational use with the SUI Test Module 1000, these modules provide a comprehensive urodynamic diagnostic tool for the clinician.

Uroflowmetry

A uroflowmetry test module 2400 may also be removably coupled to monitoring device 102. The module housing of the uroflowmetry test module 2400 may be in the form of a disposable plastic cartridge. As shown in Figures 24 and 25, the uroflowmetry test module 2400 includes a single lumen tube member 2402 having a proximal end 2404 and a distal end 2406 and a channel extending substantially therethrough. However, a balloon 2408 or other suitable elastomeric element is attached to the distal end 2406, so that the channel of the single lumen tube member is not open at the distal end. A pressure cushion can also be used instead of the balloon. A collection urinal 2410 is positioned on top of the balloon. The inner surface of the collection urinal may also contain a urinalysis strip which, when wetted by evacuated urine, allows a quantitative evaluation of standard urinalysis parameters.

The diagnostic system including the uroflowmetry test module is operated as follows. The collection chamber pot is positioned under a urinal chair 2412 to collect urine as the patient evacuates. The balloon is positioned relative to the urinal so that it substantially supports the urinal. As the urinal is filled, the pressure increases in the balloon in proportion to the weight of the fluid. When the test module is coupled to the monitoring device, the proximal end 2402 of the single lumen tube member 2402 makes contact with the pressure transducer 128 of the monitoring device 102 so that the pressure within the balloon can be captured. and interpreted by the control device. The pressure data is used to calculate the weight and volume of the fluid (of known fluid density). The stored information is then available to be reviewed on the display screen, or by hard copy via the upload media (printer assembly), or to be downloaded to a PC via a software interface on the media. loading. After the test is complete, the operator disengages the inlet pendant switches 124, and the urine and collection urinal are flushed.

The operation of the uroflowmetry module software subroutine is illustrated in Figures 8a-b. The urinary flow module subroutine begins after detection 802 of the module and an instruction to execute the urinary flow module subroutine 804. The operator is prompted to enter the patient urine flow data 840 necessary for the urine flow test routine. Once the patient data has been collected, a Urinary Flow Zero Procedure 841 is executed. The operator then enters the information necessary to initiate the urinary flow test (Urinary Flow Test I / O) and test 842 is started. After the test the software exits the urinary flow test subroutine and stores the collected data in the Data Store routine.

Vaginal speculum

Figures 26-28 illustrate a vaginal speculum assembly 2600 for use in reducing vaginal prolapse when performing a female urodynamic test, as discussed above. Uterine or vaginal prolapse occurs when the uterus or pelvic organs fall or are displaced due to weakened pelvic muscles. Prolapse must be reduced to effectively perform urodynamic testing to ensure that there are no underlying symptoms of stress urinary incontinence hidden from the pressure of vaginal prolapse, which can lead to deformation or twisting of the urethral canal. The vaginal speculum assembly 200 will allow the clinician or physician to perform a one-handed urodynamic test procedure while continuing to reduce vaginal prolapse, as well as properly place the meatal plug device or other catheter within the urethral canal. . This prolapse maneuver using the Vaginal Speculum Assembly 2600 during urodynamic testing is especially important prior to surgical repair of vaginal prolapse, since an undiagnosed case of stress urinary incontinence may surface after prolapse surgery. The urodynamic testing performed using the vaginal speculum assembly in this way allows the surgeon to determine whether additional surgery for stress urinary incontinence (SUI) should be performed at the time of prolapse repair.

Current medical practice requires the use of a fixed-in-place vaginal speculum to reduce prolapse. For example, US patents n^you 5,997,474 and 6,048,308 describe specula specifically designed for vaginal examination and treatment. US Patent No. 6,120,438 discloses a vaginal retractor device designed to retain the vaginal wall during an examination or surgical procedure. Surgical tape is often necessary to hold the speculum in place, as the doctor's hands cannot hold the speculum in place while performing a particular urodynamic procedure. None of the prior art speculum devices integrate the use of urodynamic equipment.

ES 2 368 136 T3

Referring to Figures 26 and 27, vaginal speculum assembly 2600 includes a connecting member 2602 for engaging an insertion device assembly, such as a meatal plug device 1102, or a catheter 1422 and vaginal speculum-related elements. . The vaginal speculum can be of any type well known in the art. In the illustrated embodiment, the vaginal speculum includes an upper blade 2604, a lower blade 2606, and an articulation member 2608 for joining the upper and lower blades together. The vaginal speculum also includes a handle member 2610 that is integrally attached to the lower blade, and is preferably aligned substantially perpendicular thereto. The vaginal speculum 2600 further includes an immobilization rod device 2612 connected to the upper blade 2606 to immobilize the upper and lower blades in an open position, as shown in Figure 28. The upper blade 2604 includes a rear end 2614 with a pair of blade placement openings 2616 therein. Connecting member 2602 includes flexible band 2618. The flexible band includes at one end 2620 a pair of positioning openings 2622 and at the other end 2624 a connecting element 2626. The positioning openings 2622 of the flexible band 2618 are aligned with the positioning openings 2616 of the topsheet blades to receive a pair of installation screws 2628 therein to secure the connecting member 2602 to the vaginal speculum 2600. In use, the connecting element may be coupled to the meatal plug device or catheter, as shown in Figure 26.

Although a particular embodiment of connecting member 2602 has been illustrated and described herein, those skilled in the art will recognize that various other embodiments are also possible to provide a means by which to removably couple a device that is inserted into the urethral canal to the speculum so that it is held in place within the patient.

During its operation, the vaginal speculum assembly 2600 can be used cooperatively in conjunction with the urodynamic system disclosed herein. For example, it can be used in conjunction with a urodynamic system that includes a SUI test module 1000 in performing the urodynamic testing procedure for stress urinary incontinence (SUI), such as measurement of urethral resistance pressure (URP). ) as described above. Referring to Figure 28, the physician positions the vaginal speculum assembly 2600 so that it is fully inserted into the vaginal canal 2650 in which the upper and lower blades 2604, 2606 are fully open and pressed against the vaginal walls 2650w to reduce the patient's vaginal prolapse. The physician then immobilizes the upper and lower blades of the vaginal speculum in the fully open configuration (see Figure 28) by means of the immobilization rod device 2612, and adjusts the connecting member 2602 so that the insertion member will be aligned with the urethral canal. The remaining operational stages are exactly the same as the operational stages described above in connection with the individual test modules.

Although the portable medical system disclosed herein has been described in conjunction with a diagnostic test, it should be understood that the system may also be used in conjunction with therapies and / or surgical procedures to treat urinary incontinence, such as the placement of a sling, the placement of volumetric agents, tissue contraction, etc. In this sense, the tests described in this document can be used before, during and / or after these procedures to guarantee the success of the procedures, for example, to guarantee the correct placement and / or tension of a sling.

Although exemplary embodiments and procedures have been described in detail above, those skilled in the art will understand that many variations are possible without departing from the scope of the invention, which is limited only by the appended claims.