FORCES SUCH AS PELVIC FLOOR MUSCLE

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority on United States Provisional Patent Application Serial No. 61/816,979, filed on April 29, 2013.

TECHNICAL FIELD

[0002] The present application relates to the measure of pelvic floor muscle functions, including the force of pelvic floor muscles and, more particularly, to a probe used therefor.

BACKGROUND OF THE ART

[0003] Pelvic floor muscle integrity and function are important in the maintenance of urinary continence and organ support. Contractile properties of the pelvic floor muscles may be modified in women, for instance after vaginal delivery or menopause because of trauma in the first case, or hormonal changes in the second. It is desirable to understand the contractile properties of the pelvic floor musculature, including tone (passive force), strength (active force), endurance and coordination as well as contractile property changes in these muscles following trauma, or over time. The measurement of the pelvic floor muscle contractile properties may aid in physiotherapy aimed at reducing urinary incontinence through pelvic floor reeducation, in gynaecology or urology in diagnosing the need for pelvic floor rehabilitation, and in physiotherapy in order to better target and train pelvic floor contractile dysfunction.

[0004] U.S. Patent number 6,468,232 (hereinafter, patent '232) describes a method and apparatus for measuring properties of the pelvic floor muscles. The apparatus described in patent '232 comprises a pair of blades that are spaced apart from one another in a probe end of the apparatus. The blades are interconnected on a scale located at the base of the apparatus. The scale provides a manual indication of the distance between the blades. A gage section may also be provided on the blades to measure forces. It is observed that the apparatus of this patent is voluminous when the scale is present, which may require that the patient be in a supine position when using same.

[0005] In Fig. 2A of patent '232, there is illustrated a solution in which the blades are interconnected by a base without the presence of a voluminous scale. Hence, the patient using the apparatus of Fig. 2A may not be limited to being in a supine position when using the apparatus of Fig. 2A. It is observed that the strain gages are mounted directly to a base of the blades. Hence, the readings obtained from these strain gages may be dependent on the depth of insertion of the blades, which may increase the sensitivity of the gauges and hence impact the measurement of the values provided using the apparatus of Fig. 2A of patent '232.

SU MMARY

[0006] It is an aim of the present disclosure to provide a probe for measuring pelvic floor muscle forces that addresses issues related to the prior art.

[0007] Therefore, in accordance with the present disclosure, there is provided a probe for measuring forces exerted by soft tissue of a bodily cavity, comprising: a base; a probe end adapted to be received in the bodily cavity to be exposed to said forces and comprising: a structural member projecting from the base and defining a sensor body portion with at least one surface adapted to support at least one sensor connected to a processor unit; and at least a first blade and a second blade connected to the structural member such that the blades concurrently define an outer surface of the probe end adapted to be against the soft tissue of the bodily cavity, the blades concurrently forming an inner cavity therebetween in which at least the sensor body portion of the structural member is enclosed, the first blade and the second blade being cantilevered with respect to the structural member such that said forces applied on the blades are transmitted to the structural member.

[0008] Further in accordance with the present disclosure, the first blade is connected at a proximal end of the structural member and projects distally, and the second blade is connected at a distal end of the structural member and projects proximally.

[0009] Still further in accordance with the present disclosure, the blades each have a blade portion projecting from an annular body, the annular body being for connection to the structural member.

[0010] Still further in accordance with the present disclosure, the annular body of at least one of the blades receives therein the structural member.

[0011] Still further in accordance with the present disclosure, the annular body of at least one of the blades receives therein a fastener by which the blade is connected to the structural member.

[0012] Still further in accordance with the present disclosure, the sensor body portion is located in the inner cavity between an interconnection of the first blade and the structural member, and an interconnection of the second blade and the structural member.

[0013] Still further in accordance with the present disclosure, the sensor body portion has one surface for supporting sensors for each one of the blades, the one surface facing its associated one of the blades. [0014] Still further in accordance with the present disclosure, the blades are made of plastic and the structural member is made of metal.

[0015] Still further in accordance with the present disclosure, the base incorporates a female wire connector.

[0016] Still further in accordance with the present disclosure, the female wire connector is wired to the at least one sensor internally of the probe end.

[0017] Still further in accordance with the present disclosure, the blades concurrently define a circular section for the probe end extending the length of the sensor body portion.

[0018] Still further in accordance with the present disclosure, a hemispherical cap is at the end of the probe end.

[0019] Still further in accordance with the present disclosure, the blades concurrently define a cylindrical body.

[0020] Still further in accordance with the present disclosure, the sensors are strain gauges.

[0021] Still further in accordance with the present disclosure, there are four of said blades.

[0022] Still further in accordance with the present disclosure, two of the blades are connected at a proximal end of the structural member and project distally, and two other of said blades are connected at a distal end of the structural member and project proximally.

[0023] Still further in accordance with the present disclosure, each of the blades has a quarter-circular section.

[0024] Still further in accordance with the present disclosure, an optical measurement unit has at least one light emitting sensor in the probe end.

[0025] Still further in accordance with the present disclosure, electrodes of an EMG measurement unit are in the probe end.

[0026] Still further in accordance with the present disclosure, a pressure sensor is at a tip of the probe end.

[0027] Still further in accordance with the present disclosure, the blades each have a semi-circular section.

[0028] Further in accordance with another embodiment of the present disclosure, there is provided a probe for measuring pelvic floor muscle forces comprising: a base; a structural member projecting from the base and defining a sensor body portion with at least one or two surfaces adapted to support sensors; and at least a first blade and a second blade connected to the structural member to define a probe body, with the structural member being enclosed within the at least two blades, the first blade and the second blade being cantilevered with respect to the structural member such that forces applied on the blades are transmitted to the structural member.

[0029] In accordance with yet another aspect of the present disclosure, there is provided a probe for measuring pelvic floor muscle forces in more than one direction (two directions) comprising: a base attach to one or more structural member; and two or more blades attached to either the base or the floating end of 1 or 2 internal perpendicular structures adapted to support 4 sensors each; the first blade and the second blade being cantilevered with respect to the structural member such that forces applied antero-posteriorly on the external structural members are transmitted perpendicular to the (antero-posterior) internal structure and the 4 sensors the third and fourth blade being cantilevered with respect to the structural member such that forces applied latero-laterally on the external structural members are transmitted perpendicular to the (latero-lateral) internal structure and the 4 sensors.

DESCRIPTION OF THE DRAWINGS

[0030] Fig. 1 is an assembly view of a probe for measuring forces exerted by soft tissue of a bodily cavity in accordance with the present disclosure;

[0031] Fig. 2 is an enlarged view of a base of the probe of Fig. 1 ;

[0032] Fig. 3 is a perspective view of the base and a first cantilevered blade of the probe of Fig. 1 ;

[0033] Fig. 4 is a perspective view of a base and a first cantilevered blade with a structural bar of a probe in accordance with another embodiment of the present disclosure; and

[0034] Fig. 5 is a perspective view of the probe of Fig. 1 as assembled for insertion in the bodily cavity.

DETAILED DESCRIPTION

[0035] Referring to the drawings and more particularly to Figs. 1 to 3, there is illustrated at 10 a probe for measuring forces exerted by soft tissue of a bodily cavity, such as pelvic floor forces, in accordance with an embodiment of the present disclosure. Other uses are contemplated, such as the measurement of anal sphincter muscle forces. However, for simplicity, the detailed description will refer to the use for the measurement of pelvic floor muscle forces within the vaginal cavity. The probe 10 can comprise a base 12 and a probe end 13. The probe end 13 is to be inserted in the measured cavity while the base 12 is the interface between the probe end 13 and a processing unit. The processing unit is devised to interpret the readings obtained from the probe 10.

[0036] Referring concurrently to Figs. 1 and 2, the base 12 is shown in greater detail. The base 12 comprises a cylindrical body 20, illustrated as having a generally circular section. However, the body 20 may have other geometries than a cylinder. It is observed that the cylindrical body 20 may have an outer diameter of greater dimension than that of the probe end 13. Therefore, the outer diameter of greater dimension may preclude the base 12 from being inserted or moving inadvertently into the cavity.

[0037] As the base 12 is the interface between the probe end 13 and a processing unit, a wire connector 21 may be built in the cylindrical body 20 and exposed to an exterior of the cavity when the probe end 13 is in the cavity for being connected to a male wire connector, with all wires between the wire connector 21 and the gauges being concealed within the base 12 and a body of the probe end 13. In the illustrated embodiment, the wire connector 21 is the female component but may alternatively be a male component. It is observed that the wire connector 21 projects from a lateral face of the cylindrical body 20 but may alternatively project from the bottom face of the cylindrical body 20. The base 12 may also feature visual markers. For instance, it may be desired to properly align the probe end 13. Accordingly, a line and indicia may be provided on a lateral surface of the cylindrical body 20 for the visual alignment of the base 20. In an embodiment, the base 20 is to be aligned with the symphysis pubis (antero-posterior) of the pelvis, namely between the pubic bone and the insertion of the pubovaginal muscle. In another embodiment, the probe 10 may be oriented along the latero-lateral axis of the pelvis, namely between the two levator ani muscles.

[0038] Referring to Figs. 1 and 3, the probe end 13 projects upwardly from the base 12. For clarity purposes, when reference is made herein to the upward orientation, it relates to the orientation of the probe 10 when used with a standing patient. It is however understood that the probe end 13 does not project upwardly from the base 12 when the probe 10 is used with the patient in a supine position, i.e. , the probe end 13 is cranially oriented along the cranial-caudal axis of the patient. The probe end 13 comprises a structural bar 30 or like structural member, acting as a sensor body (a. k.a. , proof body). The structural bar 30 is typically made of a rigid and relatively stiff material such as a metal (e.g. , aluminum). The structural bar 30 has a lower interface 31 by which the structural bar 30 is secured to the cylindrical body 20 of the base 12. At the opposed end of the structural bar 30, an upper interface 32 is provided. Both the lower interface 31 and the upper interface 32 have a generally cylindrical body with a circular section, although other geometries may be used as well. In an embodiment, the lower interface 31 and the upper interface 32 are integrally and continuously formed with the sensor body portion of the structural bar 30. A connector 33 is defined at the end of the upper interface 32. In the illustrated embodiment, the connector 33 may be a tapped bore to be used with a fastener, such as a bolt. The tapped bore may be machined and/or cast into the free end of the structural bar 30.

[0039] Still referring to Figs. 1 and 3, sensor surfaces 34 are defined between the lower interface 31 and the upper interface 32. The sensor surfaces 34 are generally flat and smooth and are parallel to one another. The sensor surfaces 34 will receive thereon sensors such as strain gages, flexion gauges, deformation sensors and appropriate circuit arrangements for communication with a processing unit (e.g. , Wheatstone bridge, differential resistance arrangement, etc). As shown in Figs. 1 and 3, according to an embodiment, the sensors A and B are respectively provided at a distal end and at a proximal end of each of the sensor surfaces 34 (only one of each sensor A and B shown in Figs. 1 and 3 as only one of the sensor surfaces 34 is visible).

[0040] An outer shell of the probe end 13 is formed by a first cantilevered blade 40 connected to the lower interface 31 of the structural bar 30. The first cantilevered blade 40 has an annular base 41 that is mounted about the lower interface 31. A blade portion 42 projects upwardly from the annular base 41. In the illustrated embodiment, the annular base 41 and the blade portion 42 are an integral monolithic piece. Other constructions are considered as well. When the probe end 13 is installed in the cavity, the blade portion 42 is one of the interfaces of the probe end 13 with the tissue of the cavity. Hence, forces sustained by the blade portion 42 will be transmitted to the annular base 41 and thus have an impact on the structural bar 30. Therefore, by having gauges on the sensor surfaces 34 of the structural bar 30, forces sustained by the blade portion 42 will be measured.

[0041] Referring to Fig. 1 , a second cantilevered blade 50 has a similar configuration to that of the first cantilevered blade 40. The second cantilevered blade 50 has an annular blade 51 and a blade portion 52, with these components being separate, or integral (monolithic). However, when the second cantilevered blade 50 is mounted to the structural bar 30, the blade portion 52 projects downwardly from the annular base 51 to the contrary of the blade portion 42 projecting upwardly of the annular base 41 , again relative to the probe 10 being inserted in a standing patient. The blade portion 52 is the other interface of the probe end 13 with the tissue of the cavity. Hence, when the annular base 51 is mounted on the upper interface 32 of the structural bar 30, the flexions and forces sustained by the blade portion 52 will be transmitted to the upper interface 32 of the structural bar 30.

[0042] A cap 60 may be mounted atop the annular base 51 and secured to the structural bar 30 by way of a fastener 61 cooperating with the tapped bore of the connector 33. The cap 60 is shaped to provide a generally smooth and continuous surface to the probe end 13 to facilitate its insertion in the cavity. Other configurations are considered, such as providing the cap 60 directly onto the annular base 51. In Fig. 5, the cap 60 is shown having a hemispherical shape, while the cantilevered blades 40 and 50 concurrently form a cylinder. [0043] The force applied on either one of the blade portions 42 and 52 is measured for instance by two (2) pairs of strain gages placed on the sensor surfaces 34 of the structural bar 30. Accordingly, the arrangement of cantilevered blades 42 and 50 as connected to the structural bar 30 allows the measurement of the force without increased sensitivity related to the point of application of the force on the blade portions 42 and/or 52. More specifically, the first blade portion 42 is connected at a proximal end of the structural bar 30 and projecting distally, and the second blade portion 52 is connected at a distal end of the structural bar 30 and projects proximally, allowing suitable measurements in a compact format.

[0044] Hence, as shown in Fig. 5, when the first cantilevered blade 40 and the second cantilevered blade 50 are both mounted onto the structural bar 30, the probe end 13 has a generally phallic shape, of circular section. This entails that both of the first cantilevered blade 40 and the second cantilevered blade 50 have a substantially semi-circular section, to concurrently define the circular section of the probe end 13. The diameter of the probe end 13, resulting from the combination of the cantilevered blades 40 and 50, is selected to ensure that the probe end 13 remains in the cavity unless pulled out, while not exerting excessive pressure on the soft tissue by being overly large. For instance, a suitable diameter range for the probe end 13 is from 15 to 30 mm (0.59 to 1 .1 8 inches). It is also observed that the probe end 13 is relatively compact, in that its length is not excessively longer than its diameter. In an embodiment, both cantilevered blades 40 and 50 and fully inserted in the cavity during use, as opposed to prior art systems in which the cantilevered blades project out of the cavity. Hence, the "leveraging" effect of having long cantilevered blades is reduced by having shorter cantilevered blades, such as the dimensioning shown in the figures, with the cantilevered blades 40 and 50 concealed in the cavity during use. For instance, the probe end 13 has a penetrating length of 50 to 75 mm (1 .96 to 29.5 inches).

[0001] There are slits between the edges of the first cantilevered blade 40 and the second cantilevered blade 50. These slots are kept to a minimum width, sufficient to prevent contact between the first cantilevered blade 40 and the second cantilevered blade 50 when the probe end 13 is inserted in the cavity so as not to have contact falsify the readings from gauges. Moreover, the gauges are strategically positioned to isolate as much as possible the effect of each single cantilevered blade, 40 and 50, to obtain an independent measure of the force sustained by each cantilevered blade 40 and 50. Hence, an individual assessment of the forces produced by soft tissue on each side of the probe end 13 may be obtained, as opposed to obtaining a single global measure encompassing the forces produced by soft tissue on both sides of the probe end 13.

[0002] As observed partially from Fig. 2, the probe end 13 may have an enlarged central portion relative to its opposed ends, which enlarged portion is generally aligned with the pelvic floor muscles when the probe 10 is being used. There are advantages to this. For instance, there is better contact of the probe end 13 with the pelvic floor muscles so that the muscle force can be applied directly without any displacement of the probe 10 in the vagina. Moreover, the enlarged center part compared to the external part makes the probe end 13 stay inside the vagina even when the patient is in the standing position.

[0003] According to an embodiment, the first cantilevered blade 40 and the second cantilevered blade 50 are made of an economical material (e.g. , aluminum, plastic) such as to be thrown away after use (e.g. , especially the plastic version). On the other hand, it may be considered to reuse the structural bar 30 and the base 12, for instance with a shield such as a condom thereon, and with a subsequent cleaning process, such as disinfection or sterilization (provided a sterilization process could be used that would not affect the bond of the sensors on the sensor surfaces 34). These components, as well as the cantilevered blades 40 and 50, should preferably be disinfected prior to use. The height of the probe end 13 may be within wide ranges, as mentioned above. The strain gages may be arranged in a differential configuration to render the force measurement independent of leverage and thus of the dept of insertion of the probe end in the cavity. According to an embodiment, the spacing between the cantilevered blades 40 and 50 may be varied and is typically between 0 and 5-15 mm. Distance may be varied and measured to determine the opening dimensions of the cavity, and to have suitable contact between the probe end 13 and the tissue of the cavity.

[0004] Referring to Fig. 4, there is illustrated a structural bar 30' with four (4) different sensor surfaces relative to the blade portion 42'. The probe 10' of Fig. 4 is designed to measure pelvic floor forces along two axes, namely the antero-posterior axis and the latero- lateral axis.

[0005] The probe 10 is connected to an appropriate processing unit (including wireless connection), and may be used to provide substantially real-time data. In such an embodiment, as the probe 10 may be used to provide real-time data relating to the pelvic floor muscle function i.e., passive and active forces, the probe 10 may be used as diagnostic tool to assess pelvic floor muscle function or as a biofeedback apparatus to treat pelvic floor muscle dysfunction conditions such as urinary and fecal incontinence, pelvic organ prolapse or painful or hypertonic pelvic floor. Other uses are considered as well.

[0006] For instance, the probe 10 may be equipped with components for vascular measurement, i.e. , an optical measurement unit could be added to the probe end 13 to measure or evaluate tissues blood flow rate, hemodynamic and oxygenation characteristics of the soft tissue. It is contemplated to place the optical measurement unit to obtain measurements in 3 areas, among others, in the case of pelvic floor muscle applications: periurethral tissues, pelvic floor muscles, and peri-vaginal mucosal tissues. The optical measurement unit, generally shown having light emitting sensor at 70 would be located on the external surface of the external body of the probe end 13 anteriorly to monitor peri- urethral vascularity, laterally to measure pelvic floor muscle vascularity, or at both locations (but with measurement taken at a more superficial depth) and posteriorly to monitor perivaginal mucosa.

[0007] This optical measurement unit may be used to monitor peripheral vascularisation in women after a traumatic vaginal delivery, with vulvo-vaginal diseases, with urinary incontinence, with pelvic organ prolapse or in aging women with vaginal atrophy, prior to any intervention for the previous condition such as physiotherapy, medications and surgery and/or after them, to determine their effect on blood flow in the tissues.

[0008] Surface electrodes could also be added to the probe end 13 in order to measure the EMG activity of the pelvic floor muscle for example, or to provide therapeutic neuromuscular electrical stimulation (N MES) to the pelvic floor muscle. For instance, surface EMG electrodes could provide information on pelvic floor muscle activation and EMG activity at rest and during contraction. Further, surface N MES is well suited in pelvic floor muscle applications, when a women electrotherapy treatment is needed such as for pain (TENS-like frequencies (transcutaneous electrical nerve stimulation) or for weakness or atrophy Estim-like frequencies (erotic electrostimulation)). An EMG/NMES measurement unit may have two surface electrodes that would be applied postero-laterally on the external surface of the probe end 13 of the probe 10. The electrodes may be made of platinum or any other conductive material known in the related art.

[0009] A pressure measurement system could be added to the probe 10 and processor in order to measure deep intra-vaginal pressure (a surrogate of intra-abdominal pressure), in pelvic floor muscle applications. The pressure sensor could be added to the cap 60 of the probe end 13 in order be the deepest part of the probe 10 when inserted in the vagina, in pelvic floor muscle applications. This additional system may be used to monitor and give feedback to women with pelvic floor muscle dysfunctions, urinary incontinence and/or prolapse or in women after gynaecological surgery in which deep intra-abdominal pressure should be kept low. Measurement could be performed at rest, during pelvic floor muscle exercises or any activities likely to increase intra-vaginal pressure.

[0010] All these additional measurements could be taken at the same time as pelvic floor muscle force measurement to have a more complete assessment of PFM function.