US20120053017A1

US20120053017A1 - Method and apparatus for exercising pelvic floor muscles

Info

Publication number: US20120053017A1
Application number: US13/319,577
Authority: US
Inventors: Ira Kushnir
Original assignee: PEFLEX MEDICAL INSTRUMENTS Ltd
Current assignee: PEFLEX MEDICAL INSTRUMENTS Ltd
Priority date: 2009-05-14
Filing date: 2010-05-13
Publication date: 2012-03-01
Also published as: WO2010131252A3; EP2429626A2; EP2429626A4; WO2010131252A2

Abstract

An exercising set for exercising the pelvic floor muscles of a patient comprises: at least one insert fitted for a human body cavity mechanically interconnected to a force generating means by means of a connector. The human body cavity is selected from: woman's vaginal cavity or any user's inner rectal cavity. The force generating means is adapted to generate a pulling force which is lower than the contraction force of said patient's pelvic floor muscles when applied on the at least one insert to prevent the insert leaving the human body cavity.

Description

FIELD OF THE INVENTION

The present invention relates to a method and an apparatus for physical exercising, and more particularly a method and an apparatus for exercising of pelvic floor muscles.

BACKGROUND OF THE INVENTION

The most important function of the pelvic floor is to support organs that are located in the pelvis and to help supporting the breathing process. Dysfunctions in the pelvic floor muscles can cause various symptoms and related problems such as urinary and fecal incontinence, prolapses, detrusor instability, infections, inflammations and pain in the vaginal and rectum area.
Pregnancy may also cause various dysfunctions of the pelvic floor muscles leading to sexual disorders such as severe pain, anorgasmia and the like.
Pelvic floor dysfunction can often result from trauma, radiotherapy, incorrect toilet behavior, excessive coughing, heavy lifting, hormonal changes, neurological disorders, aging and may other causes.
Today various exercising methods such as Pilates, the Paula Method or Yoga enable many women and men to strengthen their pelvic floor muscles. Unfortunately, these exercises are hard to practice since it is extremely hard to know whether all the pelvic floor muscles are being exercised. To separate the inner pelvic muscles that are being practiced from other abdominal and hip muscles requires high expertise and there is no precision in the level of progress of the pelvic muscles build up.
Inner vaginal weights (often called “inner vaginal cones”) are devices that can be inserted into the patient's vagina in a similar way to inserting a tampon into the vagina of a female patient.
To practice the pelvic floor muscles the patient is required to simply hold the weight inside the vaginal cavity as long as she can. The weight of the cone is held by the patient's pelvic floor muscles, which hold the cone inside the vaginal cavity and thereby exercises these specific muscles.
The weight of the cones can be increased by replacing a lighter cone with a heavier one, for instance, to allow the patient to progress with the exercises by applying increasing loads upon the muscles.
This practice has proven extremely efficient in strengthening pelvic floor muscles, yet the device itself causes several problems.
One major problem with these cone weights is that due to their weight they can be stuck in a niche inside the patient's body cavity when the pelvic muscles are not exercised, in this situation the cones may stretch soft tissues inside that cavity, which in time, may lead to pelvic prolapse.
Each cone may be a single weight of a predefined weight, requiring the patient takes out a first cone of weight “W1” from her vagina and insert a new cone of weigh “W2” where W1<W2 to increase the force required by the pelvic floor muscles to hold the cone therein.
The cone may alternatively be comprised of a containing device enabling to open and close, where the weights can be removably placed therein, so that the patient can place a first weight “W1” in the device, insert the device into her vagina and then take it out, place another weight “W2” therein and insert the device again. These steps have to be repeated each time the patient needs to increase/decrease the weight in the cone.
Since the cone has to be inserted into the body cavity of the patient, the cone has to be repeatedly cleaned each time it is taken out and inserted into the patient's body cavity.
Since each exercising session can require exchanging more than one weight to increase and decrease the load applied on the pelvic floor muscles, this can be a tiresome job, which may lead the patient to either neglect the exercising altogether or skip the sterilizing process, which may be hazardous to the patient's health and hygiene.
U.S. Pat. No. 5,213,557 discloses a device for exercising pelvic floor muscles by insertion into the vagina of a woman comprises at least one weight, and a casing with two or more parts releasably and sealingly connected, to define an internal cavity for receiving one or more of the weights. The cavity is preferably of plastics material, the parts having a snap fit connection, and a retrieval tag may also be incorporated. A set of weights is preferably provided, so that the mass of the device can be varied by choosing one or more of the weights.
U.S. Pat. No. 5,407,412 discloses a plurality of devices having a physiologically inert plastics outer surface and each have identical size and shape, but are of graded weights. A device is inserted into the vagina of a subject, and if the pelvic floor muscles are capable of retaining that weight, the device is replaced by a heavier one. The heaviest device that can be retained is a measure of a pelvic floor muscle strength, and the muscles can be exercised by retaining the device for a predetermined time, such as 15 to 20 minutes per day.
U.S. Pat. No. 6,165,108 discloses an apparatus and method for exercising and improving the muscle tone of the feminine pelvic floor muscles utilizing an elongated vaginal insert having enlarged rounded ends and a substantially reduced cross-sectional middle portion. The ends of the apparatus are of different sizes in order to facilitate different levels of exercise, thus giving the apparatus a disproportional hourglass shape. The enlarged ends gradually reduce in circumference proximate the middle portion of the apparatus, thus creating two inclined surfaces.
U.S. Pat. No. 6,068,581 discloses a pelvic floor muscle weight training kit includes a casing with a cap and a bottom, a set of weights, and a retaining member mounted on each of the weights. The cap has a first inside thread, and the bottom has a second inside thread. Each of the weights is different in shape and weight and is replaced in the casing individually. The retaining member has a third thread. The first and second threads of the casing are capable of being threaded with the third thread of the retaining member such that each of the weights is retained in a universal casing individually. The pelvic floor muscle weight training kit also provides for a method of testing and/or exercising pelvic floor muscles.
U.S. Pat. No. 6,183,402 discloses a vaginal weight is provided which includes a tubular portion with a rounded end for enabling smooth insertion into a vagina. Another flat end and/or roughened surface disposed on the tubular portion enables user sensed vaginal resistance during outward movement of the weight in order to cause enhanced facilitation. A method utilizing the weights of the invention provides for exercising and examining the striated musculature.
US patent application No. 2008/0096736 A1 discloses an exercise device for strengthening the pelvic muscles of a patient including a hollow body member, a stud fastening the body member to an end cap to close the interior of the body member, and a plurality of weights removably mounted to the stud to permit the device to have different weights to provide the necessary exercise for different patients and for varying the weight of the device as the pelvic muscles of the patient strengthen.

SUMMARY OF THE INVENTION

It is one object of the present invention to provide an exercising set for exercising the pelvic floor muscles of a patient, which comprises: at least one insert fitted for a human body cavity mechanically interconnected to a force generating means by means of a connector. The human body cavity is selected from: woman's vaginal cavity or any user's inner rectal cavity.
It is within the scope of the present invention that the force generating means is adapted to generate a pulling force which is lower than the contraction force of the patient's pelvic floor muscles when applied on the at least one insert to prevent the insert leaving the human body cavity.
It is another object of the present invention to provide the exercising set as defined above, wherein the exercising set further comprises an indicator adapted to provide indication and feedback regarding the displacement of the force generating means caused by the contraction of the patient's pelvic floor muscles.
It is another object of the present invention to provide the exercising set as defined above, wherein the indicator comprises a displacement sensor selected from a group consisting of: an accelerometer, a laser displacement sensor, RF sensor, a visual indicator, or any combination thereof.
It is another object of the present invention to provide the exercising set as defined above, wherein the at least one insert comprises connection means adapted to mechanically connect the at least one insert to the connector.
It is another object of the present invention to provide the exercising set as defined above, wherein the connector is selected from a group consisting of: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof.
It is another object of the present invention to provide the exercising set as defined above, wherein the spring is a compression spring.
It is another object of the present invention to provide the exercising set as defined above, wherein the connector is provided with a grasping means selected from: a fastener or a holder. the grasping means is adapted to join the connector with the connection means.
It is another object of the present invention to provide the exercising set as defined above, wherein the insert is a tampon.
It is another object of the present invention to provide the exercising set as defined above, wherein the insert is provided with at least one disposable coating layer adapted to cover the at least one insert.
It is another object of the present invention to provide the exercising set as defined above, wherein the coating layer is made of elastic isolating materials.
It is another object of the present invention to provide the exercising set as defined above, wherein the insert is provided with an applicator adapted to assist the insertion of the insert into the human body cavity.
It is another object of the present invention to provide the exercising set as defined above, wherein the connector is selected from a group consisting of: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof.
It is another object of the present invention to provide the exercising set as defined above, wherein the force generating means comprises an assembly of one or more weights which are releasably interconnected.
It is another object of the present invention to provide the exercising set as defined above, wherein the assembly of one or more weights is arranged in vertical row.
It is another object of the present invention to provide the exercising set as defined above, wherein the one or more weights are interconnected via means selected from: magnetic means, screw means, fastening means, or any combination thereof.
It is another object of the present invention to provide the exercising set as defined above, wherein the assembly of one or more weights is accommodated in a weight-holder. the weight-holder is mechanically connected to the connector.
It is another object of the present invention to provide the exercising set as defined above, wherein the pulling force applied on the assembly of one or more weights and on the insert is the gravity force.
It is another object of the present invention to provide the exercising set as defined above, further comprises a vibrator adapted to is mechanically connected to the assembly of one or more weights in a way that allows the vibrator to vibrate the assembly of one or more weights.
It is another object of the present invention to provide the exercising set as defined above, wherein the force generating means comprises a pull mechanism for applying a pulling force on the insert.
It is another object of the present invention to provide the exercising set as defined above, wherein the pull mechanism is driven by an energy selected from a group consisting of: a mechanical, an electrical, a magnetic, a pneumatic, a thermal, or any combination thereof.
It is another object of the present invention to provide the exercising set as defined above, wherein the pull mechanism is an electrical motor with a cam. the direction, the speed and the time of the rotation of the electrical motor are fully controllable. the connector is connected to the cam. the pull mechanism is adapted to convert the round movement of the electrical motor to a linear movement of the connector.
It is another object of the present invention to provide the exercising set as defined above, wherein the pull mechanism is mechanically fixed to the surface it is located on.
It is another object of the present invention to provide the exercising set as defined above, wherein the rotation axis of the cam is perpendicular to the connector.
It is another object of the present invention to provide the exercising set as defined above, wherein the exercising set is adapted for training of when the patient is in a position selected from: vertical, horizontal, or any other predetermined inclination.
It is another object of the present invention to provide the exercising set as defined above, wherein the horizontal training further comprises a treatment bed adapted to accommodate the patient on the same. in the horizontal training, the force generating means is located on the treatment bed in front of the patient.
It is another object of the present invention to provide a method for training pelvic floor muscles of a patient by a resistance to a pulling force generated by an exercising set. The method comprises steps of:

a. providing exercising set for exercising the pelvic floor muscles of a patient, comprises: at least one insert fitted for a human body cavity mechanically interconnected to a force generating means by means of a connector. the human body cavity is selected from: woman's vaginal cavity or any user's inner rectal cavity.
b. inserting the at least one insert into the human body cavity.
c. generating a pulling force via the force generating means.
d. squeezing the human body cavity by the patient, by contracting the pelvic muscles of the same.

It is within the scope of the present invention that the step (d) of squeezing the human body cavity by the patient is adapted to prevent the insert from leaving the human body cavity, such that the force generated by the force generating means is lower than the contraction force of the pelvic muscles.
It is another object of the present invention to provide the method as defined above, wherein the at least one insert comprises connection means. further wherein the method further comprises step of connecting the at least one insert to the connector via the connection means.
It is another object of the present invention to provide the method as defined above, further comprises step of providing the exercising set with an indicator adapted to provide indication and feedback regarding the displacement of the force generating means caused by the contraction of the patient's pelvic floor muscles.
It is another object of the present invention to provide the method as defined above, wherein the indicator comprises a displacement sensor selected from a group consisting of: an accelerometer, a laser displacement sensor, RF sensor, a visual indicator, or any combination thereof.
It is another object of the present invention to provide the method as defined above, further comprises step of selecting the connector from a group comprises: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof.
It is another object of the present invention to provide the method as defined above, wherein the spring is a compression spring.
It is another object of the present invention to provide the method as defined above, further comprises step of connecting the connector to the connecting means via a grasping means selected from: a fastener or a holder.
It is another object of the present invention to provide the method as defined above, wherein the at least one insert is a tampon.
It is another object of the present invention to provide the method as defined above, further comprises step of providing the at least one insert with at least one disposable coating layer adapted to cover the at least one insert.
It is another object of the present invention to provide the method as defined above, wherein the coating layer is made of elastic isolating materials.
It is another object of the present invention to provide the method as defined above, wherein the step (b) of inserting the at least one insert into the human body cavity is performed by using an applicator adapted to insert the at least one insert into the human body cavity.
It is another object of the present invention to provide the method as defined above, further comprises step of selecting the connector from a group comprises: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof.
It is another object of the present invention to provide the method as defined above, wherein the force generating means comprises an assembly of one or more weights which are releasably interconnected.
It is another object of the present invention to provide the method as defined above, wherein the assembly of one or more weights is arranged in vertical row.
It is another object of the present invention to provide the method as defined above, wherein the one or more weights are interconnected via means selected from: magnetic means, screw means, fastening means, or any combination thereof.
It is another object of the present invention to provide the method as defined above, wherein the assembly of one or more weights is accommodated in a weight-holder. the weight-holder is mechanically connected to the connector.
It is another object of the present invention to provide the method as defined above, wherein the pulling force applied on the assembly of one or more weights and on the insert is the gravity force.
It is another object of the present invention to provide the method as defined above, further comprises step of providing the exercising set with a vibrator adapted to is mechanically connected to the assembly of one or more weights in a way that allows the vibrator to vibrate the assembly of one or more weights.
It is another object of the present invention to provide the method as defined above, wherein the force generating means comprises a pull mechanism for applying a pulling force on the insert.
It is another object of the present invention to provide the method as defined above, wherein the pull mechanism is driven by an energy selected from a group consisting of: a mechanical, an electrical, a magnetic, a pneumatic, a thermal, or any combination thereof.
It is another object of the present invention to provide the method as defined above, wherein the pull mechanism is an electrical motor with a cam. the direction, the speed and the time of the rotation of the electrical motor are fully controllable. the connector is mechanically connected to the cam. the pull mechanism is adapted to convert the round movement of the electrical motor to a linear movement of the connector.
It is another object of the present invention to provide the method as defined above, wherein the pull mechanism is mechanically fixated to the surface it is located on.
It is another object of the present invention to provide the method as defined above, wherein the rotation axis of the cam is perpendicular to the connector.
It is another object of the present invention to provide the method as defined above, wherein the exercising set is adapted for training of when the patient is in a position selected from: vertical, horizontal, or any other predetermined inclination.
It is another object of the present invention to provide the method as defined above, wherein the horizontal training further comprises a treatment bed to accommodate the patient on the same. in the horizontal training, the force generating means is located on the treatment bed in front of the patient.

BRIEF DESCRIPTIONS OF THE DRAWINGS

In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments is adapted to now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which

FIG. 1 is a schematic illustration of an exercising set and a patient, for exercising woman's pelvic floor muscles, according to some embodiments of the invention in a vertical position of the patient;

FIG. 2 is a schematic illustration of an exercising set, for exercising patient's pelvic floor muscles, according to other embodiments of the invention that comprises a wire and an assembly of weights;

FIG. 3 is a schematic illustration of an exercising set, for exercising patient's pelvic floor muscles, according to other embodiments of the invention that comprises a spring and an assembly of weights;

FIG. 4 is a schematic illustration of an exercising set, for exercising patient's pelvic floor muscles, according to other embodiments of the invention that comprises a spring, an assembly of weights and a vibrator;

FIG. 5 is a schematic illustration of an exercising set, for exercising patient's pelvic floor muscles, according to other embodiments of the invention that comprises a wire and a pull mechanism;

FIG. 6 is a schematic illustration of an exercising set, for exercising patient's pelvic floor muscles, according to other embodiments of the invention that comprises a spring and a pull mechanism;

FIG. 7 is a schematic illustration of an exercising set and a patient, for exercising female's pelvic floor muscles, according to other embodiments of the invention in a horizontal position of the patient;

FIGS. 8 a-b is a schematic illustration of an exercising set and a patient, for exercising female's pelvic floor muscles, according to other embodiments of the invention.

DETAILED DESCRIPTIONS OF THE INVENTION

FIG. 1 schematically illustrates an embodiment of the exercising set 100 for exercising in a vertical position female's 200 pelvic floor muscles, comprising at least one insert 50, a connector 30, and force generating means 5. The insert 50 is mechanically interconnected to the force generating means 5 by means of connector 30. The insert 50 is for example, a tampon.
The force generating means 5 is adapted to apply a pulling force on the insert 50, such that the patient 200 is stimulated to contract the pelvic muscles to prevent the insert 50 from leaving the human body cavity.
According to the preferred embodiment of the present invention, patient 200 is female.
According to some embodiments of the present invention, insert 50 may have a rounded curved shape suited to fit in the vaginal cavity 210 to which it is designed to be inserted. For example, the shape of insert 50 may be slightly narrower at the top part and slightly wider at the bottom part, in a manner that fits the inner side of a standard woman's vaginal genitalia or any user's rectal inner body cavity 210 (e.g. a pear shape or a tampon shape).
The insert 50 may have a smooth surface to allow easy and painless insertion of the insert 50 into the vaginal cavity 210. Additionally, the set 100 may include lubrication material (e.g. Vaseline or any other lubrication for inner body tissue) for the user to put on the surface of the insert 50. The insert 50 may have little weight in comparison to the force generating means 5 required for the exercise.
According to some embodiments, connector 30 is selected from a group consisting of: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof.
FIG. 2 schematically illustrates a specific embodiment of the exercising set 100 a, which comprises an insert 50, a connector which is a wire 32, and a force generating means which is according to this embodiment is an assembly of weights 10. The insert 50 is mechanically interconnected to assembly of weights 10 by means of wire 32. According to this embodiment, the insert 50 is unlimitedly a tampon.
According to some embodiments of the invention, as illustrated in FIG. 2, insert 50 may comprise a connection means 55 such as a string (e.g. a cotton string similar to a tampon string), which extends from the lower part of the insert 50. The other end of the connection member may be free enabling to connect to the same the wire 32.
The overall size of the insert 50 may be either in the range of standard tampon sizes or smaller. The smaller the insert 50 is, the harder it may be for the patient to hold it in the vaginal cavity. Therefore, the patient may be required to apply more muscles' strength to narrow the annular pelvic muscles in order to hold the insert 50 inside the vaginal cavity, especially while the insert 50 is interconnected with an assembly of weights 10 having to also hold the weight of the assembly of weights pushing the insert 50 downwards and out of the body cavity.
According to some embodiments of the present invention, the tampon which is used in the exercising set may be characterized by a varying size. For example, one size (e.g., big, regular, etc.) of a tampon may be used at the beginning of the treatment course, a smaller size may be used after a predetermined period of time, and the size may be reduced more at the rest of the treatment course. The main idea behind the reduction of the tampon's size is that as the tampon is smaller, more contraction force of the pelvic muscles is needed in order to hold the tampon.
According to some embodiments of the invention, as illustrated in FIG. 2, the embodiment of the exercising set 100 a may further comprise one or more disposable hygiene coating layer 52 enabling the user to cover the insert 50 before inserting it into the vaginal cavity and remove the coating layer 52 when the insert 50 is removed from the vaginal cavity. Coating layer 52 may be made of elastic isolating materials, which may be sterilized, such as sterile rubber (e.g. such as used for condoms). Coating layer 52 may be made of materials that enable isolating the insert 50 from the body cavity preventing substances and particles from diffusing from one side of the layer 52 to another. Additionally, the coating layer 52 may further comprise lubrication materials covered on the outer surface of the coating layer 52 to allow easy insertion of the insert 50 and layer 52 into the vaginal cavity.
According to some embodiments of the invention, as illustrated in FIG. 2, the embodiment of the exercising set 100 a may further comprise a wire 32 which has a role of a connector. Wire 32 is provided with fastener 38 to join the wire 32 with the connection means of the insert 50. For example, the fastener 38 may comprise crocodile clips connected mechanically to the wire 32 to hold the free end of the connection member 55 by tightly clutching to it.
The length of the connection means 55 may be suitable to enable an upper part of the connection means 55 to be inserted along with the insert 50 inside the female's vaginal cavity, while the rest of the connection means 55 (meaning the lower part of the connection means 55) emerges from the vaginal cavity. Once the insert 50 is fully inserted therein, the lower part of the connection means 55, the fastener 38, the connector 32 and the force generating means are out of the vaginal cavity.
The assembly of weights 10 may comprise one or more weights 8 that can be connected to the wire 32 through various means (e.g. a loop, a ring or a hook member) in the connection point 39. The weights 8 in the assembly of weights 10 are arranged in a vertical row.
Once the insert 50 is securely seated inside the vaginal cavity, the number of weights 8 in the assembly of weights 10 can be increased or decreased in order to change the gravity force applied on the weights and consequently on the pelvic floor muscles of the patient. The connection of the weights 8 to the assembly of weights 10 can be performed by screwing means (or magnetic means) of one weight 8 into another. In some embodiment of the exercising set 100 a, the assembly of weights 10 may comprise 5 weights 8, weighing 25, 50, 100, 150, 200, 250, 300 gr. respectively.
According to some embodiments of the invention, as illustrated in FIG. 2, an applicator 300 enabling to guide the insert 50 into the female's vaginal cavity may be added to the set 100 a. The applicator 300 may be a cylindrical device comprising a tube and a guide stick or cylinder enabling receiving the insert 50 at its top edge and guiding it into the vaginal cavity by placing the insert 50 at the edge of the applicator 300, inserting a portion of the applicator 300 into the vaginal cavity and pushing the guide stick or cylinder along the tube to allow pushing the insert 50 further inside the vaginal cavity. The applicator 300 may be similar to a tampon applicator or any other medicine applicator suited for inserting medicine into the inner pelvic area as known in the art, where the applicator's 300 size is compatible to the size of the insert 50.
FIG. 3 schematically illustrates a further embodiment of the exercising set 100 b. This embodiment comprises elements which are similar to the elements of the embodiment illustrated in FIG. 2, except for the connector, which in this case is a spring 34.
FIG. 4 schematically illustrates a further embodiment of the exercising set 100 c. This embodiment comprises elements and composition which are similar to the elements and composition of the embodiments 100 a and 100 b, in the means of a connector which can be a wire or a spring 34, and in the means of force generating means which is an assembly of weights 10. Embodiment 110 c illustrates an addition of a vibrator 12 connected mechanically to the assembly of weights 10 in a way that allows the vibrator 12 to vibrate the assembly of weights 10. In one embodiment of exercising set 100, the connection of the vibrator 12 to the assembly of weights 10 may be performed by screwing (or attaching by other means) the vibrator into the lower of the lowest weight 8 in the assembly of weights 10. The vibration of the vibrator 12 creates variability in the force applied on the assembly of weights 10, and consequently requires variable contraction of pelvic floor muscles.
FIG. 5 schematically illustrates some embodiment of the exercising set 100 d, comprising an insert 50; a wire 32; and at least one pull mechanism 6 which is according to some embodiment of the invention is an electrical motor with a cam 4. The insert 50 is for example a tampon. The insert 50 is mechanically interconnected to the pull mechanism 6 by means of a wire 32. The pull mechanism 6 converts the round movement of the cam 4 to a linear movement of the wire 32, and creates a pulling force applied on the insert 50. The pull mechanism 6 is connected to the wire 32 in the connection point 40 through various connection means such as a loop, while the wire is able to rotate around the connection point when the cam 4 is rotating. The pull mechanism 6 is mechanically fixated to the floor 1. The rotation axis of the cam 4 is perpendicular to the wire 32. The direction, the speed and the time of the rotation of the electrical motor are fully controllable, for example, through a remote control.
FIG. 6 schematically illustrates a further embodiment of the exercising set 100 e. This embodiment comprises elements which are similar to the elements of the embodiment illustrated in FIG. 5, except for the connector, which in this case is a spring 34.
FIG. 7 schematically illustrates a further embodiment of the exercising set 101. This embodiment comprises elements which are similar to the elements of the embodiment illustrated in FIG. 2 in the exercising set 100 a, except for a horizontal position of the patient 200 which may be lying on a treatment bed 2. The connector 30 can be a wire or a spring as presented in embodiments 100 a-100 e in FIGS. 2-6. The force generating means is the pull mechanism 6 as presented in embodiments 100 d-100 e in FIGS. 5-6. The pull mechanism 6 is mechanically connected to the treatment bed 2.
FIGS. 8 a-b schematically illustrates a specific embodiment of the present invention, in which the force generating means is an assembly of weights 110, which are connected to spring 120. According to the preferred embodiment of the present invention, spring 120 is a contraction spring, which is contacted when the gravity force is applied on the assembly of weights 110.
According to other embodiment, the weights are interconnected via magnetic means.
According to other embodiment, the connector of the present invention is provided with a grasping means 130 selected from: a fastener or a holder; said grasping means 130 being adapted to join said connector with said connection means.
According to other embodiment, the exercising set further comprises an indicator adapted to provide indication and feedback regarding the displacement of said force generating means caused by the contraction of said patient's pelvic floor muscles. The indicator may be connected to the force generating means, and more specifically to the assembly of weights. The indicator may comprise a displacement sensor selected from a group consisting of: an accelerometer, a laser displacement sensor, RF sensor, a visual indicator, or any combination thereof.
In the embodiment of an accelerometer as a displacement sensor, the indicator may also comprise integrators, and when the weights move in the Z axis, and indication means such as LED or sound indication means will be activated.
In the embodiment of a laser as a displacement sensor, the laser may be used in order to detect the displacement by sending as receiving light in the direction of the floor, or in another direction.
In the embodiment of a RF sensor as a displacement sensor, the differences between the sent and the received signals will be detected, the displacement will be measured.
In the embodiment of a visual indicator as a displacement sensor, the user may visually detect that a predetermined movement has occurred. For example, a laser visual indication.
In a further embodiment of the exercising set embodiments 100 and 101, when the connector is a spring, the properties of the spring are the following:
The length of the spring is 5 cm.
For weights of 50-100 gr., the constant of the spring is k=15-20.
For weights of 100-300 gr., the constant of the spring is k=36-46.
The inventors have found that in the preferred embodiment of the invention, the contraction spring is characterized by k which is about k=80 (with one spring), implemented with weights up to 300 gr. The spring which is used in different embodiments of the present invention, is characterized by at least configuration: a loose condition, and a compressed/expanded condition in which an elastic energy is stored within the spring.
In a further embodiment of the exercising set embodiments 100 and 101, when using a pull mechanism 6 (for example in FIG. 5-6), the following parameters of the pull mechanism 6 may be configurable:

- 1) Type of force: plain continuous or impulses.
- 2) Force intensity [N]
- 3) In case of impulses as a force type, the length of the time in which the force is applied (T_force) and the length of the time in which the force is not applied (T_rest) may be set. When T_force=T_rest, the overall frequency may be set.
- 4) The overall time of exercising procedure.

The pull mechanism 6 may also be programmable to specific pre-defined exercising program sets, which may be modified as needed.
The exercising set in the embodiment 100 has been tested on 150 women. Below are presented a few success stories:

- 1) Ravit has suffered from Stress incontinence. She has been treated with the exercising training set in 15 treatment series. During the treatment series, her condition has been improved. Towards the end of the treatment series, she has raised the weigh of weight assembly in the training set and the difficulty of the treatment series has been raised. In the end of the treatment series, her condition was much better (for example, laughing, sneezing and coughing, didn't cause incontinence).
- 2) Stefany has suffered from urge incontinence. She has been treated with the exercising training set in 12 treatment series. Towards the end of the treatment series, she indicated an improvement in the ability to control her urinary system exits. There frequency of the urinary exits was much lower.
- 3) Osnat has suffered from vestibulitis. She has been treated with the exercising training set in 20 treatment series. Towards the end of the treatment series the pain disappeared, though, she still has a low sexual desire, and has to be under the accompaniment of a sexologist.

Claims

1-50. (canceled)

51. An exercising set for exercising the pelvic floor muscles of a patient, comprising: at least one insert fitted for a human body cavity mechanically interconnected to a force generating means by means of a connector; said human body cavity being selected from: woman's vaginal cavity or any user's inner rectal cavity;

wherein said force generating means is adapted to generate a pulling force which is lower than the contraction force of said patient's pelvic floor muscles when applied on said at least one insert to prevent said insert leaving said human body cavity.

52. The exercising set of claim 51, wherein said insert is a tampon.

53. The exercising set of claim 51, wherein said exercising set further comprises an indicator adapted to provide indication and feedback regarding the displacement of said force generating means caused by the contraction of said patient's pelvic floor muscles.

54. The exercising set of claim 53, wherein said indicator comprises a displacement sensor selected from a group consisting of: an accelerometer, a laser displacement sensor, RF sensor, a visual indicator, or any combination thereof.

55. The exercising set of claim 51, wherein at least one of the following is being held true (a) said at least one insert comprises connection means adapted to mechanically connect said at least one insert to said connector; (b) said spring is a compression spring.

56. The exercising set of claim 51, wherein said connector is selected from a group consisting of: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof; further wherein said connector is provided with a grasping means selected from: a fastener or a holder; said grasping means being adapted to join said connector with said connection means.

57. The exercising set of claim 51, wherein said insert is provided with at least one disposable coating layer adapted to cover said at least one insert.

58. The exercising set of claim 57, wherein said coating layer is made of elastic isolating materials.

59. The exercising set of claim 51, wherein said insert is provided with an applicator adapted to assist the insertion of said insert into said human body cavity.

60. The exercising set of claim 51, wherein said connector is selected from a group consisting of: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof.

61. The exercising set of claim 51, wherein at least one of the following is being held true (a) said force generating means comprises an assembly of one or more weights which are releasably interconnected; (b) said assembly of one or more weights is arranged in vertical row; (c) said one or more weights are interconnected via means selected from: magnetic means, screw means, fastening means, or any combination thereof; (d) said assembly of one or more weights is accommodated in a weight-holder; said weight-holder being mechanically connected to said connector; (e) said pulling force applied on said assembly of one or more weights and on said insert is the gravity force; (f) said exercising set further comprising a vibrator adapted to being mechanically connected to said assembly of one or more weights in a way that allows said vibrator to vibrate said assembly of one or more weights.

62. The exercising set of claim 51, wherein at least one of the following is being held true (a) said force generating means comprises a pull mechanism for applying a pulling force on said insert; (b) said pull mechanism is driven by an energy selected from a group consisting of: a mechanical, an electrical, a magnetic, a pneumatic, a thermal, or any combination thereof; (c) said pull mechanism is an electrical motor with a cam; the direction, the speed and the time of the rotation of said electrical motor are fully controllable; said connector being connected to said cam; said pull mechanism is adapted to convert the round movement of said electrical motor to a linear movement of said connector; (d) said pull mechanism is mechanically fixed to the surface it is located on; (e) the rotation axis of said cam is perpendicular to said connector.

63. The exercising set of claim 51, wherein at least one of the following is being held true (a) said exercising set is adapted for training of when said patient is in a position selected from: vertical, horizontal, or any other predetermined inclination; (b) said horizontal training further comprises a treatment bed adapted to accommodate said patient on the same; in said horizontal training, said force generating means being located on said treatment bed in front of said patient.

64. A method for training pelvic floor muscles of a patient by a resistance to a pulling force generated by an exercising set, said method comprising steps of:

a. providing exercising set for exercising the pelvic floor muscles of a patient, comprising: at least one insert fitted for a human body cavity mechanically interconnected to a force generating means by means of a connector; said human body cavity being selected from: woman's vaginal cavity or any user's inner rectal cavity;

b. inserting said at least one insert into said human body cavity;

c. generating a pulling force via said force generating means; and,

d. squeezing said human body cavity by said patient, by contracting the pelvic muscles of the same;

wherein said step (d) of squeezing said human body cavity by said patient is adapted to prevent said insert from leaving said human body cavity, such that the force generated by said force generating means is lower than the contraction force of said pelvic muscles; further wherein said at least one insert is a tampon.

65. The method as recited in claim 64, further comprising at least one step selected from (a) providing said exercising set with an indicator adapted to provide indication and feedback regarding the displacement of said force generating means caused by the contraction of said patient's pelvic floor muscles; (b) providing said at least one insert with connection means; further wherein said method further comprises step of connecting said at least one insert to said connector via said connection means; (c) providing said indicator with a displacement sensor selected from a group consisting of: an accelerometer, a laser displacement sensor, RF sensor, a visual indicator, or any combination thereof; (d) performing said step (b) of inserting said at least one insert into said human body cavity by using an applicator adapted to insert said at least one insert into said human body cavity.

66. The method as recited in claim 64, further comprising step of selecting said connector from a group comprising: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof; further wherein said spring is a compression spring.

67. The method as recited in claim 64, further comprising at least one step selected from (a) connecting said connector to said connecting means via a grasping means selected from: a fastener or a holder; (b) providing said at least one insert with at least one disposable coating layer adapted to cover said at least one insert; wherein said coating layer is made of elastic isolating materials; (c) selecting said connector from a group comprising: a string, a filament, a thread, a rope, a cable, a wire, a cord, an elastic band, a rubber band, a spring, or any combination thereof.

68. The method as recited in claim 64, wherein at least one of the following is being held true (a) said force generating means comprises an assembly of one or more weights which are releasably interconnected; (b) said assembly of one or more weights is arranged in vertical row; (c) said one or more weights are interconnected via means selected from: magnetic means, screw means, fastening means, or any combination thereof; (d) said assembly of one or more weights is accommodated in a weight-holder; said weight-holder being mechanically connected to said connector; (e) said pulling force applied on said assembly of one or more weights and on said insert is the gravity force; (f) said exercising set is provided with a vibrator adapted to being mechanically connected to said assembly of one or more weights in a way that allows said vibrator to vibrate said assembly of one or more weights.

69. The method as recited in claim 64, wherein at least one of the following is being held true (a) said force generating means comprises a pull mechanism for applying a pulling force on said insert; (b) said pull mechanism is driven by an energy selected from a group consisting of: a mechanical, an electrical, a magnetic, a pneumatic, a thermal, or any combination thereof; (c) said pull mechanism is an electrical motor with a cam; the direction, the speed and the time of the rotation of said electrical motor are fully controllable; said connector being mechanically connected to said cam; said pull mechanism is adapted to convert the round movement of said electrical motor to a linear movement of said connector; (d) said pull mechanism is mechanically fixated to the surface it is located on.

70. The method as recited in claim 64, wherein at least one of the following is being held true (a) the rotation axis of said cam is perpendicular to said connector; (b) said exercising set is adapted for training of when said patient is in a position selected from: vertical, horizontal, or any other predetermined inclination; (c) said horizontal training further comprises a treatment bed to accommodate said patient on the same; in said horizontal training, said force generating means being located on said treatment bed in front of said patient.