Devices and methods for controlling and preventing bowel leakage

Abstract

A device configured to be inserted into a person's anus, the device comprising an elongated body having a front end and a rear end, the elongated body containing a hollow void; a cap coupled to the elongated body; a string coupled to a proximal part of the cap, wherein the proximal part of the cap is closer to the elongated body than a distal part of the cap, and wherein application of a rearward pulling force on the string moves the distal part of the cap towards a front section of the elongated body.

Description

DEVICES AND METHODS FORCONTROLLING AND PREVENTING BOWEL LEAKAGEFIELD OF THE INVENTION

[0001] The invention, in some embodiments thereof, relates to controlling and preventing bowel leakage.BACKGROUND OF THE INVENTION

[0002] Bowel leakage, or in some forms, Fecal incontinence (FI) or encopresis, is a lack of control over defecation, leading to involuntary loss of bowel contents - including flatus (gas), liquid stool elements and mucus, or solid feces. Physical solutions for controlling bowel leakage include insertion of absorbents, such as diapers or tampons, or plugs, as well as surgical interventions.

[0003] Known plugs and diapers may cause physical pain, and many of them cannot be carried or worn by persons for long periods of time, due, at least in part, to the technical problem of creating lateral pressure on the rectal wall, which may be both dangerous and painful. The rectum includes two regions, separated by what is known as the dentate line, and the region below the dentate line is dense with nerve endings, such that the presence of a device in that area is painful. Moreover, the peristaltic movements of the intestines tend to push out anything found within the intestines, and, therefore, these devices are pushed out of the patient’s body, thus being ineffective.SUMMARY OF THE INVENTION

[0004] Embodiments disclose a device configured to be inserted into a person's anus, the device comprising: an elongated body having a front end and a rear end, the elongated body containing a hollow void; a cap coupled to the elongated body; a string coupled to a proximal part of the cap, wherein the proximal part of the cap is closer to the elongated body than a distal part of the cap, and wherein application of a rearward pulling force on the string moves the distal part of the cap towards a front section of the elongated body.

[0005] In some cases, the cap has a normal position in which the cap extends rearwards from the elongated body, the cap has an insertion position in which the distal part of the cap collapsesonto the elongated body towards a rear end of the elongated body; and the cap has a removal position in which a distal part of the cap points towards the front section of the elongated body.

[0006] In some cases, the device further comprises a handle coupled to the string. In some cases, the proximal part of the cap is located in the elongated body, and wherein the string is coupled to the cap from within the elongated body, such that the cap moves circularly when the string is pulled.

[0007] In some cases, the cap includes a first section coupled to the elongated body and a second section coupled to the first section and extending farther from the elongated body than the first section. In some cases, the first section has a rigidity level that is higher than a rigidity level of the second section. In some cases, the first section is made from a material that is different from that of the second section. In some cases, the first section is wider than the second section.

[0008] In some cases, the device comprises a plurality of caps connected to the elongated body at multiple distances from a front-most point of the elongated body. In some cases, the device comprises an insertion member coupled to a rear section of the elongated body.

[0009] In some cases, the insertion member comprises a pin configured to be inserted into the hollow void of the elongated body and an elongated cavity extending away from the elongated body. In some cases, the cap comprises one or more rings extending upwards or downwards from the cap. In some cases, the string is contained in the hollow void.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0011] In the drawings :

[0012] Fig. 1 shows a device configured to be inserted into a person's anus, in accordance with some embodiments of the invention;

[0013] Fig. 2A shows the device with caps in an insertion position, in accordance with some embodiments of the invention;

[0014] Fig. 2B shows the device with caps in a normal position, in accordance with some embodiments of the invention;

[0015] Fig. 2C shows the device with caps in a removal position, in accordance with some embodiments of the invention;

[0016] Figs. 3A-3B show an insertion member of the device, in accordance with some embodiments of the invention;

[0017] Figs. 4A-4B show the device with caps having rings, in accordance with some embodiments of the invention;

[0018] Fig. 5 shows the device with caps having a narrowing width, in accordance with some embodiments of the invention; and,

[0019] Fig. 6 shows the device with caps having two parts made of different materials, in accordance with some embodiments of the invention.DETAILED DESCRIPTION OF THE INVENTION

[0020] At least some implementations described herein address the technical problem of creating lateral pressure on the rectal wall. The technical solution may include a device configured to be inserted into a person's anus, the device comprising an elongated body and at least one cap coupled to the elongated body. The cap has a normal position in which the cap extends towards a rear end of the elongated body. The cap has an insertion position in which a distal part of the cap collapse onto the elongated body, towards the rear end of the elongated body. The cap has a removal position in which a distal part of the cap points towards a front section of the elongated body. The device may also include a string coupled to the cap, wherein pulling the string moves the cap from the normal position to the removal position. The string may be contained in a hollow void of the elongated body. In some other cases, the string may be placed outside the hollow void, for example be coupled to the proximal parts of the caps by tying the string to holes in the caps or to other elements in the caps. The string may be sewed to the caps, may be welded, may be soldered thereto, or connected to the caps using other techniques that enable movement of the caps in response to pulling the string.

[0021] The angle between the cap and the elongated body during the insertion position or during the normal position ensures that the device remains above the dentate line of the rectum, despite the normal peristaltic motion of the rectum, which aims to push the device outside the person's anus. This angle maintains the device in the rectum, preventing the device from descending below the dentate line, one of the most sensitive areas of the human body.

[0022] Fig. 1 shows a device configured to be inserted into a person's anus, in accordance with some embodiments of the invention. The device comprises an elongated body 120 with one or more caps, such as caps 130, 132, 135, coupled to elongated body 120. The caps may be coupled to the elongated body 120 in a manner that enables the caps to move from the normal position to the insertion position and from the normal position to the removal position. The caps may be partially contained inside the elongated body 120 via an aperture of the elongated body 120, such that pulling the string 122 causes circular movement of the caps. That is, the farther section of the caps, i.e., the most remote or distal edge relative to the elongated body 120, moves a larger distance than does the closer section of the caps, i.e., the closest or proximal side of the caps, which is closer to the elongated body 120.

[0023] The elongated body 120 may have a circular cross section, in which the central longitudinal axis has substantially the same distance from the sidewalls of the elongated body 120. The elongated body 120 may have other shapes of cross sections, for example polygonal or other shapes. The elongated body 120 may be made of a soft yet semi-rigid biocompatible medical grade polymer, such as Silicon, Thermoplastic elastomer (TPE) and the like. The material from which elongated body 120 is made should be sufficiently rigid to allow it to be inserted into a patient’s anus, yet sufficiently soft and flexible so as not to cause damage to the walls of the anus during insertion. The diameter of the elongated body 120 may be the same along the entire length of the elongated body 120 or may vary.

[0024] The elongated body 120 may have a void or a cavity 140 that can accommodate a string coupled to the caps running therethrough. The void or cavity 140 may also accommodate an insertion pin 118. As such the internal diameter of the cavity 140 of the elongated body 120 may be larger than the insertion pin's 118 diameter. The insertion pin 118 may be part of an insertion member that may include multiple cavities 110, 112 and 115, for example enabling a person to insert one or more fingers to each of the multiple cavities 110, 112 and 115.

[0025] In some embodiments, the elongated body 120 may be made from a uniform material. In some other embodiments, the elongated body 120 may be made from a plurality of materials, including at least a rigid portion forming the body of the elongated body and a semi-rigid portion or soft portion in which the caps connect to the elongated body 120.

[0026] Caps 130, 132, 135 may be connected to the external part of the elongated body 120. The caps may cover the entire circumference of elongated body 120 or a portion of the circumference at a particular height or a plurality of heights along elongated body 120. For example, in one embodiment, the device may include one cap that surrounds the elongated body 120 at a particular height along elongated body 120, e.g., in the shape of an umbrella. The device may also include two caps extending at two, e.g., opposite, sides of the elongated body 120 at substantially the same height.

[0027] In some cases, the device may include a plurality of layers of caps, for example three layers of caps, as layers may be defined as caps connected at different heights along the elongated body 120. Each layer may include one cap that surrounds the elongated body 120 at a particular height along elongated body 120. Alternatively, each layer may include two or more caps extending at two, e.g., opposite, or more sides of the elongated body 120 at substantially the same height. Similarly, some layers may include one cap that surrounds the elongated body 120 at a particular height along elongated body 120, and some layers may include two or more caps extending at different sides of the elongated body 120 at substantially the same height.

[0028] The caps may be of uniform or different sizes, strengths, or materials. Each cap may gradually widen from the distal end towards the elongated body 120 to enhance strength and reduce flexibility. Each cap may be made of a soft, biocompatible, medical-grade polymer attached to the elongated body 120. In some cases, at least one of the caps may be produced separately to attach to the elongated body 120 or be made of the same material and form as the elongated body 120. Increased rigidity might be necessary to ensure that a pulling force on the string folds the cap onto the elongated body 120, into the removal position, creating a smaller device profile for easy, painless retrieval.

[0029] Fig. 2A shows the device with caps in an insertion position, in accordance with some embodiments of the invention. In the insertion position, the distal part of the cap points towardsthe rear section of the elongated body 120. A user of the device may move the caps 130, 132, 135 to point towards rear section of the elongated body 120 using the user's hands or using a device.

[0030] Fig. 2B shows the device with caps in a normal position, in accordance with some embodiments of the invention. In the normal position, the cap, or caps, extends rearwards from the elongated body. The normal position may be defined as the position in which the angle between the caps and the rear-pointing longitudinal axis of the elongated body 120 is less than 90 degrees, meaning the caps point rearward. The normal position can also be defined as a position in which the distal part of the caps is closer than the proximal part of the caps to an imaginary line being perpendicular to the longitudinal line of the elongated body at the rear end of the elongated body 120. The caps 130, 132, 135 may move independently from the insertion position to the normal position after the device is inserted into the person's anus, for example, as a result of moving into a mechanical equilibrium according to the size, shape and structure of the caps. The caps 130, 132, 135 may move to the insertion position due to forces applied by the user inserting the device into the person's body or by forces applied by the anal canal. Then, when the device passes the dentate line, the caps may no longer be pushed towards the elongated body by a rigid canal and move back to their normal position. The normal position is dictated by the physical properties of the caps. For example, the proximal part of the caps, closer to the elongated body 120, is more rigid and / or heavier than the distal part of the caps. This way, the distal part of the caps is easily collapsed onto the elongated body 120 when inserted into the anal canal, and after passing the anal canal, go back to the normal position, towards the rear side of the elongated body 120.

[0031] Fig. 2C shows the device with caps in the removal position, in accordance with some embodiments of the invention. In the removal position, the distal part of the caps points towards a front section of the elongated body 120. The front section of the elongated body 120 is the section of the elongated body 120 inserted into the person's anus before the rear section, and the rear section of the elongated body 120 is the section of the elongated body 120 inserted into the person's anus after the front section.

[0032] The caps may be moved into the removal position in response to application of a pulling force on the handle 125 that is coupled to the string 122 and is contained in a hollow void of the elongated body 120 and coupled to the cap. The caps 130, 132, 135 may move to the removal position in view of another mechanical, chemical or physical process, such as pulling or otherwisemaneuvering a spring, a pin, a connector and other components or objects that can be connected to or stored in the device. In some exemplary embodiments, the distance between the handle 125 and the rearmost end of the elongated body 120 is larger in the removal position than in the normal position, as the handle 125 is likely to be placed at the end of the string 122 that is pulled to move the caps to the removal position. Similarly, the handle 125 is farther from the rearmost end of the elongated body 120 when in the normal position than in the insertion position.

[0033] Fig. 2C also shows rings 412, 415 at the bottom part of the cap 135. The ring 412 is closer to the elongated body 120 than ring 415. Hence, ring 415 has a larger diameter. Other caps may also include rings. The rings may be glued to the caps or otherwise connected thereto. The rings may be made as a single sheet of material as the caps. The rings may be located at an upper surface or bottom surface of the caps. The rings are shown in the removal position but are also connected to the caps in the insertion position and in the normal position. The device may include the rings when the caps are made of two parts having a different rigidity level, for example by having a wider proximal part than the distal part or by having a proximal part being more rigid than the proximal part. The different rigidity levels may be achieved by using different materials or using the same material with different rigidity.

[0034] Figs. 3A-3B show an insertion member of a device configured to be inserted into a person's anus, in accordance with some embodiments of the invention. Fig. 3A shows an exemplary side view of the insertion member. Fig. 3B shows an exemplary rear view of the insertion member. In some embodiments, the insertion member may be inserted into a rear section of the elongated body 120. In some embodiments, the insertion member may comprise a pin 118 configured to be inserted into the elongated body 120. The insertion member may be removable from the elongated body 120, for example by sliding the pin 118 rearwards. In some embodiments, the insertion member may comprise a pin 118 configured to be inserted into a rear section of the elongated body 120. The insertion member may include multiple cavities 110, 112 and 115, for example enabling a person to insert finger or fingers to each of the multiple cavities 110, 112 and 115.

[0035] Figs. 4A-4B show the device with caps having rings, in accordance with some embodiments of the invention. Fig. 4A shows an exemplary rear view, and Fig. 4B shows an exemplary perspective view of the cap and the rings. The rings 412, 415 may protrude upwards ordownwards from cap 418, in the general direction of the rear section of the elongated body 410 or towards the front section of the elongated body 410. The rings 412 and 415 may have a width in the range of 20 percent to 150 percent larger than the width of the cap 418. The width of the cap 418 and the rings 412, 415 may be defined as a distance in the longitudinal axis of the elongated body 410.

[0036] Fig. 5 shows the device with caps having narrowing width, in accordance with some embodiments of the invention. Cap 101 is coupled to the elongated body 102, for example via stitches or any other kind of connection technique. The proximal part 512 of cap 101 is closer to the elongated body 102 than the distal part 515 of the cap 101. The proximal part 512 of cap 101 is wider than the distal part 515 of the cap. This shape of the cap 101 enables the cap 101 to rotate easily around the connection point between the cap 101 and the elongated body 102.

[0037] Fig. 6 shows the device with caps having two parts made of different materials, in accordance with some embodiments of the invention. The proximal part 207 of the cap is closer to the elongated body 202 than the distal part 201 of the cap. The proximal part 207 of the cap is made of a material that is more rigid than the material used to form the distal part 201 of the cap. The difference between the rigidity levels enables the cap to rotate easily around the connection point between the cap and the elongated body 202. String 204 may be coupled to the proximal part 207 of the cap, inside a hollow void of the elongated body 202. Fig. 6 shows the device in an insertion position, in which the angle 206 between the cap and the rear-pointing longitudinal axis of the elongated body 202 is significantly smaller than ninety (90) degrees, for example eighty degrees at most.

[0038] In order to insert the device into a patient’s anus, the caps may be brought into the insertion position, in which the distal portion of the caps points towards to the rear part of the elongated body 120, as the forward part of the elongated body comes in physical contact with the user's body before the rear part does. In order to remove the device from a patient’s anus, the caps are brought into the removal position, in which the distal portion of the caps points towards to the front part of the elongated body 120. The rear part of the elongated body 120 may be close to the handle 125 used to pull the string 122 when removing the device from the person's anus. In order to maintain the device within the anus of a patient, the caps move into the normal position, in which the distal portion of the caps points slightly rearwards, forming an angle of less than 90degrees with a rear-directing line of the longitudinal axis of the elongated body 120. The subject matter encompasses all the techniques that enable the caps to be placed in the three positions disclosed above, and to switch from one position to another.

[0039] In some cases, the device may include an insertion pin 118 configured to be inserted into a hollow void of the elongated body 120 from a rear side of the elongated body 120. The insertion pin 118 may be secured to a handle that enables a person or a machine to insert the insertion pin 118 into the hollow void of the elongated body 120. The handle may include multiple compartments 110, 112, 115 connected to each other and having an opening in a rear side thereof. The openings may enable a person to enter fingers to grip the device via the compartments 110, 112, 115.

[0040] In some cases, the device may include a string 122 located in a void inside the elongated body 120 and connected to the caps. The string 122 may be made of a thin, strong, biocompatible, medical-grade polymer. The string 122 may be attached at multiple spots around all the caps that extend from the elongated body 120. In some cases, string 122 may be connected to a rear part of the elongated body. In some cases, string 122 may be connected directly to the caps without being contained in the hollow void of the elongated body 120. In operation, application of a pulling force on the string 122 from the rear side of the device moves the caps into the removal position by causing the distal portion of the caps to turn towards the forward part of the elongated body 120, resulting in a softer, less painful, and easier removal of the device from the person's anus.

[0041] In some cases, the device may include a handle 125 coupled to the string 122. Pulling the handle 125 results in pulling the string 122. The handle 125 may be in any appropriate shape, such as the shape of a ring, a pole, or a polygonal or elliptical shape, or a combination thereof. The handle 125 may be made of a soft polymer. The handle 125 may be made with a hole for pulling out the device using one finger. The handle 125 may remain outside the elongated body 120. For safety, the size of the handle 125 may be larger than the internal diameter of the hollow void within the elongated body 120 in order to prevent the device from passing through the anal sphincter. The device may move upwards in the rectum but not beyond the string's length.

[0042] The descriptions of the various embodiments of the invention have been presented for purposes of illustration but are not intended to be exhaustive or limited to the embodimentsdisclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

[0043] It is expected that during the life of a patent maturing from this application many relevant files and / or records will be developed and the scope of the term file and / or record is intended to include all such new technologies a priori.

[0044] As used herein, the term “about” refers to ± 10 %.

[0045] The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to". This term encompasses the terms "consisting of' and "consisting essentially of'.

[0046] The phrase "consisting essentially of' means that the composition or method may include additional ingredients and / or steps, but only if the additional ingredients and / or steps do not materially alter the basic and novel characteristics of the claimed composition or method.

[0047] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0048] The word “exemplary” is used herein to mean “serving as an example, instance or illustration”. Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0049] The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the invention may include a plurality of “optional” features unless such features conflict.

[0050] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specificallydisclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0051] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0052] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0053] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the invention is intended to embrace all such alternatives, modifications and variations.

Claims

CLAIMS1. A device configured to be inserted into a person's anus, the device comprising: an elongated body having a front end and a rear end, the elongated body containing a hollow void; a cap coupled to the elongated body; a string coupled to a proximal part of the cap, wherein the proximal part of the cap is closer to the elongated body than a distal part of the cap, and wherein application of a rearward pulling force on the string moves the distal part of the cap towards a front section of the elongated body.

2. The device of claim 1 , wherein the cap has a normal position in which the cap extends rearwards from the elongated body; wherein the cap has an insertion position in which the distal part of the cap collapses onto the elongated body towards a rear end of the elongated body; and wherein the cap has a removal position in which a distal part of the cap points towards the front section of the elongated body.

3. The device of claim 1, further comprising a handle coupled to the string.

4. The device of claim 1, wherein the proximal part of the cap is located in the elongated body, and wherein the string is coupled to the cap from within the elongated body, such that the cap moves circularly when the string is pulled.

5. The device of claim 1, wherein the cap includes a first section coupled to the elongated body and a second section coupled to the first section and extending farther from the elongated body than the first section.

6. The device of claim 5, wherein the first section has a rigidity level that is higher than a rigidity level of the second section.

7. The device of claim 5, wherein the first section is made from a material that is different from that of the second section.

8. The device of claim 5, wherein the first section is wider than the second section.

9. The device of claim 1, comprises a plurality of caps connected to the elongated body at multiple distances from a front-most point of the elongated body.

10. The device of claim 1, further comprising an insertion member coupled to a rear section of the elongated body.

11. The device of claim 10, wherein the insertion member comprises a pin configured to be inserted into the hollow void of the elongated body and an elongated cavity extending away from the elongated body.

12. The device of claim 1, wherein the cap comprises one or more rings extending upwards or downwards from the cap.

13. The device of claim 1, wherein the string is contained in the hollow void.

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