WEARABLE PERINEUM LEAKAGE CONTROL DEVICE
20240189086 ยท 2024-06-13
Inventors
Cpc classification
A61F2/0009
HUMAN NECESSITIES
A61H2011/005
HUMAN NECESSITIES
A61F13/47209
HUMAN NECESSITIES
A61F13/5605
HUMAN NECESSITIES
A61F2250/0012
HUMAN NECESSITIES
A61H7/001
HUMAN NECESSITIES
International classification
A61F2/00
HUMAN NECESSITIES
Abstract
A perineum control device attachable to the user's undergarment, belt or similar clothing to apply pressure to the perineum to control various conditions including leakages of body fluids from the urethral, anal, and vaginal openings. The device and method comprise one or more front and rear retractors having a retractable cord supporting a bridge or band member positioned against a user's perineum. When a user puts on their undergarment, or tensioned and retractable cords exert a constant and predetermined upward compression force to an attached sanitary article (such as pads/napkins). The force pushes/pulls the article against the perineum increasing the perineum pressure above an abdominal or bladder pressure, which prevents or mitigates leakages and/or prolapses. The device keeps the article in constant close contact with the orifices of the perineum regardless of a user's vigorous movements and regardless of a user's body size, shape, and anatomical differences.
Claims
1. A perineum control device for applying pressure to the perineum region of a user, the perineum control device being attachable to a portion of an undergarment or belt or similar and having a perineum covering region or portion, the perineum control device comprising: a retractor being attachable to a portion of the undergarment or the belt; a retracting member in operative communication with the retractor and positionable proximate to the user's perineum, wherein operation of the retractor exerts a force on the retracting member; a bridge member coupled to a portion of the retracting member and positionable proximate the user's perineum, wherein the bridge member is movable with respect to the retracting member; and wherein the retractor is configured to retract the retracting member causing a constant upward force on the retracting member, which causes a constant and predetermined force being applied to the bridge member against the perineum region of the user.
2. The perineum control device of claim 1, further comprising an end support member coupled to the retracting member and the bridge member.
3. The perineum control device of claim 1, wherein the retractor defines an interior further comprising: a rotatable spool disposed in the interior of the retractor, wherein the retracting member is at least partially spooled on the rotatable spool; a biasing member in operative communication with at least the rotatable spool; and wherein the biasing member is configured to move the rotatable spool and retracting member from an extended state to a retracted state such that the biasing member applies the constant upward force on the retracting member.
4. The perineum control device of claim 1, wherein the retractor comprises a first retractor and a second retractor, each being in operative communication with the retracting member.
5. The perineum control device of claim 4, wherein the first retractor and second retractor each comprise: a rotatable spool coupled to the retractor, the retracting member being at least partially spooled on the rotatable spool; a retracting member in operative communication with at least the rotatable spool; and wherein the biasing member is configured to move the rotatable spool and retracting member from an extended state to a retracted state such that the biasing member applies the constant and predetermined upward force on the retracting member.
6. The perineum control device of claim 1, wherein the bridge member comprises: a front support portion configured to support a front of the perineum region of a user; a rear support portion configured to support a rear of the perineum region of a user; and wherein the front support portion and rear support portion each extend at an angle away from the bridge member.
7. The perineum control device of claim 6, further comprising: an absorbent member disposed on an upper surface of the bridge member and positionable against the perineum, the absorbent member having a shape approximating a shape of the bridge member; a fastening mechanism disposed on the upper surface of the bridge member and configured to fasten the absorbent member to the bridge member; and wherein the absorbent member is configured to absorb a fluid.
8. The perineum control device of claim 1, further comprising: an absorbent member disposed on the upper surface of the bridge member and positionable against the perineum; a fastening mechanism disposed on the upper surface of the bridge member and configured to fasten the absorbent member to the bridge member; and wherein the absorbent member is configured to absorb a fluid.
9. The perineum control device of claim 1, further comprising: a coupling mechanism disposed on a portion of the bridge member and configured to adjustably couple a portion of the retracting member to the bridge member.
10. The perineum control device of claim 1, wherein the retractor comprises a pair of first retractors and a pair of second retractors, the first pair of retractors and the second pair of retractors each being in operative communication.
11. The perineum control device of claim 8, further comprising: a first retracting member extending between and being retractably coupled to the first pair of retractors; a second retracting member extending between and being retractably coupled to the second pair of retractors; an end support member extending between the first retracting member and the second retracting member, the bridge member being supported by a portion of the end support member; connectors being coupled to and extending between portions of the first retracting member and the second retracting member; and wherein the end support member extends across the perineum region of a user.
12. The perineum control device of claim 1, further comprising a stopper coupled to a portion of the retracting member and selectively abuttable against an opening in the retractor, wherein the stopper is configured to stop the retracting member at a predetermined retraction point.
13. A method for applying pressure to a perineum region of a user, the user wearing a garment having a belt member, the method comprising the steps of: providing a front retractor configure to couple to a front portion of the belt member, the front retractor having a front retracting member; providing a rear retractor configured to couple to a rear portion of the belt member, the rear retractor having a rear retracting member; providing a bridge member configured to be coupled to and extend between the front retracting member and the rear retracting member, wherein the bridge member is configured to be positioned proximate the perineum region of the user; and wherein the front retractor and rear retractor are configured to apply a constant and predetermined pulling force onto the front retracting member and the rear retracting member that causes the bridge member to press against the perineum region.
14. The method for applying pressure to a perineum region of claim 13, wherein the step of providing a front retractor comprises providing a pair of front retractors and the step providing a rear retractor comprises coupling a pair of rear retractors.
15. The method for applying pressure to a perineum region of claim 13, further comprising the steps of providing a coupling mechanism coupled to a portion of the bridge member, the coupling mechanism being configured to adjustably couple the bridge member to the front retracting member and the rear retracting member.
16. The method for applying pressure to a perineum region of claim 15, wherein the coupling mechanism comprises:
17. The method for applying pressure to a perineum region of claim 15, wherein the coupling mechanism comprises one or more hook members coupled to a portion of the bridge member, wherein the one or more hook members are configured to receive a portion of the front retracting member and a portion of the rear retracting member.
18. The method for applying pressure to a perineum region of claim 17, wherein the one or more hook members comprises a first set of hook members configured in a first orientation to receive the front retracting member and a second set of hook members configure to a second orientation to receive the rear retracting member, wherein first set of hook members and second set of hook members are oriented opposite of each other.
19. The method for applying pressure to a perineum region of claim 13, further comprising the step of providing an absorbent member disposed on a portion of the bridge member, wherein the absorbent member is configured to absorb any body fluids.
20. The method for applying pressure to a perineum region of claim 13, further comprising the step of providing an absorbent member removably disposed on a portion of the bridge member, wherein the bridge member and absorbent member are provided in a saddle configuration conformable to the perineum region of the user.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The device of the present invention (hereinafter, device) is described in detail below with reference to examples of preferred embodiments illustrated in the accompanying drawings. The invention may be developed in multiple embodiments, with all sharing key design features such as use of retraction mechanisms (which may be spring-loaded tensioners as shown in the drawings or otherwise motorized retraction mechanisms) to secure the device to the user's perineum region.
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DETAILED DESCRIPTION OF THE INVENTION
[0064] The accompanying drawings illustrate a method and example embodiments of a leakage control device, appliance, and method to control involuntary leakages (e.g., bodily discharges such as urine and feces) from openings of the pelvic lumens. The pelvic lumens include the urethra, vagina, and rectum or anus. The pelvic lumens are generally located in the perineum region of a female user. While the invention will be described in use with a female, it is contemplated herein that the device of the present invention can also be used with the male anatomy.
[0065] It will be apparent to those skilled in the art from this disclosure that the following descriptions of examples of embodiments are provided for illustration only and not for any purpose of limiting the invention or substantially identical embodiments thereof. Multiple embodiments are possible for key invention concepts such as the use of retraction mechanisms for securing the various potential embodiments of the device. The invention may be varied in construction and details without departing from its scope, and the overall idea of using retraction mechanisms to control leakage of bodily discharges from openings in the user's or user's perineum region.
[0066] Referring now to the drawings,
[0067] As illustrated in
[0068] The retractor or retraction mechanism 16 is actively coupled to a retracting member or cord 20, and if present, the retracting intermediate support member 26 and/or support members 27. The retracting member or cord 20, and if present, the retracting intermediate support member 26 and/or support members 27 extend between the retraction mechanism 16 and undergarment, or between two retractors or retraction mechanisms 16, and pass over the perineum region of the user. The retraction mechanism 16 is configured to pull or retract the retracting member or cord 20, and the intermediate support members 26 and/or support members 27, if present. The retraction force of the retractor or retraction mechanism 16 applies a compressive force against one or more areas of the perineum, causing an increase in perineal pressure. The perineal pressure counteracts a bladder pressure, thereby preventing or mitigating leakage.
[0069] As shown on
[0070] In an example embodiment of the present invention, as particularly illustrated in
[0071] In one embodiment of the present invention, the biasing member or spring 21 comprises a constant force spring mounted or positioned in the central interior cavity 22 of the spool 18. The biasing member or spring 21 includes an inner end 23 that is coupled to, in contact with, or mates with a portion of the post 19. A slot 24 may be formed on or in the shaft of the post 19 to receive and retain the inner end 23 of the biasing member or spring 21. The biasing member or spring 21 also includes an outer end 25 that is tethered on, positioned against, or coupled to a portion of the spool 18. In an example embodiment, an inner surface of the barrel 18c of the spool 18 may comprise a slot, lip, ridge, or fastening mechanism that is configured to retain the outer end 25 of the biasing member or spring 21 in contact with the spool 18.
[0072] In another example embodiment of the invention, the biasing member or spring 21 may comprise a spiral torsion spring that is configured to provide a constant and predetermined tension or force. Other biasing members or springs 21, mechanisms, or configurations are also possible and should be considered to be within the spirit and scope of the invention.
[0073] The biasing member or spring 21 is configured to store energy created when the retracting member or cord 20 is pulled or extended out of the housing 17, which applies constant and predetermined force/torque to the spool 18, thereby causing the pulled-out retracting member or cord 20 to automatically retract and rewind on the spool 18. The constant and predetermined retracting force is applied to the slider or bridge member 34 that extends along or across the perineum. The constant and predetermined force imparts pressure against the perineum stopping the leakage.
[0074] In one example embodiment of the invention, using end support members or straps 27 coupled to the retracting member or cord 20 wound about the spool 18. As the spool 18 automatically moves to the wound or coiled state it pulls on the retracting member or cord 20 and the end support members or straps 27. The end support members or straps 27 press against bridge member 34, which presses against the perineum causing an increase in the perineal pressure that overcomes the bladder pressure, and thereby prevents or mitigates leakage.
[0075] In another variation of the present invention, the retracting member or cord 20 includes one or more adjustment portions or intermediate support members 26 extending outside of the housing 17 and interconnecting the retracting members or cords 20 with the end support members or straps 27. The intermediate support members 26 and end support members or straps 27 may be composed of the same or different materials.
[0076] As briefly mentioned above, a bridge member or assembly 34 can be connected or coupled to the retracting members or cords 20 or the end support members or straps 27, if present. The bridge member 34 enables a user to more precisely direct the applied pressure to the perineum. It also enables a user to adjust the location or position of the bridge member 34 for their anatomy.
[0077] The constant and predetermined tension force of the biasing member or spring 21 is generally equal to the constant and predetermined force applied along the retracting member or cord 20, intermediate support members 26, the end support members or straps 27, and the bridge member 34. The force remains constant regardless of the length or amount of the retracting member or cord 20 extending of the housing 17. The constant and consistent force of the retractor or retracting mechanism 16 ensures the leakage control device 10 is effective and safe to operate. Applying an acceptable level of pressure is important because if the pressure is too high it may increase the risk of vesicouretral reflux (where urine goes back up to the kidney causing kidney damage over time (reflux nephropathy)) and if the pressure is too low it may allow leakage.
[0078] In the example embodiment of
[0079] Referring to
[0080] In one example embodiment of the present invention, the bridge member 34 is part of a slide assembly 31 adjustably coupled to and movable along the end support members or straps 27. As particularly illustrated in
[0081] The leakage control device 10 may include one or more fastening member or component(s) 36 to secure, attach, or couple the leakage control device 10 on the waistband of the users' undergarments or other portions of a users' garments. In the example embodiment of
[0082] Referring to
[0083] In order to repair or replace components of the leakage control device 10, the housing 17 may comprise one or more covers 39 that provide selective access to the interior cavity 22 of the spool(s). The one or more covers 39 are configured to couple to or fasten to another portion of the housing 17. In one example embodiment, the one or more covers 39 comprise a coupling arrangement such as a hollow bushing 40 that mates with the post 19. The coupling arrangement or bushing 40 is also able to support at least a portion of the rotatable spool 18. Fasteners such as screws may also be used to secure the one or more covers 39 to the housing 17. The fasteners may extend through and be coupled to a portion of the post 19.
[0084] The internal cavity 22 of the spool(s) 18 may also contain one or more covers, doors, or seals 41 to protect the biasing member or spring 21. The one or more doors 41 can include one or more sealing members capable of retaining a lubricating material inside of the internal cavity 22, which is used to extend the life of the biasing member or spring 21. The one or more doors 41 can be secured to a portion of the spool 18 by any type of clipping mechanism or fastener.
[0085] Turning to another example embodiment of the invention,
[0086] Use of the leakage control device 10 is particularly illustrated in
[0087] The retraction forces of the retraction mechanisms 16 tension the retracting members 20, intermediate support members 26, and end support members or straps 27 by generating a sufficient upward force on the bridge member 34 positioned on the end support members or cords 27. The predetermined and constant upward force presses the bridge member 34 against the perineum openings holding the bridge member 34 and/or absorbent/sanitary article 43 in close contact with the openings. Compression of the perineum prevents an involuntary leakage of bodily fluids and discharges when the pressure of a discharge is up to or below a predetermined pressure level, and alleviates and absorbs leakage of discharges, when their pressure is above the predetermined levels, via application of pressure resistance to and obstruction of liquid flow, thus controlling the flow from the openings. The predetermined pressure is not set too high to avoid the risk of vesicouretral reflux where urine goes back up to the kidneys resulting in reflux nephropathy over time.
[0088] The retracting member or cords' 20 retraction and upward compression forces remain constant and predetermined, keeping the bridge member 34 and/or absorbent/sanitary article 43 in close proximity with perineum openings regardless of the position of the undergarment's waistband with the attached retraction mechanisms 16 on the users' body and/or the users' panty styles. The article position and constant and predetermined pressure against the openings are not affected by vigorous motions of the user's body. One size of the device fits all users regardless of their body sizes, shapes, or the differences in anatomy of the perineum.
[0089] All the above factors may change pull-out length of the retracting member or cords 20 without a change in a value of the retraction mechanisms' 16 constant and predetermined retraction force. A disposable absorbable sanitary article 43 can be removably secured on the bridge member 34 by any means such as adhesive, snap fastener, hook and loop type attachment, etc. The leakage control device 10 can be used with a wide variety of readily available disposable or reusable absorbent sanitary articles, or with a custom shaped and designed pad, which is part of the invention concept. (The term disposable or reusable absorbent sanitary article 43 includes, but is not limited to, hygiene products such as incontinence pads, menstrual pads, liners, napkins, interlabial pads, and other sanitary products.)
[0090] Turning now to
[0091] Similar to other embodiments, one or more end support members or straps 27, or combined intermediate support members 26 and end support members or straps 27 are operatively coupled to the retracting members or cords 20 of the retraction mechanisms 16 to provide consistent and constant and predetermined retracting force along their length. As particularly illustrated in
[0092] Referring to
[0093] The retracting member or cord 20 may extend through two openings 70a and 70b formed in the housing 17. In this configuration, each end support member or strap 27, or combination intermediate support member 26 and end support members or straps 27, are individually controlled by a separate retracting members or cords 20 and its respective consistent force. This enables an increase in the incremental adjustment of the leakage control device 10 to the movement of the user.
[0094] Turning now to the example embodiment illustrated in
[0095] As particularly illustrated in
[0096] The branches 83 and their flexibility also help to protect a user's skin from the retracting members or cords 20 or the end support members or straps 27 while also providing overall comfort to the user. As illustrated in
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[0098] Turning to
[0099] In this particular embodiment of the present invention, the leak control device 10 includes additional adjustments that can be made at the bridge member 34. As illustrated in
[0100] In another example embodiment of the invention, as illustrated in
[0101] In order to prevent movement of the absorbent member 43, the leakage control device comprise one or more securing mechanism 90 secured to and extending between the bridge member 34 and the absorbent member 43. As illustrated in
[0102] The leak control device 10 may be made with a retraction mechanism (e.g. clock spring or power spring) or type of constant force mechanism other than the mechanism described herein, although mechanisms with more complex designs would likely be more costly to produce and complex to use. Regardless, the mechanisms' way of function should not affect the functional advantages of the devices of the present invention. Although examples of particular embodiments of the present invention have been illustrated and described below, various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover all such changes and modifications that are within the scope of the invention.