Patent Publication Number: US-11376154-B2

Title: Pelvic prolapse treatment belt

Description:
FIELD 
     Disclosed aspects relate to the treatment of pelvic organ prolapse and related conditions. 
     BACKGROUND 
     The pelvis (the plural generally called the pelves or pelvises) is either the lower part of the trunk of the human body between the abdomen and the thighs, or the skeleton embedded in it, sometimes also called bony pelvis or pelvic skeleton. The pelvic region of the trunk includes the bony pelvis, the pelvic cavity which is the space enclosed by the bony pelvis, the pelvic floor, below the pelvic cavity, and the perineum below the pelvic floor. The pelvic cavity comprises a meshwork of smooth muscle, ligaments, blood vessels, and connective tissues that attach to the inner walls of the pelvic girdle. The pelvic skeleton is formed in the area of the back, by the sacrum and the coccyx and anteriorly and to the left and right sides, by a pair of hip bones.
     The two hip bones connect the spine with the lower limbs. The hip bones are attached to the sacrum posteriorly, connected to each other anteriorly, and joined with the two femurs at the hip joints. The gap enclosed by the bony pelvis, called the pelvic cavity, is the section of the body underneath the abdomen.   

       FIG. 1  is a lateral view of the anatomy of a normal female&#39;s pelvic cavity shown as  100 , where none of the organs of the female pelvic cavity  100  are shown prolapsed. The pubic bone  105  is shown as well as the pelvic floor muscle  108  located at the bottom of the pelvic cavity  100  which supports the contents of the pelvis comprising the female pelvic organs. The female pelvic organs are shown as the bladder  121  coupled to urethra  122 , the uterus  131  that is coupled to the cervix  132  which is coupled to the vagina  133 , and the rectum  141  that is coupled to the anus  142 . 
     The pelvic floor muscle  108  being at the base of the pelvic cavity  100  assists in supporting all of these organs to prevent prolapse. However, one or more of the uterus  131 , vagina  133 , anus  142 , urethra  122 , bladder  121 , cervix  132 , and the small bowel can prolapse in a condition commonly referred to as pelvic organ prolapse (POP). 
     POP generally relates to a condition where the muscles including the pelvic floor muscle  108  and ligaments supporting a woman&#39;s pelvic organs weaken enough to allow one or more of the pelvic area organ(s) to slip out of their normal place (and thus to prolapse). There are different types of POP, including vaginal vault prolapse, bladder prolapse also known as cystocele prolapse, rectal prolapse, uterine prolapse, urethral prolapse, cervical prolapse, and small bowel prolapse. 
     In certain cases, POP occurs due to the damage of the pelvic floor muscle  108  and its associated tissue that supports the intra-abdominal contents causing the contents of the abdominal cavity to extend through the weakest support points and extrude through the vaginal walls. This weakness can be at the bladder area, the uterine area, or the rectal/enterocele area. The POP condition can worsen over time, and the patient may thus eventually need corrective surgery to remedy this condition. 
     POP is generally treated by invasive methods comprising surgical implants generally including meshes which may be applied in combination with sutures to hold the mesh in place. Alternatively, POP can be treated with sutures that close the parted pelvic floor muscle and associated tissues in a known “non-mesh” technique. Meshes are usually applied in open surgical procedures, although meshes may sometimes be applied in laparoscopic surgical procedures. 
     SUMMARY 
     This Summary is provided to introduce a brief selection of disclosed concepts in a simplified form that are further described below in the Detailed Description including the drawings provided. This Summary is not intended to limit the claimed subject matter&#39;s scope. 
     Disclosed aspects include pelvic prolapse treatment belts for non-invasively treating a variety of POP conditions, such as uterine prolapse, bladder prolapse (or cystocele prolapse), vaginal prolapse, rectal prolapse, urethral prolapse, cervical prolapse, and small bowel prolapse. The pelvic prolapse treatment belt can also treat other related conditions such as vulvar varicose veins, pubic swelling, perineal edema, genital lymphedema, and symphysis pubis dysfunction (SPD). A disclosed pelvic prolapse treatment belt comprises a main structural member having through-hole regions (through-holes) on respective sides and first and second straps attached to what is referred to herein as a ‘compression pad’ that is configured for being positioned over the pelvic floor muscle for providing upward and inward pressure. The straps are configured to be pulled by the wearer through the through-holes and then secured to the main structural member. The upward and inward pressure applied helps alleviate pain and discomfort associated with POP condition(s) by helping to push the prolapsed organ(s) back into its/their proper place. 
     The main structural member has an inner and outer side for wrapping around the wearer being configured for after a wearer steps into the belt for pulling the main structural member up to their hips. The through-holes are located on the respective sides of a wearer&#39;s spine. The compression pad is attached to the main structural member and has a wider top and narrower bottom which is configured for placing over the pelvic floor muscle and associated tissue of the wearer to provide added support. The compression pad can optionally be within an outer pad that can be encased around the compression pad, and to also provide padding. 
     A first and a second strap are attached to the narrower bottom that have a length sufficient for extending over the wearer&#39;s buttocks. The straps are sized for being pulled by the wearer through the through-holes and have a distal end having an attachment feature for then attaching to the outer side of the main structural member which may also have an attachment feature. Once the straps are attached to the main structural member, upward pressure is applied to the pelvic floor muscle and associated tissue which helps push the prolapsed organ(s) back into its/their proper place, thus alleviating pain and/or discomfort associated with a POP condition. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a lateral view of the anatomy of a normal female pelvic cavity, where none of the organs within the female pelvic cavity are shown prolapsed. 
         FIG. 2A  is a front-view depiction an example pelvic prolapse prevention belt laying out flat, thus not on a wearer, showing a compression pad with a first strap and a second strap attached to the bottom of the compression pad. Although the pelvic prolapse prevention belt has through-holes in the main structural member, they are not shown in  FIG. 2A , nor in  FIG. 2B  described below, due to these both of these FIGs. being front-views. 
         FIG. 2B  is a front-view depiction an example pelvic prolapse prevention belt laying out flat, showing an outer pad over a compression pad, according to an example aspect. 
         FIG. 2C  shows a back-view depiction of the pelvic prolapse prevention belt shown in  FIG. 2B , again laying out flat, showing a plurality of through-holes formed through the main structural member, with the straps attached to the bottom of the compression pad and/or the outer pad, according to an example aspect. 
         FIG. 3  shows an example of a front-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s shown in  FIG. 2B  main structural member positioned around their hips with the compression pad shown positioned on their pelvic floor muscle and associated tissue, with the wearer holding one strap in her left hand and the other strap in her right hand, according to an example aspect. 
         FIG. 4  shows an example of a front-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s shown in  FIG. 2B  main structural member positioned around their hips with the compression pad on their pelvic cavity including over their pelvic floor muscle and associated tissue, with the straps now fastened with their hooks to respective sides of the main structural member which may have loops, according to an example aspect. 
         FIG. 5  shows an example of a back-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s shown in  FIG. 2B  main structural member positioned around their hips, with the straps fed through the center two through-holes, with the wearer holding one strap in her left hand and the other strap in her right hand, according to an example aspect. 
         FIG. 6  shows an example of a back-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s shown in  FIG. 2B  main structural member positioned around their hips, with the straps fed through the center two through-hole now attached to the main structural member, such as using a hooks and loops-based attachment, according to an example aspect. 
         FIG. 7  shows an example of a back-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s shown in  FIG. 2B  main structural member positioned around their hips, with the straps fed through the outer ones of through-holes on each side, with the wearer holding one strap in her left hand and the other strap in her right hand, according to an example aspect. 
         FIG. 8  shows an example of a back-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s shown in  FIG. 2B  main structural member positioned around their hips, with the straps fed through the outer two through-holes, and now attached to the main structural member using a hooks and loops-based attachment, according to an example aspect. 
         FIG. 9  shows an example of a side-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s shown in  FIG. 2B  main structural member positioned around their hips with the compression pad on their pelvic floor muscle and associated tissue, with one strap fastened to the main structural member using a hooks and loops-based attachment, according to an example aspect. 
         FIG. 10  shows an example of a side-view depiction of the wearer having the disclosed pelvic prevention prolapse belt&#39;s shown in  FIG. 2B  main structural member positioned around their hips with the compression pad on their pelvic floor muscle and associated tissue, with both straps fastened to the main structural member using a hooks and loops-based attachment, according to an example aspect. 
     
    
    
     DETAILED DESCRIPTION 
     Disclosed aspects are described with reference to the attached figures, wherein like reference numerals are used throughout the figures to designate similar or equivalent elements. The figures are not drawn to scale and they are provided merely to illustrate certain disclosed aspects. Several disclosed aspects are described below with reference to example applications for illustration. It should be understood that numerous specific details, relationships, and methods are set forth to provide a full understanding of the disclosed aspects. 
       FIG. 2A  is a front-view depiction an example pelvic prolapse prevention belt  200  laying out flat, showing a compression pad  202  with a first strap  205  and a second strap  206  both attached to the bottom of the compression pad  202 . There is shown a first hook  205   a  on the distal end of the first strap  205 , and a second hook  206   a  on the distal end of the second strap  206 . Alternatively, one or both of the hooks  205   a ,  206   a  shown can be replaced by loops.  FIG. 2B  is a front-view depiction an example pelvic prolapse prevention belt  250  laying out flat, having all the features shown in the pelvic prolapse prevention belt  200  shown in  FIG. 2A , but also having an outer pad  203  shown as an optional feature over the compression pad  202 . 
     The compression pad  202  can comprise a foam material having a minimum porosity of at least 25%, such as having a porosity from 25% to 90%, and having a thickness between 1 mm and 6 mms. The compression pad  202  is shown having a tapered shape with its top portion being the widest. Although the pelvic prolapse prevention belt  200  has through-holes in the main structural member  201 , as noted above, they are not shown in  FIG. 2A , nor in  FIG. 2B  described below, due to these FIGs. being front-views. 
     The main structural member  201  has an inner side and an outer side that has a length sufficient for wrapping around wearer, and is configured for after a wearer steps into the belt for pulling the main structural member  201  up to their hips. The main structural member  201  generally has a width between 1 and 5 inches. 
       FIG. 2C  shows a back-view depiction of the example pelvic prolapse prevention belt  250  shown in  FIG. 2B  having the outer pad  203  over the compression pad  202  that can encase the compression pad  202 , again laying out flat, now showing a plurality of through-holes  209   a ,  209   b ,  209   c , and  209   d  (two through-holes on each side), thus being through a full thickness of the main structural member  201 . The outer pad  203  can comprise for example nylon, polyester, satin, spandex, rayon, cotton, or a mixture of these. There may be more than two through-holes on each side of the belt, such as 3, 4, or 5 through-holes on each side of the main structural member  201 , although there are generally 2 to 4 through-holes on each side of the belt. 
     Disclosed through-holes can comprise grommets, buttonhole openings, slits, or die-cut holes. A grommet is known to be a ring or edge strip inserted into a hole through thin material, typically a sheet of textile fabric, sheet metal, composite of carbon fiber, wood, or honeycomb. Grommets are generally flared or collared on each side to keep them in place and are commonly made from metal, plastic, or rubber. The through-holes  209   a - 209   d  are generally within a distance of 10″ (inches) to the right side and left side of the wearer&#39;s spine. 
     The location of the through-holes  209   a - 209   d  allows the wearer to decide the placement of the straps  205 ,  206  therethrough, and thus the level of pressure applied, for their individual comfort. The straps  205 ,  206  can comprise an elastomeric material and can have a length to width ratio of 10:1 to 50:1. The straps  205 ,  206  each get pulled by the wearer through one of the through-holes  209   a - 209   d  which as described above creates leverage, allowing the wearer to (by choosing from the available through-holes  209   a - 209   d  on each side) to increase or decrease the amount of upward and inward pressure they apply to their pelvic floor muscle and its associated tissue by the compression pad  202 . 
     The compression pad  202  and/or the outer pad  203  is attached the main structural member  201 , such as by stitching or by an adhesive, and the compression pad  202  is configured to be positioned between the wearer&#39;s legs, over their pelvic floor muscle and associated tissue, thus for being placed on top of and thus structurally supporting the wearer&#39;s the prolapsed organ(s). The first strap  205  and a second strap  206  are attached to the bottom of the compression pad  202  and/or the outer pad  203 . 
     The straps  205 ,  206  have sufficient length to extend over the buttocks of the wearer, then through any of the through-holes  209   a - d  on the main structural member  201 , and then finally to attach to an attachment feature (such as loops in the case of hooks  205   a ,  206   a ) provided by the main structural member  201 . As noted above, the straps  205 ,  206  function for adjusting (for tightening and or loosening) the upward and inward pressure on the pelvic floor muscle and associated tissue received from the compression pad  202 . The straps  205 ,  206  when placed through a through-hole  209   a - 209   d  each create leverage, allowing the wearer to tighten or loosen the amount of upward and inward pressure they feel on their pelvic floor muscle from the compression pad  202 . 
     The main structural member  201  can be formed from a single material or a mixture of two or more different materials. The material for the main structural member  201  can be selected from elastomeric or non-elastomeric materials. For example, the main structural member  201  can comprise neoprene that can have hooks or loops (the opposite of what is on the distal end the straps  205 ,  206  shown by example as hooks  205   a ,  206   a ) to attach to after being directed be the wearer through a respective through-hole  209   a - 209   d  in the main structural member  201  shown in  FIG. 2C  to be one part of a hook-based fastener arrangement. Neoprene is known to be a family of synthetic rubbers produced by polymerization of chloroprene, where neoprene is known to exhibit good chemical stability and maintains flexibility over a wide temperature range. A known hook and loop-based arrangement is VELCRO, or a similar fastening mechanism may also be used. 
     The outer pad  203  comprises a soft material as compared to the material of the compression pad  202 . As noted above the compression pad  202  can comprise a foam material. The foam material can comprise a rigid foam defined herein to have a Young&#39;s modulus in compression of at least 2 MPa at room temperature, typically in the range of 2 to 50 MPa. The compression pad  202  can comprise in one specific example a breathable foam (a rigid foam such as extruded polystyrene (XPS) or a polyurethane foam) in the density range of 0.04 to 3.5 grams per cubic centimeter. Both open cell and closed cell foams are both generally possible. Besides a foam, the compression pad can  202  can comprise a more rigid material such as hard plastic, rubber, or silicone. The compression pad  202  can have a thickness between 1 mm and 6 mm. Other materials for the compression pad  202  may include a spacer fabric (spacer fabrics are known to be a kind of 3D manufactured textile structures in which two outer fabric layers are connected by a layer of pile threads), mesh, or neoprene (rubber). 
     The outer pad  203  has a thickness that is generally 0.2 mm to 3 mm. The outer pad  203  can comprise materials including nylon, polyester, satin, or cotton, with the material being a soft material generally being selected for the comfort of the wearer. 
     The outer surface of the main structural member  201  can include loops or hooks, such as in the case of loops the loops can comprise unbreakable durability loop fabric (UBL) for the purpose of attaching hooks to the hooks  205   a ,  206   a  of the straps  205 ,  206 . The inside surface of the main structural member  201  generally comprises a soft fabric such as nylon, polyester, satin, or cotton. Sewn or otherwise attached such as using hooks and loops to the outside of the lower portion of the main structural member  201  can be the outer pad  203  which can encase the compression pad  202 . 
     The compression pad  202 , or the compression pad  202  having an outer pad  203 , generally has a shape that tapers from being relatively wide at the top to the being relatively narrow bottom, generally by a 35% to a 70% reduction in width, in one arrangement forming a triangle-like shape in roughly the top half. The tapered shaped portion, such as being substantially triangular in shape, with a wider top as compared to the bottom enables fitting correctly over the pelvic floor muscle and its associated tissue of the wearer and through the disclosed strapping system comprising the straps  205 ,  206 , and the through-holes  209   a - 209   d , for providing adequate upward and inward directed pressure. 
     Sewn or otherwise attached to the narrower end of the outer pad  203  are a first strap  205  and a second strap  206 . The straps  205  and  206  generally comprise an elastomeric material and are generally sized with a maximum length to width ratio of 50:1. An elastomer as known in chemical arts is a polymer with viscoelasticity (i.e., both viscosity and elasticity) that has very weak intermolecular forces, generally low Young&#39;s modulus, and high failure strain compared with other materials. IUPAC (The International Union of Pure and Applied Chemistry) defines the term “elastomer” by a “polymer that displays rubber-like elasticity.” The straps  205 ,  206  can also comprise a non-elastomeric material. Non-elastomeric material for the straps can include non-stretch nylon, cotton, and polyester. 
     The straps  205 ,  206  can be sewn on side-by-side to the bottom of the compression pad  202  and/or the outer pad  203 . The respective ones of the straps  205 ,  206  on the wearer&#39;s left and right side, respectively, are for placing through a through-hole  209   c  or  209   d  for the first strap  205 , and through-hole  209   a  or  209   b  for the second strap  206 , of the wearer&#39;s choosing provided on the back of the main structural member  201 . The straps  205 ,  206  are for feeding from the inside of the main structural member  201  to the outside of the main structural member  201  through one of the through-holes  209   a - 209   d  on each side of the belt of the wearer&#39;s choice. 
     Once the respective straps are fed through their wearer&#39; selected through-hole  209   a - 209   d  on each side of the pelvic prolapse prevention belt, the wearer takes the first strap  205  which when on their right into their right hand, and the second strap  206  when on their left end into their left hand, and then pulls them towards the front of the pelvic prolapse prevention belt which causes the compression pad  202  and/or the outer pad  203  to create upward and inward pressure to the pelvic floor muscle and its associated tissue thus pushing against the prolapsed organ(s). The wearer then attaches the attachment features shown by example hooks  205   a ,  205   b  on the distal ends of the respective straps  205 ,  206  to the outside surface of main structural member  201 , such as using a hook and loop attachment, for example, VELCRO. 
     The pelvic prolapse prevention belt is applied by a wearer in essentially the same manner as pulling up underwear. The wearer steps into the pelvic prolapse prevention belt  200  or  250  and pulls the main structural member  201  up to their hips. The pelvic prolapse prevention belt can be worn over or under any garment. 
     The first and second straps  205 ,  206  are then extended over a buttocks of the wearer so that the compression pad  202  (with an optional outer pad  203  thereon) is over the pelvic floor muscle and associated tissue of the wearer. After the extending of the first and second straps  205 ,  206 , the first and the second straps  205 ,  206  are directed through ones of the through-holes  209   a - 209   d  by feeding the first and the second straps  205 ,  206  through from an inside to and outside of the through-holes  209   a - 209   d . The straps  205 ,  206  are thus fed by the wearer through selected ones of the available through-holes  209   a - 209   d  of the main structural member  201  on respective sides of the wearer&#39;s spine. 
     The through-holes  209   a - 209   d  are generally placed within 10 inches to each side of the wearer&#39;s spine to create an upward and inward directed pressure to the pelvic floor muscle and its associated tissue when the straps are fed through the through-holes  209   a - 209   d  of the wearer&#39;s choosing from the inside of the main structural member  201  to the outside. The wearer then pulls the straps  205 ,  206  towards the front of their body to obtain the desired tension level, thus, creating a user personalized or user-controlled upward and inward pressure onto their prolapsed organ(s). After the pulling, the wearer then attaches the straps  205 ,  206  to an attachment feature (such as loops) on the outer side of the main structural member  201 . 
       FIG. 3  shows an example of a front-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s  250  main structural member  201  positioned around their hips with the compression pad  202  having its outer pad  203  thereon shown positioned on their pelvic floor muscle and associated tissue. The wearer is shown holding the second strap  206  in her left hand and the first strap  205  in her right hand. As described below, the wearer then attaches the hooks  205   a ,  206   a  on the ends of the straps  205 ,  206  to a suitable attachment feature on the main structural member  201 . 
       FIG. 4  shows an example of a front-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s  250  main structural member  201  positioned around their hips with the compression pad  202  having its outer pad  203  thereon shown positioned on their pelvic floor muscle and associated tissue, with the respective straps  205 ,  206  now fastened with their hooks  205   a  and  206   a  attached to attachment features located on respective sides of the main structural member  201 , according to an example aspect. In this arrangement where the straps  205 ,  206  include hooks  205   a  and  206   a , the main structural member  201  may have loops. 
       FIG. 5  shows an example of a back-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s  250  main structural member  201  positioned around their hips, with the straps  205 ,  206  fed through the center two through-holes shown as  209   b  and  209   c  according to an example aspect. Regarding  FIG. 5 , as well as  FIGS. 6-8  described below, the outer pad  203  shown for the pelvic prolapse prevention belt  250  in  FIGS. 2B, 2C, 3, and 4  cannot be seen from these back-views. The compression pad  202 , and when present the outer pad  203  over the compression pad  202 , cover the pelvic cavity/pelvic floor muscle, but do not extend up over the buttock, making them non-visible from a back-view. The wearer is shown holding the first strap  205  in her right hand and the second strap  206  in her left hand. 
       FIG. 6  shows an example of a back-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s  250  main structural member  201  positioned around their hips, with the straps  205 ,  206  fed through the center two through-hole shown as  209   b  and  209   c  now attached to the main structural member  201 , according to an example aspect. For example, the straps  205 ,  206  can be attached to the main structural member  201  using a hooks and loops-based fastener arrangement. 
       FIG. 7  shows an example of a back-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s  250  main structural member  201  positioned around their hips, with the straps  205 ,  206  fed through the outer ones of the through-holes on each side shown as  209   a  and  209   d , respectively, holding the first strap  205  in her right hand and the second strap  206  in her left hand, according to an example aspect.  FIG. 8  shows an example of a back-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s  250  main structural member  201  positioned around their hips, with the straps  205 ,  206  fed through the outer two through-holes shown as  209   d  and  209   a , respectively, and now attached to the main structural member  201  using hooks and loops, according to an example aspect.  FIG. 9  shows an example of a side-view depiction of a wearer having the disclosed pelvic prolapse prevention belt&#39;s  250  main structural member  201  positioned around their hips with the compression pad  202  and outer pad  203  on their pelvic floor muscle and associated tissue, with the left strap  206  fastened to the main structural member  201  using hooks and loops, according to an example aspect. 
       FIG. 10  shows an example of a side-view depiction of the wearer having the disclosed pelvic prevention prolapse belt&#39;s  250  main structural member  201  positioned around their hips with the compression pad  202  and outer pad  203  on their pelvic floor muscle and associated tissue, with both straps  205 ,  206  fastened to the main structural member  201  using hooks and loops. 
     While various disclosed aspects have been described above, it should be understood that they have been presented by way of example only, and not limitation. Numerous changes to the subject matter disclosed herein can be made in accordance with this Disclosure without departing from the spirit or scope of this Disclosure. In addition, while a particular feature may have been disclosed with respect to only one of several implementations, such feature may be combined with one or more other features of the other implementations as may be desired and advantageous for any given or particular application.