Anal narrowing treatment method

A minimally invasive treatment for anal stenosis and fecal incontinence using lidocaine and hyaluronic acid injections addresses the limitations of conventional surgery by reducing recovery time, minimizing infection risk, and restoring natural bowel function.

WO2025057438A1PCT designated stage expired Publication Date: 2025-03-20HONDA MASAKI
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Patent Information

Application Number
PCT/JP2023/037480
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-13
Filing Date
2023-10-17
Publication Date
2025-03-20

AI Technical Summary

Technical Problem

Conventional surgical methods for treating anal stenosis and fecal incontinence are invasive, lead to prolonged recovery times, and risk infection, as they require cutting through muscle and sphincter tissues, disrupting natural bowel function during healing.

Method used

A minimally invasive treatment method involving alcohol disinfection, application of 2% lidocaine hydrochloride jelly, injection of 1% lidocaine and hyaluronic acid into the anal and rectal areas, and optional general anesthesia, to narrow the anus and restore normal function without cutting through muscles or sphincters.

Benefits of technology

This method allows for immediate closure of the anus, reduces the risk of infection, enables defecation within a day or two post-treatment, and allows for adjustable closure and correction of anal shape, improving both bowel function and sexual function.

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Abstract

To provide a treatment method for narrowing the opening of the anus while allowing bowel movement. This invention comprises the following treatments: (a) performing alcohol disinfection on the anus part, and then applying 2% of lidocaine hydrochloride jelly (xylocaine jelly); (b) injecting lidocaine 1% liquid into the skin, mucous membrane part, and muscle part in the vicinity of the surface of the anus and the rectum connected to the anus; (c) injecting hyaluronic acid into a plurality of locations of the skin, mucous membrane part, and muscle part near the surface of the anus and rectum; and (d) performing alcohol disinfection on the locations where the hyaluronic acid was injected, and affixing a gauze.
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Description

Anal stenosis treatment

[0001] The present invention relates to a treatment method for improving the condition in which the anus becomes loose or remains dilated, resulting in stool leakage and other problems, and narrowing the anal opening while allowing bowel movements.

[0002] The anus can become loose or remain dilated due to factors such as everyday constipation, hemorrhoids, aging, congenital factors, and sexual activity. If left untreated, this can lead to incontinence (leaking) during loose stools, forcing the wearer to wear diapers or pads, or causing pain and discomfort in the anal area, interfering with daily life. It can also make sexual activity less enjoyable for LGBT people.

[0003] Treatment for mild fecal incontinence caused by loosening of the anal sphincter can sometimes be achieved by improving daily life, including adjusting diet and fluid intake, and by focusing on anal muscle exercises. However, when anal dilation does not return to normal, the traditional treatment has mainly been surgical removal of the anal area and part of the lower rectum connected to the anus, followed by stitching up the removed area to narrow the anus.

[0004] The large intestine mainly absorbs water and rarely performs digestive functions. The rectum is the part of the large intestine that connects to the anus and is composed of three layers of membranes: the mucosa, the muscularis, and the serous membrane. However, the lower rectum and the anus are outside the abdominal cavity and do not have a serous membrane.

[0005] The rectum is lined with simple columnar epithelium, and the anal surface is covered with stratified squamous epithelium, which is resistant to mechanical stimuli. The internal circular muscle is developed just above the anus, forming the internal anal sphincter, and in addition to the sphincter made of smooth muscle, there is also the external anal sphincter made of striated muscle.

[0006] The anus is opened and closed reflexively by the sphincter muscle, which is made up of smooth muscle, and the external anal sphincter muscle, which is made up of striated muscle, opens and closes the anus in accordance with the will.

[0007] For this reason, conventional surgical procedures using a scalpel (including an electric scalpel) to remove the anus and the lower rectum connected to the anus cut away not only the mucosa and muscle layer, but also the sphincter and striated muscle components. Therefore, even if the excised area is stitched up after the procedure, the patient must wait for the natural healing power of the operated area to recover, and during that time the patient is unable to defecate.

[0008] For this reason, it takes a long time, generally about two weeks to a month, to fully heal, and if the patient defecates before he has fully healed or if loose stool soaks into the surgical site, the wound may worsen and never recover. In this case, since feces contain a large amount of E. coli, if E. coli infects the wound at the surgical site, it will cause suppuration, and it often becomes necessary to treat the suppuration of the wound over a long period of time by administering antibiotics, etc.

[0009] Therefore, in order to solve the various problems mentioned above, the present application provides a treatment method for narrowing the anal opening to treat anal dilation and fecal incontinence, which comprises the following procedures: (a) applying 2% lidocaine hydrochloride jelly (generic name: xylocaine jelly) to the anal area after disinfecting it with alcohol; (b) injecting 1% lidocaine solution into the skin, mucous membrane, and muscle near the surface of the anus and the rectum connected thereto; (c) injecting hyaluronic acid into multiple locations of the skin, mucous membrane, and muscle near the surface of the anus and rectum; and (d) disinfecting the areas where the hyaluronic acid was injected with alcohol and covering them with gauze.

[0010] Here, instead of or in addition to the procedure (b), general anesthesia using intravenous anesthesia or nitrous oxide anesthesia is performed.

[0011] Furthermore, depending on the symptoms, the injection of hyaluronic acid in the treatment (b) may be performed together with the injection of an exosome complex or a substance containing stem cells.

[0012] Conventional surgical procedures for removing the anus and rectum have meant that patients are unable to naturally defecate from the anus for two weeks or more after the surgery, after which they have no choice but to wait for recovery through natural healing.

[0013] On the other hand, with this treatment method, the anus closes immediately after the procedure, and there is little risk of the area becoming infected and suppurating due to mold such as E. coli. Furthermore, the wound caused by the needle used to inject hyaluronic acid closes in about half a day, so defecation becomes possible the day after or the day after the procedure.

[0014] In addition, hyaluronic acid is originally widely distributed and present in the human body, including the skin and joints, so it is not only safe but also an essential body tissue component, and the injection amount can be determined according to the symptoms, so the injection site and injection amount of hyaluronic acid liquid can be determined according to the dilated state of the anus, and the degree of closure of the anus after treatment can be adjusted.In addition, this treatment method can correct the distorted state of the anus to an appropriate or desirable shape, and improve or adjust the contact state of the rectum with the prostate gland.

[0015] The present invention provides a method for treating a dilated anus and narrowing the anal opening to treat fecal incontinence, in which the anal area is disinfected with alcohol before the procedure.

[0016] Next, 2% lidocaine hydrochloride jelly (xylocaine jelly) is applied, and 1% lidocaine solution is injected. In this case, depending on the symptoms of the affected area, intravenous anesthesia or general anesthesia using nitrous oxide may be administered.

[0017] Hyaluronic acid is then injected into multiple locations in the skin, mucous membrane, and muscle near the surface of the affected anus and rectum, depending on the severity of the anal opening.

[0018] Here, we will briefly explain hyaluronic acid. Hyaluronic acid is widely distributed in the bodies of humans and vertebrates, and is found mainly in the skin, joints, and vitreous body of the eye. In humans, half of the hyaluronic acid is found in the skin, and it is also found in the extracellular matrix widely in the body, such as in the brain, where it also protects cell tissues.

[0019] As is widely known, hyaluronic acid has physiological functions in the skin, preventing dryness through its ability to retain water and protecting cell tissue. It is also known that retaining water provides viscosity and reduces wear on joints.

[0020] Hyaluronic acid is a type of linear glycosaminoglycan (mucopolysaccharide) that, as mentioned above, has high water-retaining properties and is viscous due to its water retention. It is widely distributed in the body and plays an important role in the skin, cartilage, and eyeballs.

[0021] The molecular weight of hyaluronic acid can reach 2 million, but the minimum is 411. The higher the molecular weight of hyaluronic acid, the less it is absorbed by the body. For this reason, in this treatment, the amount of low molecular weight hyaluronic acid and high molecular weight hyaluronic acid is adjusted depending on the symptoms. If necessary, it is also possible to inject approximately 1 cc or more of a filler agent that is not permanently absorbed by the body.

[0022] Hyaluronic acid is a substance that is safe for the human body, and so it is generally known for its use in beauty products, but it has also been approved for use in medical procedures both in Japan and overseas.

[0023] In this treatment, hyaluronic acid is injected together with the injection of the exosome complex or stem cell-containing substance depending on the severity of the anal dilatation symptoms. If the amount of hyaluronic acid injected is too much or the patient experiences some discomfort after the treatment, a hyaluronic acid solution can be injected to dissolve the hyaluronic acid.

[0024] Furthermore, in this treatment method, the injection of hyaluronic acid is accompanied by the injection of a substance containing an exosome complex or stem cells.

[0025] Here, the exosome complex is a multiprotein complex present in the nuclei of eukaryotes and archaea that degrades various RNAs. The core of the exosome is composed of six proteins accompanied by other proteins, and exhibits exoribonuclease activity, degrading RNA from its termini. In eukaryotic cells, it also exhibits endoribonuclease activity, capable of cleaving RNA chains in the middle. This results in the production of autoantibodies that target the constituent proteins of the exosome, thereby promoting regeneration of the treatment site.

[0026] Finally, this treatment ends with disinfecting the area where the hyaluronic acid was injected with alcohol and then covering it with gauze.

[0027] As mentioned above, in conventional surgical procedures for removing the anus and rectum, patients are unable to defecate for one month after surgery and have no choice but to wait for recovery through natural healing. However, with this treatment method, the anus closes immediately after the procedure, and the wound caused by the needle used to inject hyaluronic acid closes in about half a day, so patients are able to defecate the next day or the day after.

[0028] Furthermore, hyaluronic acid is a safe substance that is widely distributed throughout the body, including in the skin and joints, so the injection site and amount of hyaluronic acid liquid can be determined arbitrarily depending on the state of anal dilation, making it possible to adjust the degree of closure of the anus after the procedure.

Claims

1. A method for narrowing the anal opening to treat a dilated anus and fecal incontinence, comprising the steps of: (a) applying 2% lidocaine hydrochloride jelly (xylocaine jelly) to the anus after disinfecting the anus with alcohol; (b) injecting 1% lidocaine solution into the skin, mucous membrane, and muscle near the surface of the anus and the rectum connected thereto; (c) injecting hyaluronic acid into multiple sites of the skin, mucous membrane, and muscle near the surface of the anus and rectum; and (d) disinfecting the areas where the hyaluronic acid was injected with alcohol and covering them with gauze.

2. The method for treating anal stenosis according to claim 1, wherein general anesthesia using intravenous anesthesia or nitrous oxide anesthesia is performed instead of or in addition to the procedure (b).

3. The method for treating anal stenosis according to claim 1 or 2, wherein the injection site and amount of the hyaluronic acid liquid are determined according to the state of anal dilation.

4. The method for treating anal stenosis according to claim 3, wherein the injection of hyaluronic acid in the treatment (b) is performed together with the injection of an exosome complex or a substance containing stem cells.

Citation Information

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