Classifications

• • A—HUMAN NECESSITIES
  • A47—FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
  • A47F—SPECIAL FURNITURE, FITTINGS, OR ACCESSORIES FOR SHOPS, STOREHOUSES, BARS, RESTAURANTS OR THE LIKE; PAYING COUNTERS
  • A47F7/00—Show stands, hangers, or shelves, adapted for particular articles or materials
  • A47F7/02—Show stands, hangers, or shelves, adapted for particular articles or materials for jewellery, dentures, watches, eye-glasses, lenses, or the like
  • A47F7/024—Show stands, hangers, or shelves, adapted for particular articles or materials for jewellery, dentures, watches, eye-glasses, lenses, or the like with provisions for preventing unauthorised removal
  • A47F7/0246—Show stands, hangers, or shelves, adapted for particular articles or materials for jewellery, dentures, watches, eye-glasses, lenses, or the like with provisions for preventing unauthorised removal for rectangular articles, e.g. books, cassettes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
  • A61F5/445—Colostomy, ileostomy or urethrostomy devices

Definitions

• the subject of the invention is a neosphincter for stoma treatment, which is a stoma accessory that can be used to provide a sphincter function to small or large intestinal stomas which are to be formed or have already been formed.
• a stoma is an exteriorized bowel-end opening, which has different types. The most common of these is colostomy (stoma of the large intestine), which can be a coecostomy, transversostomy, descendostomy, sigmoidostomy or rectostomy, depending on the location. Small intestinal stomas include jejunostomy and ileostomy, and the opening diverted from the urinary tract to the abdominal wall is urostomy.
• a single-barrel stoma is usually an end stoma containing an outlet, and is usually formed by the intestinal end that leads to it.
• Double-barrel stomas are formed by a resection of a bowel segment, which is then brought forward onto the surface of the abdomen.
• a stoma can be temporary or permanent, depending on the severity of the treated condition.
• Temporary stomas are created during emergency surgeries (e.g. for colonic ileus, i.e. Hartmann's surgery) or during oncology surgeries (e.g. deep rectal resection in conjunction with protective ileostomy formation).
• Permanent stoma formation is performed for the total removal of the rectum, inoperable tumours, or when requested by the patient.
• Circulatory problems can be caused by a narrow opening in the abdominal wall or by a stoma that is too tight. They may also be caused by an occlusion or ligation of the feeding artery of the intestinal wall, besides, thrombosis and embolism may also lead to circulatory disturbances. If the stoma does not fully adhere to the skin and subcutaneous tissues, a complete or partial stomal detachment may develop. In case of a partial detachment, a fissure may develop, which may extend into the deeper layers, and the stoma may partially or completely sink in. In case of a stoma detachment, the stoma is released.
• stoma detachment may include poor surgical technique, poor quality tools (e.g. sutures), poor wound healing due to infection, malnutrition, haemorrhage, steroid treatment or the formation of fistulas.
• poor quality tools e.g. sutures
• the intestinal mucosa is placed on the surface of the stoma.
• the mucosa has an excellent blood supply and lymphatic system.
• On physical impact e.g. during cleaning, minor tissue haemorrhages may occur, which may spontaneously disappear after a few minutes. If bleeding recurs later, it is heavy and difficult to stop, therefore immediate surgery is necessary.
• the opening of the retracted stoma is below the level of the skin.
• Stoma retraction can be caused by necrosis, the detachment of the stoma, or it can be a consequence of both. This may be due to obesity, scarring or the shortness of the bowel section released during the surgery. In case of obesity, the excessive accumulation of abdominal fat tissue around the retracted stoma leads to the formation of a trench.
• Parastomal hernias are hernias forming around the stoma. They are common in colostomy, but can develop after the formation of stomas in the small intestine as well.
• stoma is not fully fastened to the rectus muscle, or too large an opening is created in the muscle fascia.
• Parastomal hernias occur as protuberances and, in addition to being a cosmetic issue, they can make stoma management difficult (e.g. difficulty in placing and securing stoma bags), functional disturbances can occur, e.g. defecation may suddenly occur with high pressure or great pain.
• Dermatitis inflammation of the skin
• Ulceration and thinning of the skin (atrophy) can also occur, mainly due to an excessively strong adhesion.
• granulomas There may also be polypoid growths on the stoma, called granulomas. Normally the intestine inside the abdominal wall remains completely intact and the functions of the stoma are not impaired either. The cause may be, for instance, chemical or mechanical irritation. Mucosal outgrowths (polyps) can make the placement of stoma bags more complicated.
• stomas consist of an intestinal end or bowel section that is brought out through an opening in the abdominal wall and fixed, with no closing function, while the faeces is discharged by peristalsis (the movements of the intestine), usually into a specially designed device called stoma bag.
• the devices used to treat stoma are well known from the current state of technology.
• NeosphincterTM artificial anal sphincter has three components: an inflatable hose, a pressure-control balloon and a pump.
• the hose is placed around the upper anal canal, from where a tube is lead along the perineum to the pump, which is located at the scrotum or labia.
• the pump is connected with a tube to a pressure control balloon implanted in the abdominal wall.
• the balloon contains about 40 ml special liquid that is difficult for X-rays to pass through.
• Patent document US 4571749 A describes an implantable hydraulic urinary sphincter system for individuals who are unable to prevent or control unintentional passing of urine.
• the device consists of an artificial urinary sphincter and a control unit to maintain continence while the sphincter exerts minimal pressure on the urethra.
• the device automatically controls the sphincter pressure by sensing the pressure in the bladder and/or abdominal wall.
• the device can be operated manually when the patient wants to empty urine.
• the device can be filled with fluid or the fluid pressure can be restored without the need for surgical intervention.
• Patent document US 2008/0242918 A1 proposes a device for the treatment of urinary and faecal incontinence in which at least one long electrode is placed in the pelvic muscle of the patient.
• the control unit of the device receives the abdominal stress signals and stimulates the muscle with the waves emitted by the electrode, thereby eliminating involuntary urination due to stress.
• Patent document EP 1734895 B1 is an inserted prosthetic system for rectal treatment comprising a compressor, interconnected hose tubes formed as a hollow body and a bi-directional micro-pump for the inflation and deflation of the hose tubes.
• the micro-pump can be operated either by a separate control unit or manually by the patient.
• the primary aim of our invention is to provide a biocompatible neosphincter that restores intestinal sphincter function and has a simple structural design, which can be easily removed and replaced from the stoma, thus allowing a much simpler and more convenient colectomy (bowel resection) surgery.
• Another aim of our invention is to provide a neosphincter that can be tailored to the patient's size using a 3D printing technique before surgery.
• An additional goal of our invention is to provide a neosphincter that greatly reduces or eliminates the likelihood of stoma complications, namely, the narrowing of the intestinal lumen is not possible due to the attachment to the neosphincter, stoma recurrence is excluded, and parastomal hernias and prolapses of the intestine are prevented as well thanks to the structural design of the device.
• our invention is a neosphincter that can be placed on the oral end of the transected intestinal segment, with the intestinal end sutured to the device. The device surrounds the exteriorized bowel segment, thus supporting the intestinal wall.
• the neosphincter stimulates the intestinal wall at two points, thereby causing the oral segment to contract immediately after insertion and triggering a sphincter-like function.
• the intestinal segment develops a re-thickened, circular muscle tissue , similar to the anal sphincter, so that the sphincter is not permanently open.
• the stoma can be opened by pressing the abdomen.
• the device is made of a sewable, tissue-friendly, biocompatible copolymer, to achieve the quickest possible tissue integration with human tissue after use.
• the neosphincter as per the invention, is a hollow sheathed body with an extended ring, which is divided by the ring into two parts, a longer lower part and a shorter upper part. The free ends of the lower and upper part are flanged.
• the rim of the lower part is designed to prevent the abdominal wall from collapsing and is at least twice as thick as the sheathed body.
• the rim of the upper part helps the attachment of intestinal wall to the device by a seam, and is at least one and a half times the thickness of the sheathed body.
• the edge of the ring is surrounded by a flange, to which a metal band or magnetic ring can be attached, which allows the stoma bag to be fixed without adhesive.
• the length of the neosphincter depends on the thickness of the subcutaneous layer, while its diameter depends on the elasticity and diameter of the intestinal wall.
• Figure 1 represents a side view of the neosphincter shown in half-view and half-section.
• the neosphincter is a medical device comprising a hollow sheathed body 1 and ring 6, and can be purposefully produced by 3D printing.
• Length LI of the sheathed body 1 is 10-50% larger than the internal diameter d, which depends on the thickness of the subcutaneous layer, e.g. 40 mm for a 30 mm thick subcutaneous layer.
• the internal diameter d of the sheathed body 1 is 110-130% of the diameter of the exteriorized intestine, and its thickness VI is 3-5 mm.
• Ring 6 divides the sheathed body 1 into two parts: a longer lower part 2 and a shorter upper part 3, with the length L3 of the lower part 2 being 25-50% longer than the length L2 of the upper part 3.
• lower edge 4 is designed at the free end of the lower part 2 with a thickness V2 at least twice the thickness VI of the sheathed body 1.
• the free end of the upper part 3 is also designed with an upper rim 5 which helps to suture the intestinal wall to the device. Thickness V3 of the upper edge 5 is at least one and a half times the thickness VI of the sheathed body 1.
• the external diameter D of ring 6 is 2.5 to 3 times the internal diameter d of the sheathed body 1, and the thickness V4 is up to 1 mm less than the thickness VI of the sheathed body 1.
• the edge of ring 6 is surrounded by a flange 7.
• the thickness V5 of ring 6 and flange 7 is at least one and a half times the thickness VI of the sheathed body 1.
• a metal band or a magnetic ring can be attached to flange 7, which allows the stoma bag to be fixed without adhesive.
• the material of the neosphincter is a sewable biocompatible copolymer such as butylene/poly(alkylene ether) phthalate. It can be produced preoperatively by 3D printing at the site of surgery, with dimensions to perfectly match the patient's organ characteristics.
• a neosphincter for an intestine with a diameter of 24-28 mm can be made with the following dimensions:
• the intestinal end is folded over the upper edge 5 of the neosphincter, slightly turned outwards and secured to the upper edge 5 of the neosphincter with knotted seromuscular sutures.
• knotted sutures are used for closing the remaining skin openings.
• neosphincter as per the invention, is suitable for resolving the tasks outlined in the objectives, because
• the material is biocompatible and non-allergenic.

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• Health & Medical Sciences (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Urology & Nephrology (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)
• Prostheses (AREA)

Applications Claiming Priority (2)

Publications (1)

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Citations (4)

• 2021
  • 2021-04-15 HU HUP2100151A patent/HU231399B1/hu unknown
  • 2021-07-06 WO PCT/IB2021/056046 patent/WO2022219388A1/en active Application Filing

Patent Citations (4)

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