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WO2023219577A1 - Dispositif de réduction de surface du petit intestin pour traitement d'obésité non chirurgical - Google Patents

Dispositif de réduction de surface du petit intestin pour traitement d'obésité non chirurgical Download PDF

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Publication number
WO2023219577A1
WO2023219577A1 PCT/TR2022/050411 TR2022050411W WO2023219577A1 WO 2023219577 A1 WO2023219577 A1 WO 2023219577A1 TR 2022050411 W TR2022050411 W TR 2022050411W WO 2023219577 A1 WO2023219577 A1 WO 2023219577A1
Authority
WO
WIPO (PCT)
Prior art keywords
reducing device
small intestinal
area reducing
transorally
intestinal area
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/TR2022/050411
Other languages
English (en)
Inventor
Erhan AYSAN
Ali Umit KESKIN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Yeditepe Universitesi
Original Assignee
Yeditepe Universitesi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yeditepe Universitesi filed Critical Yeditepe Universitesi
Priority to PCT/TR2022/050411 priority Critical patent/WO2023219577A1/fr
Publication of WO2023219577A1 publication Critical patent/WO2023219577A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • 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
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves

Definitions

  • the present invention relates to a device which is suitable for implanting into the gastrointestinal to reduce the small intestinal area for treatment of obesity without surgery.
  • Obesity is a worldwide health problem which may be further worsened by global COVID-19 pandemic. Obesity decreases the productivity and quality of life of those individuals who are affected. It may cause social, psychological disorders and chronic diseases such as diabetes and cardiac problems.
  • Recent bariatric surgery practices involve alteration of a patient’s digestive tract. Some of these surgical procedures are based on reducing the volume of the stomach. Since the volume of the stomach is reduced, weight loss is gradually accomplished. Some bariatric surgery practices include reversible bypass procedures such as jejuno-ileal bypass, gastric bypass and Roux-en-Y gastric bypass. Other practices include irreversible gastric sleeve (restrictive) procedures which require permanent removal of a large section of the patient’s stomach. However, since the sleeve placement in duodenum extending into the small intestine may block mixing of pancreato-hepatobiliary enzyme secretions with the chyme.
  • IGB intragastric balloons
  • IGB practice volume of the placed balloon which is generally made from silicon, gelatin capsule or polyurethane and filled with air, carbon dioxide or liquid prevents ingestion of food into the stomach which reduces the desire for food. Since it is a non-surgical (endoscopic placement or swallowable) and reversible (removal of the balloon) practice, IGB is one of the most preferable treatment for obese patients.
  • nausea, vomiting, and discomfort are the most known complications of IGB which are usually occur during and/or shortly after their insertion and removal of the IGB.
  • IGB blockage risk of the balloon on the exit of the stomach (pylori) due to squeezingpushing action of the stomach is another issue of IGB which is usually relieved by changing the position of the patient.
  • Another critical problem of IGB is that it has a potential risk of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled IGB.
  • Hyperinflation involves the spontaneous filling of IGB with additional air or liquid while the balloon is in the stomach, this usually requires IGB removal.
  • the mechanism of acute pancreatitis development could be related to pressure from the IGB and distended stomach causing direct injury to the pancreatic parenchyma, compression of the pancreatic duct, and/or indirect pancreatic injury through duodenal obstruction.
  • Figure 1 is a schematic view of a small intestinal area reducing device comprising spherical occupancy means (not showing the anchoring means) in one exemplary embodiment of the present invention.
  • Figure 2 is a schematic view of a small intestinal area reducing device comprising spherical occupancy means (not showing the anchoring means) wherein the linking member is an integral part of the connection member in one exemplary embodiment of the present invention.
  • Figure 3 is a schematic view of a small intestinal area reducing device comprising spherical occupancy means (not showing the anchoring means) with polymer cover which is also acting as a linking member in one exemplary embodiment of the present invention.
  • Figure 4 is a schematic view of a small intestinal area reducing device comprising spherical occupancy means (not showing the anchoring means) with polymer cover in one exemplary embodiment of the present invention.
  • Figure 5a is a schematic view of a small intestinal area reducing device comprising ellipsoid occupancy means (not showing the anchoring means) without polymer cover in one exemplary embodiment of the present invention.
  • Figure 5b is a schematic view of a small intestinal area reducing device comprising ellipsoid occupancy means (not showing the anchoring means) with polymer cover in one exemplary embodiment of the present invention.
  • Figure 6 is a schematic view of a part of gastrointestinal tract into which a small intestinal area reducing device is implanted wherein the device comprises spherical occupancy means and a dental anchoring means in one exemplary embodiment of the present invention.
  • the elements illustrated in the figures are numbered as follows:
  • Embodiments of the present invention relates to a transorally implantable small intestinal area reducing device (1) for treating obesity comprising at least one solid occupancy means (2); an anchoring means (3) for anchored to at least a tooth, nose or lip; at least one elongated connection member (4) which physically connects the occupancy means (2) and the anchoring means (3).
  • the invention works as follows:
  • peristaltic movements When the orally ingested foods pass through stomach and duodenum and then enter into the small intestine, they are pushed from proximal to distal small intestine by segmental contraction and relaxation movements called peristaltic movements. During peristaltic movements, if the food remains stable or stuck in a certain intestinal region, the small intestine segments gather into the proximal region of the intestine and try to push the food to distal end of small intestine by making more severe peristaltic movements. Meanwhile, the length of the small intestine shortens and hence the overall small intestinal absorption area decreases. Based on this fundamental physiological information, in this invention, small intestinal area reducing device (1) mimics as a remained/ stuck food inside the small intestine.
  • the small intestinal area reducing device (1) is suitable for transoral implantation (also suitable for removal after implantation) and preferably implanted to a body via a non-invasive endoscopic techniques.
  • the occupancy means (2) is placed into the small intestinal and secured its position in the small intestine by the anchoring means (3) which is suitable for anchored to at least a tooth, nose or lip and physically connected the occupancy means (2).
  • the anchoring means (3) does not allow the occupancy means (2) to migrate from its implanted position to any other position in the small intestinal.
  • the connection member (4) is long enough such that the occupancy means (2) is settled floating inside small intestine
  • the small intestinal area reducing device (1) triggers the peristaltic movements of small intestine.
  • Solid character of the occupancy means (2) enhance the activation of the peristaltic movements of small intestine. Since the small intestinal area reducing device (1) is anchored to teeth, nose or lip the peristaltic movements continue to contract small intestine segments and make the small intestine shortened. Small intestine segments are accumulated in the proximal end of the small intestine in the manner of an accordion in the region where implant device is floating. By shortening small intestine, nutrition absorption area of the small intestine is naturally reduced.
  • the small intestinal area reducing device (1) does not occupy a volume in the stomach to induce satiation and thus it does not limit oral intake.
  • Small intestinal area reducing device (1) is anchored and floats at a fixed region inside the small intestine. This prevents any obstruction of secretions in the intermediate region including duodenum and the sphincter of Oddi (the smooth muscle that surrounds the end portion of the common bile duct and pancreatic duct to allow bile and pancreatic juice to flow into small intestine.
  • One embodiment of the invention comprises a plurality of occupancy means (2) constituting a cascading form and at least one linking member (5).
  • Linking member (5) links (physically and flexibly) two adjacent occupancy means (2) and limits the maximum distance between the said adjacent occupancy means (2).
  • the linking member (5) is an integral part of the connection member (4).
  • the occupancy means (2) is in the form of a sphere or ellipsoid.
  • connection member (4) is a biocompatible thread.
  • One embodiment of the invention comprises a thorough hole (a hole crossing over the whole body of the occupancy means (2)) on each occupancy means (2) for receiving the connection member (4).
  • Connection member (4) passes through the thorough hole.
  • a knot (6) on an inlet and an outlet of the thorough hole is provided such that occupancy means (2) is attached to a fixed position on the connection member (4) and so the maximum distance between adjacent occupancy means (2) are limited/fixed.
  • occupancy means (2) is made of a biocompatible metal, glass, ceramic, porcelain, wood, silicone, high-density polyethylene, polyvinylchloride or composites.
  • metal occupancy means (2) has a non-ferromagnetic property.
  • One embodiment of the invention comprises a polymer cover (7) on the occupancy means (2).
  • polymer cover (7) it is possible to link adjacent occupancy means (2) with or without (polymer cover (7) itself may also acting as a linking member (5)) linking member (5) such that distance between occupancy means (2) are fixed.
  • the polymer cover (7) is made from silicon.
  • the polymer cover (7) is in the form of a hose both ends of which is closed wherein the occupancy means (2) fixed inside the hose. It must be noted that the hose does not provide any kind of passage way within the gastrointestinal tract.
  • One embodiment of the invention comprises a polymer filler filling cavities between the occupancy means (2) inside the hose. In this embodiment, it is ensured that the fixed distance between adjacent occupancy means (2) are remained.
  • One embodiment of the invention comprises a plurality of occupancy means (2) constituting a cascading form and at least one linking member (5).
  • Linking member (5) links (physically and flexibly) two adjacent occupancy means (2) and limits the maximum distance between the said adjacent occupancy means (2).
  • the linking member (5) is an integral part of the connection member (4).
  • the occupancy means (2) is in the form of a sphere or ellipsoid.
  • the connection member (4) is a biocompatible thread.
  • One embodiment of the invention comprises a thorough hole (a hole crossing over the whole body of the occupancy means (2)) on each occupancy means (2) for receiving the connection member (4).
  • Connection member (4) passes through the thorough hole.
  • a knot (6) on an inlet and an outlet of the thorough hole is provided such that occupancy means (2) is attached to a fixed position on the connection member (4) and so the maximum distance between adjacent occupancy means (2) are limited/fixed.
  • occupancy means (2) is made of a biocompatible metal, glass, ceramic, porcelain, wood, silicone, high-density polyethylene, polyvinylchloride or composites.
  • metal occupancy means (2) has a non-ferromagnetic property.
  • One embodiment of the invention comprises a polymer cover (7) on the occupancy means (2).
  • polymer cover (7) it is possible to link adjacent occupancy means (2) with or without (polymer cover (7) itself may also acting as a linking member (5)) linking member (5) such that distance between occupancy means (2) are fixed.
  • the polymer cover (7) is made from silicon.
  • the polymer cover (7) is in the form of a hose both ends of which is closed wherein the occupancy means (2) fixed inside the hose. It must be noted that the hose does not provide any kind of passage way within the gastrointestinal tract.
  • One embodiment of the invention comprises a polymer filler filling cavities between the occupancy means (2) inside the hose. In this embodiment, it is ensured that the fixed distance between adjacent occupancy means (2) are remained.
  • the anchoring means may be a gastric type anchoring means which is suitable for anchored to stomach. Gastric anchoring means has been described in a previous patent (TR 201900613) granted to the authors of present patent application.
  • the anchoring means (3) is a nose type anchoring means (3) is fixed by a nose clip or nose piercing.
  • the cartilaginous structure that covers the nostril is the most common area for a nose piercing.
  • Another nose piercing is a nasal septum piercing through the columella (a cartilaginous structure that separates the right and left sides of the nose). Nose piercings are also done on the third eye and bridge of the nose.
  • the anchoring means (3) is a dental type anchoring means (3) which may be fixed to at least a tooth by using dental metal brackets or alternatively fixed to oral cavity a lingual arch.
  • the anchoring means (3) is a lip type anchoring means (3) which may be fixed by lip piercing such as Lip Frenulum Piercing (Frowny Piercing, a piercing through the thin layer of skin that connects the lower lip to the mouth).
  • lip piercing such as Lip Frenulum Piercing (Frowny Piercing, a piercing through the thin layer of skin that connects the lower lip to the mouth).
  • One embodiment of the invention comprises a connection hole (8) on the solid occupancy means (2) for receiving and attaching the connection member (4).

Landscapes

  • Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (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)
  • Prostheses (AREA)

Abstract

Des modes de réalisation de la présente invention concernent un dispositif de réduction de surface du petit intestin, transoralement implantable (1) pour traiter l'obésité comprenant au moins un moyen d'occupation solide (2), un moyen d'ancrage (3), au moins un élément de liaison allongé (4) qui relie physiquement le moyen d'occupation (2) et le moyen d'ancrage (3).
PCT/TR2022/050411 2022-05-10 2022-05-10 Dispositif de réduction de surface du petit intestin pour traitement d'obésité non chirurgical Ceased WO2023219577A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/TR2022/050411 WO2023219577A1 (fr) 2022-05-10 2022-05-10 Dispositif de réduction de surface du petit intestin pour traitement d'obésité non chirurgical

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/TR2022/050411 WO2023219577A1 (fr) 2022-05-10 2022-05-10 Dispositif de réduction de surface du petit intestin pour traitement d'obésité non chirurgical

Publications (1)

Publication Number Publication Date
WO2023219577A1 true WO2023219577A1 (fr) 2023-11-16

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Application Number Title Priority Date Filing Date
PCT/TR2022/050411 Ceased WO2023219577A1 (fr) 2022-05-10 2022-05-10 Dispositif de réduction de surface du petit intestin pour traitement d'obésité non chirurgical

Country Status (1)

Country Link
WO (1) WO2023219577A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007076021A2 (fr) * 2005-12-22 2007-07-05 Wilson-Cook Medical Inc. Poche gastrique pour traiter l’obesite
WO2008023374A2 (fr) * 2006-08-23 2008-02-28 Svip 2 Llc Dispositifs et procédés destinés à modifier un comportement alimentaire
WO2009147670A1 (fr) * 2008-06-03 2009-12-10 Svip 8 Llc Dispositifs a ancrage tissulaire
US20100100115A1 (en) * 2008-10-20 2010-04-22 Wilson-Cook Medical Inc. Foam filled intragastric balloon for treating obesity
US20120095385A1 (en) * 2010-10-18 2012-04-19 Allergan, Inc. Intragastric implants with duodenal anchors
WO2018213650A1 (fr) * 2017-05-17 2018-11-22 Valentx, Inc. Dispositifs et procédés de dérivation gastro-intestinale

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007076021A2 (fr) * 2005-12-22 2007-07-05 Wilson-Cook Medical Inc. Poche gastrique pour traiter l’obesite
WO2008023374A2 (fr) * 2006-08-23 2008-02-28 Svip 2 Llc Dispositifs et procédés destinés à modifier un comportement alimentaire
WO2009147670A1 (fr) * 2008-06-03 2009-12-10 Svip 8 Llc Dispositifs a ancrage tissulaire
US20100100115A1 (en) * 2008-10-20 2010-04-22 Wilson-Cook Medical Inc. Foam filled intragastric balloon for treating obesity
US20120095385A1 (en) * 2010-10-18 2012-04-19 Allergan, Inc. Intragastric implants with duodenal anchors
WO2018213650A1 (fr) * 2017-05-17 2018-11-22 Valentx, Inc. Dispositifs et procédés de dérivation gastro-intestinale

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