WO2020070145A1 - Système d'implant - Google Patents

Système d'implant

Info

Publication number
WO2020070145A1
WO2020070145A1 PCT/EP2019/076623 EP2019076623W WO2020070145A1 WO 2020070145 A1 WO2020070145 A1 WO 2020070145A1 EP 2019076623 W EP2019076623 W EP 2019076623W WO 2020070145 A1 WO2020070145 A1 WO 2020070145A1
Authority
WO
WIPO (PCT)
Prior art keywords
internal
external
ring
rings
internal ring
Prior art date
Application number
PCT/EP2019/076623
Other languages
English (en)
Inventor
Eric SEJOR
Original Assignee
Chu De Nice
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 Chu De Nice filed Critical Chu De Nice
Publication of WO2020070145A1 publication Critical patent/WO2020070145A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/4404Details or parts
    • A61F5/4408Means for securing receptacles or bags to the body otherwise than by adhesives, e.g. belts, straps or harnesses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices
    • A61F5/449Body securing means, e.g. belts, garments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices
    • A61F2005/4455Implantable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices
    • A61F2005/4486Colostomy, ileostomy or urethrostomy devices with operable locking ring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0255Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for access to the gastric or digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0261Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0291Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body method or device for implanting it in the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0247Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0294Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a specific shape matching the shape of a tool to be inserted therein, e.g. for easy introduction, for sealing purposes, guide

Definitions

  • the present disclosure generally relates to an implant system.
  • it relates to an implant for holding a portion of a body canal near an artificial (i.e. made by a practitioner) cutaneous opening or a natural body opening.
  • enterostomies or ureterostomies are accomplished by severing the body canal, i.e. the intestine or the ureter, which is to be externalized and then suturing the wall of the severed canal portion to the edge of an opening which is created, usually, in the abdomen.
  • the wall of the canal and the skin surrounding the opening heal together to permanently secure the canal portion to the outer surface of the body, thereby creating a stoma.
  • a container in particular a stoma bag, is usually attached to the skin, around the canal opening, to receive the feces or urine discharged from this opening.
  • the suturing of the canal portion to the edge of the abdominal opening is commonly done with separate stitches using a surgical needle and a bioabsorbable thread.
  • the suturing can be difficult, is somewhat risky (in particular because of the use of a needle) and takes time.
  • an adaptator is disclosed in patent document US 2012/0136324.
  • the surgical procedure for positioning the adaptator is relatively complex: it involves, in particular, attaching a part of the adaptator (i.e. the flange of the sleeve) to the skin through suturing and introducing an expansion fluid through valves to inflate a balloon.
  • the invention relates to an implant system for performing, in particular but not only, surgical procedures like an enterostomy or an ureterostomy.
  • surgical procedures aim to externalize a portion of a body inner canal and maintain the canal portion on the edge of an opening which has been created in the outer surface of the body.
  • the body canal may be an inner canal such as the ileum, jejunum, colon, etc.
  • the implant system comprises:
  • At least one internal ring which is non-deformable and adapted to contact with the internal face of a body canal
  • the holder for holding and inserting the internal ring into the body canal
  • the holder comprising a handle and a base connected to the handle, the handle being elongated in the direction of insertion of the internal ring into the body canal, and the base being adapted to releasably fit inside and hold the internal ring
  • at least one external ring being an assembly of at least two circumferential portions, the external ring being adapted to be clamped around the internal ring by joining and holding the circumferential portions together, so as to pinch a wall of the body canal between the internal and external rings.
  • the internal and external rings form part of the implant per se, while the holder is used to put the implant in place.
  • the holder is mechanically connected to the internal ring for inserting the internal ring into the body canal. Once the implant is in place, the holder is disconnected from the internal ring.
  • the wall of the body canal can be pinched between the internal and external rings.
  • the internal and external rings are positioned, respectively, inside and around the body canal and pinch the body canal between them.
  • the external ring rests on the body outer surface and prevents the body canal from retracting inside the body, while the internal ring prevents the invagination of the canal wall.
  • the implant thus allows a portion of the body canal to be maintained at the opening formed in the outer surface of the body. After a few days, the wall of the body canal and the skin surrounding the opening heal together to permanently secure the body canal portion to the edge of the opening, and no suturing is needed. In the meantime, the membrane or wall of the body canal, which is pinched between the internal and external rings, dies (i.e. becomes necrotic) due to tissue compression. In the end, if the spontaneous fall of the implant does not occur, it is possible to remove easily the rings and the dead membrane, thereby obtaining an externalized body canal with a canal opening substantially flush with the body outer surface.
  • the implant system may be used, in particular, for performing an enterostomy or an ureterostomy, it may also be used for holding a portion of a body canal such as the colon, the jejunum or the ileum, near a natural body opening such as the anal canal. Accordingly, the implant system may be used for performing colo-anal, jejuno-anal, or ileo-anal anastomosis.
  • the adjectives "internal” and "external” are used in relation to the radial direction.
  • the internal ring is disposed inside the external ring.
  • an internal part or face of a circular or tubular element is, according to a radial direction, closer to the central axis of the element than the external part or face of the element.
  • a cross-sectional dimension shall be understood as a linear dimension measured across an opening, a cavity or a body, and the skilled person will readily recognize that this is, e.g., the diameter of a circular opening or the diameter of a cylindrical or spherical member.
  • any reference to the words top, bottom, up and down, and the like, in the present disclosure refers to the orientation shown in the appended drawings, as well as the normal connotations of these words when applied to such an implant, and is not intended to restrict positioning of the implant in actual use.
  • the bottom or lower side of a part is oriented towards the patient's body.
  • the top or upper side designates the opposite side and is oriented towards the outside.
  • the internal ring is defined as being "non-deformable", which means that it is not foldable, collapsible or inflatable. This also means that the internal ring is sufficiently rigid to support, without deformation or with very low deformation, the clamping force exerted by the external ring.
  • the handle is defined as being "elongated in the direction of insertion of the internal ring into the body canal", which means that its dimension in the direction of insertion is far larger than its dimension in a direction perpendicular to the direction of insertion.
  • the direction of insertion substantially corresponds to the direction of the central axis (or revolution axis) of the internal ring.
  • the external ring has an internal face provided with a peripheral groove, the peripheral groove being adapted to receive an external part of the internal ring.
  • the internal ring has an external bulge or flange, or first external flange, adapted to fit inside the peripheral groove. In other words, the external ring is clamped around the first external flange.
  • the internal ring has another external bulge or flange, or second external flange.
  • the first and second external flanges may also be called upper and lower external flanges, the first external flange being more towards the outside of the patient's body than the second external flange, when the implant is implanted.
  • the second external flanges is away or distant from the first external flange and, when the external ring is clamped around the first external flange, the second external flange is away or distant from the external ring.
  • the second external flange is under the patient's skin, whereas the external ring is outside of the patient's body and rests on the outer surface of the patient's body.
  • the second external flange may have a larger cross-sectional dimension than the first external flange.
  • Such a second external flange allows a lower portion of the internal ring to be blocked in the body tissues under the body outer surface, i.e. under the skin. It prevents the internal ring and the body canal to be exteriorized out of the body more than necessary.
  • the external ring has a lower or bottom face provided with glue.
  • the bottom face can be glued to the outer surface of the body, around the opening, which allows the implant to be fixed in position.
  • This may be useful, in particular, when the internal ring is not provided with a second external flange.
  • this feature may also be used in combination with a second external flange. It may be useful when the second external flange does not provide an effective fixing, which may be the case, for instance, when the cutaneous opening is too large as compared to the second external flange.
  • the internal ring has an internal face provided with at least one notch, and the base of the holder is provided with at least one finger adapted to cooperate with the notch for connecting the holder to the internal ring.
  • the internal ring may be provided with at least two notches evenly distributed along the internal face.
  • the internal ring may be provided with three notches offset by 120° or four notches offset by 90°. This configuration allows the holder to be connected inside the internal ring, in a simple, stable and efficient manner. Of course, other types of connections could be used, including mechanical or magnetic connections.
  • the implant comprises two internal rings and two external rings, the external rings being merged into a eight-shaped collar adapted to be clamped around the two internal rings.
  • Such a configuration is dedicated to loop stoma or double-barreled stoma.
  • each of the two internal rings has an external face with a flat surface and the two internal rings are adapted to be disposed adjacent to each other with their flat surfaces facing each other.
  • the flat surfaces allow a better pinching of the canal walls pinched between the two internal rings.
  • the external ring or the eight-shaped collar is in two halves connected with a hinge, and the two halves may clip with each other.
  • FIGS 1 to 5 illustrate a first example of an implant system.
  • FIG 1 is a perspective view of an example of an internal ring.
  • FIG 2 is a top view of the internal ring of FIG 1.
  • FIG 3 is a perspective view of an example of a holder.
  • FIG 4 is a perspective view of an example of an external ring.
  • FIG 5 is an exploded view of the internal ring, the external ring and a holder assembled together.
  • FIGS 6A to 6D illustrate different steps of an enterostomy using the first example of implant.
  • FIGS 7 to 10 illustrate a second example of an implant system.
  • FIG 7 is a perspective view of an example of internal rings, when viewed from above.
  • FIG 8 is a perspective view of an example of internal rings, when viewed from below.
  • FIG 9 is a perspective view of an example of a eight-shaped collar formed by two external rings.
  • FIG 10 shows the internal rings, the eight-shaped collar, two holders and a spacer assembled together.
  • FIGS 11 A to 11 F illustrate different steps of an enterostomy using the second example of implant system.
  • FIGS 1 to 5 illustrate a first example of an implant system comprising an internal ring 2 (see FIGS 1 , 2), a holder 20 (see FIG 3) and an external ring 40 (see FIG 4).
  • the internal ring 2 has an internal face 4, an external side face 5, upper face 3 and lower face 9.
  • the external side face 5 is intended to be in contact with an internal face 101 of a body canal 100 and is provided with two external flanges 7, 8: an upper flange 7 which is intended to be placed above the patient's skin 110 and a lower flange 8 which is intended to be placed under the patient's skin 110, in the abdominal tissues, as illustrated in FIGS 6B, 6C.
  • the lower flange 8 has a larger cross- sectional dimension than that of the upper flange 7 and of an artificial cutaneous opening 105, so that the lower flange 8 allows a lower part of the internal ring 2 to be blocked under the skin 110, thereby preventing the internal ring 2 and the body canal 100 to come out of the patient's body more than necessary.
  • the internal face 4 of the internal ring 2 is provided with notches 10.
  • the notches 10 may have a "L" shape with a portion extending circumferentially and a portion extending axially, as illustrated in FIG 1 , and open into the upper face 3 and the internal face 4.
  • the internal face 4 is provided with four notches 10 angularly offset by 90°.
  • the upper face 3 of the internal ring 2 may also be provided with a recess or hole 11 into which a sharp end of an ancillary instrument (not shown) can fit, in order to prevent the internal ring 2 from rotating relative to the external ring 40 when disconnecting the holder 20 from internal ring 2.
  • the holder 20 comprises an elongated handle 21 and a base 23 connected to one end of the handle 21.
  • the base 23 is adapted to fit inside the internal ring 2 and is provided, on its outer edge, with fingers 25 protruding radially.
  • the fingers 25 are adapted to cooperate with the notches 10 for connecting the holder 20 to the internal ring 2. After connection, the practitioner can hold the internal ring 2 by means of the holder 20, as illustrated in FIG 6A.
  • the external ring 40 has an internal face 42, and external side face 44, upper face 46 and lower face 47.
  • the lower face 47 is intended to rest on the patient's skin 110.
  • the external ring 40 is adapted to be clamped around the internal ring 2 so as to pinch a membrane or wall of the body canal 100 between the internal and external rings.
  • the internal face 42 is provided with a peripheral groove 43.
  • the peripheral groove 43 is adapted to receive the upper flange 7 of the internal ring 2.
  • the external ring 40 is an assembly of at least two circumferential portions, and is adapted to be clamped around the internal ring 2 by joining and holding the circumferential portions together, so as to pinch a wall of the body canal between the internal and external rings 2, 40.
  • the external ring 40 as a whole is deformable because its circumferential portions can be moved with respect to one another in order to be mechanically connected and disconnected.
  • the circumferential portions per se may be non- deformable, which means that each circumferential portion is sufficiently rigid to support, without deformation or with very low deformation, the clamping force.
  • the external ring 40 is in two parts or halves 40A, 40B, which can be joined together and clamped around the internal ring 2, as shown in FIG 5.
  • one half 40A of the external ring 40 is provided with hooks 41 and the other half 40B is provided with notches 49.
  • the hooks 41 and notches 49 cooperate with each other to join and hold the two halves 40A, 40B clamped around the internal ring 2.
  • the halves or the circumferential portions may be hinged together.
  • FIGS 6A to 6D illustrate different steps of an enterostomy using the first example of implant system.
  • the holder 20 is connected to the internal ring 2, which allows the practitioner to insert the internal ring 2 into the open end of a severed portion of the body canal 100 which is still inside the patient's body.
  • a tie 99 is passed around the body canal 100, just above the internal ring 2, so as to tie on the body canal 100 to the holder 20.
  • a portion of the body canal 100 can be passed through the opening 105, which has been created before or after the installation of the implant system, and then externalized the whole by pulling the holder 20, as illustrated in FIG 6A by the black arrow.
  • the holder 20 is pulled until the upper flange 7 is just above the patient's skin 110 and the lower flange 8 is in the abdominal tissues 109, just under the patient's skin 110.
  • the external ring 40 is then assembled and clamped around the internal ring 2, thereby pinching the wall of the body canal 100 between the internal and external rings 2, 40.
  • the holder 20 is then disconnected from the internal ring 2 and put aside.
  • the external ring 40 rests on the skin 110 (i.e. its lower face 47 is in contact with the skin 110) and prevents the internal ring 2 and the body canal 100 from retracting inside the body, as illustrated in FIG 6C.
  • the lower flange 8 of the internal ring 2 prevents the internal ring 2 and the body canal 100 from coming out of the patient's body more than necessary.
  • the lower face 47 of the external ring may be provided with glue so that the external ring 40 may be stuck onto the skin 110, thus maintaining the internal ring 2 and the body canal 100 in position.
  • the end portion of the body canal 100 extending beyond the upper face 46 of the external ring 40 may be cut by means of an appropriate surgical tool, such as a scalpel, as illustrated by the dotted line in FIG 6C.
  • an appropriate surgical tool such as a scalpel
  • the internal and external rings 2, 40 thus allow a portion of the body canal 100 to be maintained at the opening 105 formed in the patient's skin 110.
  • the membrane or wall of the body canal 100 and the skin 110 surrounding the opening 105 heal together to permanently secure the body canal portion to the edge of the opening 105.
  • the wall of the body canal 100 which is pinched between the internal and external rings 2, 40 ceases to be vascularized, necroses and comes off, causing the spontaneous fall of the implant within a time frame sufficient to allow the creation of adhesions between the body canal and the tissues surrounding the opening 105. If, for any reason, the spontaneous fall of the implant does not occur, it is possible to remove easily the rings 2, 40 and the necrosed portion body canal because this portion is weak. This results in a body canal 100 with an open end being flush with the skin 110, called stoma, as illustrated in FIG 6D.
  • FIGS 7 to 10 illustrate a second example of an implant system.
  • This example differs from the first example mainly by the fact that it comprises two internal rings 2 and two external rings 40.
  • the internal rings 2 are illustrated in FIGS 7 and 8.
  • each internal ring has an internal face 4, and external side face 5, upper face 3 and lower face 9.
  • the external side face 5 is intended to be in contact with an internal face 101 of a body canal 100 and is provided with one external bulge or flange 7.
  • the internal face 4 of each internal ring 2 is provided with two notches 10 diametrically opposed, i.e. offset by 180°.
  • Each internal ring 2 has a flat surface 19 on its external side face 5 and the internal rings 2 are adapted to be disposed adjacent to each other with their flat surfaces 19 facing each other, as illustrated in FIGS 7, 8.
  • the internal rings 2 of the second example of FIGS 7, 8 differ from the internal ring 2 of the first example of FIGS 1 , 2, they could be much more similar.
  • the internal rings 2 of the second example could have two external flanges 7, 8, and more than two notches 10, like in the first example.
  • the second example of implant further comprises two external rings 40 merged into an eight-shaped collar 80 and adapted to be clamped around the two internal rings 2.
  • the eight-shaped collar 80 may comprise two halves 81 connected with a hinge 82. The two halves 81 can be joined and held together, i.e. eight-shaped collar 80 can be locked in a closed position, by a hook and notch system 83 or any other appropriate locking system.
  • the eight-shaped collar 80 is adapted to be closed or clamped around the two internal rings 2.
  • the internal face 42 of each external ring 40 is provided with a peripheral groove 43 adapted to receive or arrange the external flange 7 of an internal ring 2.
  • the internal rings 2 have different cross-sectional dimensions, so there is a big internal ring 2 and a small one. Similarly, there are big and small external rings 40 to be clamped around the big and small internal rings 2, respectively.
  • Each holder 20 is substantially similar to the holder of FIG 3.
  • Each holder comprises a stem or handle 21 and a base 23 connected to one end of the handle 21 , and fingers adapted to cooperate with the notches 10 of an internal ring 2 for connecting the holder 20 to the internal ring 2. This allows the practitioner to hold each internal ring 2 by means of a holder 20.
  • a spacer 50 is adapted to be placed between the handles 21 of the holders for maintaining the holders 20 and, therefore, the internal rings 2, at a predetermined distance, as illustrated in FIGS 10 and 11 C.
  • the spacer 50 is a piece of rigid material provided with two tubular through holes 56 into which the handles 21 can fit.
  • FIG 10 shows the two internal rings 2, the eight-shaped collar 80, the two holders 20 and the spacer 50 assembled together.
  • FIGS 11 A to 11 F illustrate different steps of an enterostomy using the second example of implant system.
  • an opening 105 is formed in the patient's abdomen and a loop of intestine, which is an example of body canal 100, is passed through the opening 105 and externalized.
  • a loop of intestine which is an example of body canal 100
  • two adjacent branches 111 , 112 of the body canal 100 go through the opening 105.
  • two holes 121 , 122 are made trough the externalized loop of the body canal 100.
  • a first holder 20 is connected to a first internal ring 2, which allows the practitioner to insert the first internal ring 2 through the opening 121 , into the first branch 1 11 of the body canal 100, as illustrated in FIG 11A.
  • a second holder 20 is connected to a second internal ring 2 for inserting the second internal ring 2 through the opening 122, into the second branch 112 of the body canal 100, as illustrated in FIG 11 B.
  • the first and second internal rings 2 are then positioned adjacent to each other with their flat surfaces 19 facing each other, so as to pinch the adjacent walls of the first and second branches 111 , 112 between their flat surfaces 19. It is to be noted that the intestine walls are better pinched, i.e. more evenly, between flat surfaces than between cylindrical surfaces, and that a better pinching promotes the necrosis of the intestine walls.
  • the first and second internal rings 2 are maintained in an appropriate position by means of the spacer 50 which is positioned onto the handles 21 of the holder 20, as illustrated in FIG 11 C.
  • the eight-shaped collar 80 is then assembled and clamped around the two internal rings 2, thereby pinching the walls of the first and second branches 111 , 112 of the body canal 100 between the internal and external rings 2, 40, as illustrated in FIG 11 D.
  • the holders 20 are then disconnected from the internal rings 2 and put aside.
  • the eight-shaped collar 80 rests on the skin 110 (i.e. its lower face 87 is in contact with the skin 110) and prevents the internal ring 2 and the body canal 100 from retracting inside the body.
  • the lower face 87 may be provided with glue so as to stick the external eight- shaped collar 80 onto the skin 110, thus maintaining the internal rings 2 and the body canal 100 in position.
  • the portion of the body canal 100 extending beyond the eight-shaped collar 80 may be cut by means of an appropriate surgical tool, such as a scalpel, as illustrated in FIG 11 E.
  • an appropriate surgical tool such as a scalpel
  • the internal rings 2 and the eight-shaped collar 80 allow the first and second branches 111 , 112 of the body canal 100 to be maintained at the opening 105 formed in the patient's skin 110. After a few days, the wall of the body canal 100 and the skin 110 surrounding the opening 105 heal together to permanently secure the first and second branches 111 , 112 to the edge of the opening 105. In the meantime, the wall or membrane of the body canal 100 which is pinched between the internal rings 2 and the eight-shaped collar 80, and between the flat surfaces 19 of the internal rings 2, ceases to be vascularized, necroses and comes off, causing the fall of the implant. This results in a body canal 100 with a double-barreled opening flush with the skin 110, as illustrated in FIG 11 F.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
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  • Anesthesiology (AREA)
  • Pulmonology (AREA)
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Abstract

L'invention concerne un système d'implant comprenant au moins un anneau interne (2) conçu pour entrer en contact avec une face interne d'un canal corporel, au moins un support (20) pour maintenir et insérer l'anneau interne (2) dans le canal corporel, le support (20) comprenant une poignée et une base reliée à la poignée, la base étant conçue pour s'adapter à l'intérieur et maintenir la bague interne (2), et au moins un anneau externe (40A, 40B) conçu pour être serré autour de l'anneau interne (2) de façon à ce qu'une paroi du canal corporel soit pincée entre les anneaux interne et externe.
PCT/EP2019/076623 2018-10-02 2019-10-01 Système d'implant WO2020070145A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18306301 2018-10-02
EP18306301.5 2018-10-02

Publications (1)

Publication Number Publication Date
WO2020070145A1 true WO2020070145A1 (fr) 2020-04-09

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WO (1) WO2020070145A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4265244A (en) 1979-02-07 1981-05-05 Johnson & Johnson Stoma adaptor
US4786283A (en) * 1985-11-21 1988-11-22 Futuraprodukter Hb Fixing device for stomy bag
WO1997024086A1 (fr) * 1995-12-29 1997-07-10 Manfred Kretschmer Orifice artificiel pour corps humain ou animal
EP2211728A1 (fr) * 2007-10-11 2010-08-04 Milux Holding SA Système permettant de traiter un patient atteint de troubles intestinaux
US20120136324A1 (en) 2009-07-14 2012-05-31 Stimatix Gi Ltd. Ostomy containment device
WO2015137663A1 (fr) * 2014-03-10 2015-09-17 동국대학교 경주캠퍼스 산학협력단 Sphincter anal artificiel présentant un dispositif d'ouverture et de fermeture

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4265244A (en) 1979-02-07 1981-05-05 Johnson & Johnson Stoma adaptor
US4786283A (en) * 1985-11-21 1988-11-22 Futuraprodukter Hb Fixing device for stomy bag
WO1997024086A1 (fr) * 1995-12-29 1997-07-10 Manfred Kretschmer Orifice artificiel pour corps humain ou animal
EP2211728A1 (fr) * 2007-10-11 2010-08-04 Milux Holding SA Système permettant de traiter un patient atteint de troubles intestinaux
US20120136324A1 (en) 2009-07-14 2012-05-31 Stimatix Gi Ltd. Ostomy containment device
WO2015137663A1 (fr) * 2014-03-10 2015-09-17 동국대학교 경주캠퍼스 산학협력단 Sphincter anal artificiel présentant un dispositif d'ouverture et de fermeture

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