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
  • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
  • A61F5/445—Colostomy, ileostomy or urethrostomy devices
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T29/00—Metal working
  • Y10T29/49—Method of mechanical manufacture
  • Y10T29/49826—Assembling or joining

Definitions

• a reservoir known as a "Kock pouch" from the distal part of the ileum. It is formed in such a way that nipple valve is created which serves to close the reservoir, whilst allowing it to be drained intermittently by means of a catheter.
• WO 2009/024568 proposes a cylindrical body formed of two axially-spaced tubular parts.
• the outer tubular part penetrated the skin and was provided with means for connection to a bag or lid.
• the inner tubular part was attached to an anchoring flange of the type previously described.
• the two parts were connected together by a "distance means" comprising either radially-spaced legs or a rigid cylindrical ingrowth mesh which allowed for the generation of a tissue bond between the abdominal wall and the bowel.
• the implant is preferably used in combination with an external detachable device mounted to the cylindrical part of the implant. In the context of a continent system, this is preferably a lid. However, the implant could be used with a bag. Furthermore, as will be discussed more fully below, the implant may be used in conjunction with a so-called healing device which stabilises the implant and prevents relative movement between the tissue and implant as it heals.
• the invention provides a method of implanting an ostomy implant into the abdominal wall of a patient, the method comprising: providing implant having: a cylindrical part for mounting an external detachable device thereto; a preferably cylindrical ingrowth mesh; and a circular flange for anchoring the implant; the cylindrical part and circular flange being attached to opposite ends of the ingrowth mesh; and implanting the implant into the abdominal wall of a patient such that the epidermis meets the ingrowth mesh and is able to attach therethrough directly to serosal tissue of a bowel segment inside the implant.
• a healing device may be used after surgery and so the method preferably further comprises mounting a healing device to the cylindrical part of the implant during the healing phase in order to protect the implant and/or prevent it from being retracted below skin level.
• a lid may be mounted to the cylindrical part of the implant.
• the method preferably uses an implant having the preferred features described above. As set out aboverthe-use of-a-healing-device ⁇ n ⁇ mportariHeature-Gf certain aspects of this invention.
• the invention provides a method for providing a percutaneous port for continent ostomy in a subject in need of the same, which comprises percutaneous implanting of an ostomy implant in the abdominal wall of the subject for encircling and engaging an externalised length of a body duct, and providing a healing device to prevent the implant from being distracted below the abdominal wall of the subject.
• the healing device preferably further includes cap or lid that surrounds and sealingly closes the protruding part of the implant, and preferably also mating means for removable attachment to the mating means of the implant body.
• Figures 6 and 7 are perspective views of a specially designed insertion instrument for positioning an implant in the abdominal wall;
• Figure 8 is a partially-sectioned elevation of a healing device attached to the free protruding end of a known implant;
• Figure 10 shows the (known) implant of Figures 8 and 9 implanted in a patient prior to the addition of the healing device;
• Figures 11 and 12 illustrate the completion of the method of an embodiment of the invention where continuity through the implant is restored;
• FIGS 2 and 3 illustrate an embodiment 1 of an implant according to an embodiment of the invention. It comprises a circular anchoring flange 2, a cylindrical mesh cylinder 3 and a cylindrical end part 4.
• the implant is formed from machined titanium, with the various components laser-welded together.
• annular gap G ( Figure 3) is formed between the inner face of the cylindrical end part 4 and the outer face of the mesh cylinder 3.
• the anchoring flange 2 is as described in the applicant's earlier patent applications referred to in the introduction. It has inner 5 and outer 6 concentric rings connected by S-shaped members 7 to form an axially resilient structure. A multitude of holes 8 are provided to allow ingrowth of tissue through the rings.
• Figures 4 and 5 illustrate the implant 1 in use after it has been implanted in a patient.
• the circular anchoring flange 2 is located immediately above the muscle layer M and that the length L of the skin-penetrating part of the inder 3 is sufficient that the end part 4 is entirely clear of the surface of the epidermis 10 of the abdominal wall.
• the implant may, for example, have any of the dimensions set out in Tables 1 and 2 below.
• a section of bowel 11 is externalised through the internal diameter of the mesh cylinder 3.
• the epidermis 10 meets the ingrowth mesh 3, and is therefore able to contact the serosal surface 12 of the bowel 11.
• the tissues grow through the mesh cylinder 3 to provide attachment between abdominal wall tissue, including the epidermis and bowel.
• the serosal tissue is able to grow into the annular gap G.
• tissue ingrowth occurs through the anchoring flange 2 and through other parts of the ingrowth mesh, in the known manner.
• Figure 5 illustrates the relationship between the implant 1 and a pouch 13 formed in the bowel in the known manner.
• the resilient tissue that forms the bowel is constricted as it passes through the implant to form a valve, this provides a continent system such that the pouch may be emptied at intervals using a catheter in a similar manner to the Kock pouch.
• a removable lid (not shown) may additionally be provided to prevent leakage and to protect the stoma. Thus, there is no need for a bag.
• the implant may be that of the embodiment described above, or another type e.g. be the implant according to the applicants own International patent applications WO 2007/099500 A1 , WO
• the implant is e.g. made of commercially pure titanium Gr. 2, machined to desired shape, and blasted with aluminium oxide.
• Other biological acceptable materials e.g., plastics, can also be used.
• the preferred materials are dimensionally stable materials that can resist sterilization and use in medial treatments.
• the implant 20 of this embodiment consists of a cylinder 21 ending with a circular flange 22.
• the cylindrical portion closest to the flange is formed by ribs 24 allowing ingrowth of connective tissue to prevent epithelial downgrowth and promote connective tissue interdigitation.
• the ribs 24 have numerous holes 25.
• the ie cylindrical portion is solid-walled.
• the previously-mentioned applications can be referred to for further details of this implant.
• the circular flange 22 is penetrated with multiple small holes 23 to allow ingrowth of connective tissue.
• a laser cut titanium ingrowth mesh 26 is integrated by means of laser welding on the inside of the cylinder.
• the first stage of the method is for the implant and the instrumentation to be decontaminated with ultrasonic cleaning in detergent and alcohol followed by sterilization by means of autoclaving.
• Table 1 Examples of implant configurations (canine).
• a healing device 39 is provided for attachment to the free protruding circular end of the implant 20 during the healing phase.
• the healing device 39 protects the implant and prevents the implant from being retracted below the skin level.
• the healing device 39 comprises a healing plate 35 which is designed to rest on the skin surface.
• the healing plate is provided with an external screw thread 36 for coupling with a complementary internal screw thread 37 of an optional cap 38 which can be used to surround and sealingly close the protruding part of the implant 20 at least during healing, and optionally also subsequently. It may also include an O-ring 34 serving for sealing against the exterior circumferential wall of the implant 20.
• the healing device is shown attached to a further design of implant 50.
• a catheter is introduced through the implant and secured to the healing plate. 20. Closing the abdominal incision.
• Stage two is performed 3-4 weeks after implantation.
• the two stages described above are preferably combined into a single stage.

Landscapes

• Health & Medical Sciences (AREA)
• Epidemiology (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)
• Orthopedics, Nursing, And Contraception (AREA)

Priority Applications (8)

Applications Claiming Priority (2)

Publications (1)

Family

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Family Applications (1)

Country Status (10)

Cited By (6)

Families Citing this family (21)

Citations (3)

Family Cites Families (5)

• 2010
  • 2010-04-28 ES ES10717731.3T patent/ES2635217T3/es active Active
  • 2010-04-28 DK DK10717731.3T patent/DK2424473T3/en active
  • 2010-04-28 JP JP2012507811A patent/JP5628295B2/ja not_active Expired - Fee Related
  • 2010-04-28 SI SI201031513T patent/SI2424473T1/sl unknown
  • 2010-04-28 PT PT107177313T patent/PT2424473T/pt unknown
  • 2010-04-28 EP EP10717731.3A patent/EP2424473B1/en not_active Not-in-force
  • 2010-04-28 PL PL10717731T patent/PL2424473T3/pl unknown
  • 2010-04-28 US US13/266,876 patent/US9226848B2/en active Active
  • 2010-04-28 WO PCT/GB2010/000851 patent/WO2010125346A1/en not_active Ceased
  • 2010-04-28 CN CN201080018525.8A patent/CN102421395B/zh not_active Expired - Fee Related

Patent Citations (3)

Non-Patent Citations (3)

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