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WO2025172332A1 - Implantable tissue connector - Google Patents

Implantable tissue connector

Info

Publication number
WO2025172332A1
WO2025172332A1 PCT/EP2025/053669 EP2025053669W WO2025172332A1 WO 2025172332 A1 WO2025172332 A1 WO 2025172332A1 EP 2025053669 W EP2025053669 W EP 2025053669W WO 2025172332 A1 WO2025172332 A1 WO 2025172332A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
connector
conduit
tissue connector
human
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.)
Pending
Application number
PCT/EP2025/053669
Other languages
French (fr)
Inventor
Peter Forsell
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.)
Implantica Patent Ltd
Original Assignee
Implantica Patent Ltd
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 Implantica Patent Ltd filed Critical Implantica Patent Ltd
Publication of WO2025172332A1 publication Critical patent/WO2025172332A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/064Blood vessels with special features to facilitate anastomotic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis for blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132End-to-end connections
    • 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/042Urinary bladders
    • 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
    • A61F2/00Filters 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
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/0086Special surfaces of prostheses, e.g. for improving ingrowth for preferentially controlling or promoting the growth of specific types of cells or tissues
    • 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/044Oesophagi or esophagi or gullets
    • 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/045Stomach, intestines
    • 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/046Tracheae
    • 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/047Urethrae
    • 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/048Ureters
    • 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; Colostomy devices
    • A61F5/445Colostomy, ileostomy or urethrostomy devices

Definitions

  • the living tissue When the tissue connector is implanted in a human being or animal, the living tissue is first pulled over the conduit's outer surface including the bulge, and then the blocking ring is advanced from the other side of the bulge over the living tissue towards the bulge such that the living tissue is located intermediate the conduit's outer surface and the blocking ring.
  • This has the effect that, when the tissue tends to slip off of the conduit, it will carry the blocking ring towards and against the bulge.
  • the living tissue will be compressed between the bulge and the blocking ring, thereby preventing any further slippage.
  • This effect is self-enhancing with increasing slipping force. As the force tends to decrease again, the compression force decreases accordingly so that blood circulation within the living tissue is not negatively affected longer than necessary.
  • the clearance should be slightly smaller than the thickness of the living tissue so as not to severely affect blood circulation within the living tissue but nevertheless ensure sufficient frictional contact.
  • the implantable tissue connector according to the present disclosure comprises, similar to the above-mentioned prior art tissue connector, at least one bulge extending outwardly from the conduit's outer surface in a circumferential direction of the conduit about at least part of the conduit's circumference. Furthermore, at least one blocking ring is loosely fitted over the outer surface of the conduit with a clearance between the conduit's outer surface and the blocking ring for mounting living tissue within said clearance.
  • the blocking ring has an inner cross-sectional diameter which is smaller than or substantially identical to an outer cross-sectional diameter of the at least one bulge so as to prevent the blocking ring from slipping over the bulge when living tissue is mounted within the clearance.
  • the surface texture comprises at least one recess or through hole, or both at least one recess and at least one through hole, for the fibrotic tissue to grow into.
  • the recess or through hole may be machined into the surface of the blocking ring or the blocking ring may be cast along with the recess or through holes.
  • the dimensions of recesses and/or through holes can be easily controlled and chosen according to the specific application.
  • the blocking ring may comprise two, three, four, five, six, seven, eight, nine, ten or more than ten of the at least one recess or through hole. For instance, they may be arranged in parallel. However, it is sufficient to provide the recesses or through holes only on a radial inner side of the blocking ring's outer surface, which is the side of the blocking ring which faces the conduit's outer surface and, thus, contacts the natural living tissue.
  • the at least one recess or through hole has a depth of between 0.5 and 1.5 mm, more preferably about 1 mm, so that the fibrotic tissue may anchor in the surface of the blocking ring.
  • the at least one recess or through hole includes an undercut extending underneath the surface of the blocking ring, so as to further enhance the anchoring effect.
  • the undercut extends between 0.1 to 0.5 mm, more preferably about 0.3 mm, in a direction along the surface of the blocking
  • the blocking ring may have a hollow interior.
  • the weight of the blocking ring is accordingly decreased and it is easier for the living tissue to carry the blocking ring along the conduit.
  • the at least one through hole may extend from the surface of the blocking ring up to the hollow interior so that the fibrotic tissue may even grow into the hollow interior of the blocking ring, thereby further strengthening the connection between the fibrotic tissue and the blocking ring.
  • the blocking ring may have a multi-layer structure, wherein an outer layer thereof provides said surface texture.
  • an inner part of the blocking ring may provide the necessary stiffness to the blocking ring, whereas that material and structure of the outer layer may be chosen such that the outer layer optimally fulfills the purpose for fibrotic tissue to grow thereinto.
  • the outer layer may comprise a sleeve having at least one depression and/or perforation forming said at least one recess for the fibrotic tissue to grow into.
  • the sleeve may be injection molded or dip molded onto the inner part the blocking ring. At least in the case of dip molding, the depressions and/or perforations may be produced in a separate machining step, whereas in the case of injection molding, they may integrally formed in the outer layer.
  • the blocking ring likewise has a multilayer structure including an outer layer, but in this case the outer layer comprises an open cell foam having open cells for the fibrotic tissue to grow into.
  • the outer layer comprises an open cell foam having open cells for the fibrotic tissue to grow into.
  • the open cell foam may comprise open cell foam made of polyurethane or, more preferably, silicone.
  • the biocompatibility of silicone for long term applications is better than that of polyurethane.
  • the open cell foam may comprise open cell foam made of metal.
  • Biocompatible metal foams with cell sizes ranging from 0.4 - 5.0 mm are available e.g. the Fraunhofer Institute for Manufacturing Technology and Advanced Materials (IFAM), Dresden, and offer an adjustable porosity of between 75 and 96 %.
  • the metal is or comprises a biocompatible metal, such as one of: titanium, a titanium alloy, tantalum.
  • the blocking ring again has a multi-layer structure including an outer layer, but in this case the outer layer comprises a textile structure or net-like structure with interstices for the fibrotic tissue to grow into.
  • the outer layer comprises a textile structure or net-like structure with interstices for the fibrotic tissue to grow into.
  • this may be advantageous over other manufacturing methods because with a textile structure or net-like structure a great number of interstices can be produced. Also, such structures can be produced with different interstice sizes, according to the specific needs.
  • the net-like structure may comprise a wire mesh.
  • the wires of the mesh may be made of a biocompatible polymer and/or metal, such as - again - polyurethane, silicone, titanium, a titanium alloy, tantalum.
  • the wire mesh comprises wires having a round or oval cross section so as to prevent injuring the living tissue.
  • the textile structure may comprise a knitted, woven, non-woven or braided structure.
  • the knitted as well as the braided structure may be knitted/braided around the inner part of the blocking ring.
  • the knitted, woven, non-woven or braided structures may also be produced separately and attached to the inner part of the blocking ring in a subsequent manufacturing step, such as by bonding.
  • the outer layer may have a thickness of 3 mm or less, preferably between 0.5 and 1.5 mm, more preferably about 1 mm.
  • the blocking ring has an inner cross-sectional diameter which is smaller than or substantially identical to an outer cross-sectional diameter of the at least one bulge so as to prevent the blocking ring from slipping over the bulge when living tissue is mounted within the clearance.
  • the size of the clearance in a radial direction depends upon the intended use of the tissue connector, i.e. upon the thickness of the tubular living tissue to which the tissue connector is connected. Accordingly, the size may be at average between 0.1 to 0.4 mm, 0.4 to 0.8 mm, 0.8 to 1.3 mm, 1.3 to 2 mm, 2 to 3 mm, 3 to 4 mm, 4 to 5 mm, over 5 mm.
  • the clearance should be slightly smaller than the thickness of the living tissue so as not to severely affect blood circulation within the living tissue but nevertheless ensure sufficient frictional contact.
  • both the conduit and the blocking ring should preferably be made from biocompatible material.
  • This preferably comprises polymers, such as polytetrafluoroethylene (PTFE), ePTFE, silicone, polyurethane (PU) and/or polyetheretherketone (PEEK), wherein PTFE and silicone are preferred.
  • PTFE polytetrafluoroethylene
  • ePTFE ePTFE
  • silicone silicone
  • PU polyurethane
  • PEEK polyetheretherketone
  • other materials such as ceramics and metals, in particular titanium and stainless steel, can be used as well and are preferable for their strength.
  • the tissue connector may be fitted into a human's esophagus.
  • the conduit of the tissue connector should have an inner diameter of between 2 and 3.5 cm to provide for a snug fit.
  • the clearance between the conduit and the blocking ring should be in the range of 2.5 to 5 mm.
  • the inner diameter should be chosen between 1.5 and 2.5 cm, depending upon the position where at the human's trachea it is to be connected, in order to provide for a snug fit.
  • the clearance between the conduit and the blocking ring should be in the range of 1 to 2 mm.
  • the inner diameter of the conduit should be between 2 and 3 cm.
  • the clearance between the conduit and the blocking ring should be in the range of 3 to 4 mm.
  • the inner diameter of the conduit should be between 3 and 5.5 cm to provide for a snug fit.
  • the clearance between the conduit and the blocking ring should be in the range of 2 to 3.5 mm.
  • the tissue connector may also be fitted into a human's urethra.
  • the conduit should have an inner diameter of between 0.4 and 0.8 cm.
  • the clearance between the conduit and the blocking ring should be in the range of 0.5 to 1.5 mm.
  • the tissue connector may be fitted into a human's ureter, in which case the inner diameter of the conduit should be chosen between 0.4 and 0.7 cm.
  • the clearance between the conduit and the blocking ring should be in the range of 2 to 4 mm.
  • the tissue connector may also be connected to the kidney.
  • the inner diameter of the conduit should be in the range of 1 and 5 cm, depending upon the position where at the human's pelvic it is to be connected.
  • the clearance between the conduit and the blocking ring should be in the range of 0.5 to 1.5 mm.
  • the tissue connector may also be fitted into a human's blood vessel.
  • the inner diameter of the conduit should be chosen approximately similar to the inner diameter of the respective blood vessel.
  • the inner diameter may be chosen between 0.1 and 0.5 cm in the case of particularly small blood vessels.
  • the tissue connector may as well be connected to the human's aorta or the heart's atrium or ventricle, in which case the inner diameter of the conduit is in the range of 2 to 3 cm.
  • the clearance between the conduit and the blocking ring should be in the range of 1 to 2 mm.
  • the tissue connector may also be used as an intermediate piece to replace a part of tubular living tissue and may as well be used to connect different types of tubular living tissue, such as where a biological transplant of a third party's body is to be connected to the organs of a patient.
  • the tissue connector may particularly be used and be adapted for connecting it to at last one of an implantable reservoir, an implantable pump, an implantable motor, an implantable medical device and a biological transplant.
  • the artificial items may even form a part of the tissue connector, either integrally formed therewith or separately connected thereto.
  • the reservoir, pump, motor and/or medical device may also be incorporated in the tissue connector between the first and second ends of the conduit.
  • the biological transplant may be any transplant, such as a transplanted heart to be connected by means of the tissue connector to the patient's aorta and/or to other blood vessels (pulmonary arteria etc.).
  • the aforementioned reservoir may consist of a biological transplant, but it may as well be made from tissue material of the patient into whom the reservoir is to be implanted.
  • the reservoir may be a fecal excrements collecting container, such as a urine bladder or an intestine.
  • the reservoir may also be a reservoir for medical drugs for the patient's needs and is preferably adapted to be filled with at least one medical drug.
  • Such medical drug reservoir may or may not be connected to a medical device, such as an implantable drug delivery device, which medical device may additionally include a pump for pumping the drug from the reservoir into the patient's body and possibly a motor for the pump.
  • any other implantable medical devices may also be connected to the organs of the patient by means of the tissue connector, with or without a pump, motor and/or reservoir.
  • tissue connector with or without a pump, motor and/or reservoir.
  • these are an artificial heart, a penile prothesis, an artificial urine bladder, an artificial urethra, an artificial esophagus, an artificial trachea and the like.
  • biological transplants include a urine bladder, an intestine, a urethra, a ureter, a kidney, a bowel, a heart, an esophagus, a trachea, a blood vessel and the like.
  • the tissue connector of the present invention can be implanted in a human being or animal either in open surgery or by subcutaneous surgery. In either case, the skin will have to be cut before free- dissecting an appropriate location within the patient's body adjacent to the tubular living tissue and, after the conduit of the tissue connector has been connected with one or both ends to the tubular tissue, at least the skin will have to be sutured at the end of the surgery.
  • the steps of cutting the skin and free-dissecting the appropriate location within the patient's body comprise the steps of inserting a needle-like tube into the patient's body, such as the patient's thorax or abdomen, filling through said needle gas into the patient's body, i.e. into the thorax cavity or abdomen cavity, cutting a key-hole, inserting at least one, preferably two, laparoscopic trocars through the key-hole towards said location, advancing one or more medical instruments and a camera through the at least one trocar towards said location, i.e. into the thorax or abdomen, and dissecting an area of the tubular part of living tissue with the aid of the dissecting tool.
  • the tissue connector may be supplied to said location through the at least one trocar or through a separate incision.
  • Figure 3 shows a second embodiment of the tissue connector with two connecting ends.
  • FIG. 4 shows a third embodiment of the tissue connector as an alternative to the second embodiment.
  • Figure 5 shows a partial cross section through the tissue connector with a blocking ring according to a first embodiment
  • Figure 6 shows a plan view of the bulge connector of Figure 5.
  • Figures 7 to 12 show cross sections of further embodiments of the bulge connector.
  • tissue connector of aspect 38, wherein the fecal excrements collecting container comprises one of the following: a urine bladder, an intestine.
  • tissue connector of aspect 36 wherein said biological transplant is a transplant of the following group of transplants comprising: a urine bladder, an intestine, a urethra, a ureter, a kidney, a bowel, a heart, an esophagus, a trachea, a blood vessel.
  • tissue connector of any one of aspects 1 to 42 comprising a flow restrictor for partial or complete restriction of flow through the conduit.
  • tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's small bowel.
  • tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's large bowel.
  • tissue connector of aspect 59 wherein said conduit is sized so as to be snuggly fitted into the human's aorta or the heart's atrium or ventricle.
  • tissue connector of any one of aspects 1 to 43 as a connector to the human's esophagus.
  • tissue connector of any one of aspects 1 to 43 as a connector to the human's trachea.
  • tissue connector of any one of aspects 1 to 43 as a connector to the human's stomach.
  • tissue connector of any one of aspects 1 to 43 as a connector to the human's small bowel.
  • tissue connector of any one of aspects 1 to 43 as a connector to the human's large bowel.
  • tissue connector of any one of aspects 1 to 43 as a connector to the human's urethra.
  • tissue connector of any one of aspects 1 to 43 as a connector to the human's ureter.
  • tissue connector of any one of aspects 1 to43 as a connector to the human's pelvic part of the kidney.
  • tissue connector of any one of aspects 1 to 43 as a connector to the human's blood vessel.
  • tissue connector of aspect 70 as a connector to the human's aorta or the heart's atrium or ventricle.
  • tissue connector of any one of aspects 1 to 43 as a connector between the human's kidney and a reservoir.
  • tissue connector of any one of aspects 1 to 43 as a connector between the human's intestine and a reservoir.
  • tissue connector of any one of aspects 76 or 73, wherein the reservoir is artificial or a biological transplant is artificial or a biological transplant.
  • step of connecting the second end of the conduit of the tissue connector to the second section of tubular part of living tissue comprises the steps of inserting the second end of the conduit into the second section of the tubular part of living tissue, including inserting the bulge into the second section of the tubular part of

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Pulmonology (AREA)
  • Physiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

An implantable tissue connector adapted so as to be connectable to a tubular part of living tissue within a patient's body, comprises a conduit with a bulge extending outwardly from the conduit's outer surface in a circumferential direction. The blocking ring loosely fits over the conduit with a clearance between the conduit and the blocking ring for mounting tubular living tissue within the clearance. The blocking ring has an inner cross‐sectional diameter which is smaller than or substantially identical to an outer cross‐sectional diameter of the bulge so as to prevent the blocking ring from slipping over the bulge when living tissue is mounted within the clearance. A surface of the blocking ring facing the conduit has a surface texture configured for fibrotic tissue to grow into.

Description

IMPLANTABLE TISSUE CONNECTOR
Background of the invention
[0001] The present invention relates to an implantable tissue connector that is specifically adapted to be connected to a tubular part of living tissue within a patient's body, such as to the end of the human's large bowel when an artificial exit to the large bowel is to be provided. However, the implantable tissue connector of the present invention is not limited to such application and can be used in connection with many other kinds of tubular living tissue, as will be described in more detail below.
[0002] Connecting the end of the human's large bowel to an artificial exit, such as to a fecal excrements collecting container, or connecting a shortened large bowel to the patient's natural intestinal exit has always proven difficult and often unreliable. Leakage can occur where the connection is not tight over the lifetime. Blood circulation can be prohibited in the end area of the bowel tissue, which can negatively affect the muscle functions and peristaltic movement of the bowel and which can even lead to starvation of the respective portion of the bowel. Furthermore, the peristaltic movement of the bowel will continuously act upon the connection and, thus, the connection can fail over time.
[0003] WO 2009/046998 A2 discloses an implantable tissue connector for connecting tubular living tissue in a patient's body, which connection is reliable over time and does not severely harm the living tissue. The connector comprises a conduit, a bulge extending outwardly from the conduit's outer surface in a circumferential direction, and a blocking ring which is loosely fitted over the outer surface of the conduit with a clearance between the conduit's outer surface and the blocking ring for mounting living tissue within the clearance. The blocking ring has an inner cross-sectional diameter which is smaller than or substantially identical to an outer cross-sectional diameter of the bulge so as to prevent the blocking ring from slipping over the bulge when living tissue is mounted within the clearance. When the tissue connector is implanted in a human being or animal, the living tissue is first pulled over the conduit's outer surface including the bulge, and then the blocking ring is advanced from the other side of the bulge over the living tissue towards the bulge such that the living tissue is located intermediate the conduit's outer surface and the blocking ring. This has the effect that, when the tissue tends to slip off of the conduit, it will carry the blocking ring towards and against the bulge. By this action, the living tissue will be compressed between the bulge and the blocking ring, thereby preventing any further slippage. This effect is self-enhancing with increasing slipping force. As the force tends to decrease again, the compression force decreases accordingly so that blood circulation within the living tissue is not negatively affected longer than necessary. The clearance should be slightly smaller than the thickness of the living tissue so as not to severely affect blood circulation within the living tissue but nevertheless ensure sufficient frictional contact.
[0004] In one embodiment, a flexible sleeve having an ingrowth layer is provided on the conduit near the bulge. The flexible sleeve is rolled or folded upon itself and then unrolled or unfolded so as to cover an end part of tubular tissue which is pulled over an end of the conduit so as to extend over the bulge. After the flexible sleeve has been unrolled over the tubular tissue, the blocking ring is pushed over the flexible sleeve against the bulge. After a while, securing threads sutured through the tubular tissue and conduit will have been absorbed by the patient's body and, about during the same time, living tissue will have formed in and connect the tubular tissue to the ingrowth layer of the flexible sleeve. Therefore, as the tubular tissue tends to be pulled off of the end of the conduit, the blocking ring will also be moved, press the tubular tissue and the flexible sleeve against the bulge and thereby prohibit any further slippage of the tubular tissue over the bulge. The friction coefficient between the blocking ring and the outer surface of the flexible sleeve should be higher than the friction coefficient which the conduit's outer surface has in relation to the tubular tissue. Thus, the flexible sleeve supports a reliable connection between the ring and the tubular tissue at the time when the tubular tissue moves.
Summary of the invention
[0005] It is an object of the present invention to provide an improved implantable tissue connector for reliably connecting tubular living tissue in a patient's body.
[0006] The implantable tissue connector according to the present disclosure comprises, similar to the above-mentioned prior art tissue connector, at least one bulge extending outwardly from the conduit's outer surface in a circumferential direction of the conduit about at least part of the conduit's circumference. Furthermore, at least one blocking ring is loosely fitted over the outer surface of the conduit with a clearance between the conduit's outer surface and the blocking ring for mounting living tissue within said clearance. The blocking ring has an inner cross-sectional diameter which is smaller than or substantially identical to an outer cross-sectional diameter of the at least one bulge so as to prevent the blocking ring from slipping over the bulge when living tissue is mounted within the clearance.
[0007] Accordingly, when the tissue connector is implanted in a human being or animal, the living tissue may be pulled over the conduit's outer surface including the bulge. Then the blocking ring may be advanced from the other side of the bulge over the living tissue towards the bulge such that at least part of the living tissue is located intermediate the conduit's outer surface and the blocking ring. This has the effect that, when the tissue tends to slip off of the conduit, it will carry the blocking ring towards and against the bulge. By this action, the living tissue is compressed between the bulge and the blocking ring, thereby preventing any further slippage. This effect is self-enhancing with increasing slipping force. As the force tends to decrease again, the compression force will decrease accordingly so that blood circulation within the living tissue will not be negatively affected longer than necessary. Thus, the connection is reliable over time and does not severely harm the living tissue.
[0008] However, according to the present disclosure, the surface of the blocking ring facing the conduit's outer surface is provided with a surface texture configured for fibrotic tissue to grow into. That is, the patient's body produces fibrotic tissue on all implanted foreign objects. Such fibrotic tissue may grow together with the natural living tissue and thereby contribute to the effect that the blocking ring is carried with the living tissue on which it is placed when the living tissue moves relative to the conduit, such as due to longitudinal vessel contraction. This effect is enhanced by providing the surface of the blocking ring with a surface texture configured for fibrotic tissue to grow into. On the one hand, the surface of the blocking ring is accordingly enlarged, thereby stimulating the growth of fibrotic tissue on the blocking ring. On the other hand, by growing into the surface texture, the connection between the blocking ring and the natural living tissue is strengthened.
[0009] According to a first aspect of the present disclosure, the surface texture comprises at least one recess or through hole, or both at least one recess and at least one through hole, for the fibrotic tissue to grow into. For instances, the recess or through hole may be machined into the surface of the blocking ring or the blocking ring may be cast along with the recess or through holes. In any case, the dimensions of recesses and/or through holes can be easily controlled and chosen according to the specific application.
[00010] For instance, the at least one recess or through hole may have an extension of 2 mm or more in at least one of a direction parallel to a longitudinal axis of the conduit and a circumferential direction of the blocking ring. Thus, the width of the recesses is preferably 2 mm or more in at least one width direction so that a substantial amount of fibrotic tissue can form therein.
[00011] Preferably, an extension of the at least one recess or through hole is larger in a circumferential direction of the blocking ring than in a direction parallel to a longitudinal axis of the conduit. That is, the forces acting on the blocking ring when the blocking ring is pulled against the bulge act in a longitudinal direction of the conduit, and such forces can be counter-acted best when the recess and/or through holes into which the fibrotic tissue has grown is oriented perpendicular to such pulling direction, namely in a circumferential direction of the blocking ring. In one embodiment, the recesses extend all around the conduit, i.e. forming a continuous recess around the conduit.
[00012] The blocking ring may comprise two, three, four, five, six, seven, eight, nine, ten or more than ten of the at least one recess or through hole. For instance, they may be arranged in parallel. However, it is sufficient to provide the recesses or through holes only on a radial inner side of the blocking ring's outer surface, which is the side of the blocking ring which faces the conduit's outer surface and, thus, contacts the natural living tissue.
[00013] Preferably, the at least one recess or through hole has a depth of between 0.5 and 1.5 mm, more preferably about 1 mm, so that the fibrotic tissue may anchor in the surface of the blocking ring. In one embodiment, the at least one recess or through hole includes an undercut extending underneath the surface of the blocking ring, so as to further enhance the anchoring effect. Preferably, the undercut extends between 0.1 to 0.5 mm, more preferably about 0.3 mm, in a direction along the surface of the blocking
[00014] The blocking ring may have a hollow interior. The weight of the blocking ring is accordingly decreased and it is easier for the living tissue to carry the blocking ring along the conduit. In particular, the at least one through hole may extend from the surface of the blocking ring up to the hollow interior so that the fibrotic tissue may even grow into the hollow interior of the blocking ring, thereby further strengthening the connection between the fibrotic tissue and the blocking ring.
[00015] Further, the blocking ring may have a multi-layer structure, wherein an outer layer thereof provides said surface texture. This way, an inner part of the blocking ring may provide the necessary stiffness to the blocking ring, whereas that material and structure of the outer layer may be chosen such that the outer layer optimally fulfills the purpose for fibrotic tissue to grow thereinto. [00016] Thus, regarding said first aspect of the present disclosure, the outer layer may comprise a sleeve having at least one depression and/or perforation forming said at least one recess for the fibrotic tissue to grow into. The sleeve may be injection molded or dip molded onto the inner part the blocking ring. At least in the case of dip molding, the depressions and/or perforations may be produced in a separate machining step, whereas in the case of injection molding, they may integrally formed in the outer layer.
[00017] According to a second aspect of the present disclosure, the blocking ring likewise has a multilayer structure including an outer layer, but in this case the outer layer comprises an open cell foam having open cells for the fibrotic tissue to grow into. This may be advantageous over other manufacturing methods because with an open cell foam a great number of openings can be produced simultaneously. Also, open cell foams can be produced with different cell sizes, according to the specific needs.
[00018] Preferably, the open cell foam may comprise open cell foam made of polyurethane or, more preferably, silicone. The biocompatibility of silicone for long term applications is better than that of polyurethane. Alternatively, the open cell foam may comprise open cell foam made of metal. Biocompatible metal foams with cell sizes ranging from 0.4 - 5.0 mm are available e.g. the Fraunhofer Institute for Manufacturing Technology and Advanced Materials (IFAM), Dresden, and offer an adjustable porosity of between 75 and 96 %. For the present purpose, the metal is or comprises a biocompatible metal, such as one of: titanium, a titanium alloy, tantalum.
[00019] According to a third aspect of the present disclosure, the blocking ring again has a multi-layer structure including an outer layer, but in this case the outer layer comprises a textile structure or net-like structure with interstices for the fibrotic tissue to grow into. Again, this may be advantageous over other manufacturing methods because with a textile structure or net-like structure a great number of interstices can be produced. Also, such structures can be produced with different interstice sizes, according to the specific needs.
[00020] For instance, the net-like structure may comprise a wire mesh. The wires of the mesh may be made of a biocompatible polymer and/or metal, such as - again - polyurethane, silicone, titanium, a titanium alloy, tantalum. Preferably, the wire mesh comprises wires having a round or oval cross section so as to prevent injuring the living tissue. The textile structure may comprise a knitted, woven, non-woven or braided structure. In particular, the knitted as well as the braided structure may be knitted/braided around the inner part of the blocking ring. However, the knitted, woven, non-woven or braided structures may also be produced separately and attached to the inner part of the blocking ring in a subsequent manufacturing step, such as by bonding.
[00021] In all of these aspects, the outer layer may have a thickness of 3 mm or less, preferably between 0.5 and 1.5 mm, more preferably about 1 mm.
[00022] As mentioned above, the blocking ring has an inner cross-sectional diameter which is smaller than or substantially identical to an outer cross-sectional diameter of the at least one bulge so as to prevent the blocking ring from slipping over the bulge when living tissue is mounted within the clearance. The size of the clearance in a radial direction depends upon the intended use of the tissue connector, i.e. upon the thickness of the tubular living tissue to which the tissue connector is connected. Accordingly, the size may be at average between 0.1 to 0.4 mm, 0.4 to 0.8 mm, 0.8 to 1.3 mm, 1.3 to 2 mm, 2 to 3 mm, 3 to 4 mm, 4 to 5 mm, over 5 mm. The clearance should be slightly smaller than the thickness of the living tissue so as not to severely affect blood circulation within the living tissue but nevertheless ensure sufficient frictional contact.
[00023] While the cross-sectional diameter of the blocking ring should preferably be smaller than the cross-sectional diameter of the bulge, it can in some instances be identical or even somewhat larger than this because the thickness of the living tissue, even in a compressed state, adds up to the cross-sectional diameter of the bulge so that altogether the blocking ring is prevented from slipping over the bulge. Therefore, in case of particularly thick living tissue, the inner cross-sectional diameter of the blocking ring may be even somewhat larger than the outer cross-sectional diameter of the bulge.
[00024] In regards of the materials, both the conduit and the blocking ring should preferably be made from biocompatible material. This preferably comprises polymers, such as polytetrafluoroethylene (PTFE), ePTFE, silicone, polyurethane (PU) and/or polyetheretherketone (PEEK), wherein PTFE and silicone are preferred. However, other materials, such as ceramics and metals, in particular titanium and stainless steel, can be used as well and are preferable for their strength.
[00025] The conduit can be substantially longer than the particular portion of the conduit to which the tubular tissue is connected. In that case, it is preferable that the bulge is located proximately to the respective end of the conduit so that the part of the tissue drawn over the conduit is not excessively large. The larger the overlapping part of the tissue is, the larger may become problems of blood circulation within that part of the tissue.
[00026] Where the tissue connector is intended to connect two different ends of tubular living tissue material, it may have two of the aforementioned bulges, preferably located proximately to the respective ends of the conduit, with at least one and preferably at least two blocking rings located intermediate the two bulges. Of course, more than one blocking ring and/or more than one bulge may be provided for each end of the conduit.
[00027] In order to facilitate the step of inserting the end or ends of the conduit into the tubular living tissue, it is advantageous to taper the free end portion of the conduit's end or ends towards the edge of said free end portion. Alternatively or in addition, the free end portion may be provided with a rounded edge. The rounded edge will help to prevent any damage to the living tissue when the tissue is pulled over the free end of the conduit.
[00028] As mentioned at the outset, the use of the tissue connector of the present invention is not limited to its application at the end of the human's large bowel. It can be advantageously used in many other applications.
[00029] For instance, the tissue connector may be fitted into a human's esophagus. In this case, the conduit of the tissue connector should have an inner diameter of between 2 and 3.5 cm to provide for a snug fit. The clearance between the conduit and the blocking ring should be in the range of 2.5 to 5 mm. [00030] Where the tissue connector is connected to a human's trachea, the inner diameter should be chosen between 1.5 and 2.5 cm, depending upon the position where at the human's trachea it is to be connected, in order to provide for a snug fit. The clearance between the conduit and the blocking ring should be in the range of 1 to 2 mm.
[00031] Where the tissue connector is fitted into a human stomach, the inner diameter of the conduit can vary with enlarged boundaries. The clearance between the conduit and the blocking ring should be in the range of 3.5 to 5 mm.
[00032] The tissue connector may also be fitted into a human's gall bladder or its connecting outlet channels. In that case, the conduit should have an inner diameter of between 0.5 and 1.3 cm. The clearance between the conduit and the blocking ring should be in the range of 0.5 to 1.5 mm.
[00033] In case that the tissue connector is fitted into a human's small bowel, the inner diameter of the conduit should be between 2 and 3 cm. The clearance between the conduit and the blocking ring should be in the range of 3 to 4 mm.
[00034] In case of the human's large bowel, whose diameter is highly stretchable, the inner diameter of the conduit should be between 3 and 5.5 cm to provide for a snug fit. The clearance between the conduit and the blocking ring should be in the range of 2 to 3.5 mm.
[00035] The tissue connector may also be fitted into a human's urethra. In this case, the conduit should have an inner diameter of between 0.4 and 0.8 cm. The clearance between the conduit and the blocking ring should be in the range of 0.5 to 1.5 mm.
[00036] Also, the tissue connector may be fitted into a human's ureter, in which case the inner diameter of the conduit should be chosen between 0.4 and 0.7 cm. The clearance between the conduit and the blocking ring should be in the range of 2 to 4 mm.
[00037] The tissue connector may also be connected to the kidney. In order to snuggly fit it into a human's pelvic part of the kidney, the inner diameter of the conduit should be in the range of 1 and 5 cm, depending upon the position where at the human's pelvic it is to be connected. The clearance between the conduit and the blocking ring should be in the range of 0.5 to 1.5 mm.
[00038] The tissue connector may also be fitted into a human's blood vessel. In this case, the inner diameter of the conduit should be chosen approximately similar to the inner diameter of the respective blood vessel. As an example, the inner diameter may be chosen between 0.1 and 0.5 cm in the case of particularly small blood vessels. The tissue connector may as well be connected to the human's aorta or the heart's atrium or ventricle, in which case the inner diameter of the conduit is in the range of 2 to 3 cm. The clearance between the conduit and the blocking ring should be in the range of 1 to 2 mm.
[00039] The tissue connector may also be used as an intermediate piece to replace a part of tubular living tissue and may as well be used to connect different types of tubular living tissue, such as where a biological transplant of a third party's body is to be connected to the organs of a patient.
[00040] The tissue connector may particularly be used and be adapted for connecting it to at last one of an implantable reservoir, an implantable pump, an implantable motor, an implantable medical device and a biological transplant. The artificial items may even form a part of the tissue connector, either integrally formed therewith or separately connected thereto. The reservoir, pump, motor and/or medical device may also be incorporated in the tissue connector between the first and second ends of the conduit. [00041] The biological transplant may be any transplant, such as a transplanted heart to be connected by means of the tissue connector to the patient's aorta and/or to other blood vessels (pulmonary arteria etc.).
[00042] Instead of being artificial, the aforementioned reservoir may consist of a biological transplant, but it may as well be made from tissue material of the patient into whom the reservoir is to be implanted. For instance, the reservoir may be a fecal excrements collecting container, such as a urine bladder or an intestine.
[00043] The reservoir may also be a reservoir for medical drugs for the patient's needs and is preferably adapted to be filled with at least one medical drug. Such medical drug reservoir may or may not be connected to a medical device, such as an implantable drug delivery device, which medical device may additionally include a pump for pumping the drug from the reservoir into the patient's body and possibly a motor for the pump.
[00044] Any other implantable medical devices may also be connected to the organs of the patient by means of the tissue connector, with or without a pump, motor and/or reservoir. Examples of these are an artificial heart, a penile prothesis, an artificial urine bladder, an artificial urethra, an artificial esophagus, an artificial trachea and the like. Examples of biological transplants include a urine bladder, an intestine, a urethra, a ureter, a kidney, a bowel, a heart, an esophagus, a trachea, a blood vessel and the like.
[00045] The tissue connector of the present invention can be implanted in a human being or animal either in open surgery or by subcutaneous surgery. In either case, the skin will have to be cut before free- dissecting an appropriate location within the patient's body adjacent to the tubular living tissue and, after the conduit of the tissue connector has been connected with one or both ends to the tubular tissue, at least the skin will have to be sutured at the end of the surgery.
[00046] Where the tissue connector is implanted by subcutaneous surgery, the steps of cutting the skin and free-dissecting the appropriate location within the patient's body comprise the steps of inserting a needle-like tube into the patient's body, such as the patient's thorax or abdomen, filling through said needle gas into the patient's body, i.e. into the thorax cavity or abdomen cavity, cutting a key-hole, inserting at least one, preferably two, laparoscopic trocars through the key-hole towards said location, advancing one or more medical instruments and a camera through the at least one trocar towards said location, i.e. into the thorax or abdomen, and dissecting an area of the tubular part of living tissue with the aid of the dissecting tool.
The tissue connector may be supplied to said location through the at least one trocar or through a separate incision.
[00047] The invention will now be described in more detail in context with some preferred embodiments of the invention as shown in the accompanying drawings.
Brief description of the drawings
[00048] Figure 1 shows an exemplary view of a patient with one tissue connector connected to the patient's aorta and another tissue connector connected to the end of the patient's large bowel. [00049] Figure 2 shows a cross section of a first embodiment of the tissue connector in a state connected to living tissue.
[00050] Figure 3 shows a second embodiment of the tissue connector with two connecting ends.
[00051] Figure 4 shows a third embodiment of the tissue connector as an alternative to the second embodiment.
[00052] Figure 5 shows a partial cross section through the tissue connector with a blocking ring according to a first embodiment,
[00053] Figure 6 shows a plan view of the bulge connector of Figure 5. and
[00054] Figures 7 to 12 show cross sections of further embodiments of the bulge connector.
Detailed description
[00055] Figure 1 schematically shows a body 100 of a patient with a first tissue connector 1 connected to the end of the patient's large bowel 50 and a second tissue connector la interconnecting two pieces of the patient's aorta 60. The tissue connector 1 may either connect the large bowel 50 to the patient's anus or to an artificial anus which may include an excrements collecting container. The tissue connector la may include between its two ends a heart valve, a blood pump, a drug delivery device or the like.
[00056] The tissue connectors 1 and la shown in Figure 1 represent only a few of many different possible locations and applications of the tissue connector within the human's or, alternatively, an animal's body. Further examples of possible applications have already been outlined further above.
[00057] Figure 2 shows a first embodiment of the tissue connector 1 connected to a tubular part of living tissue 80. The tissue connector 1 comprises a conduit 2 with a first end 3 and a second end 4. The second end 4 of the conduit 2 has already been inserted into an end portion of living tissue 80. The inner cross section of the conduit 2 is selected to approximately match the inner cross section of the tubular living tissue 80 so as not to obstruct any flow of material. The thickness of the wall 5 of the conduit, which is typically circular, is chosen to provide sufficient strength so that it does not collapse under the forces that will act upon the conduit during use, while providing sufficient flexibility where needed. On the other hand, the thickness should not be chosen too large since the living tissue will have to be stretched over the outer surface 6 of the conduit 2 without damage and without excessively affecting blood circulation within the end portion 81 of the living tissue 80.
[00058] The wall 5 of conduit 2 is tapered towards its leading edge 7. In addition, the leading edge 7 is rounded. These two measures prevent damage to the living tissue 80 when the conduit 2 is inserted into the end portion 81 of the living tissue 80.
[00059] The first end 3 may serve and be adapted to be connected to an implantable medical device, an implantable reservoir, an implantable pump, an implantable motor or a combination of the afore mentioned items (generally designated with 200). It may also be connected to any other implantable device 200. The implantable device 200 may even form a part of the tissue connector 1, either integrally or attached thereto.
[00060] The implantable device 200 may also be a medical device replacing one or more of the patient's organs, such as an artificial urine bladder, a fecal excrement's collecting container, an artificial urethra, an artificial heart, an artificial esophagus, an artificial trachea or the like. Alternatively, the first end 3 of the conduit 2 may be connected to a biological implant obtained from a third party's body, such as a urine bladder, an intestine, a urethra, a ureter, a kidney, a bowel, a heart, an esophagus, a trachea, a blood vessel or the like.
[00061] The device 200 may also comprise a flow restrictor for partial or complete restriction of flow through the conduit. This can be suitable e.g. in the case where the tissue connector is located at the end of the patient's large bowel.
[00062] The device 200 may also be placed between the tissue connector 1 and a second tissue connector lb with conduit 2b, as is indicated in Figure 2 by dotted lines. This arrangement is practical where the device 200 has to be placed at a location within one of the patient's organs, such as in a blood vessel, in which case the blood vessel would be divided and the device 200 placed between the two tissue connectors 1 and lb connected to the respective free ends of the divided blood vessel. As an example, the device 200 could include a flow restrictor, such as an artificial heart valve, or a drug delivery reservoir. [00063] Apart from the conduit 2 and the optional device 200, the tissue connector 1 of the embodiment shown in Figure 2 has a bulge 15 that extends outwardly from the conduit's outer surface 6 in a circumferential direction of the conduit 2 about at least a part of the conduit's circumference. Furthermore, at least one blocking ring 30 loosely fitting over the outer surface 6 of the conduit 2 with a clearance between the outer surface 6 and the blocking ring 30 is provided for mounting the tubular living tissue 80 within the clearance. The blocking ring has an inner cross-sectional diameter which is about the same as the outer cross-sectional diameter of the bulge 15. This prevents the blocking ring from slipping over the bulge when the living tissue 80, as shown in Figure 2, is mounted within the clearance.
[00064] When an axial force tends to pull the tubular living tissue 80 from the outer surface 6 of the conduit 2, the blocking ring 30 will move with the tubular tissue 80, thereby compressing the tubular tissue 80 against the bulge 15, so as to prevent any further slippage of the tubular tissue 80 over the bulge 15. This is a self-enhancing effect. Preferably, the blocking ring in this and in the subsequently described embodiments is made from a material that has a friction coefficient in relation to living human (outer) mucosa tissue that is higher than a friction coefficient which the conduit's outer surface has in relation to living human (inner) serosa tissue.
[00065] Figure 3 shows a second embodiment of the tissue connector 1 comprising the conduit 2 with each of its first and second ends 3 and 4 having a circumferential bulge 15. Between the two bulges 15 two blocking rings 30 are arranged. Tubular living tissue 80 has been pulled over the conduit 2 and through the blocking rings 30, and the blocking rings 30 have then been pushed into a position closest to the bulges 15. Therefore, when stretching forces are applied to the tubular tissue 80 in the one or the other direction, depending upon the direction one of the two blocking rings 30 will move towards the associated bulge 15, thereby clamping the tissue 80 between the blocking ring 30 and the bulge 15 and prohibiting any further slippage of the tissue 80 off the conduit 2.
[00066] The embodiment shown in figure 3 is particularly suitable to strengthen weak sections in a tubular part of living tissue or to seal a porous section, such as a porous section of the patient's intestine. [00067] The same tissue connector as shown in figure 3 may also be used to connect two separate ends of tubular tissue or to connect one end of tubular tissue with another end of a hose or the like that may lead e.g. to an implantable medical device or to an exit port, such as an artificial body exit. [00068] Figure 4 shows a third embodiment that can be used as an alternative to the embodiment previously discussed in relation to figure 3. Again, the conduit 2 has two bulges 15 to prevent the tubular tissue 80 from slipping off of the conduit. However, in this embodiment the bulges 15 are arranged in close proximity to one another so that a single blocking ring 30 located between the two bulges 15 in an axial direction of the conduit will be sufficient to cooperate with one or the other of the two bulges 15 depending upon the direction of the stretching force acting upon the tissue 80.
[00069] Figure 5 shows a partial cross section through the tissue connector 1 with a blocking ring 30 according to a first embodiment. Accordingly, a tubular part of living tissue 80 has been pulled over the leading edge 7 of the conduit 2 and further over the bulge 15 located next to the leading edge 7, so as to lie against the wall 5 of the conduit 2. Then, the blocking ring 30 has been pushed over the living tissue 80 close to or against the bulge 15 so that the living tissue 80 is arranged within the clearance between the bulge 15 and an outer surface of the conduit's wall 5. In this first embodiment, the blocking ring 30 is made of a solid material having recesses 31A to 31G in its surface 32. There may be more or less recesses as compared to what is shown in Figure 5. The recesses 31A to 31G are provided only in the area 33 of the surface 32 which faces the outer surface of the conduit 1, as is further illustrated in Figure 6. That is, Figure 6 shows a plan view of the blocking ring 30 of Figure 5. As can be seen, the recesses 31A to 31G extend in a circumferential direction of the blocking ring 30, namely in this embodiment continuously all around the conduit 2. Alternatively, the recesses 31A to 31G may be interrupted. In any case, the extension of the recesses 31A to 31G is larger in a circumferential direction of the blocking ring 30 than in a direction parallel to a longitudinal axis of the conduit 2.
[0070] Further shown in Figure 5 is fibrotic tissue 90 grown over the material of both the conduit 2 and blocking ring 30. In the region where the blocking ring 30 contacts the tubular part of living tissue 80, the fibrotic tissue 90 connects to the living tissue 80. The recesses 31A to 31G strengthen such connection in that the fibrotic tissue 90 has grown into those recesses 31A to 31G.
[0071] Figures 7 to 12 show further embodiments of the blocking ring 30. In the embodiment shown in Figure 7, the recesses 31 each include an undercut 31' which extends underneath the surface 32 of the blocking ring 30. The undercut 31' may extend between 0.1 to 0.5 mm in a direction along the surface 32 of the blocking ring 30, preferably in both - opposite - directions, as shown in Figure 7.
[0072] The blocking ring 30 according to the embodiment shown in Figure 8 differs from the embodiments shown in Figures 5 through 7 in that the blocking ring 30 has a multi-layer structure including an inner part 34 and an outer layer 35, wherein the outer layer 35 provides the surface texture in the form of recesses 31 formed in the outer surface of the outer layer 35. The materials of the inner part 34 and outer layer 35 differ in that the material and dimensions of the inner part 34 are selected to provide the required stiffness to the blocking ring 30, whereas the material and structure of the outer layer 35 are selected so as to provide the desired properties for the fibrotic tissue 90 to grow into the surface 32 of the blocking ring 30.
[0073] The blocking ring 30 according to the embodiment shown in Figure 9 differs from the blocking ring 30 shown in Figure 8 in that the outer layer 35 has through holes 36 instead (or possible in addition to) the recesses 31. In general, the through holes 36 may substantially have the same cross-sectional form as the recesses 31 and 31A to 31G as described in relation to Figures 5 to 8, in particular undercuts as described in relation to Figure 7. The through holes 36 extend through the outer layer 35 up to the inner part 34 of the blocking ring 30.
[0074] The embodiment of the blocking ring 30 shown in Figure 10 differs from the blocking ring as described in relation to Figure 9 only in that the blocking ring 30 is hollow. That is, the blocking ring 30 does not have the inner part 34. This renders the blocking ring 30 relatively light-weight and, in addition, allows for the fibrotic tissue 90 to grow through the through holes 36 into the interior of the blocking ring 30, thereby further strengthening the connection between the fibrotic tissue 90 and the blocking ring 30. [0075] Figure 11 shows another embodiment of the blocking ring 30 having a multi-layer structure. In this embodiment, the outer layer 35 is made of an open cell foam 37. The fibrotic tissue 90 may grow into the open cells of the open cell foam 37. The open cell foam may be made of polyurethane or, preferably, silicone. Alternatively, the open cell foam may be made of metal, such as titanium, a titanium alloy or tantalum.
[0076] Figure 12 shows an even further embodiment of the blocking ring 30 with a multi-layer structure. Here, the outer layer 35 is made of a material providing interstices 38 instead of the open cells 37 shown in the embodiment of Figure 11. For instance, the outer layer 35 may be made of a textile, such as a textile having a knitted, woven, non-woven or braided structure, whereas the net-like structure may comprise a wire mesh, wherein the wires of the wire mesh preferably have a round or oval cross section so as to prevent any injury to the tubular part of living tissue 80.
[00077] Preferred embodiments of the present disclosure are specified in the following list of aspects:
1. An implantable tissue connector (1) adapted so as to be connectable to a tubular part of living tissue (80) within a patient's body, comprising a conduit (2) having at least a first end (3) and a second end (4) and further having an outer surface (6) with at least one bulge (15) extending outwardly from the conduit's outer surface (6) in a circumferential direction of the conduit (2) about at least a part of the conduit's circumference, and at least one blocking ring (30) loosely fitting over the conduit's outer surface (6) with a clearance between the conduit's outer surface (6) and the blocking ring (30) for mounting tubular living tissue (80) within the clearance, said blocking ring (30) having an inner cross sectional diameter which is smaller than or substantially identical to an outer cross sectional diameter of the at least one bulge (15) so as to prevent the blocking ring (30) from slipping over the bulge (15) when living tissue is mounted within the clearance, wherein a surface (32) of the blocking ring facing the conduit's outer surface (6) has a surface texture (31; 31A-G; 36; 37; 38) configured for fibrotic tissue (90) to grow into.
2. The tissue connector of aspect 1, wherein the surface texture (31; 31A-G; 36; 37; 38) comprises at least one recess (31; 31A-G) or through hole (36), or both at least one recess (31; 31A-G) and at least one through hole (36), for the fibrotic tissue (90) to grow into.
3. The tissue connector of aspect 2, wherein the at least one recess (31; 31A-G) or through hole (36) has an extension of 2 mm or more in at least one of: a direction parallel to a longitudinal axis of the conduit (2) and a circumferential direction of the blocking ring (30). 4. The tissue connector of aspect 2 or 3, wherein an extension of the at least one recess (31; 31A-G) or through hole (36) is larger in a circumferential direction of the blocking ring (30) than in a direction parallel to a longitudinal axis of the conduit (2).
5. The tissue connector of any one of aspects 2 to 4, comprising two, three, four, five, six, seven, eight, nine, ten or more than ten of the at least one recess (31; 31A-G) or through hole (36).
6. The tissue connector of any one of aspects 2 to 5, wherein the at least one recess (31; 31A-G) or through hole (36) has a depth of between 0.5 and 1.5 mm.
7. The tissue connector of any one of aspects 2 to 6, wherein the at least one recess (31; 31A-G) or through hole (36) has a depth of about 1 mm.
8. The tissue connector of any one of aspects 2 to 7, wherein the at least one recess (31; 31A-G) extends all around the conduit.
9. The tissue connector of any one of aspects 2 to 8, wherein the at least one recess (31; 31A-G) or through hole (36) includes an undercut (31') extending underneath the surface (32) of the blocking ring (30).
10. The tissue connector of aspect 9, wherein the undercut extends between 0.1 to 0.5 mm in a direction along the surface (32) of the blocking ring (30).
11. The tissue connector of aspect 9 or 10, wherein the undercut (31') extends about 0.3 mm in a direction along the surface (32) of the blocking ring (30).
12. The tissue connector of any one of aspects 1 to 11, wherein the blocking ring (30) has a hollow interior.
13. The tissue connector of any one of aspects 2 to 11, wherein the blocking ring (30) has a hollow interior and wherein the at least one through hole (36) extends from the surface (32) of the blocking ring (30) up to the hollow interior.
14. The tissue connector of any one of aspects 1 to 13, wherein the blocking ring (30) has a multi-layer structure including an outer layer (35) providing said surface texture.
15. The tissue connector of any one of aspects 2 to 12, wherein the blocking ring (30) has a multi-layer structure including an outer layer (35) providing said surface texture, wherein the outer layer (35) comprises a sleeve having at least one depression or perforation forming said at least one recess (31) for the fibrotic tissue (90) to grow into.
16. The tissue connector of any one of aspects 1 to 7, wherein the blocking ring (30) has a multi-layer structure including an outer layer (35) comprising an open cell foam having open cells (37) for the fibrotic tissue (90) to grow into.
17. The tissue connector of aspect 16, wherein the open cell foam comprises open cell foam made of polyurethane.
18. The tissue connector of aspect 16, wherein the open cell foam comprises open cell foam made of silicone.
19. The tissue connector of aspect 16, wherein the open cell foam comprises open cell foam made of metal.
20. The tissue connector of aspect 16, wherein the metal comprises one of: titanium, a titanium alloy, tantalum. 21. The tissue connector of any one of aspects 1 to 7 , wherein the blocking ring (30) has a multi-layer structure including an outer layer (35), wherein the outer layer (35) has a textile structure or net- like structure with interstices (38) for the fibrotic tissue (90) to grow into.
22. The tissue connector of a aspect 21, wherein the net-like structure comprises a wire mesh.
23. The tissue connector of aspect 22, wherein the wire mesh comprises wires having a round or oval cross section.
24. The tissue connector of a aspect 21, wherein the textile structure comprises a knitted, woven, nonwoven or braided structure.
25. The tissue connector of any one of aspects 14 to 24, wherein the outer layer (35) has a thickness of 3 mm or less.
26. The tissue connector of aspect 25, wherein the outer layer (35) has a thickness of between 0.5 and 1.5 mm.
27. The tissue connector of aspect 25, wherein the outer layer (35) has a thickness of about 1 mm. MATERIALS
28. The tissue connector of any one of aspects 1 to 27, wherein the blocking ring is made from a material of the following group of materials comprising: titanium, stainless steel, ceramics, polytetrafluoroethylene, silicone, polyurethane.
29. The tissue connector of aspect 28, wherein the blocking ring is made of polytetrafluoroethylene, polyurethane or silicone.
30. The tissue connector of any one of aspects 1 to 29, wherein the conduit is made from a material of the following group of materials comprising: titanium, stainless steel, ceramics, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyetheretherketone (PEEK), silicone, polyurethane, polypropylene, other biocompatible polymer material.
31. The tissue connector of any one of aspects 1 to 30, wherein the at least one bulge is located proximately to said first end of the conduit.
32. The tissue connector of any one of aspects 1 to 30, wherein the conduit has at least two of said bulges with the at least one blocking ring being located intermediate said at least two bulges.
33. The tissue connector of aspect 32, wherein the at least two bulges are each located proximate one of said at least first and second ends of the conduit.
34. The tissue connector of any one of aspects 1 to 33, wherein - depending upon the intended use - the clearance is in the range of one of the following ranges: 0.1 to 0.4 mm, 0.4 to 0.8 mm, 0.8 to 1.3 mm, 1.3 to 2 mm, 2 to 3 mm, 3 to 4 mm, 4 to 5 mm, over 5 mm.
GENERAL ASPECTS
35. The tissue connector of any one of aspects 1 to 34, wherein said second end of the conduit is adapted for connecting the tissue connector to at least one of the following items: an implantable reservoir, an implantable pump, an implantable motor, an implantable medical device, a biological transplant.
36. The tissue connector of any one of aspects 1 to 35, wherein between the first and second ends of the conduit or connected to the second end of the conduit, there is provided at least one of the following items: a reservoir, a pump, a motor, a medical device. 37. The tissue connector of aspect 36, wherein the reservoir is artificial or a biological transplant or made from tissue material of a patient into whom the reservoir is to be implanted.
38. The tissue connector of any one of aspects 35 to 37, wherein the reservoir is a fecal excrements collecting container.
39. The tissue connector of aspect 38, wherein the fecal excrements collecting container comprises one of the following: a urine bladder, an intestine.
40. The tissue connector of any one of aspects 35 to 37, wherein the reservoir is adapted to be filled with at least one medical drug for patient needs.
41. The tissue connector of aspect 36, wherein said medical device is a device of the following group of devices comprising: a drug delivery system, an artificial urine bladder, a fecal excrements collecting container, an artificial urethra, an artificial heart, an artificial esophagus, an artificial trachea.
42. The tissue connector of aspect 36, wherein said biological transplant is a transplant of the following group of transplants comprising: a urine bladder, an intestine, a urethra, a ureter, a kidney, a bowel, a heart, an esophagus, a trachea, a blood vessel.
43. The tissue connector of any one of aspects 1 to 42, comprising a flow restrictor for partial or complete restriction of flow through the conduit.
44. The tissue connector of any one of aspects 1 to 43, wherein the conduit has an inner diameter of between 0.1 and 0.5 cm.
45. The tissue connector of any one of aspects 1 to 43, wherein the conduit has an inner diameter of between 0.5 and 1 cm.
46. The tissue connector of any one of aspects 1 to 43, wherein the conduit has an inner diameter of between 1 and 2 cm.
47. The tissue connector of any one of aspects 1 to 43, wherein the conduit has an inner diameter of between 2 and 3 cm.
48. The tissue connector of any one of aspects 1 to 43, wherein the conduit has an inner diameter of between 3 and 4 cm.
49. The tissue connector of any one of aspects 1 to 43, wherein the conduit has an inner diameter of 4 cm or over.
50. The tissue connector of any of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's esophagus.
51. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's trachea.
52. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's stomach.
53. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's gall bladder or its connecting outlet channels.
54. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's small bowel. 55. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's large bowel.
56. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's urethra.
57. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's ureter.
58. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's pelvic part of the kidney.
59. The tissue connector of any one of aspects 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's blood vessel.
60. The tissue connector of aspect 59, wherein said conduit is sized so as to be snuggly fitted into the human's aorta or the heart's atrium or ventricle.
USE
61. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's esophagus.
62. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's trachea.
63. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's stomach.
64. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's gall bladder or its connecting outlet channels.
65. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's small bowel.
66. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's large bowel.
67. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's urethra.
68. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's ureter.
69. A use of the tissue connector of any one of aspects 1 to43 as a connector to the human's pelvic part of the kidney.
70. A use of the tissue connector of any one of aspects 1 to 43 as a connector to the human's blood vessel.
71. The use of the tissue connector of aspect 70 as a connector to the human's aorta or the heart's atrium or ventricle.
72. A use of the tissue connector of any one of aspects 1 to 43 as a connector between the human's kidney and a reservoir.
73. A use of the tissue connector of any one of aspects 1 to 43 as a connector between the human's intestine and a reservoir.
74. The use of the tissue connector of any one of aspects 76 or 73, wherein the reservoir is artificial or a biological transplant.
METHOD OF TREATMENT (IMPLANTATION)
75. A method of treating a human being or an animal by implanting the tissue connector of any one of aspects 1 to 34 in a patient's body, comprising the steps of - cutting the skin,
- free-dissecting a location within the patient's body adjacent a tubular part of living tissue,
- connecting the first end of the conduit of the tissue connector to a first section of the tubular part of living tissue by inserting the first end of the conduit including the bulge into the first section of the tubular part of living tissue and advancing the blocking ring over the living tissue towards the bulge such that at least part of the living tissue is located intermediate the conduit's outer surface and the blocking ring, and
- suturing at least the skin after connecting the living tissue to the tissue connector has been completed.
76. The method of aspect 75, wherein suturing is performed through an outer wall of the conduit including a portion of the living tissue.
77. The method of aspect 77, wherein a thread is used for suturing which is made from a material that is absorbable by a patient's body.
78. The method of any one of aspects 75 to 77, comprising the step of connecting the second end of the conduit of the tissue connector to a different type of living tissue.
79. The method of any one of aspects 75 to 77, comprising the step of connecting the second end of the conduit of the tissue connector to a second section of said tubular part of living tissue.
80. The method of aspect 79, wherein the step of connecting the second end of the conduit of the tissue connector to the second section of tubular part of living tissue comprises the steps of inserting the second end of the conduit into the second section of the tubular part of living tissue, including inserting the bulge into the second section of the tubular part of
81. The method of any one of aspects 75 to 80, wherein the human's throat is selected as the tubular part of living tissue.
82. The method of any one of aspects 75 to 80, wherein the human's trachea is selected as the tubular part of living tissue.
83. The method of any one of aspects 75 to 90, wherein the human's small bowel is selected as the tubular part of living tissue.
84. The method of any one of aspects 75 to 90, wherein the human's large bowel is selected as the tubular part of living tissue.
85. The method of any one of aspects 75 to 90, wherein the human's urethra is selected as the tubular part of living tissue.
86. The method of any one of aspects 75 to 90, wherein the human's ureter is selected as the tubular part of living tissue.
87. The method of any one of aspects 75 to 90, wherein the pelvic part of a human's kidney is selected as the tubular part of living tissue.
88. The method of any one of aspects 83 to 87, wherein the steps of cutting the skin and free-dissecting a location within the patient's body comprise the steps of:
- inserting a needle-like tube into the abdomen of a patient's body,
- filling the abdomen with gas thereby expanding the abdominal cavity,
- positioning at least two laparoscopic trocars in the patient's body, - inserting a camera into the abdomen through one of the trocars,
- inserting a dissecting tool through another one of the trocars, and
- dissecting an area of the tubular part of living tissue with the aid of the dissecting tool.
89. The method of any one of aspects 83 to 87, wherein the step of free-dissecting a location within the patient's body comprises opening the patient's abdomen for open surgery.
90. The method of any one of aspects 75 to 80, wherein a human's blood vessel is selected as the tubular part of living tissue.
91. The method of any of one aspects 75 to 80, wherein the human's aorta is selected as the tubular part of living tissue.
92. The method of any of one aspects 75 to 91, wherein the steps of cutting the skin and free-dissecting a location within the patient's body comprises the steps of:
- inserting a needle-like tube into the thorax of a patient's body,
- filling the thorax with gas thereby expanding the thorax cavity,
- positioning at least two laparoscopic trocars in the patient's body,
- inserting a camera into the thorax through one of the trocars,
- inserting a dissecting tool through another one of the trocars, and
- dissecting an area of the tubular part of living tissue with the aid of the dissecting tool.
93. The method of any one of aspects 90 to 91, wherein the step of free-dissecting a location within the patient's body comprises opening the patient's thorax for open surgery.
94. The method of any one of aspects 75 to 87 or 90, wherein the steps of cutting the skin, free- dissecting the location adjacent the tubular part of living tissue and connecting the tissue connector to the tubular part of living tissue comprise:
- inserting a needle-like tube into the patient's body,
- filling through said needle gas into the patient's body,
- cutting a key-hole,
- inserting at least one laparoscopic trocar through the key-hole towards said location,
- advancing one or more medical instruments and a camera through the at least one trocar towards said location,
- dissecting said location, and
- supplying the tissue connector to said location through the at least one trocar or through a separate incision.

Claims

1. An implantable tissue connector (1) adapted so as to be connectable to a tubular part of living tissue (80) within a patient's body, comprising a conduit (2) having at least a first end (3) and a second end (4) and further having an outer surface (6) with at least one bulge (15) extending outwardly from the conduit's outer surface (6) in a circumferential direction of the conduit (2) about at least a part of the conduit's circumference, and at least one blocking ring (30) loosely fitting over the conduit's outer surface (6) with a clearance between the conduit's outer surface (6) and the blocking ring (30) for mounting tubular living tissue (80) within the clearance, said blocking ring (30) having an inner cross sectional diameter which is smaller than or substantially identical to an outer cross sectional diameter of the at least one bulge (15) so as to prevent the blocking ring (30) from slipping over the bulge (15) when living tissue is mounted within the clearance, wherein a surface (32) of the blocking ring facing the conduit's outer surface (6) has a surface texture (31; 31A-G; 36; 37; 38) configured for fibrotic tissue (90) to grow into.
2. The tissue connector of claim 1, wherein the surface texture (31; 31A-G; 36; 37; 38) comprises at least one recess (31; 31A-G) or through hole (36), or both at least one recess (31; 31A-G) and at least one through hole (36), for the fibrotic tissue (90) to grow into.
3. The tissue connector of claim 2, wherein the at least one recess (31; 31A-G) or through hole (36) has an extension of 2 mm or more in at least one of: a direction parallel to a longitudinal axis of the conduit (2) and a circumferential direction of the blocking ring (30).
4. The tissue connector of claim 2 or 3, wherein an extension of the at least one recess (31; 31A-G) or through hole (36) is larger in a circumferential direction of the blocking ring (30) than in a direction parallel to a longitudinal axis of the conduit (2).
5. The tissue connector of any one of claims 2 to 4, comprising two, three, four, five, six, seven, eight, nine, ten or more than ten of the at least one recess (31; 31A-G) or through hole (36).
6. The tissue connector of any one of claims 2 to 5, wherein the at least one recess (31; 31A-G) or through hole (36) has a depth of between 0.5 and 1.5 mm.
7. The tissue connector of any one of claims 2 to 6, wherein the at least one recess (31; 31A-G) or through hole (36) has a depth of about 1 mm.
8. The tissue connector of any one of claims 2 to 7, wherein the at least one recess (31; 31A-G) extends all around the conduit.
9. The tissue connector of any one of claims 2 to 8, wherein the at least one recess (31; 31A-G) or through hole (36) includes an undercut (31') extending underneath the surface (32) of the blocking ring (30).
10. The tissue connector of claim 9, wherein the undercut extends between 0.1 to 0.5 mm in a direction along the surface (32) of the blocking ring (30).
11. The tissue connector of claim 9 or 10, wherein the undercut (31') extends about 0.3 mm in a direction along the surface (32) of the blocking ring (30).
12. The tissue connector of any one of claims 1 to 11, wherein the blocking ring (30) has a hollow interior.
13. The tissue connector of any one of claims 2 to 11, wherein the blocking ring (30) has a hollow interior and wherein the at least one through hole (36) extends from the surface (32) of the blocking ring (30) up to the hollow interior.
14. The tissue connector of any one of claims 1 to 13, wherein the blocking ring (30) has a multi-layer structure including an outer layer (35) providing said surface texture.
15. The tissue connector of any one of claims 2 to 12, wherein the blocking ring (30) has a multi-layer structure including an outer layer (35) providing said surface texture, wherein the outer layer (35) comprises a sleeve having at least one depression or perforation forming said at least one recess (31) for the fibrotic tissue (90) to grow into.
16. The tissue connector of any one of claims 1 to 7, wherein the blocking ring (30) has a multi-layer structure including an outer layer (35) comprising an open cell foam having open cells (37) for the fibrotic tissue (90) to grow into.
17. The tissue connector of claim 16, wherein the open cell foam comprises open cell foam made of polyurethane.
18. The tissue connector of claim 16, wherein the open cell foam comprises open cell foam made of silicone.
19. The tissue connector of claim 16, wherein the open cell foam comprises open cell foam made of metal.
20. The tissue connector of claim 16, wherein the metal comprises one of: titanium, a titanium alloy, tantalum.
21. The tissue connector of any one of claims 1 to 7, wherein the blocking ring (30) has a multi-layer structure including an outer layer (35), wherein the outer layer (35) has a textile structure or net- like structure with interstices (38) for the fibrotic tissue (90) to grow into.
22. The tissue connector of a claim 21, wherein the net-like structure comprises a wire mesh.
23. The tissue connector of claim 22, wherein the wire mesh comprises wires having a round or oval cross section.
24. The tissue connector of a claim 21, wherein the textile structure comprises a knitted, woven, nonwoven or braided structure.
25. The tissue connector of any one of claims 14 to 24, wherein the outer layer (35) has a thickness of 3 mm or less.
26. The tissue connector of claim 25, wherein the outer layer (35) has a thickness of between 0.5 and 1.5 mm.
27. The tissue connector of claim 25, wherein the outer layer (35) has a thickness of about 1 mm.
28. The tissue connector of any one of claims 1 to 27, wherein the blocking ring is made from a material of the following group of materials comprising: titanium, stainless steel, ceramics, polytetrafluoroethylene, silicone, polyurethane.
29. The tissue connector of claim 28, wherein the blocking ring is made of polytetrafluoroethylene, polyurethane or silicone.
30. The tissue connector of any one of claims 1 to 29, wherein the conduit is made from a material of the following group of materials comprising: titanium, stainless steel, ceramics, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyetheretherketone (PEEK), silicone, polyurethane, polypropylene, other biocompatible polymer material.
31. The tissue connector of any one of claims 1 to 30, wherein the at least one bulge is located proximately to said first end of the conduit.
32. The tissue connector of any one of claims 1 to 30, wherein the conduit has at least two of said bulges with the at least one blocking ring being located intermediate said at least two bulges.
33. The tissue connector of claim 32, wherein the at least two bulges are each located proximate one of said at least first and second ends of the conduit.
34. The tissue connector of any one of claims 1 to 33, wherein - depending upon the intended use - the clearance is in the range of one of the following ranges: 0.1 to 0.4 mm, 0.4 to 0.8 mm, 0.8 to 1.3 mm, 1.3 to 2 mm, 2 to 3 mm, 3 to 4 mm, 4 to 5 mm, over 5 mm.
35. The tissue connector of any one of claims 1 to 34, wherein said second end of the conduit is adapted for connecting the tissue connector to at least one of the following items: an implantable reservoir, an implantable pump, an implantable motor, an implantable medical device, a biological transplant.
36. The tissue connector of any one of claims 1 to 35, wherein between the first and second ends of the conduit or connected to the second end of the conduit, there is provided at least one of the following items: a reservoir, a pump, a motor, a medical device.
37. The tissue connector of claim 36, wherein the reservoir is artificial or a biological transplant or made from tissue material of a patient into whom the reservoir is to be implanted.
38. The tissue connector of any one of claims 35 to 37, wherein the reservoir is a fecal excrements collecting container.
39. The tissue connector of claim 38, wherein the fecal excrements collecting container comprises one of the following: a urine bladder, an intestine.
40. The tissue connector of any one of claims 35 to 37, wherein the reservoir is adapted to be filled with at least one medical drug for patient needs.
41. The tissue connector of claim 36, wherein said medical device is a device of the following group of devices comprising: a drug delivery system, an artificial urine bladder, a fecal excrements collecting container, an artificial urethra, an artificial heart, an artificial esophagus, an artificial trachea.
42. The tissue connector of claim 36, wherein said biological transplant is a transplant of the following group of transplants comprising: a urine bladder, an intestine, a urethra, a ureter, a kidney, a bowel, a heart, an esophagus, a trachea, a blood vessel.
43. The tissue connector of any one of claims 1 to 42, comprising a flow restrictor for partial or complete restriction of flow through the conduit.
44. The tissue connector of any one of claims 1 to 43, wherein the conduit has an inner diameter of between 0.1 and 0.5 cm.
45. The tissue connector of any one of claims 1 to 43, wherein the conduit has an inner diameter of between 0.5 and 1 cm.
46. The tissue connector of any one of claims 1 to 43, wherein the conduit has an inner diameter of between 1 and 2 cm.
47. The tissue connector of any one of claims 1 to 43, wherein the conduit has an inner diameter of between 2 and 3 cm.
48. The tissue connector of any one of claims 1 to 43, wherein the conduit has an inner diameter of between 3 and 4 cm.
49. The tissue connector of any one of claims 1 to 43, wherein the conduit has an inner diameter of 4 cm or over.
50. The tissue connector of any of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's esophagus.
51. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's trachea.
52. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's stomach.
53. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's gall bladder or its connecting outlet channels.
54. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's small bowel.
55. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's large bowel.
56. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's urethra.
57. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's ureter.
58. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's pelvic part of the kidney.
59. The tissue connector of any one of claims 1 to 43, wherein said conduit is sized so as to be snuggly fitted into a human's blood vessel.
60. The tissue connector of claim 59, wherein said conduit is sized so as to be snuggly fitted into the human's aorta or the heart's atrium or ventricle.
61. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human’s esophagus.
62. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human's trachea.
63. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human's stomach.
64. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human's gall bladder or its connecting outlet channels.
65. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human's small bowel.
66. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human's large bowel.
67. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human's urethra.
68. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human's ureter.
69. A use of the tissue connector of any one of claims 1 to43 as a connector to the human's pelvic part of the kidney.
70. A use of the tissue connector of any one of claims 1 to 43 as a connector to the human's blood vessel.
71. The use of the tissue connector of claim 70 as a connector to the human's aorta or the heart's atrium or ventricle.
72. A use of the tissue connector of any one of claims 1 to 43 as a connector between the human's kidney and a reservoir.
73. A use of the tissue connector of any one of claims 1 to 43 as a connector between the human's intestine and a reservoir.
74. The use of the tissue connector of any one of claims 76 or 73, wherein the reservoir is artificial or a biological transplant.
75. A method of treating a human being or an animal by implanting the tissue connector of any one of claims 1 to 34 in a patient's body, comprising the steps of
- cutting the skin,
- free-dissecting a location within the patient's body adjacent a tubular part of living tissue,
- connecting the first end of the conduit of the tissue connector to a first section of the tubular part of living tissue by inserting the first end of the conduit including the bulge into the first section of the tubular part of living tissue and advancing the blocking ring over the living tissue towards the bulge such that at least part of the living tissue is located intermediate the conduit's outer surface and the blocking ring, and
- suturing at least the skin after connecting the living tissue to the tissue connector has been completed.
76. The method of claim 75, wherein suturing is performed through an outer wall of the conduit including a portion of the living tissue.
77. The method of claim 77, wherein a thread is used for suturing which is made from a material that is absorbable by a patient's body.
78. The method of any one of claims 75 to 77, comprising the step of connecting the second end of the conduit of the tissue connector to a different type of living tissue.
79. The method of any one of claims 75 to 77, comprising the step of connecting the second end of the conduit of the tissue connector to a second section of said tubular part of living tissue.
80. The method of claim 79, wherein the step of connecting the second end of the conduit of the tissue connector to the second section of tubular part of living tissue comprises the steps of inserting the second end of the conduit into the second section of the tubular part of living tissue, including inserting the bulge into the second section of the tubular part of
81. The method of any one of claims 75 to 80, wherein the human's throat is selected as the tubular part of living tissue.
82. The method of any one of claims 75 to 80, wherein the human's trachea is selected as the tubular part of living tissue.
83. The method of any one of claims 75 to 90, wherein the human's small bowel is selected as the tubular part of living tissue.
84. The method of any one of claims 75 to 90, wherein the human's large bowel is selected as the tubular part of living tissue.
85. The method of any one of claims 75 to 90, wherein the human's urethra is selected as the tubular part of living tissue.
86. The method of any one of claims 75 to 90, wherein the human's ureter is selected as the tubular part of living tissue.
87. The method of any one of claims 75 to 90, wherein the pelvic part of a human's kidney is selected as the tubular part of living tissue.
88. The method of any one of claims 83 to 87, wherein the steps of cutting the skin and free-dissecting a location within the patient's body comprise the steps of:
- inserting a needle-like tube into the abdomen of a patient's body,
- filling the abdomen with gas thereby expanding the abdominal cavity,
- positioning at least two laparoscopic trocars in the patient's body,
- inserting a camera into the abdomen through one of the trocars,
- inserting a dissecting tool through another one of the trocars, and
- dissecting an area of the tubular part of living tissue with the aid of the dissecting tool.
89. The method of any one of claims 83 to 87, wherein the step of free-dissecting a location within the patient's body comprises opening the patient's abdomen for open surgery.
90. The method of any one of claims 75 to 80, wherein a human's blood vessel is selected as the tubular part of living tissue.
91. The method of any of one claims 75 to 80, wherein the human's aorta is selected as the tubular part of living tissue.
92. The method of any of one claims 75 to 91, wherein the steps of cutting the skin and free-dissecting a location within the patient's body comprises the steps of:
- inserting a needle-like tube into the thorax of a patient's body,
- filling the thorax with gas thereby expanding the thorax cavity,
- positioning at least two laparoscopic trocars in the patient's body,
- inserting a camera into the thorax through one of the trocars,
- inserting a dissecting tool through another one of the trocars, and
- dissecting an area of the tubular part of living tissue with the aid of the dissecting tool.
93. The method of any one of claims 90 to 91, wherein the step of free-dissecting a location within the patient's body comprises opening the patient's thorax for open surgery.
94. The method of any one of claims 75 to 87 or 90, wherein the steps of cutting the skin, free- dissecting the location adjacent the tubular part of living tissue and connecting the tissue connector to the tubular part of living tissue comprise:
- inserting a needle-like tube into the patient's body,
- filling through said needle gas into the patient's body,
- cutting a key-hole, - inserting at least one laparoscopic trocar through the key-hole towards said location,
- advancing one or more medical instruments and a camera through the at least one trocar towards said location,
- dissecting said location, and - supplying the tissue connector to said location through the at least one trocar or through a separate incision.
PCT/EP2025/053669 2024-02-16 2025-02-12 Implantable tissue connector Pending WO2025172332A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE2450186-8 2024-02-16
SE2450186 2024-02-16

Publications (1)

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Application Number Title Priority Date Filing Date
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WO (1) WO2025172332A1 (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3357432A (en) * 1965-02-09 1967-12-12 Edwards Lab Inc Anastomotic coupling
WO2009046998A2 (en) 2007-10-11 2009-04-16 Milux Holding Sa Implantable tissue connector
EP2209439B1 (en) * 2007-10-11 2015-12-23 Kirk Promotion LTD. System for treating a patient having an intestinal disorder
US20190022368A1 (en) * 2017-07-20 2019-01-24 Merit Medical Systems, Inc. Methods and systems for coupling conduits

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3357432A (en) * 1965-02-09 1967-12-12 Edwards Lab Inc Anastomotic coupling
WO2009046998A2 (en) 2007-10-11 2009-04-16 Milux Holding Sa Implantable tissue connector
EP2209439B1 (en) * 2007-10-11 2015-12-23 Kirk Promotion LTD. System for treating a patient having an intestinal disorder
EP3025676A1 (en) * 2007-10-11 2016-06-01 Kirk Promotion LTD. Implantable tissue connector
US20190022368A1 (en) * 2017-07-20 2019-01-24 Merit Medical Systems, Inc. Methods and systems for coupling conduits

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