WO2023057129A1 - Medical implant, particularly clip, for intra-vascular/intra-luminal application - Google Patents

Medical implant, particularly clip, for intra-vascular/intra-luminal application Download PDF

Info

Publication number
WO2023057129A1
WO2023057129A1 PCT/EP2022/073946 EP2022073946W WO2023057129A1 WO 2023057129 A1 WO2023057129 A1 WO 2023057129A1 EP 2022073946 W EP2022073946 W EP 2022073946W WO 2023057129 A1 WO2023057129 A1 WO 2023057129A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical implant
fixation member
engaging elements
fixation
connection structure
Prior art date
Application number
PCT/EP2022/073946
Other languages
French (fr)
Inventor
Sebastian Klaus
Original Assignee
Biotronik Ag
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 Biotronik Ag filed Critical Biotronik Ag
Publication of WO2023057129A1 publication Critical patent/WO2023057129A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227—Spring clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00407—Ratchet means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00579—Barbed implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00668—Type of implements the implement being a tack or a staple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00982—General structural features
    • A61B2017/00991—Telescopic means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0645—Surgical staples, i.e. penetrating the tissue being elastically deformed for insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132—End-to-end connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0007—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present invention relates to a medical implant and a medical implant delivery system.
  • Perforated or ruptured arteries appearing in interventional procedures can lead to emergency situations especially in the coronaries. Therefore, an efficient and fast way of closing a vascular leakage or unintended luminal pathways is desirable.
  • covered stents or a temporary sealing with an inflated dilatation balloon are used to seal such leakages.
  • a temporary use of a dilatation balloon can often not seal all leakages (depending on severity).
  • covered stents are complex to manufacture, expensive and show worse clinical outcome compared to uncovered stents regarding e.g. re-stenosis behavior.
  • the problem to be solved by the present invention therefore is to provide a minimally invasive medical implant that seals vascular leakages or unintended luminal pathways fast and reliable.
  • a medical implant particularly clip, for connecting two tissue portions to one another, comprising: a first and a second fixation member,
  • connection structure wherein the first fixation member is connected to the second fixation member via the connection structure, wherein the first fixation member is configured to engage with the first tissue portion, and wherein the second fixation member is configured to engage with the second tissue portion such that the connection structure extends between the tissue portions to connect the tissue portions to one another.
  • the respective tissue portion forms a lumen
  • the first fixation member is configured to be inserted into the lumen of the first tissue portion and to engage with an inner side of the first tissue portion to anchor the first fixation member to the inner side of the first tissue portion
  • the second fixation member is configured to be inserted into the lumen of the second tissue portion and to engage with an inner side of the second tissue portion to anchor the second fixation member to the inner side of the second tissue portion.
  • the first tissue portion can be a first vessel section and the second tissue portion can be a second vessel section, the two vessel sections can be arranged on either side of a rupture, or of a perforation, or of a side branch of the vessel so that the connection structure extends along - depending on the case - the rupture, or perforation, or side branch, particularly so as to close said rupture, perforation, or side branch.
  • the medical implant according to the present invention can also be used to handle unwanted luminal pathways, e.g., to reduce the size of the opening or close a side branch intentionally to reduce or block further blood flow through it.
  • the connecting structure is configured to pull the tissue portions towards one another.
  • this allows e.g., a vascular leakage to be closed by longitudinally pulling together the affected vascular area (e.g., ruptured or perforated portion of the vessel) by means of a medical implant from inside the vessel.
  • the affected vascular area e.g., ruptured or perforated portion of the vessel
  • the latter is closed by body own material.
  • an unwanted side branch of a vessel can be closed.
  • fixation members of the medical implant serve to connect to the respective tissue portion, particularly to tissue of the vessel wall such that by means of the fixation members an anchoring of the fixation members to the tissue can be established.
  • connection structure is an elastically deformable connection structure.
  • connection structure is a length-adjustable connection structure comprising a first part and a second part, the first part configured to engage with the second part at a plurality of different positions, each engagement of the first part with the second part at one of said positions corresponding to a different length of the length-adjustable connection structure.
  • first and second fixation member are configured to get to their final relative position with respect to one another by means of a linear ratchet mechanism.
  • the connection structure comprises at least one connection member having a meandering shape, or is formed as a connection member having a meandering shape, wherein the respective connection member extends between the fixation members along a longitudinal axis of the medical implant, the respective connection member particularly forming a spring element configured to be tensioned and thereby elongated in the direction of the longitudinal axis which particularly causes the fixation members to be pulled towards one another which helps closing the ruptured/perforated portion of the vessel and anchoring the fixation members to the vessel when the fixation members are engaged with the vessel wall on either side of said ruptured or perforated portion of the vessel.
  • the fixation members each comprise a frame structure, each frame structure carrying at least one fixation arrangement formed by engaging elements being arranged side by side in particular.
  • the respective engaging element forms a protrusion.
  • the size, number, and shape, particularly a sharpness of a tip or other portion of the protrusion can vary depending on the involved first and second tissue portions and particularly depending on technical and particularly clinical circumstances like sensitivity of a vessel wall towards such elements.
  • the protrusions can have one of an elongated shape, a fish scale shape, a blade-like shape, a hook shape.
  • the engaging element/protrusions can also be formed as barbed hooks.
  • the respective engaging element/protrusion comprises a tip for engaging with the respective tissue portion, particularly vessel wall.
  • the tip can be rounded.
  • the respective engaging element can comprise a tapered shape forming said tip.
  • the respective engaging element can comprise two longitudinal portions arranged at an angle towards another and integrally connected to one another in a connecting region that forms the tip.
  • the respective tip is configured to engage with the inner side of the wall of the tissue portion/vessel in order to establish an anchoring of the fixation members in the tissue of the wall of the tissue portion/vessel.
  • the respective engaging element particularly when being formed by two joined longitudinal portions, can have a fish scale shape.
  • the engaging elements are configured to self-erect due to an elastic property of the engaging elements from a retracted state (wherein the retracted state can be maintained by arranging the medical implant in an enclosure tightly enclosing the medical implant in a circumferential direction of the medical implant) to an advanced state in which the engaging elements are arranged at an angle with respect to the respective frame structure.
  • said enclosure can be formed by at least one parts of a catheter shaft of a delivery catheter (see also below).
  • the tips of the engaging elements of the at least one fixation arrangement of the first fixation member and the tips of the engaging elements of the at least one fixation arrangement of the second fixation member point towards each other in a direction of a longitudinal axis of the medical implant along which longitudinal axis the first fixation member, connection structure and second fixation member extend and are connected to one another.
  • the tips of the engaging elements of the at least one fixation arrangement of the first fixation member and the tips of the engaging elements of the at least one fixation arrangement of the second fixation member are further apart from one another in the direction of the longitudinal axis of the medical implant than in the retracted state due to the engaging elements being arranged at said angle with respect to the respective frame structure in the advanced state.
  • connection structure is configured to be tensioned to pull the fixation members towards one another when the engaging elements are engaged with the inner side of the wall of the vessel, particularly so as to prevent disengagement of the engaging elements from the wall of the vessel.
  • This tensioning can e.g., be established by using an elastically deformable connection structure that provides a restoring force pulling the tissue portions (e.g., vessel sections) towards one another or by a length-adjustable connection structure that is shortened by a desired amount to pull the tissue portions (e.g., vessel sections) towards one another see also above.
  • the frame structure of the first fixation member comprises a first leg and an opposing second leg, each leg extending along a longitudinal axis of the medical implant, wherein the engaging elements of the first fixation member extend from the first leg to the second leg of the frame structure of the first fixation member.
  • the frame structure of the second fixation member can comprise a first leg and an opposing second leg, each leg extending along a longitudinal axis of the medical implant, wherein the engaging elements of the second fixation member extend from the first leg to the second leg of the frame structure of the second fixation member.
  • the medical implant and its components particularly comprise a ribbon-like shape.
  • the frame structure of the first fixation member together with the engaging elements of the first fixation member forms a circumferential scaffold that extends along a circumferential direction in a plane perpendicular to a longitudinal axis of the medical implant.
  • the frame structure of the second fixation member together with the engaging elements of the second fixation member preferably forms a circumferential scaffold that extends along a circumferential direction in a plane perpendicular to the longitudinal axis of the medical implant.
  • the medical implant rather comprises a cylindrical, particularly stent-like shape.
  • the medical implant comprises a first x-ray marker and a second x-ray marker, the first x-ray marker being arranged on a first connecting portion of the medical implant connecting the first fixation member to the connection structure, and the second x-ray marker being arranged on a second connecting portion of the medical implant connecting the connection structure to the second fixation member.
  • the medical implant comprises a connector element being connected to an end of the first fixation member, wherein the connector element is configured to engage with a locking feature (e.g. in the shape of a locking opening) of a delivery catheter configured for delivering the medical implant to an implantation site, wherein particularly the locking feature is a locking feature of an inner catheter member that is moveable inside a lumen of an outer catheter shaft of the delivery catheter.
  • a locking feature e.g. in the shape of a locking opening
  • the connector element is configured to extends at an angle with respect to a longitudinal axis of the medical implant, particularly after deployment of the medical implant, so that when the medical implant is arranged in the lumen of the vessel, the connector element extends away from the inner side of the wall of the vessel towards a center of the lumen of the vessel.
  • the connector element can comprise an eyelet in which an x-ray marker is arranged.
  • a medical implant delivery system for delivering the medical implant to an implantation site in a lumen of a ruptured or perforated vessel
  • the medical implant delivery system comprises a medical implant according to the present invention and a deliver catheter, the delivery catheter comprising an outer catheter shaft comprising a distal end section for accommodating the medical implant during delivery, and a slot formed in a distal tip of the distal end section of the outer catheter shaft through which the medical implant is releasable from the delivery catheter.
  • the delivery catheter comprises an inner catheter member slidably arranged in a lumen of the outer catheter shaft, wherein the inner catheter member comprises a locking feature at a distal end of the inner catheter member, the locking feature being configured to releasably engage the connector element of the medical implant.
  • Fig. 1 shows a plan view onto an embodiment of a medical implant according to the present invention (left-hand side) and a cross section of the medical implant (right-hand side),
  • Fig. 2 shows a top view of the embodiment of Fig. 1,
  • Fig. 3 shows a distal end section of an embodiment of a delivery catheter that can be used to deliver the medical implant according to Figs. 1 to 2 to an implantation site in a perforated or ruptured vessel (left-hand side); furthermore, on the righthand side a plan view onto the face side of the tip of the delivery catheter is shown, and
  • Fig. 4 shows a further embodiment of a medical implant according to the present invention (right-hand side) as well as a distal end section of a suitable delivery catheter (left-hand side);
  • Fig 5 shows a cross-sectional view of the medical implant of Fig. 4 along the plane V-V of Fig. 4
  • Fig. 6 shows an alternative embodiment of a connection structure of the medical implant according to the present invention, wherein the upper portion of Fig. 6 shows the medical implant with the connections structure and the lower portion of Fig. 6 shows a different view of the connection structure indicating engagement between a first and a second part of the connection structure.
  • Fig. 1 shows in conjunction with Fig. 2 an embodiment of a medical implant 2 according to the present invention.
  • the medical implant can be used to connect two tissue portions, particularly vessel sections to one another, for instance so as to close a rupture or perforation of the vessel or to close an unwanted side branch of the vessel.
  • the (minimally-invasive) medical implant 2 according to the present invention is also helpful in many other (intra vascular/ intra-luminal) applications where persistent or temporary contraction forces on body structures are needed or spatial proximity of or to certain tissues has to be created to achieve certain biological, medical, drug-releasing effects etc.
  • the e.g., ribbon-like structure of the medical implant 2 can be cut out of e.g., a Nitinol tube similar in diameter like the target vessel.
  • the medical implant 2 comprises a first and a second fixation member 20, 22 that are connected to one another in the direction of a longitudinal axis L of the implant 2 by a connection structure 21 that forms a spring and can be tensioned (elongated) in the direction of the longitudinal axis L.
  • the connection structure 21 is formed by a meandering connection member 210, wherein the meandering shape allows controlled pre-loading in the axial direction L of the implant 2.
  • Each fixation member 20, 22 comprises a frame structure 200, 220 with e.g., fish scale like engaging elements 201, 221 on both sides of the connection structure 21 /connection member 210 that forms a springlike center section with longitudinal elastic behavior of the implant 2.
  • connection structure 21 instead of an elastically deformable connection structure 21 as shown in Fig. 1, also a length-adjustable connection structure 21 can be used, wherein here, as an example, the connection structure comprises a first part 260 and a second part 250, the first part 260 being connected to the second fixation member 22 and the second part being connected to the first fixation member 20, wherein the first part 260 is configured to engage with the second part 250 at a plurality of different positions, wherein particularly each position is defined by an opening 253 of the second part 250 into which the first part 260 can engage with a protrusion 261 of the first part 260.
  • each engagement of the first part’s protrusion 261 into one of said openings 253 corresponds to a different length of the length-adjustable connection structure 21.
  • the second part can comprise two members 251, 252 between which the first part 260 is slidably arranged.
  • the engaging elements 201, 221 are configured to hook up in the target tissue of the vessel wall.
  • the engaging elements 201, 221 of both sides 20, 22 point to each other, clip-like, with the respective elastic element 201, 221 providing contraction force for secure hook-up.
  • the engaging elements 201, 221 and the tips 202, 222 of the engaging elements 201, 221 are preferably designed with a fine-tuned sharpness (could be barbed with additional secondary hooks) suitable for the target tissue and contraction force to be used at.
  • Fig. 1 shows a straight shape of the implant 2, but it can be prebend as well to potentially facilitate better deployment.
  • the medical implant 2 or components thereof can comprise a concave curvature or profile in a cross section perpendicular to the longitudinal axis L so that the implant 2 conforms to a curvature of the vessel wall.
  • Spatial identification of the fixation members 20, 22 and connection structure 21 within the vessel, the leaking area as well as relatively to the delivery catheter 3 can be provided by x- ray-markers 203, 223 e. g. placed at the transit! ons/connecting portions of first fixation member 20 to connection structure 21 and connection structure 21 to second fixation member 22 (cf. Fig. 1).
  • the deliver catheter 3 comprises an outer catheter shaft 31 having a distal tip 33 (cf. Fig. 3) at which the shaft 31 preferably comprises an asymmetrically placed slot 33 (cf. Fig. 3 right-hand side) where the medical implant 2 is released from.
  • X-ray markers 310 on the shaft 31 of the delivery catheter 3 enable the physician to place the implant 2 aligned to the leaking area of the target vessel.
  • the distal engaging elements 221 of the distal second fixation member 22 of the medical implant 2 are released by for example using an inner member 30 of the delivery catheter 3 (cf. Fig. 1) to push the implant 2 in the distal direction inside the outer shaft 31.
  • distal engaging elements 221 might be released from the catheters distal opening by pulling back the outer catheter shaft.
  • each engaging element 221 leaves the slot 32 it erects itself, e.g. via Nitinol’s reversible elastic behavior (other elastic materials may also be used instead of Nitinol).
  • the engaging elements 221 are hooked up in the target area distal of the leak first by placing them in lateral contact with the vessel wall and then moving backwards the whole delivery catheter 3 axially. As soon as the distal engaging elements 221 have hooked up sufficiently the connection structure 21 is released and preferably kept under steady spring force by gently pulling back and holding the delivery catheter 3.
  • the inner member 30 and its locking feature 300 e.g. an opening
  • proximal first engaging elements 201 are released while pressing the catheter tip 33 slightly sidewards to the target area. This can be facilitated by a certain catheter design.
  • the proximal engaging elements 201 then hook up securely in the vessel wall under ongoing contraction force with their counterparts, the distal engaging elements 221. As a result, the tube-like vessel portion between the two hook-up areas that is to be sealed is contracted and the leak(s) are closed.
  • the proximal end of the medical implant 2 features an eyelet formed in the connector element 23 with an integrated x-ray marker 230, the connector 23 and the marker 230 being bent away from the target tissue.
  • This connector 23, comprising a constriction at a transition to the first fixation element 20 / frame 200 (for easy engagement with the locking feature 300 or other means such as snare-like elements, see also below) is configured to enable (acute) de-hooking of the implant 2 if repositioning or retrieval is required either by using the catheters locking feature 300 (Fig. 1) or a snare-like element from inside the delivery catheter 3 or a separate snare device or other retrieval devices capable of grabbing the connector 23.
  • the medical implant 2 can also have a stent-like structure having a cylindrical shape as shown in Fig. 4.
  • the frame structure 200 of the first fixation member 20 together with the engaging elements 201 of the first fixation member 20 forms a circumferential scaffold that extends along a circumferential direction in a plane V-V perpendicular to a longitudinal axis L of the medical implant 2.
  • the first fixation member 20 comprises e.g., four (or more or less) fixation arrangements, each comprising a plurality of engaging elements 201, wherein the fixation arrangements are arranged side by side in a circumferential direction of the scaffold 20, 201.
  • the connection structure 21 can now comprise four (or more or less) connection members 210, each comprising a meandering shape.
  • the second fixation member 22 can be shaped analogously and may also comprise four (or more or less) fixation arrangements each being formed out of a plurality of engagement elements 221, which fixation arrangements are arranged side by side in the circumferential direction of the second fixation member / scaffold 22. Particularly, as indicated in the cross-sectional view shown in Fig. 5, the second fixation member 22 can comprise four frame structures 220 arranged side by side in the circumferential direction of the second fixation member 22 and being integrally connected to one another.
  • the respective frame structure 220 each comprises a plurality of engaging elements 221 having tips 222.
  • the first fixation member 20 can be formed in an analogous fashion.
  • the medical implant now forms an essentially cylindrical scaffold comprised of the first and second fixation members / scaffolds 20, 22 and e.g., one to four or more meandering connection members 210 connecting the scaffolds 20, 22 to one another.
  • the transition structures circumferentially placed between the different frame structures 200, 220/fixation arrangements and/or the fixation arrangements themselves can be designed as being able to provide a radial expansion similar to self-expanding stents when released from the catheter.
  • the orientation of the engaging elements of either side 20, 22 of the implant 2 is preferably designed as described above with reference to the ribbon-like implant 2 (cf. Fig. 1 and 2).
  • Nitinol for a permanent implant
  • other (resorbable) materials can be used (e.g. for a temporary implant), e.g. polymers with sufficient elastic behavior (for erecting the engaging elements and generating the axial contraction force) or e. g. polymers with less elastic behavior when using a length-adjustable connection structure e.g. a ratchet mechanism.
  • hooks, barbed hooks, or anchors particularly being smaller in size but larger in numbers could also be used as engaging elements.
  • the engaging elements 201, 221 would not necessarily point towards each other clip-like as described above but can show all kinds of orientations.
  • the medical implant 2 according to the present invention can be applied in a fast and easy manner.
  • An (acute) repositioning of the implant 2 is possible in principle.
  • the design and number of the engaging elements (fish scale elements) 201, 221 is adjustable in a wide range enabling good adaption to the compatibility requirements of the target vessels.
  • using a medical implant / clip 2 according to the present invention is likely to seem intuitive for a physician to use (anticipation of functionality), since stent-like structures are very familiar to physicians.
  • the flat shape of ribbon-like embodiment of the implant 2 eases integration into a low-profile catheter.
  • the cylindrical shape of the other embodiment is very close to a stent structure and would also enable the use of catheters similar to stent delivery catheters.
  • resorbable materials e.g., polymer-based
  • Fig. 1 shows the use of circumferential frame structures 200, 220 for the fixation members 20, 22.
  • the engaging elements/protrusions 201, 221 e.g., in the form of fish scales
  • the engaging elements 201, 221 can form the respective structure in the circumferential direction thus also allowing to increase the angle a indicated in Fig. 4 to provide also radial expansion of the respective structure 200, 220.
  • the engaging elements 201, 221 would not only erect themselves out of a shell surface of the respective structure 200, 220, but also the angles a would open up at the same time.
  • elements providing radial expansion of the respective structure 200, 220 can also be elements provided in addition to the engaging elements 201, 221 to separate features allowing anchoring of the implant from features allowing radial expansion of the medical implant 2.

Landscapes

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

Abstract

The present invention relates to a medical implant (2) for connecting a first and a second tissue portion to one another, comprising: a first and a second fixation member (20, 22), a connection structure (21), wherein the first fixation member (20) is connected to the second fixation member (22) via the connection structure (21), and wherein the first fixation member (20) is configured to engage with the first tissue portion, and wherein the second fixation member is configured to engage with the second tissue portion such that the connection structure (21) extends between the tissue portions to connect the tissue portions to one another.

Description

Applicant: BIOTRONIK AG
Date: August 29, 2022
Our Reference: 20.115P-WO
MEDICAL IMPLANT, PARTICULARLY CLIP, FOR INTRA-VASCULAR/
INTRA-LUMINAL APPLICATION
The present invention relates to a medical implant and a medical implant delivery system.
Perforated or ruptured arteries appearing in interventional procedures can lead to emergency situations especially in the coronaries. Therefore, an efficient and fast way of closing a vascular leakage or unintended luminal pathways is desirable.
So far, for instance covered stents or a temporary sealing with an inflated dilatation balloon are used to seal such leakages. However, a temporary use of a dilatation balloon can often not seal all leakages (depending on severity). Furthermore, covered stents are complex to manufacture, expensive and show worse clinical outcome compared to uncovered stents regarding e.g. re-stenosis behavior.
Based on the above, the problem to be solved by the present invention therefore is to provide a minimally invasive medical implant that seals vascular leakages or unintended luminal pathways fast and reliable.
This problem is solved by a medical implant according to claim 1 and a medical implant delivery system having the features of claim 14.
Preferred embodiments of these aspects of the present invention are stated in the sub claims and are described below.
According to claim 1 a medical implant, particularly clip, for connecting two tissue portions to one another, is disclosed, comprising: a first and a second fixation member,
- a connection structure, wherein the first fixation member is connected to the second fixation member via the connection structure, wherein the first fixation member is configured to engage with the first tissue portion, and wherein the second fixation member is configured to engage with the second tissue portion such that the connection structure extends between the tissue portions to connect the tissue portions to one another.
According to a preferred embodiment, the respective tissue portion forms a lumen, wherein the first fixation member is configured to be inserted into the lumen of the first tissue portion and to engage with an inner side of the first tissue portion to anchor the first fixation member to the inner side of the first tissue portion, and wherein the second fixation member is configured to be inserted into the lumen of the second tissue portion and to engage with an inner side of the second tissue portion to anchor the second fixation member to the inner side of the second tissue portion. Particularly, the first tissue portion can be a first vessel section and the second tissue portion can be a second vessel section, the two vessel sections can be arranged on either side of a rupture, or of a perforation, or of a side branch of the vessel so that the connection structure extends along - depending on the case - the rupture, or perforation, or side branch, particularly so as to close said rupture, perforation, or side branch.
Thus, apart from repairing damages in vessels such as ruptures and perforations, the medical implant according to the present invention can also be used to handle unwanted luminal pathways, e.g., to reduce the size of the opening or close a side branch intentionally to reduce or block further blood flow through it.
Particularly, the connecting structure is configured to pull the tissue portions towards one another. Advantageously, this allows e.g., a vascular leakage to be closed by longitudinally pulling together the affected vascular area (e.g., ruptured or perforated portion of the vessel) by means of a medical implant from inside the vessel. Particularly, by axially contracting the vessel or tissue sections neighboring the leaking area, the latter is closed by body own material. In the same manner, also an unwanted side branch of a vessel can be closed.
Particularly, the fixation members of the medical implant serve to connect to the respective tissue portion, particularly to tissue of the vessel wall such that by means of the fixation members an anchoring of the fixation members to the tissue can be established.
Furthermore, for tensioning the medical implant, the connection structure is an elastically deformable connection structure. According to a further embodiment, the connection structure is a length-adjustable connection structure comprising a first part and a second part, the first part configured to engage with the second part at a plurality of different positions, each engagement of the first part with the second part at one of said positions corresponding to a different length of the length-adjustable connection structure. Particularly, the first and second fixation member are configured to get to their final relative position with respect to one another by means of a linear ratchet mechanism.
According to an embodiment of the medical implant, the connection structure comprises at least one connection member having a meandering shape, or is formed as a connection member having a meandering shape, wherein the respective connection member extends between the fixation members along a longitudinal axis of the medical implant, the respective connection member particularly forming a spring element configured to be tensioned and thereby elongated in the direction of the longitudinal axis which particularly causes the fixation members to be pulled towards one another which helps closing the ruptured/perforated portion of the vessel and anchoring the fixation members to the vessel when the fixation members are engaged with the vessel wall on either side of said ruptured or perforated portion of the vessel.
Furthermore, according to an embodiment of the medical implant, the fixation members each comprise a frame structure, each frame structure carrying at least one fixation arrangement formed by engaging elements being arranged side by side in particular.
According to an embodiment, the respective engaging element forms a protrusion.
Particularly, the size, number, and shape, particularly a sharpness of a tip or other portion of the protrusion can vary depending on the involved first and second tissue portions and particularly depending on technical and particularly clinical circumstances like sensitivity of a vessel wall towards such elements. Particularly, the protrusions can have one of an elongated shape, a fish scale shape, a blade-like shape, a hook shape. Particularly, the engaging element/protrusions can also be formed as barbed hooks.
Furthermore, according to an embodiment, the respective engaging element/protrusion comprises a tip for engaging with the respective tissue portion, particularly vessel wall. The tip can be rounded. According to a further embodiment, the respective engaging element can comprise a tapered shape forming said tip. Particularly, the respective engaging element can comprise two longitudinal portions arranged at an angle towards another and integrally connected to one another in a connecting region that forms the tip. Particularly, the respective tip is configured to engage with the inner side of the wall of the tissue portion/vessel in order to establish an anchoring of the fixation members in the tissue of the wall of the tissue portion/vessel. According to an embodiment, the respective engaging element, particularly when being formed by two joined longitudinal portions, can have a fish scale shape.
According to yet another embodiment of the medical implant, the engaging elements are configured to self-erect due to an elastic property of the engaging elements from a retracted state (wherein the retracted state can be maintained by arranging the medical implant in an enclosure tightly enclosing the medical implant in a circumferential direction of the medical implant) to an advanced state in which the engaging elements are arranged at an angle with respect to the respective frame structure. Particularly, said enclosure can be formed by at least one parts of a catheter shaft of a delivery catheter (see also below).
Furthermore, according to an embodiment of the medical implant, in the retracted state, the tips of the engaging elements of the at least one fixation arrangement of the first fixation member and the tips of the engaging elements of the at least one fixation arrangement of the second fixation member point towards each other in a direction of a longitudinal axis of the medical implant along which longitudinal axis the first fixation member, connection structure and second fixation member extend and are connected to one another. According to a further embodiment of the medical implant, in the advanced state, the tips of the engaging elements of the at least one fixation arrangement of the first fixation member and the tips of the engaging elements of the at least one fixation arrangement of the second fixation member are further apart from one another in the direction of the longitudinal axis of the medical implant than in the retracted state due to the engaging elements being arranged at said angle with respect to the respective frame structure in the advanced state.
According to a further embodiment of the medical implant, the connection structure is configured to be tensioned to pull the fixation members towards one another when the engaging elements are engaged with the inner side of the wall of the vessel, particularly so as to prevent disengagement of the engaging elements from the wall of the vessel. This tensioning can e.g., be established by using an elastically deformable connection structure that provides a restoring force pulling the tissue portions (e.g., vessel sections) towards one another or by a length-adjustable connection structure that is shortened by a desired amount to pull the tissue portions (e.g., vessel sections) towards one another see also above.
Particularly, in an embodiment, the frame structure of the first fixation member comprises a first leg and an opposing second leg, each leg extending along a longitudinal axis of the medical implant, wherein the engaging elements of the first fixation member extend from the first leg to the second leg of the frame structure of the first fixation member. Likewise, the frame structure of the second fixation member can comprise a first leg and an opposing second leg, each leg extending along a longitudinal axis of the medical implant, wherein the engaging elements of the second fixation member extend from the first leg to the second leg of the frame structure of the second fixation member. Particularly, in this configuration, the medical implant and its components (fixation members and connection structure) particularly comprise a ribbon-like shape.
Furthermore, according to an alternative embodiment, the frame structure of the first fixation member together with the engaging elements of the first fixation member forms a circumferential scaffold that extends along a circumferential direction in a plane perpendicular to a longitudinal axis of the medical implant. Further, likewise, the frame structure of the second fixation member together with the engaging elements of the second fixation member preferably forms a circumferential scaffold that extends along a circumferential direction in a plane perpendicular to the longitudinal axis of the medical implant. Here, in contrast to said ribbon-like shape, the medical implant rather comprises a cylindrical, particularly stent-like shape.
According to a further embodiment of the medical implant, the medical implant comprises a first x-ray marker and a second x-ray marker, the first x-ray marker being arranged on a first connecting portion of the medical implant connecting the first fixation member to the connection structure, and the second x-ray marker being arranged on a second connecting portion of the medical implant connecting the connection structure to the second fixation member.
Furthermore, in an embodiment, the medical implant comprises a connector element being connected to an end of the first fixation member, wherein the connector element is configured to engage with a locking feature (e.g. in the shape of a locking opening) of a delivery catheter configured for delivering the medical implant to an implantation site, wherein particularly the locking feature is a locking feature of an inner catheter member that is moveable inside a lumen of an outer catheter shaft of the delivery catheter.
Particularly, in an embodiment, the connector element is configured to extends at an angle with respect to a longitudinal axis of the medical implant, particularly after deployment of the medical implant, so that when the medical implant is arranged in the lumen of the vessel, the connector element extends away from the inner side of the wall of the vessel towards a center of the lumen of the vessel. Particularly, the connector element can comprise an eyelet in which an x-ray marker is arranged.
According to a further aspect of the present invention, a medical implant delivery system for delivering the medical implant to an implantation site in a lumen of a ruptured or perforated vessel is disclosed, wherein the medical implant delivery system comprises a medical implant according to the present invention and a deliver catheter, the delivery catheter comprising an outer catheter shaft comprising a distal end section for accommodating the medical implant during delivery, and a slot formed in a distal tip of the distal end section of the outer catheter shaft through which the medical implant is releasable from the delivery catheter.
Particularly, according to an embodiment of the medical implant delivery system, the delivery catheter comprises an inner catheter member slidably arranged in a lumen of the outer catheter shaft, wherein the inner catheter member comprises a locking feature at a distal end of the inner catheter member, the locking feature being configured to releasably engage the connector element of the medical implant.
In the following, embodiments of the present invention as well as further features and advantages of the present invention shall be described with reference to the Figures, wherein
Fig. 1 shows a plan view onto an embodiment of a medical implant according to the present invention (left-hand side) and a cross section of the medical implant (right-hand side),
Fig. 2 shows a top view of the embodiment of Fig. 1,
Fig. 3 shows a distal end section of an embodiment of a delivery catheter that can be used to deliver the medical implant according to Figs. 1 to 2 to an implantation site in a perforated or ruptured vessel (left-hand side); furthermore, on the righthand side a plan view onto the face side of the tip of the delivery catheter is shown, and
Fig. 4 shows a further embodiment of a medical implant according to the present invention (right-hand side) as well as a distal end section of a suitable delivery catheter (left-hand side);
Fig 5 shows a cross-sectional view of the medical implant of Fig. 4 along the plane V-V of Fig. 4, Fig. 6 shows an alternative embodiment of a connection structure of the medical implant according to the present invention, wherein the upper portion of Fig. 6 shows the medical implant with the connections structure and the lower portion of Fig. 6 shows a different view of the connection structure indicating engagement between a first and a second part of the connection structure.
Fig. 1 shows in conjunction with Fig. 2 an embodiment of a medical implant 2 according to the present invention. Particularly, the medical implant can be used to connect two tissue portions, particularly vessel sections to one another, for instance so as to close a rupture or perforation of the vessel or to close an unwanted side branch of the vessel. Furthermore, the (minimally-invasive) medical implant 2 according to the present invention is also helpful in many other (intra vascular/ intra-luminal) applications where persistent or temporary contraction forces on body structures are needed or spatial proximity of or to certain tissues has to be created to achieve certain biological, medical, drug-releasing effects etc.
The e.g., ribbon-like structure of the medical implant 2 can be cut out of e.g., a Nitinol tube similar in diameter like the target vessel. The medical implant 2 comprises a first and a second fixation member 20, 22 that are connected to one another in the direction of a longitudinal axis L of the implant 2 by a connection structure 21 that forms a spring and can be tensioned (elongated) in the direction of the longitudinal axis L. The connection structure 21 is formed by a meandering connection member 210, wherein the meandering shape allows controlled pre-loading in the axial direction L of the implant 2. Each fixation member 20, 22 comprises a frame structure 200, 220 with e.g., fish scale like engaging elements 201, 221 on both sides of the connection structure 21 /connection member 210 that forms a springlike center section with longitudinal elastic behavior of the implant 2.
Alternatively, as shown in Fig. 6, instead of an elastically deformable connection structure 21 as shown in Fig. 1, also a length-adjustable connection structure 21 can be used, wherein here, as an example, the connection structure comprises a first part 260 and a second part 250, the first part 260 being connected to the second fixation member 22 and the second part being connected to the first fixation member 20, wherein the first part 260 is configured to engage with the second part 250 at a plurality of different positions, wherein particularly each position is defined by an opening 253 of the second part 250 into which the first part 260 can engage with a protrusion 261 of the first part 260. Thus, each engagement of the first part’s protrusion 261 into one of said openings 253 corresponds to a different length of the length-adjustable connection structure 21. Particularly, for forcing the protrusion 261 into the respective opening 253, the second part can comprise two members 251, 252 between which the first part 260 is slidably arranged.
The engaging elements 201, 221 are configured to hook up in the target tissue of the vessel wall. The engaging elements 201, 221 of both sides 20, 22 point to each other, clip-like, with the respective elastic element 201, 221 providing contraction force for secure hook-up. The engaging elements 201, 221 and the tips 202, 222 of the engaging elements 201, 221 are preferably designed with a fine-tuned sharpness (could be barbed with additional secondary hooks) suitable for the target tissue and contraction force to be used at.
The view of Fig. 1 (left-hand side) shows a straight shape of the implant 2, but it can be prebend as well to potentially facilitate better deployment. As shown in Fig. 1 on the right-hand side, the medical implant 2 or components thereof can comprise a concave curvature or profile in a cross section perpendicular to the longitudinal axis L so that the implant 2 conforms to a curvature of the vessel wall.
Spatial identification of the fixation members 20, 22 and connection structure 21 within the vessel, the leaking area as well as relatively to the delivery catheter 3 can be provided by x- ray-markers 203, 223 e. g. placed at the transit! ons/connecting portions of first fixation member 20 to connection structure 21 and connection structure 21 to second fixation member 22 (cf. Fig. 1).
Particularly, deployment of the medical implant 2 can be performed via a delivery catheter 3. The deliver catheter 3 comprises an outer catheter shaft 31 having a distal tip 33 (cf. Fig. 3) at which the shaft 31 preferably comprises an asymmetrically placed slot 33 (cf. Fig. 3 right-hand side) where the medical implant 2 is released from. X-ray markers 310 on the shaft 31 of the delivery catheter 3 enable the physician to place the implant 2 aligned to the leaking area of the target vessel. First, only the distal engaging elements 221 of the distal second fixation member 22 of the medical implant 2 are released by for example using an inner member 30 of the delivery catheter 3 (cf. Fig. 1) to push the implant 2 in the distal direction inside the outer shaft 31. In a similar manner the distal engaging elements 221 might be released from the catheters distal opening by pulling back the outer catheter shaft. As soon as each engaging element 221 leaves the slot 32 it erects itself, e.g. via Nitinol’s reversible elastic behavior (other elastic materials may also be used instead of Nitinol).
The engaging elements 221 are hooked up in the target area distal of the leak first by placing them in lateral contact with the vessel wall and then moving backwards the whole delivery catheter 3 axially. As soon as the distal engaging elements 221 have hooked up sufficiently the connection structure 21 is released and preferably kept under steady spring force by gently pulling back and holding the delivery catheter 3. The inner member 30 and its locking feature 300 (e.g. an opening) being engaged with the connector element 23 of the implant 2 enables the user to bring or hold the implant 2 in each required axial position during the whole procedure.
In a next step the proximal first engaging elements 201 are released while pressing the catheter tip 33 slightly sidewards to the target area. This can be facilitated by a certain catheter design. The proximal engaging elements 201 then hook up securely in the vessel wall under ongoing contraction force with their counterparts, the distal engaging elements 221. As a result, the tube-like vessel portion between the two hook-up areas that is to be sealed is contracted and the leak(s) are closed.
Furthermore, the proximal end of the medical implant 2 features an eyelet formed in the connector element 23 with an integrated x-ray marker 230, the connector 23 and the marker 230 being bent away from the target tissue. This connector 23, comprising a constriction at a transition to the first fixation element 20 / frame 200 (for easy engagement with the locking feature 300 or other means such as snare-like elements, see also below) is configured to enable (acute) de-hooking of the implant 2 if repositioning or retrieval is required either by using the catheters locking feature 300 (Fig. 1) or a snare-like element from inside the delivery catheter 3 or a separate snare device or other retrieval devices capable of grabbing the connector 23.
Instead of the ribbon-type implant 2 described above, the medical implant 2 can also have a stent-like structure having a cylindrical shape as shown in Fig. 4.
Here, the frame structure 200 of the first fixation member 20 together with the engaging elements 201 of the first fixation member 20 forms a circumferential scaffold that extends along a circumferential direction in a plane V-V perpendicular to a longitudinal axis L of the medical implant 2. Particularly, the first fixation member 20 comprises e.g., four (or more or less) fixation arrangements, each comprising a plurality of engaging elements 201, wherein the fixation arrangements are arranged side by side in a circumferential direction of the scaffold 20, 201. Correspondingly, the connection structure 21 can now comprise four (or more or less) connection members 210, each comprising a meandering shape. The second fixation member 22 can be shaped analogously and may also comprise four (or more or less) fixation arrangements each being formed out of a plurality of engagement elements 221, which fixation arrangements are arranged side by side in the circumferential direction of the second fixation member / scaffold 22. Particularly, as indicated in the cross-sectional view shown in Fig. 5, the second fixation member 22 can comprise four frame structures 220 arranged side by side in the circumferential direction of the second fixation member 22 and being integrally connected to one another. The respective frame structure 220 each comprises a plurality of engaging elements 221 having tips 222. The first fixation member 20 can be formed in an analogous fashion.
As result, the medical implant now forms an essentially cylindrical scaffold comprised of the first and second fixation members / scaffolds 20, 22 and e.g., one to four or more meandering connection members 210 connecting the scaffolds 20, 22 to one another. The transition structures circumferentially placed between the different frame structures 200, 220/fixation arrangements and/or the fixation arrangements themselves can be designed as being able to provide a radial expansion similar to self-expanding stents when released from the catheter. The orientation of the engaging elements of either side 20, 22 of the implant 2 is preferably designed as described above with reference to the ribbon-like implant 2 (cf. Fig. 1 and 2).
Furthermore, instead of using Nitinol (for a permanent implant) other (resorbable) materials can be used (e.g. for a temporary implant), e.g. polymers with sufficient elastic behavior (for erecting the engaging elements and generating the axial contraction force) or e. g. polymers with less elastic behavior when using a length-adjustable connection structure e.g. a ratchet mechanism.
Furthermore, hooks, barbed hooks, or anchors, particularly being smaller in size but larger in numbers could also be used as engaging elements. Then, the engaging elements 201, 221 would not necessarily point towards each other clip-like as described above but can show all kinds of orientations.
The present invention offers multiple advantages. Particularly, the medical implant 2 according to the present invention can be applied in a fast and easy manner. An (acute) repositioning of the implant 2 is possible in principle. The design and number of the engaging elements (fish scale elements) 201, 221 is adjustable in a wide range enabling good adaption to the compatibility requirements of the target vessels. Furthermore, using a medical implant / clip 2 according to the present invention is likely to seem intuitive for a physician to use (anticipation of functionality), since stent-like structures are very familiar to physicians. Furthermore, the flat shape of ribbon-like embodiment of the implant 2 eases integration into a low-profile catheter. On the other hand, the cylindrical shape of the other embodiment is very close to a stent structure and would also enable the use of catheters similar to stent delivery catheters.
Furthermore, there is no need for an expensive membrane used in covered stents being potentially the reason for worse clinical outcomes of covered stents vs uncovered (regular) ones. Further, using a stent-like structure, many design and test methods known from stent development can be used. Furthermore, with Nitinol (and e.g., tantal x-ray markers) materials known for their biocompatibility and regulatory acceptance are proposed; ingrowth behavior of the designs is supposed to be very similar to the one from stents as long as suitable designs for tissue engagement are used.
Further, using resorbable materials, e.g., polymer-based, would provide a temporary solution without the many disadvantages of permanent implants.
Particularly, Fig. 1 shows the use of circumferential frame structures 200, 220 for the fixation members 20, 22. Alternatively, it is also possible to use stent-like structures for the frame structure 200 and/or 220 instead. In such a case, the engaging elements/protrusions 201, 221 (e.g., in the form of fish scales) can form the respective structure in the circumferential direction thus also allowing to increase the angle a indicated in Fig. 4 to provide also radial expansion of the respective structure 200, 220. Then, the engaging elements 201, 221 would not only erect themselves out of a shell surface of the respective structure 200, 220, but also the angles a would open up at the same time. Alternatively, elements providing radial expansion of the respective structure 200, 220 can also be elements provided in addition to the engaging elements 201, 221 to separate features allowing anchoring of the implant from features allowing radial expansion of the medical implant 2.

Claims

Claims
1. A medical implant (2), in particular for connecting a first and a second tissue portion to one another, comprising: a first and a second fixation member (20, 22),
- a connection structure (21), wherein the first fixation member (20) is connected to the second fixation member (22) via the connection structure (21), and wherein the first fixation member (20) is configured to engage with the first tissue portion, and wherein the second fixation member is configured to engage with the second tissue portion such that the connection structure (21) extends between the tissue portions to connect the tissue portions to one another.
2. The medical implant according to claim 1, wherein the respective tissue portion forms a lumen, wherein the first fixation member is configured to be inserted into the lumen of the first tissue portion and to engage with an inner side of the first tissue portion to anchor the first fixation member to the inner side of the first tissue portion, and wherein the second fixation member is configured to be inserted into the lumen of the second tissue portion and to engage with an inner side of the second tissue portion to anchor the second fixation member to the inner side of the second tissue portion
3. The medical implant according to claim 1 or 2, wherein the connection structure (21) is an elastically deformable connection structure (21), or wherein the connection structure (21) is a length-adjustable connection structure comprising a first part (260) and a second part (250), the first part (260) configured to engage with the second part (250) at a plurality of different positions, each engagement of the first part (260) with the second part (250) at one of said positions corresponding to a different length of the length- adjustable connection structure (21).
4. The medical implant according to one of the preceding claims, wherein the connection structure (21) comprises at least one connection member (210) having a meandering shape, or wherein the connection structure (21) is formed as a connection member (210) having a meandering shape. The medical implant according to one of the preceding claims, wherein the fixation members (20, 22) each comprise a frame structure (200, 220), each frame structure (200,
220) carrying at least one fixation arrangement formed by engaging elements (201, 221). The medical implant according to claim 5, wherein the respective engaging element (201, 221) forms a protrusion forming a tip (202, 222) configured to engage with the respective tissue portion. The medical implant according to claim 5 or 6, wherein the engaging elements (201,
221) are configured to self-erect due to an elastic property of the engaging elements (201, 221) from a retracted state that can be maintained by arranging the medical implant (2) in an enclosure tightly enclosing the medical implant (2) in a circumferential direction of the medical implant (2), to an advanced state in which the engaging elements (201, 221) are arranged at an angle with respect to the respective frame structure (200, 220). The medical implant according to claims 4 and 5, wherein in the retracted state the tips (202) of the engaging elements (201) of the at least one fixation arrangement of the first fixation member (20) and the tips (222) of the engaging elements (221) of the at least one fixation arrangement of the second fixation member (22) point towards each other in a direction of a longitudinal axis (L) of the medical implant (2). The medical implant according to claims 4 and 5 or according to claim 6, wherein in the advanced state, the tips (202) of the engaging elements (201) of the at least one fixation arrangement of the first fixation member (20) and the tips (222) of the engaging elements (221) of the at least one fixation arrangement of the second fixation member (22) are further apart from one another than in the retracted state due to the engaging elements (201, 221) being arranged at said angle with respect to the respective frame structure (200, 220) in the advanced state. - 16 - The medical implant according to one of the claim 5 to 9, wherein the frame structure
(200) of the first fixation member (20) comprises a first leg (231) and an opposing second leg (232), each leg (231, 232) extending along a longitudinal axis (L) of the medical implant (2), wherein the engaging elements (201) of the first fixation member (20) extend from the first leg (231) to the second leg (232) of the frame structure (200) of the first fixation member (20); and/or wherein the frame structure (220) of the second fixation member (20) comprises a first leg (241) and an opposing second leg (242), each leg (241, 242) extending along a longitudinal axis (L) of the medical implant (2), wherein the engaging elements (221) of the second fixation member (22) extend from the first leg (241) to the second leg (242) of the frame structure (220) of the second fixation member (22). The medical implant according to one of the claims claim 5 to 9, wherein the frame structure (200) of the first fixation member (20) together with the engaging elements
(201) of the first fixation member (20) forms a circumferential scaffold that extends along a circumferential direction in a plane perpendicular to a longitudinal axis (L) of the medical implant (2); and/or wherein the frame structure (220) of the second fixation member (22) together with the engaging elements (221) of the second fixation member (22) forms a circumferential scaffold that extends along a circumferential direction in a plane perpendicular to a longitudinal axis (L) of the medical implant (2). The medical implant according to one of the preceding claims, wherein the medical implant (2) comprises a first x-ray marker (203) and a second x-ray marker (223), the first x-ray marker (203) being arranged on a first connecting portion connecting the first fixation member (20) to the connection structure (21), and the second x-ray marker (223) being arranged on a second connecting portion connecting the connection structure (21) to the second fixation member (22). The medical implant according to one of the preceding claims, wherein the medical implant (2) comprises a connector element (23) being connected to an end of the first - 17 - fixation member (20), wherein the connector element (23) is configured to engage with a locking feature (300) of a delivery catheter (3), wherein optionally the connector element (23) extends at an angle with respect to a longitudinal axis (L) of the medical implant (2) so that when the medical implant (2) is arranged in the lumen of the vessel, the connector element (23) extends away from the inner side of the wall of the vessel towards the lumen of the vessel. A medical implant delivery system, comprising a medical implant (2) according to one of the preceding claims and a delivery catheter (3) for delivering the medical implant (2) to an implantation site in a lumen of a ruptured or perforated vessel, wherein the delivery catheter (3) comprises an outer catheter shaft (31) comprising a distal end section (31a) for accommodating the medical implant (2) during delivery and a slot (32) formed in a distal tip (33) of the distal end section (31a) of the outer catheter shaft (31) through which the medical implant (2) is releasable from the delivery catheter (3). The medical implant delivery system according to claim 14, wherein the delivery catheter (3) comprises an inner catheter member (30) slidably arranged in a lumen of the outer catheter shaft (31), wherein the inner catheter member (30) comprises a locking feature (300) at a distal end of the inner catheter member (30), the locking feature (300) being configured to be engaged by the connector element of the medical implant according to claim 12.
PCT/EP2022/073946 2021-10-05 2022-08-29 Medical implant, particularly clip, for intra-vascular/intra-luminal application WO2023057129A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP21200834.6 2021-10-05
EP21200834 2021-10-05

Publications (1)

Publication Number Publication Date
WO2023057129A1 true WO2023057129A1 (en) 2023-04-13

Family

ID=78302573

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2022/073946 WO2023057129A1 (en) 2021-10-05 2022-08-29 Medical implant, particularly clip, for intra-vascular/intra-luminal application

Country Status (1)

Country Link
WO (1) WO2023057129A1 (en)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020029079A1 (en) * 1996-10-11 2002-03-07 Transvascular, Inc. Devices for forming and/or maintaining connections between adjacent anatomical conduits
US20070093839A1 (en) * 2005-09-12 2007-04-26 Beckendorf Brandon G Compression staple
US20080086168A1 (en) * 2006-09-28 2008-04-10 Ryan Cahill Implant-catheter attachment mechanism using snare and method of use
US20100324653A1 (en) * 2007-05-11 2010-12-23 Nicola Rubenstein Device for connecting two blood vessels
US20160361154A1 (en) * 2009-11-03 2016-12-15 Gregory C. Sampognaro Closure device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020029079A1 (en) * 1996-10-11 2002-03-07 Transvascular, Inc. Devices for forming and/or maintaining connections between adjacent anatomical conduits
US20070093839A1 (en) * 2005-09-12 2007-04-26 Beckendorf Brandon G Compression staple
US20080086168A1 (en) * 2006-09-28 2008-04-10 Ryan Cahill Implant-catheter attachment mechanism using snare and method of use
US20100324653A1 (en) * 2007-05-11 2010-12-23 Nicola Rubenstein Device for connecting two blood vessels
US20160361154A1 (en) * 2009-11-03 2016-12-15 Gregory C. Sampognaro Closure device

Similar Documents

Publication Publication Date Title
US10779970B2 (en) Devices and methods for treating aneurysms and other vascular conditions
US10687968B2 (en) Sealable endovascular implants and methods for their use
US10105250B2 (en) Dual capture device for stent graft delivery system and method for capturing a stent graft
US10034669B2 (en) Anastomosis devices and methods
AU2007212623B2 (en) Delivery system and method for self-centering a proximal end of a stent graft
US11259945B2 (en) Dual capture device for stent graft delivery system and method for capturing a stent graft
US20070219627A1 (en) Prosthesis Fixation Apparatus and Methods
US20090030435A1 (en) Method and apparatus for anchoring cardiovascular implants
WO2006037088A2 (en) Method and device for extravascular intervention
WO2023057129A1 (en) Medical implant, particularly clip, for intra-vascular/intra-luminal application
US10646325B2 (en) Stent migration device and method
JP2021516094A (en) System for deploying artificial bypass vessels
AU2013260693B2 (en) Sealable endovascular implants and methods for their use
US20110295358A1 (en) Endoluminal prosthesis

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22769286

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 22769286

Country of ref document: EP

Kind code of ref document: A1