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WO2010076035A1 - Dispositif comportant un appareil pouvant être implanté dans un vaisseau du corps d'un patient et un revêtement et procédé de fabrication de ce dispositif - Google Patents

Dispositif comportant un appareil pouvant être implanté dans un vaisseau du corps d'un patient et un revêtement et procédé de fabrication de ce dispositif Download PDF

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Publication number
WO2010076035A1
WO2010076035A1 PCT/EP2009/009339 EP2009009339W WO2010076035A1 WO 2010076035 A1 WO2010076035 A1 WO 2010076035A1 EP 2009009339 W EP2009009339 W EP 2009009339W WO 2010076035 A1 WO2010076035 A1 WO 2010076035A1
Authority
WO
WIPO (PCT)
Prior art keywords
lining
vessel
implantable device
implantable
diameter
Prior art date
Application number
PCT/EP2009/009339
Other languages
German (de)
English (en)
Inventor
Günter BERTHOLDT
Katharina Seiffe
Original Assignee
Bioregeneration Gmbh
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 Bioregeneration Gmbh filed Critical Bioregeneration Gmbh
Priority to EP09799556A priority Critical patent/EP2385806A1/fr
Publication of WO2010076035A1 publication Critical patent/WO2010076035A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
    • 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
    • A61F2002/8483—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
    • 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

  • Apparatus comprising a device and a liner implantable in a vessel of the body of a patient, and methods of making same
  • the present invention relates to a device having a device implantable in a vessel of the body of a patient according to the preamble of claim 1 and a method of manufacturing such a device according to claim 21. It further relates to using cellulose or tissue material for lining an implantable device according to claim 24.
  • Vascular occlusions or vascular stenoses can be treated by replacing at least one blood vessel section. For example, the thorax is opened and an aortocoronary bypass is placed.
  • the affected vessel sections may be dilated minimally invasively by balloon catheter and then a medical implant such as a stent may be used to support the vessel wall and keep the vessel lumen open.
  • a medical implant such as a stent may be used to support the vessel wall and keep the vessel lumen open.
  • the object of the present invention is to provide a further device with a device implantable in a vessel of the body of a patient. It is a further object of the present invention to provide a method for producing such a device and the use of suitable materials for a lining of such a device.
  • the device according to the invention comprises a device which can be implanted in a vessel of the body of a patient and which has at least one passage opening through which fluid flows in the direction of flow of the vessel, and a lining which is arranged in an interior of the passage opening.
  • a "vessel of the body of a patient” refers to a fluid-perfused hollow organ or portions thereof of a patient, and more particularly to such a fluid-perfused hollow organ Examples include blood vessels such as arteries or veins, a bile duct, ureter, urethra, and the like. may fall under the term “vessel” according to the invention.
  • a "patient” in the sense of the present invention may be a human or an animal.
  • An “implantable device” as used herein describes a device that can be introduced into at least a portion of a vessel for retention therein, particularly for permanent retention.
  • Suitable implantable devices include expandable and self-expanding devices.
  • Such an implantable device may be introduced into the vessel of a patient's body. It may be suitable for expanding and further keeping the vessel open.
  • the implantable device may comprise at least one layer comprising a pharmaceutically active agent.
  • the device according to the invention can have means for expanding the device which can be implanted in a vessel.
  • a "flow direction of the vessel” denotes the direction in which a fluid located in the vessel of the patient's body flows Flow direction understood the main flow direction.
  • the main flow direction may be substantially coincident with a longitudinal direction of the vessel.
  • a "fluid” according to the invention comprises blood, bile, urine, other secretions, stomach contents and the like.
  • a "fluid-passageway” means an opening of the implantable device suitable for permitting passage of the fluid, such opening may be an aperture extending the entire length of the implantable device, and may be a fluid-inflatable, variable-volume lumen.
  • This cavity may be created after insertion of the implantable device into the vessel of the patient's body and expanding it to expand the vessel.
  • a "lining" within the meaning of the present invention may be a layer and / or coating and / or a coating or the like, which may be disposed in at least a portion of the implantable device Means be arranged.
  • lining will be used for simplicity in the interior of the through-hole of the implantable device, wherein the lining may be entirely made of a particular material and may further comprise sections of different materials.
  • the placement of the liner "in an interior of the port” means that the liner is disposed within the implantable device such that it is insertable into the vessel of a patient's body together with the implantable device.
  • the liner may extend the full length of the implantable device.
  • the liner may also extend beyond one or more edges, preferably all edges, of the implantable device.
  • the liner may be adapted to the shape of the interior of the implantable device. Such a shape may be a tubular shape.
  • the liner may abut the inside of the implantable device.
  • the liner may be in a folded form inside the through opening of the implantable device.
  • the liner may contact portions of the inner wall of the implantable device.
  • the lining may be permanently or detachably connected to the implantable device, wherein a "firm connection” may denote a positive, positive and / or cohesive connection.
  • the lining may also be present in the device according to the invention without being connected to the implantable device.
  • the lining can be expandable. In particular, in the expanded state, the lining can itself form a fluid-through passage opening.
  • the liner may include devices and / or coatings and / or coatings. These may preferably be configured to advantageously allow the fluid to pass better or to advantageously prevent or hinder adhesion of the fluid or components thereof to the liner.
  • the lining may have at least one layer which is provided with a pharmaceutical agent.
  • the pharmaceutical agent present in the lining may also be provided in the implantable device. In the implantable device, however, a pharmaceutical active substance other than that which is present in or on the lining may also be provided. Further, the implantable device may be free of any pharmaceutical agent.
  • the device according to the invention can be used for eliminating a vasoconstriction or a vascular occlusion and / or for preventing a stricture.
  • vascular occlusion For the purposes of the present invention, strictures may include, but are not limited to, stenoses such as pyloric stenosis, carotid stenosis, coronary stenosis, aortic valve stenosis, auditory canal stenosis.
  • a vessel constriction can also be understood to mean any section of the vessel which due to its geometry, position or other reasons can lead to undesired or disadvantageous flow phenomena such as turbulence of the fluid flowing through the vessel, such as an aneurysm.
  • liners in which at least a portion of the same cellulose, e.g. microcrystalline and / or microbial cellulose, and / or homologous and / or autologous vascular tissue, or consists of such.
  • WO 2007/093445 The cellulose and a tubular embodiment thereof are described, for example, in WO 2007/093445 of the present applicant. Its content is hereby incorporated by reference into the present disclosure. The same applies to documents and disclosures to which the aforementioned WO 2007/093445 A1 itself refers for the production and processing of cellulose, for example WO 01/61026 A1. Their content in this regard is hereby by way of reference in each case part of the present disclosure.
  • the cellulose which have the lining or from which it can consist, in one embodiment, of a microcrystalline and / or microbial cellulose.
  • a microbial cellulose in one embodiment of the invention is produced by the exclusive or non-exclusive use of cellulose-producing microorganisms.
  • the cellulose-producing microorganisms may be cellulose-producing bacteria, e.g. a strain of the microorganism Acetobacter xylinum (eg AX 5, strain collection of the Institute of Biotechnology für or Gluconacetobacter xylinus, DSM No. 6513, DSZM Braunschweig) or other microorganisms, especially bacteria, which due to genetic modification have the ability to produce of cellulose such as Acetobacter xylinum or Gluconacetobacter xylinus.
  • a suitable procedure for cultivating the aforementioned strains is i.a. in DE 10 2006 007 412 Al and WO 01/61026 Al, the relevant disclosures of which are hereby incorporated by reference.
  • a microcrystalline cellulose in an embodiment according to the invention is understood as meaning a cellulose which has a plurality of chains of cellulose with these hydrogen bonds connecting to one another or consists entirely or essentially of such chains and their hydrogen bridge compounds.
  • the tissues of the lining may suitably be derived by known methods from the patient himself or from another human or animal.
  • the liner itself is fluid impermeable.
  • the lining which flows through the lining in a passage opening formed by this can preferably not or not substantially or not penetrate the lining in this embodiment.
  • the liner may be configured as a fluid-impermeable barrier between the interior of the through-opening of the implantable device and an exterior of the liner and / or the implantable device.
  • Such a fluid-impermeable barrier may be the penetration of the fluid present in the through-opening of the liner and / or the implantable device in a radial direction and / or a circumferential direction of the implantable device or device according to the invention, at least in the region in which the liner have, prevent or limit as far as possible.
  • the device according to the invention at least in the implanted state at least along a main flow direction, a first diameter, a second diameter and a third diameter, in this order, wherein the second diameter is larger than the first and / or third diameter.
  • a "main flow direction” may be a longitudinal direction of the vessel, a flow direction through the through-hole, a longitudinal direction of the through-hole.
  • the "first diameter" may be the diameter of the liner 10.
  • the first diameter may be increased from a minimum value of a condition of the liner to be implanted to a value of an expanded state thereof.
  • the "second diameter" may be one or the diameter of the implantable device or passageway thereof, and the second diameter may also be increased from a minimum implantable device implantable state value to an expanded state value thereof may be greater than the first and / or the third diameter in the implanted state, in particular in the expanded state of the implantable device.
  • the "third diameter” can again be a diameter of the lining, preferably in a region of the device according to the invention, which according to its plantation downstream.
  • the third diameter may be increased from a minimum value of a condition of the liner to be implanted to a value of an expanded state thereof.
  • the "third diameter" may be, preferably at least substantially, the diameter of the affected vessel of the patient's body, in particular, the third diameter may be the diameter of the vessel at a non-constricted or occluded site of the vessel the native vessel diameter of a vessel portion, in which the lining after implantation of the device according to the invention should come to rest - preferably at least substantially - correspond.
  • the first and the third diameter may be the same. This can advantageously facilitate the production of the device according to the invention and in particular its lining.
  • diameter may refer to an inner diameter of the respective region for both the first, second and third diameters, but may also refer to a distance between a luminal center and the center of a material layer. He may also refer to a state of complete expansion of the device according to the invention or corresponding portions thereof, in particular also in a non-implanted state, to which no appreciable forces are applied, regardless of whether such a state of use is ever properly achieved in use ,
  • diameter may refer to a state prior to expansion or expansion.
  • a further embodiment of the present invention provides means for connecting the lining in the region of the first and / or the third diameter with the implantable device and / or with a vessel wall, for example a blood vessel wall. This can advantageously prevent or hinder unintended slippage or runaway by the fluid.
  • the implantable device is designed as a stent.
  • Such a “stent” may be made of plastic and / or metal, such as a shape memory alloy, such as Nitinol or others.
  • the stent may have more or less flexible limbs, loops, cells, meander patterns, or combinations thereof. It can be designed as a, preferably elastic, metal or alloy braid.
  • Suitable stents are disclosed, for example, in US 5,639,274, US 5,198,416, EP 1 266 639, EP 1 400 219 and EP 0 554 082. Their contents are hereby incorporated herein by reference. However, all other known stents which are obvious to a person skilled in the art in connection with the present invention can also be used as an implantable device of the device according to the invention and as such are provided by the Applicant and are hereby disclosed.
  • the implantable device is spirally wound or configured in a spiral shape. This can e.g. by twisting the implantable device prior to implanting the same in a longitudinal direction of the through-hole or the vessel while applying a biasing force to the same.
  • the implantable device can thus - but in other ways - be designed to expand itself.
  • the device of the invention may also include other or alternative means for facilitating and / or promoting expansion of the implantable device, such as balloon catheters and the like.
  • the implantable device and / or the liner has a number of attachment means for engaging the wall of the vessel.
  • the term “number" may designate one or more fastening devices.
  • a first portion of the fastening devices may be provided at an edge region of the implantable device and / or the lining located upstream of the fluid flow direction of the vessel. If fastening devices are provided only at an edge region of the implantable device and / or the lining located upstream of the fluid flow direction of the device, as is envisaged in a preferred embodiment, this embodiment advantageously permits attachment with comparatively little effort and only slight impairment of the vessel wall.
  • a second portion of the attachment means may be configured on a peripheral edge of the implantable device and / or the liner downstream of the fluid flow direction of the vessel. In such, likewise preferred embodiment is advantageously provided for a higher strength of the attachment.
  • the first share and the second share may be the same or different sizes. The latter can advantageously simplify the method for producing the device according to the invention.
  • Each such fastening device may be a hook or barb, a loop, eyelet, clip, a clip, a claw, an anchor, in particular a dynamic anchor and the like.
  • a “dynamic anchor” may include elements such as protrusions, arms, or the like that change shape or orientation upon penetration of portions of the vessel wall or upon entry into such portions, so that arms of the anchor may entangle, or spread, and onto them Way beneficial to contribute to increased strength of the connection anchor with vessel.
  • the fastening devices may preferably be biocompatible or biodegradable or degradable. They can be absorbable. For example, a degradation of the fastening device take place at a time at which the device according to the invention or sections thereof, such as the lining of the vessel wall, for example by ingrowth or growth already protects against a Wegschissemmen and the like.
  • the attachment means may each be adapted to engage the wall (e.g., intima and / or media and / or adventitia) of the vessel. It may be made of a suitable material such as plastic, metal, a shape memory alloy such as nitinol.
  • the device according to the invention can advantageously find support in at least one of the layers of the vessel wall after its implantation.
  • the at least one attachment means for engaging the wall of the vessel may transition from a first position in which it could not engage the wall to a second position in which it may engage the wall. It may also preferably proceed to a subsequent third position.
  • the "transition" from a first position to a second position can be achieved by unfolding the at least one fastening device, eg automatically by mechanical coupling, by a shape memory mechanism of the fastening device, by expansion of the device according to the invention or parts thereof, in particular of the implantable device Shear forces and the like, take place.
  • the "first position” may be a position before implantation of the device according to the invention into the vessel
  • the "second position” may be a position after implantation of the device according to the invention and / or a position after expansion of the implantable device and / or lining of the device according to the invention be.
  • a third position may be present after anchoring by means of dynamic anchors - as described above - after penetrating vessel wall sections.
  • the device according to the invention includes at least one detachable holding device for holding the implantable device in a first position.
  • Such a “first position” may be a position suitable for implanting the implantable device, such as a collapsed configuration, of the implantable device.
  • the "holding device” may be attached to the implantable device and / or be positively and / or positively connected thereto.
  • the holding device may be suitable for holding the implantable device in the first position against an internal stress of the device according to the invention or parts thereof.
  • a releasable holding device may be a sheath of the implantable device, a thread arrangement wound around or by the implantable device, a clamp, a clamping device and / or the like.
  • the releasable holding device can be designed to be heat-stable and, for example, after implantation of the device according to the invention, decompose or loosen under the effect of the temperature prevailing in the vessel of the patient's body.
  • the releasable holding device can be made chemolabile and can be used e.g. after implanting the device according to the invention under the influence of the conditions prevailing in the vessel of the patient's body, such as a pH, decomposing or dissolving.
  • the releasable holding device can be designed to be unstable to other biological, chemical, physical or other effectors such as radiation or magnetism and, for example, after implantation of the device according to the invention under the action decompose or release a corresponding radiation or magnetism on the holding device.
  • the releasable holding device may e.g. be designed as a shell or include such.
  • a sheath may comprise the implantable device or device of the invention externally and thereby prevent it from deploying or expanding.
  • the releasable holding device can be configured as a thread arrangement or comprise such.
  • a thread arrangement may comprise one or more threads.
  • Unfolding or expanding the implantable device can be done automatically by releasing the holding device after its implantation by removing or releasing the holding device, such as cutting a thread, peeling or opening a shell, and / or by removing the restrictive effect of the holding device.
  • the unfolding can be based on internal stress of the device according to the invention.
  • the lining is foldable. This accordingly includes a possibility of unfolding the lining, in particular during implantation of the device according to the invention.
  • the lining is folded over and / or everted at at least one end of the implantable device.
  • the liner may be folded or everted at both ends.
  • the implantable device and the lining each have a non-closed cross-section over their longitudinal extent.
  • a “longitudinal extent" of the implantable device and of the lining of the device according to the invention denotes the longitudinal direction of the implantable device according to the invention.
  • the flow direction of the fluid extending orientation. This may be, for example, the longitudinal direction of the jacket of a tubular implantable device and / or lining of the device according to the invention. It can be perpendicular to the circumferential direction of the lining.
  • a “non-closed cross-section” means that the edges opposite each other in a rolled-up state of the implantable device and the liner can but do not need to - without being connected to each other, but also over their entire length without mutual contact - that is, open, ie, spaced apart, eg, in a circumferential direction of the through-hole or implantable device
  • the edges may be open along a straight line or along any curve, for example.
  • the tube formed of the implantable device and the liner may be open in a longitudinal region between the opposing edges as previously discussed. However, the two opposing impact edges may overlap each other.
  • the degree of overlap here is essentially not limited, but may preferably be selected so as to ensure a passage opening suitable for the flow of fluid and / or to use as little material of the implantable device and the lining as possible for forming the passage opening.
  • the object according to the invention is also achieved by a method according to claim 21, which is suitable for producing a device according to the present invention.
  • a method of making a device according to the invention may comprise co-rolling a first layer of material of the implanted device and a second layer of material of the lining.
  • the first and the second "layer" can be flat or flat, but in any case can be rolled up,
  • the first and the second layer can each be made up of a plurality of layers be connected.
  • the first and the second layer may be positively and / or positively and / or materially connected to each other or merely arranged on each other.
  • further layers may also be arranged, which may serve to adapt and / or connect the layers to one another.
  • the two layers can be rolled up together, ie preferably in a common working step, after the second layer has been arranged on the first layer.
  • the assembly may preferably be rolled up to form a spiral or tubular shape having the liner on its inner circumference of each ply and the second layer of the implantable device on each outer perimeter of each ply.
  • the rolling up of the two layers can take place while applying a tension to at least one of the layers.
  • the first and / or the second layer may be under residual stress after being rolled up.
  • a holding device as defined above, can also be provided on the implantable device and / or on the lining of the device according to the invention.
  • a coiled arrangement of implantable device and liner of the device of the invention is suitable for implantation in a vessel of the body of a patient.
  • the method may further comprise further steps of arranging further means for deploying the implantable device and / or the liner, such as balloon catheters.
  • the object according to the invention is also achieved by use according to claim 24, which in turn is suitable for producing a device according to the present invention.
  • the present invention thus provides a device which can advantageously be introduced minimally invasively into a region of a vasoconstriction or a vascular occlusion.
  • the lining according to the invention can prevent a renewed constriction or reclosure of the affected vessel and thus advantageously serve for longer-term keeping open of the vessel.
  • the lining can stabilize the vessel inner wall particularly well if the first and the third diameter of the device according to the invention are the same size.
  • the vessel wall By securing the implantable device and / or the liner by means of the fastening devices to at least one layer of the vessel wall, the vessel wall can be further stabilized, thus ensuring longer-term keeping open become. In addition, slipping of the device according to the invention within the vessel can be prevented in an advantageous manner.
  • the inherent stress of the implantable device and / or the lining and / or the use of a holding device which is preferably used in the present invention, can advantageously bring about unfolding of the rolled-up arrangement and, in particular, lining without substantial stretching stress. Due to lack of tensile stress, especially the lining, it can be configured in a particularly suitable material thickness and with a particularly suitable material.
  • the Matterbuchen the fasteners of a first, for example, folded position before implantation in a second, for example, unfolded position after implantation advantageously allows a simple and secure transport of the device according to the invention in the vessel and advancing the device according to the invention in the vessel.
  • the fastening devices which can be configured for example as hooks or barbs, are not disturbing in this case.
  • Fig. Ia shows a longitudinal section of a first embodiment of the device according to the invention
  • FIG. 1b shows a cross section through the device according to the invention of FIG. 1a in the region of fastening devices
  • Fig. Ic shows a cross section through the device according to the invention of Fig. Ia in the region of the implantable device
  • Fig. 2a shows in perspective a second embodiment of the invention
  • Fig. 2b shows a cross-section of the device according to the invention of Fig. 2a;
  • Fig. 2c shows in perspective the device according to the invention in a relaxed state
  • Fig. 3a shows a fastening device of a third embodiment of the device according to the invention shown in a cross-section in a first position
  • FIG. 3 b shows the fastening device of the device according to the invention
  • Fig. 4a shows a further fastening device in a first position
  • Fig. 4b shows the fastening device in a second position.
  • Fig. 1 shows a longitudinal section of a device 1 according to the invention.
  • implantable device 3 having a second diameter 5 and a stent, e.g. formed as a cellulose tube lining 7 with a first diameter 9 and a third diameter 13.
  • a vessel of the body of a patient with a vessel wall 11 having a diameter 13 '(which may correspond substantially to the third diameter 13) is expanded by implantation of the device 1 according to the invention or already previously.
  • the lining 7 is fastened to the vessel wall 11 on four exemplary oval elements 15 shown.
  • a body fluid, such as blood, may flow through a port 17.
  • the liner 7 may be made fluid-impermeable such that no fluid can enter the space between the liner 7 and the implantable device 3, which may be a cavity 19.
  • the native or original vessel lumen is restored by widening it with the stent 3 and inserting the liner 7 into the vessel as before.
  • the original flow conditions can in this case be restored by introducing the device according to the invention.
  • FIG. 1b shows a cross section through the device 1 according to the invention of FIG. 1a in the region of eight fastening devices 15 distributed over the circumference.
  • 1c shows a cross section through the device 1 according to the invention of FIG. 1a in the region of the implantable device 3.
  • FIG. 2 a shows in perspective a second embodiment of the device 1 according to the invention in a tensioned or folded state.
  • Device 3 is spirally wound. Inside is also a folded one
  • Lining 7 The arrangement is made of e.g. trained as a thread assembly
  • the lining 7 is in each case turned outwards. This can advantageously contribute to a simple yet secure attachment of the lining 7 to the implantable device 3.
  • Fig. 2b shows a cross section of the device 1 according to the invention of Fig. 2a.
  • the tensioned spirally wound implantable device 3 surrounds the folded liner 7.
  • An e.g. body temperature decomposable holding means 21 holds the assembly of implantable device 3 and folded liner 7 in a tensioned state.
  • Fig. 2c shows in perspective the device 1 according to the invention of Fig. 2a and 2b in a relaxed state.
  • the spirally wound implantable device 3 is in a relaxed state (the releasable retainer has been removed).
  • the liner is unfolded to provide a passageway 17 suitable for passing fluid therethrough.
  • the spirally wound implantable device 3 of Figures 2a, 2b and 2c may be a self-expanding stent.
  • the spiral is under tension caused by the severing of the holding device 21, e.g. a thread assembly can be solved.
  • the coil may contain attachment means, eg, barbs, in an active position which will drill into the vessel wall, eg, a blood vessel wall, thus providing a, particularly permanent, fixation to the vessel wall.
  • attachment means eg, barbs
  • an outer shell as a holding device 21, from which the spiral is pushed or pulled out with the cellulose tube.
  • a roller can also be used as lining 7, as shown in FIGS. 3 a and 3 b, which are made of two or more flexible limbs, preferably of equal size with the lining 7, on two opposite edges. Loops, cells, Gurandermustern or combinations thereof, preferably elastic, metal mesh is attached. Both are rolled up and introduced under tension into the vessel and positioned there. If the tension is released by severing the holding device 21, then the roller forms a tube which, at least in sections thereof, preferably adapts to the vessel diameter.
  • FIG. 3a shows a fastening device of the cross-cut device according to the invention of a third embodiment in a first position.
  • the fastening device 23 is designed as an example barbs.
  • the barbs are applied to the outer periphery of the implantable device or displaced into depressions, cells or the like thereof.
  • the first state may be a state prior to implantation of the device according to the invention.
  • Fig. 3b shows the fastening device of the device according to the invention of Fig. 3a in a second position.
  • the fastening device 23 is placed in the relaxed state of the device 1 according to the invention on the outer circumference of the implantable device. In this position, a connection by means of the fastening device
  • the second state can be
  • the device 1 according to the invention is rather open in the region 24b.
  • Fig. 4a shows further fastening means 23 in a first position.
  • the fastening devices 23 are configured, for example, as opposing barbs.
  • the barbs provided on the outer circumference of the implantable device can be twisted by helical winding of the implantable device by torsion in such a way that they do not impede handling and implantation of the device according to the invention as far as possible.
  • the first state may be a state prior to implantation of the device according to the invention.
  • FIG. 4b shows the fastening devices 23 of FIG. 4a in a second position.
  • the fasteners 23 are deployed after relaxing the implantable device for hooking into at least one layer of the vessel wall at the outer periphery of the implantable device.
  • the second state may be a state after implantation of the device according to the invention.

Landscapes

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

Abstract

L'invention concerne un dispositif (1) comportant un appareil (3) pouvant être implanté dans un vaisseau du corps d'un patient, pourvu d'au moins une ouverture traversante (17) perméable aux fluides dans le sens d'écoulement du vaisseau, et un revêtement (7) disposé à l'intérieur de l'ouverture traversante (17). Le dispositif (1) peut servir à éliminer un rétrécissement ou une obstruction de vaisseau, voire à maintenir un vaisseau ouvert de façon durable. L'invention concerne également un procédé de fabrication d'un tel dispositif.
PCT/EP2009/009339 2009-01-02 2009-12-31 Dispositif comportant un appareil pouvant être implanté dans un vaisseau du corps d'un patient et un revêtement et procédé de fabrication de ce dispositif WO2010076035A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP09799556A EP2385806A1 (fr) 2009-01-02 2009-12-31 Dispositif comportant un appareil pouvant être implanté dans un vaisseau du corps d'un patient et un revêtement et procédé de fabrication de ce dispositif

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009003890.6 2009-01-02
DE102009003890A DE102009003890A1 (de) 2009-01-02 2009-01-02 Vorrichtung mit einer in ein Gefäß des Körpers eines Patienten implantierbaren Einrichtung und einer Auskleidung sowie Verfahren zum Herstellen derselben

Publications (1)

Publication Number Publication Date
WO2010076035A1 true WO2010076035A1 (fr) 2010-07-08

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EP (1) EP2385806A1 (fr)
DE (1) DE102009003890A1 (fr)
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WO2012151088A1 (fr) * 2011-05-02 2012-11-08 Cook Medical Technologies Llc Ancres biodégradables et bioabsorbables pour stent
DE102020101232A1 (de) 2019-01-21 2020-07-23 Advanced Angioneers UG (haftungsbeschränkt) Endoluminal implantierbare Vorrichtung

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WO2000028921A2 (fr) * 1998-11-16 2000-05-25 Endotex Interventional Systems, Inc. Prothese endovasculaire a bande enroulee avec exosquelette
EP1121911A2 (fr) * 2000-02-01 2001-08-08 Cordis Corporation Stent à greffer autoexpansible
WO2001067992A1 (fr) 2000-03-13 2001-09-20 Jun Yang Stent pourvu d'un revetement d'administration de medicaments
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WO2008023160A1 (fr) 2006-08-23 2008-02-28 Evexar Medical Limited Améliorations apportées à des appareils médicaux ou afférentes à ces derniers

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DE102009003890A1 (de) 2010-07-08
EP2385806A1 (fr) 2011-11-16

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