EP4267046A1 - Implant et ensemble comportant une source de rayonnement et un implant - Google Patents

Implant et ensemble comportant une source de rayonnement et un implant

Info

Publication number
EP4267046A1
EP4267046A1 EP21840948.0A EP21840948A EP4267046A1 EP 4267046 A1 EP4267046 A1 EP 4267046A1 EP 21840948 A EP21840948 A EP 21840948A EP 4267046 A1 EP4267046 A1 EP 4267046A1
Authority
EP
European Patent Office
Prior art keywords
implant
core
filler
filament
jacket
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21840948.0A
Other languages
German (de)
English (en)
Inventor
Benedict Bauer
Thomas Gerhard Gries
Jeanette Ortega
Ioana Slabu
Thomas Schmitz-Rode
Benedikt Mues
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rheinisch Westlische Technische Hochschuke RWTH
Original Assignee
Rheinisch Westlische Technische Hochschuke RWTH
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 Rheinisch Westlische Technische Hochschuke RWTH filed Critical Rheinisch Westlische Technische Hochschuke RWTH
Publication of EP4267046A1 publication Critical patent/EP4267046A1/fr
Pending legal-status Critical Current

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
    • A61F2/82—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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/128—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18—Materials at least partially X-ray or laser opaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A61N1/403—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals for thermotherapy, e.g. hyperthermia
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/009—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof magnetic
    • 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
    • A61F2250/0001—Means for transferring electromagnetic energy to implants
    • 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
    • A61F2250/0047—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 thermal conductivity

Definitions

  • Implant and arrangement comprising a radiation source and an implant
  • the present invention relates to an implant, such as in particular a stent.
  • the present invention relates to an implant applicable in magnetically induced hyperthermia.
  • the present invention also relates to an arrangement having such an implant and a radiation source for emitting electromagnetic radiation.
  • Therapeutic hyperthermia is known per se and can achieve significant advantages in cancer treatment, for example.
  • EP 1 489 985 B1 describes the use of a material in a vessel treatment device which has a magnetic susceptibility which is heat sensitive.
  • the vascular treatment device can then be remotely and non-invasively heated using an applied magnetic field to a preselected temperature at which the vascular treatment device becomes substantially non-magnetically susceptible.
  • the material can be provided, for example, as a coating on a stent, with the core of the stent being able to be a metal, for example. If the stent is made of a polymer, the material can be embedded in the polymer or the pure material can be coated onto the polymer. This document does not describe a two-layer polymer structure.
  • US 2003/0004563 A1 describes a stent that is used for implantation in a body.
  • the stent can be constructed from a polymer to which an additive has been added.
  • the additive can have particles of a metal and/or a radiopaque material, for example in the nanometer range.
  • paramagnetic or ferromagnetic materials can be used to be visible in an MRI process.
  • a double-layer structure is used in such a way that there is an inner polymer core onto which a layer of the pure MR material is applied.
  • the polymeric backbone can be produced, for example, by means of melt spinning. This document also does not describe a two-layer polymer structure.
  • US 2010/0087731 A1 describes a tubular stent which is formed from a large number of filaments, the filaments being constructed from a solid, bioabsorbable polymer material with active substance particles dispersed therein, which are visible by magnetic resonance imaging (MRI).
  • the active ingredient particles are superparamagnetic iron oxide (SPIO) particles.
  • SPIO particles improve the visibility of the polymer stent under MRI and also allow for accurate monitoring of stent degradation. As the stent degrades, the SPIO particles are released and either flow downstream or become embedded by nearby macrophages. The amount of SPIO particles within the remaining stent body is reduced, resulting in a different MRI signal. By quantifying the change in signal, the amount of remaining biodegradable stent in situ can be derived and the stent degradation rate accurately calculated. This document also does not describe a two-layer polymer structure.
  • US 2016/0024699 A1 describes a melt-spun fiber in which an additive is provided which can be detected magnetically or via X-rays and has a size of less than 31 micrometers.
  • the additive may be a metal, for example, or an X-ray opaque material.
  • the additive can be present in the core and/or in the shell of a polymer matrix.
  • Such a fiber is used, for example, in a wide variety of products, in order in particular to be able to detect contamination of products produced with these fibers.
  • this document does not describe an implant and furthermore the possibility of forming a tubular structure is not described.
  • DE 102018 005 070 A1 relates to a method for producing a stent graft.
  • the method includes providing a graft made from a first polymer-based material and applying a stent structure with a plurality of struts made from a second polymer-based material to the graft using an additive manufacturing process.
  • the invention also relates to a stent graft produced using the method. In such a stent graft, however, the overall tubular structure is provided with struts, and no multi-layer structure is described at the fiber level.
  • the object of the present invention to provide a measure by which at least one disadvantage of the prior art is at least partially overcome. It is in particular an object of the present invention to create a measure by means of which the applicability of an implant, in particular a stent, can be improved.
  • the present invention relates to an implant for implantation in a body, in particular in a hollow organ or a vessel of a body, the implant being composed of a filament which has at least one polymeric matrix material in which a magnetically heatable filler is arranged, the filament having a cross-section with a core-shell structure, wherein the core forms a polymeric reinforcement structure, and wherein the shell comprises the polymeric matrix material in which the magnetically heatable filler is arranged, the loading of the filler in the shell is greater than in the core.
  • such an arrangement can offer clear advantages over solutions from the prior art, for example for use in hyperthermia or in hyperthermic therapy, or also in imaging using magnetic resonance imaging (MRT) or magnetic particle imaging (MPI).
  • MRT magnetic resonance imaging
  • MPI magnetic particle imaging
  • the implant described here is used in particular for implanting in a body, in particular of a living being, for example in a human body, with implantation in a vessel or hollow organ of the body, for example in a vein, the trachea, bile ducts and ureters and tubes, being particularly preferred as will be described later in more detail.
  • the implant can in particular have a flexibility in order to be introduced into the body, for example into the vessel or hollow organ, in a compressed and/or deformed state and to assume its desired application form at the desired position.
  • the implant is formed from a filament, which can also be referred to as a fiber.
  • the filament can be processed in a manner known per se using fiber processing methods familiar to a person skilled in the art. Examples of such fiber processing methods or textile-related further processing include, for example, the crossing or intertwining of the filaments, as occurs in weaving, warp-knitting, knitting, lace production, braiding and the production of tufted products.
  • the implant can be a fleece, although it can be preferred that the filament is not a fleece.
  • the filament can be produced by a spinning process.
  • coextrusion can be used to create the core-shell structure.
  • a coextrusion process in particular, but not limited to this, makes it possible to produce a core-sheath structure at the fiber level.
  • the core is designed in the form of a thread and the sheath has a tubular structure and at least partially encloses the core.
  • the filament from which the implant is formed in particular by a fiber processing method, is designed as a multi-layer structure at the fiber level.
  • the core is thread-like and thus formed from solid material.
  • the sheath is tubular and formed around the core. This is possible, for example, by using two coaxial nozzles in an extrusion process, which form the core inside and the jacket radially around the core as a tubular structure.
  • a tubular structure is to be understood in particular as meaning that the jacket has a tubular structure, so that the jacket covers the core completely or over the entire surface on the outside, in that the jacket runs around the core.
  • the interior of the tube shape is then in particular completely filled by the core.
  • both the core and the jacket can preferably form a closed layer, with the layers preferably being free of pores. In principle, however, pores in the core or in the jacket should be included in the present invention.
  • a particularly high strength can be achieved by a coextrusion process for producing the filament, since the materials, in particular polymer materials, are oriented. This is an advantage over an additive manufacturing process, for example, in which the materials are mostly unoriented.
  • the filament has at least one polymeric matrix material in which a magnetically heatable filler is arranged.
  • the magnetically heatable filler in be homogeneously finely distributed in the matrix material, it being provided in the implant described here that the filler is present only in a predefined area along the cross section of the filament. The more homogeneous the distribution of the filler, the more homogeneous and defined the hyperthermic therapy can ultimately be carried out.
  • the magnetically heatable filler in the context of the present invention this should in particular be one that heats up triggered by a magnetic field or an electromagnetic field.
  • the heating takes place in particular in a defined and reproducible manner, so that when a magnetic field with known parameters is applied, such an effect is achieved that the filler or, in particular, the filament can be heated to a defined temperature value.
  • hyperthermia as will be described in detail later, it is advantageous if the filler can be heated in such a way that the filament has a temperature in a range from 40°C to 100°C, preferably in a range from 41 °C to 44°C.
  • thermo ranges such as in a range from 41° C. to 44° C., or also other temperature ranges in particular in the aforementioned ranges can be set in a very defined manner. This is possible in particular through the selection and loading of the fillers and the parameters of their magnetic excitation.
  • high temperatures in particular could allow performing thermal ablative procedures analogous to high intensity focused ultrasound (HIFU), radio frequency induced thermal therapy (HITT), or laser induced interstitial thermal therapy (LITT).
  • Thermoablative methods aim at killing (coagulation) the target tissue with temperatures of about 80 - 100°C or in low temperature ranges, for example in a range of 41°C to 44°C with in particular apoptotic cell damage, whereby undesired necrosis can be avoided .
  • the implant according to the invention can be used in thermoablative procedures, in particular in the deeper Temperature range, basically used to generate particularly therapeutically effective heat or for imaging.
  • the implant or the filament described here is characterized in that the filament has a cross section with a core-sheath structure as described above, the core forming a polymeric reinforcement structure and the sheath having the polymeric matrix material , in which the magnetically heatable filler is arranged, the loading of the filler in the shell being greater than in the core.
  • the core may also include the matrix material provided in the sheath or be formed from a different polymer.
  • the magnetically heatable filler is thus predominantly present in the outer region, whereas the core has less of the magnetically heatable filler or is in particular free of it.
  • a polymeric reinforcement structure is formed in the core.
  • a reinforcement structure of the core is to be understood in the context of the present invention in particular in that the core represents a reinforcement for the jacket, in particular in that the core has greater stability or strength than the jacket.
  • reinforcement may relate to the tensile strength of the filament.
  • the structure of the filament described above and thus the construction of the implant can make it possible for a particularly effective therapeutic effect, in particular in the field of hyperthermic therapy, to be combined with a particularly advantageous applicability of the implant.
  • the implant can be heated intracorporeally via electromagnetic excitation by the magnetically heatable filler.
  • the temperature achieved is particular proportional to or dependent on the particle loading.
  • Sufficiently high heating to the therapeutically effective temperature of 41°C to 44°C, for example to destroy tumor tissue, requires a high particle loading of the filler while complying with medical safety limits with regard to the parameter selection of the electromagnetic field.
  • This high loading usually poses a major problem for the processability into a monocomponent fiber.
  • the causes of this are the fiber's tensile strength, which decreases with increasing particle loading, and the filter service life during the production of the fiber or filament.
  • the improved stability can be made possible, in particular with high particle loads, which is necessary for effective use in hyperthermic therapy, in particular for combating tumors.
  • the temperature of the magnetically heatable filler can be increased by electromagnetic excitation, particularly as a result of a high particle load be made possible, which can allow a particularly reliable destruction of the tumor tissue.
  • a high degree of flexibility or a high degree of freedom in the particle loading is thus made possible, since the strength of the jacket, which decreases at high loadings, can be compensated for by the properties of the core and thus the reinforcement structure formed by the core. In addition, it becomes possible to enable sufficient elasticity under bending stress. With a high loading of filler, the materials can become brittle, which can limit the bending radius. According to the invention, production can thus be improved since, for example, in the single-thread braiding process, which can be used for example for the production of a stent, the achievable angles on the deflection pins can be improved. Thus, the applicability can be improved.
  • This hyperthermia treatment takes advantage of the fact that tumor tissue reacts more sensitively to increased temperature than healthy normal tissue.
  • a high particle load is advantageous, which according to the invention can be achieved without loss of the above-mentioned mechanical properties of the implant as a whole, for example.
  • an implant with as little material as possible and therefore space-saving can always be obtained, which can nevertheless allow a high level of effectiveness for the desired use.
  • a similarly high level of heating can be achieved with a simultaneous cost reduction, since only part of the fiber cross section needs to have a particle load.
  • hyperthermia cancer cells, for example, react more sensitively to heat than healthy body cells.
  • increases in temperature to more than 43 °C or 44 °C lead to cell death through necrosis, even in healthy body cells.
  • the cellular necrosis that can occur above 43°C, such as above 44°C is often the result of very severe damage to a cell, which reacts with cell membrane loss.
  • An inflammatory reaction occurs, causing inflammation and scarring.
  • Apoptosis approximately in a temperature range of 41 °C to 43 °C or up to 44 °C, is a form of programmed cell death with a gradual decomposition of the cell.
  • the DNA is fragmented.
  • An inflammatory reaction is avoided and the membrane itself remains intact. It is generally assumed that the toxic effect of hyperthermia (apoptotic or necrotic) is caused by denaturation of thermolabile proteins in the cytoplasm and intranuclear. There is a co-effect through further aggregation with other proteins or DNA, which hinders cell replication.
  • the hyperthermia treatment ensures better blood circulation in the tumor and sensitizes the tissue to absorb medication and the rays of radiation treatment, such as radiotherapy.
  • Decisive for the effect of Hyperthermia treatment include the level of temperature in the target area and the duration of the application.
  • the magnetically heatable filler serves to avoid necrosis.
  • Cell death occurs through apoptosis: Apoptosis is part of the metabolism of every cell and is therefore also called natural, controlled cell death. As explained above, there is no inflammatory reaction (as in the case of necrosis) and it is also ensured that the affected cell dies without damaging the neighboring tissue.
  • the implant of the invention thus offers a gentle and effective method for hyperthermic therapy.
  • the magnetically heatable filler can preferably be a superparamagnetic filler.
  • the superparamagnetic effect of nanoferrites describes a magnetic property of very small particles of a ferromagnetic or ferrimagnetic material. If these show no permanent magnetization even at temperatures below the Curie temperature after a previously applied magnetic field has been switched off, this is referred to as the superparamagnetic effect.
  • An accumulation of nanoferrites in the polymer matrix therefore behaves macroscopically like a paramagnet, but still has the high magnetic saturation of a ferromagnet and accordingly reacts to inductive fields like a soft-magnetic ferromagnet.
  • superparamagnetic fillers examples include, in particular, ferrites, such as, for example, superparamagnetic iron oxide particles, such as magnetite or maghemite.
  • the filler in particular the superparamagnetic filler, has a crystallite size, which can also be referred to as core size or magnetic core size, in a range from greater than or equal to 3 nm to less than or equal to 100 nm, about greater than or equal to 10 nm to less than or equal to 30 nm, the crystallite size at which a material has superparamagnetic properties can be highly dependent on the material. Due to their physical properties, such nanoparticles, also known as magnetic nanoparticles (MNP), can allow the advantages described to be particularly effective in diagnostic (contrast agent in magnetic resonance tomography (MRT)) and therapeutic applications.
  • MNP magnetic nanoparticles
  • nanoparticles tend to form agglomerates with a size of a few micrometers (macroscopic agglomerates), for example ⁇ 10 pm, due to their magnetic attraction and the large surface-to-volume ratio.
  • agglomerates act like imperfections and significantly influence the properties of the resulting nanocomposites.
  • One way to improve the material properties is to distribute the particles homogeneously in the end product.
  • Two manufacturing processes are currently being used to manufacture nanocomposites, the melt-mixing process using extrusion, for example as a Melt spinning process with a twin screw extruder, as well as the solution blending process, applied industrially. In-situ polymerization, particle functionalization or ultrasonic waves are used to homogenize the nanoparticles in the matrix.
  • the spinning process is particularly advantageous in which, in addition to the particle-loaded functional component, the shell, a second component, the core, is also spun to produce the implant according to the invention, which ensures a significant improvement in mechanical strength both during the spinning process and after completion can be.
  • the coextrusion of two materials is used in the melt spinning process.
  • the spinning process follows the melt blending process with the twin screw extruder. This can be done in one step, but also in two steps.
  • the product of the melt mixing process, also called compounding, is granules. This is then spun into fibers in the melt spinning process.
  • the implant has a tubular structure, ie in particular a tubular or hose-shaped structure.
  • the implant can be a stent.
  • the filament built up from a core-sheath structure can thus be processed into the tubular structure by fiber processing processes.
  • the implant can be advantageous for hyperthermal therapeutic applications.
  • This structure can particularly preferably be effective when introduced into hollow organs or into vessels, for example in cancer therapy.
  • the implant described here thus enables particularly advantageous properties, in particular in the therapy of cancer patients or also for the hyperthermic treatment of stenoses.
  • cancer is the second highest cause of death in Germany.
  • the tumor mass often infiltrates or narrows vessels and hollow organs such as veins, the trachea, bile ducts, and ureters and ducts.
  • Stenoses are often caused by intimal hyperplasia, the proliferation of cells.
  • stent thrombosis this is a typical complication after stent implantation.
  • the above can lead to a life-threatening situation.
  • the tumor mass is removed surgically, and stenoses occurring in the cardiovascular area are often treated with medication.
  • local recurrences often lead to renewed closure or restenosis.
  • metal stents are often used to keep the hollow body or vessel open, but this is often only temporarily effective and means that repeated interventions are necessary.
  • the implant described here is based on the fact that the tumor or tumor tissue can be destroyed by local hyperthermia or that any tumor-related or stenosis-related constrictions or occlusions of the hollow organ or vessel can be removed and the hollow structures can thereby be uncovered again.
  • the increased stability means that it can be introduced into the hollow organ or a vessel without any problems.
  • the hyperthermic properties enable defined heating of the implant, which has an effective effect on gentle therapy.
  • the filament can form an open-pored implant that can maintain the basic advantages, namely maintaining the vessel diameter, while avoiding the disadvantages, namely in particular the ingrowth of tumor tissue, through the hyperthermic removal of ingrown tissue.
  • the implant when used in a hollow organ or a vessel, can be introduced to the affected area via a catheter system.
  • self-expansion can be used to expand the implant in the lumen and fix it in the vessel or organ wall.
  • the implant is heated locally, several times if necessary, via an alternating magnetic field, as already explained above.
  • the treatment of a tumor growing into a hollow organ, vessel or other cavity can, as already described, be carried out non-invasively via electromagnetic heating. As a result, the patient could be spared the sometimes dangerous repeated surgical procedures. Since the regular revision operations would be omitted, there would also be significant cost savings for the healthcare system.
  • the filament can have a crossed or an intertwined structure.
  • the filament can be processed into the implant in particular by fiber processing processes known per se and, in particular, not be a fleece. This allows a defined and equally stable structure to be created, which can improve use as an implant.
  • the filament has a braided structure.
  • a braided structure in particular can have advantages for therapy in a hollow organ or in a vessel.
  • a textile stent can be made possible in a braided structure, which has a high degree of flexibility and the fibers are subject to little mechanical stress during production.
  • a braid in particular can be compressed without any problems in order to be inserted into a hollow organ or a vessel, and it can be given its desired non-compressed shape in the hollow organ due to a sufficient mechanical restoring force.
  • a mesh can have advantages over other products from fiber-processing processes or even over nonwovens or nonwovens.
  • the magnetically heatable filler is present in the jacket in a proportion of greater than or equal to 0.1% by weight to less than or equal to 90% by weight, preferably greater than or equal to 3% by weight to less or equal to 30% by weight.
  • the filler can be heated in such a way that the implant is heated to the desired temperature in a range of approximately 41° C. to 44° C. as described above.
  • the implant according to the invention can have reduced mechanical properties, such as reduced stability, particularly in this configuration with a monocomponent structure, ie without the reinforcement layer, so that the present invention can have effective advantages in this configuration in particular.
  • polymeric matrix material it can be advantageous that this is selected from the list consisting of polypropylene, polyethylene terephthalate, polyvinylidene fluoride, polyethylene, polyamide and thermoplastic polyurethane. It has been shown that these polymers in particular are suitable for receiving a filler in a homogeneously distributed manner. In addition, they can be sufficiently heated by the filler so that they do not adversely affect hyperthermic therapy or only to a limited extent. In addition, the polymers described here are also well suited as implants due to their inertness and are also not degraded or not significantly degraded by the human body, so that long-term use as an implant is also possible.
  • the core forms a polymeric reinforcement structure which has the same polymeric matrix material, for example consists of this, as the sheath.
  • the compatibility as an implant can be further increased since only a material that comes into contact with the body needs to be introduced into the body, any repulsive reactions or the risk of them can thus be further avoided.
  • the core can also be advantageous for the core to be free of the magnetically heatable filler.
  • the reinforcement structure can have particularly high stability or particularly advantageous mechanical properties, since the stability is not reduced at all by fillers present in the polymeric material.
  • the thickness of the filaments can be reduced or, with the same thickness, an increasing loading of the sheath with a filler can be made possible.
  • the ratio of the thickness of the core to the thickness of the cladding is in a range from greater than or equal to 1/19 to less than or equal to 19/1.
  • the shell can have a proportion, based on the combination of core and shell, of greater than or equal to 30% by weight to less than or equal to 70% by weight.
  • amplification can be made possible that is sufficient to enable problem-free use as an implant, for example in hollow organs or vessels, while a high loading to reach a therapeutically effective temperature is still possible.
  • the core-sheath structure or the implant forms a two-layer structure, i.e. the filament consists of the sheath and the core. Additional material can also be dispensed with in this configuration.
  • the subject matter of the invention is also an arrangement of a radiation source for emitting electromagnetic radiation and an implant, the implant having a magnetically heatable filler.
  • the arrangement is characterized in that the implant is configured as previously described.
  • Such an arrangement allows the radiation source to inductively heat up the magnetically heatable filler in a defined and reproducible manner by magnetic relaxation processes, and the implant can be used in a defined manner for hyperthermic therapy.
  • the implant and the radiation source can be matched to one another in such a way that the implant can be heated to a temperature within a range, at least in the jacket, by electromagnetic radiation emitted by the radiation source from 40°C to 100°C, for example from 41°C to 44°C.
  • the implant can be heated to a temperature within a range, at least in the jacket, by electromagnetic radiation emitted by the radiation source from 40°C to 100°C, for example from 41°C to 44°C.
  • a corresponding tuning of emitted radiation to the implant can be done on the part of the electromagnetic radiation, in particular by setting a suitable frequency are made possible.
  • Exemplary frequencies and field amplitudes include a range of 10 kHz to 1 MHz and 1 kA/m to 100 kA/m.
  • Such areas can be advantageous because with a suitable combination of frequency and field amplitude, the unintentional heating of tissue can be counteracted particularly effectively by the formation of so-called eddy currents.
  • eddy currents it is taken into account that the energy deposition of the tissue is frequency-dependent.
  • a corresponding tuning of emitted radiation, i. H. the frequency and field amplitude and the direction of the magnetic field, on the implant can be done on the part of the implant in particular by the design of the particle properties, z. B. their size, their crystallinity, their magnetic behavior, in particular their magnetic relaxation, their stabilizing coat, which affects the homogeneous distribution of small or no agglomerates in the polymer.
  • the design of the particles also provides for an arrangement of individual particles in the polymer in the form of a chain or as an agglomerate, which results in the enhanced response to the applied magnetic field.
  • FIG. 1 is a schematic view of a filament for an implant according to the present invention.
  • FIG 2 shows the mode of operation of an implant according to the invention.
  • FIG. 1 shows a schematic view of a filament 10 for an implant 26 according to the present invention.
  • the implant 26 is used in particular for implanting in a body, in particular in a hollow organ 22 of a body, as shown in FIG. 2, in order to combat tumors of the hollow organ.
  • the implant 26 can also be introduced into a vessel.
  • the implant 26 is constructed from the filament 10, such as in a braided structure.
  • the filament 10 has at least one polymeric matrix material 18 in which a magnetically heatable, in particular superparamagnetic, filler 20 is arranged.
  • FIG. 1 shows that the filament 10 has a cross section with a core-sheath structure 12 such that the core 14 forms a polymeric reinforcement structure.
  • the core 14 is thread-like and designed as a fiber or filament and the sheath 16 has a tubular structure and at least partially encloses the core 14 .
  • the jacket 16 has the polymeric matrix material 18 in which the magnetically heatable, in particular nanoscale, filler 20 is arranged. It can be seen that the loading of the filler 20 in the sheath 16 is greater than in the core 14. In particular, the core 14 is free of the filler 20. Furthermore, the core-sheath structure 12 or the filament 10 is in particular a two-layer structure educated. In particular, the magnetically heatable filler 20 in the jacket 16 can be present in a proportion of greater than or equal to 0.1% by weight to less than or equal to 90% by weight. Furthermore, the matrix material 18 can be selected from the group consisting of polypropylene, polyethylene terephthalate, polyvinylidene fluoride, polyethylene, polyamide and thermoplastic polyurethane. The material of the core 14 can be formed from the same material mentioned above.
  • the filament 10 which can also be referred to as a bicomponent fiber, can be processed into an implant 26, in particular a stent, with the aid of textile manufacturing processes. Braiding is a preferred manufacturing process.
  • the implant 26 can then, as shown in FIG.
  • the implant 26 is designed as a magnetically inductively heatable textile stent.
  • the filament braided structure is used as a textile stent.
  • This braided structure consists of polymer fibers which have incorporated nanoferrites as filler 22 .
  • the nanoferrites to be used are synthesized and compounded together with the polymer in a twin-screw extruder to form a spinnable masterbatch. This masterbatch is then spun into inductively heatable fibers using the melt spinning process.
  • a coextrusion of core material and shell material is carried out.
  • the implant 26 or the stent is advanced via a catheter system to the appropriate point in the body or in the hollow organ 22 or vessel and then expanded by means of self-expansion.
  • the nanoferrites When excited in an electromagnetic field, the nanoferrites convert the absorbed energy of the field into heat and release it into the environment.
  • a radiation source 30 which emits electromagnetic radiation in such a way that the filler 20 is heated to preferably 43.degree.
  • the radiation source 30 can form a coherent or coordinated arrangement 28 with the implant 26 .
  • tumors that have grown around the implant 26 or corresponding tumor tissue 24 can be destroyed. As described, this is possible in particular through the use of specific superparamagnetic nanoferrites with an adjustable saturation temperature as filler 20 .
  • the achievable surface temperature depends significantly on the parameters of the magnetic field, which must be matched to the properties of the nanoferrites and the fibers incorporated with nanoferrites, and on the level of particle loading or filler loading of the filament 10 .
  • the parameter selection of the electromagnetic field is limited by compliance with medical safety limits. However, these can easily be achieved according to the present invention, since the filler loading can be selected to be sufficiently high through the reinforcement layer of the core 14 .
  • the nanoferrites emit the absorbed inductive energy as heat via the polymer fibers to the tumor tissue 24 and act as an intrinsic thermostat. In the process, the tumor tissue 24 is destroyed by a local increase in temperature, as is shown in FIG.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Inorganic Chemistry (AREA)
  • Composite Materials (AREA)
  • Materials Engineering (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Multicomponent Fibers (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un implant (26) destiné à être implanté dans un corps, en particulier un organe creux (22) d'un corps. L'implant (26) est constitué d'un filament (10) qui présente au moins un matériau de matrice polymère (18) dans lequel est disposée une charge (20) pouvant être chauffée magnétiquement. Le filament (10) a une section transversale avec une structure noyau-enveloppe (12). L'invention est caractérisée en ce que le noyau (14) forme une structure de renforcement de polymère, et l'enveloppe (16) a le matériau de matrice polymère (18) dans lequel est disposée la charge pouvant être chauffée magnétiquement (20), la teneur en charge (20) dans l'enveloppe (16) étant supérieure à la teneur en charge dans le noyau (14).
EP21840948.0A 2020-12-22 2021-12-21 Implant et ensemble comportant une source de rayonnement et un implant Pending EP4267046A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020134541.0A DE102020134541A1 (de) 2020-12-22 2020-12-22 Implantat und Anordnung aufweisend eine Strahlungsquelle und ein Implantat
PCT/EP2021/087083 WO2022136426A1 (fr) 2020-12-22 2021-12-21 Implant et ensemble comportant une source de rayonnement et un implant

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EP4267046A1 true EP4267046A1 (fr) 2023-11-01

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US (1) US20240041622A1 (fr)
EP (1) EP4267046A1 (fr)
JP (1) JP2023554527A (fr)
DE (1) DE102020134541A1 (fr)
WO (1) WO2022136426A1 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6585755B2 (en) 2001-06-29 2003-07-01 Advanced Cardiovascular Polymeric stent suitable for imaging by MRI and fluoroscopy
US7918883B2 (en) 2002-02-25 2011-04-05 Boston Scientific Scimed, Inc. Non-invasive heating of implanted vascular treatment device
US8465453B2 (en) * 2003-12-03 2013-06-18 Mayo Foundation For Medical Education And Research Kits, apparatus and methods for magnetically coating medical devices with living cells
US20100087731A1 (en) 2008-10-07 2010-04-08 Medtronic Vascular, Inc. Method for Tracking Degradation of a Biodegradable Stent Having Superparamagnetic Iron Oxide Particles Embedded Therein
CN102379762B (zh) * 2011-08-02 2015-03-25 上海微创医疗器械（集团）有限公司 一种带凹槽的生物可降解支架及其制备方法
US10753022B2 (en) 2014-07-25 2020-08-25 Illinois Tool Works, Inc. Particle-filled fiber and articles formed from the same
DE102018005070A1 (de) 2018-06-26 2020-01-02 Rheinisch-Westfälische Technische Hochschule (Rwth) Aachen Stentgraft und Verfahren zu dessen Herstellung

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WO2022136426A1 (fr) 2022-06-30
JP2023554527A (ja) 2023-12-27
US20240041622A1 (en) 2024-02-08
DE102020134541A1 (de) 2022-06-23

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