WO2022243319A1 - Dispositif et procédé de décellularisation et/ou de nettoyage de tissus - Google Patents

Dispositif et procédé de décellularisation et/ou de nettoyage de tissus Download PDF

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Publication number
WO2022243319A1
WO2022243319A1 PCT/EP2022/063324 EP2022063324W WO2022243319A1 WO 2022243319 A1 WO2022243319 A1 WO 2022243319A1 EP 2022063324 W EP2022063324 W EP 2022063324W WO 2022243319 A1 WO2022243319 A1 WO 2022243319A1
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WO
WIPO (PCT)
Prior art keywords
tissue
container
liquid
rinsing liquid
holder
Prior art date
Application number
PCT/EP2022/063324
Other languages
German (de)
English (en)
Inventor
Robert Mau
Rainer Bader
Hermann Seitz
Christoph DROBEK
Anika Jonitz-Heincke
Mathias Lorenz
Daniela SCHWERDT
Original Assignee
Universität Rostock
Hochschule Wismar
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Filing date
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Application filed by Universität Rostock, Hochschule Wismar filed Critical Universität Rostock
Publication of WO2022243319A1 publication Critical patent/WO2022243319A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3203—Fluid jet cutting instruments
    • 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
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4644—Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0088—Liquid substances
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • A61L27/3691—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00969—Surgical instruments, devices or methods, e.g. tourniquets used for transplantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/322—Skin grafting apparatus
    • A61B2017/3225—Skin grafting apparatus with processing of harvested tissue
    • 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
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4644—Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • A61F2002/4646—Devices for cleaning bone graft
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs

Definitions

  • the invention relates to an apparatus and a method for decellularizing and/or cleaning tissue.
  • the invention can be assigned to the field of biomedical engineering.
  • the tissue prior to the implantation of allografts and xenografts, the tissue is pretreated by extensive chemical sterilization and cleaning methods.
  • aggressive media such as aqueous solutions with detergents, peroxides, organic solvents, acids and alcohols or beta and gamma rays is established (Putzer et al., 2014; Hiemer et al., 2016).
  • this pre-treatment - which is necessary according to the current state of the art - can be detrimental to the integrity and mechanical properties of the allograft of any type.
  • cartilage tissue can be dehydrated or its protein structures denatured (Benders et al., 2013; Hiemer et al., 2016), the biomechanical properties of bone tissue can be negatively affected (Haimi et al., 2008), and lead to ligament replacement in allografts even moderate doses of radiological irradiation or chemical treatment to damage (Lansdown et al., 2017).
  • Mechanical methods such as ultrasound, water jet or shear flow enable a gentle decellularization of a wide variety of tissues without resorting to aggressive chemical media. Cleaning with mechanical methods, especially in combination with prior treatment of the allografts with high pressure (HHD treatment), can lead to rapid, inexpensive and, above all, effective tissue devitalization.
  • HHD treatment high pressure
  • a device that enables a uniform, reproducible allograft or xenograft treatment in automated processes in a rinsing chamber based on the mechanical methods mentioned above and can thus provide biomechanically and biologically optimized replacement tissue is currently not known.
  • the publication EP 0988069 B1 discloses a method for the treatment of fixed biological tissue, which method is intended to inhibit the calcification of the biological tissue after its implantation in a mammalian body.
  • the method includes contacting the biological tissue with a treatment solution, causing relative movement between the tissue and the solution, and heating the solution.
  • An additional treatment of the tissue with ultrasound is not disclosed.
  • the publication DE 19508279 C1 discloses a device which has a built-in UV lamp and a vessel for the blood or tissue extract to be illuminated in a housing, the blood and tissue extract being placed in the radiation range of the lamp and driven by a rotary drive can be rotated in the radiation range. An additional treatment of the tissue with ultrasound is not disclosed. Presentation of the invention
  • a further object is to provide a device by means of which tissue materials of different types can be decellularized and cleaned in an automated process.
  • the device for for:
  • Decellularizing and/or cleaning tissue has the following components: a liquid-tight container, at least one ultrasound source for emitting an ultrasound signal, at least one liquid jet generator for providing a jet of rinsing liquid, at least one tissue holder for holding the tissue.
  • the tissue holder is placed in the container.
  • the at least one ultrasonic source is arranged such that the ultrasonic signal is transmitted onto the tissue in the tissue holder, and the at least one liquid jet generator is arranged such that the jet of irrigation liquid is directed onto the tissue in the tissue holder.
  • the device has a housing in which the liquid-tight container and/or the at least one ultrasound source and/or the at least one liquid jet generator is/are arranged.
  • the tissue holder is movably arranged in the liquid-tight container.
  • the tissue holder is movably arranged in the container that the tissue holder is driven by the impingement of the liquid jet on the tissue holder and/or on the tissue.
  • the tissue holder is movably mounted in the container in such a way that it can be driven by a drive device.
  • the drive device can be a motor unit, for example, which is arranged outside the container or waterproof inside the container.
  • the drive device can also be the ultrasound source or, as already described, the liquid jet itself, which is generated, for example, with a pump and/or with a nozzle.
  • the movement of the tissue or the tissue support can be, for example, a rotational movement, a translational movement or a combination thereof.
  • the tissue holder is configured in a tissue-specific manner for receiving a type of tissue.
  • the types of tissue which are preferably of human and animal origin, can be soft tissue or flart tissue, for example.
  • the tissue materials can be used as tissue samples in their original form as taken. However, the tissue can also be in the form of granules or other shapes.
  • the tissue holder for tissue-specific tissue recording can have, for example, a frame and/or a grid and/or a clamp holder and/or a screw holder. Other equivalent attachment and/or flapping options for the tissue/tissue samples are conceivable.
  • the liquid-tight container of the device has a drain.
  • the device has a pipe and pump system which is designed in such a way that the to supply at least one liquid jet generator for providing the jet of washing liquid with washing liquid and/or to remove the washing liquid from the liquid-tight container by means of the drain.
  • the pipe and pump system preferably has a reservoir in which the flushing liquid is arranged.
  • the pipe and pumping system has at least one pump which supplies the liquid jet generator with the flushing liquid at the pressure of the hole.
  • the device according to the invention has a filter system which is designed in such a way that the rinsing liquid is subjected to sterile filtration.
  • the filter system is arranged, for example, in the pipe and pump system.
  • the filter system preferably has a vacuum filter and/or a vacuum pump.
  • the device also has a control unit which is designed in such a way to control the ultrasound source and/or the pump system and/or the liquid jet generator and/or the drive device of the tissue holder.
  • the at least one ultrasound source has at least one sonotrode, by means of which the ultrasound signals from the ultrasound source are transmitted to the container and/or the rinsing liquid and/or the tissue.
  • the container is preferably designed as a disposable plastic product.
  • water and/or isotonic saline and/or a buffer solution such as phosphate buffered saline and/or Ringer's solution and/or a cell culture medium.
  • a buffer solution such as phosphate buffered saline and/or Ringer's solution and/or a cell culture medium.
  • Other media that can be used as rinsing liquid are conceivable.
  • the object is also achieved by means of a method for
  • Decellularizing and/or cleaning tissue having the following method steps: a. Inserting and fixing the tissue in a liquid-tight container and b. introducing rinsing liquid into the container (3) and carrying out an ultrasonic treatment of the tissue (2) and/or c. Application of rinsing liquid to the tissue (2) for treating the tissue with pressure and/or shear flow forces and/or d. introducing irrigation fluid into the container (3) and rotating the tissue (2) to subject the tissue (2) to shear flow forces.
  • rinsing liquid is applied to the tissue in method step c) by means of a jet of liquid.
  • a jet of liquid is provided by means of a liquid jet generator, which is connected to a reservoir with rinsing liquid and/or to a rinsing liquid circuit.
  • the movement of the tissue in method step d) preferably takes place by means of a rotatably and/or drivably mounted tissue holder.
  • the movement of the tissue can be a rotational movement and/or a translational movement.
  • the tissue or the tissue holder is moved by means of the jet of rinsing liquid impinging on the tissue and/or on the movably mounted tissue holder and/or by a drive device.
  • the drive device can be the ultrasonic source, for example, with the movement being achieved by the ultrasonic signals generated.
  • the drive device can also be a motor unit.
  • the motor unit may be a motor with a shaft, the tissue mount being arranged on the shaft of the motor unit. It is possible that a motor unit is used, which generates a translatory movement of the tissue holder and/or the tissue.
  • the method according to various embodiments can have the following method step: setting a power of the ultrasound source and/or setting pump parameters for generating the jet of rinsing liquid and/or setting an application duration of the method and/or setting drive parameters.
  • treatment programs can be created, for example, by means of the control unit and/or by means of a software program or the like. Parameters for controlling the ultrasound source and/or for controlling the pump system and/or for setting a time factor can be stored in these.
  • the treatment programs are adapted to the type and size of the tissue.
  • sterile filtration of the rinsing liquid takes place in a further method step. This can, for example, after a leak and / or pumping out of the container and / or before reinserting into the container and / or before applying the rinsing liquid again to the tissue.
  • the rinsing liquid is preferably pumped out via a drain in the container.
  • allografts/tissue pretreated by high pressure can be decellularized and cleaned in an automated process by means of mechanical cleaning processes (ultrasound, liquid jet and/or shear flow).
  • the rinsing process can be carried out according to a defined protocol/program, depending on the tissue, by means of simultaneous or sequential application of the cleaning processes.
  • the immune reaction in the recipient of the tissue to be transplanted can be reduced by flushing the allografts or xenografts.
  • the rinsing device should be easier to handle as an apparatus/device than the previously used industrial processes for which chemically aggressive media have to be handled.
  • FIG. 1 shows a schematic structure of a device according to the invention
  • FIG. 1 shows a device 1 according to the invention for decellularizing and/or cleaning tissue 2 .
  • the device 1 according to various embodiment variants has a container 3 which is designed to be liquid-tight.
  • the device 1 has at least one ultrasound source 4 for emitting a Ultrasonic signal 41, and at least one liquid jet generator 5 for providing a jet of rinsing liquid 51.
  • the liquid jet generator 5 can be designed, for example, as a cannula or nozzle.
  • the device 1 has at least one tissue holder 6 for receiving the tissue 2 , the tissue holder 6 being arranged in the container 3 .
  • the at least one ultrasound source 4 is arranged in such a way that the ultrasound signal 41 or the ultrasound waves are sent to the tissue 2 in the tissue holder 6 .
  • the at least one liquid jet generator 5 is arranged in such a way that the liquid jet 51 is directed onto the tissue 2 in the tissue holder 6 .
  • the device 1 has a
  • Tissue holder 6 is movably arranged in the container 3, whereby a rotational movement and/or a translational movement of the tissue 2 is achieved.
  • a movement of the tissue holder 6 with the tissue 2 can be achieved by the impingement of the liquid jet 51 on the tissue holder 6 and/or on the tissue 2 .
  • the tissue holder 6 can have a drive device.
  • a drive device can, for example, have a motor unit which generates a rotational movement and/or a translational movement of the tissue holder 6 .
  • the drive device can also be the ultrasound source and/or the liquid jet generator.
  • the tissue holder 6 is preferably configured in a tissue-specific manner for receiving a type of tissue; for example, the tissue holder can have a frame for tissue-specific tissue recording. In Soft tissue, for example fascial tissue, can be clamped in this frame.
  • Soft tissue for example fascial tissue
  • a further alternative embodiment of a tissue holder 6 is the use of a grid and/or basket, in or on which the tissue 2 is accommodated in the form of granules. Further alternative types of flapping for the tissue holder 6 are conceivable.
  • the container 3 has an outlet 9 . Liquid, in particular the rinsing liquid, can be drained and/or sucked out of the container 3 via this outlet 9 .
  • the device preferably according to various aspects
  • a pipe and/or pump system 8 is configured in such a way that the at least one cannula 5 is supplied with rinsing liquid to provide the rinsing liquid jet 51 and/or the rinsing liquid is removed from the container 3, for example by means of the outlet 9.
  • the device 1 has a control unit 10 which is designed in such a way that it controls the at least one ultrasound source 4 and/or the pump system 8 and/or the at least one cannula 5 .
  • the ultrasound source has at least one sonotrode.
  • the container 3 is designed in such a way that by attaching one or more ultrasonic actuators to the container 3, the latter itself functions as an ultrasonic bath.
  • the container 3 is preferably designed as a disposable plastic product.
  • the device according to the invention has a filter system (not shown here) which is such is designed to carry out a sterile filtration of the rinsing liquid.
  • the filter system is preferably in the pipe - and pump system 8 arranged.
  • the filter system preferably has a vacuum filter and/or a vacuum pump.
  • the rinsing liquid preferably contains water and/or isotonic
  • Saline and/or a buffer solution and/or a Ringer's solution and/or cell culture medium are included in the Saline and/or a buffer solution and/or a Ringer's solution and/or cell culture medium.
  • the method according to the invention for decellularizing and/or cleaning tissue 2 is carried out as follows: a. inserting and fixing the tissue 2 in the liquid-tight container 3 and b. introducing rinsing liquid into the container 3 and carrying out an ultrasonic treatment of the tissue 2 and/or c. Application of rinsing liquid to the tissue 2 for treatment of the tissue with pressure and/or shear flow forces and/or d. Introducing irrigation fluid into the container 3 and rotating the tissue 2 to subject the tissue 2 to shear flow forces.
  • the application of rinsing liquid to the tissue 2 in method step c) preferably takes place by means of a liquid jet 51 which is provided by a liquid jet generator 5 .
  • the jet of liquid 51 is directed onto the tissue 2 by means of pressure and/or braid pressure.
  • the tissue 2 is preferably moved by means of a tissue holder 6 that is rotatably and/or drivably mounted.
  • the movement of the tissue 2 is a rotational movement and/or a translational movement.
  • the movement is achieved, for example, by applying the rinsing liquid to the tissue 2 and/or the tissue holder 6 .
  • the Movement can also be achieved by the ultrasonic waves 41 of the ultrasonic source 4 and/or by a drive unit, which has a motor, for example.
  • the movement of the tissue 2 or the tissue holder 6 causes the rinsing liquid to be applied to the tissue 2 from all sides.
  • a movement which is achieved by means of the rapid movement which is achieved, for example, with the drive unit, in combination with an applied liquid jet (e.g. without pressure or high pressure) can also achieve an application of shearing forces to the tissue, similar to a liquid jet which is applied with pressure or high pressure applied to the fabric.
  • the rinsing liquid can be pumped out of the container 3 via an outlet 9 in a further method step.
  • a sterile filtration of the rinsing liquid is conceivable in a further process step. The sterile filtration can take place after the rinsing liquid has run out and/or been pumped out of the container 3 and/or before the rinsing liquid is reintroduced into the container 3 and/or before the rinsing liquid is applied to the tissue 2 again.
  • a device according to claim 1 or a device as shown in Figure 1 can be used.
  • the user of the device can make various settings to carry out the method, for example settings for the power of the ultrasound source and/or settings for the pump parameters for generating the jet of rinsing liquid and/or settings for the duration of use.
  • These settings can be tissue-specific.
  • Treatment programs/treatment protocols can also be created for this purpose. For example, for different tissue types, different Treatment protocols are created that the user can set when using a specific type of tissue.
  • Ultrasonic treatment and treatment with rinsing liquid can be applied simultaneously or sequentially.
  • tissue 2 Decellularization and/or cleaning of tissue 2, as is also shown by way of example in FIG. 1, from a liquid-tight container 3 in which tissue 2 is decellularized.
  • the container 3 is compactly accommodated in a housing 7 together with one or more ultrasound sources 4 and one or more cannulas 5, for example four cannulas 5.
  • the container 3 is preferably designed as a sphere with two half-shells (as shown in FIG. 1). However, other shapes of the container 3 are conceivable.
  • the container 3 has at least one outlet 9 through which the rinsing liquid with cell debris can be removed.
  • tissue-specific designed tissue holder 6 in the container 3 for fixing the tissue 2 to be cleaned.
  • the tissue holder 6 can be movably mounted in the container 3 so that the commercial sample 2 - stimulated by the ultrasound 41 or the spray jet/shear flow 51 - can rotate and an even washing result is achieved.
  • the ultrasonic actuator 4 is controlled via external control units 10 and the cannulas 5 for the jet of rinsing liquid or the shear flow 51 are supplied with rinsing medium by means of external pumps 8 (e.g. syringe or hose pumps) and the rinsing liquid with cell residues is sucked out again.
  • the flushing system is controlled via a PC or a controller with user interface 10.
  • transplant tissue 2 is introduced into the opened container 3 and fixed in a tissue holder 6 .
  • the tissue holder 6 is preferably specifically adapted to the respective type of tissue 2 .
  • soft tissue such as fascial tissue
  • the container 3 is then closed, for example by means of a screw connection.
  • the container 3 together with the ultrasound source 4 and liquid jet generators 5 is preferably fixed in a housing 7 .
  • the tissue 2 For the application with ultrasound 41, the tissue 2 must be immersed in a liquid rinsing medium (preferably isotonic saline solution, buffer solution such as PBS, Ringer's solution) so that the cavitation generated by the ultrasound 41 can produce its erosive effect. Cells are detached from the tissue 2 as a result of the erosion.
  • a liquid rinsing medium preferably isotonic saline solution, buffer solution such as PBS, Ringer's solution
  • the ultrasound application is preferably implemented via an ultrasound source 4 with a sonotrode.
  • the container 3 itself can function as an ultrasonic bath by attaching one or more ultrasonic actuators.
  • a further possibility is to position the container 3 in a separate ultrasonic tank with liquid, with the ultrasonic excitation being transmitted from the tank via the liquid to the container 3 and thus also to the rinsing liquid inside the container 3 .
  • the liquid jet 51 one or more liquid jet generators 5 are guided into the container 3, through which the liquid rinsing medium is jetted onto the tissue 2 at high pressure in a pump and/or pipe system 8, thereby detaching cells from the tissue.
  • the pump and pipe system 8 preferably has a reservoir and at least one pump.
  • the intensity of the treatment (power of the ultrasound source 4, pump parameters for generating the liquid jet 51) and the duration of use can be set, for example, using a user interface 10 and depending on the type of tissue 2 (hard or soft tissue) and other properties of the allograft 2 (e.g. its mass or shape) can be adjusted.
  • Treatment protocols can be programmed with one or more mechanical treatment types. If different types of mechanical cleaning are selected, they can be cleaned simultaneously (e.g. ultrasonic treatment and at the same time rinsing with a liquid jet 51) or sequentially (eg first breaking down the tissue matrix by means of ultrasound 41 and then rinsing out the cell residues by means of a spray jet 51). The rinsing liquid with the cell remains is pumped out via the outlet 9 as required or continuously.
  • the tissue 2 can be removed directly from the container 3 or from the holder 6 .
  • the container 3 is opened again and the tissue holder 6 with the tissue 2 is removed. Since the rinsing device 1 comes into contact with human or animal cell material during operation and can only be cleaned with great effort, the container 3 and/or the spray jet generator 5 is preferably designed as a disposable plastic product, while the ultrasound source 4 and the control periphery 10 are simple are easy to clean and can be used permanently.

Abstract

L'invention concerne un dispositif et un procédé de décellularisation et/ou de nettoyage de tissus. L'invention vise par conséquent à éliminer les inconvénients existants selon l'état de la technique et à décellulariser et nettoyer des allogreffes ou des xénogreffe dans un processus automatisé. L'invention vise en outre à proposer un dispositif permettant de décellulariser et de nettoyer des matières tissulaires de différents types dans un processus automatisé. Le dispositif comporte une source d'ultrasons (4) et un dispositif de production de jet de liquide (5).
PCT/EP2022/063324 2021-05-19 2022-05-17 Dispositif et procédé de décellularisation et/ou de nettoyage de tissus WO2022243319A1 (fr)

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DE102021112930.3A DE102021112930A1 (de) 2021-05-19 2021-05-19 Vorrichtung und Verfahren zum Dezellularisieren und/oder Reinigen von Gewebe Beschreibung

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5513662A (en) * 1991-12-31 1996-05-07 Osteotech, Inc. Preparation of bone for transplantation
DE19508279C1 (de) 1995-03-08 1996-05-09 Hans Mueller Gerät zur Bestrahlung von Blut und/oder Gewebsextrakten mit UV-Licht
US6024735A (en) * 1996-03-20 2000-02-15 Lifenet Research Foundation Process and composition for cleaning soft tissue grafts optionally attached to bone and soft tissue and bone grafts produced thereby
EP0988069B1 (fr) 1997-06-13 2002-11-27 Edwards Lifesciences Corporation Traitement des tissus biologiques pour reduire la calcification
WO2005112627A1 (fr) * 2004-04-20 2005-12-01 Regeneration Technologies, Inc. Processus et appareil de traitement d'implants
US20070160493A1 (en) * 2006-01-10 2007-07-12 Allosource Apparatus and Methods For Treating Allograft Products
US20170232145A1 (en) * 2012-09-04 2017-08-17 University Of Leeds Composite Bone Implants
US20180071079A1 (en) * 2011-12-09 2018-03-15 The Board Of Trustees Of The Leland Stanford Junior University Methods of treating a musculoskeletal tissue interface injury using decellularized composite tissue bioscaffolds

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5513662A (en) * 1991-12-31 1996-05-07 Osteotech, Inc. Preparation of bone for transplantation
DE19508279C1 (de) 1995-03-08 1996-05-09 Hans Mueller Gerät zur Bestrahlung von Blut und/oder Gewebsextrakten mit UV-Licht
US6024735A (en) * 1996-03-20 2000-02-15 Lifenet Research Foundation Process and composition for cleaning soft tissue grafts optionally attached to bone and soft tissue and bone grafts produced thereby
EP0988069B1 (fr) 1997-06-13 2002-11-27 Edwards Lifesciences Corporation Traitement des tissus biologiques pour reduire la calcification
WO2005112627A1 (fr) * 2004-04-20 2005-12-01 Regeneration Technologies, Inc. Processus et appareil de traitement d'implants
US20070160493A1 (en) * 2006-01-10 2007-07-12 Allosource Apparatus and Methods For Treating Allograft Products
US20180071079A1 (en) * 2011-12-09 2018-03-15 The Board Of Trustees Of The Leland Stanford Junior University Methods of treating a musculoskeletal tissue interface injury using decellularized composite tissue bioscaffolds
US20170232145A1 (en) * 2012-09-04 2017-08-17 University Of Leeds Composite Bone Implants

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