DE102004008459A1 - Implant, useful as stents, comprises a fabric and at least a radiopaque marker, which passes in a direction along the implant - Google Patents

Implant, useful as stents, comprises a fabric and at least a radiopaque marker, which passes in a direction along the implant

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Publication number
DE102004008459A1
DE102004008459A1 DE200410008459 DE102004008459A DE102004008459A1 DE 102004008459 A1 DE102004008459 A1 DE 102004008459A1 DE 200410008459 DE200410008459 DE 200410008459 DE 102004008459 A DE102004008459 A DE 102004008459A DE 102004008459 A1 DE102004008459 A1 DE 102004008459A1
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DE
Germany
Prior art keywords
characterized
thread
implant
radiopaque
implant according
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.)
Withdrawn
Application number
DE200410008459
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German (de)
Inventor
Reinhard Dr.med. Benthin
Helmut Dr.Rer.Nat. Goldmann
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Aesculap AG
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Aesculap AG
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Filing date
Publication date
Application filed by Aesculap AG filed Critical Aesculap AG
Priority to DE200410008459 priority Critical patent/DE102004008459A1/en
Publication of DE102004008459A1 publication Critical patent/DE102004008459A1/en
Application status is Withdrawn legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/04X-ray contrast preparations
    • A61K49/0404X-ray contrast preparations containing barium sulfate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Abstract

The invention relates to an implant, in particular a vascular implant, with textile structure and at least one radiopaque marker, which preferably extends in a longitudinal direction of the implant. As a radioopaque marker at least one thread with radiopaque properties is incorporated into the textile structure with the same textile bond as other threads of the textile structure.

Description

  • The The invention relates to an implant, in particular a vascular implant, with textile structure and at least one radiopaque marker, the preferably in a longitudinal direction of the implant runs.
  • longitudinal Implants, in particular tubular Vascular grafts, usually have at least one guideline in the longitudinal direction of the implant runs. This guideline is intended as an orientation guide when implanting a vascular prosthesis represent an undesirable Twisting the vascular prosthesis too avoid.
  • In order to be able to control the position of an implant even after implantation or during a confusing operation, implants are permanently or temporarily provided with radio-opaque markers, whereby it is possible to check the position of the implant by means of X-ray images. So it is from the EP 0 894 481 A2 and the US 6,626,936 B2 Known to incorporate metallic wires with radio opaque properties in endoprostheses, which are subsequently herauslösbar from the endoprosthesis. From this document it is also known to provide permanent markers, for example in the form of short pieces of wire, which are wound around textile crossing points of the implant. Such markers may also be in the form of spot spots of radiopaque material that are permanently attached to the structure of the endoprosthesis. The radiopaque markers may be formed from a polymer containing radioopaque fillers, such as barium sulfate.
  • at Stents made of metal, as described for example in WO 94/01056 are known to process different metal wires, of which one for the the stent possesses necessary elastic properties and a Other consists of a radiopaque material.
  • From the EP 0 215 475 A1 It is known to make a multi-layer surgical sponge, wherein a radiopaque strand is incorporated. The connection of the layers is done by needling or gluing.
  • In the EP 0 699 423 B1 describes a thin-walled vascular prosthesis, which can be brought to its place of use with the help of a catheter. The vascular prosthesis may have a radiopaque guideline that may extend along the prosthesis. The guideline can consist of metallic fibers. Also, polymeric fibers can be coated or filled with radio-opaque particles. The radiopaque guideline helps the surgeon to position the prosthesis correctly.
  • The WO 95/21592 describes stents attached to one end with radiopaque Markers are provided. As such, wires of gold or platinum can be provided be that about pieces of wire of the stent are wound. The radiopaque markers can also tubular be formed and pieces of wire surrounded by the stent.
  • The Manufacture of the radio-labeled implants is consuming, as special measures for insertion or attachment of the markers are required. Become frequent Also, the properties of the implants by the markers in unwanted Way changed.
  • It Object of the invention, an implant with a radioactive To create markers that can be produced in a simple manner and themselves in terms of its mechanical and biocompatible properties behaves as one Implant without marker.
  • The Invention is characterized in that as a radioopaque marker at least one non-metallic thread with radiopaque properties in the textile structure of the implant with the same textile Bond insoluble is incorporated like other threads the textile structure.
  • According to the invention, at least one thread with radiopaque properties is processed in the same way as the other threads in the production of the implant or in the production of the textile structure on which it is based, so that no special measures have to be taken with the subsequent attachment radioactive markers or the processing of non-related materials. The normal machines can be used to make the implants. The threads with radioo Properties can be used instead of or in addition to other threads. The implants according to the invention are preferably those of non-metallic materials, in particular implants made of filaments of polymeric material. Here are primarily polyester (polyethylene terephthalate) and polypropylene in question. The filaments with radiopaque properties are preferably made of polymeric material, in particular using the same polymer as the other filaments.
  • Preferably is the at least one thread with radiopaque properties as one in the longitudinal direction of the implant extending continuous longitudinal marking. In the event of of bifurcations can be the longitudinal marker also be branched.
  • at the textile structure is preferably a warp knit or a tissue. When knitted fabric is at least one thread with radiopaque properties were involved in the textile structure. In a fabric, it is woven and lies here especially as Thread of the chain in front. The number of threads with radiopaque properties is usually between 1 and 10, in particular between 1 and 4, where already one thread can be enough. If several threads are provided, so can these lie directly next to each other, increasing the detectability is improved. It is also possible, The strings at intervals to arrange one another, e.g. distributed over the circumference of a vascular prosthesis, something extra Conclusions about the Placement of an implant allowed.
  • Of the Thread with radiopaque properties can be a monofilament thread, a pseudo-monofilament thread, a multifilament thread or a hybrid thread be, i. a thread consisting of a thread with radiopaque properties and a thread with non-radiopaque properties. Preferably is the structure of the thread with structure radiopaque properties the rest used threads adapted as possible uniform properties to obtain. For implants made of monofilament threads, such as stents, the thread with radiopaque properties is preferably also monofilament and in particular adapted to the thread size. For implants made of multifilament threads the at least one thread with radiopaque properties is preferably also multifilament.
  • at a preferred embodiment The invention is the threads with radiopaque properties in the textile structure so before that The strings or at least the radiopaque fibers of threads in the use of the implant are free of tensile stress.
  • It has been shown to be threads With radiopaque properties often do not have the tensile strengths and Have bending strengths as comparable conventional threads without radioopaque properties. This is due to the fact that non-metallic materials, in particular polymers, first with material need to be provided the threads make radioopak. For example, the threads need to be treated with radiopaque be coated or it will be hollow fibers with radiopaque agents filled or polymers prior to making the suture material with radiopaque fillers provided, which is preferred. Due to the relatively high share on radioopaque substances, the proportion of normal polymeric fiber material decreases accordingly, so that at substantially the same geometry a little less affordable mechanical properties must be accepted. This can be compensated by the threads with radiopaque properties be largely mechanically relieved in textile composite, in particular strain relief.
  • For a relief the threads With radiopaque properties there are various possibilities. So it is possible the at least one thread with radiopaque properties in the Production of the implant or its textile basic structure with lower tension than the rest To supply threads, if possible even without tension. In similar Way is it possible the at least one thread with radiopaque properties with overfeeding to work into the textile structure. The at least one thread with radiopaque properties can be considered in the textile structure Velor thread and / or as a thread with a float. Of the Thread with radiopaque properties can also be used as a thread be educated. In particular, he can at least partially as textured thread present. Is the at least one thread with radiopaque properties in the form of a multifilament thread, the both from fibers with radiopaque properties as well as normal Fibers without radioopaque properties is formed, then it is too possible, the mechanical discharge of fibers with radiopaque properties thereby causing the fibers with radiopaque properties longer in the thread are as the normal fibers. This can be done by that the fibers are curled with radiopaque properties or textured, whereas the fibers have no radioopaque properties present in the thread substantially as smooth or stretched fibers.
  • In a preferred embodiment of the invention, the at least one thread is radiopaque Properties of a spinnable polymer, in particular a thermoplastic polymer, formed, and at least one finely divided material with radiopaque properties is incorporated into the polymer, in particular melted. Particularly suitable for the production of the threads or the fibers forming them is a mass containing the radioopaque agent as filler, wherein the mass is preferably a melt or a solution. From such a mass threads or fibers can be produced with a high proportion of radiopaque substances. Preferably, fibers or filaments with radiopaque properties contain 10 to 90, in particular 20 to 65 wt.% Radioopaque agent. With a filler content of radioopaque agent of more than 50%, the mechanical stability decreases. Here preferably a mechanical relief is used. Threads with radiopaque properties which have an elongation at break of at least 20% are preferred.
  • Become Fibers with radiopaque properties with fibers without such properties mixed to a multifilament thread, then the percentage is radiopaque substances correspondingly lower in such mixed threads. mixed threads can be obtained by using fibers with radiopaque properties and Fibers without radiopaque properties are twisted together. It is also possible, at least one multifilament thread of fibers with radiopaque properties with at least one multifilament thread of fibers without radioopaque Properties converge if necessary under mutual rotation allow.
  • When radiopaque agents are known X-ray contrast agents, in particular Barium sulfate. The radio-opaque agent is preferably in finely pulverized Form ago with a particle size <1 micron, in particular of approx. 0.3 μm. To have a particularly good connection between the radiopaque agent and to achieve the polymer of the thread material, the radioopaque Agent at the surface the powder particles be modified. Suitable is an inorganic Modification, in particular with silicon and / or aluminum compounds, as well as an organic modification.
  • The fibers or threads with radiopaque properties are preferably free of other fillers, in particular titanium dioxide (TiO 2 ). This makes it possible to set the content of fillers with radiopaque properties very high.
  • Provided it is intended to implant the implant with an optically visible, i. contrasting, to provide Guideline, then runs the at least one thread with radiopaque properties preferably along this guideline. It is possible to have at least one Thread with radiopaque properties even as a contrasting color Guideline form. For this purpose, the polymer material of the thread dyed accordingly become. It is also possible in a multifilament thread, a mixture of fibers with radiopaque Properties and of non-radioactivity but dyed fibers to use.
  • Further Features of the invention will become apparent from the following description of preferred embodiments the invention in conjunction with the drawings and the dependent claims. in this connection can they individual features each for alone or in combination in one embodiment of the Invention be realized.
  • example 1
  • The preparation of the implant can be done in a conventional manner, much as in the US 4,193,137 is described using a chain-knit Doppelvelourprothese with bifurcation. For the formation of the radiopaque marker, for example, barium sulfate-containing textured threads are supplied as velor threads, which form loops in the knit.
  • Example 2
  • manufacturing of multifilament yarn
  • Polyester (Polyethylenterephtalat) with 54 wt.% Finely divided to better integrate organically modified barium sulfate (BaSO 4 ) is melted as granules in a twin-screw extruder and extruded using a 500 micron nozzle to a multifilament yarn. The filament count is 40, for example.
  • The obtained raw yarns can be at a temperature of, for example 100 ° C easily Stretch in the ovens by a factor of 2 to 5. The strength of the drawn multifilament yarn is depending on the draw ratio and Stretching conditions at 5 to 20 cN / tex. During or after the stretching can the yarns of a crimping treatment, in particular texturing, be subjected. In this form, the yarns can then as usual multifile Yarns are fed to a warp knitting machine or loom.
  • Instead of a polyester with 54 wt.% Barium sulfate, it is also possible to use a polyester which is filled with inorganically modified barium sulfate and contains less barium sulfate. Here, the filament count can be increased accordingly to obtain comparable radiopaque properties. It has also proven to be expedient to treat the filaments with a lubricant to avoid electrostatic charging during processing. Suitable for this purpose is a solution of Limanol GL AS in H 2 O (14%).
  • Example 3
  • Examples 1 and 2 are repeated under the following conditions, wherein the number of knitted filaments with radiopaque properties is between 1 and 4.
    Nozzle: 250 μ or 500 μ / 40 capillaries
    Capillary number: 20-40
    Particle size BaSO 4 : ~ 0.3 μm
    Extrusion: single screw extruder, argon coating, temperature profile 280-290 ° C, spin finish, spinning pump speed (10-40 rpm), drawing (4 times)
    Drawing: drawing temperature 80-150 ° C, fixing temperature> 135 ° C, total draw ratio 2.40-4.00, titre analogous to PET, elongation ≥ 20
  • The Properties of the threads with radiopaque properties are shown in Tables 1 and Second
  • Table 1: Strengths and titers of the different BaSO 4 containers in comparison
    Figure 00100001
  • Table 2: Test results for 25 and 40% BaSO 4 content.
    Figure 00100002
  • Figure 00110001

Claims (15)

  1. Implant, in particular vascular implant, with textile structure and at least one radiopaque marker, which preferably extends in a longitudinal direction of the implant, characterized in that as a radioopaque marker at least one thread with radiopaque properties in the textile structure with the same textile bond as other threads of the textile Structure is incorporated.
  2. Implant according to claim 1, characterized in that that the textile structure is a knitted fabric and the at least one Thread with radioopaque properties is acted upon.
  3. Implant according to claim 1, characterized in that that the textile structure is a fabric and the at least one Thread with radiopaque properties, preferably in the chain, with woven in.
  4. Implant according to one of the preceding claims, characterized characterized in that the thread is multifilament.
  5. Implant according to one of the preceding claims, characterized characterized in that threads with radiopaque properties or at least radioopaque fibers of these Threads in the textile structure so that they are free in use Tensile stress are.
  6. Implant according to one of the preceding claims, characterized characterized in that the at least one thread with radiopaque properties with overfeeding is incorporated in the textile structure.
  7. Implant according to one of the preceding claims, characterized characterized in that the at least one thread with radiopaque properties a thread is.
  8. Implant according to one of the preceding claims, characterized in that the at least one thread with radiopaque properties of a combination of smooth fibers and non-smooth fibers is formed.
  9. Implant according to claim 4, characterized in that that the at least one multifilament thread with radiopaque properties from fibers with radiopaque properties and fibers without such Properties is composed.
  10. Implant according to one of the preceding claims, characterized characterized in that the at least one thread with radiopaque properties is formed from a thermoplastic polymer and at least one finely divided material with radiopaque properties in the polymer integrated, in particular melted.
  11. Implant according to one of the preceding claims, characterized characterized in that the at least one thread, in particular fibers of the thread, from a radioopaque agent as a filler containing mass are made.
  12. Implant according to one of the preceding claims, characterized characterized in that the radioopaque agent added material 10-90, especially 20-65 Percent by weight contains radioopaque agent.
  13. Implant according to one of the preceding claims, characterized in that the at least one thread with radiopaque properties, in particular radio-opaque fibers of the thread, are free of titanium dioxide (TiO 2 ) and in particular also free of other fillers.
  14. Implant according to one of the preceding claims, characterized in that the implant, in particular the vascular prosthesis, has at least one color-contrasting guideline and the at least one Thread runs along this guideline.
  15. Implant according to one of claims 10-14, characterized that threads lying in the guideline With radiopaque properties a combination of dark, in particular black, colored Fibers and contrast agent-enriched, in particular present as cotton threads, Fibers is.
DE200410008459 2004-02-17 2004-02-17 Implant, useful as stents, comprises a fabric and at least a radiopaque marker, which passes in a direction along the implant Withdrawn DE102004008459A1 (en)

Priority Applications (1)

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DE200410008459 DE102004008459A1 (en) 2004-02-17 2004-02-17 Implant, useful as stents, comprises a fabric and at least a radiopaque marker, which passes in a direction along the implant

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102012218262A1 (en) * 2012-10-05 2014-04-10 Aesculap Ag Textile stent for patient, has orientation unit comprising thread without metallic coating and/or thread coated with amount of metal smaller than metal-coated thread on outer surface of stent at outer side of orientation unit
DE102012218263A1 (en) * 2012-10-05 2014-04-10 Aesculap Ag Textile vascular implant, particularly woven or knitted vascular implant, comprises orientation unit, which is continuously extended on outer surface of the vascular implant and differs from remaining outer surface of vascular implant
DE102013201698A1 (en) * 2013-02-01 2014-08-07 Aesculap Ag Vascular prosthesis e.g. bypass prosthesis has radiopaque threads that are extended in longitudinal direction, and are comprised of metal or metal alloy threads
DE102013201707A1 (en) * 2013-02-01 2014-08-07 Aesculap Ag Vascular prosthesis e.g. aorta sine prosthesis, for use as vessel patch i.e. two-dimensional sheet, of patient for e.g. replacement of defective wall, has orientation unit extending along direction of prosthesis and comprising interruptions
DE102009024648B4 (en) 2009-06-03 2018-05-09 Aesculap Ag Marked venous sheath, in particular for the restoration of the venous valve function of varicose veins

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994001056A1 (en) * 1992-07-13 1994-01-20 Boston Scientific Corporation Tubular medical prosthesis
WO1994016646A1 (en) * 1993-01-19 1994-08-04 Schneider (Usa) Inc. Clad composite stent
DE4424242A1 (en) * 1994-07-09 1996-01-11 Ernst Peter Prof Dr M Strecker In the body of a patient percutaneously implantable endoprosthesis
EP0788802A2 (en) * 1996-02-08 1997-08-13 Schneider (Usa) Inc., Titanium alloy self-expanding stent
EP0855170A2 (en) * 1997-01-23 1998-07-29 Schneider (Usa) Inc., Stent graft with braided polymeric sleeve
EP0680278B1 (en) * 1991-10-09 1999-01-20 Boston Scientific Corporation Impregnated stent
DE10045325A1 (en) * 2000-09-12 2002-04-04 Alco Advanced Lightweight Cons Highly flexible implant for intra- or endovascular applications (stent) and manufacturing processes
DE69624834T2 (en) * 1995-10-11 2003-07-24 Schneider Usa Inc Braided composite prosthesis

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0680278B1 (en) * 1991-10-09 1999-01-20 Boston Scientific Corporation Impregnated stent
WO1994001056A1 (en) * 1992-07-13 1994-01-20 Boston Scientific Corporation Tubular medical prosthesis
WO1994016646A1 (en) * 1993-01-19 1994-08-04 Schneider (Usa) Inc. Clad composite stent
DE4424242A1 (en) * 1994-07-09 1996-01-11 Ernst Peter Prof Dr M Strecker In the body of a patient percutaneously implantable endoprosthesis
DE69624834T2 (en) * 1995-10-11 2003-07-24 Schneider Usa Inc Braided composite prosthesis
EP0788802A2 (en) * 1996-02-08 1997-08-13 Schneider (Usa) Inc., Titanium alloy self-expanding stent
EP0855170A2 (en) * 1997-01-23 1998-07-29 Schneider (Usa) Inc., Stent graft with braided polymeric sleeve
DE10045325A1 (en) * 2000-09-12 2002-04-04 Alco Advanced Lightweight Cons Highly flexible implant for intra- or endovascular applications (stent) and manufacturing processes

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102009024648B4 (en) 2009-06-03 2018-05-09 Aesculap Ag Marked venous sheath, in particular for the restoration of the venous valve function of varicose veins
DE102012218262A1 (en) * 2012-10-05 2014-04-10 Aesculap Ag Textile stent for patient, has orientation unit comprising thread without metallic coating and/or thread coated with amount of metal smaller than metal-coated thread on outer surface of stent at outer side of orientation unit
DE102012218263A1 (en) * 2012-10-05 2014-04-10 Aesculap Ag Textile vascular implant, particularly woven or knitted vascular implant, comprises orientation unit, which is continuously extended on outer surface of the vascular implant and differs from remaining outer surface of vascular implant
DE102013201698A1 (en) * 2013-02-01 2014-08-07 Aesculap Ag Vascular prosthesis e.g. bypass prosthesis has radiopaque threads that are extended in longitudinal direction, and are comprised of metal or metal alloy threads
DE102013201707A1 (en) * 2013-02-01 2014-08-07 Aesculap Ag Vascular prosthesis e.g. aorta sine prosthesis, for use as vessel patch i.e. two-dimensional sheet, of patient for e.g. replacement of defective wall, has orientation unit extending along direction of prosthesis and comprising interruptions

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