Abstract: The present invention relates to a modular supramolecular bioresorbable or biomedical material comprising (i) a polymer comprising at least two 4H-units and (ii) a biologically active compound. Optionally, the supramolecular bioresorbable or bio medical material comprises a bioresorbable or biomedical polymer as third component to tune its properties (mechanical and bioresorption properties). The supramolecular bioresorbable or biomedical material is especially suitable for biomedical applications such as controlled release of drugs, materials for tissue-engineering, materials for the manufacture of a prosthesis or an implant, medical imaging technologies.

Abstract: The invention provides biomatrix compositions comprising cross-linked lactoferrin, either alone or in combination with other organic or inorganic components. Also provided are methods of making and using the biomatrix compositions. As described herein, cross-linked lactoferrin biomatrix retains the bioactivities of the lactoferrin molecule. The biomatrix composition can act as a matrix for cell adhesion and growth and is particularly useful in musculoskeletal tissue regeneration. The biomatrix compositions can be pre-formed or injectable and can act as a cell, drug or protein delivery vehicle.

Abstract: A hydrogel-metal assembly is provided. An intervening polymer network is used to bond together a water-swollen hydrogel layer and a biocompatible surface-modified metallic layer. The hydrogel layer is a water-swollen hydrogel layer of at least two interpenetrating polymers. The surface of the biocompatible surface-modified metallic layer is surface-modified with an inorganic material. The intervening polymer network has been chemically grafted to the inorganic material of the biocompatible surface-modified metallic layer through bi-functional linker molecules. The intervening polymer network is further physically or chemically cross-linked with the polymers of the water-swollen hydrogel. The hydrogel-metal assembly can be adapted to form a medical device, medical implant, an artificial implant, an orthopedic implant, or at least as part of a joint.

Abstract: A preform for making a prosthetic limb socket includes an injection molded disk of thermoplastics material, and a peripheral portion of the disk is supported by a rigid metal ring. The ring and the peripheral disk portion have an interfitting connection which permits the disk and ring to be heated in an oven. The ring and softened disk are then inverted and stretched downwardly over a positive model of a residual limb while a vacuum is introduced through holes within the model to form a plastic socket which conforms to the model. The interfitting connection may be peripherally spaced studs on the ring and projecting into corresponding holes in the disk or may be an annular rib or arcuate rib sections on the ring which project into an annular recess or arcuate cavities within the disk. After the plastic cools, the ring is separated for reuse.

Abstract: Methods for fabricating coatings for implantable medical devices are disclosed. The method comprises forming a coating on an implantable device comprising an interpenetrating network or semi-interpenetrating network. The interpenetrating network or semi-interpenetrating network comprises poly(ethylene glycol) and an aliphatic polyester copolymer. It is also provided an implantable device and a method of using the implantable device.

Abstract: An image is captured or otherwise converted into a signal in an artificial vision system. The signal is transmitted to the retina utilizing an implant. The implant consists of a polymer substrate made of a compliant material such as poly(dimethylsiloxane) or PDMS. The polymer substrate is conformable to the shape of the retina. Electrodes and conductive leads are embedded in the polymer substrate. The conductive leads and the electrodes transmit the signal representing the image to the cells in the retina. The signal representing the image stimulates cells in the retina.

Abstract: The invention relates to medical technology and could be used in manufacturing artificial cardiac valves having one or more cusps made of a polymer composite. The method for manufacturing a cusp of an artificial cardiac valve, includes the steps of: manufacturing a casting mold, and molding a cusp from a polymer composite comprising 78 to 92% by weight of polyamide and 8 to 22% by weight of radiographic contrast medium dispersed therein. The polymer composite can comprise additionally fine acetylene black in amount of 1 to 2% by weight. The preferred radiographic contrast medium is barium sulphate. In one embodiment of the method, the casting mold is manufactured for the molding size 1 to 5% less than necessary, and the cusp is placed after molding into an anticoagulant solution and matured therein until expanding by 1 to 5%.

Abstract: Certain embodiments of the invention include forming a material in situ by introducing into a space within a patient a water soluble polymer precursor of at least about 10,000 molecular weight solubilized in a flowable aqueous solution. Functional groups on the polymer precursor undergo covalent bonding in situ to form a solid and nonbiodegradable material having a swellability less than about 20% v/v and a Young's modulus of at least about 100 kPa within about 30 seconds to about 30 minutes of initiating a chemical reaction of the functional groups to form the solid material.

Abstract: Certain embodiments of the invention include forming a material in situ by introducing into a space within a patient a water soluble polymer precursor of at least about 10,000 molecular weight solubilized in a flowable aqueous solution. Functional groups on the polymer precursor undergo covalent bonding in situ to form a solid and nonbiodegradable material having a swellability less than about 20% v/v and a Young's modulus of at least about 100 kPa within about 30 seconds to about 30 minutes of initiating a chemical reaction of the functional groups to form the solid material.

Abstract: The present invention relates to amphiphilic block copolymers comprising at least one block of hydrophilic units and at least one block of hydrophobic units, wherein at least one hydrophobic block contains siloxane units. The present invention may be particularly useful as a tissue adhesive or as a coating for an intraocular lens (IOL). As an IOL coating, copolymers according to the invention may be used, for example, to promote tissue adhesion for the prevention of posterior capsule opacification.

Abstract: Provided are an artificial dura mater having a laminated constitution of at least two layers of in vivo degradable polymers, at least one layer of them being a substrate layer, the substrate layer being formed of a lactic acid/glycolic acid/?-caprolactone copolymer, the copolymer having a component molar ratio of 60-85:3-15:10-30 mol % and the copolymer having an average chain length that satisfies the following expressions (1) to (3) and a process for the production thereof, and when this artificial dura mater is used, no liquid leakage is caused since the bloating of suture holes is small, and the period of time for which it retains its strength is suitably a little longer than the period of time required for the regeneration of an autodura mater, 2<L(LA)<[LA%/(LA%+GA%+CL%)]×X×0.058??(1) 1<L(GA)<[GA%/(LA%+GA%+CL%)]×X×0.58??(2) 1<L(CL)<[CL%/(LA%+GA%+CL%)]×X×0.

Abstract: A biocompatible material having excellent biocompatibility such as small interaction with a component of a living body such as a protein or blood cell. A biocompatible material comprising a polymer obtained by polymerizing a monomer composition comprising an amino acid-type betaine monomer represented by the formula (I): wherein R1 is a hydrogen atom or a methyl group; R2 is an alkylene group having 1 to 6 carbon atoms; each of R3 and R4 is independently an alkyl group having 1 to 4 carbon atoms; R5 is an alkylene group having 1 to 4 carbon atoms; and Z is an oxygen atom or an —NH group; and a polymerizable monomer represented by the formula (II): wherein R1 is as defined above; and R6 is a monovalent organic group, in a weight ratio, i.e. amino acid-type betaine monomer/polymerizable monomer, of from 1/99 to 100/1. The biocompatible material can be suitably used, for example, in food, a food additive, a medicament, a quasi-drug, a medical device, cosmetics, a toiletry article, or the like.

Abstract: A crosslinkable macromer system and related methods of preparing the system and using the system in the form of a crosslinked matrix between a tissue site and an implant article such as a tissue implant or on the porous surface of a prosthetic device. The macromer system includes two or more polymer-pendent polymerizable groups and one or more multifunctional initiator groups. The polymerizable groups and the initiator group(s), when polymer-pendent, can be pendent on the same or different polymeric backbones. The macromer system provides advantages over the use of polymerizable macromers and separate, low molecular weight initiators, including advantages with respect to such properties as nontoxicity, efficiency, and solubility. A macromer system of the invention can be used as an interface between the tissue site and implant article in a manner sufficient to permit tissue growth through the crosslinked matrix and between the tissue site and implant.

Abstract: The present invention relates to a modular supramolecular bioresorbable or biomedical material comprising (i) a polymer comprising at least two 4H-units and (ii) a biologically active compound. Optionally, the supramolecular bioresorbable or bio medical material comprises a bioresorbable or biomedical polymer as third component to tune its properties (mechanical and bioresorption properties). The supramolecular bioresorbable or biomedical material is especially suitable for biomedical applications such as controlled release of drugs, materials for tissue-engineering, materials for the manufacture of a prosthesis or an implant, medical imaging technologies.

Abstract: A medical device comprising a substrate having a plasma polymerized functionality bonded to at least a portion of the substrate. A superoxide dismutase mimic agent having a complimentary functional group to the plasma polymerized functionality is bonded to the portion of the substrate by bonding to the plasma polymerized functionality. The functionalities can be carboxylate, amine, or sulfate groups and/or polyethylene glycol and can optionally include crosslinking groups.

Abstract: A component made from a crosslinked polymeric material, wherein the crosslinked polymeric material has a reduced crystallinity is described. An associated method for fabricating such a component is also described.

Abstract: Polymer composite implantable medical devices, such as stents, and methods of manufacturing such devices are disclosed.

Abstract: A medical device comprising a substrate having a plasma polymerized functionality bonded to at least a portion of the substrate. A superoxide dismutase mimic agent having a complimentary functional group to the plasma polymerized functionality is bonded to the portion of the substrate by bonding to the plasma polymerized functionality.

Abstract: Certain embodiments of the invention include forming a material in situ by introducing into a space within a patient a water soluble polymer precursor of at least about 10,000 molecular weight solubilized in a flowable aqueous solution. Functional groups on the polymer precursor undergo covalent bonding in situ to form a solid and nonbiodegradable material having a swellability less than about 20% v/v and a Young's modulus of at least about 100 kPa within about 30 seconds to about 30 minutes of initiating a chemical reaction of the functional groups to form the solid material.

Abstract: A prosthetic nucleus prepared from blends of polyvinylalcohol and polyvinyl pyrollidone or its copolymers for replacement of the nucleus pulposus in intervertebral discs is provided. Also provided are methods of replacing the nucleus pulposus and treating disc degeneration-associated pain in mammals using this prosthetic nucleus.

Abstract: A crosslinkable macromer system and related methods of preparing the system and using the system in the form of a crosslinked matrix between a tissue site and an implant article such as a tissue implant or on the porous surface of a prosthetic device. The macromer system includes two or more polymer-pendent polymerizable groups and one or more initiator groups (e.g., polymer-pendent initiator groups). The polymerizable groups and the initiator group(s), when polymer-pendent, can be pendent on the same or different polymeric backbones. The macromer system provides advantages over the use of polymerizable macromers and separate, low molecular weight initiators, including advantages with respect to such properties as nontoxicity, efficiency, and solubility. A macromer system of the invention can be used as an interface between the tissue site and implant article in a manner sufficient to permit tissue growth through the crosslinked matrix and between the tissue site and implant.

Abstract: An anisotropic bending element which contains at least the following layers: I. a reinforcing layer I, which contains a fibrous reinforcing component I with a tensile modulus of elasticity of from 1,800 to 20,000 N/mm2, and II. an elastomeric layer II with a tensile modulus of elasticity of from 2 to 1,300 N/mm2; the component I of the reinforcing layer or layers I and the total amount of elastomer of the layer or layers II having in relation to one another a weight ratio of 1:99 to 40:60 and, in the case of bending about an axis running parallel to the reinforcing layer I, the ratio of the rigidity of the complete bending element in the case of a positive direction of rotation in relation to the rigidity in the case of a negative direction of rotation being 1:1.2 or more. The bending element can be used, for example, as an insert part for sports shoes.

Abstract: The present invention provides an artificial dura mater which comprises an amorphous or low crystallinity polymer as a constituent component and which prevents the cerebrospinal fluid leakage.

Abstract: Intraocular lenses and methods producing the same are provided. The intraocular lens includes an optic and a haptic that are integrally formed together. The haptic has a polyimide coating. The polyimide coating promotes fibrosis in the surrounding eye tissue to enhance the anchoring of the IOL after it is implanted in an eye.

Abstract: A soft and elastic prosthetic liner blank for customizing to an individual user is formed from thermoplastic material and molded to a hollow, generally rotation symmetric shape having at least one radial dimension. The liner blank has an open proximal end for insertion of the residuum of an amputee's arm or leg and a closed distal end, and the liner blank further having a material composition allowing thermo-forming of the liner blank while maintaining elasticity in the thermally applied shape. The radius of the liner blank is dimensioned to accommodate and to adopt, through plastic deformation, any sectional profile included in the positive copy.

Abstract: A novel coating for medical devices provides nitric oxide delivery using nanofibers of linear poly(ethylenimine)diazeniumdiolate. Linear poly(ethylenimine)diazeniumdiolate releases nitric oxide (NO) in a controlled manner to tissues and organs to aid the healing process and to prevent injury to tissues at risk of injury. Electrospun nano-fibers of linear poly(ethylenimine) diazeniumdiolate deliver therapeutic levels of NO to the tissues surrounding a medical device while minimizing the alteration of the properties of the device. A nanofiber coating, because of the small size and large surface area per unit mass of the nanofibers, provides a much larger surface area per unit mass while minimizing changes in other properties of the device.

Abstract: This invention provides a new class of medical devices and implants comprising amorphous metal alloys. The medical devices and implants may be temporary or permanent and may comprise other materials as well, such as polymers, ceramics, and conventional crystalline or polycrystalline metal alloys.

Abstract: Compositions and methods for forming hydrogels in situ through a combination of physical and chemical crosslinking processes are provided in which physical crosslinking is mediated by one or more natural or synthetic components that stabilize the a hydrogel-forming precursor solutions at a deposition site for a period of time sufficient for more resilient chemical crosslinks to form. Methods of using such hydrogels as tissue coatings to prevent postsurgical adhesion formation, as tissue augmentation or luminal occlusion aids, as matrices for carrying cells, drugs or other bioactive species, as tissue sealants or adhesives, and as medical device coatings also are provided.

Abstract: A medical prosthesis includes a body having a silicone skin and a silicone foam body core. The skin and foam body core are both resilient. The core includes a plurality of voids and a plurality of discontinuities. Some of the discontinuities communicate with more than one void.

Abstract: A work hardened articulating surface for anatomical prosthetics. Articulating surfaces of prosthetics are work hardened to decrease the wear and increase the longevity of the prosthetic after implantation. The articulating surface can be hardened in any number of ways, for example the articulating surface can be formed from stock material that has been work hardened throughout or the articulating surface can be work hardened prior to final finishing of the prosthetic component. Regardless, the hardened articulating surface reduces wear after implantation while eliminating the need for a separate bearing component.

Abstract: The invention concerns an endoprosthesis comprising a carrier structure which contains a metallic material wherein the metallic material contains a magnesium alloy of the following composition: magnesium: >90%, yttrium: 3.7%-5.5%, rare earths: 1.5%-4.4% and balance: <1%.

Abstract: The present invention is a synthetic, biocompatible, bioabsorbable, porous foam tissue scaffolds possessing physicochemical properties suitable for use in the repair and regeneration of dermal tissue and to methods of preparing the foam scaffold.

Abstract: An hydratable porous polymer comprising a polymerized polyorganosiloxane macromonomer of formula I Q—[M—L]c—M—Q  (I) wherein c is in the range of from 0 to 5, preferably in the range of from 0 to 3; M may be the same or different and is a difunctional block of molecular weight in the range of from 100 to 8000 and wherein at least one M comprises a residue from a difunctional polymer or copolymer comprising siloxane repeat units of formula II where R1 and R2 may be the same or different and are selected from the group consisting of hydrogen, optionally substituted alkyl, alkenyl, alkynyl, aryl, haloalkyl, haloalkenyl, haloalkynyl, haloaryl, heterocyclyl, and haloheterocyclyl; L is a difunctional group; and Q may be the same or different and is a polymerizable group.

Abstract: The aggregation of platelets on the surface of a foreign body exposed to the flowing blood of a living being (such as plastic tubing, a balloon or the end of a catheter surgically inserted in a blood vessel, a stent implanted therein or synthetic grafts, which surface normal promotes such platelet aggregation to form a coating firmly affixed to that surface which would restrict the flow of blood past that surface or to form a blood clot detachable from that surface), is inhibited by a gas permeable coating on the surface of a physiologically acceptable polymer as which contains dissolved or dispersed therein a nitrosyl-containing organometallic compound, such as sodium nitroprusside, which is protected from diffusion from the coating and from direct contact with the blood and which slowly decomposes at the body temperature within the coating and in so doing releases a platelet aggregation-inhibiting amount of nitric oxide which diffuses from the coating during the period when platelet aggregation by the surfa

Abstract: A socket device of a prosthetic includes a liner with a variable viscosity fluid disposed between the socket and the user's stump. The variably viscosity fluid varies the softness or stiffness of socket. In addition, the variable viscosity fluid conforms to the contours of the user's stump for a more customized fit. The variable viscosity fluid can include a shear stiffening material that increases in viscosity as a load or strain, or rate of loading or rate of strain, applied, or a magneto or electro rheologic fluid responsive to a magnetic or electric field.

Abstract: We make a substrate biocompatible by contacting it with a starting material and initiating alternating charge layer electrostatic self assembly to form a thin film. Starting materials may be poly(vinylpyrrolidone), poly{bis-(carboxylatophenoxy)phosphazene}, poly(methacrylic acid), poly(l)-lysine, poly(ethylene glycol), poly(D-glucosamine), poly(l-glutamic acid), poly(diallyldimethylamine), poly(ethylenimine), hydroxy fullerene, long-sidechain fullerene, or other polymers that participate in electrostatic self-assembly. The thin film fabrication advantageously may be at room temperature. A biocompatible thin film that is uniform and homogeneous can be provided. Optionally, ZrO2, Al2O3 or TiO2 nanoclusters also may be used in the film assembly. The film may be used in a drug delivery device or a medical device. The film may be used for tissue engineering.

Abstract: Biocompatible prostheses, specifically, biocompatible heart valves, are described which comprise a blend of a polyurethane (PU) and a polysiliconeurethane (PSU). Preferably, the polyurethane is a polyetherurethane (PEU). More preferably, it is a polyetherurethane urea (PEUU). Such prostheses typically exhibit reduced mineralization or thrombosis and/or reduced biological degradation.

Abstract: A suturing ring to attach the body of an implantable heart valve to heart tissue by sutures is composed of a fabric containing an inorganic antimicrobial agent. The fabric can have a material coating the fibers of the fabric in which particles of the agent are embedded. The coating material can be elastomeric and the fabric porous, to improve its flexibility, or non-porous and the fabric ring can be coated with a tissue compatible substance such as collagen. One type of ring has an annular top part to fit over one of top and bottom surfaces of the valve body and defining an opening to the heart valve, a step wall depending from the annular top part to extend along said valve body wall and an outwardly extending flange through which the sutures are to be sewn.

Abstract: A method for implanting cells onto a prosthesis includes the steps of: (a) providing a prosthesis including a porous tube, where at least 25% of the pores on the inner surface of the tube have diameters of more than about 40 &mgr;m, at least 25% of the pores on the outer surface of the tube have diameters of less than about 30 &mgr;m, and the tube includes a substantially continuous layer of a biocompatible material; (b) contacting the prosthesis with a suspension of cells; and (c) providing a pressure differential between the inner surface and the outer surface, whereby the cells are retained in the pores of the inner surface. A method for obtaining an endothelial cell culture from a blood sample involved:(a) obtaining a sample for mononuclear cells from a blood sample; and (b) culturing the sample of mononuclear cells, without further cell separation, on a cell adhesive polymer-coated solid support in the presence of endothelial growth factors.

Abstract: Artificial skin having a thickness of 100 to 1,000 &mgr;m, and prepared from a polymer which, when formed into a thin film having a thickness of 100-1,000 &mgr;m, exhibits a percent transmission of light having a wavelength of 450-280 nm of at least 10%. In the artificial skin of the present invention, grooves which imitate furrows are provided on one surface. Also disclosed is a method for evaluating UV screening agents making use of the artificial skin of the present invention, on the basis of the relation between UV shielding power of a UV screening agent and UV transmission through the artificial skin.

Abstract: An implantable prosthesis can be formed from an improved biocompatible material that provides for cellular colonization of the biocompatible material. Specifically, the biocompatible material is a rigid porous material. In embodiments of particular interest, the implantable prosthesis is a mechanical heart valve prosthesis with a rigid occluder. In some embodiments, the rigid occluder is formed from the biocompatible material. A filler comprising a hydrogel or a structural protein can be located within the pores. In some embodiments, a bioactive agent is within the pores. In some embodiments, the rigid occluder is formed from a polymer material, a carbonaceous solid or a ceramic material. The pores can extend through the rigid material.

Abstract: A preform for making a prosthetic limb socket includes an injection molded flat circular disk of rigid thermoplastics material, and the disk has a peripheral portion with an embedded reinforcing ring which was spaced as an insert within the mold cavity. The preform is heated within an oven on a flat surface support ring, and the softened disk is manually drawn and stretched downwardly over a positive model of a residual limb while vacuum is introduced through small holes within the model to form a plastic socket which conforms to the positive model. After the plastic cools, the annular base portion of the disk with the embedded reinforcing ring is trimmed from the socket, and the model is removed from the socket.

Abstract: A method of providing a therapeutic, diagnostic or lubricious hydrophilic coating on an intracorporeal medical device and the coated device produced thereby, wherein the coating is durable. In one embodiment, the coating comprises a polymerized base coat and a top coat having a therapeutic, diagnostic or hydrophilic agent, where the base coat has a binding component which binds to the top coat, and a grafting component which binds to the binding component and adheres to the device. In another embodiment, the coating comprises a blend of an agent, a grafting component, and salt. In one embodiment, the therapeutic agent is superoxide dismutase or a superoxide dismutase mimic. The coating of the invention may be applied to a medical device with a polymeric surface such as a polymeric catheter, or a metal device such as a stent coated with a polymeric primer or without a primer.

Abstract: One embodiment of a hollow spinal spacer (10) includes a curved anterior wall (11) having opposite ends (12, 13), a posterior wall (15) having opposite ends (16, 17), two lateral walls (20, 21), each integrally connected between the opposite ends (12, 13, 16, 17) of the anterior (11) and posterior (15) walls to define a chamber (30). The walls (11, 15, 20, 21) include a superior face (35) and an inferior face (40). The superior face (35) defines a first opening (36) in communication with the chamber (30) and includes a first vertebral engaging surface (37). The inferior face (40) defines a second opening (41) in communication with the chamber (30) and includes a second vertebral engaging surface (42).

Abstract: An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring. The template may have an outwardly-facing groove to receive and retain the ring.

Abstract: Nucleus pulposus implants that are resistant to migration in and/or expulsion from an intervertebral disc space are provided. In one form of the invention, an implant includes a load bearing elastic body surrounded in the disc space by an anchoring, preferably resorbable, outer shell. In certain forms of the invention, the elastic body is surrounded by a supporting member, such as a band or jacket, and the supporting member is surrounded by the outer shell. Kits for forming such implants are also provided. In another form of the invention, an implant is provided that has locking features and optional shape memory characteristics. In yet another aspect of the invention, nucleus pulposus implants are provided that have shape memory characteristics and are configured to allow short-term manual, or other deformation without permanent deformation, cracks, tears, breakage or other damage. Methods of forming and implanting the implants are also described.

Abstract: A coating composition is provided comprising hyaluronic acid or a salt thereof and a blocked polyisocyanate in a solvent comprising water. A method is provided for preparing the coating on a substrate comprising forming a coating mixture of hyaluronic acid or a salt thereof and a blocked polyisocyanate in a solvent comprising water; applying the coating mixture to the substrate; and curing the coating.

Abstract: The invention relates to an osteoinductive biomaterial, which is based on a ceramic material and which has a total porosity of 20 to 90%, wherein macropores are present having a size ranging from 0.1 to 1.5 mm, and wherein micropores are present having a size ranging from 0.05 to 20 &mgr;m. The invention further relates to a process for preparing said osteoinductive biomaterial.

Abstract: The present invention comprises a poly (vinyl alcohol) hydrogel construct having a wide range of mechanical strengths for use as a human tissue replacement. The hydrogel construct may comprise a tissue scaffolding, a low bearing surface within a joint, or any other structure which is suitable for supporting the growth of tissue.

Abstract: A soft and elastic prosthetic liner blank for customizing to an individual user is formed from thermoplastic material and molded to a hollow, generally rotation symmetric shape having at least one radial dimension. The liner blank has an open proximal end for insertion of the residuum of an amputee's arm or leg and a closed distal end, and the liner blank further having a material composition allowing thermo-forming of the liner blank while maintaining elasticity in the thermally applied shape. The radius of the liner blank is dimensioned to accommodate and to adopt, through plastic deformation, any sectional profile included in the positive copy.