Osteosynthesis system and method for making it

FIELD: medicine.

SUBSTANCE: group of inventions refers to surgery and may be used for making external osteosynthesis implants. An osteosynthesis system comprises a piece part on an external surface of which there is a layer of a polymer film in the electret state with the layer of the polymer film made of a fusible element. The group of inventions refers to a method for making the osteosynthesis system involving preparation the layer of the polymer film on an external surface of the piece part by coating the surface of the piece system with a fine fusible polymer powder, fusion thereof on the surface of the piece part and electrostatic charging of the prepared film.

EFFECT: group of invention provides making a uniform coating of the electret layer on the surface of the piece part of the osteosynthesis system firmly attached to the surface of the piece part that enables faster fusion of bone fragments due to electric stimulation and prevented implant corrosion.

10 cl, 1 ex

 

The technical field

The invention relates to medicine, and more particularly to surgery, and can be used in particular for the manufacture of bone implants submersible osteosynthesis.

Characterization of analogs

Known bone implant for submersible osteosynthesis, including billet of titanium alloy (see website on the Internet www.vimpel-btf.ru/page 9.html for more information.).

A method of manufacturing the implant includes forming the workpiece, the cleaning of the surface.

The disadvantage of analog is a high percentage of rejection by the patient's bone implant analog, the occurrence of complications, slowing down the process of osteosynthesis damaged bone and surrounding soft tissue of the patient. In addition, corrosion of the implant with the loss of its mechanical strength.

Characteristics of prototype

The closest analogues of the claimed device is a device for osteosynthesis, comprising a workpiece on the outer surface of which is a layer of polymer film electret state (see description to the system of the USSR №1454482). And the film made from polytetrafluoroethylene (FT-4), one side of which is deposited conductive layer of aluminium to improve the quality of electret.

The prototype of the method of obtaining a device for osteosynthesis of the prototype is the way (see description to the system of the USSR №1454482), including recip is tion on the outside surface of the film CFT-4 conductive layer of aluminum. Why take the finished film PB-4 with a thickness of 30-200 μm, on which is applied by vacuum deposition of a thin layer (0.2-0.6 µm) aluminum. Then the surface of the film CFT-4 electrified. Then the electret film placed on the workpiece and thus obtained a device for osteosynthesis - a prototype is slid into the wound, the charged surface is placed on the bone in the area of fracture and fixed with screws bone fragments. To attach the film layer CFT-4 directly to the surface of the workpiece implant impossible due to the very poor adhesion of the film CFT-4 to the surface of the metal plate of the implant.

The disadvantage of the prototype device and the prototype of this method is the impossibility of providing high-quality fastening device prototype with the surface of the metal plate of the implant.

Furthermore, the method-prototype implant does not protect against corrosion, because it does not provide a tight fit of the film CFT-4 to the surface of the plate.

In addition, in the method prototype is impossible to provide a bond film harvesting complex forms.

Technical task

Technical problem arising from the prior art, is to improve the quality of the bonding of the polymer film with the outer surface of the workpiece implant.

The goal of the project is achieved through what is claimed is a device for osteosynthesis includes the workpiece, on the outer surface of which is a layer of polymer film electret state.

Moreover, the layer of the polymer film is made of fusible copolymer of polytetrafluoroethylene. Execution of the polymer film of PB-4M allows you to implement a method, which improves the quality of the bonding of the dielectric polymer film from the surface of the metal blank implant.

The workpiece is made of stainless steel, for example stainless steel, which is one of embodiments of the material of the implant.

The workpiece is made of titanium and its alloys, which is another variant of execution of workpiece material of the implant.

The goal of the project is also achieved by the fact that the claimed method of producing a device for osteosynthesis includes obtaining on the outer surface of the workpiece layer polymer film.

And on the surface of the workpiece causing the fine powder fusible polymer, upravlyaut on the surface of the workpiece, excite the resulting film.

The claimed method allows you to apply evenly from all sides of the workpiece powder polymer. After melting and subsequent cooling of the polymer particles firmly bonded to the surface of the workpiece, forming a uniform layer of polymer film on the entire surface of the workpiece than DOS is ikaetsya the solution to the problem of improving the quality of bonding of the polymer film with the outer surface of the workpiece.

The fine powder (for example, f-4MB) is applied in dry form by spraying it on the surface of the workpiece in an electrostatic field, which is one of the options for applying fusible powder of the polymer on the workpiece.

The fine powder (for example, f-4D) is applied to the surface of the workpiece in the form of suspension, after which the workpiece is dried before melting, which is another option for applying fusible powder of the polymer on the workpiece.

A suspension of fine powder (for example, f-4D) is applied to the surface of the workpiece by spraying it with a gas jet, which is another way of applying a suspension of powder fusible polymer on the workpiece.

A suspension of fine powder is deposited on the surface of the workpiece by immersing the workpiece in a suspension (f-4D), which is another option for applying fusible powder of the polymer on the workpiece.

The operation of applying a suspension of fine powder, drying (in the case of suspension) and the melt surface of the workpiece is repeated before the formation of the outer workpiece implant homogeneous layer dielectric film fusible polymer. After the electrification of the obtained dielectric film our procurement becomes the claimed device for osteosynthesis, ready to install in the human body.

The proposed mouth of austo and the manufacturing method are a new technical solution to a technical problem, because they are not known from the prior art.

An example of specific performance

As an example of the use of the claimed device in medicine will consider the procurement of any form, used to hold bone fragments marrow implant for immersion fixation, made of titanium, the surface of which is made from bonded with him the film layer f-4D with a thickness of 20-100 μm and charged to the required current density.

For the manufacture of the specified implant take a template of the future implant in the form of a plate made of titanium, clean the surface from contamination. Sprayed with pulverizator suspension f-4D on the plate surface from all sides. Dry the surface. Upravlyaut in a furnace at a temperature of 250÷300°C. Cool the workpiece to 20÷25°C. Then 5÷7 times repeat the cycle of applying a layer of the suspension, drying, melting to obtain a homogeneous layer. After that, the obtained dielectric layer of a polymeric film electrify any known method, for example, by means of corona discharge.

Obtained by the claimed method implant submersible osteosynthesis has on the entire surface of uniform coverage of the electret layer is firmly bonded to the plate surface of the implant, which cannot be obtained in the device and method prototype.

In addition, due to the strong bond film p is the surface of the workpiece is to protect the implant from the aggressive environment of the body to prevent corrosion of the implant, what is not to provide a device prototype.

In addition, using the proposed method it is possible to obtain high-quality electret coating workpieces of irregular shape in contrast to the prototype.

Thus, thanks to the new essential features of the claimed device and the new essential features of the proposed method, a common technical problem arising from the prior art, which is solved completely, and therefore, this technical solution meets the criterion of "industrial applicability"because this problem is solved completely.

The invention is at the stage of pilot production. Clinical trials are conducted. Planned foreign patenting, the mass use of the claimed invention in the domestic and foreign medical practice.

1. A device for osteosynthesis, comprising a workpiece on the outer surface of which is a layer of polymer film electret state, characterized in that the layer of a polymeric film made of a fusible polymer.

2. The device according to claim 1, characterized in that the layer of the polymer film is made of fusible copolymer of polytetrafluoroethylene.

3. The device according to claim 1, characterized in that the workpiece is made of stainless steel.

4. The device according to claim 1, characterized in that h is of the workpiece is made of titanium and its alloys.

5. A method of obtaining a device for osteosynthesis, comprising obtaining on the outer surface of the workpiece layer polymer film, characterized in that on the surface of the workpiece causing the fine powder fusible polymer, upravlyaut on the surface of the workpiece, excite the resulting film.

6. The method according to claim 5, characterized in that the fine powder fusible polymer is applied in a dry form by spraying it on the surface of the workpiece in an electrostatic field.

7. The method according to claim 5, characterized in that the fine powder fusible polymer applied to the surface of the workpiece in the form of suspension, after which the workpiece is dried before melting.

8. The method according to claim 7, characterized in that a suspension of fine powder fusible polymer applied to the surface of the workpiece by spraying it with a gas jet.

9. The method according to claim 7, characterized in that a suspension of fine powder fusible polymer applied to the surface of the workpiece by immersing the workpiece in a suspension.

10. The method according to claim 5, wherein the operation of applying a suspension of fine powder fusible polymer, drying and melting the surface of the workpiece is repeated until a homogeneous film layer.



 

Same patents:

FIELD: chemistry.

SUBSTANCE: invention relates to N-substituted monomers and polymers, methods of producing such monomers and polymers and methods for their use for different medical purposes, e.g., in medical devices. Disclosed is a polymer which contains a repeating unit of formula (I), where X1 and X2 are independently selected from Br and I; y1 and y2 are equal to zero or an integer from 1 to 4, A1 is selected from a group consisting of , , , and , R3 is selected from C1-C30 alkyl, and C1-C30 heteroalkyl, C5-C30 aryl, C6-C30 alkylaryl and C2-C30 heteroaryl; R4 is selected from H, C1-C30 alkyl and C1-C30 heteroalkyl; R1 is (A) or (B); Z is O or S; R5 and R6 are selected from -CH=CH-, -CHJ1-CHJ2- and -(CH2)a-; a equals zero or an integer from 1 to 8; J1 and J2 are independently selected from H, Br and I; Q is a group which contains 20 or more carbon atoms; Rx is selected from optionally substituted branched or straight C7-C30 alkyl and optionally substituted C6-C30 aryl; and Ry is selected from hydrogen, optionally substituted branched or straight C1-C30 alkyl and optionally substituted C6-C30 aryl. Also disclosed are versions of said polymer, methods of producing said polymers and a medical device containing the disclosed polymers. The medical device is preferably a stent.

EFFECT: disclosed polymer has improved physical and chemical properties and is suitable for use in implantable medical devices.

31 cl, 1 dwg, 2 tbl, 3 ex

Tissues adhesives // 2443435

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. What is described is a multilayer tissue adhesive sheet which contains a structure layer or a laminated plastic attached to a layer supposed to contact with tissue. The structure layer or the laminated plastic contains one or more synthetic polymers showing film-forming properties, while the tissue contact layer contains tercopolymer poly(VP-AAc-AAc(NHS)). The synthetic polymers showing film-forming properties are preferentially biodegradable polyesters, while the tissue reactive groups are most preferentially NHS-polyester groups.

EFFECT: sheet shows better flexibility and herewith keeps high adhesive strength.

26 cl, 2 dwg, 8 ex

FIELD: medicine.

SUBSTANCE: compositions, methods and sets applied to sealing of injured tissues are described herein; the compositions are produced by combining of the first transversally cross-linked component with the second transversally cross-linked component to the effect of formation of the porous matrix with spans, and combining of the porous matrix with the hydrocarbon gel forming component applied to filling-in at least some of the spans.

EFFECT: compositions have minimal turgescing properties.

15 cl, 15 tbl, 14 dwg, 26 ex

Implants with fk506 // 2332959

FIELD: medicine.

SUBSTANCE: invention refers to implants, in particular, to intracavernous or intravascular implants, and is preferable for treatment or preventive maintenance of coronary or peripheric narrowings or occlusions of vessels, in particular, narrowings, or stenosis or restenosis respectively, preferably for prevention of restenosis which, in chemically covalent or incovalent to the bound or physically fixed form, contain FK506, to the method of their obtaining and application.

EFFECT: reduction of inflammation centres.

52 cl, 7 dwg, 10 tbl, 9 ex

FIELD: medicine, plastic and reconstructive surgery.

SUBSTANCE: the present innovation deals with the ways for obtaining spongiform material out of biological tissues applied for treating contour skin deformations in plastic surgery or filling in volumetric defects of organs and soft tissues in reconstructive surgery. It is important to obtain spongiform material of wide functional properties and clinical efficiency. The method deals with mechanical purification of allogeneic connective-tissue neoplasms against the residues of adjacent tissues and foreign contaminations followed by washing in running water, treatment with 3%-hydrogen peroxide solution, rinsing in 0.9%-sodium chloride solution, homogenization till obtaining the homogeneous viscous mass to form the body of the required geometrical shape and size to subject it for frosting-defrosting cycles at the quantity of 2-7, moreover, frosting should be fulfilled steadily at the rate of about 0.1-1°C/min up to -40...-45°C to be kept at the temperature mentioned for 24 h followed by complete defrosting of biomaterial at +4°C, and in the course of the last cycle after frosting up to the desired temperature it is necessary to subject biomaterial for vacuum freeze drying to achieve the constant weight, then it should be hermetically sealed and sterilized with gamma-irradiation at the dosage of 2.5 MRad.

EFFECT: higher efficiency.

FIELD: medicine, thoracic surgery.

SUBSTANCE: the present innovation deals with treating the main bronchus stump during pneumonectomy and repeated operations on postoperational bronchial fistulas. One should apply an elastic hollow conductor under the bronchus, moreover, it is necessary to introduce one branch of pre-cooled clamp for soft tissues made of the fusion with a shape-memory effect. Then this conductor should be withdrawn out of operation wound, moreover, another branch should be applied onto opposite side of the bronchus. Then one should cover bronchial stump, tracheal bifurcation and adjacent tissues with granules out of porous titanium nickelide at particles size being ,1-1,0 mm at the quantity of 0.03-0.06 g/sq. cm. The innovation enables to decrease the number of postoperational complications, shorten the terms for healing bronchial stump and duration of operation due to proper applying the clamp for soft tissues.

EFFECT: higher reliability of sealing bronchial stump.

8 dwg, 3 ex

FIELD: medicine.

SUBSTANCE: method involves placing cell-free dermal matrix into antibiotic solution before transplantation. The cell-free dermal matrix is poured with acetone cooled to -20°C in 1:10 proportion the day before transplantation. Desiccation and degreasing being done, the matrix is placed into antibiotic or antiseptic solution or their combination.

EFFECT: enhanced effectiveness in suppressing pathogenic microflora.

The invention relates to medicine, namely to surgery

FIELD: medicine.

SUBSTANCE: group of inventions relates to field of medicine. Tube for percutaneous endoscopic gastrostomy contains on surface region or inside this region chemical composition possessing antiseptic or antimicrobial action, releasing metal ions or colloidal metal. Chemical compound is contained in form of nanoparticles. Described is tube for enteral feeding containing coating with parylene or polyparylene. Into said coating introduced is and/or on it applied is chemical compound which possesses antiseptic or antimicrobial action, releasing ions of metal or colloidal metal.

EFFECT: acceleration of release of metal ions/colloidal metal due to which risk of infection, caused by introduction of food tube is reduced.

14 cl, 4 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a method for blanket or continuous coating of a grid or mesh stent (an endoprosthesis) for vessels and other tubular organs. The first stage of the method consists in applying a first thin layer coating only surfaces of bearing elements of the stent; the second stage consists in applying a blanket coating which covers both a grid of the bearing elements of the stent, and the in-between gaps. What is also described is an endoprosthesis manufactured by said method.

EFFECT: endoprosthesis can keep the lumen permanently open while being elastic and flexible enough.

16 cl, 20 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, namely a medical composition used for drug storage and delivery, particularly coatings for medical devices, self-contained films, cell cultivation matrixes, etc. The composition contains 3-hydroxybutyrate and 3-hydroxyvalerate (3-PHB/3-PHV) copolymer, and at least one biologically active substance selected from a group of antibiotics or nonsteroid anti-inflammatory preparations in the following proportions, wt %: 3-PHB/3-PHV copolymer 1-6; biologically active substance 1-5; solvent the rest. Additionally, the composition contains a surfactant or polyethylene glycol or gelatin. The composition is presented in the form of microparticles or film.

EFFECT: creation of the biologically active polymeric medical composition of wide spectrum of action and application showing biological compatibility and haematological compatibility, optimal physical-chemical properties, as well as an ability for slow biological resorption in vivo with making no toxic products and negative reactions in use.

18 cl, 8 dwg, 1 tbl

Tissues adhesives // 2443435

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. What is described is a multilayer tissue adhesive sheet which contains a structure layer or a laminated plastic attached to a layer supposed to contact with tissue. The structure layer or the laminated plastic contains one or more synthetic polymers showing film-forming properties, while the tissue contact layer contains tercopolymer poly(VP-AAc-AAc(NHS)). The synthetic polymers showing film-forming properties are preferentially biodegradable polyesters, while the tissue reactive groups are most preferentially NHS-polyester groups.

EFFECT: sheet shows better flexibility and herewith keeps high adhesive strength.

26 cl, 2 dwg, 8 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, more specifically to stents and bag catheters with improved rapamycin release coating, and also to methods for producing such coatings.

EFFECT: production of stents and bag catheters with improved rapamycin release coating.

10 dwg, 24 ex

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine, and can be used for making an implanted prostheses and blood compatible coating for such prostheses. A process of making a blood compatible product (6) involves the following stages: making a mould (7) having a product configuration (6); adjusting a polytetrafluoroethylene membrane to the product configuration (6) by heating of the membrane and attaching it to the mould (7) be exposing to differential pressure generated between two membrane surfaces; cooling of the membrane adjusted in such a way with simultaneously keeping it in a condition of attaching to the mould (7); and removing the adjusted membrane from the mould (7). The membrane is made of a porous polytetrafluorethylene which was not thermostabilised to adjust the membrane to the product configuration (6), and membrane fibres have no preferential orientation, and heating of the membrane when adjusting the membrane to the product configuration (6) is performed at gel point of said porous polytetrafluorethylene. The invention also refers to a cardiac prosthesis in which at least one of its portions comprises a blood compatible coating generated by implementing said process.

EFFECT: group of inventions allows making the blood compatible irregular products made of polytetrafluorethylene.

9 cl, 9 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine and follow-up care (medical rehabilitation), and can be used for antiseptic surface preparation of medical devices made of polymeric materials used in minor orthopaedics. A method consists in forming on a device surface an antiseptic coating of a preparation containing biocide based on a nanodispersed powder of bentonite intercalated by silver or/and copper ions in a plastic binder solution. The particle size of the bentonite powder is no more than 150 nm. The antiseptic coating process is executed in two stages. At the first stage, a surface of the device made of a polymeric material based on silicon rubbers of molecular weight 2·105-6·105 is modified in low-temperature oxygen plasma at oxygen (O2) consumption 0.8-7 l/h, working pressure equal to (70-135)±5 Pa, at high-frequency electromagnetic radiation of frequency 13.56 MHz and power 20-40 Wt, during (2-3)±1 minutes. At the second stage, the modified surface of the device is treated with the antiseptic preparation wherein the plastic binder is fluoracrylic polymer in solvent based on perfluoroisobutylmethyl and perfluorobutylmethyl esters in the ratio, wt %: fluoracrylic polymer - 1-3, solvent - the rest, with perfluoroisobutylmethyl ester - 20-80 wt % and perfluorobutylmethyl ester - 20-80 wt %. The antiseptic preparation has the following proportions: biocide: plastic binder in solvent, as 1:(50-100) weight parts.

EFFECT: use of the invention enables forming a coating with antiseptic and service effective properties on the surface of the devices made of organosilicon polymers of molecular weight 2·105-6·105.

2 cl, 3 ex

Stent coating // 2380059

FIELD: medicine.

SUBSTANCE: invention concerns medicine and is intended for cardiovascular surgery in stenting of arteries. In a stent coating containing a polymer material with an active antiproliferative substance, said polymer material presents a copolymer of butyric and valeric acids, while the active antiproliferative substance is rubomycinum. The amount of the copolymer of butyric and valeric acids per one stent is 2-15 mg/stent, while rubomycinum composes a polymer layer in amount 0.002-0.025 mg/stent.

EFFECT: creation of simpler stent coating expressing biocompatibility and haemocompatibility, with optimal physical-mechanical properties, and also slow bioresorbility in vivo without production of toxic products and negative reactions from a vascular wall while in service.

3 cl, 3 dwg, 1 tbl, 5 ex

FIELD: medicine.

SUBSTANCE: invention concerns medicine. The device implanted into a human body or an animal is described, containing the bioblasted polymer including units of ethylene carbonate of the formula (A): -(-C(O)-CH2-CH2-O-)- (A), in number of 70-100 molar % which possesses internal viscosity 0.4-4.0 dl/g at determination in chloroform at 20°C in concentration of 1 g/dl and 5-50°C vitrification temperature, blasted at the expense of superficial erosion which is supervised on the mechanism of non-hydrolytic scission.

EFFECT: restoration of normal blood flow and keeping an artery opened after installation of a balloon catheter.

13 cl, 1 dwg, 2 ex

FIELD: medicine.

SUBSTANCE: invention relates to method of manufacturing medication-releasing medical device, selected from group consisting of vascular devices, prostheses, probes, catheters, tooth implants or similar, applied in treatment an/or prevention of vessel restenosis, which leads to acute circulatory collapse , conditioned by reduction of circulating blood weight. Claimed method includes application on device by means of submerging into suitable solution or by means of dispersion, of at least one medication layer, when necessary introduced into polymer able to release said medication; polymer which has active functional groups, selected from group consisting of amino groups and sulphhydryl groups capable of chemical binding of biological molecules in one step by means of cold plasma methods; and biological molecules on said polymer surface. Also described is medication-releasing medical device, obtained by said method and application of polymers with reactive functional groups for covering medical devices, preferably vessel stents, by means of cold plasma application.

EFFECT: due to application of definite class of polymers using cold plasma, claimed method is more technological, namely facilitates application of polymer without destroying its functional groups properties and better polymer binding with biomolecules resulting in slower, controlled release of medication from medical device.

36 cl, 1 tbl, 5 ex, 2 dwg

FIELD: medicine.

SUBSTANCE: described are soft, having high index of refraction acrylic materials for devices. Materials include di-block or tri-block macromers, containing hydrophilic side chains.

EFFECT: materials have improved stability to reflections.

17 cl, 6 tbl, 12 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine. There are described soft acrylic materials having a high refraction coefficient for apparatuses. The materials contain diblock- or triblock-marcomers containing a hydrophilic block in a polymer backbone.

EFFECT: materials have better gloss resistance.

17 cl, 3 tbl, 7 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Described are soft acryl materials for ophthalmologic or otorhinolaryngologic devices, which have high refraction coefficient.

EFFECT: materials contain macromer with hydrophilic side chain for giving stability to appearance of glitter.

20 cl, 6 tbl, 1 ex

Up!