CA1130208A - Biodestructive material for bone fixation elements - Google Patents

Biodestructive material for bone fixation elements

Info

Publication number
CA1130208A
CA1130208A CA337,468A CA337468A CA1130208A CA 1130208 A CA1130208 A CA 1130208A CA 337468 A CA337468 A CA 337468A CA 1130208 A CA1130208 A CA 1130208A
Authority
CA
Canada
Prior art keywords
per cent
weight
material according
biodestructive
toxic
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.)
Expired
Application number
CA337,468A
Other languages
French (fr)
Inventor
Sergei I. Belykh
Anatoly B. Davydov
Gennady L. Khromov
Anatoly D. Moschensky
Ilya A. Movshovich
Gennady I. Roitberg
Gennady Voskresensky
Gely G. Pershin
Valery A. Moskvitin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
VSEOJUZNY NAUCHNO-ISSLEDOVATELSKY I ISPYTATELNY INSTITUT MEDITSINSKOI TEKHNIKI
Original Assignee
VSEOJUZNY NAUCHNO-ISSLEDOVATELSKY I ISPYTATELNY INSTITUT MEDITSINSKOI TEKHNIKI
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by VSEOJUZNY NAUCHNO-ISSLEDOVATELSKY I ISPYTATELNY INSTITUT MEDITSINSKOI TEKHNIKI filed Critical VSEOJUZNY NAUCHNO-ISSLEDOVATELSKY I ISPYTATELNY INSTITUT MEDITSINSKOI TEKHNIKI
Priority to CA337,468A priority Critical patent/CA1130208A/en
Application granted granted Critical
Publication of CA1130208A publication Critical patent/CA1130208A/en
Expired legal-status Critical Current

Links

Landscapes

  • Materials For Medical Uses (AREA)

Abstract

Abstract of the Disclosure This invention relates to medical technique and more particularly it relates to biodestructive materials used to manufacture elements for fixation of bone fragments.
Said material contains a matrix of non-toxic polymer resolvable is the body consisting of hydrophilic and hydro-phobic repeat units, and a reinforcing component of non--toxic fibres or threads resolvable in the body. The matrix polymer is preferably a copolymer of methyl methacrylate and N-vinyl pyrrolidone, and the reinforcing component is preferably fibre or threads of polyamide and oxycellulose.
Said material can be used in medicine for fixation of bone fragments in fractures of injuries of bones.

Description

~za~

~IOD~TRUCTIVE MA~RIA~ FOR BONE
~I~ATION ~`LEME~S
This in~ention relates to modical technique, and more par~icularly it relates to biodestructive materials used for fixation of bone -tissues.
Biodes-tructive material can be used in medical techni-que for -the manufacture of connecting elemen~s for rsndering medical aid in i~juries. Such eleme~ts are, for example, va-rious pins, staples; xods, plates, etc.~ intended for f`ixa-tion of bones in frac-tures.
Known in the prior art are variou~ connecting elements manufactur~d ~rom metal alloys. But they have certai~ dis-advantages, which are in the firsb instance associated with the removal of the fixation elemen-ts from the reg~nerated bo~e by sur~ical methods. Moreover, metal alloys often pro-duce marked reactions in bone tissues, and even ga~ and toxic products can be produced by alloys co~taining mag~esium~
~el,u pl, s A4~oy~ were made -to use polymers, e.g. polymethyl meth-acrylate, for the manufacture of bone f ixa-tion elements (Blumin, I.I. Kheifitz, A.V., "Vestnik Ehirurghii i Anesteæi-ologhii, 1955, 11, 80 - 83). But polymethyl methacrylate does no~ have the required strength and is not resolved in the body, which again involves repeated operations for extraction of the fixtures.
~ nown in the prior art are also methods for the manufact-ure of bone fixatio~ elements fxom the protei~ fractio~s o~
- 2 -human blood (Golovi~, G.V., '~oprosy Voss-tanovitelnoi Khir-urghii, Travmatologhii i Ortopedii", S~erdlo~sk~ 1957, 6, 211 - 217). But th~ physico-mechanical properties of such materials do not meet the requirements, while the time of its resolu-tion in the body is shorter than the time re~uir-ed ~or the regeneration of the bone tissue~
Attempts were made to use materials consistin~ o~ a rein~orcing componsnt in the form ~ ~ibres or ~abric, for example, glass ~ibre, carbon fibre, glass fabrics, and a polymer bi~di~g component, for example~ unsaturated poly-ester~ epoxy, polyamide, etc., but despite the high ~trength, bone con~ecti~e fixtures manufa¢tured out of these materials proved lne~eative because they are either toxic or do not resol~e in the body.
The object of the invention is to provide a biodestruct-ive material ~or the manufacture of bone fixation elame~ts which would b~ able to resol~e i~ ths body at the wan~ed terms, would be harmless, and would possess the high physico-mechanical properties ensuring reliable ~ixation o~ bone fra~ments.
Accordlng to the invention, propo~ed is a biodestructive material for the ma~u~acture of bcne fixation elements compr~
ising a matrix of a non-toxic rssolvable polymer consisti~g o~ hydrophilic and hydrophobic repsat units3 and a rein~orc-ing compone~t made out of non-toxic resol~able ~ibres or threads,.

' , ~3~

The hydrophilic uni-ts~ which enter into -the matxix polymer ~xe, for example7 N-~inyl pyrrolidone, acryl amide, vinyl caprolactam, monomethacrylic ester of ethylene glycol, methacryl~nide, acr~lic acid~ and also any o-t~er compound which ~orms water-solllble non-toxic polymers or polymers u~limi-tadly swellable in water.
~ he hydrophobic units which enter i~-to the ma~rix poly-mer are, for e~ample, methyl m0-thacrylatea butyl methacryl-ate, vinyl acetate, alpha-ethoxycyanacrylate~ ethyl acryl-ate, and also other compounds which form ~on -toxic water--insoluble pol~mers.
~ he fibres used as reinforcement for the bone fixation ol~ment$ are, for example, sg~the-kic non-toxic fibres or threads o~ polyamide, oxycellulose, poly~i~yl alcohol, or their mixtures, and also natural non-toxic resolvable ~ibres and -threads, such as catgut~ collagen, dextxan ~ibres and thread~, and the like.
As has been sta-ted above, proposed is a novel biodeæt-ructive material used ~or fixation of bone ~ragme~ts~ which, according to the invention, comprises a matrix of a non-tox-ic polymer formed from hydrophilic and hydrophobic units and a reinforcing component of non-toxic threads or fibres resol-vable i~ the body~
Said polymer is prepared by the known methQd, i.s~ by polymerization or copolymerization of the starting hydrophil-ic and hydrophobic monomexs i~ a medium o~ inert solve~s, 20~

~or example, in benzen~, toluene, in the presencc of initia-tors of radical pol~meriza~ion, for e~ample, dinitrile azo--bisiisobutyric acid, or 4j4-azo-bis-(4-cyanpentonic)acid.
It is recommended that the fi~ished polymer contained ~rom 20 to L~ per cent by weight o~ hydrophilic unit3, which en-sures bettsr resultæO
If the polymer contains less than 20 per cent o~ h~dro-philic units, the biodestruction of the polymer in the pati-ent body will be more protracted. If the matrix polymer con-tains more than 40 per cent of the hydrophilic units, the material swells in excess and does not ensure -the required strength of the material during -the period of bone fragment consolidatio~.
~ he proce~s for the manufacturo of the biodestructive material ¢on~ist~ in that the ~tarting polymer is di~solved in an inert organic ~olvent, for exa~ple, in acetone, tolue-ne, or ethyl acetate, and the obtained solution is used to impregnate threads or fibres of the reinforcing component.
~he material is then dried to remove the solvent. ~he obtain-ed material contains the matrix in the quantity from 20 to 50 per cent and the rei~orcing component from 50 to 80 per cent by weight. Said ~eight proportions of the ~atrix a~d the rein~orcing compone~t ensure the required physico-mecha-nical properties o~ the ma-terial intended for the fixation of fractured bones.

, ~ .
. .
' , ~:~L3~;~0~

Theproposed biodestructive material o~ers the follow-ing advantages lo It rules out the necessity o~ an additional operation for the extraction o~ the connecting element.
2. Makes it po~sible to adjust the ~3ize of the conneot-ing element straight during the operation b~ usin~ mechanical tools so that it might fit properly each particul~r ~ragme~t of bone without limiting mobility o~ the adjacent joints dur-ing ths period of the bone fragment co~solidatio~.
Variou3 connecting elements, such as pin~, rods, staples, can be manufactured out o~ the pxoposed biodesctructlve mate-rial; it iB placed into compression moulds and pressed at a temperature o~ ~ooa and speci~ic pre~sure to 300 kg/~q.om.
~he mould is -then cooled and the fini~hed ar-ticle extracted.
It is recommended to use a biodestructive material in which the matrix i~ a copolymer of methyl methacrylate a~d ~-vinyl pyrrolidone, and the rei~orci~g elament is polyamide ~ibre. The star-ting components o~ this material are readily available commercial product~, and the physico-mecha~ical properties of the resulting material adequately meet the ra-quireme~tsu For a better understanding o~ the invention, the follow-ing examples of i-ts practical embodiment are given by wa~ il-lustratio~.

~:~3~;~0~3 28.8 g of polyamide fibre are impregnated with acetone solu-tion containing 11.2 g of copolymer of me~hyl methacryl-ate and ~-vinyl pyrrolidone. ~he conte~t o~ N-~inyl pyrroli-done in the copolymer is 31.2 per cent by weight. r~h~ ~ibre is then dried -to remove the solvent and the obtained mate-rial is placed i~ a compression mould where it is pressed at a temperature o~ 160C and a pressure o~ 280 kg/sqOcm, The mould is then cooled to a temperature o~ 40C~ the pres sure is released, and the article removed ~rom the mould.
The article prepared in this example is a red, 12 mm in diameter ~nd 410 mm long. It has the ~ollowi~g charac~-eris-tics:
Plexing strength 2700 kg/s~.cm elasticitg modulus in bend 45,200 kg/sq.cm rssolution tims in a livi~g body about two years period of reliable fixation o~ bone fragme~ts 8 - 9 month8 Exam~le 2 The biodestructive ma~erial a~d the article out of it are prepared b~ -the procedure described in Example 1, e~-cept -that 8 g of` the copolymer o~' methyl methacrylate and N-vinyl pyrrol~done and ~2 g o-~ polyamide fibre are used.
The ~inished ar~icle is a rod ha~ing the same d~me~sions as in Example 1. Its characteristics are as follows7 -~ ` ~

flexing strength 2400 kg~sq~cm elas-ticity modulus i~ bend 32?600 kg/s~.cm resolution time about two ge~rs period of reliable fixa-tion of bone fragments ~ - 9 months ~ .
~ he biod~structive material and the connectiYe element out of it are prepared by -the procedure described in Exampla 1 except that 20 g of the copolymer of methyl methacrylate a~d N-~inyl pyrrolidona and 20 g of polyamide fibre are used.
The article manufactured of this material is a rod h~vi~g the same dimensions as specified in E2ample 1. ~he rod has the followin~ characteristics:
flexing s-trength 2610 ~g/sq.cm elastici-ty modulus in be~d 39~0 kg/~cm resolution time about two years period of reliable fi~a-tion of bone fragme~ts 8 - 9 months A biodestructive material, prepared from 30.1 g of the copolymer of methyl methacrylate and ~-vinyl pyrrolidone (N-vinyl pyrrolidone content is 39~6 per cent bg wei~ht) and 66.9 g o~ carboxyethyl cellulose fibre (PD 330)9 is used for th~ manufacture of a rod, 13 mm in diameter a~d 415 mm long.
~he procedure is the same as described in Example lo The rod ~as the followi~g characteris~ics:

~30;20~

~lexing stre~gth 1890 kg/s~.cm elasticity modulus in be~d 25,000 k~/s~cm resolution time 1,,7 year period o~ reliable fixation o~ bone fragments 4,.5 - 6 mon-ths Exa~
~ he biodestructive ~aterial and the article out of it are prepared by a procedure described in ExampIe 1, excep-t that 28.2 g of the copolymer of meth~l methacxylate ~nd ~
nyl pyrrolidone ~-~inyl pyrrolidone conten-t o~ -the copolymer being 33~6 per cen-t by weight) and 64.7 g of polyamide fibre and ~,1 g of carboxymethyl cellu}ose Eibre are u~ed. ~he red manuEactured out of this ma-terial ha~ the dime~ions ~peci-~ied in Example 4 a~d i9 charac-terized by the followlng pro-perties:
flexing strength 2840 k~/sq~cm alasticity modulus in bend 259000 kg/s~cm rssolution time 21 months period of reliable fixation of bone fragments 5 - 7 mont~s ~xample 6 The biod~structive ~aterial and -the connective eleme~t out of it are manufactured b~ the procedure described in ~xample 1, e2cept that 20.1 g of the copolymer of mathyl methacrylate and N-vin~l p~rrolidone (N-vinyl pyrrolidone content of the copolymer being 35.2 per ce~t by weight) and 12,7 g of catgut fibres, and 38.2 ~ o~ polya~ide fibres are used -to prepare the matexial. ~he fixation rod ma~u~actured from this material has the dimensions speciEied in Example 4 and is characterized by the following-propertifls~
~lexing strength ~160 kg/sq.cm elasticity modulus in bend 9800 kg/sq.cm resolution time 1~ year period oE reliable fixatiorl of bone fragments ~ - 5 months Example 7 ~ he biodestructi~e material and -the cor~ecting elements out of it are prepared by the procedure described in Examp~
le 1, except that 20.1 g of a copolymer o~' butylmethacryla~e and ~-vingl pyrroiidone, and 69.2 g of polyamide :Eibre are used to manu-Eacbure the ma~erialO The rod prepared from thi~
material has the ~ollowing characteristics:
fleæing stre~gth 1920 kg/s~.cm elas-ticit~ modulus in bend 9200 k~/sq.cm resolution time 2~7 yeax period of reliable fixation of bone fragments 9 months ~ he biodes-tructive material and the connectin~ elem~nt out o~ it are manufaGtured by the procedure described in Eæample 1, except -tha-t ~2 g of a copolymer o~ acrylamids and ethyl acrylate (t~e acrylamide content of the copol~mer ;208 being 22 per sent by weight), a~ld 69 g o~ carboxyethyl c~l~
lulose fibres are u~ed -to prepare t~e material. ~he article mar~actured ~rom this ma-terial is a fixa-tio~ rod ha~ring the f ollowi~g characteristics:
~lexing stre~gth 1790 k@;/sqOclrl ela~ticity modulu~ n bend 8700 kgJsq.cm resolution-time 1.3 year period of reliable f ixation of bone fragme~ts ~ - 5 moxlth~

Claims (7)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A biodestructive material for bone fixation ele-ments comprising a matrix of a non-toxic resolvable polymer (20-50 wt. per cent) consisting of hydrophilic (20-40 wt. per cent) and hydrophobic (60-80 wt. per cent) monomers, and a reinforcing component made of non-toxic and resolvable threads or fibers in the body.
2. A material according to claim 1, in which the ma-trix polymer contains of from 60 to 80 per cent by weight of alkyl-acrylates or mixtures thereof.
3. A material according to claim 1, in which the matrix polymer contains of from 60 to 80 per cent by weight of methylmethylacrylate.
4. A material according to claim 1, 2 or 3, in which the matrix polymer contains of from 20 to 40 per cent by weight of N-vinyl-pyrrolidone or acrylamide.
5. A material according to claim 1, 2 or 3, which contains from 50 to 80 per cent by weight of reinforcing com-ponent.
6. A material according to claim 1, 2 or 3, contain-ing from 60 to 80 per cent by weight of fibers of polyamide, oxycellulose, polyvinyl alcohol or mixtures thereof as reinforc-ing component.
7. A material according to claim 1, containing from 20 to 40 per cent by weight of a copolymer consisting of 25-28 per. cent by weight of N-vinylpyrrolidone and 72-75 per cent by weight of methyl methacrylate, and 60-80 per cent by weight of the reinforcing component made of polyamide fibers.
CA337,468A 1979-10-12 1979-10-12 Biodestructive material for bone fixation elements Expired CA1130208A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA337,468A CA1130208A (en) 1979-10-12 1979-10-12 Biodestructive material for bone fixation elements

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA337,468A CA1130208A (en) 1979-10-12 1979-10-12 Biodestructive material for bone fixation elements

Publications (1)

Publication Number Publication Date
CA1130208A true CA1130208A (en) 1982-08-24

Family

ID=4115339

Family Applications (1)

Application Number Title Priority Date Filing Date
CA337,468A Expired CA1130208A (en) 1979-10-12 1979-10-12 Biodestructive material for bone fixation elements

Country Status (1)

Country Link
CA (1) CA1130208A (en)

Similar Documents

Publication Publication Date Title
US4263185A (en) Biodestructive material for bone fixation elements
EP0258692B1 (en) Surgical prothesis
DE60113121T3 (en) PREPARATION OF NETWORKED HYALURONIC ACID AND ITS HYDROGEL, PRODUCTS MANUFACTURED AND ITS USES
Flynn et al. Fiber templating of poly (2-hydroxyethyl methacrylate) for neural tissue engineering
EP0401844B1 (en) Resorbable moulded articles and method for their preparation
DE60222415T2 (en) RESERVABLE POLYMERIC COMPOSITIONS
DE69917224T2 (en) BIODEGRADABLE POLYMERS WITH SHAPED MEMORY
DE69534759T2 (en) Polyanionic polysaccharides and hydrophobic bioabsorbable polymer-containing compositions
DE60029228T2 (en) HOMOPOLYMERS CONTAINING NETWORKS AND OCCURRED IMPLANTS MANUFACTURED THEREOF
US5080665A (en) Deformable, absorbable surgical device
EP1994071B1 (en) Shape memory polymer with polyester and polyether segments and process for its preparation and programming
EP0323993B1 (en) Absorbable material for fixation of tissues
WO2008067531A2 (en) Fiber reinforced composite material
DE2947985A1 (en) Matrix material for fixing bone fractures - consisting of a copolymer of hydrophilic and hydrophobic monomers reinforced with resorbable non-non-toxic fibres
DE3928933A1 (en) PERIODONTIUM REGENERATING MATERIALS
EP1994948A2 (en) Method for producing hydrogel composition comprising crosslinked polyethylene oxide
DE60028809T2 (en) HYDROGELE FOR ORTHOPEDIC REPAIR
Kettunen et al. Mechanical properties and strength retention of carbon fibre-reinforced liquid crystalline polymer (LCP/CF) composite: an experimental study on rabbits
JPH01198553A (en) Biodegradable and absorbable surgical material and its preparation
CA1130208A (en) Biodestructive material for bone fixation elements
US20150158209A1 (en) Method for preparing a chitosan-based porous layer
Hasirci et al. High strength bioresorbable bone plates: preparation, mechanical properties and in vitro analysis
Kolařík et al. Mechanical properties of model synthetic tendons
CN1548168A (en) Continuous carbon fiber reinforced composite material for bone repair
CA1277602C (en) Surgical devices with layered composite structure

Legal Events

Date Code Title Description
MKEX Expiry