MXPA02002931A - Resorbable implant materials - Google Patents
Resorbable implant materialsInfo
- Publication number
- MXPA02002931A MXPA02002931A MXPA/A/2002/002931A MXPA02002931A MXPA02002931A MX PA02002931 A MXPA02002931 A MX PA02002931A MX PA02002931 A MXPA02002931 A MX PA02002931A MX PA02002931 A MXPA02002931 A MX PA02002931A
- Authority
- MX
- Mexico
- Prior art keywords
- tissue
- resorbable
- treated
- alkylating
- amine
- Prior art date
Links
- 239000000463 material Substances 0.000 title abstract description 35
- 239000007943 implant Substances 0.000 title abstract description 13
- 210000001519 tissues Anatomy 0.000 abstract description 46
- 230000002152 alkylating Effects 0.000 abstract description 4
- 238000004132 cross linking Methods 0.000 abstract description 3
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 abstract description 2
- 210000004872 soft tissue Anatomy 0.000 abstract description 2
- HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 24
- 150000001412 amines Chemical class 0.000 description 12
- 102000008186 Collagen Human genes 0.000 description 10
- 108010035532 Collagen Proteins 0.000 description 10
- 229960005188 collagen Drugs 0.000 description 10
- 229920001436 collagen Polymers 0.000 description 10
- 210000003516 Pericardium Anatomy 0.000 description 9
- 239000004744 fabric Substances 0.000 description 8
- 238000000034 method Methods 0.000 description 8
- 210000004379 Membranes Anatomy 0.000 description 7
- 239000002168 alkylating agent Substances 0.000 description 7
- 239000012528 membrane Substances 0.000 description 7
- 241000283690 Bos taurus Species 0.000 description 6
- 125000003277 amino group Chemical group 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 239000000243 solution Substances 0.000 description 5
- 210000002808 Connective Tissue Anatomy 0.000 description 4
- 238000005804 alkylation reaction Methods 0.000 description 4
- 239000003153 chemical reaction reagent Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- GOOHAUXETOMSMM-UHFFFAOYSA-N propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 description 4
- 208000005881 Bovine Spongiform Encephalopathy Diseases 0.000 description 3
- 102000020504 Collagenase family Human genes 0.000 description 3
- 108060005980 Collagenase family Proteins 0.000 description 3
- 241001269524 Dura Species 0.000 description 3
- FEMOMIGRRWSMCU-UHFFFAOYSA-N Ninhydrin Chemical compound C1=CC=C2C(=O)C(O)(O)C(=O)C2=C1 FEMOMIGRRWSMCU-UHFFFAOYSA-N 0.000 description 3
- 238000002835 absorbance Methods 0.000 description 3
- 238000004166 bioassay Methods 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 239000000835 fiber Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 238000007634 remodeling Methods 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 201000001042 variant Creutzfeldt-Jakob disease Diseases 0.000 description 3
- 210000000109 Fascia Lata Anatomy 0.000 description 2
- 210000004303 Peritoneum Anatomy 0.000 description 2
- 239000002251 absorbable suture material Substances 0.000 description 2
- 230000000890 antigenic Effects 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 230000001413 cellular Effects 0.000 description 2
- 230000002490 cerebral Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 229960002424 collagenase Drugs 0.000 description 2
- 230000000991 decompressive Effects 0.000 description 2
- 230000004059 degradation Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 201000009910 diseases by infectious agent Diseases 0.000 description 2
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N iso-propanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000006011 modification reaction Methods 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 230000001954 sterilising Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 210000004876 tela submucosa Anatomy 0.000 description 2
- 239000002759 woven fabric Substances 0.000 description 2
- 229940100198 ALKYLATING AGENTS Drugs 0.000 description 1
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 210000004204 Blood Vessels Anatomy 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate dianion Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 1
- 241000123112 Cardium Species 0.000 description 1
- 210000004207 Dermis Anatomy 0.000 description 1
- 229920004937 Dexon® Polymers 0.000 description 1
- 229940110715 ENZYMES FOR TREATMENT OF WOUNDS AND ULCERS Drugs 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 210000003709 Heart Valves Anatomy 0.000 description 1
- 210000000936 Intestines Anatomy 0.000 description 1
- 206010022773 Intracranial pressure increased Diseases 0.000 description 1
- 229920000954 Polyglycolide Polymers 0.000 description 1
- 241000532784 Thelia <leafhopper> Species 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K Trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
- 206010046459 Urethral obstruction Diseases 0.000 description 1
- 230000003187 abdominal Effects 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 230000001464 adherent Effects 0.000 description 1
- 125000000217 alkyl group Chemical group 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
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- 239000000427 antigen Substances 0.000 description 1
- 102000038129 antigens Human genes 0.000 description 1
- 108091007172 antigens Proteins 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 238000006065 biodegradation reaction Methods 0.000 description 1
- 125000004432 carbon atoms Chemical group C* 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
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- 238000007887 coronary angioplasty Methods 0.000 description 1
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- 238000004108 freeze drying Methods 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 230000002458 infectious Effects 0.000 description 1
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- 230000001264 neutralization Effects 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 239000003692 nonabsorbable suture material Substances 0.000 description 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N oxane Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 230000001717 pathogenic Effects 0.000 description 1
- 244000052769 pathogens Species 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 229920000747 poly(lactic acid) polymer Polymers 0.000 description 1
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Abstract
A noncrosslinked, decellularized and purified mammalian tissue (e.g., bovinepericardium) having particular use as an implantable resorbable material. The material is treated by alkylating its primary amine groups in a manner sufficient to reduce the antigenicity of the tissue, permitting the treated tissue to be used in vivo and without crosslinking, and in turn, permitting it to be resorbable. The material can be used in surgical repair of soft tissue deficiencies for a certain period of time while the implant itself is gradually remodeled or absorbed by the host. Also provided are a method of preparing such a material as well as a method of using such a material for surgical repair.
Description
REABSORBIBLE IMPLANT MATERIALS TECHNICAL FIELD
The invention relates to materials for use as implants within the body, and in particular with resorbable materials} remodelables for such use.
BACKGROUND OF THE INVENTION Currently there are resorbable materials (occasionally referred to as absorbable or "castable") for use in prosthetic applications, for example, patches, implants and / or com? prosthetic device components.
Synthetic resorbable materials made of polyesters, polylactide and polyglycolide, for example, have found use in various fields of medicine (See, for example, Ashammaki, NA, J. Biomed, Mater. Res., 33: 297-303; 1996 ). Commercial versions of these materials are available under the trade names of V: .cryl® (Ethicon, Inc.) and Dexon® (Davis &Geck, Inc.). The gradual composition of these polymers is facilitated by hydrolysis, and catalyzed by the biochemical action of host tissues (Hanbrough, J.F., et al, J. Burn Care Rehab., 14: 485-494, 1993). Those materials
they can be produced as membranes or as a woven mesh in the case of the production of resorbable suture.
Although synthetic resorbable materials are a more recent phenomenon, collagen materials have been used as prosthetic inserts for many years, as in the case of freeze-dried human dura, dating from 1954. As a common practice they last for a long time. several years, such collagenous materials have been crosslinked as an agent such as glutaraldehyde, to dissolve the antigenicity of a xenograft while increasing its resistance to enzymatic degradation produced by host tissue responses (Gratzer, PF, et al., J. Biomed, Mater. Res., 31: 533-543; 1996) Polyepoxy compounds have also been used for such purposes, however they are more stable with respect to the resulting alkylated amines in collagen (Sung, HW., Et al. ., J. Biomater, Sci. Polymer Edn., 8: 587-600, 1997). Although cross-linked tissues work well as long-term implants, they are not resorbable, and therefore, do not promote remodeling of the host tissue, or in turn, the eventual replacement of a graft by the body itself.
Aesculap AG & Co (B. Braun Surgical) offers products under the trademark of Lyoplan®, in the form of a resorbable replacement based on bovine pericardium for hard matter. Lyoplan is produced by a process that
* - f ******,
It involves the mechanical removal of adherent fat and connective tissue, chemical treatment to inactivate enzymes and potential pathogens, lyophilization, cutting to various sizes, packaging and terminal sterilization with ethylene oxide. The product is indicated to be used to cover lasting cerebral and cerebellar effects, for decompressive duraplasty in cases of increased intracranial pressure, to cover spinal dural effects and for decompressive spinal duraplasty. It has been observed that this material is completely remodeled within one year after implantation.
Tutogen Medical, I nc. It provides pericardial products processed under the brand name Tutoplast, in the form of a preserved human pericardium, dehydrated with solvent, and radiated with gamma radiation. Tutoplast® tissue processing involves perfect cleaning, processing, dehydration and preservation. It is said that the process leaves no harmful residues and minimizes the antigenic potential. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native pericardium, while providing the basic formative structure to support replacement by new endogenous tissue. This tissue is indicated for use in a variety of surgical applications, including duraplasty (as a substitute for material
biodegradable infusion to be used in the treatment of urethral obstructions. Stack, et al., U.S. Patent No. 5,306,286 describes an absorbable stent to be placed inside the blood vessel during coronary angioplasty. Duran, U.S. Patent No. 5,376,112 discloses an annuloplasty ring to be implanted in the heart to function in conjunction with the native heart valve. In another aspect, U.S. Patent No.
,837,278 (Geistlich, et al., "Resorbable Collagen Membrane for Use in Guided Regeneration of
"Fabric" describes the use of a collagen-containing membrane in the guided generation of tissue The Patent provides a resorbable collagen membrane for use in guided tissue regeneration where one face of the membrane is fibrous thereby allowing growth cell on the Lia and the opposite face of the membrane that is smoothed, thus inhibiting the cellular addition on it.
Finally, see U.S. Patent No. 5,413,798 (Scholl, et al.) 1, which describes a process for treating bovine pericardial tissue to increase resistance to biological degradation by wet chemical processing. The use of a tissue is exemplified in the form of an implant, which after three and six months after
used in a variety of applications, including as patches, suture and support members for the stapling line, and warranties.
SUMMARY OF THE INVENTION
The present invention provides a non-crosslinked, decellularized and purified mammalian tissue (e.g., bovine pericardium) which has particular use as an implantable material so that it is resorbable and removable. The material is prepared by alkylating the primary amine groups of the natural tissue in a manner sufficient to reduce the antigenicity of the tissue, and in turn, to a degree that allows the treated tissue to be used in vivo and without crosslinking, thereby allowing this be absorbable
The material can be used, for example, in the surgical repair of soft tissue deficiencies, for a period of time, while the implant itself is gradually remodeled or absorbed by the host. In a related aspect, the invention provides a method for preparing such material, as well as a method for using such material for surgical repairs. As used herein with respect to a material of the present invention, the word "reabsorb" and inflexions thereof will refer to
a material that, once implanted in vivo, is reabsorbed by the body and with time and without undue harmful effects in or inside the body itself. The word "remodel" and inflections thereof, as used herein with respect to a material of the present invention, will refer to a resorbable material that is adapted, for example, by virtue of its location and method of implant within the body. , to encourage and / or allow the body to replace some or all of the structures and / or functions of the implant with newly formed natural tissue. While not intending to be bound by theory, at least in some embodiments of the present invention, remodeling seems to occur by a gradual bodily process in which substantial portions of the implant material are gradually reabsorbed, while an inherent fibrous network of the implant be retained on the site. The network, in turn, is used by the body as a scaffold for the generation of new woven or tissue components.
In a preferred embodiment, the invention provides a resorbable implantable material comprising a non-crosslinked, decellularized and purified mammalian tissue having most of its free alkylated amine groups. In a particularly preferred embodiment, the tissue is selected from the group consisting of pericardium, peritoneum, fascia lata, dura dura, dernis and submucosa of the intestine
and the material has been alkylated by an alkylating agent selected from the group consisting of 1,2-epoxy-R compounds where R is an alkyl group of up to 6 carbon atoms. Such material may be provided in any suitable form, for example,] as flat or textured sheets or strips, and may be adapted for use in a variety of surgical applications, including those selected from the group consisting of plasty, thoracic, abdominal surgery. , urological, ophthalmic, cardiac and vascular.
DETAILED DESCRIPTION
A woven fabric of the present invention can be obtained from any suitable source, including mammalian sources for example, in the form of collagenous connective tissue with three-dimensional inter-braided fibers. Such tissues generally involve serous and fibrosarcoma membranes. In a particularly preferred embodiment, the tissue source is selected from bovine pericardium, peritoneum, fascia lata, dura, stem, dermis and submucosa of the small intestine. In a further preferred embodiment, the tissue is bovine pericardium, and is treated using a method as described herein to provide the treated tissue with an optimum combination of biocompatibility, thickness and other physical and physiological properties.
The fabrics of the present invention may be provided from durja material, for example, for use in neurosurgical applications. Collagenous connective tissue with three-dimensional inter-braided fibers, when treated in the de-rusted form here, retains the multidirectional and mechanical strength of the native hard matter, while providing the basic formative structure to support replacement with new endogenous tissue.
Although it is desirable to reduce or eliminate the antigenic properties of material based on xenographic or even allographic tissue to be implanted in a body, if the absorption and / or remodeling of the body material is desired, cross-linking can not be effected. To effect in a specific manner such a modification of a material based on collagen, a monofunctional reagent is used. The reagent is "monofunctional" since it is adapted to react with, and therefore terminate and "crown" the available amine functionalities of the tissue proteins, but will not react more with adjacent groups. An optimum reagent of this invention, therefore, is preferably a relatively small and structurally simple compound that, after reacting with group > Proteins such as amines will bind to those groups but in such a way that they do not alter the biological properties of the collagen matrix to a degree that renders the tissue unsuitable for its intended use.
In a particularly preferred embodiment, a woven fabric of the present invention is treated by a process that includes renting a greater percentage of the available amine groups to a sufficient degree to allow the tissue to be implanted and used in vivo. Preferably a fabric is processed by alkylating its amines to a sufficient degree to react 80% or more, preferably 90% more, more preferably 95% or more of the amine groups originally present. The efficiency and degree of alkylation can be determined by a variety of means, as described herein, including the use of a ninhydrin-based assay ("am: .nas index") to determine the comparative level of amine groups, before and after after the treatment (see, for example, Sung HW, et al., Art Org., 21: 50-58; 1997. Sung, HW, et al., J. Biomed, Mater.Res. 33: 177-186. ). Preferably the efficiency and degree of the alkylation process is further evaluated by determining the unreacted amounts in the incubation of the batch of the alkylating agent used.
Preferred alkylating agents can be used, for example, at a pH between about 9 and about 11, and at a concentration between about 2% (w / w) and about 5%
(weight / weight), exposing the tissue to a solution containing the agent for at least 48 hours.
the branching of the collagen polymer by the action of the alkylating agent and the subsequent alteration of the collagen matrix (Tu, R., et al., J. iomed, Mater. Res., 28: 677-684, 1994).
In a preferred embodiment, the tissue of the present invention is also treated with a base such as sodium hydroxide (NaOH), to further reduce the possibility of further transmission of Bovine Spongiform Encephalopathy (BSE). Histological analyzes of tissue treated with NaOH (pericardium, for example) reveal a virtually complete decellularization due to this treatment Since it is known that the cellular component of the tissue contains the vast majority of antigen loading (Corutman, DW et al. ., J. Biomed, Mater. Res., 28: 655-666.; 1994), decellularization treatment with NaOH may complement the use of an alkylating agent to reduce antigenicity.
A fabric of the present invention can be used to manufacture a prosthetic article having any suitable shape or configuration, and in any dimensions suitable for its intended use. For example, the fabric may be proportioned and packaged in a flat configuration (eg, sheet, or ribbon-like), with either or both surfaces thereof being optimally textured or moaiified (eg, by bonding).
covalent, trapped and / or adsorption of biologically active factors, lubricating agents, antimicrobial agents and the like).
In a preferred embodiment, a process of the present invention includes the steps of:
a) obtain pericardi from an appropriate source (eg, approved by the USDA)
b) cleaning the weave and optionally, and preferably, treating the ejido, for example, to decellularize this and / or to • produce / eliminate the infectivity of BSE of potential,
c) alkylating the tissue (e.g., hydroxypropylation using propylene oxide) to coat a larger percentage of available amine groups * (by eject, potentially reactive), and optionally,
d) end processing; 1, which includes one or more of the following steps: washing, drying, sterilizing and packaging the fabric.
Natural tissues suitable for use in the process of the present invention preferably meet strict specifications during donor selection and laboratory testing to reduce the risk of transmission of infectious diseases. The process
in such a way that the free edges of the implant do not exceed the areas where the possibility of adhesion may present a problem. Absorbable or non-absorbable suture material, for example glue, etc. can be used to fix the tissue in place. For a continuous suture, absorbable suture material and round atraumatic needles are recommended, although the size of the suture depends on the surgical indication. The suture should be located two to three millimeters from the edge of the graft. Better results are obtained by folding the section in suture sites that are under moderate to high stress. The weaves of the present invention provide a variety of features and advantages, including the fact that they are immediately available for surgery and can save valuable time in the operating room.
In addition, there is no secondary surgery site and less stress for the patient; The bual can result in less time under anesthesia, painless as a weakness of the patient, and the patient} . Since tissues can be made available in a wide range of sizes, the surgeon can choose the necessary size, leading to minimal waste. As with biological products, it is not possible to provide an absolute guarantee of freedom from infectious infectious diseases such as
stannous, 0.16% (w / v), pH 5.0] 95-100 ° C for 30 minutes. 5. Cool the tubes to room temperature. 6. Add 250 μl of collagenase sample to 1.0 ml of 50% isopropanol. Vortex stir and read the absorbance 570 nm. 8. The absorbance at 570 nm is divided by the weight of the piece of tissue to give the OD / mg. The OD / mg is the value of the amount of collagen peptide that has been degraded by the action of the collagenase enzyme. The results of the collagenase assay are determined by comparing the mu-test with both positive (untreated) and negative (cross-linked with glutaraldehyde) control samples.
Amine index. The amine number can be defined as the percentage of initiating amines available that have been modified (and therefore rendered substantially unreactive in vi tro) by reaction with amine reagents. Such modification will render the amine incapable of producing "Ruhemann purple" when introduced into ninhydrin, and the relevant assay may be carried out as follows:
1. 200 μl of DI water was added to 25-30 milligrams of tissue. 2. Add one thousand Llitro of ninhydrin solution to each tube. 3. Incubate the tubes at 95-100 ° C for 30-35 minutes. 4. Cool the tubes to room temperature. 5. Add 250 μl of sample to one milliliter of 50% isopropanol solution. 6. Vortex and see absorbance at 570 nm. 7. The amine number is calculated. To calculate the percentage of modified original amines, the following formula is used: Amine index (%) = [* control (OD / mg) -sample (OD / mg)] x 100 control (OD / mg) The OD / mg was dividing the OD @ 570 by the weight of the piece of tissue. * The control is unmodified tissue
Test for the quantification of Alkylating Agent without
React The purpose of this test is to confirm that although 100% of the alkylation of the amine is typically not achieved, this is not due to the lack of an alkylating agent
NaOH and Neutralization 1. Weigh 40-45 grams of bovine pericardium. 2. Place the per.cardium in one liter of NaOH 1.0
M (40 grams of NaOH in a .itro of DI water) for 60-65 minutes. Take a sample to measure the pH at the end of the wash. 3. Decant the STaOH, gently squeeze the tissue and place it in two liters of DI water filtered for 30-35 minutes. 4. Decant DI water and place tissue in two liters of cijtrato buffer (28 grams of sodium citrate and 2.0 grams of citric acid in two liters of DI water) for 60-65 minutes. Take a sample to measure the pH at the end of the wash. 5. Decant the citrate buffer, gently squeeze the tissue and mix the tissue in another two liters of DI water for 30-35 minutes.
Fabric Alkylation 1. Prepare a solution of 5% Propylene Oxide (50 milliliters of propylene oxide in 950 milliliters of 0.2 M carbonate buffer, pH 10.5-10.6). 2. Place the fabric treated with NaOH in propylene oxide solution.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09396279 | 1999-09-15 |
Publications (1)
Publication Number | Publication Date |
---|---|
MXPA02002931A true MXPA02002931A (en) | 2003-11-07 |
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