Design and Development of a resorbable Bone Adhesive
可吸收骨粘合剂的设计与开发
基本信息
- 批准号:7325484
- 负责人:
- 金额:$ 12.99万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2007
- 资助国家:美国
- 起止时间:2007-08-01 至 2008-01-31
- 项目状态:已结题
- 来源:
- 关键词:AccountingAdhesive cementAdhesivesAmino AcidsAnimal ModelBenignBiocompatibleBiologicalBone MarrowBone RegenerationBone SurfaceCaliberCharacteristicsChemicalsChemistryClassClinical TrialsComplicationConsultationsDataDefectDevelopmentDevicesDistalDrug FormulationsEngineeringEnvironmentFractureGoalsGrowthHandHealedHumanIn VitroInjection of therapeutic agentJointsLeadLiteratureMarketingMethodsMolecularObject AttachmentOffice VisitsOperating RoomsOperative Surgical ProceduresOrthopedicsOutcomePerformancePhasePlastic SurgeonPolyurethanesProceduresProcessRadialRateResearch Project GrantsRisk FactorsSafetySiteStromal CellsStructureSurgeonTemperatureTensile StrengthTestingTimeTissue AdhesivesToxic effectUnited States Food and Drug AdministrationViscositybasebiomaterial compatibilitybonebone healingcostdesignhealingin vivosample fixationsugarwound
项目摘要
DESCRIPTION (provided by applicant): The orthopedic small bone and joint device market is 1.8 billion with an 8.9% growth. Small bone and joint problems account for 51% of office visits to orthopedic surgeons and 24% of surgical procedures. Fixation of small bones (i.e., distal radial fractures) is complicated by the difficulty in using screws and pins, and complication rates due to intra-articular misalignment and non-unions is as high as 62% (Weber 1986). Bone adhesives and cements are currently not used in many of these procedures because they are made from chemical compounds that bond bone but do not permit bone regrowth. An ideal adhesive for bone repair should promote rather than retard osteoblastic activity (Drobnic 2006), and should resorb in the timeframe of naturally healing bone. The long-term goal of this project is to create a resorbable small bone adhesive which would satisfy the surgical need for a strong, resorbable adhesive to adhere small bone fragments during internal fixation. The hypothesis of the proposed Phase I research project is that Cohera's proprietary biocompatible polyurethane tissue adhesive can be engineered into a viscous formulation for ease of delivery, with an appropriate strength profile that will be effective in bonding small bone fractures. To test this hypothesis, the following specific aims will be accomplished: 1) Optimize the physical characteristics of uncured bone adhesive. In brief, the physical characteristics of the adhesive (such as viscosity, cure time and exothermic temperature during cure) must be engineered to produce an adhesive that can be delivered in small volumes by injection in an operating room environment while meeting established performance requirements. 2) Optimize the physical characteristics of cured bone adhesive. The candidate formulations developed under Specific Aim 1 will be tested for tensile strength, Young's modulus, and pore diameter. The target characteristics are tailored to provide an environment for bone regrowth while maintaining strength during healing. During Phase II of the project, the bone adhesive will be tested in vivo to demonstrate efficacy in reduction and fixation of small bone fractures. This research project will include 1) finalizing the product specifications, 2) performing efficacy testing in an accepted animal model for small bone repair, 3) establishing resorption rates in vivo, and 4) evaluating bone regrowth in the defect. Positive outcomes will lead to studies in humans to provide data to the FDA in support of a Pre-market Approval (PMA). . Currently available bone adhesives and cements may bond bone surfaces together, but do not resorb over time and transition the wound to natural healed bone. This leads to a high rate of non-unions when cement eventually separates from the bone. The long-term goal of this project is to create a resorbable, small bone adhesive which would satisfy the surgical need for a method of bone fixation that permits bone regrowth while maintaining strength during healing.
描述(申请人提供):骨科小骨关节器械市场规模为18亿件,增长8.9%。小骨和关节问题占骨科医生办公室就诊的51%,占外科手术的24%。小骨(即桡骨远端骨折)的固定因使用螺钉和钉的困难而变得复杂,关节内错位和骨不连引起的并发症发生率高达62%(Weber 1986)。骨粘合剂和骨水泥目前在许多此类手术中都没有使用,因为它们是由结合骨骼但不允许骨骼再生的化合物制成的。一种理想的骨修复粘合剂应该促进而不是抑制成骨细胞的活动(Drobnic 2006),并且应该在自然愈合骨骼的时间框架内吸收。该项目的长期目标是创造一种可吸收的小骨粘合剂,以满足外科手术对坚固的可吸收粘合剂的需求,以便在内固定过程中粘连小骨碎片。拟议的第一阶段研究项目的假设是,Cohera专有的生物相容聚氨酯组织粘合剂可以设计成一种粘性配方,以便于输送,并具有适当的强度分布,将有效地粘合小骨骨折。为了验证这一假设,将实现以下具体目标:1)优化未固化骨粘接剂的物理特性。简而言之,粘合剂的物理特性(如粘度、固化时间和固化过程中的放热温度)必须经过精心设计,以生产一种可以在手术室环境中通过注射小容量输送的粘合剂,同时满足既定的性能要求。2)优化固化骨胶的物理性能。根据特定目标1开发的候选配方将进行抗拉强度、杨氏模数和孔径测试。目标特征是量身定做的,为骨骼再生提供环境,同时在愈合期间保持强度。在该项目的第二阶段,将在体内测试骨胶粘合剂,以证明对小骨折的复位和固定效果。这项研究项目将包括1)最终确定产品规格,2)在公认的小骨修复动物模型中进行有效性测试,3)建立体内吸收率,以及4)评估缺损处的骨再生。积极的结果将导致人体研究向FDA提供数据,以支持上市前批准(PMA)。。目前可用的骨粘合剂和骨水泥可以将骨表面粘合在一起,但不会随着时间的推移而吸收,并将伤口过渡到自然愈合的骨。当骨水泥最终从骨中分离时,这会导致很高的不愈合率。该项目的长期目标是创造一种可吸收的小骨粘合剂,以满足外科对骨固定方法的需求,这种方法允许骨再生,同时在愈合过程中保持强度。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Eric J. Beckman其他文献
Solubilization and Activity of Proteins in Compressible-Fluid Based Microemulsions
基于可压缩流体的微乳液中蛋白质的溶解和活性
- DOI:
10.1038/nbt1292-1584 - 发表时间:
1992-12-01 - 期刊:
- 影响因子:41.700
- 作者:
Guadalupe Ayala;Sanjay V. Kamat;Claire Komives;Eric J. Beckman;Alan J. Russell - 通讯作者:
Alan J. Russell
Green processing using ionic liquids and CO2
使用离子液体和二氧化碳的绿色加工
- DOI:
10.1038/19887 - 发表时间:
1999-05-06 - 期刊:
- 影响因子:48.500
- 作者:
Lynnette A. Blanchard;Dan Hancu;Eric J. Beckman;Joan F. Brennecke - 通讯作者:
Joan F. Brennecke
Putting carbon dioxide to work
让二氧化碳发挥作用
- DOI:
10.1038/531180a - 发表时间:
2016-03-09 - 期刊:
- 影响因子:48.500
- 作者:
Eric J. Beckman - 通讯作者:
Eric J. Beckman
An experimental feasibility study on the use of CO<sub>2</sub>-soluble polyfluoroacrylates for CO<sub>2</sub> mobility and conformance control applications
- DOI:
10.1016/j.petrol.2019.106556 - 发表时间:
2020-01-01 - 期刊:
- 影响因子:
- 作者:
Husain A. Zaberi;Jason J. Lee;Robert M. Enick;Eric J. Beckman;Stephen D. Cummings;Chris Dailey;Mihai Vasilache - 通讯作者:
Mihai Vasilache
Design of highly CO2-soluble chelating agents for carbon dioxide extraction of heavy metals
- DOI:
10.1557/jmr.1995.0530 - 发表时间:
2011-03-03 - 期刊:
- 影响因子:2.900
- 作者:
Ali V. Yazdi;Eric J. Beckman - 通讯作者:
Eric J. Beckman
Eric J. Beckman的其他文献
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{{ truncateString('Eric J. Beckman', 18)}}的其他基金
Sprayable Surgical Adhesive for Seroma Prevention
用于预防血清肿的可喷涂手术粘合剂
- 批准号:
7480136 - 财政年份:2007
- 资助金额:
$ 12.99万 - 项目类别:
Sprayable Surgical Adhesive for Seroma Prevention
用于预防血清肿的可喷涂手术粘合剂
- 批准号:
7649490 - 财政年份:2007
- 资助金额:
$ 12.99万 - 项目类别:
Design and Development of Sprayable Surgical Adhesive
喷雾式手术粘合剂的设计与开发
- 批准号:
7266829 - 财政年份:2007
- 资助金额:
$ 12.99万 - 项目类别:
相似海外基金
Bond strength of adhesive cement to Ag-Pd-Au-Cu alloys
胶粘剂与Ag-Pd-Au-Cu合金的粘结强度
- 批准号:
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Grant-in-Aid for Scientific Research (C)