CN107106209A - 可远程调节的交互式骨骼再成形植入物 - Google Patents
可远程调节的交互式骨骼再成形植入物 Download PDFInfo
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Abstract
根据一些实施方式,提供了用于再成形骨骼的系统和方法。该系统可以包括:植入物主体;致动器,该致动器耦接到植入物主体;传感器,该传感器被配置为检测指示生物条件的参数;收发器;以及控制器。收发器可以被配置为向外部遥控发送与参数关联的数据,并且从外部遥控接收指令。最后,控制器被配置为响应于来自外部遥控的指令移动致动器,其中,致动器调节植入物主体。该方法可以包括以下步骤:测量指示生物条件的参数;从可植入装置向外部遥控发送与参数关联的数据;从外部遥控向可植入装置发送指令;以及响应于来自外部遥控的指令驱动骨骼生长装置。
Description
背景技术
本发明涉及用于骨骼的逐步修整或骨骼畸形的矫正的矫形方法和装置。具体地,本发明涉及被配置为执行多个过程(包括骨骼的延长、骨骼的缩短、骨折的愈合、骨骼角度的变化、骨骼的旋转、骨骼的弯曲度或扭力的调节、关节或椎骨的重新对齐或重新定位、脊柱形状的重组或支撑、或其组合)的各种骨骼再成形装置,所有这些过程被认为是如这里所用的“再成形”的种类。更具体地,本发明涉及考虑可以基于指示生物条件的所测量参数在外部被调节的骨骼再成形装置的方法和系统。
长度和角姿态可调节的外部固定装置常用于矫正肢体的长骨骼的特定角缺陷和纵向缺陷。这种固定装置基本上包括保持插入骨骼受缺陷影响的部分中的多组接骨螺钉的夹钳,这种夹钳可滑动地安装在可纵向定位在要治疗的肢体外部的元件或引导件上。
矫正通常在压缩/牵张装置的帮助下逐步进行,该压缩/牵张装置作用于移动夹钳,同时骨骼硬皮再生其本身以许可其操纵,直到获得期望矫正为止。
例如,在肢体延长时,骨骼通常用手术分成两段,并且在手术骨骼切口上方和下方将线和半钉插入到骨段中,并且将线和半钉附接到由支柱或可伸缩连接杆互连的刚性框架的环。刚性框架用于在一时间段期间将两个骨段纵向逐步推离(例如,每天一毫米)。这允许骨骼逐渐形成在由该牵张技术产生的骨段之间的间隙中。一旦实现期望的延长量(例如,5-6cm),则将外部装置稳定到固定位置中,并且留在骨段上,直到新形成的骨骼的完整矿化发生为止(例如,3-6个月,这取决于病理性质和延长量)。
类似地,在畸形矫正中,骨骼用手术分成(通常在畸形的顶端处)两段,并且在手术骨骼切口上方和下方将线和半钉插入到骨段中,并且将线和半钉附接到刚性框架的环。刚性框架的相对环由螺杆连接在一起,该螺杆具有所附单平面或多平面铰链和用于在一时间段期间将两个骨段成角度地逐步推离的角牵张器。
这种外部固定装置的使用可能呈现特定缺点。外部固定器可能笨重,对于患者痛苦,并且还使患者经受钉道感染、关节僵直、食欲丧失、抑郁、软骨损伤以及其它副作用的风险。使外部固定器处于适当位置还延迟复原的开始。在一些情况下,外部固定器的可见性可能导致患者窘迫或不安全。
响应于这些缺点,本领域开发了可以被定位在皮肤以下和/或骨骼中的可植入装置。这些装置被设计为通过向骨骼施加力(包括促进愈合的压缩力、促进延长的牵张力以及改变骨骼角度/弯曲度的角向力)来矫正骨骼畸形。这些可植入装置的一些期望方面是它们可以在定义的时间段期间施加稳定力,不具有可能烦扰患者或引起疼痛的外部线或杆,已降低感染风险,并且不容易看见。
然而,即使是这些可植入装置在一些情况下也可能具有限制。比如,由于它们在皮肤下的位置,护理提供者可能难以观察、监测并调节一些植入物。同样地,有时将执行另外的手术过程,以按治疗需要增量地调节植入物。另外的手术过程使患者暴露于增大的感染风险、更长的愈合时间、损伤以及加剧的疼痛。
在其它情况下,即使在对植入物的调节可以借助皮肤来进行的情况下,植入物的疗效也可能不太理想。施力不足可能导致差的骨骼重新形成和/或需要更长的恢复时间。施力过度可能导致损伤、另外的骨骼变形以及更长的恢复时间。而且,频繁地访问以查看用于调节的执行器可能耗时或在其它方面对患者不便。
由此,尽管存在现有技术的努力,但仍然存在对用于控制可植入骨骼再成形装置的改进技术的需要,以便提高装置的性能和效率。
发明内容
根据一个实施方式,提供了一种骨骼生长装置。该骨骼生长装置包括植入物主体、致动器、传感器、收发器以及控制器。致动器耦接到植入物主体。传感器被配置为检测指示生物条件的可测量参数。收发器被配置为向外部遥控发送与可测量参数关联的数据,并且从外部遥控接收指令。最后,控制器被配置为响应于来自外部遥控的指令移动致动器,其中,致动器调节植入物主体。
根据另一个实施方式,提供了一种用于骨骼生长装置的外部遥控。该外部遥控包括第一收发器、输入以及控制器。第一收发器被配置为从骨骼生长装置接收与可测量参数关联的数据,并且发送用于骨骼生长装置的指令。输入用于从护理提供者接收护理信息。最后,控制器被配置为:1)接收与可测量参数关联的数据和护理信息;并且2)基于与可测量参数关联的数据和护理信息中的至少一个生成用于骨骼生长装置的指令。
根据另一个实施方式,提供了一种使用可植入装置治疗患者的方法。该方法包括以下步骤:测量指示生物条件的可测量参数;从可植入装置向外部遥控发送与可测量参数关联的数据;从外部遥控向可植入装置发送指令;以及响应于来自外部遥控的指令驱动骨骼生长装置。
附图说明
下文中将连同被提供以示出且不限制所公开方面的附图描述所公开的方面,附图中,同样的附图标记表示同样的元件。
图1是示例骨骼再成形植入物的高级示意图。
图2是示例外部遥控器的高级示意图。
图3示出了例示植入物可以如何附接到骨骼且与外部遥控器通信的一个实施方式。
图4示出了例示植入物可以如何附接到骨骼的两侧且还可以与外部遥控器通信的另一个实施方式。
图5示出了例示植入物可以如何附接到椎骨且还可以与外部遥控器通信的另一个实施方式。
图6是可以由外部激励调节的可植入装置的示例。
图7是可植入装置可以如何使用螺钉附接到骨骼的示例。
图8例示了具有可植入髓内装置的示例实施方式。
图9是适于轴向延长和缩短的骨骼再成形装置的侧视图。
图10a例示了沿着线10a-10a截取的图9的装置的纵剖面图。
图10b例示了来自圆圈10b区域的图10a的延长装置的详细视图。
图11例示了用于无线控制并与图8的可植入装置通信的示例外部遥控器。
图12例示了图9的装置的内部部件中的一些的立体图。
具体实施方式
这里描述了提供与骨骼再成形装置有关的方法和系统的各种实施方式,这些骨骼再成形装置可以响应于由植入物测量的参数被外部控制并调节,以使得响应于从植入物上的传感器获得的生物响应的可测量标记来对于每个患者优化治疗。
当然,将理解,可以在不偏离本公开的精神的情况下进行所例示的另选示例的形式的各种省略、替换以及变化和另选示例的细节。另外,这里描述的各种特征和处理可以独立于彼此使用,或者可以以各种方式组合。所有可能的组合和子组合旨在落在本公开的范围内。这里描述的另选方案中的许多包括类似的部件,并且同样地,这些类似部件可以在本发明的不同方面中互换。
存在对可以针对治疗被有效和/或自适应地调节的可植入骨骼成形装置的长久需要。本公开描述了若干例示性示例,这些示例详细说明了植入物可以如何测量指示生物条件(例如,成骨)的患者的参数并解释或显示这种信息,以便进一步治疗处理。
根据本发明被预期为可潜在治疗的条件的示例包括先天畸形(天生缺陷)(诸如先天短股骨、腓侧半肢畸形(作为膝盖与脚踝之间的两块骨骼中的一块的腓骨的缺乏)、单侧萎缩(身体一半的萎缩)以及奥利埃氏(Ollier)病(还被称为多软骨瘤病、软骨发育不良以及软骨瘤病);发育畸形(诸如多发性神经纤维瘤(引起一条腿的过度生长的罕见情况);以及因佝偻病(脊柱炎)或继发性病变产生的弓形腿);外伤后损伤(诸如生长板裂缝、骨连接不正或骨不连(在骨骼未完全接合或在骨折之后接合在错误位置中)、缩短和畸形、骨骼缺陷、感染和疾病(诸如骨髓炎)(通常由于细菌引起的骨骼感染)、脓毒性关节炎(感染或细菌关节炎)以及脊髓灰质炎(可能导致肌肉萎缩的病毒性疾病,引起永久畸形));切除肿瘤后的重构;身材矮小(诸如软骨发育不全(手臂和腿非常短但躯干在尺寸上更正常的侏儒症的形式))、原发性身材矮小;以及可以鉴于这里的本公开对本领域技术人员明显的其它示例。
图1示出了骨骼成形植入物1000的示例高级示意图。骨骼成形植入物1000具有若干操作模块1004。这些操作模块可以包括传感器1005、致动器1006以及收发器1007。在一些实施方式中,传感器1005可以如由该示例中例示的那样机载到植入物。然而,如稍后将例示且描述的那样,传感器还可以离开处理器或与处理器相邻。传感器1005可以包括箔式应变计、半导体应变计、应力传感器、pH传感器、温度计、压力传感器、位移传感器(例如,电阻随着薄膜被拉伸而变化的薄膜电阻器)、电导/电阻传感器、声传导/声阻传感器、生物传感器(例如,被配置为感测血小板、红细胞、生长因子以及骨骼愈合的其它生物促进因素的存在或聚集的传感器)和/或本领域中已知用于生物或生理测量相关数据的任何其它传感器。
这些前面提及的传感器可以用于测量指示生物条件(诸如成骨、骨化、骨骼传导、骨骼诱导以及骨骼促进)。在一些情况下,所测量参数可以指示缺陷(诸如再生障碍性贫血、另外的骨折、脆骨或不适当的骨骼愈合)。所测量的参数还可以允许计算血流量、骨骼量、骨骼组成、骨骼密度、骨骼厚度、骨骼灌注、骨骼强度以及骨骼氧化。传感器还可以通常被配置为测量其它生物参数(诸如温度、脉冲、血流量、血氧合、身体组成、呼吸、心博、移动、血量、pH、心跳、新陈代谢以及血液成分)。
致动器1006可以由驱动磁体系统、电动马达、螺线管/棘轮系统、压电系统(例如,蠕动马达)、形状记忆合金(例如,Nitol(尼托尔))、磁致伸缩元件、手势和/或本领域中已知的驱动致动器的任何方式来致动。致动器1006的移动可以驱动骨骼成形植入物的修改,诸如以下内容:轴向伸长、轴向缩短、弯曲(例如,畸形矫正)、扭转(例如,创伤)、活性介质的表达(例如,释放治疗或生长因子)、跨骨折或骨骼递送治疗电流、超声、无线电波或磁通量、跨骨折或骨骼递送治疗压缩或振动(例如,1Hz振动)、移动、能量或物质的任何治疗递送、和/或前面提及的条款的任何组合。活性介质可以包括HMG-CoA还原酶、表皮生长因子(EGF)、血管内皮生长因子(VEGF)、纤维母细胞生长因子(FGF)、抗微生物剂和/或抗菌剂。美国专利第2012/0276205号公开出版物中描述促进骨骼生长的更多活性介质,以引证的方式将该公开并入在此。这些活性介质可以由致动器1006来递送,或者以另外方式给予患者,以促进骨骼调节。
收发器1007可以被配置为与其它内部组件和外部部件通信。例如,收发器1007可以被配置为向内部传感器(诸如传感器1005)发送和接收信息。同样,例如,收发器1007可以向外部源(诸如外部遥控(ERC)装置)发送/接收数据。在一些实施方式中,收发器1007可以向外部源(诸如ERC)发送由传感器1005、处理器/控制器1001、存储器1002或骨骼成形植入物1000的任何部分获得的数据。该数据可以是原始数据(例如,电流的变化)、所测量参数(例如,温度、位移以及张力)、所处理信息(例如,状态或生物条件)、指令、询问信号、或与植入物或外部装置相关的任何其它数据、信息或信号。在一些情况下,收发器1007可以向外部装置(诸如ERC)发送动作后状态信息。例如,这种信息可以包括治疗历史、状态日志、诊断信息、来自传感器1005的所记录数据和/或关于生物条件的数据。
收发器1007还可以被配置为使用蓝牙(例如,低功耗蓝牙)、ZigBee、Wi-Fi、感应无线数据传输、医学植入物通信服务(MICS)、射频、近场通信(NFC)、全球移动通信系统(GSM)或任何其它形式的无线数据传输。
在特定实施方式中,收发器1007还可以被配置为与另一个外部装置(诸如数据云、个人计算机、移动电话、寻呼器、平板电脑、移动装置、医院系统或由患者或护理提供者使用的任何其它装置)直接或间接通信。在一些情况下,可以期望植入物向护理提供者发送诊断、状态和/或治疗信息,使得护理提供者可以评估可植入装置(诸如植入物1000)的性能,并且提供评论或向患者实际执行治疗。在一些情况下,外部装置可以将状态信息、固件更新、治疗指令、评论、安全锁或与植入物的性能和/或患者的治疗相关的其它数据、信息或协议发回植入物。
操作模块1004可以耦接到处理器/控制器1001,以执行操作(诸如借助收发器1007发送/接收数据,处理来自传感器1005的传感器数据,控制致动器1006,管理系统功能等)。处理器/控制器1001还可以耦接到存储器1002,该存储器可以包括易失性和非易失性存储器,并且可以向处理器/控制器提供指令和数据。处理器/控制器1001通常基于在存储器1002内存储的程序指令来执行逻辑和算术运算。存储器1002中的指令可以被执行为实现这里描述的方法。处理器/控制器1001还可以包含用于定时治疗的时钟或耦接到该时钟。
为了提供操作能量,电源1003可以耦接到处理器/控制器1001、存储器1002和/或操作模块1004。电源1003可以为电池(诸如锂电池、锂离子电池、镍镉电池、镍金属氢化物电池、镍氢电池、碳锌电池、氧化银电池、锌碳电池、锌空气电池、氧化汞电池、碱性电池或本领域中已知且适于皮下植入的任何其它类型的电池)。特定电池可以由外部激励或短暂的经皮连接来充电。电源还可以包括燃料电池、电容器、电感耦接、运动供电的压电发电机、运动供电的电磁发电机、经皮端口(诸如用于液压连接、电连接以及其它连接以转换电力的端口)和/或能量采集系统(例如,使用身体热量、呼吸周期、身体移动或生物化学反应的系统)。电源1003可以基于多个因素(诸如寿命(例如,电池寿命)、生物相容性、电力、可充电性、尺寸、电流和电压输出、成本、可替换性、可移动部分的有无以及与可植入装置的性能有关的其它因子)来选择。
电源还可以根据电力需求由电力管理策略来管理。例如,电力管理策略可以构成供电、睡眠以及空载周期。在一些情况下,电力管理策略可以将植入物100的总电力和总预期使用寿命考虑在内。在一些情况下,电力管理策略由处理器/控制器1001来实现。
图2示出了ERC 2000的示例高级示意图。ERC 200具有若干操作模块。针对植入物的可选电源2005可以用于向包括电源1003、处理器1001、存储器1002或操作模块1004中的任一个的植入物1000的任何部分供电。针对植入物的电源2005可以借助经皮端口(诸如用于电连接或液压连接的经皮端口)或任何类型的经皮连接(递送电力或燃料的针穿刺)来供给能量。针对植入物的电源2005还可以通过促进能量采集系统来供电。例如,骨骼再成形植入物1000可以通过从身体热量、呼吸周期、身体移动、生物化学反应和/或可能在人身体中可用的任何形式的能量获得能量来接收电力。针对植入物的电源2005可以逐步增强那些操作,以向植入物1000供给更多电力。用例示的方式,如果植入物1000从身体热量接收能量,则到植入物的电力可以包含被管理为升高植入物位置处的温度的化学和/或加热设备。
为了向植入物1000供电,针对植入物的电源2005还可以产生运动、振动、电流、磁力、电感或电容,该植入物可以包含例如运动供电的电磁发电机、运动供电的压电马达、耦接电感器、电容器、电池和/或本公开中描述或本领域中已知的任何电源。
移动器2006可以使得(例如,激励)骨骼再成形植入物1000移动。例如,移动器2006可以通过向致动器施加机械、电、磁、电容、电感或任何其它类型的力或能量来使得致动器1006移动。本公开中将进一步论述这种移动的特定例示性示例。例如,移动器2006可以包括使可伸缩植入物内的被动磁体旋转的磁体。移动器2006的旋转使得植入物伸长和/或缩短。
收发器2007被配置为与其它内部或外部部件通信。例如,收发器2007可以从诸如植入物1000的可植入装置发送或接收信息。在一些实施方式中,收发器2007可以与植入物的收发器(诸如收发器1007)通信,以交换信息,该信息包括原始数据(例如,电流的变化)、所测量参数(例如,温度、位移以及张力)、所处理信息(例如,状态或生物条件)、指令、询问信号、或与植入物或外部装置相关的任何其它数据、信息或信号。
在特定实施方式中,收发器2007还可以被配置为与另一个外部装置(诸如数据云、个人计算机、移动电话、寻呼器、平板电脑、移动装置、医院系统或由患者或护理提供者使用的任何其它装置)通信。在一些情况下,可以期望ERC向护理提供者发送诊断、状态和/或治疗信息,使得护理提供者可以评估可植入装置(诸如植入物1000)的性能,并且向患者提供服务。在一些情况下,外部装置可以向ERC发回状态信息、固件更新、治疗指令、评论、安全锁或与植入物的性能和/或患者的治疗相关的其它数据。
收发器2007可以被配置为使用蓝牙(例如,低功耗蓝牙)、ZigBee、Wi-Fi、感应无线数据传输、医学植入物通信服务(MICS)、射频、近场通信(NFC)、全球移动通信系统(GSM)或任何其它形式的无线数据传输来通信。
操作模块2004可以耦接到处理器/控制器2001,以执行操作(诸如借助收发器2007发送/接收数据,控制针对植入物的电源2005,控制移动器2006,管理系统功能等)。处理器/控制器2001还可以耦接到存储器2002,该存储器可以包括易失性和非易失性存储器,并且可以向处理器/控制器提供指令和数据。处理器/控制器2001通常基于在存储器2002内存储的程序指令来执行逻辑和算术运算。存储器2002中的指令可以被执行为实现这里描述的方法。处理器/控制器1001还可以包含用于定时治疗的时钟或耦接到该时钟。在一些情况下,处理器/控制器2001可以被编程为基于所编程的数据和/或从植入物获得的数据来对植入物进行调节。
为了提供操作能量,电源2003可以耦接到处理器/控制器2001、存储器2002和/或操作模块2004。电源2003可以采取在本公开中描述的任何形式(例如,与电源1003类似的装置),可以插入到电插座中,或者使用本领域中已知的任何其它电源或能源。
电源2003还可以根据电力需求由电力管理策略来管理。例如,电力管理可以构成供电、睡眠以及空载周期。在一些情况下,电力管理策略可以将ERC 2000的总电力和总预期使用寿命考虑在内。在一些情况下,电力管理策略由处理器/控制器2001来实现。
另外,显示器/UI可以机载在ERC 2000上或在ERC 200之外。例如,显示器/UI 2008被示出为在ERC 2000上。然而,显示器/UI 2008还可以在ERC 2000之外并借助无线或有线数据路径(诸如高清晰度多媒体接口、显示器端口、蓝牙(例如,低功耗蓝牙)、ZigBee、Wi-Fi、感应无线数据传输、医学植入物通信服务(MICS)、射频、近场通信(NFC)、全球移动通信系统(GSM)或本领域中已知的任何其它形式的数据传输)连接到ERC 2000(例如,与处理器/控制器2001通信)。在一些实施方式中,显示器/UI 2008包括触摸屏、监视器、电视、液晶显示器或视觉显示信息的任何其它方式。显示器/UI 2008还可以包括触摸面板、按钮选择、键盘、鼠标、语音输入、滚动球、手势界面或本领域中已知的输入信息的任何其它方式。在一些情况下,显示器/UI 2008可以耦接到扬声器或声音产生装置,该扬声器或声音产生装置例如可以播放音频数据、哔哔响或拉响警报。
在一些情况下,可以期望显示器/UI 2008向护理提供者示出所测量参数和/或生物条件。护理提供者然后可以基于所显示信息作出治疗决策。比如,显示器/UI 2008可以示出附接到可植入装置的传感器的位移。如果传感器附接到骨骼上的两个点且传感器移动以相距更远,则该事件可以暗示成骨和/或骨骼延长正在发生。护理提供者然后可以增大或减小置于骨骼上的力或调节速率,作为查核该信息的结果。在一些情况下,护理提供者可以直接控制由植入物输出的力。例如,护理提供者可以向ERC 2000发送指令,该指令可以被上传到植入物1000。另选地,在一些实施方式中,护理提供者可以直接向植入物1000发送指令。
在其它实施方式中,护理提供者可以向ERC 2000发送限制,在ERC 2000中,患者在用ERC 2000调节植入物1000时具有的控制量限于一范围的值。例如,护理提供者可放入安全开关和/或覆盖特征。在一些情况下,护理提供者可以使用覆盖控制来整体关闭植入物操作(诸如在存在紧急事件时)。
在一些情况下,ERC 2000可以另外耦接到成像器(诸如超声、x射线、磁共振成像或计算机断层扫描)。在一些情况下,可以期望将外部遥控器与便携式成像器(诸如超声)耦接,以便对骨骼区域成像。该信息可以用显示器/UI 2008来显示,和/或发送到用于由用户(例如,护理提供者)观看的外部装置。图像可以提供关于骨骼愈合、治疗进展、和/或其它临床相关数据的另外信息。另外信息还可以通知骨骼再成形植入物的调节。
植入物1000与ERC 2000之间的例示性交互如下。植入物1000(例如,使用传感器1005)检测指示生物条件的可测量参数。植入物1000然后(例如,持续、定期或响应于询问)向ERC 2000发送数据。数据可以为ERC 2000处理的原始数据或已经由植入物1000处理的数据。ERC 2000然后可以鉴于所存储的患者信息解释数据和/或向护理提供者显示数据。ERC2000然后向植入物1000发送指令,并且植入物1000响应于这些指令作用。在一些情况下,植入物1000可以向ERC 2000发送动作后状态信息(诸如治疗历史)。
例如,对于经受股骨延长过程的特定患者,最佳牵张率可以近似为1mm每天。然而,成骨率以及与不同牵张速率关联的不适等级可以因患者而异。指示成骨率的由植入物记录的反馈可以用于优化用于给定情况的牵张速率。来自机载传感器的应变计数据或其它数据可以用于监测成骨的进展。该数据可以由ERC从植入物检索,该ERC(内部地或与临床人员结合)可以确定特定患者可以或应将牵张速率降低至不多于大约0.5mm每天或不多于大约0.75mm每天。另选地,在这里公开的植入物和控制系统(内部地或与临床人员结合)在给定的情况下可以确定患者可以受益于或愿意将牵张速率增大至不多于大约1.5mm或不多于大约2mm每天。
另外,ERC可以可选地被提供有将由患者进行的微调谐调节。这将使得患者能够使经编程牵张速率偏离数量为不多于大约5%(在一些实现中不多于大约10%,并且在其它实现中不多于大约25%)的预设速率的增大或减小。在预定括号限值外部进行调节的尝试将没有效果。以该方式,将给予患者足够控制以使得牵张速率的微调谐能够将患者的不适等级或其它期望考虑在内。
图3例示了一个实施方式。未修整的胫骨10附接有骨骼再成形植入物12。骨骼再成形植入物12可以被配置为轴向伸展或压缩,和/或扭转或实现期望临床结果必须的其它移动。
骨骼再成形植入物12被设置有用于附接到骨骼10的至少第一附接点14和第二附接点16。在所例示的实施方式中,第一附接点14和第二附接点16可以为用于容纳第一接骨螺钉15和第二接骨螺钉17的孔。植入物12附接到骨骼可以以各种方式中的任一个(诸如通过在第一附接点和第二附接点中的每一个处使用一个或两个或更多个接骨螺钉)来完成。另选地,第一附接点和第二附接点可以连接到板,粘附地固定到骨骼,固定到包围骨骼的至少一部分或潜在地环绕骨骼的轴环或环或具有实现期望临床结果的足够结构完整性的其它附接结构。
骨骼位于第一接骨螺钉15与第二接骨螺钉17之间的部分是治疗区域,在该治疗区域上方,将分配由骨骼再成形植入物12生成的力。虽然未例示,但是第一接骨螺钉15与第二接骨螺钉17之间的骨骼10通常将包含期望矫正的一个或更多个骨骼畸形。同样未用图表示的,第一接骨螺钉15与第二接骨螺钉17之间的骨骼10可以包含骨损伤(诸如骨折)。
可以设置一个或更多个传感器23和24。一个或更多个传感器可以被固定到植入物主体12上的位置。传感器还可以期望地位于连接点15和17上,或位于与骨骼接触的位置。传感器23和24被配置为测量指示生物条件(例如,成骨或本公开中描述的生物条件中的任一个)的参数。传感器还可以为本公开中描述或本领域中已知的任何类型(或任何类型的组合)。例如,在所例示的具体配置中,两个传感器23和24可以感测应力(应变计)或例如可以使用光(诸如红外(IR)光)、激光、电流、电感、薄膜电阻器、声学器件或测量本领域中已知的对象之间的距离的任何其它方式来感测彼此之间的距离。该距离测量可以与成骨相互关联。例如,如果传感器相互远离彼此移动,则成功成骨可能正在发生,从而延长传感器之间的距离。
处理器25可以解释传感器的输出,以计算所测量的参数。例如,在测量骨骼上的张力时,传感器23和24可以输出与张力相关的电流。处理器然后可以基于那些电输出计算张力。另外,处理器25还可以编译由传感器获得的数据(例如,随着时间的过去而产生的张力和/或由传感器测量的不同参数),以用于生物结论。例如,通过把pH、温度、张力以及位移作为因素计入,处理器25可以确定成骨是否正在发生,而且确定成骨的速率和圆周规则性或不规则性的标记。处理器25另外可以计算能够施加于骨骼以用于有效治疗处理或增加疗效的力的量、力的增大量或力的减小量。
在一些实施方式中,处理器25可以控制处理的修整。例如,处理器25可以驱动耦接到植入物主体12的致动器,其中,致动器可以改变施加于骨骼的力的量或角度。例如,植入物主体12可以包含使植入物主体12收缩或伸展的马达、磁线圈和/或弹性构件。收缩可以在骨骼的至少一侧上施加更多的压缩力,而伸展可以在骨骼的至少一侧上施加更多的牵张力。在任何一种情况下,植入物主体32由于其在骨骼一侧上的位置还可以对骨骼施加角向力。
还可以设置一个或更多个收发器18。收发器18可以由电缆20(或在其它实施方式中无线地)与骨骼再成形植入物12或一个或更多个传感器23和24通信。收发器18另选地可以处于植入物内或由植入物承载。根据植入物的功能,电缆可以包括电、光、流体或其它导管。收发器18可以被配置用于发送和接收信息。例如,收发器18可以被配置为使用之前提及的模式(诸如感应无线数据传输或任何其它形式的无线数据传输)中的任何一个来与外部装置通信。在一些实施方式中,收发器18被配置为向ERC发送数据。数据可以为由传感器23和24生成的数据、由处理器25输出的数据、状态信息、生物条件、对来自外部装置的信息的请求或在本公开中描述的任何其它相关信息。
在一些实施方式中,收发器18可以被配置为持续发送数据。这种持续发送可能是期望的,以允许外部遥控监测患者的情况并在必要时作出反应措施。然而,在一些情况中,持续发送可能要求更多的电力,并且对于可植入装置可能导致低电池寿命。在其它实施方式中,收发器18可以被配置为定期(诸如每分钟、每小时、每天、每周、每月、每年和/或包括在前面提及的时间段中的任何两个之间的任何时间的任何时间段)发送数据。在其它实施方式中,收发器18可以被配置为响应于由ERC 22或某一其它外部装置产生的询问信号而发送数据。在又一些实施方式中,收发器18可以被配置为响应于事件(例如,所测量参数的突然变化、达到所测量参数的预设触发阈值、所检测生物条件或植入物状态的变化(例如,植入物的损坏或植入物缺乏电池))而发送数据。
收发器18还可以被配置为接收从ERC 22发送的数据。该数据可以包含指令(诸如使处理器驱动致动器的指示)。该数据还可以提供收发器发送数据的状态或请求。该数据还可以提供固件更新和/或对算法、协议或治疗的更新。
在一些实施方式中,还可以设置电源26。电源26可以为电池或在本公开中论述的任何电源。电源如图例示的可以被承载在植入物12内或上或植入物附近。
在一些实施方式中,存储器可以耦接到处理器25,以便例如存储处理器数据、固件、指令、电力管理数据以及要由收发器在询问时输出的信息。
ERC 22可以为具有与ERC 2000相同的功能的ERC。具体地,ERC 22可以与收发器18通信,以从植入物接收数据并向植入物发送响应指令。在一些情况下,植入物响应于ERC 22的指令而动作。例如,ERC 22的指令可以使得耦接到植入物主体12的致动器驱动。
图4例示了另一个实施方式。该实施方式具有两个骨骼再成形植入物主体40和50。在一些实施方式中,植入物主体40和50中的每一个可以耦接到其自己的传感器。例如,植入物主体40具有传感器55和57,并且植入物主体50具有传感器52和54。可以根据期望存在一个或更多个内部或外部电源58来对植入物供电。还可以根据期望存在一个或更多个内部或外部收发器51,以对于植入物主体40和50发送和接收信息。还可以根据期望存在一个或更多个处理器53,以处理数据。
在特定情形下可期望在骨骼上具有两个(或更多个)植入物(诸如植入物40和50),以便更好地支持骨骼结构。这些植入物根据治疗应用联合地或独立地操作。例如,同时从两侧对骨骼沿相同方向施加相同压力的两个植入物可以在成骨期间防止或倾向于矫正骨骼的弯曲度和/或其它畸形。另一方面,为了改进骨骼弯曲度,可以通过压缩一个植入物并且牵张另一个植入物和/或向不同植入物施加不同的力来对骨骼施加另外的角向力。在又一个应用中,成骨在一些情况下可能跨骨骼以不同的速率发生。使用多个植入物可以通过应用补偿压缩或牵张治疗来补偿这些骨骼生长差异。
应理解,可以存在一个或更多个植入物被固定到骨骼的许多配置。例如,本领域中存在使用在各种点处附接到股骨或脊柱的四个或更多个植入物主体的配置。本公开的实施方式不限于将植入物附接到骨骼的任何特定形成或方式。
图5例示了可以置于身体其它部位中的类似可植入装置。例如,为了调节脊柱的弯曲度,可以沿着脊柱植入一个或更多个可植入装置510和520。为了例示性目的,植入物510被示出为由两个锚定装置511和512附接到两个邻接的椎骨,而另一个装置520被示出为通常在单独过程中(为了方便起见两个装置都被例示在同一个骨骼上)由两个锚定装置521和522附接到非邻接的椎骨。本实施方式可以用于调节脊柱的弯曲度(诸如以减轻腰椎间盘突出症等)。
在一些实施方式中,植入物被配置为被外部调节。例如,图6示出了伸展或伸缩杆410。杆410的相对端使用传统手术螺钉被固定到骨骼上所选的位置。例如,杆410可以如图7或图3中所示的那样使用螺钉542被固定到骨骼。另外或另选地,杆410可以用作髓内植入物或用作植入物12、40、50、510和/或520的一部分或与植入物12、40、50、510和/或520结合。这样,应理解,对杆410的外部控制调节可以基于指示生物条件的所测量参数来进行。例如,植入物40、50、510和/或520的传感器如在本公开中描述的那样向ERC发送相关数据或信息。ERC或护理提供者可以使用该信息来确定ERC是否应调节植入物。
杆410可以在精确外部控制下随着时间的过去而缓慢产生受控力,并且被完全隔离或植入皮肤以下,并且受皮肤提供的自然屏障保护。杆410还可以足够小、强劲、简单以致容易制造,对意外驱动免疫且是生物惰性的。
拾波线圈430从被使得与线圈430接近的外部手持能量源(诸如低频电磁辐射生成器)接收能量。这种手持能量源的一些示例是ERC 22、62和/或522。杆410被植入在皮肤屏障之下,而能量源在身体之外。外部感应电源可以以传统线频率被驱动。在线圈430能够高效地驱动肌肉线438的情况下,然后具有控制二极管的存储电容器可以被添加在具有线圈430的电路中,或者更复杂地,可以使用具有二极管电压倍增器和控制二极管的电池。一方面,可以采用线圈430与线438之间的阻抗匹配的任何装置,另一方面,可以采用线圈430与感应电源之间的阻抗匹配的任何装置。外部电源的使用和感应供电的被植入线圈在本领域中是众所周知的且例如常用于对所植入的起搏器装置充电。
在一些另选方案中,能量可以被馈送到拾波线圈中,直到足够的能量被存储在电容器中以驱动马达428为止。在马达428点火时,手持装置可以感测放电,并且关掉规定闭锁时段。在其它另选方案中,机载电池或电源帮助对电容器充电,由此要求显著更多个控制电子器件。例如,这种机载电池或电源可以为电源26、58和/或516。
在特定实施方式和另选方案中,内部处理器(诸如处理器25、53和/或515)诸如可以通过启用或停用杆410的伸展/收缩或通过对这种伸展/收缩进行限制来另外控制电源和/或马达428。处理器还可以处理来自ERC的另外指令、数据、状态等。
在一些情况下,植入物可以被置于骨骼内部(诸如骨髓管内部)。图8示出了被置于骨骼内部的这种植入物110。植入物具有耦接到植入物主体的至少一个传感器,并且在所例示实现中具有诸如应变计或这里在别处公开的其它传感器的两个传感器301和303。植入物还具有处理器302、电源304以及收发器305。
图9进一步详细说明了一个特定植入物110和它如何驱动。植入物110在牵张轴114中具有可以借助其放置螺钉的一个或更多个牵张轴螺孔122。同样,壳112附接到具有可以借助其放置螺钉的一个或更多个壳螺孔124的端盖330。图10a示出了髓内延长装置110的壳112包括磁体壳128和花键壳126。壳126、128可以借助于焊接、粘接或其它接合技术来附接到彼此。磁体壳128在一端(该端与具有花键壳126的界面相对)处通过附接端盖130可密封地封闭。端盖130可以借助于焊接、粘接或其它接合技术来附接到磁体壳128。在使用时,借助于在螺母140内部转动的导螺杆136从壳112驱动牵张轴114,该导螺杆136被固定到与牵张轴114的腔137邻近的内表面。导螺杆136以间接方式机械耦接到被包含在磁体壳128内的圆柱形永磁体134。受外部调节装置180(图11)磁驱动的圆柱形永磁体134的旋转实现导螺杆136的旋转。
圆柱形磁体134例如使用诸如环氧树脂的粘合剂被固定地包含在磁体外壳158内。磁体外壳158相对于磁体壳128旋转。圆柱形磁体134可以为诸如Nd-Fe-B的稀土磁体,并且可以除了被保护在磁体外壳158内(例如,用环氧树脂密封地装罐)之外,还涂布有聚对二甲苯或其它保护涂层。磁体外壳158在附接到径向轴承132内部的一端上包含轮轴160。径向轴承132的外径被固定到径向轴承132的内部。径向轴承132的外径被固定到端盖130的内部。该布置允许圆柱形磁体134以最小抗扭力旋转。在其另一相对端处,磁体外壳158包括附接到第一行星齿轮组154的轮轴161。在图10b中示出的,轮轴161包括第一行星齿轮组154的太阳齿轮,太阳齿轮使第一行星齿轮组154的行星齿轮转动。第一行星齿轮组154用来降低旋转速度并提高从圆柱形磁体134向导螺杆136产生的扭矩递送。第二行星齿轮组156被示出在第一行星齿轮组154与导螺杆136之间,以便进一步的速度降低和扭矩增大。为了实现期望速度和扭矩递送,可以调节行星齿轮组的数量和/或齿轮中齿的数量。例如,附接到具有4:1齿轮比的两个行星齿轮组(齿轮组均处于在股骨远端具有磁体位置的9mm装置内部)的每英寸具有八十(80)个螺纹的导螺杆在大于离外部装置的平均距离或间隙的距离或间隙下可以实现至少100lb的牵张力。
在图12中,已经去除壳部件,以露出各种内部特征(包括轴环,该轴环允许牵张轴114在壳112内滑动,并且保持牵张轴114能够在壳112内旋转)。这允许骨骼100的全稳定性。
图11例示了用于借助于传递扭矩的磁耦接来无创地控制骨骼再成形植入物130的ERC 180的示例。ERC 180包括:磁手持件178(例如,移动器);控制箱176(包含处理器),该控制箱176可以与手持件集成;以及电源174,诸如电池或用于连接到标准电力出口的外部插头。控制箱176包括控制面板182,该控制面板182具有一个或更多个控制器(按钮、开关或触觉、动作、音频或光传感器)和显示器184。显示器184可以为视觉的、听觉的、触觉的等,或前面提及的特征的一些组合、或本公开中描述的任何其它显示器/UI。控制箱176还可以包含收发器,该收发器用于与植入物的收发器305和/或其它外部装置通信。凭借植入物110,收发器可以获得或发送信息,该信息包括原始数据(例如,电流的变化)、所测量参数(例如,温度、位移或张力)、所处理信息(例如,状态或生物条件)、指令、询问信号、或与植入物或外部装置相关的任何其它数据、信息或信号。凭借另一个外部装置,ERC 180例如可以向护理提供者发送和接收诊断、状态、处理信息和/或从植入物获得的任何数据,使得护理提供者可以评估可植入装置(诸如植入物110)的性能,并且向患者提供服务。
ERC 180还可以基于从植入物获得的数据被编程和/或实现协议。例如,ERC 180(或护理提供者)可以确定将减慢或加速压缩或牵张速率,并且因此调节植入物。另选地,ERC可以显示输入或使得ERC传递到植入物的用于患者的适当调节。另外,在一些情况下,ERC 180可以将用户的能力限于根据治疗限制对治疗进行调节。
本领域普通技术人员还将理解,关于这里所公开的多个方面描述的各种例示性逻辑块、模块、处理器、装置、电路以及算法步骤可以被实现为电子硬件(例如,可以使用源编码或一些其它技术设计的数字实现、模拟实现或两者的组合)、包含指令的各种形式的程序或设计代码(这里为方便起见可以被称为“软件”或“软件模块”)或两者的组合。为了清楚地例示硬件和软件的该互换性,上面已经总体鉴于各种例示性部件、块、模块、电路以及步骤的功能描述了它们。这种功能是被实现为硬件还是软件取决于特定应用和对整个系统强加的设计限制。技术人员可以对于每个具体应用以各种方式来实现所述功能,但这种实现决策不应被解释为引起从本公开范围的偏离。
关于这里所公开的多个方面且关于附图描述的各种例示性逻辑块、模块以及电路可以被实现在集成电路(IC)、接入终端或接入点内或由它们执行。IC可以包括被设计为执行这里描述的功能的通用处理器、数字信号处理器(DSP)、专用集成电路(ASIC)、现场可编程门阵列(FPGA)或其它可编程逻辑装置、离散门或晶体管逻辑、离散硬件部件、电部件、光部件、机械部件或其任何组合,并且可以执行驻留在IC内部、IC外部或这两者的代码或指令。逻辑块、模块以及电路可以包括与网络内或装置内的各种部件通信的天线和/或收发器。通用处理器可以为微处理器,但在另选方案中,处理器可以为任何传统处理器、控制器、微控制器或状态机。处理器还可以被实现为计算装置的组合(例如,DSP和微处理器、多个微处理器、一个或更多个微处理器连同DSP内核、或任何其它这种配置的组合)。模块的功能可以以如这里教导的某一其它方式来实现。这里(例如,关于附图中的一个或更多个)描述的功能可以在一些方面中对应于用于所附权利要求中的功能的类似指定“装置”。
如果在软件中实现,则功能可以被存储在计算机可读介质上或者可以作为计算机可读介质上的一个或更多个指令或代码来发送。这里公开的方法或算法的步骤可以在可以驻留在计算机可读介质上的处理器可执行软件模块中实现。计算机可读介质包括计算机存储介质和通信介质这两者,通信介质包括可以使得能够从一个地点向另一个地点传送计算机程序的任何介质。存储介质可以为可由计算机访问的任何可用介质。用示例的方式且不限制,这种计算机可读介质可以包括RAM、ROM、EEPROM、光盘储存器、磁盘储存器或其它磁存储装置、或可以用于存储可以由计算机访问的指令或数据结构形式的期望程序代码的任何其它介质。同样,任何连接可以被适当称为计算机可读介质。上述内容的组合还可以被包括在计算机可读介质的范围内。另外,方法或算法的操作可以作为代码和指令的一个或任何组合或集合驻留在机器可读介质和计算机可读介质上,该机器可读介质和计算机可读介质可以被结合在计算机程序产品中。
将理解,所公开的任何处理中的步骤的任何具体顺序或层次是样本方法的示例。基于设计偏好,将理解,处理中的步骤的具体顺序或层次可以在保持在本公开的范围内的同时来重新排列。所附方法权利要求以样本顺序呈现各种步骤的元素,并且不旨在限于所呈现的具体顺序或层次。
对本公开中描述的实现的各种修改对本领域技术人员是显而易见的,并且这里定义的一般原理可以在不偏离本公开的精神或范围的情况下被应用于其它实现。由此,本公开不旨在限于这里示出的实现,而是符合与这里公开的权利要求、原理以及新型特征一致的最宽范围。词语“示例”在这里排它地用于意指“充当示例、实例或例示”。这里被描述为“示例”的任何实现不必须被解释为比其它实现优选或有利。
在单独实现的环境中在该本说明书中描述的特定特征还可以在单个实现中组合实现。相反,在单个实现的环境中描述的各种特征还可以单独在多个实现中或以任何合适的子组合实现。而且,虽然特征在上面可以被描述为以特定组合来起作用且甚至初始被这样要求保护,但来自所要求保护组合的一个或更多个特征在一些情况下可以从组合切除,并且所要求保护的组合可以指向子组合或子组合的变体。
类似地,虽然以特定顺序在附图中描绘操作,但这不应被理解为:为了实现期望的结果,要求这种操作以所显示的特定顺序或以相继顺序来执行,或者执行所有所例示的操作。在特定情况下,多重任务处理和并行处理可以是有利的。而且,上述实现中的各种系统部件的分离不应被解释为在所有实现中要求这种分离,并且应理解,所述程序部件和系统一般可以一起集成在单个软件产品中或包装到多个软件产品中。另外,其它实现在以下权利要求的范围内。在一些情况下,权利要求中列出的动作可以以不同的顺序来执行并且仍然实现期望的结果。
Claims (30)
1.一种骨骼生长装置,所述骨骼生长装置包括:
植入物主体;
致动器,所述致动器耦接到所述植入物主体;
传感器,所述传感器被配置为检测指示生物条件的可测量参数;
收发器,所述收发器被配置为向外部遥控发送与所述可测量参数关联的数据,并且从所述外部遥控接收指令;以及
控制器,所述控制器被配置为响应于来自所述外部遥控的所述指令移动所述致动器,其中,所述致动器调节所述植入物主体。
2.根据权利要求1所述的装置,所述装置还包括存储器,所述存储器被配置为存储与所述可测量参数关联的所述数据、来自所述外部遥控的所述指令、以及状态信息中的至少一个。
3.根据权利要求1所述的装置,其中,所述植入物主体还包括所述植入物主体与骨骼的第一部分之间的第一连接点和所述植入物主体与骨骼的第二部分之间的第二连接点。
4.根据权利要求3所述的装置,其中,所述调节包括在所述第一连接点与所述第二连接点之间应用压缩。
5.根据权利要求3所述的装置,其中,所述调节包括向所述骨骼施加力,所述力至少具有与延伸穿过所述第一附接点和所述第二附接点的直线不平行的分量。
6.根据权利要求3所述的装置,其中,所述调节包括施加力以延长所述第一附接点与所述第二附接点之间的距离。
7.根据权利要求1所述的装置,其中,所述生物条件是成骨。
8.根据权利要求3所述的装置,其中,所述可测量参数是所述第一连接点与所述第二连接点之间的距离。
9.根据权利要求3所述的装置,其中,所述可测量参数是所述第一连接点与所述第二连接点之间的运动。
10.根据权利要求1所述的装置,其中,所述可测量参数是血流量、温度、张力、pH、应力、骨骼组成、骨骼量、骨骼密度、骨骼厚度、骨骼灌注、骨骼强度、骨骼氧化、导电性以及活性介质的存在中的至少一个。
11.根据权利要求1所述的装置,所述装置还包括电源。
12.根据权利要求11所述的装置,其中,所述电源被配置为由所述外部遥控来充电。
13.根据权利要求1所述的装置,所述装置还包括被配置为从外部源接收能量的能量接收元件。
14.根据权利要求1所述的装置,其中,所述植入物主体是髓内装置。
15.一种用于骨骼生长装置的外部遥控,所述外部遥控包括:
第一收发器,所述第一收发器被配置为从所述骨骼生长装置接收与可测量参数关联的数据,并且发送用于所述骨骼生长装置的指令;
输入端,所述输入端用于从护理提供者接收护理信息;以及
控制器,所述控制器被配置为:
接收与可测量参数关联的所述数据和护理信息,
基于与可测量参数关联的所述数据和护理信息中的至少一个生成用于所述骨骼生长装置的所述指令。
16.根据权利要求15所述的外部遥控,其中,所述输入端包括第二收发器,所述第二收发器被配置为向护理提供者发送患者信息,并且从所述护理提供者接收护理信息。
17.根据权利要求16所述的外部遥控,其中,所述第一收发器和所述第二收发器是一个收发器。
18.根据权利要求15所述的外部遥控,其中,来自护理提供者的所述护理信息是所述指令。
19.根据权利要求15所述的外部遥控,所述外部遥控还包括被配置为显示患者信息的显示器。
20.根据权利要求15所述的外部遥控,其中,所述输入端是用户界面。
21.根据权利要求15所述的外部遥控,所述外部遥控还包括能量发送器,所述能量发送器被配置为向所述骨骼生长装置供电。
22.根据权利要求15所述的外部遥控,所述外部遥控还包括移动器,所述移动器被配置为驱动所述骨骼生长装置。
23.根据权利要求22所述的外部遥控,其中,所述移动器使用磁体、热以及电流中的至少一个来驱动所述骨骼生长装置。
24.根据权利要求15所述的外部遥控,所述外部遥控还包括存储器,所述存储器被配置为存储与可测量参数关联的所述数据、所述护理信息以及所述指令中的至少一个。
25.一种使用可植入装置治疗患者的方法,所述方法包括以下步骤:
测量指示生物条件的可测量参数;
从所述可植入装置向外部遥控发送与所述可测量参数关联的数据;
从所述外部遥控向所述可植入装置发送指令;以及
响应于来自所述外部遥控的所述指令驱动所述骨骼生长装置。
26.根据权利要求25所述的治疗患者的方法,其中,测量可测量参数包括测量骨骼的第一部分与骨骼的第二部分之间的压缩。
27.根据权利要求25所述的治疗患者的方法,其中,测量可测量参数包括测量骨骼的第一部分与骨骼的第二部分之间的距离。
28.根据权利要求25所述的治疗患者的方法,其中,测量生长参数包括测量骨骼的第一部分与骨骼的第二部分之间的运动。
29.根据权利要求25所述的装置,其中,所述生物条件是成骨。
30.根据权利要求25所述的装置,其中,所述驱动还包括从所述外部遥控接收驱动能量。
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CN111938794B (zh) * | 2020-08-20 | 2022-03-15 | 四川大学华西医院 | 基于应力自适应调节的智能化骨科外支架系统 |
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US11357547B2 (en) | 2022-06-14 |
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DK3209226T3 (da) | 2021-02-01 |
AU2015335766B2 (en) | 2020-01-30 |
KR20170075757A (ko) | 2017-07-03 |
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US10314619B2 (en) | 2019-06-11 |
ES2834654T3 (es) | 2021-06-18 |
AU2015335766A1 (en) | 2017-05-18 |
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