CN116474207A - Mobile infusion pump device with integrated sensor - Google Patents

Abstract

An integrated sensor and infusion device is disclosed herein. For example, the present technology includes an integrated sensor and infusion device for sensing physiological parameters and delivering a medicament to a user's body based at least in part on the sensed parameters. The device may include an insertion assembly comprising: a carrier assembly including a cannula carrier, a trocar assembly removably coupled to the carrier assembly, and a drive assembly including a torsion spring coupled to the trocar assembly such that when actuated, the torsion spring rotates to drive the trocar assembly and carrier assembly axially downward to insert an infusion cannula and sensor electrode into the skin of a user. The drive assembly may include a plurality of coupled drive wheels and/or a scissor assembly having a plurality of interacting links.

Description

Translated fromChinese

带有集成传感器的移动式输注泵装置Ambulatory Infusion Pump Unit with Integrated Sensors

相关申请的交叉引用Cross References to Related Applications

本申请要求于2022年1月21日提交的美国临时申请号63/267,022和于2022年5月31日提交的美国临时申请号63/365,544的优先权权益，这些申请各自的全部内容通过援引并入本文。This application claims the benefit of priority to U.S. Provisional Application No. 63/267,022, filed January 21, 2022, and U.S. Provisional Application No. 63/365,544, filed May 31, 2022, the entire contents of each of which are incorporated herein by reference.

技术领域technical field

本技术总体上涉及医疗装置，更具体地涉及具有集成的连续葡萄糖监测仪的胰岛素递送装置。The present technology relates generally to medical devices, and more particularly to insulin delivery devices with integrated continuous glucose monitors.

背景技术Background technique

移动式输注泵是相对较小的、至少基本上独立的装置，用于将药物和其他可输注物质(统称为“药剂”)引入用户体内。一些输注泵被配置为佩戴在腰带上、携带在衣服口袋中等。其他输注泵被配置为以类似贴片的方式粘附在皮肤上。输注泵的优势在于它们可以用于例如在临床环境之外持续或甚至连续地皮下引入(或“输注”)药剂。输注泵的优势还在于它们大大降低了皮下进入事件(例如基于针头的注射)的频率。可以由输注泵引入的药剂的一个示例是胰岛素的液体制剂。可以由输注泵引入的其他示例药剂包括但不限于治疗癌症的药物和抑制疼痛感的药物。Ambulatory infusion pumps are relatively small, at least substantially self-contained devices used to introduce drugs and other infusible substances (collectively "medications") into the body of a user. Some infusion pumps are configured to be worn on a belt, carried in a clothing pocket, and the like. Other infusion pumps are configured to stick to the skin in a patch-like fashion. An advantage of infusion pumps is that they can be used for continuous or even continuous subcutaneous introduction (or "infusion") of medicaments, for example outside of a clinical setting. Infusion pumps are also advantageous in that they greatly reduce the frequency of subcutaneous entry events such as needle-based injections. One example of a medicament that can be introduced by an infusion pump is a liquid formulation of insulin. Other exemplary pharmaceutical agents that may be introduced by an infusion pump include, but are not limited to, drugs to treat cancer and drugs to suppress pain sensation.

在某些情况下，移动式输注泵可以基于实时监控装置获得的测量值自动分配药剂(例如，胰岛素)。在胰岛素输注泵的情况下，这种实时监测装置可以采取连续葡萄糖监测仪(CGM)的形式。这种CGM的示例包括具有传感器部件的可穿戴装置，该传感器部件可以插入用户的皮肤以随时间连续或定期记录用户的葡萄糖水平。In some cases, the ambulatory infusion pump can automatically dispense medication (eg, insulin) based on measurements obtained by a real-time monitoring device. In the case of insulin infusion pumps, this real-time monitoring device may take the form of a continuous glucose monitor (CGM). Examples of such CGMs include wearable devices with sensor components that can be inserted into the user's skin to continuously or periodically record the user's glucose levels over time.

输注泵装置和单独的传感器装置的使用给用户带来了复杂性，并且需要在用户皮肤上留出很大的空间来实施。尽管已经提出了集成了输注泵和CGM两者的组合装置，但此类装置通常体积庞大且昂贵。此外，在组合装置中，传感器部件可能位置太靠近胰岛素递送插管而无法获得用户的准确生理学胰岛素读数。相应地，仍然需要开发具有集成传感器的改进的移动式输注泵装置。The use of an infusion pump device and a separate sensor device introduces complexity to the user and requires a significant amount of space on the user's skin to implement. Although combination devices integrating both an infusion pump and a CGM have been proposed, such devices are generally bulky and expensive. Furthermore, in combination devices, the sensor component may be located too close to the insulin delivery cannula to obtain accurate physiological insulin readings for the user. Accordingly, there remains a need to develop improved ambulatory infusion pump devices with integrated sensors.

发明内容Contents of the invention

一方面，本技术包括一种集成式传感器与输注装置。该装置包括储器组件，该储器组件包括被配置为将药剂容纳在其中的储器。该装置还包括传感器电子组件，该传感器电子组件被配置为从传感器接收信号。该装置还包括插入组件，该插入组件具有：载体组件，该载体组件包括插管载体、背离插管载体向下延伸的输注插管、以及在与输注插管侧向间隔开的位置处背离插管载体向下延伸的传感器电极，其中输注插管流体联接到储器；套管针组件，该套管针组件包括套管针连杆、被配置为可移除地接合输注插管的第一套管针、以及被配置为可移除地接合传感器电极的第二套管针，该套管针组件可移除地联接到载体组件；以及驱动组件，该驱动组件包括扭转弹簧，该扭转弹簧联接到套管针组件，使得当被致动时，扭转弹簧进行旋转以驱动套管针组件和载体组件轴向向下，以将第一套管针、输注插管、第二套管针和传感器电极插入用户的皮肤中。In one aspect, the technology includes an integrated sensor and infusion set. The device includes a reservoir assembly including a reservoir configured to receive a medicament therein. The device also includes a sensor electronics assembly configured to receive a signal from the sensor. The device also includes an insertion assembly having: a carrier assembly including a cannula carrier, an infusion cannula extending downwardly away from the cannula carrier, and a sensor electrode extending downwardly away from the cannula carrier at a location laterally spaced from the infusion cannula, wherein the infusion cannula is fluidly coupled to the reservoir; a trocar assembly including a trocar linkage, a first trocar configured to removably engage the infusion cannula, and a second trocar configured to removably engage the sensor electrode, The trocar assembly is removably coupled to the carrier assembly; and a drive assembly including a torsion spring coupled to the trocar assembly such that when actuated, the torsion spring rotates to drive the trocar assembly and carrier assembly axially downward to insert the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the skin of the user.

该装置还可以包括装置壳体，该装置的每个部件被配置为在第一套管针、输注插管、第二套管针和传感器电极被插入用户的皮肤中之前被容纳在装置壳体内，并且其中，第一套管针、输注插管、第二套管针和传感器电极伸出壳体以插入用户的皮肤中。该装置还可以配置为使得扭转弹簧的第一旋转量驱动第一套管针、输注插管、第二套管针和传感器电极进入用户的皮肤中，并且第二旋转量将第一套管针和第二套管针从用户的皮肤缩回，同时将输注插管和传感器电极留在用户的皮肤中。扭转弹簧经由手动触发机构被致动，和/或可以经由远程触发机构被致动。第一套管针可以被配置为在输注插管的内腔内延伸。传感器电极可以被配置为被可移除地接纳在第二套管针的凹部内。The device may also include a device housing, each component of the device configured to be received within the device housing prior to insertion of the first trocar, infusion cannula, second trocar, and sensor electrode into the user's skin, and wherein the first trocar, infusion cannula, second trocar, and sensor electrode extend out of the housing for insertion into the user's skin. The device may also be configured such that the first amount of rotation of the torsion spring drives the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the user's skin, and the second amount of rotation retracts the first trocar and the second trocar from the user's skin while leaving the infusion cannula and sensor electrode in the user's skin. The torsion spring is actuated via a manual trigger mechanism, and/or may be actuated via a remote trigger mechanism. The first trocar can be configured to extend within the lumen of the infusion cannula. The sensor electrode may be configured to be removably received within the recess of the second trocar.

在一些实施例中，驱动组件进一步包括经由驱动轮联接到扭转弹簧的剪刀式组件，该剪刀式组件包括在第一区域处联接到套管针连杆的第一连杆和在第二区域处联接到套管针连杆的第二连杆，其中，扭转弹簧在被致动时被配置为使驱动轮旋转以经由剪刀式组件致使套管针连杆轴向移动以驱动第一套管针、输注插管、第二套管针和传感器电极进入用户的皮肤中。在一些实施例中，驱动轮设置在壳体内，并且驱动轮包括被接纳在第一连杆的凸轮槽内的销，使得驱动轮的旋转致使该销在凸轮槽内滑动并致使第一连杆相对于驱动轮壳体旋转。第二连杆联接到第一连杆，使得第一连杆的旋转引起第二连杆的相反旋转。驱动组件在被致动时可以使剪刀式组件从未击发位置移动到插入位置，在该未击发位置时，输注插管和传感器电极设置在装置的壳体内，并且在该插入位置时，输注插管和传感器电极延伸超出该装置的壳体。在一些实施例中，在未击发位置时，第一连杆和第二连杆呈现展开状态，在该展开状态下它们沿不平行的轴线延伸，并且其中，在插入位置时，第一连杆和第二连杆呈现收拢状态，在该收拢状态下它们彼此更接近于平行地延伸。In some embodiments, the drive assembly further includes a scissor assembly coupled to the torsion spring via a drive wheel, the scissor assembly including a first link coupled to the trocar link at a first region and a second link coupled to the trocar link at a second region, wherein the torsion spring, when activated, is configured to rotate the drive wheel to cause the trocar link to move axially via the scissor assembly to drive the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the skin of the user. In some embodiments, the drive wheel is disposed within the housing and the drive wheel includes a pin received in a cam slot of the first link such that rotation of the drive wheel causes the pin to slide within the cam slot and cause the first link to rotate relative to the drive wheel housing. The second link is coupled to the first link such that rotation of the first link causes opposite rotation of the second link. The drive assembly, when actuated, can move the scissor assembly from an unfired position in which the infusion cannula and sensor electrodes are disposed within the housing of the device to an insertion position in which the infusion cannula and sensor electrodes extend beyond the housing of the device. In some embodiments, in the unfired position, the first link and the second link assume a deployed condition in which they extend along non-parallel axes, and wherein in the inserted position the first link and the second link assume a collapsed condition in which they extend closer to parallel to each other.

在一些实施例中，驱动组件进一步包括联接到扭转弹簧的第一驱动轮、以及第二驱动轮，该第二驱动轮与该第一驱动轮配合，使得第一驱动轮的旋转引起第二驱动轮的旋转。第一驱动轮可以包括第一销并且第二驱动轮可以包括第二销，第一销和第二销中的每一个延伸到套管针连杆的凸轮槽中，使得第一驱动轮和第二驱动轮的旋转致使套管针连杆轴向移动。套管针连杆沿向下方向的轴向移动可以引起载体组件沿向下方向的轴向移动。第一驱动轮沿第一方向的旋转可以引起第二驱动轮沿相反的第二方向旋转。该装置还可以包括：其中插管载体包括被配置为将第一销可释放地接纳在其中的第一凸轮轨道和被配置为将第二销可释放地接纳在其中的第二凸轮轨道。该装置还可以被配置为使得，当套管针组件和载体组件各自处于向下插入位置时，第一销和第二销分别与第一凸轮轨道和第二凸轮轨道接合，并且其中，当套管针组件相对于载体组件向上缩回时，第一销和第二销与第一凸轮轨道和第二凸轮轨道脱接合。In some embodiments, the drive assembly further includes a first drive wheel coupled to the torsion spring, and a second drive wheel that cooperates with the first drive wheel such that rotation of the first drive wheel causes rotation of the second drive wheel. The first drive wheel may include a first pin and the second drive wheel may include a second pin, each of the first and second pins extending into a cam slot of the trocar link such that rotation of the first drive wheel and the second drive wheel causes the trocar link to move axially. Axial movement of the trocar link in the downward direction may cause axial movement of the carrier assembly in the downward direction. Rotation of the first drive wheel in a first direction may cause rotation of the second drive wheel in an opposite second direction. The device may also include wherein the cannula carrier includes a first cam track configured to releasably receive the first pin therein and a second cam track configured to releasably receive the second pin therein. The device may also be configured such that the first pin and the second pin engage the first cam track and the second cam track, respectively, when the trocar assembly and the carrier assembly are each in a downwardly inserted position, and wherein the first pin and the second pin disengage from the first cam track and the second cam track when the trocar assembly is retracted upward relative to the carrier assembly.

在另一方面，一种集成式传感器与输注装置包括：扭转弹簧；联接到扭转弹簧的驱动轮；联接到驱动轮的剪刀式组件，该剪刀式组件包括第一连杆和第二连杆；具有与其联接的第一和第二套管针的滑块，该滑块在第一区域处联接到第一连杆并且在第二区域处联接到第二连杆；可移除地联接到第一套管针的输注插管；以及可移除地联接到第二套管针的传感器电极，其中，扭转弹簧在被致动时被配置为时驱动轮旋转以经由剪刀式组件致使滑块轴向移动以驱动第一套管针、输注插管、第二套管针和传感器电极进入用户的皮肤中。In another aspect, an integrated sensor and infusion device includes: a torsion spring; a drive wheel coupled to the torsion spring; a scissor assembly coupled to the drive wheel, the scissor assembly including a first link and a second link; a slider having first and second trocars coupled thereto, the slider coupled to the first link at a first region and coupled to the second link at a second region; an infusion cannula removably coupled to the first trocar; When actuated, the drive wheel is configured to rotate to cause the slider to move axially via the scissor assembly to drive the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the user's skin.

在一些实施例中，装置的每个部件被配置为在第一套管针、输注插管、第二套管针和传感器电极被插入用户的皮肤中之前被容纳在装置壳体内，并且其中，第一套管针、输注插管、第二套管针和传感器电极延伸出壳体以插入用户的皮肤中。在一些实施例中，扭转弹簧的第一旋转量驱动第一套管针、输注插管、第二套管针和传感器电极进入用户的皮肤中，并且第二旋转量使第一套管针和第二套管针从用户的皮肤缩回，同时将输注插管和传感器电极留在用户皮肤中。在一些实施例中，扭转弹簧经由手动触发机构被致动。在一些实施例中，扭转弹簧经由远程触发机构被致动。在一些实施例中，第一套管针被配置为在输注插管的内腔内延伸。在一些实施例中，传感器电极被配置为被可移除地接纳在第二套管针的凹部内。In some embodiments, each component of the device is configured to be housed within the device housing prior to insertion of the first trocar, infusion cannula, second trocar and sensor electrode into the user's skin, and wherein the first trocar, infusion cannula, second trocar and sensor electrode extend out of the housing for insertion into the user's skin. In some embodiments, the first amount of rotation of the torsion spring drives the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the user's skin, and the second amount of rotation retracts the first trocar and the second trocar from the user's skin while leaving the infusion cannula and sensor electrode in the user's skin. In some embodiments, the torsion spring is actuated via a manual trigger mechanism. In some embodiments, the torsion spring is actuated via a remote trigger mechanism. In some embodiments, the first trocar is configured to extend within the lumen of the infusion cannula. In some embodiments, the sensor electrode is configured to be removably received within the recess of the second trocar.

在一些实施例中，驱动轮设置在驱动轮壳体内，并且驱动轮包括被接纳在第一连杆的凸轮槽内的销，使得驱动轮的旋转致使该销在凸轮槽内滑动并致使第一连杆相对于驱动轮壳体旋转。在一些实施例中，第二连杆联接到第一连杆，使得第一连杆的旋转引起第二连杆的相反旋转。在一些实施例中，驱动组件在被致动时使剪刀式组件从未击发位置移动至插入位置，在未击发位置时，输注插管和传感器电极设置在装置的壳体内，并且在插入位置时，输注插管和传感器电极延伸超出装置的壳体。在一些实施例中，在未击发位置时，第一连杆和第二连杆呈现展开状态，在该展开状态下它们沿不平行的轴线延伸，并且其中，在插入位置时，第一连杆和第二连杆呈现收拢状态，在该收拢状态下它们彼此平行地延伸。In some embodiments, the drive wheel is disposed within the drive wheel housing, and the drive wheel includes a pin received in a cam slot of the first link such that rotation of the drive wheel causes the pin to slide within the cam slot and cause the first link to rotate relative to the drive wheel housing. In some embodiments, the second link is coupled to the first link such that rotation of the first link causes opposite rotation of the second link. In some embodiments, the drive assembly, when actuated, moves the scissor assembly from an unfired position in which the infusion cannula and sensor electrodes are disposed within the housing of the device to an inserted position in which the infusion cannula and sensor electrodes extend beyond the housing of the device. In some embodiments, in the unfired position, the first link and the second link assume a deployed condition in which they extend along non-parallel axes, and wherein in the inserted position the first link and the second link assume a collapsed condition in which they extend parallel to each other.

在另一方面，一种集成式传感器与输注装置包括：扭转弹簧；联接到该扭转弹簧的第一驱动轮；第二驱动轮，该第二驱动轮与该第一驱动轮配合，使得第一驱动轮的旋转引起第二驱动轮的旋转；具有与其联接的第一和第二套管针的滑块，该滑块在第一区域处联接到第一驱动轮并且在第二区域处联接到第二驱动轮；可移除地联接到第一套管针的输注插管；以及可移除地联接到第二套管针的传感器电极，其中，扭转弹簧在被致动时被配置为使驱动轮旋转以致使滑块轴向移动以驱动第一套管针、输注插管、第二套管针和传感器电极进入用户的皮肤中。In another aspect, an integrated sensor and infusion device comprising: a torsion spring; a first drive wheel coupled to the torsion spring; a second drive wheel cooperating with the first drive wheel such that rotation of the first drive wheel causes rotation of the second drive wheel; a slider having first and second trocars coupled thereto, the slider coupled to the first drive wheel at a first region and to the second drive wheel at a second region; an infusion cannula removably coupled to the first trocar; and a sensor electrode removably coupled to the second trocar, Wherein the torsion spring, when actuated, is configured to rotate the drive wheel to cause the slider to move axially to drive the first trocar, the infusion cannula, the second trocar and the sensor electrode into the user's skin.

在一些实施例中，装置的每个部件被配置为在第一套管针、输注插管、第二套管针和传感器电极被插入用户的皮肤中之前被容纳在装置壳体内，并且其中，第一套管针、输注插管、第二套管针和传感器电极延伸出壳体以插入用户的皮肤中。在一些实施例中，扭转弹簧的第一旋转量驱动第一套管针、输注插管、第二套管针和传感器电极进入用户的皮肤中，并且第二旋转量使第一套管针和第二套管针从用户的皮肤缩回，同时将输注插管和传感器电极留在用户皮肤中。在一些实施例中，第一旋转量为大致180度，并且第二旋转量为额外的大致180度。在一些实施例中，扭转弹簧经由手动触发机构被致动。在一些实施例中，扭转弹簧经由远程触发机构被致动。在一些实施例中，第一套管针被配置为在输注插管的内腔内延伸。在一些实施例中，传感器电极被配置为被可移除地接纳在第二套管针的凹部内。在一些实施例中，第一驱动轮包括第一销，并且第二驱动轮包括第二销，第一销和第二销中的每一个延伸到套管针连杆的凸轮槽中，使得第一驱动轮和第二驱动轮的旋转使套管针连杆轴向移动。在一些实施例中，套管针连杆沿向下方向的轴向移动引起载体组件沿向下方向的轴向移动。在一些实施例中，第一驱动轮沿第一方向的旋转引起第二驱动轮沿第二相反方向的旋转。在一些实施例中，插管载体包括被配置为将第一销可释放地接纳在其中的第一凸轮轨道和被配置为将第二销可释放地接纳在其中的第二凸轮轨道。在一些实施例中，套管针组件和载体组件各自处于向下插入位置，并且其中，当套管针组件相对于载体组件向上缩回时，第一销和第二销与第一凸轮轨道和第二凸轮轨道脱接合。In some embodiments, each component of the device is configured to be housed within the device housing prior to insertion of the first trocar, infusion cannula, second trocar and sensor electrode into the user's skin, and wherein the first trocar, infusion cannula, second trocar and sensor electrode extend out of the housing for insertion into the user's skin. In some embodiments, the first amount of rotation of the torsion spring drives the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the user's skin, and the second amount of rotation retracts the first trocar and the second trocar from the user's skin while leaving the infusion cannula and sensor electrode in the user's skin. In some embodiments, the first amount of rotation is approximately 180 degrees, and the second amount of rotation is an additional approximately 180 degrees. In some embodiments, the torsion spring is actuated via a manual trigger mechanism. In some embodiments, the torsion spring is actuated via a remote trigger mechanism. In some embodiments, the first trocar is configured to extend within the lumen of the infusion cannula. In some embodiments, the sensor electrode is configured to be removably received within the recess of the second trocar. In some embodiments, the first drive wheel includes a first pin and the second drive wheel includes a second pin, each of the first and second pins extending into a cam slot of the trocar link such that rotation of the first drive wheel and the second drive wheel axially moves the trocar link. In some embodiments, axial movement of the trocar link in the downward direction causes axial movement of the carrier assembly in the downward direction. In some embodiments, rotation of the first drive wheel in a first direction causes rotation of the second drive wheel in a second opposite direction. In some embodiments, the cannula carrier includes a first cam track configured to releasably receive the first pin therein and a second cam track configured to releasably receive the second pin therein. In some embodiments, the trocar assembly and the carrier assembly are each in a downwardly inserted position, and wherein the first pin and the second pin disengage the first cam track and the second cam track when the trocar assembly is retracted upward relative to the carrier assembly.

在一些实施例中，储器容纳了包括胰岛素的药剂。在一些实施例中，传感器电极包括葡萄糖监测电极。在一些实施例中，输注插管延伸到用户的皮肤中至少3、4、5、6、7、8、9、10mm或更深。在一些实施例中，传感器电极延伸到用户的皮肤中至少7、8、9、10、11、12、13、14mm或更深。在一些实施例中，输注插管和传感器电极彼此侧向间隔开至少10、11、12、13、14、15、16、17、18、19、20mm或更大。在一些实施例中，当位于用户的皮肤上时，装置在用户皮肤上的最大高度小于约10、11、12、13、14、15、16、17、18、19、20mm或更大。In some embodiments, the reservoir contains a medicament comprising insulin. In some embodiments, the sensor electrodes include glucose monitoring electrodes. In some embodiments, the infusion cannula extends at least 3, 4, 5, 6, 7, 8, 9, 10 mm or more deep into the user's skin. In some embodiments, the sensor electrodes extend at least 7, 8, 9, 10, 11, 12, 13, 14 mm or deeper into the user's skin. In some embodiments, the infusion cannula and sensor electrode are spaced laterally apart from each other by at least 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm or more. In some embodiments, when positioned on the user's skin, the maximum height of the device on the user's skin is less than about 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm or greater.

在另一方面，一种用于操作集成式传感器与输注装置的方法包括将装置壳体设置在用户的皮肤上，该装置包括：驱动组件，该驱动组件包括扭转弹簧；输注插管，该输注插管流体联接到被配置为容纳药剂的储器；以及传感器电极。该方法还包括致动该驱动组件以使扭转弹簧旋转，从而驱动输注插管和传感器电极进入用户的皮肤中。该方法还包括经由传感器电极获得生理学测量值。该方法还包括至少部分地基于该生理学测量值，经由输注插管将药剂递送到用户体内。In another aspect, a method for operating an integrated sensor and infusion device includes disposing a device housing on the skin of a user, the device comprising: a drive assembly including a torsion spring; an infusion cannula fluidly coupled to a reservoir configured to hold a medicament; and sensor electrodes. The method also includes actuating the drive assembly to rotate the torsion spring, thereby driving the infusion cannula and the sensor electrode into the user's skin. The method also includes obtaining physiological measurements via the sensor electrodes. The method also includes delivering a medicament to the user via the infusion cannula based at least in part on the physiological measurement.

在一些实施例中，药剂包括胰岛素。在一些实施例中，生理学测量值包括血糖测量值。在一些实施例中，该装置进一步包括联接到输注插管和传感器电极的插管载体。在一些实施例中，该装置进一步包括套管针组件，该套管针组件包括套管针连杆，该套管针连杆联接到被配置为可释放地接合输注插管的第一套管针和被配置为可释放地接合传感器电极的第二套管针。在一些实施例中，驱动组件进一步包括经由驱动轮联接到扭转弹簧的剪刀式组件，并且其中，驱动轮的旋转致使剪刀式组件从展开构型移动到收拢构型，在该展开构型中，剪刀式组件的第一和第二连杆沿相交的轴线定向，在该收拢构型中，剪刀式组件的第一和第二连杆基本上彼此平行地定向。在一些实施例中，驱动组件进一步包括联接到扭转弹簧的第一驱动轮、以及第二驱动轮，该第二驱动轮与该第一驱动轮配合，使得第一驱动轮的旋转引起第二驱动轮的旋转，并且其中，第一驱动轮和第二驱动轮的旋转驱动该输注插管和传感器电极进入用户的皮肤中。In some embodiments, the medicament includes insulin. In some embodiments, the physiological measurements include blood glucose measurements. In some embodiments, the device further includes a cannula carrier coupled to the infusion cannula and the sensor electrodes. In some embodiments, the device further includes a trocar assembly including a trocar link coupled to a first trocar configured to releasably engage the infusion cannula and a second trocar configured to releasably engage the sensor electrode. In some embodiments, the drive assembly further includes a scissor assembly coupled to the torsion spring via a drive wheel, and wherein rotation of the drive wheel causes the scissor assembly to move from an expanded configuration in which the first and second links of the scissor assembly are oriented along intersecting axes to a collapsed configuration in which the first and second links of the scissor assembly are oriented substantially parallel to each other. In some embodiments, the drive assembly further includes a first drive wheel coupled to the torsion spring, and a second drive wheel that cooperates with the first drive wheel such that rotation of the first drive wheel causes rotation of the second drive wheel, and wherein rotation of the first drive wheel and the second drive wheel drives the infusion cannula and sensor electrode into the user's skin.

根据以下附图、描述和权利要求，其他技术特征对于本领域技术人员而言将是清楚的。Other technical features will be apparent to those skilled in the art from the following figures, descriptions and claims.

附图说明Description of drawings

参考以下附图可以更好地理解本技术的许多方面。附图中的部件不必按比例绘制。而是，重点放在清楚地说明本披露的原理上。Many aspects of the technology can be better understood with reference to the following figures. Features in the figures are not necessarily drawn to scale. Rather, emphasis is placed upon clearly illustrating the principles of the disclosure.

图1A是根据本技术的几个实施例的具有集成传感器的输注装置的立体图，该输注装置包括可抛式组件和耐用组件。1A is a perspective view of an infusion set with integrated sensors including a disposable component and a durable component, according to several embodiments of the present technology.

图1B是图1A的装置的立体图，其中耐用组件被移除。FIG. 1B is a perspective view of the device of FIG. 1A with durable components removed.

图2是图1B的可抛式组件的立体图，为了清楚起见省略了上部壳体。2 is a perspective view of the throwable assembly of FIG. 1B , with the upper housing omitted for clarity.

图3A和图3B分别展示了根据本技术的几个实施例的插入组件处于未击发位置和击发位置时的立体图。3A and 3B illustrate perspective views of an insertion assembly in an unfired position and a fired position, respectively, according to several embodiments of the present technology.

图4A和图4B分别展示了插入组件处于未击发位置和击发位置时的放大立体详图。Figures 4A and 4B show enlarged perspective detail views of the insertion assembly in the unfired and fired positions, respectively.

图5是图4A和图4B所示插入组件的驱动组件的分解立体图。Figure 5 is an exploded perspective view of the drive assembly of the insertion assembly shown in Figures 4A and 4B.

图6展示了根据本技术的几个实施例的驱动组件的套管针滑块的立体图。6 illustrates a perspective view of a trocar slide of a drive assembly in accordance with several embodiments of the present technology.

图7A至图7C分别展示了根据本技术的几个实施例的插管载体组件的前立体图、后立体图和截面图。7A-7C illustrate front perspective, rear perspective and cross-sectional views, respectively, of a cannula carrier assembly in accordance with several embodiments of the present technology.

图8A和图8B分别展示了根据本技术的几个实施例的传感器组件的前立体图和后立体图。8A and 8B illustrate front and rear perspective views, respectively, of a sensor assembly in accordance with several embodiments of the present technology.

图9A和图9B展示了根据本技术的几个实施例的与驱动组件的曲轴接合的剪刀式组件的立体图。9A and 9B illustrate perspective views of a scissor assembly engaged with a crankshaft of a drive assembly, according to several embodiments of the present technology.

图10A至图10C展示了根据本技术的几个实施例的剪刀式组件的连杆的立体图。10A-10C illustrate perspective views of linkages of a scissor assembly in accordance with several embodiments of the present technology.

图11A和图11B分别展示了根据本技术的几个实施例的驱动组件处于未击发位置和插入位置时的立体图。11A and 11B illustrate perspective views of a drive assembly in an unfired and inserted position, respectively, according to several embodiments of the present technology.

图12A是根据本技术的几个实施例的具有集成传感器的输注装置的立体图，该输注装置包括可抛式组件和耐用组件。12A is a perspective view of an infusion set with integrated sensors including a disposable component and a durable component in accordance with several embodiments of the present technology.

图12B是图12A的装置的立体图，其中耐用组件被移除。12B is a perspective view of the device of FIG. 12A with durable components removed.

图12C是图12B的可抛式组件的立体图，其中为了清楚起见，省略了上部壳体。12C is a perspective view of the throwable assembly of FIG. 12B with the upper housing omitted for clarity.

图13是根据本技术的几个实施例的插入组件的立体图。Figure 13 is a perspective view of an insertion assembly in accordance with several embodiments of the present technology.

图14是根据本技术的几个实施例的插入组件的驱动组件的立体图。14 is a perspective view of a drive assembly of an insertion assembly in accordance with several embodiments of the present technology.

图15是根据本技术的几个实施例的套管针组件的立体图。15 is a perspective view of a trocar assembly in accordance with several embodiments of the present technology.

图16A和图16B分别是根据本技术的几个实施例的具有传感器组件的插管载体组件的前立体图和后立体图。16A and 16B are front and rear perspective views, respectively, of a cannula carrier assembly with a sensor assembly in accordance with several embodiments of the present technology.

图17是根据本技术的几个实施例的如图16A和图16B所示的传感器组件的立体图。17 is a perspective view of the sensor assembly shown in FIGS. 16A and 16B in accordance with several embodiments of the present technology.

图18A和图18B分别是根据本技术的几个实施例的插入组件处于未击发和插入位置时的端视图。18A and 18B are end views, respectively, of an insertion assembly in unfired and inserted positions in accordance with several embodiments of the present technology.

图19A至图19C展示了根据本技术的几个实施例的多传感器装置的可抛式组件的几个立体图。19A-19C illustrate several perspective views of a disposable assembly of a multi-sensor device in accordance with several embodiments of the present technology.

具体实施方式Detailed ways

I.概述I.Overview

本技术涉及可穿戴装置，这些可穿戴装置既可以递送药剂(例如，通过使用插入用户皮肤中的插管进行输注)，也可以监测一个或多个生理学参数(例如，通过插入用户皮肤中的传感器电极或其他感测元件)。在一些实施例中，递送的药剂可以包括胰岛素，并且感测电极可以被配置为获得葡萄糖测量值，以用于推导或推断用户的血糖水平。根据一些示例，该装置可以包括壳体，该壳体中容纳了部件，包括储器、递送药剂的电机、以及将输注插管和传感器电极驱逐出壳体并进入用户皮肤中的插入组件。在操作中，壳体可以放在用户的皮肤上。在将该装置施加至皮肤后，用户启动插入组件以将输注插管和传感器电极插入皮下。虽然通常期望将装置的尺寸最小化，但尺寸的减小存在实际限制。例如，将传感器电极和输注插管放置得太靠在一起可能降低传感器获得的读数的准确性。这样，在输注插管与传感器电极之间也可能存在最小侧向间隔。此外，为了有效地输送药剂并获得准确的传感器读数，输注插管和/或传感器电极应插入到用户皮肤表面下方的足够深度。相应地，插入机构为了使输注插管和传感器电极能够刺入用户的皮肤达到足够的深度，可能需要最小“行进”距离。实现这些方面(足够的侧向间隔和足够的行进深度)通常会导致笨重和/或不希望地大的装置。The technology relates to wearable devices that can both deliver medication (e.g., through infusion using a cannula inserted into the user's skin) and monitor one or more physiological parameters (e.g., through sensor electrodes or other sensing elements inserted into the user's skin). In some embodiments, the delivered medicament may include insulin, and the sensing electrodes may be configured to obtain glucose measurements for use in deriving or inferring the user's blood glucose level. According to some examples, the device may include a housing housing components including a reservoir, a motor to deliver the medicament, and an insertion assembly to expel the infusion cannula and sensor electrodes out of the housing and into the user's skin. In operation, the housing can be placed on the user's skin. After applying the device to the skin, the user activates the insertion assembly to insert the infusion cannula and sensor electrodes subcutaneously. While it is generally desirable to minimize the size of devices, there are practical limits to size reduction. For example, placing the sensor electrodes and the infusion cannula too close together may reduce the accuracy of the readings obtained by the sensor. In this way, there may also be a minimum lateral separation between the infusion cannula and the sensor electrodes. Additionally, the infusion cannula and/or sensor electrodes should be inserted to a sufficient depth below the user's skin surface for effective drug delivery and accurate sensor readings. Accordingly, the insertion mechanism may require a minimum "travel" distance in order for the infusion cannula and sensor electrodes to penetrate the user's skin to a sufficient depth. Achieving these aspects (sufficient lateral spacing and sufficient depth of travel) often results in a cumbersome and/or undesirably large device.

在本技术的实施例中，可以使用特定的插入组件来实现足够的行进深度和足够的侧向间隔两者，而不需要过分的装置尺寸(例如，不过度增加装置的高度)。在各种示例中，驱动组件可以采取联接到套管针组件的扭转弹簧的形式，套管针组件包括被配置为分别与输注插管和传感器电极可释放地接合的第一套管针和第二套管针。当驱动组件被致动时，扭转弹簧进行旋转以使套管针组件轴向向下击发，从而驱动输注插管和传感器电极两者轴向向下并从装置壳体出来。通过扭转弹簧的继续旋转，套管针组件可以向上缩回到装置壳体中，同时输注插管和传感器电极保持在插入用户皮肤中的位置。In embodiments of the present technology, specific insertion assemblies can be used to achieve both sufficient depth of travel and sufficient lateral spacing without requiring undue device size (eg, without unduly increasing the height of the device). In various examples, the drive assembly may take the form of a torsion spring coupled to a trocar assembly including first and second trocars configured to releasably engage the infusion cannula and the sensor electrode, respectively. When the drive assembly is actuated, the torsion spring rotates to fire the trocar assembly axially downward, thereby driving both the infusion cannula and sensor electrodes axially downward and out of the device housing. By continued rotation of the torsion spring, the trocar assembly can be retracted upward into the device housing while the infusion cannula and sensor electrodes remain in place for insertion into the user's skin.

在一些实施例中，驱动组件可以采取联接到扭转弹簧的剪刀式组件的形式。剪刀式组件可以包括第一和第二连杆，它们在展开的未击发状态下沿相交的轴线对齐(例如，形成X形)。当扭转弹簧进行旋转以击发套管针组件时，第一和第二连杆移动到收拢状态，在该状态下它们彼此更紧密地平行。在此过程中，套管针组件轴向向下移动，从而也引起输注插管和传感器电极轴向向下移动并进入用户的皮肤中。In some embodiments, the drive assembly may take the form of a scissor assembly coupled to a torsion spring. The scissor assembly may include first and second links aligned along intersecting axes (eg, forming an X-shape) in the deployed, unfired state. When the torsion spring is rotated to fire the trocar assembly, the first and second links move to a retracted condition in which they are more closely parallel to each other. During this process, the trocar assembly moves axially downward, thereby also causing the infusion cannula and sensor electrodes to move axially downward and into the user's skin.

在一些实施例中，驱动组件可以采取双曲柄组件的形式，其中第一驱动轮联接到扭转弹簧，并且第二驱动轮联接到第一驱动轮，使得扭转弹簧的旋转引起第一驱动轮和第二驱动轮沿相反方向旋转。第一驱动轮和第二驱动轮中的每一个可以包括各自的销，该销被配置为接合套管针组件的凸轮槽，使得驱动轮的旋转引起套管针组件的轴向移动(例如，在向下的方向上移动以击发输注插管和传感器电极超出装置壳体，以及在向上的方向上移动以将套管针组件缩回到装置壳体中)。In some embodiments, the drive assembly may take the form of a double crank assembly where a first drive wheel is coupled to a torsion spring and a second drive wheel is coupled to the first drive wheel such that rotation of the torsion spring causes the first and second drive wheels to rotate in opposite directions. Each of the first drive wheel and the second drive wheel may include a respective pin configured to engage a cam slot of the trocar assembly such that rotation of the drive wheel causes axial movement of the trocar assembly (e.g., in a downward direction to fire the infusion cannula and sensor electrode out of the device housing, and in an upward direction to retract the trocar assembly into the device housing).

II.具有剪刀式驱动组件的装置的示例性组件II.Exemplary Components of Devices with Scissor-Driven Assemblies

图1A是根据本技术的几个实施例的具有集成传感器的输注装置(“装置100”)的立体图，该输注装置包括耐用组件200和可抛式组件300。图1B展示了装置100，其中耐用组件200被移除。在操作中，装置的底侧(未示出)被配置为粘附到用户的皮肤，而顶侧背离用户的皮肤。装置100包括耐用组件200和可抛式组件300，每个组件具有各自的壳体202和302。耐用组件200和可抛式组件300可以设置在粘合垫(未示出)上，该粘合垫具有粘合剂背衬以固定到用户的皮肤上。在各种实施例中，装置100可以具有约35-60mm的长度；约30-45mm的宽度；以及约8-18mm的总厚度或高度。合适的壳体材料包括但不限于塑料或其他弹性模量为200,000-1,000,000psi的材料。1A is a perspective view of an infusion set with integrated sensors ("device 100") that includes a durable assembly 200 and a disposable assembly 300, in accordance with several embodiments of the present technology. Figure IB illustrates device 100 with durable component 200 removed. In operation, the bottom side of the device (not shown) is configured to adhere to the user's skin, while the top side faces away from the user's skin. Device 100 includes a durable assembly 200 and a disposable assembly 300 each having a respective housing 202 and 302 . Durable assembly 200 and disposable assembly 300 may be disposed on an adhesive pad (not shown) having an adhesive backing for securing to the user's skin. In various embodiments, device 100 may have a length of about 35-60 mm; a width of about 30-45 mm; and an overall thickness or height of about 8-18 mm. Suitable housing materials include, but are not limited to, plastic or other materials with a modulus of elasticity of 200,000-1,000,000 psi.

为了使用输注装置100，用户(例如，患者)将可抛式组件300连接到耐用组件200。除非可抛式组件300的储器已被充分预装载，否则用户通过设置在装置100的下表面上的填充端口将期望量的药剂注入储器中。为了将装置100粘附到用户，可以在装置100的底侧上露出粘合剂背衬并且可以将装置100施加到皮肤表面。在一些实施例中，用户随后触发插入，这使得输注插管和传感器电极两者都被插入到壳体302之外并进入用户的皮肤，如下文更详细描述的。To use infusion set 100 , a user (eg, a patient) connects disposable assembly 300 to durable assembly 200 . Unless the reservoir of the disposable assembly 300 has been sufficiently preloaded, the user injects the desired amount of medicament into the reservoir through a fill port provided on the lower surface of the device 100 . To adhere the device 100 to the user, the adhesive backing can be exposed on the underside of the device 100 and the device 100 can be applied to the skin surface. In some embodiments, the user then triggers the insertion, which causes both the infusion cannula and sensor electrodes to be inserted out of housing 302 and into the user's skin, as described in more detail below.

耐用组件200可以包括壳体202，其容纳了一个或多个电子部件，例如蜂鸣器或其他警报装置、一个或多个电池或其他能量供应源、微处理器、包括一个或多个霍尔效应传感器的线圈组件(用作电机定子)、一个或多个无线收发器和/或被配置为对装置100的操作供电和/或进行控制的任何其他合适的部件。在一些实施例中，能量供应源是可充电电池，例如可充电锂离子电池，其具有足够的功率来连续驱动电机而不需要电容器或其他额外的能量存储装置。Durable assembly 200 may include a housing 202 that houses one or more electronic components, such as a buzzer or other alarm device, one or more batteries or other power supply sources, a microprocessor, a coil assembly including one or more Hall effect sensors (serving as a motor stator), one or more wireless transceivers, and/or any other suitable components configured to power and/or control the operation of device 100. In some embodiments, the energy supply source is a rechargeable battery, such as a rechargeable lithium-ion battery, having sufficient power to continuously drive the motor without the need for capacitors or other additional energy storage devices.

具体参考图1B，耐用组件200可以包括接纳件(未示出)，该接纳件被配置为装配在可抛式组件300的突起303上以使得两者可释放地配合在一起。耐用组件200内的电子部件可以与可抛式组件300内的相应部件无线通信。例如，耐用组件200内的磁定子可以驱动可抛式组件300内的磁电机转子311电机，该磁电机转子进而可以驱动联接到可抛式组件300的储器内的柱塞的推动器309，例如通过使用电磁扭矩联接，这是一种没有直接机械联接或电接触的联接。这些设计提供了相对简单地变得防水或至少耐水的额外优点。Referring specifically to FIG. 1B , durable assembly 200 may include a receiver (not shown) configured to fit over protrusion 303 of throwable assembly 300 such that the two releasably mate together. Electronic components within durable assembly 200 may communicate wirelessly with corresponding components within disposable assembly 300 . For example, a magnetic stator within the durable assembly 200 may drive a magneto rotor 311 motor within the disposable assembly 300, which in turn may drive a pusher 309 coupled to a plunger within the reservoir of the disposable assembly 300, such as by using an electromagnetic torque coupling, which is a coupling without direct mechanical or electrical contact. These designs offer the added advantage of being relatively simple to make waterproof or at least water resistant.

此外，在一些实施例中，可抛式组件300内的电子部件可以将数据传输到耐用组件200内的电子部件。例如，可抛式组件300内的连续葡萄糖监测仪(CGM)可以收集在可抛式组件300的电子器件内被调节(例如，放大、处理、数字化等)的低电平(例如，毫伏)CGM信号。经预处理的CGM数据接着可以被无线传输到耐用组件200内的电子部件以进行额外处理和/或以便无线传输到外部装置(例如，智能手机、平板电脑等)。这种传输可以包括例如蓝牙低功耗(BLE)或其他用于无线传输数据的节能方法。由于可抛式组件300和耐用组件200如此靠近地定位在一起，并且由于传输路径是一致且明确定义的，因此传输所需的功率可以相对较低(与分立的CGM位于患者腹部的与贴片泵装置相反的一侧的系统相比)。另外，通过在可抛式组件300内提供电源(例如，电池)，耐用组件200与可抛式组件300之间的这种预处理和数据通信可以在两者之间没有物理电连接的情况下进行。Additionally, in some embodiments, electronic components within disposable assembly 300 may transmit data to electronic components within durable assembly 200 . For example, a continuous glucose monitor (CGM) within the disposable assembly 300 may collect low level (e.g., millivolt) CGM signals that are conditioned (e.g., amplified, processed, digitized, etc.) within the electronics of the disposable assembly 300. The pre-processed CGM data may then be wirelessly transmitted to electronic components within durable assembly 200 for additional processing and/or for wireless transmission to an external device (eg, smartphone, tablet, etc.). Such transfers may include, for example, Bluetooth Low Energy (BLE) or other power-efficient methods for wirelessly transferring data. Because the disposable assembly 300 and durable assembly 200 are located so close together, and because the delivery path is consistent and well-defined, the power required for delivery can be relatively low (compared to systems where a discrete CGM is located on the opposite side of the patient's abdomen from the patch pump device). Additionally, by providing a power source (eg, a battery) within disposable assembly 300, such preprocessing and data communication between durable assembly 200 and disposable assembly 300 can occur without a physical electrical connection between the two.

可抛式组件300(在图2中更详细地示出，其中壳体302的一部分被移除)可以包括储器组件304和插入组件400，每个组件都安装在底板350上。储器组件304可以包括驱动组件306、储器308、以及联接到柱塞310的推动器309。推动器309可以联接到驱动组件，并且推动器309和柱塞310都可以容纳在储器308内。驱动组件306可以包括磁电机转子311和齿轮系312。齿轮系312联接到位于储器308中的推动器。磁电机转子311可以通过齿轮系312机械附接以影响柱塞310在储器308内的平移。在操作中，推动器309和柱塞310在储器内的平移(例如，通过磁电机转子311的致动)致使流体(例如，药剂)被驱逐出储器308并且经输注插管递送到用户的皮下治疗部位。Disposable assembly 300 (shown in more detail in FIG. 2 with a portion of housing 302 removed) may include reservoir assembly 304 and insert assembly 400 , each mounted on base plate 350 . The reservoir assembly 304 may include a drive assembly 306 , a reservoir 308 , and a pusher 309 coupled to a plunger 310 . Pusher 309 may be coupled to the drive assembly, and both pusher 309 and plunger 310 may be housed within reservoir 308 . Drive assembly 306 may include a magneto rotor 311 and a gear train 312 . Gear train 312 is coupled to a pusher located in reservoir 308 . The magneto rotor 311 may be mechanically attached by a gear train 312 to effect translation of the plunger 310 within the reservoir 308 . In operation, translation of pusher 309 and plunger 310 within the reservoir (e.g., by actuation of magneto rotor 311) causes fluid (e.g., medicament) to be expelled from reservoir 308 and delivered via the infusion cannula to the user's subcutaneous treatment site.

储器308可以预先填充有药剂。例如，药剂可以是U-100胰岛素或U-500胰岛素或其他浓度的胰岛素以适应不同的用户使用情况，或者可以是用户可通过填充端口(未示出)填充的。在储器308由用户填充的那些情况下，用户可以用药剂将储器完全填充至满容量，或者用户可以选择引入较少的药剂并且不完全填充储器。由于未知量的药剂可能被注入到用户填充的储器中，因此柱塞-推动器调零过程(或“柱塞寻找”)可能是用户启动的，或者可能是泵操作的自动方面。柱塞寻找过程在任何药剂分配之前精确地确定和/或设定推动器在接合柱塞之前精确地行进多远，从而能够通过计算来确定储器中的药剂量，并因此估计排空前时间和可抛式组件更换时间。可以在共同拥有的美国申请号17,454,600中找到关于柱塞寻找过程的额外细节，该申请的全部内容通过援引并入本文。Reservoir 308 may be pre-filled with medicament. For example, the dose may be U-100 insulin or U-500 insulin or other strengths of insulin to suit different user usage, or may be user fillable through a fill port (not shown). In those instances where the reservoir 308 is filled by the user, the user may fill the reservoir completely to full capacity with medicament, or the user may choose to introduce less medicament and not completely fill the reservoir. Since an unknown amount of medicament may be injected into a user-filled reservoir, the plunger-pusher zeroing process (or "plunger seek") may be user-initiated, or may be an automatic aspect of pump operation. The plunger seek process determines and/or sets exactly how far the pusher travels before engaging the plunger before any medicament is dispensed, enabling calculations to determine the amount of medicament in the reservoir and thus estimate time to empty and disposable assembly replacement time. Additional details regarding the plunger finding process can be found in commonly owned US Application No. 17,454,600, which is incorporated herein by reference in its entirety.

插入组件400被配置为将输注插管402和传感器电极404两者分别经由第一端口406和第二端口408插入到壳体302之外。一旦插入到用户的皮肤中，流体联接到储器308的输注插管402就可以将药剂(例如，胰岛素)递送穿过其到达用户。此外，一旦将传感器电极404插入用户的皮肤中，传感器电极就可以检测一个或多个生理学参数，例如皮内和/或皮下空间中的葡萄糖水平。如本领域普通技术人员所知，在皮内和/或皮下空间中获得的葡萄糖测量值可以用于推导或推断用户的血糖水平。经由传感器电极404获得的此类生理学参数可以可选地用于控制经由输注插管402的药剂递送。例如，当用户的葡萄糖升高到预定阈值以上时(如根据经由传感器电极404获得的读数确定的)，可以启动磁电机转子311(例如，通过耐用组件200中的电子器件)以将柱塞310驱动适当的量，从而将药剂从储器308中经由输注插管402分配到用户体内。Insertion assembly 400 is configured to insert both infusion cannula 402 and sensor electrode 404 out of housing 302 via first port 406 and second port 408 , respectively. Once inserted into the user's skin, infusion cannula 402 fluidly coupled to reservoir 308 can deliver medicament (eg, insulin) therethrough to the user. Additionally, once the sensor electrodes 404 are inserted into the user's skin, the sensor electrodes can detect one or more physiological parameters, such as glucose levels in the intradermal and/or subcutaneous space. Glucose measurements obtained in the intradermal and/or subcutaneous space may be used to derive or infer a user's blood glucose level, as is known to those of ordinary skill in the art. Such physiological parameters obtained via sensor electrodes 404 may optionally be used to control drug delivery via infusion cannula 402 . For example, when the user's glucose rises above a predetermined threshold (as determined from readings obtained via sensor electrodes 404), magneto rotor 311 may be activated (e.g., by electronics in durable assembly 200) to drive plunger 310 an appropriate amount to dispense medicament from reservoir 308 via infusion cannula 402 into the user.

图3A和图3B分别展示了插入组件400处于未击发位置和击发位置时的立体图，并且图4A和图4B分别展示了插入组件400处于未击发位置和击发位置时的放大立体图。参照图3A至图4B一起，插入组件400包括驱动组件410、载体组件412、套管针组件414和传感器电子组件416。载体组件412可以联接到输注插管402和传感器电极404，并且套管针组件可以被配置为与载体组件可释放地配合以将载体组件从未击发状态(如图3A和图4A所示)向下移动至插入状态(如图3B和图4B所示)。如图所示，在未击发状态下(图3A和图4A)，输注插管402和传感器电极404都缩回而被布置在壳体302(图3A至图4B中未示出)内。在击发状态(图3B和图4B)下，输注插管402和传感器电极404都延伸穿过孔406和408、超出壳体302、并插入用户的皮肤中。3A and 3B show perspective views of the insertion assembly 400 in the unfired and fired positions, respectively, and FIGS. 4A and 4B show enlarged perspective views of the insertion assembly 400 in the unfired and fired positions, respectively. Referring to FIGS. 3A-4B together, insertion assembly 400 includes drive assembly 410 , carrier assembly 412 , trocar assembly 414 , and sensor electronics assembly 416 . The carrier assembly 412 can be coupled to the infusion cannula 402 and the sensor electrode 404, and the trocar assembly can be configured to releasably engage the carrier assembly to move the carrier assembly down from the unfired state (as shown in FIGS. 3A and 4A ) to the inserted state (as shown in FIGS. 3B and 4B ). As shown, in the unfired state (FIGS. 3A and 4A), both infusion cannula 402 and sensor electrode 404 are retracted to be disposed within housing 302 (not shown in FIGS. 3A-4B). In the fired state (FIGS. 3B and 4B), both infusion cannula 402 and sensor electrode 404 extend through apertures 406 and 408, beyond housing 302, and into the user's skin.

如本文关于驱动组件所使用的，“未击发状态”可以指驱动组件尚未将套管针组件或载体组件向下移出壳体并进入患者的皮肤中的状态。“插入状态”可以指中间位置，此时套管针组件和载体组件都已经向下移动、移出壳体、并且进入患者的皮肤中。“完全击发状态”可以指驱动组件已将套管针组件向上缩回并退出患者身体同时留下载体组件(包括传感器和插管)延伸超出壳体和/或进入患者体内的最终位置。As used herein with respect to the drive assembly, an "unfired state" may refer to a state in which the drive assembly has not moved the trocar assembly or carrier assembly down out of the housing and into the patient's skin. "Inserted state" may refer to an intermediate position where both the trocar assembly and carrier assembly have been moved down, out of the housing, and into the patient's skin. A "fully fired state" may refer to a final position in which the drive assembly has retracted the trocar assembly upward and out of the patient while leaving the carrier assembly (including the sensor and cannula) extended beyond the housing and/or into the patient.

在各种示例中，可以选择输注插管402与传感器电极404之间的侧向距离以在插入到用户皮肤内后提供适当的性能。如果侧向距离太小，则经由输注插管402提供的药剂可能干扰经由传感器电极404获得的生理学测量值。另一方面，具有太大的侧向间隔可能导致装置100变得不期望地大和笨重。在各种实施例中，输注插管402与传感器电极404之间的侧向间隔可以是至少约10mm(例如，约14mm)。此外，在一些实施例中，可能期望将输注插管402和/或传感器电极404插入到用户皮肤表面下方的特定深度。如果输注插管402不够深，则药剂可能无法有效地递送给用户。附加地或替代地，如果传感器电极404不够深，则生理学测量值可能不可靠。在各种实施例中，插入深度(例如，当处于插入状态时，从输注插管402和/或传感器电极404的较远端头到壳体下表面的距离)可以是至少约6–10mm或更大。实现足够的侧向间隔和足够的插入深度两者提出了某些设计挑战，特别是在试图维持装置100的紧凑形状因数时。本文披露的驱动组件410的各种实施例可以为输注插管402和传感器电极404实现期望的侧向间隔和期望的插入深度两者。In various examples, the lateral distance between infusion cannula 402 and sensor electrode 404 can be selected to provide appropriate performance after insertion into the user's skin. If the lateral distance is too small, the medicament provided via the infusion cannula 402 may interfere with the physiological measurements obtained via the sensor electrodes 404 . On the other hand, having too much lateral spacing may cause the device 100 to become undesirably large and bulky. In various embodiments, the lateral separation between infusion cannula 402 and sensor electrode 404 can be at least about 10 mm (eg, about 14 mm). Additionally, in some embodiments, it may be desirable to insert infusion cannula 402 and/or sensor electrodes 404 to a particular depth below the user's skin surface. If the infusion cannula 402 is not deep enough, the medicament may not be effectively delivered to the user. Additionally or alternatively, if the sensor electrodes 404 are not deep enough, physiological measurements may be unreliable. In various embodiments, the insertion depth (eg, the distance from the distal tip of infusion cannula 402 and/or sensor electrode 404 to the lower surface of the housing when in the inserted state) can be at least about 6-10 mm or greater. Achieving both sufficient lateral spacing and sufficient insertion depth presents certain design challenges, particularly when attempting to maintain the compact form factor of device 100 . Various embodiments of drive assembly 410 disclosed herein can achieve both a desired lateral spacing and a desired insertion depth for infusion cannula 402 and sensor electrode 404 .

如下文更详细描述的，在操作中，驱动组件410可以被致动以引起套管针组件414和载体组件412两者从未击发状态(如图3A和4A所示)向下移动以将载体组件412推到插入状态(如图3B和图4B所示)。例如，套管针组件414可以邻接载体组件或以其他方式联接到载体组件412，使得套管针组件414的向下移动引起载体组件412的向下移动，而套管针组件414的向上移动不一定引起载体组件412的向上移动。在一些实施例中，一旦载体组件412处于插入状态，驱动组件410继续移动套管针组件414，使得套管针组件414向上缩回，同时载体组件412保持伸出而插管402和传感器电极404延伸超出壳体302并进入用户的皮肤。通过套管针组件414的这种继续向上移动，插入组件400移动到图3B和图4B中所示的完全击发位置。As described in more detail below, in operation, drive assembly 410 can be actuated to cause both trocar assembly 414 and carrier assembly 412 to move downwardly from an unfired state (as shown in FIGS. 3A and 4A ) to push carrier assembly 412 to an inserted state (as shown in FIGS. 3B and 4B ). For example, trocar assembly 414 may abut or otherwise be coupled to carrier assembly 412 such that downward movement of trocar assembly 414 causes downward movement of carrier assembly 412, while upward movement of trocar assembly 414 does not necessarily cause upward movement of carrier assembly 412. In some embodiments, once carrier assembly 412 is in the inserted state, drive assembly 410 continues to move trocar assembly 414 such that trocar assembly 414 is retracted upwardly while carrier assembly 412 remains extended and cannula 402 and sensor electrodes 404 extend beyond housing 302 and into the user's skin. With this continued upward movement of trocar assembly 414, insertion assembly 400 moves to the fully fired position shown in FIGS. 3B and 4B.

传感器电子组件416可以联接到载体组件414，使得两者一起从未击发位置(图3A和图4A)向下移动到击发位置(图3B和图4B)。传感器电子组件416可以包括一个或多个电子部件，该电子部件被配置为促进经由传感器电极404获得生理学测量值。这可以包括例如合适的模拟或数字部件、电路、处理器、收发器等。在图示的实施例中，传感器电子组件416包括第一电触头417，其可以在载体组件414从未击发位置(图3A)移动到击发位置(3B)时与对应的第二电触头419配合。这种移动可以使传感器电子组件416经由配合的第一和第二电触头417、419与传感器电池421电连通。通过仅在击发了插入组件400时建立与电池421的电连通，电力可以被保存，直到装置100处于操作中并且传感器电极404已经被插入用户的皮肤中。The sensor electronics assembly 416 can be coupled to the carrier assembly 414 such that the two together move down from the unfired position ( FIGS. 3A and 4A ) to the fired position ( FIGS. 3B and 4B ). Sensor electronics assembly 416 may include one or more electronic components configured to facilitate obtaining physiological measurements via sensor electrodes 404 . This may include, for example, suitable analog or digital components, circuits, processors, transceivers and the like. In the illustrated embodiment, the sensor electronics assembly 416 includes first electrical contacts 417 that can mate with corresponding second electrical contacts 419 when the carrier assembly 414 is moved from the unfired position ( FIG. 3A ) to the fired position ( 3B ). This movement may place the sensor electronics assembly 416 in electrical communication with the sensor battery 421 via mating first and second electrical contacts 417 , 419 . By establishing electrical communication with battery 421 only when insertion assembly 400 is fired, power may be conserved until device 100 is in operation and sensor electrodes 404 have been inserted into the user's skin.

如上所述，是驱动组件410使载体组件412、套管针组件414和传感器电子组件416从未击发位置移动到插入位置。如图5最佳所示，驱动组件410可以包括驱动组件壳体415、将扭转弹簧420接纳在其中的接纳件418、和驱动轮422。扭转弹簧420可以采取螺旋弹簧的形式，该螺旋弹簧包括被接纳在驱动组件壳体415中的对应接纳件(未示出)内的第一端曲柄销424、以及在驱动轮422中的开口428内延伸的第二端曲柄销426，使得扭转弹簧420的第二端曲柄销426的旋转引起驱动轮422连动旋转。驱动轮422还可以包括中心孔430，该中心孔被配置为在其中接纳中心轴承轴432。在组装构型中，扭转弹簧420可以卷绕成压缩状态，在该状态下扭转弹簧420被偏置来解卷并引起驱动轮422的旋转(或者替代地，它可以缠绕成伸展状态，在该状态下扭转弹簧420被偏置来卷起以引起驱动轮422的旋转)。无论是处于压缩状态还是伸展状态，扭转弹簧420都可以被可释放地锁定(例如，处于待发构型)，使得旋转运动被禁止，直到触发机构(参见图9B)被激活。例如，手动触发机构(例如，按下按钮或杠杆)或远程触发机构(例如，向可致动的释放机构发送无线信号)可以使旋转运动被允许，使得扭转弹簧420进行旋转，从而使驱动轮422也旋转。如下文更详细描述的，驱动轮422可以联接至剪刀式组件434，剪刀式组件进而联接至套管针组件414并将驱动轮422的旋转运动转换为套管针组件414的轴向(例如，向下和向上)移动，这进而引起载体组件412的轴向(例如，向下)移动。As noted above, it is the drive assembly 410 that moves the carrier assembly 412, trocar assembly 414, and sensor electronics assembly 416 from the unfired position to the inserted position. As best shown in FIG. 5 , drive assembly 410 may include drive assembly housing 415 , receiver 418 that receives torsion spring 420 therein, and drive wheel 422 . The torsion spring 420 may take the form of a coil spring including a first end crank pin 424 received within a corresponding receptacle (not shown) in the drive assembly housing 415, and a second end crank pin 426 extending within an opening 428 in the drive wheel 422 such that rotation of the second end crank pin 426 of the torsion spring 420 causes concomitant rotation of the drive wheel 422. Drive wheel 422 may also include a central bore 430 configured to receive a central bearing shaft 432 therein. In the assembled configuration, the torsion spring 420 may be wound into a compressed state in which the torsion spring 420 is biased to unwind and cause rotation of the drive wheel 422 (or alternatively it may be wound into an extended state in which the torsion spring 420 is biased to coil up to cause rotation of the drive wheel 422). Whether in a compressed or extended state, the torsion spring 420 can be releasably locked (eg, in a cocked configuration) such that rotational movement is inhibited until the trigger mechanism (see FIG. 9B ) is activated. For example, a manual trigger mechanism (eg, pressing a button or lever) or a remote trigger mechanism (eg, sending a wireless signal to an actuatable release mechanism) may allow rotational motion such that torsion spring 420 rotates, thereby causing drive wheel 422 to also rotate. As described in more detail below, drive wheel 422 may be coupled to scissor assembly 434, which in turn is coupled to trocar assembly 414 and translates rotational motion of drive wheel 422 into axial (e.g., downward and upward) movement of trocar assembly 414, which in turn causes axial (e.g., downward) movement of carrier assembly 412.

如上所述，套管针组件414可以用于将输注插管402和传感器电极404向下驱动并超出装置100的壳体302。如图6最佳所示，套管针组件414可以包括侧向延伸的套管针连杆436、以及各自背离套管针连杆436向下延伸的第一套管针438和第二套管针440。套管针连杆436可以经由接合孔442和凸轮槽444联接到剪刀式组件434，如本文别处所述，以使得剪刀式组件434的运动(由驱动轮422的旋转引起)致使套管针连杆436轴向向下移动，从而使第一和第二套管针438、440轴向向下移动。套管针连杆436可以包括联接到第一套管针438的第一延伸部446和联接到第二套管针440的第二延伸部448。延伸部446、448可以用作邻接载体组件412的上表面的配合表面，从而使载体组件412响应于套管针组件414的向下移动而向下移动。As described above, trocar assembly 414 may be used to drive infusion cannula 402 and sensor electrodes 404 down and beyond housing 302 of device 100 . As best shown in FIG. 6 , trocar assembly 414 may include a laterally extending trocar link 436 , and a first trocar 438 and a second trocar 440 each extending downwardly away from trocar link 436 . Trocar link 436 may be coupled to scissor assembly 434 via engagement bore 442 and cam slot 444, as described elsewhere herein, such that movement of scissor assembly 434 (caused by rotation of drive wheel 422) causes trocar link 436 to move axially downward, thereby moving first and second trocars 438, 440 axially downward. Trocar link 436 may include a first extension 446 coupled to first trocar 438 and a second extension 448 coupled to second trocar 440 . Extensions 446 , 448 may serve as mating surfaces that abut the upper surface of carrier assembly 412 , allowing carrier assembly 412 to move downward in response to downward movement of trocar assembly 414 .

第一套管针438可以被配置为与输注插管402可释放地接合，例如通过延伸到输注插管402的内腔中。第二套管针440可以被配置为与传感器电极404可释放地接合，例如通过包括槽缝或凹部，传感器电极404被可移除地布置在该槽缝或凹部中。套管针438、440中的一者或两者可以具有锋利和/或尖锐的端头以便于刺穿患者的皮肤。在各种实施例中，第一和第二套管针438、440可以由金属或其他刚性材料制成，使得第一和第二套管针438、440具有足够的结构完整性以被驱动到用户的皮肤中，从而携带着输注插管402和传感器电极404进入皮肤。一旦输注插管402和传感器电极404已经完全插入用户的皮肤中，套管针连杆436向上移动(例如，由于驱动轮422的继续旋转)。因为第一和第二套管针438、440分别与输注插管402和传感器电极404可释放地接合，所以输注插管402和传感器电极404在用户皮肤内留在原位(例如，处于如图3B和图4B所示的插入位置中)，同时第一和第二套管针438、440向上缩回。第一套管针438可以流体联接到套管402，使得当第一套管针438缩回时，它没有完全从套管释放，并且接着将流体递送到套管402中。尽管本文提到了套管针，但是任何合适的细长构件都可以用于与输注插管402和/或传感器电极404可释放地配合。这样的细长构件可以是例如管心针、杆、轴、管、针或任何其他合适的构型。The first trocar 438 can be configured to releasably engage with the infusion cannula 402 , for example by extending into the lumen of the infusion cannula 402 . The second trocar 440 may be configured to releasably engage the sensor electrode 404, for example by including a slot or recess in which the sensor electrode 404 is removably disposed. One or both of the trocars 438, 440 may have a sharp and/or pointed tip to facilitate piercing the patient's skin. In various embodiments, the first and second trocars 438, 440 may be made of metal or other rigid material such that the first and second trocars 438, 440 have sufficient structural integrity to be driven into the user's skin, carrying the infusion cannula 402 and the sensor electrodes 404 into the skin. Once infusion cannula 402 and sensor electrode 404 have been fully inserted into the user's skin, trocar linkage 436 moves upward (eg, due to continued rotation of drive wheel 422 ). Because the first and second trocars 438, 440 are releasably engaged with the infusion cannula 402 and the sensor electrode 404, respectively, the infusion cannula 402 and the sensor electrode 404 remain in place (e.g., in the inserted position as shown in FIGS. 3B and 4B ) within the user's skin while the first and second trocars 438, 440 are retracted upwardly. The first trocar 438 may be fluidly coupled to the cannula 402 such that when the first trocar 438 is retracted, it is not fully released from the cannula and then delivers fluid into the cannula 402 . Although reference is made herein to a trocar, any suitable elongated member may be used to releasably engage infusion cannula 402 and/or sensor electrodes 404 . Such an elongate member may be, for example, a stylet, rod, shaft, tube, needle, or any other suitable configuration.

图7A至图7C分别展示了载体组件412的前立体图、后立体图和截面图。如前所述，载体组件412可以与套管针组件414可释放地配合，使得套管针组件414的向下移动引起载体组件412的向下移动。载体组件412可以包括插管载体450，该插管载体侧向延伸并且包括被配置为接合套管针组件414(图6)的延伸部446、448的上配合表面452。载体组件412还包括插管隔膜454，该插管隔膜覆盖并密封从其向下延伸的插管402。插管隔膜454可以在被第一套管针438刺穿时在插管402上维持气密性的和/或基本气密性的密封。第一套管针438可以与储器流体连通，使得当被第一套管针被设置在插管402的内腔455内时，插管402与储器流体连通。传感器隔膜456设置在载体450的相反端上，并且被配置为覆盖从其向下延伸的传感器电极(为清楚起见在图7A至图7C中未示出)。隔膜456提供围绕传感器电极的流体密封以密封隔离外部环境(例如，水)以免进入泵中到达传感器电极和/或第二套管针周围。如图7B所示，载体组件412包括凸轮槽458，该凸轮槽被配置为与剪刀式组件的第一连杆的销接合(下文关于9A至图10C描述)。7A-7C illustrate front perspective, rear perspective and cross-sectional views of the carrier assembly 412, respectively. As previously described, the carrier assembly 412 can be releasably engaged with the trocar assembly 414 such that downward movement of the trocar assembly 414 causes downward movement of the carrier assembly 412 . The carrier assembly 412 may include a cannula carrier 450 extending laterally and including an upper mating surface 452 configured to engage the extensions 446, 448 of the trocar assembly 414 (FIG. 6). Carrier assembly 412 also includes cannula septum 454 that covers and seals cannula 402 extending downwardly therefrom. Cannula septum 454 may maintain an airtight and/or substantially airtight seal over cannula 402 when pierced by first trocar 438 . The first trocar 438 may be in fluid communication with the reservoir such that when disposed within the lumen 455 of the cannula 402 by the first trocar, the cannula 402 is in fluid communication with the reservoir. A sensor membrane 456 is disposed on the opposite end of the carrier 450 and is configured to cover sensor electrodes extending downwardly therefrom (not shown in FIGS. 7A-7C for clarity). Diaphragm 456 provides a fluid seal around the sensor electrode to seal off the external environment (eg, water) from entering the pump to the sensor electrode and/or around the second trocar. As shown in FIG. 7B , the carrier assembly 412 includes a cam slot 458 configured to engage a pin of the first link of the scissor assembly (described below with respect to FIGS. 9A-10C ).

如前所述，载体组件412可以联接到传感器电子组件416。图8A和图8B分别展示了传感器电子组件416的前立体图和后立体图。在所示实施例中，传感器电子组件416包括印刷电路板或其他基板460，第一电触头417设置在其上。如前所述，当载体组件414从未击发位置移动到插入位置时，这些第一电触头417可以与装置100的相应电触头419配合(图3A和图3B)。传感器电子组件416还可以包括联接到基板460的一个或多个部件462。这样的部件462可以包括例如低功率无线通信部件、数据处理电路、处理电路、数据存储装置或任何其他合适的部件。As previously described, carrier assembly 412 may be coupled to sensor electronics assembly 416 . 8A and 8B illustrate front and rear perspective views of the sensor electronics assembly 416, respectively. In the illustrated embodiment, the sensor electronics assembly 416 includes a printed circuit board or other substrate 460 on which the first electrical contacts 417 are disposed. As previously described, these first electrical contacts 417 may mate with corresponding electrical contacts 419 of the device 100 when the carrier assembly 414 is moved from the unfired position to the inserted position ( FIGS. 3A and 3B ). Sensor electronics assembly 416 may also include one or more components 462 coupled to substrate 460 . Such components 462 may include, for example, low power wireless communication components, data processing circuits, processing circuits, data storage devices, or any other suitable components.

图9A展示了包括剪刀式组件434的驱动组件410的立体图。剪刀式组件包括第一连杆464和第二连杆466。图9B展示了包括剪刀式组件434的驱动组件410的立体图，其中省略了第二连杆466并且以透明方式示出第一连杆464。图10A和10B分别展示了第一连杆464的前立体图和后立体图，并且图10C展示了第二连杆466的立体前视图。参照图9A至图10C一起，第一连杆464在其第一端469处包括第一销468，该第一销被配置为被接纳在驱动组件壳体415内的轴承孔470内。因此，第一连杆464可以围绕这个点在第一展开构型(如图9A和图9B所示)与第二收拢构型之间枢转，在第二收拢构型中第一连杆464和第二连杆466被定向为与展开构型中相比更加彼此平行。第一连杆464还包括沿第一连杆464的长度延伸的凸轮槽472。凸轮槽472被配置为接纳延伸穿过驱动轮422中的开口428的曲柄销426。在此构型中，扭转弹簧(这些图中未示出)的旋转致使曲柄销426旋转，从而将第一连杆464的第二端471向下拉动至收拢构型。第一连杆还包括包裹部分474，该包裹部分被配置为当剪刀式组件434处于收拢构型时将第二连杆466接纳在其中。包裹部分474可以包括被配置为在收拢构型时在第二连杆466的上表面上延伸的部分，并且还可以包括被配置为可滑动地接合套管针连杆的凸轮槽444(图6)的销476。在此构型中，第一连杆464的旋转运动引起套管针组件414(图6)的向下轴向移动。FIG. 9A illustrates a perspective view of drive assembly 410 including scissor assembly 434 . The scissor assembly includes a first link 464 and a second link 466 . FIG. 9B illustrates a perspective view of the drive assembly 410 including the scissor assembly 434 with the second link 466 omitted and the first link 464 shown transparently. FIGS. 10A and 10B illustrate front and rear perspective views of the first link 464 , respectively, and FIG. 10C illustrates a perspective front view of the second link 466 . Referring to FIGS. 9A-10C together, the first linkage 464 includes at a first end 469 thereof a first pin 468 configured to be received within a bearing bore 470 within the drive assembly housing 415 . Accordingly, first link 464 can pivot about this point between a first deployed configuration (as shown in FIGS. 9A and 9B ) and a second, collapsed configuration in which first link 464 and second link 466 are oriented more parallel to each other than in the deployed configuration. The first link 464 also includes a cam slot 472 extending along the length of the first link 464 . The cam slot 472 is configured to receive the crank pin 426 extending through the opening 428 in the drive wheel 422 . In this configuration, rotation of a torsion spring (not shown in these figures) causes crank pin 426 to rotate, thereby pulling second end 471 of first link 464 downward to the stowed configuration. The first link also includes a wrapping portion 474 configured to receive the second link 466 therein when the scissor assembly 434 is in the collapsed configuration. Wrap portion 474 may include a portion configured to extend over the upper surface of second link 466 in the collapsed configuration, and may also include a pin 476 configured to slidably engage cam slot 444 ( FIG. 6 ) of the trocar link. In this configuration, rotational movement of the first link 464 causes downward axial movement of the trocar assembly 414 (FIG. 6).

第一连杆464可以经由与第二连杆464中对应的孔480配合的轴承478连接到第二连杆466。轴承478和孔480可以各自沿着相应的第一连杆464和第二连杆466的中心部分布置。第二连杆464还可以包括在第一端483处的销482，该销被配置为接合驱动组件壳体415的轴承槽484。如图9A最佳所示，轴承槽484允许销482的滑动运动，从而使第二连杆466能够从展开构型(图9A中所示)移动到收拢构型，在收拢构型中销482沿着轴承槽484进一步朝驱动组件壳体415的外表面延伸。第二连杆466还可以包括在与第一端相反的第二端487上并沿向前方向延伸的第二销486。第二销486可以被配置为与套管针组件414(图6)的接合孔442配合。在操作中，第一连杆464的向下移动经由轴承478引起第二连杆466向下移动。第二连杆466的这种向下移动致使销486向下推动套管针组件414(图6)。The first link 464 may be connected to the second link 466 via a bearing 478 that mates with a corresponding hole 480 in the second link 464 . Bearings 478 and bores 480 may each be disposed along a central portion of a respective first link 464 and second link 466 . The second linkage 464 may also include a pin 482 at a first end 483 configured to engage a bearing slot 484 of the drive assembly housing 415 . As best shown in FIG. 9A , the bearing slot 484 allows sliding movement of the pin 482, thereby enabling the second link 466 to move from the deployed configuration (shown in FIG. 9A ) to the collapsed configuration in which the pin 482 extends further along the bearing slot 484 toward the outer surface of the drive assembly housing 415. The second link 466 may also include a second pin 486 extending in a forward direction on a second end 487 opposite the first end. The second pin 486 may be configured to mate with the engagement bore 442 of the trocar assembly 414 (FIG. 6). In operation, downward movement of first link 464 causes downward movement of second link 466 via bearing 478 . This downward movement of the second link 466 causes the pin 486 to push the trocar assembly 414 (FIG. 6) downward.

如图9B所示，驱动轮422可以包括被配置为与闩锁机构423可释放地接合的凹部425。在操作中，扭转弹簧可以处于紧绕的压缩状态，并且闩锁机构423可以位于凹部425内，以阻止驱动轮422旋转。为了释放驱动轮，闩锁机构423可以向上旋转或以其他方式与凹部425脱接合，从而允许驱动轮422随着扭转弹簧的解卷而旋转。在各种示例中，闩锁机构423可以被手动触发(例如，经由机械按钮或其他致动器)，或者可以被远程触发(例如，经由控制器提供的电信号来释放闩锁机构423)。As shown in FIG. 9B , drive wheel 422 may include a recess 425 configured to releasably engage latch mechanism 423 . In operation, the torsion spring may be in a tightly wound, compressed state, and the latch mechanism 423 may be located within the recess 425 to prevent the drive wheel 422 from rotating. To release the drive wheel, the latch mechanism 423 can be rotated upward or otherwise disengaged from the recess 425, allowing the drive wheel 422 to rotate as the torsion spring unwinds. In various examples, latch mechanism 423 may be manually activated (eg, via a mechanical button or other actuator), or may be remotely activated (eg, via an electrical signal provided by a controller to release latch mechanism 423 ).

图11A和图11B分别展示了联接到套管针组件414的驱动组件410在未击发位置和插入位置时的前立体图。插入位置可以代表驱动组件410的中间阶段，此时套管针载体组件414已经向下移动以将套管针插入身体中(由此将传感器电极和插管插入身体中)。在这个中间位置之后，驱动组件410可以进一步移动套管针载体组件414，现在是在向上的方向上以将套管针从患者身体缩回。如图所示，第一连杆464的销476被可滑动地接纳在套管针连杆436的凸轮槽444内，并且第二连杆466的销486与套管针连杆436的接合孔442可旋转地配合。当扭转弹簧420旋转时，曲柄销426使第一连杆464旋转，使得销476对套管针连杆436施加向下的力，同时自己也在凸轮槽444内侧向地滑动。此外，第一连杆464的这种旋转运动经由轴承478对第二连杆施加向下的力。当第二连杆466旋转时，第二连杆466的销468在轴承槽484内滑动，直到第一连杆464和第二连杆466处于图11B所示的收拢构型。在收拢构型中，第一连杆464和第二连杆466可以沿着基本上彼此平行的轴线延伸。在一些实施例中，在收拢(插入)构型中，第一连杆464和第二连杆466可能不平行，但仍然可以比在展开(未击发)构型中更接近于平行。随着扭转弹簧继续旋转，曲柄销426继续在凸轮槽427内滑动，致使剪刀式组件返回到展开的未收拢构型，从而使套管针载体组件414向上缩回，同时将插管载体组件412留在向下插入的构型。11A and 11B illustrate front perspective views of drive assembly 410 coupled to trocar assembly 414 in an unfired and inserted position, respectively. The insertion position may represent an intermediate stage of the drive assembly 410 when the trocar carrier assembly 414 has been moved downward to insert the trocar (and thereby insert the sensor electrodes and cannula) into the body. After this intermediate position, the drive assembly 410 can move the trocar carrier assembly 414 further, now in an upward direction, to retract the trocar from the patient's body. As shown, the pin 476 of the first link 464 is slidably received within the cam slot 444 of the trocar link 436 and the pin 486 of the second link 466 is rotatably engaged with the engagement hole 442 of the trocar link 436 . As torsion spring 420 rotates, crank pin 426 rotates first link 464 such that pin 476 exerts a downward force on trocar link 436 while also sliding itself laterally within cam slot 444 . Furthermore, this rotational movement of the first link 464 exerts a downward force on the second link via the bearing 478 . As the second link 466 rotates, the pin 468 of the second link 466 slides within the bearing slot 484 until the first link 464 and the second link 466 are in the collapsed configuration shown in FIG. 11B . In the collapsed configuration, the first link 464 and the second link 466 may extend along axes that are substantially parallel to each other. In some embodiments, in the stowed (inserted) configuration, first link 464 and second link 466 may not be parallel, but may still be closer to parallel than in the deployed (unfired) configuration. As the torsion spring continues to rotate, the crank pin 426 continues to slide within the cam slot 427, causing the scissor assembly to return to the deployed, collapsed configuration, thereby retracting the trocar carrier assembly 414 upward while leaving the cannula carrier assembly 412 in the downwardly inserted configuration.

III.选择具有双曲柄驱动组件的示例性装置III.Selection of Exemplary Devices with Dual Crank Drive Assemblies

如上所述，在集成式输注泵与传感器装置中，插入组件可以将输注插管和传感器电极两者插入用户的皮肤中。在各种实施例中，可能期望在输注插管与传感器电极之间维持足够的侧向间隔，并提供足够的插入深度，而不过度增加装置的整体尺寸。除了以上关于图1A至图11B所描述的剪刀式组件之外，在各种实施例中，可以使用双曲柄驱动组件将输注插管和传感器电极从装置壳体插入用户的皮肤中。As noted above, in an integrated infusion pump and sensor device, the insertion assembly can insert both the infusion cannula and the sensor electrodes into the user's skin. In various embodiments, it may be desirable to maintain sufficient lateral spacing between the infusion cannula and the sensor electrodes, and to provide sufficient insertion depth without unduly increasing the overall size of the device. In addition to the scissor assembly described above with respect to FIGS. 1A-11B , in various embodiments, a double crank drive assembly may be used to insert the infusion cannula and sensor electrodes from the device housing into the user's skin.

图12A是根据本技术的几个实施例的具有集成传感器的输注装置(“装置500”)的立体图，该输注装置包括耐用组件600和可抛式组件700。图12B展示了装置500，其中耐用组件600被移除。装置500、耐用组件600和可抛式组件700可以大致类似于上述装置100、耐用组件200和可抛式组件300。然而，如下文更详细描述的，与上述剪刀式组件相反，可抛式组件700可以包括驱动组件，该驱动组件包括多个驱动轮。12A is a perspective view of an infusion set with integrated sensors ("device 500") comprising a durable assembly 600 and a disposable assembly 700 in accordance with several embodiments of the present technology. Figure 12B illustrates device 500 with durable component 600 removed. Apparatus 500, durable assembly 600, and disposable assembly 700 may be substantially similar to apparatus 100, durable assembly 200, and disposable assembly 300 described above. However, as described in more detail below, in contrast to the scissor assemblies described above, the throwable assembly 700 may include a drive assembly that includes a plurality of drive wheels.

在图12C中更详细地示出的可抛式组件700可以包括储器组件704和插入组件800，每个组件都安装在底板750上。储器组件704可以包括驱动组件706、储器708、以及联接到柱塞710的推动器709。推动器709联接到驱动组件，并且推动器709和柱塞710都可以容纳在储器708内。在操作中，柱塞710在储器内的平移(例如，通过磁电机的致动)致使流体(例如，药剂)被驱逐出储器708并且经输注插管递送到用户的皮下治疗部位。储器708可以预先填充有药剂。例如，药剂可以是U-100胰岛素或U-500胰岛素或其他浓度的胰岛素以适应不同的用户使用情况，或者可以是用户可通过填充端口填充的。Disposable assembly 700 , shown in more detail in FIG. 12C , may include reservoir assembly 704 and insert assembly 800 , each mounted on base plate 750 . The reservoir assembly 704 can include a drive assembly 706 , a reservoir 708 , and a pusher 709 coupled to a plunger 710 . Pusher 709 is coupled to the drive assembly, and both pusher 709 and plunger 710 may be housed within reservoir 708 . In operation, translation of plunger 710 within the reservoir (eg, by actuation of a magneto) causes fluid (eg, medicament) to be expelled from reservoir 708 and delivered via the infusion cannula to the user's subcutaneous treatment site. Reservoir 708 may be pre-filled with medicament. For example, the dose may be U-100 insulin or U-500 insulin or other strengths of insulin to suit different user usage, or may be user fillable through the fill port.

插入组件800被配置为将输注插管802和传感器电极804两者分别经由第一端口806和第二端口808插入到壳体702之外。一旦被插入用户的皮肤中，流体联接到储器708(例如，通过套管针)的输注插管802可以将药剂(例如，胰岛素)递送穿过其到达用户。此外，一旦传感器电极804被插入用户的皮肤中，传感器电极804就可以检测一个或多个生理学参数，例如皮内和/或皮下空间中的葡萄糖水平。如本领域普通技术人员所知，在皮内和/或皮下空间中获得的葡萄糖测量值可以用于推导或推断用户的血糖水平。经由传感器电极804获得的这些生理学参数可以可选地用于控制经由输注插管802的药剂递送。例如，当用户的葡萄糖升高到预定阈值以上时(如根据经由传感器电极804获得的读数所确定的)，可以启动磁电机以将柱塞710驱动适当的量以将药剂从储器708经由输注插管802分配到用户体内。Insertion assembly 800 is configured to insert both infusion cannula 802 and sensor electrode 804 out of housing 702 via first port 806 and second port 808 , respectively. Once inserted into the user's skin, infusion cannula 802 fluidly coupled to reservoir 708 (eg, via a trocar) may deliver medicament (eg, insulin) therethrough to the user. Additionally, once the sensor electrodes 804 are inserted into the user's skin, the sensor electrodes 804 can detect one or more physiological parameters, such as glucose levels in the intradermal and/or subcutaneous space. Glucose measurements obtained in the intradermal and/or subcutaneous space may be used to derive or infer a user's blood glucose level, as is known to those of ordinary skill in the art. These physiological parameters obtained via sensor electrodes 804 may optionally be used to control drug delivery via infusion cannula 802 . For example, when the user's glucose rises above a predetermined threshold (as determined from readings obtained via sensor electrodes 804), the magneto may be activated to drive plunger 710 an appropriate amount to dispense medicament from reservoir 708 via infusion cannula 802 into the user.

图13是插入组件800处于插入位置时的放大立体图。如图所示，插入组件800包括驱动组件810、载体组件812、套管针组件814和传感器电子组件816。滑动引导件817定位在套管针组件814的侧向的相反两侧上并且载体组件812可以向上和向下移动。载体组件812可以联接到输注插管802和传感器电极804两者，并且套管针组件814可以被配置为与载体组件812可释放地配合以将载体组件812从未击发状态向下移动至插入状态(如图13所示)。在未击发状态(未示出)下，输注插管802和传感器电极804都缩回以便布置在壳体702内(为清楚起见在图13中未示出)。在一些示例中，在未击发状态下，输注插管和传感器电极可以类似于图3B所示的构型来布置。在插入状态(如图13所示)下，输注插管802和传感器电极804都向下延伸，并且在操作中延伸到用户的皮肤中。FIG. 13 is an enlarged perspective view of the insertion assembly 800 in the insertion position. As shown, insertion assembly 800 includes drive assembly 810 , carrier assembly 812 , trocar assembly 814 , and sensor electronics assembly 816 . Sliding guides 817 are positioned on laterally opposite sides of trocar assembly 814 and carrier assembly 812 can move up and down. Carrier assembly 812 may be coupled to both infusion cannula 802 and sensor electrode 804, and trocar assembly 814 may be configured to releasably engage carrier assembly 812 to move carrier assembly 812 downward from an unfired state to an inserted state (as shown in FIG. 13 ). In the unfired state (not shown), both infusion cannula 802 and sensor electrode 804 are retracted for placement within housing 702 (not shown in FIG. 13 for clarity). In some examples, in the unfired state, the infusion cannula and sensor electrodes can be arranged similar to the configuration shown in Figure 3B. In the inserted state (as shown in FIG. 13 ), both the infusion cannula 802 and the sensor electrodes 804 extend downwardly, and in operation, into the user's skin.

在各种示例中，可以选择输注插管802与传感器电极804之间的侧向距离以在插入到用户皮肤内后提供适当的性能。在各种实施例中，输注插管802与传感器电极804之间的侧向间隔可以是至少约10mm或更大(例如，约14mm)。此外，在一些实施例中，可能期望将输注插管802和/或传感器电极804插入到用户皮肤表面下方的特定深度。在各种实施例中，插入深度(例如，当处于插入状态时，从输注插管802和/或传感器电极804的较远端头到壳体下表面的距离)可以是至少约6–10mm或更大。In various examples, the lateral distance between infusion cannula 802 and sensor electrode 804 can be selected to provide appropriate performance after insertion into the user's skin. In various embodiments, the lateral separation between infusion cannula 802 and sensor electrode 804 can be at least about 10 mm or greater (eg, about 14 mm). Additionally, in some embodiments, it may be desirable to insert infusion cannula 802 and/or sensor electrodes 804 to a particular depth below the user's skin surface. In various embodiments, the insertion depth (eg, the distance from the distal tip of infusion cannula 802 and/or sensor electrode 804 to the lower surface of the housing when in the inserted state) can be at least about 6-10 mm or greater.

如下文更详细描述的，在操作中，驱动组件810被致动以引起套管针组件814和载体组件812两者从未击发状态向下移动以将载体组件812推至插入状态(如图13所示)。例如，套管针组件814可以邻接或以其他方式联接到载体组件812，使得套管针组件814的向下移动引起载体组件812向下移动，而套管针组件814的向上移动不会引起载体组件812的向上移动。在一些实施例中，一旦载体组件812处于插入状态，驱动组件810继续移动套管针组件814，使得套管针组件814向上缩回，同时载体组件812保持伸展，而输注插管802和传感器电极804延伸超出壳体702并进入用户的皮肤中。As described in more detail below, in operation, drive assembly 810 is actuated to cause both trocar assembly 814 and carrier assembly 812 to move downwardly from the unfired state to push carrier assembly 812 to the inserted state (shown in FIG. 13 ). For example, trocar assembly 814 may abut or otherwise be coupled to carrier assembly 812 such that downward movement of trocar assembly 814 causes downward movement of carrier assembly 812, while upward movement of trocar assembly 814 does not cause upward movement of carrier assembly 812. In some embodiments, once carrier assembly 812 is in the inserted state, drive assembly 810 continues to move trocar assembly 814 such that trocar assembly 814 is retracted upwardly while carrier assembly 812 remains extended while infusion cannula 802 and sensor electrodes 804 extend beyond housing 702 and into the user's skin.

传感器电子组件816可以联接到载体组件814，使得两者一起从未击发位置向下移动到插入位置。传感器电子组件816可以包括一个或多个电子部件，该电子部件被配置为促进经由传感器电极804获得生理学测量值。这可以包括例如合适的模拟或数字部件、电池、电路、处理器、收发器等。The sensor electronics assembly 816 can be coupled to the carrier assembly 814 such that the two move together down from the unfired position to the inserted position. Sensor electronics assembly 816 may include one or more electronic components configured to facilitate obtaining physiological measurements via sensor electrodes 804 . This may include, for example, suitable analog or digital components, batteries, circuits, processors, transceivers, and the like.

如上所述，是驱动组件810使载体组件812、套管针组件814和传感器电子组件816从未击发位置移动到插入位置。驱动组件810可以包括驱动组件壳体815。如图14最佳所示，该图展示了驱动组件810的局部分解图，其中省略了壳体815，驱动组件810包括支撑架818，该支撑架具有从其延伸的第一轴承轴820和第二轴承轴822。第一轴承轴820被配置为在其上接纳第一驱动轮824并且第二轴承轴822被配置为在其上接纳第二驱动轮826。第一驱动轮824和第二驱动轮826可以配合在一起，例如具有互锁的齿，使得第一驱动轮824的旋转引起第二驱动轮826沿相反方向的相应旋转。在各种实施例中，第一驱动轮和第二驱动轮之间的联接可以采取其他形式。As noted above, it is the drive assembly 810 that moves the carrier assembly 812, trocar assembly 814, and sensor electronics assembly 816 from the unfired position to the inserted position. Drive assembly 810 may include a drive assembly housing 815 . As best shown in FIG. 14 , which shows a partially exploded view of drive assembly 810 , with housing 815 omitted, drive assembly 810 includes a support frame 818 having a first bearing shaft 820 and a second bearing shaft 822 extending therefrom. The first bearing shaft 820 is configured to receive a first drive wheel 824 thereon and the second bearing shaft 822 is configured to receive a second drive wheel 826 thereon. The first drive wheel 824 and the second drive wheel 826 may mate together, eg, with interlocking teeth, such that rotation of the first drive wheel 824 causes a corresponding rotation of the second drive wheel 826 in the opposite direction. In various embodiments, the coupling between the first drive wheel and the second drive wheel may take other forms.

在一些实施例中，第一驱动轮824可以采取主驱动齿轮的形式并且可以联接到扭转弹簧828。扭转弹簧828可以包括具有锚定销830和延伸穿过第一驱动轮824中的孔834的第一曲柄销832的螺旋线圈。在此构型中，第一曲柄销832相对于支撑架818的旋转将引起第一驱动轮824的旋转，这又将引起第二驱动轮826的对应的相反旋转。第二驱动轮826可以采取不直接联接到扭转弹簧的空转齿轮的形式。然而，第二曲柄销836可以从第二驱动轮826延伸。如下文更详细描述的，第一和第二驱动轮824、826的旋转致使第一和第二曲柄销832、836旋转运动。当第一和第二曲柄销832、836各自被接纳在套管针组件814的凸轮槽内时，驱动轮的这种旋转运动可以致使套管针组件814轴向移动(例如，向上和向下)。In some embodiments, first drive wheel 824 may take the form of a main drive gear and may be coupled to torsion spring 828 . The torsion spring 828 may include a helical coil having an anchor pin 830 and a first crank pin 832 extending through a bore 834 in the first drive wheel 824 . In this configuration, rotation of the first crank pin 832 relative to the support bracket 818 will cause rotation of the first drive wheel 824 , which in turn will cause a corresponding opposite rotation of the second drive wheel 826 . The second drive wheel 826 may take the form of an idler gear that is not directly coupled to a torsion spring. However, the second crank pin 836 may extend from the second drive wheel 826 . As described in more detail below, rotation of the first and second drive wheels 824 , 826 causes rotational movement of the first and second crankpins 832 , 836 . This rotational movement of the drive wheel may cause the trocar assembly 814 to move axially (eg, up and down) when the first and second crank pins 832 , 836 are each received within the cam slots of the trocar assembly 814 .

如上所述，套管针组件814可以用于将输注插管802和传感器电极804向下驱动并超出装置的壳体。如图15最佳所示，套管针组件814可以包括侧向延伸的套管针滑块837、以及各自背离套管针滑块837向下延伸的第一套管针838和第二套管针840。套管针滑块837可以经由凸轮槽842联接到驱动组件810，使得曲柄销832、836的运动(由第一和第二驱动轮824、826的旋转引起)致使套管针滑块837轴向向下移动，从而使第一和第二套管针838、840轴向向下移动。套管针滑块837可以包括联接到第一套管针838的第一延伸部844和联接到第二套管针840的第二延伸部846。延伸部844、846可以用作邻接载体组件812的上表面的配合表面，从而使载体组件812响应于套管针组件814的向下移动而向下移动。As described above, trocar assembly 814 may be used to drive infusion cannula 802 and sensor electrodes 804 down and out of the housing of the device. As best shown in FIG. 15 , trocar assembly 814 may include a laterally extending trocar slide 837 , and a first trocar 838 and a second trocar 840 each extending downwardly away from trocar slide 837 . Trocar slider 837 may be coupled to drive assembly 810 via cam slot 842 such that movement of crank pins 832, 836 (caused by rotation of first and second drive wheels 824, 826) causes trocar slider 837 to move axially downward, thereby moving first and second trocars 838, 840 axially downward. Trocar slider 837 may include a first extension 844 coupled to first trocar 838 and a second extension 846 coupled to second trocar 840 . Extensions 844 , 846 may serve as mating surfaces abutting the upper surface of carrier assembly 812 , allowing carrier assembly 812 to move downward in response to downward movement of trocar assembly 814 .

第一套管针838可以被配置为与输注插管802可释放地接合，例如通过延伸到输注插管802的内腔中。第二套管针840可以被配置为与传感器电极804可释放地接合，例如通过包括槽缝或凹槽，传感器电极804被可移除地布置该槽缝或凹槽。套管针838、840中的一者或两者可以具有锋利和/或尖锐的端头以便于刺穿患者的皮肤。在各种实施例中，第一和第二套管针838、840可以由金属或其他刚性材料制成，使得第一和第二套管针838、840具有足够的结构完整性以被驱动到用户的皮肤中，从而携带着输注插管802和传感器电极804进入皮肤。一旦输注插管802和传感器电极804已经完全插入用户的皮肤中，套管针滑块837向上移动(例如，由于驱动轮824、826的继续旋转)。因为第一和第二套管针838、840分别与输注插管802和传感器电极804可移动地接合，所以输注插管802和传感器电极804在用户皮肤内留在原位(例如，处于如图13所示的插入位置中)，同时第一和第二套管针838、840向上缩回。尽管本文提到了套管针，但是任何合适的细长构件都可以用于与输注插管802和/或传感器电极804可释放地配合。这样的细长构件可以是例如管心针、杆、轴、管、针或任何其他合适的构型。The first trocar 838 can be configured to releasably engage with the infusion cannula 802 , for example by extending into the lumen of the infusion cannula 802 . The second trocar 840 may be configured to releasably engage the sensor electrode 804, for example by including a slot or groove into which the sensor electrode 804 is removably disposed. One or both trocars 838, 840 may have a sharp and/or pointed tip to facilitate piercing the patient's skin. In various embodiments, the first and second trocars 838, 840 may be made of metal or other rigid material such that the first and second trocars 838, 840 have sufficient structural integrity to be driven into the user's skin, carrying the infusion cannula 802 and sensor electrodes 804 into the skin. Once infusion cannula 802 and sensor electrodes 804 have been fully inserted into the user's skin, trocar slider 837 moves upward (eg, due to continued rotation of drive wheels 824, 826). Because the first and second trocars 838, 840 are movably engaged with the infusion cannula 802 and the sensor electrode 804, respectively, the infusion cannula 802 and the sensor electrode 804 remain in place (e.g., in the inserted position as shown in FIG. 13 ) within the user's skin while the first and second trocars 838, 840 are retracted upwardly. Although reference is made herein to a trocar, any suitable elongate member may be used to releasably engage infusion cannula 802 and/or sensor electrodes 804 . Such an elongate member may be, for example, a stylet, rod, shaft, tube, needle, or any other suitable configuration.

图16A和图16B分别展示了插管载体组件812的前立体图和后立体图，电子组件816联接至该插管载体组件。图17展示了孤立的电子组件816的立体图。参照图16A至图17一起，如前所述，载体组件812可以与套管针组件814可释放地配合，使得套管针组件814的向下移动引起载体组件812的向下移动。载体组件812可以包括插管载体850，该插管载体侧向延伸并且包括被配置为接合套管针组件814的延伸部844、846(图15)的上配合表面852。载体组件812还包括插管隔膜854，该插管隔膜覆盖并密封从其向下延伸的插管802。插管隔膜854可以在插管802上方和刺穿隔膜854的第一套管针838周围维持气密性的和/或基本气密性的密封。此外，插管802可以具有内腔，该内腔经由流体联接至储器的第一套管针838与储器流体连通，甚至在套管针组件向上移动之后也是如此。传感器隔膜856设置在载体850的相反端上，并且被配置为覆盖从其向下延伸的传感器电极804。如图16B所示，载体组件812包括第一和第二凸轮槽858、860，这些凸轮槽被配置为在下行冲程期间与驱动组件810的第一和第二曲柄销832、836接合。在驱动轮824、826并且因此曲柄销832、836继续旋转时，曲柄销在凸轮槽858、860的开口端859、861处移出第一和第二凸轮槽858、860，而不会提升载体组件812离开插入位置。16A and 16B illustrate front and rear perspective views, respectively, of cannula carrier assembly 812 to which electronics assembly 816 is coupled. FIG. 17 shows a perspective view of the electronic assembly 816 in isolation. 16A-17 together, as previously described, the carrier assembly 812 can be releasably engaged with the trocar assembly 814 such that downward movement of the trocar assembly 814 causes downward movement of the carrier assembly 812 . Carrier assembly 812 may include cannula carrier 850 extending laterally and including an upper mating surface 852 configured to engage extensions 844 , 846 of trocar assembly 814 ( FIG. 15 ). Carrier assembly 812 also includes cannula septum 854 that covers and seals cannula 802 extending downwardly therefrom. Cannula septum 854 may maintain an airtight and/or substantially airtight seal over cannula 802 and around first trocar 838 piercing septum 854 . Additionally, the cannula 802 may have a lumen in fluid communication with the reservoir via a first trocar 838 fluidly coupled to the reservoir, even after the trocar assembly is moved upwardly. A sensor membrane 856 is disposed on an opposite end of the carrier 850 and is configured to cover the sensor electrodes 804 extending downwardly therefrom. As shown in FIG. 16B , the carrier assembly 812 includes first and second cam slots 858 , 860 configured to engage the first and second crank pins 832 , 836 of the drive assembly 810 during the downstroke. As the drive wheels 824, 826 and thus the crank pins 832, 836 continue to rotate, the crank pins move out of the first and second cam slots 858, 860 at the open ends 859, 861 of the cam slots 858, 860 without lifting the carrier assembly 812 out of the inserted position.

如图所示，载体组件812可以联接到传感器电子组件816。在所示实施例中，传感器电子组件816包括印刷电路板或其他基板863，电池862和一个或多个部件864联接到其上。这样的部件864可以包括例如低功率无线通信部件、数据处理电路、处理电路、数据存储装置或任何其他合适的部件。As shown, carrier assembly 812 may be coupled to sensor electronics assembly 816 . In the illustrated embodiment, the sensor electronics assembly 816 includes a printed circuit board or other substrate 863 to which a battery 862 and one or more components 864 are coupled. Such components 864 may include, for example, low power wireless communication components, data processing circuits, processing circuits, data storage devices, or any other suitable components.

图18A和图18B分别展示了插入组件800在未击发位置和插入位置时的端视图。如图所示，在未击发位置(图18A)，承载了输注插管802和传感器电极804的插管载体组件812处于缩回位置，使得输注插管802和传感器电极804设置在装置的壳体内。通过旋转第一和第二驱动轮824、826(例如，经由联接到第一驱动轮824的扭转弹簧(未示出)的旋转)，第一和第二曲柄销832、836接合套管针组件814的凸轮槽842并将套管针组件814向下推。套管针组件814的这种向下移动致使载体组件812(和与其联接的电子组件816)向下移动到图18B所示的插入位置。在向下击发之后，套管针组件814可以向上缩回(例如，通过驱动轮824、826的继续旋转)，留下输注插管802和传感器电极804伸出并进入用户的皮肤中。因为套管针流体联接到储器和插管，所以之后可以根据需要将流体递送穿过输注插管802并进入用户体内。在各种示例中，可以通过使用机械致动的(例如，使用按钮、开关等)或远程致动的(例如，经由无线传输)释放机构如上所述来击发该装置。18A and 18B illustrate end views of the insertion assembly 800 in the unfired and inserted positions, respectively. As shown, in the unfired position (FIG. 18A), cannula carrier assembly 812 carrying infusion cannula 802 and sensor electrodes 804 is in a retracted position such that infusion cannula 802 and sensor electrodes 804 are disposed within the housing of the device. By rotating the first and second drive wheels 824, 826 (eg, via rotation of a torsion spring (not shown) coupled to the first drive wheel 824), the first and second crank pins 832, 836 engage the cam slots 842 of the trocar assembly 814 and push the trocar assembly 814 downward. This downward movement of the trocar assembly 814 causes the carrier assembly 812 (and the electronics assembly 816 coupled thereto) to move downward to the insertion position shown in FIG. 18B. After being fired downward, trocar assembly 814 may be retracted upward (eg, by continued rotation of drive wheels 824, 826), leaving infusion cannula 802 and sensor electrode 804 protruding and entering the user's skin. Because the trocar is fluidly coupled to the reservoir and cannula, fluid can then be delivered through the infusion cannula 802 and into the user's body as desired. In various examples, the device may be fired as described above using a mechanically actuated (eg, using a button, switch, etc.) or remotely actuated (eg, via wireless transmission) release mechanism.

IV.选择多传感器装置的示例性实施例IV.Selecting Exemplary Embodiments of Multi-Sensor Devices

如上所述，在集成式输注泵与传感器装置中，可抛式部件可以包括血糖传感器电极。在各种示例性实施例中，这样的装置可以附加地或替代地包括一个或多个其他传感器。如前所述，经由这样的传感器收集的数据可以从可抛式组件无线传输到耐用组件。在示例中，额外的传感器可以包括用于检测整个组件中的流体流动的液压传感器、用于检测柱塞在储器内的位置的柱塞位置传感器、用于检测机械部件(比如使柱塞移动的驱动组件)的位置、取向、应变或其他参数的机械传感器、温度传感器、压力传感器或任何其他合适的传感器。在各种示例中，传感器可以用于评估泵性能(例如，排出压力、气泡、流速、柱塞位置、柱塞力、导螺杆角位置)或装置的任何其他期望参数。As noted above, in an integrated infusion pump and sensor device, the disposable component may include blood glucose sensor electrodes. In various exemplary embodiments, such devices may additionally or alternatively include one or more other sensors. As previously mentioned, data collected via such sensors can be wirelessly transmitted from disposable components to durable components. In examples, additional sensors may include hydraulic sensors to detect fluid flow throughout the assembly, plunger position sensors to detect the position of the plunger within the reservoir, mechanical sensors to detect the position, orientation, strain, or other parameters of mechanical components such as a drive assembly that moves the plunger, temperature sensors, pressure sensors, or any other suitable sensor. In various examples, sensors may be used to assess pump performance (eg, discharge pressure, air bubbles, flow rate, plunger position, plunger force, lead screw angular position) or any other desired parameter of the device.

图19A至图19C展示了这种多传感器装置的可抛式组件900的几个视图，为了清楚起见移除了顶壳。在一些实施例中，可抛式组件900可以包括在本文别处描述的可抛式组件300和可抛式组件700的一些或所有特征，除了可抛式组件900可以包括一个或多个额外的传感器或传感器部件。图19A示出了可抛式组件900的侧面立体图，图19B示出了处于未击发位置的组件900的一部分的放大细节图，并且图19C示出了处于向下插入位置的组件900的这部分的放大细节图。在所示实施例中，可抛式组件900包括剪刀式驱动组件910以实现传感器电极904和插管902的移动。然而，本文描述的各种传感器可以同等地用于具有其他驱动机构的可抛式组件，例如本文别处描述的双曲柄驱动组件。19A-19C illustrate several views of the disposable assembly 900 of this multi-sensor device with the top case removed for clarity. In some embodiments, throwable assembly 900 may include some or all of the features of throwable assembly 300 and throwable assembly 700 described elsewhere herein, except that throwable assembly 900 may include one or more additional sensors or sensor components. 19A shows a side perspective view of the throwable assembly 900, FIG. 19B shows an enlarged detail view of a portion of the assembly 900 in the unfired position, and FIG. 19C shows an enlarged detail view of the portion of the assembly 900 in the inserted downward position. In the illustrated embodiment, the disposable assembly 900 includes a scissor drive assembly 910 to effectuate movement of the sensor electrode 904 and the cannula 902 . However, the various sensors described herein may equally be used with throwable assemblies having other drive mechanisms, such as the double crank drive assemblies described elsewhere herein.

如图19A所示，多条电迹线918可以沿着底板950延伸，可抛式组件900的各种部件安装在该底板上。这些迹线918中的至少一条可以电连接到电池921，并且迹线918中的一条或多条可以与设置在可抛式组件900周围的一个或多个传感器电连通。这样的传感器可以包括例如机械传感器(例如，设置在柱塞驱动组件906内)、柱塞位置传感器(例如，设置在储器908内或周围)、液压传感器(例如，设置在储器908与插管902之间的任何流体路径内或周围)或任何其他合适的传感器或传感器部件。一些或所有电迹线918也可以与对应的电触头917电连通。As shown in FIG. 19A, a plurality of electrical traces 918 may extend along a base plate 950 on which various components of the disposable assembly 900 are mounted. At least one of these traces 918 may be electrically connected to battery 921 , and one or more of traces 918 may be in electrical communication with one or more sensors disposed about disposable assembly 900 . Such sensors may include, for example, mechanical sensors (e.g., disposed within plunger drive assembly 906), plunger position sensors (e.g., disposed within or around reservoir 908), hydraulic sensors (e.g., disposed within or around any fluid path between reservoir 908 and cannula 902), or any other suitable sensor or sensor component. Some or all of the electrical traces 918 may also be in electrical communication with corresponding electrical contacts 917 .

如图19B和图19C最佳所示，当传感器电子组件916从未击发位置(图19B所示)移动到向下插入位置(图19C所示)时，传感器电子组件916的电触头919放置成与电触头917直接接触，后者又联接到迹线918。在这种连接状态(图19C中所示)下，可以向各种传感器以及传感器组件916的其他电气部件(例如，用于信号处理、无线传输等的部件)供电。在操作中，来自这些不同传感器的数据可以根据需要由机载电子器件进行处理，然后被无线传输到耐用组件(未示出)以进行进一步处理。尽管所示示例描绘了五条迹线，但在各种实施例中，迹线和/或电触头的数量可以更多或更少，这取决于期望的传感器配置、数量和类型等。As best shown in FIGS. 19B and 19C , when the sensor electronics assembly 916 is moved from the unfired position (shown in FIG. 19B ) to the inserted down position (shown in FIG. 19C ), the electrical contacts 919 of the sensor electronics assembly 916 are placed in direct contact with electrical contacts 917, which in turn are coupled to traces 918. In this connected state (shown in FIG. 19C ), power can be supplied to various sensors as well as other electrical components of sensor assembly 916 (eg, components for signal processing, wireless transmission, etc.). In operation, data from these various sensors may be processed as needed by onboard electronics and then wirelessly transmitted to durable components (not shown) for further processing. Although the illustrated example depicts five traces, in various embodiments, the number of traces and/or electrical contacts may be greater or lesser, depending on the desired sensor configuration, number and type, etc.

V.结论V.Conclusion

尽管是在自动套管插入和贴片泵的背景下描述这些装置和方法，但应理解，这些技术同样适用于各种医疗装置(例如，输注端口)和各种至少部分可植入的装置(例如，传感器)。此处还应注意，说明书描述的结构和方法特别适用于皮下递送高浓度胰岛素(即，U-200胰岛素及以上)，比如U-500胰岛素，以及较低浓度的胰岛素，比如U-100胰岛素。然而，应当理解，本发明适用于范围广泛的输注泵和药剂。例如，本发明还适用于药剂，例如掩盖疼痛的药物、化学疗法和其他癌症相关药物、抗生素、激素、GLP-1、胰高血糖素、可能需要高水平的递送准确度的包括大分子和蛋白质的各种其他药物，以及相对高浓度的胰岛素(即，U-200胰岛素及以上)，比如U-500胰岛素，以及较低浓度的胰岛素，比如U-100胰岛素。Although these devices and methods are described in the context of automated cannula insertion and patch pumps, it should be understood that these techniques are equally applicable to various medical devices (eg, infusion ports) and various at least partially implantable devices (eg, sensors). It should also be noted here that the structures and methods described in the specification are particularly suitable for the subcutaneous delivery of high concentrations of insulin (ie, U-200 insulin and above), such as U-500 insulin, as well as lower concentrations of insulin, such as U-100 insulin. However, it should be understood that the present invention is applicable to a wide variety of infusion pumps and medicaments. For example, the invention is also applicable to pharmaceuticals such as pain masking drugs, chemotherapy and other cancer related drugs, antibiotics, hormones, GLP-1, glucagon, various other drugs including macromolecules and proteins that may require a high level of delivery accuracy, and relatively high concentrations of insulin (i.e., U-200 insulin and above), such as U-500 insulin, and lower concentrations of insulin, such as U-100 insulin.

对本技术的示例的描述不意欲是详尽的，或不意欲将本技术限于上文披露的确切形式。在上下文允许的情况下，单数或复数术语也可以分别包括复数或单数术语。虽然上文出于展示目的描述了本技术的特定实施例和示例，但是如相关领域技术人员将认识到的，各种等同修改在本技术的范围内是可能的。例如，虽然以给定的顺序提供了各步骤，但替代性实施例可以以不同的顺序来执行这些步骤。本文描述的各种实施例也可以进行组合以提供另外的实施例。The descriptions of examples of the present technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Where the context permits, singular or plural terms may also include plural or singular terms, respectively. While specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein can also be combined to provide additional embodiments.

如本文所用，术语“一般”、“基本上”、“约”和类似术语用作近似术语而不是程度术语，并且旨在考虑测得或计算出的值的固有变化，这些变化将是本领域的普通技术人员所认可的。As used herein, the terms "generally," "substantially," "about," and similar terms are used as terms of approximation rather than of degree, and are intended to take into account inherent variations in measured or calculated values that would be recognized by one of ordinary skill in the art.

而且，除非词语“或”被明确限制为在提及具有两项或更多项的清单的情况下是指排除其他项的单一项，则在这样的清单中使用“或”应解释为包括(a)清单中的任何单一项、(b)清单中的所有项、或(c)清单中的项的任何组合。另外，术语“包括”贯穿全文用于意指至少包含所陈述的特征，从而并不排除任一更大数目的相同特征和/或额外类型的其他特征。还应了解的是，已经出于展示的目的描述了特定实施例，但是可以在不偏离本技术的情况下进行各种修改。进一步，虽然已经在这些实施例的上下文中描述了与本技术的某些实施例相关联的优点，但是其他实施例也可以呈现这些优点，并且并非所有实施例都需要必需呈现这些优点才落入本技术的范围内。因此，本披露及相关的技术可以涵盖本文中未明确示出或描述的其他实施例。Also, unless the word "or" is expressly limited to mean a single item excluding other items when referring to a list of two or more items, the use of "or" in such a list shall be construed to include (a) any single item in the list, (b) all the items in the list, or (c) any combination of items in the list. Additionally, the term "comprising" is used throughout to mean the inclusion of at least the stated features, thereby not excluding any greater number of the same features and/or additional types of other features. It should also be appreciated that specific embodiments have been described for illustrative purposes, but that various modifications may be made without departing from the technology. Further, while advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit these advantages, and not all embodiments need to exhibit these advantages to fall within the scope of the present technology. Accordingly, the present disclosure and related technology can encompass other embodiments not expressly shown or described herein.

作为总结，本公开公开了以下方面：In summary, this disclosure discloses the following aspects:

1.一种集成式传感器与输注装置，所述装置包括：1. An integrated sensor and infusion device, said device comprising:

储器组件，所述储器组件包括被配置为在其中容纳药剂的储器；a reservoir assembly comprising a reservoir configured to hold a medicament therein;

传感器电子组件，所述传感器电子组件被配置为从传感器接收信号；以及a sensor electronics assembly configured to receive a signal from the sensor; and

插入组件，所述插入组件包括：Insert components, the insert components include:

载体组件，所述载体组件包括插管载体、背离所述插管载体向下延伸的输注插管、以及在与所述输注插管侧向间隔开的位置处背离所述插管载体向下延伸的传感器电极，其中，所述输注插管流体联接到所述储器；a carrier assembly comprising a cannula carrier, an infusion cannula extending downwardly away from the cannula carrier, and a sensor electrode extending downwardly away from the cannula carrier at a location laterally spaced from the infusion cannula, wherein the infusion cannula is fluidly coupled to the reservoir;

套管针组件，所述套管针组件包括套管针连杆、被配置为可移除地接合所述输注插管的第一套管针和被配置为可移除地接合所述传感器电极的第二套管针，所述套管针组件可移除地联接到所述载体组件；以及a trocar assembly comprising a trocar linkage, a first trocar configured to removably engage the infusion cannula, and a second trocar configured to removably engage the sensor electrode, the trocar assembly removably coupled to the carrier assembly; and

驱动组件，所述驱动组件包括联接到所述套管针组件的扭转弹簧，使得当被致动时，所述扭转弹簧进行旋转以驱动所述套管针组件和所述载体组件轴向向下，以将所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极插入用户的皮肤中。a drive assembly including a torsion spring coupled to the trocar assembly such that when actuated, the torsion spring rotates to drive the trocar assembly and the carrier assembly axially downward to insert the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the skin of a user.

2.如上述方面所述的装置，其中，所述装置的每个部件被配置为在所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极被插入所述用户的皮肤中之前被容纳在装置壳体内，并且其中，所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极延伸出所述壳体以插入所述用户的皮肤中。2. The device of the preceding aspect, wherein each component of the device is configured to be housed within a device housing prior to insertion of the first trocar, the infusion cannula, the second trocar and the sensor electrode into the user's skin, and wherein the first trocar, the infusion cannula, the second trocar and the sensor electrode extend out of the housing for insertion into the user's skin.

3.如上述方面中任一方面所述的装置，其中，所述扭转弹簧的第一旋转量驱动所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极进入用户的皮肤中，并且其中，第二旋转量将所述第一套管针和所述第二套管针从所述用户的皮肤缩回，同时将所述输注插管和所述传感器电极留在所述用户的皮肤中。3. The device of any of the preceding aspects, wherein a first amount of rotation of the torsion spring drives the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the user's skin, and wherein a second amount of rotation retracts the first trocar and the second trocar from the user's skin while leaving the infusion cannula and the sensor electrode in the user's skin.

4.如上述方面中任一方面所述的装置，其中，所述第一旋转量为大致180度，并且所述第二旋转量为额外的大致180度。4. The device of any one of the preceding aspects, wherein the first amount of rotation is approximately 180 degrees and the second amount of rotation is an additional approximately 180 degrees.

5.如上述方面中任一方面所述的装置，其中，所述扭转弹簧经由手动触发机构被致动。5. The device of any one of the preceding aspects, wherein the torsion spring is actuated via a manual trigger mechanism.

6.如上述方面中任一方面所述的装置，其中，所述扭转弹簧经由远程触发机构被致动。6. The device of any one of the preceding aspects, wherein the torsion spring is actuated via a remote trigger mechanism.

7.如上述方面中任一方面所述的装置，其中，所述第一套管针被配置为在所述输注插管的内腔内延伸。7. The device of any one of the preceding aspects, wherein the first trocar is configured to extend within a lumen of the infusion cannula.

8.如上述方面中任一方面所述的装置，其中，所述传感器电极被配置为被可移除地接纳在所述第二套管针的凹部内。8. The device of any one of the preceding aspects, wherein the sensor electrode is configured to be removably received within a recess of the second trocar.

9.如上述方面中任一方面所述的装置，其中，所述驱动组件进一步包括经由驱动轮联接到所述扭转弹簧的剪刀式组件，所述剪刀式组件包括在第一区域处联接到所述套管针连杆的第一连杆和在第二区域处联接到所述套管针连杆的第二连杆，其中，所述扭转弹簧在被致动时被配置为使所述驱动轮旋转以经由所述剪刀式组件使所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极插入所述用户的皮肤中。9. The device of any preceding aspect, wherein the drive assembly further comprises a scissor assembly coupled to the torsion spring via a drive wheel, the scissor assembly comprising a first link coupled to the trocar link at a first region and a second link coupled to the trocar link at a second region, wherein the torsion spring, when actuated, is configured to rotate the drive wheel to cause the first trocar, the infusion cannula, the second trocar and the sensor via the scissor assembly Electrodes are inserted into the user's skin.

10.如上述方面中任一方面所述的装置，其中，所述驱动轮设置在壳体内并且所述驱动轮包括被接纳在所述第一连杆的凸轮槽内的销，使得所述驱动轮的旋转致使所述销在所述凸轮槽内滑动并致使所述第一连杆相对于所述驱动轮壳体旋转。10. The device of any one of the preceding aspects, wherein the drive wheel is disposed within a housing and the drive wheel includes a pin received in a cam slot of the first link such that rotation of the drive wheel causes the pin to slide within the cam slot and causes the first link to rotate relative to the drive wheel housing.

11.如上述方面中任一方面所述的装置，其中，所述第二连杆联接到所述第一连杆，使得所述第一连杆的旋转引起所述第二连杆的相反旋转。11. The device of any one of the preceding aspects, wherein the second link is coupled to the first link such that rotation of the first link causes opposite rotation of the second link.

12.如上述方面中任一方面所述的装置，其中，所述驱动组件在被致动时使所述剪刀式组件从未击发位置移动到插入位置，在所述未击发位置时，所述输注插管和传感器电极设置在所述装置的壳体内，并且在所述插入位置时，所述输注插管和传感器电极延伸超出所述装置的壳体。12. The device of any one of the preceding aspects, wherein the drive assembly, when actuated, moves the scissor assembly from an unfired position to an insertion position in which the infusion cannula and sensor electrodes are disposed within a housing of the device and in which insertion position the infusion cannula and sensor electrodes extend beyond the housing of the device.

13.如上述方面中任一方面所述的装置，其中，在所述未击发位置时，所述第一连杆和第二连杆呈现展开状态，在所述展开状态下它们沿不平行的轴线延伸，并且其中，在所述插入位置时，所述第一连杆和第二连杆呈现收拢状态，在所述收拢状态下它们彼此平行地延伸。13. The device of any one of the preceding aspects, wherein in the unfired position, the first and second links assume a deployed condition in which they extend along non-parallel axes, and wherein in the inserted position the first and second links assume a collapsed condition in which they extend parallel to each other.

14.如上述方面中任一方面所述的装置，其中，所述驱动组件进一步包括联接到所述扭转弹簧的第一驱动轮、以及第二驱动轮，所述第二驱动轮与所述第一驱动轮配合，使得所述第一驱动轮的旋转引起所述第二驱动轮的旋转。14. The device of any one of the preceding aspects, wherein the drive assembly further comprises a first drive wheel coupled to the torsion spring, and a second drive wheel cooperating with the first drive wheel such that rotation of the first drive wheel causes rotation of the second drive wheel.

15.如上述方面中任一方面所述的装置，其中，所述第一驱动轮包括第一销并且所述第二驱动轮包括第二销，所述第一销和所述第二销中的每一个延伸到所述套管针连杆的凸轮槽中，使得所述第一驱动轮和所述第二驱动轮的旋转致使所述套管针连杆轴向移动。15. The device of any preceding aspect, wherein the first drive wheel includes a first pin and the second drive wheel includes a second pin, each of the first pin and the second pin extending into a cam groove of the trocar link such that rotation of the first drive wheel and the second drive wheel causes the trocar link to move axially.

16.如上述方面中任一方面所述的装置，其中，所述套管针连杆沿向下方向的轴向移动引起所述载体组件沿所述向下方向的轴向移动。16. The device of any one of the preceding aspects, wherein axial movement of the trocar link in a downward direction causes axial movement of the carrier assembly in the downward direction.

17.如上述方面中任一方面所述的装置，其中，所述第一驱动轮沿第一方向的旋转引起所述第二驱动轮沿第二相反方向的旋转。17. The device of any one of the preceding aspects, wherein rotation of the first drive wheel in a first direction causes rotation of the second drive wheel in a second opposite direction.

18.如上述方面中任一方面所述的装置，其中，所述插管载体包括被配置为将所述第一销可释放地接纳在其中的第一凸轮轨道和被配置为将所述第二销可释放地接纳在其中的第二凸轮轨道。18. The device of any one of the preceding aspects, wherein the cannula carrier includes a first cam track configured to releasably receive the first pin therein and a second cam track configured to releasably receive the second pin therein.

19.如上述方面中任一方面所述的装置，其中，当所述套管针组件和所述载体组件各自处于向下插入位置时，所述第一销和所述第二销分别与所述第一凸轮轨道和所述第二凸轮轨道接合，并且其中，当所述套管针组件相对于所述载体组件向上缩回时，所述第一销和所述第二销与所述第一凸轮轨道和所述第二凸轮轨道脱接合。19. The device of any one of the preceding aspects, wherein the first pin and the second pin engage the first cam track and the second cam track, respectively, when the trocar assembly and the carrier assembly are each in a downwardly inserted position, and wherein the first pin and the second pin disengage from the first cam track and the second cam track when the trocar assembly is retracted upward relative to the carrier assembly.

20.一种集成式传感器与输注装置，包括：20. An integrated sensor and infusion device comprising:

扭转弹簧；torsion spring;

联接到所述扭转弹簧的剪刀式组件，所述剪刀式组件包括第一连杆和第二连杆；a scissor assembly coupled to the torsion spring, the scissor assembly including a first link and a second link;

具有与之联接的第一套管针和第二套管针的滑块，所述滑块在第一区域处联接到所述第一连杆并且在第二区域处联接到所述第二连杆；a slider having coupled thereto a first trocar and a second trocar, the slider being coupled to the first link at a first region and coupled to the second link at a second region;

可移除地联接到所述第一套管针的输注插管；以及an infusion cannula removably coupled to the first trocar; and

可移除地联接到所述第二套管针的传感器电极，a sensor electrode removably coupled to the second trocar,

其中，所述扭转弹簧在被致动时被配置为经由所述剪刀式组件致使所述滑块轴向移动以驱动所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极进入用户的皮肤。Wherein the torsion spring, when actuated, is configured to cause the slider to move axially via the scissor assembly to drive the first trocar, the infusion cannula, the second trocar and the sensor electrode into the user's skin.

21.如前述方面所述的装置，其中，所述装置的每个部件被配置为在所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极被插入所述用户的皮肤中之前被容纳在装置壳体内，并且其中，所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极延伸出所述壳体以插入所述用户的皮肤中。21. The device of the preceding aspect, wherein each component of the device is configured to be housed within a device housing prior to insertion of the first trocar, the infusion cannula, the second trocar and the sensor electrode into the user's skin, and wherein the first trocar, the infusion cannula, the second trocar and the sensor electrode extend out of the housing for insertion into the user's skin.

22.如前述方面中任一方面所述的装置，其中，所述扭转弹簧的第一旋转量驱动所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极进入用户的皮肤中，并且其中，第二旋转量将所述第一套管针和所述第二套管针从所述用户的皮肤缩回，同时将所述输注插管和所述传感器电极留在所述用户的皮肤中。22. The device of any preceding aspect, wherein a first amount of rotation of the torsion spring drives the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the user's skin, and wherein a second amount of rotation retracts the first trocar and the second trocar from the user's skin while leaving the infusion cannula and the sensor electrode in the user's skin.

23.如前述方面中任一方面所述的装置，其中，所述第一旋转量为大致120度，并且所述第二旋转量为额外的大致50度。23. The device of any one of the preceding aspects, wherein the first amount of rotation is approximately 120 degrees and the second amount of rotation is an additional approximately 50 degrees.

24.如前述方面中任一方面所述的装置，其中，所述扭转弹簧经由手动触发机构被致动。24. The device of any one of the preceding aspects, wherein the torsion spring is actuated via a manual trigger mechanism.

25.如前述方面中任一方面所述的装置，其中，所述扭转弹簧经由远程触发机构被致动。25. The device of any one of the preceding aspects, wherein the torsion spring is actuated via a remote trigger mechanism.

26.如前述方面中任一方面所述的装置，其中，所述第一套管针被配置为在所述输注插管的内腔内延伸。26. The device of any one of the preceding aspects, wherein the first trocar is configured to extend within a lumen of the infusion cannula.

27.如前述方面中任一方面所述的装置，其中，所述传感器电极被配置为被可移除地接纳在所述第二套管针的凹部内。27. The device of any one of the preceding aspects, wherein the sensor electrode is configured to be removably received within a recess of the second trocar.

28.如前述方面中任一方面所述的装置，其中，所述剪刀式组件经由设置在驱动轮壳体内的驱动轮联接到所述扭转弹簧，并且所述驱动轮包括被接纳在所述第一连杆的凸轮槽内的销，使得所述驱动轮的旋转致使所述销在所述凸轮槽内滑动并致使所述第一连杆相对于所述驱动轮壳体旋转。28. The device of any one of the preceding aspects, wherein the scissor assembly is coupled to the torsion spring via a drive wheel disposed within a drive wheel housing, and the drive wheel includes a pin received in a cam slot of the first link such that rotation of the drive wheel causes the pin to slide within the cam slot and causes the first link to rotate relative to the drive wheel housing.

29.如前述方面中任一方面所述的装置，其中，所述第二连杆包括延伸到所述第一连杆的凸轮槽中的销，使得所述第一连杆的旋转致使所述销在所述凸轮槽内滑动。29. The device of any one of the preceding aspects, wherein the second link includes a pin extending into a cam slot of the first link such that rotation of the first link causes the pin to slide within the cam slot.

30.如前述方面中任一方面所述的装置，其中，所述驱动组件在被致动时使所述剪刀式组件从未击发位置移动到插入位置，在所述未击发位置时，所述输注插管和传感器电极设置在所述装置的壳体内，并且在所述插入位置时，所述输注插管和传感器电极延伸超出所述装置的壳体。30. The device of any one of the preceding aspects, wherein the drive assembly, when actuated, moves the scissor assembly from an unfired position to an insertion position in which the infusion cannula and sensor electrodes are disposed within a housing of the device and in which insertion position the infusion cannula and sensor electrodes extend beyond the housing of the device.

31.如前述方面中任一方面所述的装置，其中，在所述未击发位置时，所述第一连杆和第二连杆呈现展开状态，在所述展开状态下它们沿不平行的轴线延伸，并且其中，在所述插入位置时，所述第一连杆和第二连杆呈现收拢状态，在所述收拢状态下它们彼此平行地延伸。31. The device of any one of the preceding aspects, wherein in the unfired position, the first and second links assume a deployed condition in which they extend along non-parallel axes, and wherein in the inserted position the first and second links assume a collapsed condition in which they extend parallel to each other.

32.一种集成式传感器与输注装置，包括：32. An integrated sensor and infusion device comprising:

扭转弹簧；torsion spring;

联接到所述扭转弹簧的第一驱动轮；a first drive wheel coupled to the torsion spring;

第二驱动轮，所述第二驱动轮与所述第一驱动轮配合，使得所述第一驱动轮的旋转引起所述第二驱动轮的旋转；a second drive wheel cooperating with the first drive wheel such that rotation of the first drive wheel causes rotation of the second drive wheel;

具有与之联接的第一套管针和第二套管针的滑块，所述滑块在第一区域处联接到所述第一驱动轮并且在第二区域处联接到所述第二驱动轮；a slider having coupled thereto a first trocar and a second trocar, the slider being coupled to the first drive wheel at a first region and coupled to the second drive wheel at a second region;

可移除地联接到所述第一套管针的输注插管；以及an infusion cannula removably coupled to the first trocar; and

可移除地联接到所述第二套管针的传感器电极，a sensor electrode removably coupled to the second trocar,

其中，所述扭转弹簧在被致动时被配置为使所述第一驱动轮旋转以致使所述滑块轴向移动以驱动所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极进入用户的皮肤中。Wherein the torsion spring, when actuated, is configured to rotate the first drive wheel to cause the slider to move axially to drive the first trocar, the infusion cannula, the second trocar and the sensor electrode into the user's skin.

33.如前述方面所述的装置，其中，所述装置的每个部件被配置为在所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极被插入所述用户的皮肤中之前被容纳在装置壳体内，并且其中，所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极延伸出所述壳体以插入所述用户的皮肤中。33. The device of the preceding aspect, wherein each component of the device is configured to be housed within a device housing prior to insertion of the first trocar, the infusion cannula, the second trocar and the sensor electrode into the user's skin, and wherein the first trocar, the infusion cannula, the second trocar and the sensor electrode extend out of the housing for insertion into the user's skin.

34.如前述方面中任一方面所述的装置，其中，所述扭转弹簧的第一旋转量驱动所述第一套管针、所述输注插管、所述第二套管针和所述传感器电极进入用户的皮肤中，并且其中，第二旋转量将所述第一套管针和所述第二套管针从所述用户的皮肤缩回，同时将所述输注插管和所述传感器电极留在所述用户的皮肤中。34. The device of any one of the preceding aspects, wherein a first amount of rotation of the torsion spring drives the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the user's skin, and wherein a second amount of rotation retracts the first trocar and the second trocar from the user's skin while leaving the infusion cannula and the sensor electrode in the user's skin.

35.如前述方面中任一方面所述的装置，其中，所述第一旋转量为大致180度，并且所述第二旋转量为额外的大致180度。35. The device of any one of the preceding aspects, wherein the first amount of rotation is approximately 180 degrees and the second amount of rotation is an additional approximately 180 degrees.

36.如前述方面中任一方面所述的装置，其中，所述扭转弹簧经由手动触发机构被致动。36. The device of any one of the preceding aspects, wherein the torsion spring is actuated via a manual trigger mechanism.

37.如前述方面中任一方面所述的装置，其中，所述扭转弹簧经由远程触发机构被致动。37. The device of any one of the preceding aspects, wherein the torsion spring is actuated via a remote trigger mechanism.

38.如前述方面中任一方面所述的装置，其中，所述第一套管针被配置为在所述输注插管的内腔内延伸。38. The device of any one of the preceding aspects, wherein the first trocar is configured to extend within a lumen of the infusion cannula.

39.如前述方面中任一方面所述的装置，其中，所述传感器电极被配置为被可移除地接纳在所述第二套管针的凹部内。39. The device of any one of the preceding aspects, wherein the sensor electrode is configured to be removably received within a recess of the second trocar.

40.如前述方面中任一方面所述的装置，其中，所述第一驱动轮包括第一销并且所述第二驱动轮包括第二销，所述第一销和所述第二销中的每一个延伸到所述滑块的凸轮槽中，使得所述第一驱动轮和所述第二驱动轮的旋转致使所述滑块轴向移动。40. The device of any one of the preceding aspects, wherein the first drive wheel includes a first pin and the second drive wheel includes a second pin, each of the first and second pins extending into a cam groove of the slider such that rotation of the first and second drive wheels causes the slider to move axially.

41.如前述方面中任一方面所述的装置，其中，所述滑块沿向下方向的轴向移动引起所述载体组件沿所述向下方向的轴向移动。41. The device of any one of the preceding aspects, wherein axial movement of the slider in a downward direction causes axial movement of the carrier assembly in the downward direction.

42.如前述方面中任一方面所述的装置，其中，所述第一驱动轮沿第一方向的旋转引起所述第二驱动轮沿第二相反方向的旋转。42. The device of any one of the preceding aspects, wherein rotation of the first drive wheel in a first direction causes rotation of the second drive wheel in a second opposite direction.

43.如前述方面中任一方面所述的装置，进一步包括插管载体，所述插管载体包括被配置为将所述第一销可释放地接纳在其中的第一凸轮轨道和被配置为将所述第二销可释放地接纳在其中的第二凸轮轨道。43. The device of any one of the preceding aspects, further comprising a cannula carrier comprising a first cam track configured to releasably receive the first pin therein and a second cam track configured to releasably receive the second pin therein.

44.如前述方面中任一方面所述的装置，其中，当套管针组件和所述载体各自处于向下插入位置时，所述第一销和所述第二销分别与所述第一凸轮轨道和所述第二凸轮轨道接合，并且其中，当所述套管针组件相对于所述载体组件向上缩回时，所述第一销和所述第二销与所述第一凸轮轨道和所述第二凸轮轨道脱接合。44. The device of any one of the preceding aspects, wherein the first pin and the second pin engage the first cam track and the second cam track, respectively, when the trocar assembly and the carrier are each in a downwardly inserted position, and wherein the first pin and the second pin disengage from the first cam track and the second cam track when the trocar assembly is retracted upward relative to the carrier assembly.

45.如前述方面中任一方面所述的装置，其中，所述储器容纳了胰岛素。45. The device of any one of the preceding aspects, wherein the reservoir contains insulin.

46.如前述方面中任一方面所述的装置，其中，所述传感器电极包括葡萄糖监测电极。46. The device of any of the preceding aspects, wherein the sensor electrodes comprise glucose monitoring electrodes.

47.如前述方面中任一方面所述的装置，其中，在所述插入状态下，所述输注插管延伸到所述用户的皮肤中至少5mm。47. The device according to any one of the preceding aspects, wherein, in the inserted state, the infusion cannula extends at least 5mm into the skin of the user.

48.如前述方面中任一方面所述的装置，其中，在所述插入状态下，所述传感器电极延伸到所述用户的皮肤中至少8mm。48. The device of any one of the preceding aspects, wherein, in the inserted state, the sensor electrodes extend at least 8 mm into the user's skin.

49.如前述方面中任一方面所述的装置，其中，所述输注插管和所述传感器电极彼此侧向地间隔至少10mm。49. The device according to any one of the preceding aspects, wherein the infusion cannula and the sensor electrode are laterally spaced from each other by at least 10mm.

50.如前述方面中任一方面所述的装置，其中，当定位在所述用户的皮肤上时，所述装置在所述用户的皮肤上的最大高度小于约20mm。50. The device of any one of the preceding aspects, wherein when positioned on the user's skin, the maximum height of the device on the user's skin is less than about 20mm.

51.一种用于操作集成式传感器与输注装置的方法，所述方法包括：51. A method for operating an integrated sensor and infusion set, the method comprising:

将装置壳体设置在用户的皮肤上，所述装置包括：A device housing is placed on the user's skin, the device comprising:

包括扭转弹簧的驱动组件；drive assembly including torsion springs;

流体联接到储器的输注插管，所述储器被配置为在其中容纳药剂；以及an infusion cannula fluidly coupled to a reservoir configured to contain a medicament therein; and

传感器电极；sensor electrodes;

致动所述驱动组件以使所述扭转弹簧旋转，从而驱动所述输注插管和所述传感器电极进入用户的皮肤中；actuating the drive assembly to rotate the torsion spring, thereby driving the infusion cannula and the sensor electrodes into the user's skin;

经由所述传感器电极获得生理学测量值；以及obtaining physiological measurements via the sensor electrodes; and

至少部分地基于所述生理学测量值，经由所述输注插管将药剂递送到所述用户的体内。A medicament is delivered to the body of the user via the infusion cannula based at least in part on the physiological measurement.

52.如前述方面所述的方法，其中，所述药剂包括胰岛素。52. The method of the preceding aspect, wherein the medicament comprises insulin.

53.如前述方面中任一方面所述的方法，其中，所述生理学测量值包括血糖测量值。53. The method of any one of the preceding aspects, wherein the physiological measurements comprise blood glucose measurements.

54.如前述方面中任一方面所述的方法，其中，所述装置进一步包括联接到所述输注插管和所述传感器电极的插管载体。54. The method of any one of the preceding aspects, wherein the device further comprises a cannula carrier coupled to the infusion cannula and the sensor electrodes.

55.如前述方面中任一方面所述的方法，其中，所述装置进一步包括套管针组件，所述套管针组件包括套管针连杆，所述套管针连杆联接到被配置为可释放地接合所述输注插管的第一套管针和被配置为可释放地接合所述传感器电极的第二套管针。55. The method of any one of the preceding aspects, wherein the device further comprises a trocar assembly comprising a trocar link coupled to a first trocar configured to releasably engage the infusion cannula and a second trocar configured to releasably engage the sensor electrode.

56.如前述方面中任一方面所述的方法，其中，所述驱动组件进一步包括联接到所述扭转弹簧的剪刀式组件，并且其中，所述扭转弹簧的旋转致使所述剪刀式组件从展开构型移动到收拢构型，在所述展开构型中所述剪刀式组件的第一连杆和第二连杆沿着相交的轴线定向，在所述收拢构型中所述剪刀式组件的第一连杆和第二连杆基本上彼此平行地定向。56. The method of any one of the preceding aspects, wherein the drive assembly further comprises a scissor assembly coupled to the torsion spring, and wherein rotation of the torsion spring causes the scissor assembly to move from an expanded configuration in which the first and second links of the scissor assembly are oriented along intersecting axes to a collapsed configuration in which the first and second links of the scissor assembly are oriented substantially parallel to each other.

57.如前述方面中任一方面所述的方法，其中，所述驱动组件进一步包括联接到所述扭转弹簧的第一驱动轮、以及第二驱动轮，所述第二驱动轮与所述第一驱动轮配合，使得所述第一驱动轮的旋转引起所述第二驱动轮的旋转，并且其中所述第一驱动轮和所述第二驱动轮的旋转驱动所述输注插管和所述传感器电极进入用户的皮肤中。57. The method of any preceding aspect, wherein the drive assembly further comprises a first drive wheel coupled to the torsion spring, and a second drive wheel, the second drive wheel cooperating with the first drive wheel such that rotation of the first drive wheel causes rotation of the second drive wheel, and wherein rotation of the first drive wheel and the second drive wheel drives the infusion cannula and the sensor electrode into the user's skin.

58.一种集成式传感器与输注装置，所述装置包括：58. An integrated sensor and infusion device, said device comprising:

插入工具，所述插入工具包括：Insertion tool, described insertion tool comprises:

用于承载输注工具和感测工具的第一载体工具；a first carrier means for carrying the infusion means and the sensing means;

第二载体工具，用于承载被配置为联接到所述输注工具的第一插入工具和被配置为联接到所述感测工具的第二插入工具；以及a second carrier tool for carrying a first insertion tool configured to be coupled to the infusion tool and a second insertion tool configured to be coupled to the sensing tool; and

驱动工具，所述驱动工具被配置为驱动所述第二载体工具和所述第一载体工具轴向向下，以将所述输注工具和所述感测工具插入用户的皮肤中。A driving tool configured to drive the second carrier tool and the first carrier tool axially downward to insert the infusion tool and the sensing tool into the user's skin.

59.如前述方面所述的装置，其中，所述驱动工具进一步被配置为使所述第二载体工具轴向向上缩回，同时将所述第一载体工具留在所述轴向向下的位置，其中所述输注工具和感测工具插入所述用户的皮肤中。59. The device of the preceding aspect, wherein the driving means is further configured to retract the second carrier means axially upwards while leaving the first carrier means in the axially downward position wherein the infusion means and sensing means are inserted into the skin of the user.

60.如前述方面中任一方面所述的装置，其中，所述输注工具包括流体联接到储器的插管。60. The device according to any one of the preceding aspects, wherein the infusion set comprises a cannula fluidly coupled to a reservoir.

61.如前述方面中任一方面所述的装置，其中，所述感测工具包括传感器电极。61. Apparatus according to any one of the preceding aspects, wherein the sensing means comprises sensor electrodes.

62.如前述方面中任一方面所述的装置，其中，所述第一载体工具包括第一套管针。62. The device according to any one of the preceding aspects, wherein the first carrier means comprises a first trocar.

63.如前述方面中任一方面所述的装置，其中，所述第二载体工具包括第二套管针。63. The device according to any one of the preceding aspects, wherein the second carrier means comprises a second trocar.

64.如前述方面中任一方面所述的装置，其中，所述驱动工具包括扭转弹簧。64. The device according to any one of the preceding aspects, wherein the driving means comprises a torsion spring.

65.如前述方面中任一方面的装置，其中，所述驱动工具包括联接到所述扭转弹簧的剪刀式组件。65. The device of any one of the preceding aspects, wherein the drive means comprises a scissor assembly coupled to the torsion spring.

66.如前述方面中任一方面所述的装置，其中，所述驱动工具包括联接到所述扭转弹簧的双曲柄组件。66. The device of any one of the preceding aspects, wherein the drive tool comprises a double crank assembly coupled to the torsion spring.

Claims (10)

1. An integrated sensor and infusion device, the device comprising:

a reservoir assembly comprising a reservoir configured to contain a medicament therein;

a sensor electronics assembly configured to receive a signal from a sensor; and

An insert assembly, the insert assembly comprising:

a carrier assembly comprising a cannula carrier, an infusion cannula extending downward away from the cannula carrier, and a sensor electrode extending downward away from the cannula carrier at a location laterally spaced from the infusion cannula, wherein the infusion cannula is fluidly coupled to the reservoir;

a trocar assembly including a trocar link, a first trocar configured to removably engage the infusion cannula, and a second trocar configured to removably engage the sensor electrode, the trocar assembly being removably coupled to the carrier assembly; and

a drive assembly including a torsion spring coupled to the trocar assembly such that when actuated, the torsion spring rotates to drive the trocar assembly and the carrier assembly axially downward to insert the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the skin of a user.

2. The device of claim 1, wherein each component of the device is configured to be housed within a device housing before the first trocar, the infusion cannula, the second trocar, and the sensor electrode are inserted into the skin of the user, and wherein the first trocar, the infusion cannula, the second trocar, and the sensor electrode extend out of the housing for insertion into the skin of the user.

3. The device of any of claims 1-2, wherein a first amount of rotation of the torsion spring drives the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the skin of the user, and wherein a second amount of rotation retracts the first trocar and the second trocar from the skin of the user while leaving the infusion cannula and the sensor electrode in the skin of the user.

4. The device of claim 3, wherein the first amount of rotation is approximately 180 degrees and the second amount of rotation is an additional approximately 180 degrees.

5. The device of any one of claims 1-4, wherein the torsion spring is actuated via a manual trigger mechanism.

6. The device of any of claims 1-4, wherein the torsion spring is actuated via a remote trigger mechanism.

7. The device of any of claims 1-6, wherein the first trocar is configured to extend within a lumen of the infusion cannula.

8. The device of any of claims 1-7, wherein the sensor electrode is configured to be removably received within a recess of the second trocar.

9. The device of any of claims 1-8, wherein the drive assembly further comprises a scissor assembly coupled to the torsion spring via a drive wheel, the scissor assembly comprising a first link coupled to the trocar link at a first region and a second link coupled to the trocar link at a second region, wherein the torsion spring, when actuated, is configured to rotate the drive wheel to insert the first trocar, the infusion cannula, the second trocar, and the sensor electrode into the skin of the user via the scissor assembly.

10. The device of claim 9, wherein the drive wheel is disposed within a housing and the drive wheel includes a pin received within a cam slot of the first link such that rotation of the drive wheel causes the pin to slide within the cam slot and causes the first link to rotate relative to the drive wheel housing.