Source: https://patents.google.com/patent/CN102573810B/en
Timestamp: 2019-05-20 07:15:46
Document Index: 396753176

Matched Legal Cases: ['art 132', 'art 130', 'art 111', 'art 60', 'art 130', 'art 130', 'art 130', 'art 130']

CN102573810B - Extended use medical device - Google Patents
Extended use medical device Download PDF
CN102573810B
CN102573810B CN201080045902.7A CN201080045902A CN102573810B CN 102573810 B CN102573810 B CN 102573810B CN 201080045902 A CN201080045902 A CN 201080045902A CN 102573810 B CN102573810 B CN 102573810B
CN201080045902.7A
CN102573810A (en
2010-09-01 Priority to PCT/US2010/002409 priority patent/WO2011028278A1/en
2012-07-11 Publication of CN102573810A publication Critical patent/CN102573810A/en
2014-04-02 Publication of CN102573810B publication Critical patent/CN102573810B/en
本发明提供一种延长使用的自含式、可穿戴医疗装置(100)。 The present invention provides a prolonged use of self-contained, wearable medical device (100). 该装置优选地配置有输注针头部署机构(108)，用于在输注循环期间将输注针头可变地插入和撤回到不同深度，或从输注部位完全撤回输注针头并在预定时间段之后再重新插入输注针头，以用于延长输注部位的可行性。 The device is preferably arranged infusion needle deployment mechanism (108), for during the infusion cycle variable infusion needle inserted and withdrawn into different depths, or fully withdrawn from the infusion site and the infusion needle at a predetermined time after infusion segment re-insert the needle to the infusion site for prolonged viability. 另一个实施例包括能同样可变地插入和撤回输注针头的双针头部署机构。 Another embodiment includes a variable can be the same infusion needle insertion and withdrawal of the double needle deployment mechanism. 流量传感器(120)优选地被提供用以检测通过输注套管的流动的阻滞并且向针头部署机构发信号以尝试在另一深度输注或部署第二输注针头。 The flow sensor (120) is preferably provided to detect the flow through the infusion cannula and a blocking signal to the needle deployment mechanism to try another second deployment depth infusion or infusion needle. 可填充容器组件(106)优选地被提供以用于在装置的延长使用期间供应药物。 Preferably fillable container assembly (106) is provided for use during prolonged medication supply means. 另一个实施例包括实现以上特征的部分可再使用的和部分一次性的医疗装置。 And another portion of the disposable medical device to achieve the above embodiment includes a feature portion reusable embodiment.
[0001] 本发明一般地涉及通过延长输注部位的可行性而提供更低成本的疗法和延长的使用期的可穿戴、自含式药物输注装置。 [0001] The present invention relates generally to the feasibility of prolonged infusion site used to provide lower cost of therapy and prolonged wearable, self-contained drug infusion device. 另外，延长使用的药物输注装置能够有效地提供以前普通可穿戴药物输注装置所无法提供的连续葡萄糖监测。 Further, prolonged use of the drug infusion device before effective to provide continuous glucose monitoring ordinary wearable drug infusion devices can not provide. 附加实施例提供一种与以上药物输注装置结合使用的可编程药物输送装置，用于提供药物治疗的更进一步控制和精度。 Additional embodiments provide a programmable drug delivery device for use in combination with the above drug infusion device, provides for more control and precision medication.
[0002] 糖尿病是以由胰岛素生产、胰岛素作用或以上两者的缺陷所导致的以高血糖水平为标志的疾病组。 [0002] Diabetes mellitus is insulin production, high levels of blood glucose disease marker group defects in insulin action, or both above caused. 在美国有2360万人(或8%的人口)患有糖尿病。 In the United States there are 23.6 million people (or 8% of the population) have diabetes. 自2005-2007年间以来糖尿病的总患病率增加了13.5%。 Since 2005-- since 2007 the total prevalence of diabetes increased by 13.5%. 糖尿病可以导致严重的并发症和过早死亡，但是存在有公知的产品可用于糖尿病患者以帮助控制疾病并且降低并发症的风险。 Diabetes can lead to serious complications and premature death, but there is a known product can be used for diabetics to help control the disease and reduce the risk of complications.
[0003] 糖尿病患者的治疗选择包括专门饮食、口服治疗和/或胰岛素疗法。 [0003] Treatment options include specialized diabetes diet, oral treatment and / or insulin therapy. 糖尿病治疗的主要目标是控制患者的血糖(糖)水平以便增加无并发症生活的机会。 The main goal of diabetes treatment is the opportunity to control the patient's blood glucose (sugar) levels in order to increase life without complications. 然而在平衡其它生活需求和环境的同时实现良好的糖尿病管理并不总是容易的。 However, to achieve good diabetes management while balancing other needs of life and the environment is not always easy.
[0004]目前，对于I型糖尿病的治疗存在每日胰岛素疗法的两种主要模式。 [0004] At present, for the treatment of type I diabetes are two principal modes of daily insulin therapy exists. 第一种模式包括注射器和胰岛素注射笔，每次注射(典型地每天三至四次)需要针刺，但是使用简单并且成本较低。 The first mode includes syringes and insulin injection pens, each injection (typically three to four times per day) requires needling, but simple to use and low cost. 另一种被广泛采用且有效用于管理糖尿病的疗法是使用常规胰岛素泵。 Another widely used and effective treatment for diabetes management is the use of a conventional insulin pump. 胰岛素泵可以通过胰岛素的连续受控输注而基于用户的个人需要来帮助用户将他们的血糖水平保持在目标范围内。 Insulin pump can be controlled based on a user's continuous infusion of insulin through a personal need to help users keep their blood sugar levels within the target range. 通过使用胰岛素泵，用户可以使他们的胰岛素疗法适应他们的生活方式，而不是使他们的生活方式适应例如胰岛素注射如何对他们起作用。 By using an insulin pump, users can make their insulin therapy to adapt to their way of life, rather than adapt their lifestyle such as insulin injection how they work.
[0005] 常规胰岛素泵能够通过放置在皮下的导管一天24小时地输送速效或短效胰岛素。 [0005] Conventional insulin pumps can be available 24 hours a day or short-acting insulin delivery in the subcutaneous placement of the catheter. 典型地以基础速率并且以单次剂量施予胰岛素剂量。 Basal rate and typically a single dose administered insulin dose. 经24小时连续地输送基础胰岛素，目标是在用餐之间和夜间将个人的血糖水平保持在一致的范围内。 Over 24 hours of continuous delivery of basal insulin, the goal is to keep the night between meals and blood glucose levels in individuals within the same range. 一些胰岛素泵能够编程胰岛素的基础速率以根据白天和晚上的不同时间而变化。 Some insulin pumps can be varied according to different times of day and night programmed basal rate of insulin. 单次剂量典型地在用户进餐时施予，并且通常提供附加的单次胰岛素注射以平衡所消耗的碳水化合物。 Typically a single dose administration of a meal when the user, and is typically provided a single additional carbohydrate to balance insulin injections consumed. 一些常规胰岛素泵允许用户根据所消耗的膳食的多少或类型来编程单次剂量的容量。 Some conventional insulin pumps allow the user to program a single dose of the capacity according to the number or type of diet consumed. 常规胰岛素泵也允许用户引入胰岛素的修正或补充单剂以在用户计算餐时剂量时补偿低血糖水平。 Conventional insulin pumps also allows the user to correct or supplement the introduction of insulin dose in a single dose to the user computing meal compensate for low blood glucose levels.
[0006] 常规胰岛素泵具有胜过其他胰岛素疗法的许多优点。 [0006] conventional insulin pump has many advantages over other insulin therapies. 胰岛素泵是随时间而非在单次注射中输送胰岛素的，因此典型地导致在美国糖尿病协会(ADA)推荐的血糖范围内的更小变动。 Insulin pumps deliver insulin is rather than in a single injection over time, typically resulting in smaller changes in the American Diabetes Association (ADA) recommended blood sugar range. 常规胰岛素泵减少了患者必须忍受的针刺次数，并让用户对糖尿病的管理更为方便有效，因此显著提高了用户的生活质量。 Conventional insulin pump reduces the number of acupuncture patients must endure, and allows users to manage diabetes is more convenient and effective, thus significantly improving the quality of life of users. 然而胰岛素泵使用麻烦并且典型地比其它疗法要贵。 However, the use of insulin pump trouble and are typically more expensive than other therapies. 从生活方式的观点来看，常规泵、管道和输注套件对于用户来说可能是不方便且麻烦的。 From the point of view of lifestyle, conventional pumps, piping and infusion set for the user may be inconvenient and cumbersome.
[0007] 胰岛素疗法的新进步提供了“可穿戴”药物输注装置，其比常规胰岛素泵成本更低且使用更为方便舒适。 [0007] New advances in insulin therapy provides a "wearable" drug infusion devices, which use more convenient and less comfortable than regular insulin pump costs. 这些装置中的一些旨在是部分或完全一次性的，并且在理论上提供常规胰岛素泵的许多优点而没有常规胰岛素泵最初的高成本和不方便性。 Some of these devices are intended to be partially or entirely disposable and regular insulin pump theoretically provide many advantages without the high cost and inconvenience of the original regular insulin pump. [0008] 能够执行与常规胰岛素泵类似的功能的可穿戴医疗装置正变得越来越流行，但是成本仍然较高。 [0008] Conventional insulin pumps can perform functions like wearable medical devices are becoming increasingly popular, but the cost is still high. 尽管每个可穿戴医疗装置的最初成本远远低于常规胰岛素泵，但是一整年地使用可穿戴医疗装置提供药物治疗的成本会由于这类医疗装置的短使用持续时间而被扩大。 Although each of the first wearable medical devices cost far lower than conventional insulin pumps, but throughout the year the cost wearable medical devices provide drug therapy such medical devices due to the short duration of use is expanded. 普通的可穿戴医疗装置典型地最多在工作3天之后被丢弃。 Common wearable medical devices typically are discarded after working up to 3 days. 这类医疗装置使用持续时间的一些驱动因素包括用于延长时间段的输注部位可行性和在这样的延长时间段期间合理地提供充足胰岛素供应且在装置的延长寿命期间有效地提供耐用电源的挑战。 Some drivers use the duration of such a medical device comprising an infusion site for prolonged periods and feasibility reasonably adequate supply of insulin during such a prolonged period of time and provide a durable power effectively extending the life of the device during the challenge. 延长可穿戴医疗装置的使用以持续5-7天将大大降低疗法的每日成本，因此能够使更大的人口负担得起由这类疗法提供的便利。 Extend the wearable medical device to use for 5-7 days will greatly reduce the daily cost of therapy, thus enabling a larger population affordable convenience provided by this type of therapy. 所以，如果这类疗法的每日成本降低，则这类可穿戴医疗装置的可用性将会增加。 So, if the daily cost of such therapy reduced the availability of this type of wearable medical devices will increase.
[0009] 因此，在本领域中存在延长可穿戴医疗装置的使用持续时间的需要，由此提供更成本有效的药物治疗，使得更多的糖尿病患者可以受益于这些装置所提供的优点。 [0009] Accordingly, there is need to extend the duration of the wearable medical device, thereby providing a more cost-effective therapy in the art, so that more patients with these devices can benefit from the advantages provided.
[0010] 另外，本领域中可用的多数可穿戴医疗装置典型地被称为“灵巧”或“简单”医疗装置。 [0010] In addition, most available in the art wearable medical devices are typically referred to as "smart" or "simple" medical device. 本领域中常用的“灵巧”贴肤泵典型地从智能控制器或主机设备接收指令和/或向其发送患者数据，而这需要泵和控制器之间的无线或有线通信。 Commonly used in the art "smart" skin pumps are typically attached to the smart controller from the host device or receive instructions and / or send patient data, which requires a wireless or wired communication between the pump and the controller. 归因于提供与主机设备的通信所必需的附加部件，“灵巧”贴肤泵典型地在尺寸上大于“简单”贴肤泵、更重且更昂贵。 Due to the additional component to provide communication with the host device necessary for "smart" skin pumps are typically attached to larger in size than "simple" skin paste pump, heavier and more expensive. 另外，为了血糖监测、单剂计算和剂量编程，典型的“灵巧”装置需要用户交互，这增加了这些装置的预期使用的复杂性和风险。 Further, in order to monitor blood glucose, single dose and dosage calculation program, a typical "smart" devices require user interaction, which increases the complexity and risk of the intended use of these devices. 在另一方面，常用的“简单”贴肤泵典型地仅提供预设基础剂量。 On the other hand, the commonly used "simple" stick skin pumps typically provide only a preset basal dose. 对于许多用户，“灵巧”装置的复杂水平是不可接受的，但他们的治疗需求又无法由“简单”贴肤泵满足。 For many users, "smart" device complexity level is unacceptable, but they can not demand their treatment by the "simple" pump attached to the skin meet. 所以，需要提供一种专门胰岛素疗法，其不由“简单”贴肤泵获得，但却无需“灵巧”贴肤泵的增加的成本和复杂性。 Therefore, it is necessary to provide a special insulin therapy, which is not a "simple" stick skin pumps available, but do not need to "smart" skin stickers increase the cost and complexity of the pump.
发明内容[0011] 本发明的示例性实施例至少解决了以上问题和/或缺点并且至少提供了下述的优点。 SUMMARY [0011] Exemplary embodiments of the present invention address at least and / or disadvantages and to provide at least the following advantages of the above problems. 因此，本发明的某些实施例的目的是提供一种可穿戴医疗装置，所述可穿戴医疗装置通过延长医疗装置的使用持续时间来进一步降低胰岛素疗法的每日成本。 Accordingly, an aim of certain embodiments of the present invention is to provide a wearable medical device, the wearable medical device to further reduce the cost of daily insulin therapy by using a medical device to extend the duration. 本发明某些实施例的另一个目的是提供一种可再编程贴肤泵，所述可再编程贴肤泵提供专门胰岛素疗法而没有典型地与“灵巧”贴肤泵关联的高成本。 Another object of certain embodiments of the present invention to provide a reprogrammable skin attached pump, the pump can be reprogrammed to provide specialized skin affixed without insulin therapy is typically associated with "smart" skin attached to the high cost associated with the pump.
[0012] 本发明的第一方面提供了一种用于在延长的使用期向用户施予药物治疗的医疗装置。 [0012] In a first aspect the present invention provides a medical device for administering drugs to a user over a prolonged period of use. 所述医疗装置包括:泵机构，用于向用户施予药物；第一和第二输送套管，用于在第一和第二输注部位将所述药物经皮输注到用户体内；以及第一和第二机构，用于分开控制所述第一和第二套管在所述第一和第二输注部位进入所述用户体内的部署。 The medical device comprising: a pump means for administering medication to a user; a first and a second delivery sheath, in a first portion and a second infusion of the drug percutaneously infused to the user body; and the first and second means for separately controlling the first and the second sleeve into the body of the user in deploying the first and the second infusion site. 所述医疗装置还包括流量感测单元，用于通过感测所述第一输送套管是否被阻塞或因其他原因而无法将药物的期望流量输送到用户而检测所述第一输注部位是否不再可行，其中当所述流量感测单元检测到所述输注部位不再可行时从用户撤回所述第一输送套管。 The medical device further comprises a flow sensing unit, whether blocked or otherwise unable to deliver the desired flow rate of medication to a user by sensing the first delivery sheath portion detects whether the first infusion It is no longer possible, wherein when the sensing unit detects the flow rate of the first conveyor from a user to withdraw the sleeve when the injection site is no longer feasible. 另外，可以在预定使用期之后从用户撤回所述第一输送套管。 Further, the first delivery sheath can be withdrawn from the user after a predetermined lifetime. 当撤回所述第一输送套管时将所述第二输送套管部署到用户体内，其中手动地或自动地致动用于控制所述第一和第二输送套管的所述第一和第二机构。 When withdrawing the first delivery sheath delivery sheath to deploy the second user to the body, which is manually or automatically actuated for controlling said first and second conveying a first and second sleeve two institutions. 所述医疗装置还包括用于供应所述医疗装置的延长使用持续时间所必需的药物容量的储存器。 The medical device further includes means for supplying said medical device to extend the duration of use of the drug required storage capacity. 所述医疗装置还可以包括用于将药物供应到相应的第一和第二输送套管的第一和第二储存器。 The medical device may further comprise means for supplying a drug to the respective first and second first and second reservoirs of the delivery sheath. 所述医疗装置还可以包括用于供应输注到用户体内的药物的可再填充储存器，所述容器包括用于接收药物的供应的端口或隔膜，或者甚至可以包括用于接收预填充容器组件的接收器。 The medical device may further comprise a user for supplying the drug infusion into the body of the refillable reservoir, said separator container includes a port for supplying or receiving the drug, or may even include a container assembly for receiving the pre-filled receiver. 另外，所述医疗装置可以包括可再使用和一次性部分，其中所述泵机构和用于控制所述第一和第二套管的部署的所述第一和第二机构容纳在所述医疗装置的所述可再使用部分内。 Further, the medical device may comprise a reusable and a disposable portion, wherein said pump means for controlling said first and accommodated in the second medical cannula deployed and the first and second means the apparatus may be provided with further portions.
[0013] 本发明的第二方面提供了一种用于在延长的使用期向用户施予药物治疗的医疗装置。 [0013] A second aspect of the present invention provides a medical device for administering drugs to a user over a prolonged period of use. 所述医疗装置包括:泵机构，用于向用户施予药物；输送套管，用于在输注部位将所述药物经皮输注到用户体内；以及机构，用于控制所述套管进入所述用户体内的部署，其中所述机构被配置成在所述医疗装置的使用持续时间内将所述套管可变地移动到第一深度和第二深度。 The medical device comprising: a pump means for administering medication to a user; delivery sheath, the infusion site for percutaneous drug infusion into the body of the user; and a mechanism for controlling the cannula into the deploying the body of the user, wherein said mechanism is configured to use the medical device within the duration of the cannula is moved to the first variable and second depths. 用于控制所述套管的部署的所述机构被配置成在预定使用期之后撤回所述套管并且在预定非使用期之后进一步将所述套管重新部署至所述用户体内。 The mechanism for controlling the deployment of the sleeve is configured to withdraw said sleeve after a predetermined period and further using the sleeve to the body of the user to redeploy after a predetermined period of non-use. 所述医疗装置也包括一次性和可再使用部分，其中所述泵机构和所述用于控制所述套管的部署的所述机构容纳在所述医疗装置的所述可再使用部分中。 The medical device also includes a reusable and a disposable portion, wherein said pump means and said means for controlling the deployment of the cannula of the medical device received in the reusable portion.
[0014] 本发明的第三方面通过以下方式延长包括用于向用户施予药物治疗的第一和第二输送套管的医疗装置的使用:在输注部位将所述第一套管部署到用户体内以用于向用户施予药物，从所述用户撤回所述第一套管，以及在第二输注部位将所述第二套管部署到所述用户体内以用于将所述药物施予所述用户。 [0014] The third aspect of the present invention by way of improving the use of the medical device comprises means for administering drugs to a user of the first and second delivery sheath: in the first portion of the infusion cannula deployed to body of the user for administering a drug to a user, the withdrawal of the sleeve from the first user, and a second portion of the infusion cannula deployed to the second body to said user for said medicament the administration user. 所述方法也通过检测所述第一套管被阻塞或无法将药物的期望流量输送到用户而确定所述输注部位是否不再可行，并且当确定所述输注部位不再可行时从所述用户撤回所述第一套管。 The method can also be blocked or not to deliver the desired medicament flow and determine whether the user is no longer feasible infusion site by detecting the first sleeve, and when it is determined from the injection site is no longer viable withdrawing the first user of said sleeve. 所述方法也可以在预定使用期之后从所述用户撤回所述第一套管。 The method may also be withdrawn from the sleeve to the first user after a predetermined lifetime. 所述部署的步骤还包括在相应的输注部位将相应的套管自动地或手动地部署到用户体内。 Further comprising the step of deploying a respective infusion site in the corresponding sleeve deployed automatically or manually to the body of the user.
[0015] 本发明的第四方面通过以下方式延长包括用于向用户施予药物治疗的单输送套管的医疗装置的使用:在输注部位将所述输送套管部署到用户体内达期望深度以用于向用户施予药物，以及将所述套管可变地移动到第二期望深度，同时将所述药物施予所述用户。 [0015] A fourth aspect of the present invention is extended in the following manner using the medical device comprises administering a drug therapy to the delivery cannula single user: an infusion site in the body of a user to deploy the delivery sheath reaches the desired depth for administering a drug to a user, and the sleeve is moved to the second variable desired depth, while administering the drug to the user. 所述方法还确定至所述用户的药物的流动是否被阻止并且当确定药物的流动被阻止时将所述套管可变地移动到所述第二期望深度。 The method also determines whether the flow of medicament to the user is prevented and the flow of the drug is determined when the sleeve is prevented from moving to the second variable desired depth. 所述方法也可以包括在预定使用期之后将所述套管可变地移动到所述第二期望深度。 The method may also include the use of a predetermined period after the sleeve is moved to said second variable desired depth.
[0016] 本发明的第五方面通过以下方式延长包括用于向用户施予药物治疗的单输送套管的医疗装置的使用:在输注部位将所述输送套管部署到用户体内达期望深度以用于向用户施予药物，确定自从部署所述输送套管之后已经过预定时间段，当确定已经过所述预定时间段时从用户撤回所述套管，以及在第二预定时间段之后重新在所述输注部位插入所述套管以用于向所述用户重新施予所述药物。 [0016] A fifth aspect of the present invention is extended in the following manner using the medical device comprises administering a drug therapy to the delivery cannula single user: an infusion site in the body of a user to deploy the delivery sheath reaches the desired depth for administering a drug to a user, determines the delivery sheath deployment since the predetermined time period has elapsed, when it is determined that the predetermined time period has elapsed from a user to withdraw the sleeve, and at a second predetermined time period after reinserting the cannula to the infusion site for re-administering the medicament to the user. 所述方法还将所述套管插入到第二期望深度。 The method also inserted into the second sleeve the desired depth.
[0017] 本发明的另一个方面提供了一种用于向用户施予药物治疗的部分一次性和部分可再使用医疗装置。 Another aspect of the [0017] present invention provides a method for administering a portion of the disposable medication therapy to a user and a portion reusable medical device. 所述医疗装置包括可再使用外壳和一次性外壳，所述再使用外壳和所述一次性外壳均具有用于彼此接合的至少一个暴露界面。 The medical device comprises a disposable and reusable housing shell, the re-use of the disposable housing and having at least one shell are joined to each other exposed interface. 所述可再使用外壳包含:泵机构，用于向用户施予药物；套管部署机构，用于部署用于将所述药物输注到用户体内的输送套管；以及控制器，用于控制所述泵机构和所述套管部署机构。 The reusable housing comprising: pump means for administering medication to a user; cannula deployment mechanism for deploying medicament for infusion into the body of the user delivery sheath; and a controller for controlling the pump mechanism and the sleeve deployment mechanism. 所述一次性外壳包含所述输送套管和用于容纳输注到所述用户体内的药物供应的储存器。 The disposable housing comprises a sleeve for receiving the delivery infusion into the body of the user of the drug supply reservoir. 所述可再使用的外壳还可以包含传感器部署机构。 The housing can be re-used may also comprise a sensor deployment mechanism.
[0018] 本发明的又一个方面提供了一种药物输送装置，所述药物输送装置具有可编程控制器、药物筒、输注针头以及设在所述输注针头和所述药物筒之间的微型泵，其中所述控制器由主机设备编程，所述主机设备计算将通过所述输注针头施予用户的药物的单次剂量并且编程所述控制器以设定要施予用户的所述剂量。 [0018] Yet another aspect of the present invention provides a drug delivery device, said drug delivery device having a programmable controller, a drug cartridge, an infusion needle and the infusion needle is disposed between the medicament cartridge and single dose micropump, wherein said controller is programmed by the host device, the host computing device by the user administering the medicament infusion needle and the controller is programmed to set the user to be administered dose. 所述药物输送装置优选地是胰岛素注射笔并且所述主机设备是本发明的示例性实施例之一的个人糖尿病管理器、血糖监测仪、单剂计算器和可穿戴药物输注装置中的一种。 Preferably, the drug delivery device is an insulin injection pens and the host device is a personal diabetes manager of one exemplary embodiment of the present invention, blood glucose monitor, a calculator and a single dose of drug infusion devices in a wearable species. 所述主机设备优选地从选自下列的至少一个因素计算单次剂量:测试条结果、身体功能传感器信号、基础速率输注历史和膳食信息。 The host device is preferably a single dose calculated from at least one factor selected from the group consisting of: a test strip results, the body function of the sensor signal, the base rate of infusion and dietary history information. 所述可编程药物输送装置优选地包括用于与所述主机设备直接通信的电接触并且可以备选地经由私域网与所述主机设备通信。 The programmable drug delivery device preferably comprises an electrical contact for direct communication with the host device and may alternatively be via a personal area network communication with the host device. 所述可编程输送装置优选地在与所述主机设备直接通信时被编程并且也包括当直接接触所述主机设备时被再充电的可再充电电池。 The programmable transport means preferably when communicating directly with the host device and also comprises programmed, when in direct contact with the host device is recharged rechargeable battery.
[0019] 本发明的最后一个方面提供了一种用于向用户施予药物治疗的可穿戴医疗装置，所述可穿戴医疗装置包括:包含储存器的整体外壳，所述储存器用于容纳药物的供应，与用于将药物输送到用户的输注套管流体连通；泵机构装置，用于通过所述输注套管将来自所述容器的药物输送至用户；以及预编程控制器，所述预编程控制器控制所述泵机构以将预编程药物输送分布提供给用户。 [0019] A final aspect of the present invention provides a wearable medical device for administering drugs to a user, the wearable medical device comprising: a unitary housing containing the reservoir, said reservoir for receiving medicament supply, and means for delivering drugs to an infusion cannula in fluid communication with a user; means a pump mechanism, for delivery to the user via the infusion cannula medicament from the container; and a preprogrammed controller, said preprogrammed controller controlling the pump mechanism to preprogrammed drug delivery profile provided to the user. 所述控制器优选地由所述医疗装置的制造商或保健提供者预编程并且可以被预编程以根据电子定时器或一天中的时间提供特定药物输注速率或者备选地可以被预编程以将药物的剂量的多种每日输注提供给用户。 The controller preferably pre-programmed by the manufacturer or health care provider and the medical device may be pre-programmed to provide a specific drug infusion rate, or alternatively, the electronic timer according to the time of day or may be pre-programmed to the infusion of multiple daily doses of the drug to the user.
[0020] 本领域技术人员将从以下结合附图公开了本发明示例性实施例的详细描述中显见本发明的目的、优点和特征。 [0020] Those skilled in the art from the following disclosure in conjunction with the accompanying drawings of the objects, advantages and features of the present invention are apparent from the detailed description of exemplary embodiments of the present invention.
[0021] 当结合附图时从本发明的某些示例性实施例的以下描述将更显见本发明某些示例性实施例的以上和其它示例性特征和优点，在附图中: [0022] 图1A是描绘了根据本发明示例性实施例的医疗装置的例示； [0021] THE DRAWINGS from the following description of certain exemplary embodiments of the present invention will become more apparent from the above and other exemplary features and advantages of certain exemplary embodiments of the present invention, in the drawings: [0022] 1A is a diagram depicting an embodiment of a medical device according to an exemplary embodiment of the present invention;
[0023] 图1B是根据本发明示例性实施例的用于医疗装置中的引动机构的例示； [0023] The embodiment of FIG. 1B is a priming mechanism for a medical device to an exemplary embodiment of the present invention;
[0024] 图2是描绘了根据本发明实施例的医疗装置的主要部件的框图； [0024] FIG. 2 is a block diagram depicting the major components of the medical device according to an embodiment of the present invention;
[0025] 图3A-3B示出了根据本发明实施例的用于医疗装置的示例性输注针头； [0025] Figures 3A-3B illustrate an exemplary infusion needle for a medical device according to an embodiment of the present invention;
[0026] 图3C-3E示出了根据本发明的示例性实施例的针头部署机构的示例性操作； [0026] FIGS. 3C-3E illustrate an exemplary needle deployment mechanism exemplary embodiment of the present invention operate;
[0027] 图4示出了根据本发明的另一个示例性实施例的医疗装置； [0027] FIG. 4 shows a medical device in accordance with another exemplary embodiment of the present invention;
[0028] 图5示出了根据本发明的另一个示例性实施例的医疗装置； [0028] FIG. 5 shows a medical device in accordance with another exemplary embodiment of the present invention;
[0029] 图6A-6F示出了根据本发明的示例性实施例的用于医疗装置中的针头部署机构； [0029] FIGS. 6A-6F illustrate a needle deployment mechanism for a medical device according to an exemplary embodiment of the embodiment according to the present invention;
[0030] 图6G-6H示出了用于医疗装置的任意示例性实施例的图6C-6F中所示的针头部署机构的附加示例性实施例； [0030] FIGS. 6G-6H illustrate additional exemplary embodiment of any of the exemplary embodiment of FIG embodiment of a medical device 6C-6F needle deployment mechanism shown in;
[0031] 图7A示出了根据本发明示例性实施例的医疗装置中的可填充/可再填充储存器； [0031] FIG 7A illustrates a medical device may be filled with an exemplary embodiment of the present invention / a refillable reservoir;
[0032] 图7B示出了根据本发明示例性实施例的医疗装置的可插入/可更换储存器组件； [0032] FIG 7B illustrates a medical device insertable exemplary embodiment of the present invention / replaceable reservoir assembly;
[0033] 图8A-8B示出了根据本发明示例性实施例的部分可再使用/部分一次性医疗装置； [0033] Figures 8A-8B illustrate the present invention in accordance with an exemplary embodiment of a portion of the reusable / disposable portion of the medical device;
[0034] 图8C-8F示出了根据本发明示例性实施例的用于部分可再使用/部分一次性医疗装置中的针头部署机构的放置； [0034] FIGS. 8C-8F illustrate a needle deployment mechanism disposed reusable / disposable portion of the medical device portion according to an exemplary embodiment of the present invention;
[0035] 图9是描绘了根据本发明示例性实施例的感测单元的主要部件的框图； [0035] FIG. 9 is a block diagram depicting the major components of the sensing unit according to an exemplary embodiment of the present invention;
[0036] 图10A-10B是示出了根据本发明示例性实施例的连续葡萄糖监测系统的主要操作的图示； [0036] FIGS. 10A-10B are diagrams illustrating main operations in accordance with a continuous glucose monitoring system according to an exemplary embodiment of the present invention;
[0037] 图11A-11C示出了根据本发明示例性实施例的用于将医疗装置附着到用户的粘合剂设计的示例性实施例； [0037] Figures 11A-11C illustrate a medical device for attaching to an exemplary embodiment of a user of the design of the adhesive to an exemplary embodiment of the present invention;
[0038] 图12A-12B示出了根据本发明示例性实施例的与医疗装置结合使用的可编程药物输送装置的附加实施例。 [0038] FIGS. 12A-12B illustrate additional embodiments of the delivery device according to a medical device used in conjunction with an exemplary embodiment of a programmable medicament of the present invention.
[0039] 贯穿各图，相似的附图标记将被理解成表示相似的元件、特征和结构。 [0039] throughout the drawings, like reference numerals will be understood to refer to like elements, features and structures.
[0040] 提供在该描述中举例说明的主题是为了帮助全面地理解本发明的示例性实施例，并且参考附图进行说明。 [0040] The subject matter provided in this description is intended to illustrate assist in a comprehensive understanding of exemplary embodiments of the present invention, and with reference to the drawings. 因此，本领域的普通技术人员将认识到可以对本文中所描述的示例性实施例做出各种变化和修改而不脱离本发明权利要求的范围和精神。 Accordingly, those of ordinary skill in the art will recognize that various changes and modifications may be made to the exemplary embodiments described herein without departing from the scope and spirit of the claimed invention. 而且，为了清楚和简洁起见省略了对公知功能和构造的描述。 Further, for clarity and brevity the description is omitted well-known functions and constructions.
[0041] 在图1和图2中示出了医疗装置100的一般实施例。 [0041] in FIG. 2 and FIG. 1 shows a general embodiment of the medical device 100. 医疗装置100优选地是通过连续输注进入或通过患者皮肤而提供液体或凝胶药剂(优选但不必须是胰岛素)的输送的可穿戴医疗装置。 Preferably, the medical device 100 is to provide a liquid or gel medicament (preferably but not necessarily insulin) wearable medical device delivered by continuous infusion into or through the skin of the patient. 这类已知医疗装置由于它们穿戴或附着于用户皮肤的性质而通常被称为“贴肤泵”。 Such medical devices are known due to their nature of the user or attached to the wearer's skin and is generally referred to as "paste pump skin." 医疗装置100 —般地包括外壳(所述外壳在图1中显示为包括上外壳部分102和下外壳部分104)、用于供应药剂的刚性或挠性药物储存器106或其它容器、输注针头机构108、以及用于控制药物通过设在输注针头机构108中的输注针头经由流动通道112输送到用户体内的泵机构114。 The medical device 100-- camel comprising a housing (the housing shown in FIG. 1 includes an upper housing portion 102 and a lower housing portion 104), for supplying medicament rigid or flexible drug reservoir 106, or other container, the infusion needle mechanism 108, and a pump means for controlling medication delivery by the infusion needle mechanism 108 provided in the flow channel 112 via the infusion needle into the body of the user 114. 医疗装置100还优选地包括微处理器或控制器116，用于指导输注针头机构和泵机构以及监测和/或控制医疗装置100的其它优选操作和系统。 The medical device 100 also preferably includes a microprocessor or a controller 116 for directing the infusion pump mechanism and the needle means and monitoring and / or control other system operations and preferably the medical device 100. 医疗装置100还可以包括可选的流量传感器120和可选的电源109，例如任何已知的电源，包括但不限于标准电池、电容器或能量收集系统，例如于2009年7月23日提交的序列号为12/458，807的共同转让并且共同未决的美国专利申请中所公开的系统，上述申请通过引用并入本文。 The medical device 100 may also include an optional flow sensor 120 and an optional power source 109, such as any known power source, including but not limited to standard battery, a capacitor or energy collection system, such as a sequence on July 23, 2009, filed commonly assigned No. 12 / 458,807 and co-pending U.S. patent application system disclosed in the above applications incorporated by reference herein.
[0042] 医疗装置100的一个示例性实施例是预编程贴肤泵。 One exemplary embodiment [0042] The medical device 100 is affixed to the skin preprogrammed pump. 预编程贴肤泵可以包括简单智能以用于提供可以在全天变化以符合睡眠和清醒胰岛素要求的定制基础输注速率。 Pre-programmed pump attached to the skin may include simple smart for change throughout the day can provide customized to meet the basal infusion rate of sleep and wakefulness insulin requirements. 预编程贴肤泵可以被编程以针对一天中的不同时间或在不同的条件下以不同的速率将一种或多种药物输送到用户。 Preprogrammed affixed to the skin of the pump can be programmed for different times of the day or at different rates to one or more drug delivery to the user under different conditions. 随着时间改变药物输送速率在本文中被称为药物输送分布(profile)。 Changing the rate of drug delivery over time it is referred to herein as a drug delivery profile (profile). 预编程贴肤泵可以由制造设施或保健提供者编程并且优选地不需要附加的用户编程。 Preprogrammed stickers skin may be provided by a pump programmed by the manufacturing facility or health care and preferably does not require additional user programming. 预编程贴肤泵甚至可以被配置成提供多种每日输注并且可以被设计成具有允许手动致动增量单次剂量的机构。 Skin paste preprogrammed pump may be configured to provide even more daily infusion and may be designed to permit manual actuation with a single dose increment mechanism. 手动致动的一种形式将需要闭合电接触(例如一个瞬时开关或两个瞬时开关)达延长持续时间，其后振动或听觉信号可以确认药物输送的完成。 One form would require manually actuated closing electrical contacts (e.g., one or two momentary switches momentary switch) for an extended duration, vibration or acoustic signal may thereafter confirm the completion of drug delivery. 用于本发明的示例性实施例中的预编程贴肤泵包括足够的智能以执行对胰岛素流动阻塞、储存器中的低胰岛素水平和其它故障状态的感测。 Preprogrammed exemplary embodiment of the present invention comprises a pump attached to the skin sufficient intelligence to execute sensing of the insulin flow blockage, lower insulin levels in the reservoir and other fault conditions. 预编程贴肤泵也优选地为用户提供这些故障状态的每一个状态的警报。 Preprogrammed pump is also preferably affixed to the skin to provide users of these alarm failure state each state. 预编程贴肤泵执行与“智能”贴肤泵类似的功能，不同之处在于与主机设备通信，因此大大降低了用这类装置提供药物治疗的成本并且增强了这类装置的易用性。 Skin paste preprogrammed pump performs "smart" skin paste-like pump function, except that the communication with the host device, thus greatly reducing the cost of providing the medication with such apparatus and enhances the ease of use of such devices. 本发明中的医疗装置100的示例性实施例优选地涉及如上所述的可预编程贴肤栗。 Exemplary embodiments of medical device 100 preferably in the present invention as described above relates to a paste skin Li may be preprogrammed.
[0043] 本领域普通技术人员将理解，在本发明的其它实施例中，医疗装置100也可以提供作为完全可编程(“灵巧”)或(“简单”)包装。 [0043] Those of ordinary skill in the art will appreciate that, in other embodiments of the present invention, the medical device 100 may be provided as a fully programmable ( "smart") or ( "simple") package. 完全可编程包装在控制适合于用户生活方式的药物施予速率方面为用户提供最大的精度和灵活性，但是需要附加成本。 Packaging fully programmable to provide maximum accuracy and flexibility for the user in controlling the drug suitable for the user's lifestyle administration rate, but requires additional costs. 完全可编程“灵巧”贴肤泵通常与血糖监测仪(BGM)或连续葡萄糖监测仪(CGM)和主机设备(例如个人糖尿病监测仪(PDM))结合使用以通过闭环控制和感测来提供个性化基础输注速率和可以在一天中的任何时间致动或调节的单剂输注。 Fully programmable "smart" skin pump generally attached to a blood glucose monitor (BGM) or a continuous glucose monitor (CGM) and a host device (e.g. a personal monitor diabetes (the PDM)) to be used in combination sensing and closed-loop control to personalize of basal infusion rate and can be actuated or adjusted at any time of day single dose infusion. “灵巧”贴肤泵优选地被配置成例如经由私域网(如先前并入的、共同未决美国申请12/458，807中所述)或无线网络与主机设备通信。 "Smart" skin paste pump is preferably configured, for example via a personal area network (e.g., previously incorporated, co-pending U.S. application 12 / 458,807 in the) communication or a wireless network with a host device. “灵巧”贴肤泵甚至可以经由有线或其它直接连接与主机设备连续地或间歇地通信。 "Smart" skin pump may even be posted continuously or intermittently communicate via a wired or other direct connection to the host device. “简单”贴肤泵可以带有很少或者没有系统智能并且一般地主要包括机械系统以用于通过预设基础速率或手动致动单次注射来提供胰岛素输注的基本控制。 "Simple" paste pump skin may have substantially little or no control intelligence systems and generally include a mechanical system for providing an insulin basal rate infusion through a preset or manually actuated single injection. 每个贴肤泵对于某个类型的用户是特别有效且期望的。 Each pump is attached to the skin is particularly effective for certain types of users and desirable. 用户的生活方式、医疗状况、经济状况和操作医疗装置的能力在很大程度上决定哪类贴肤泵包装适合于该用户。 User's lifestyle, health status, economic status and ability to operate the medical device to a large extent determine the type of skin attached to the pump package suitable for the user. 接下来可以在上述的贴肤泵包装的每一个中实现本发明示例性实施例的特定特征和功能。 Next, specific features and functions of the present invention may be implemented in the exemplary each of said pump affixed skin package in an embodiment.
[0044] 根据本发明将使用的贴肤泵的附加实施例、特征和特定功能可以在Robert IConnelly等人的共同转让的美国专利第6，589，229号、共同未决并且共同转让的美国专利序列号12/458，807以及与本申请同日申请的、名称为“Flexible and Conformal PatchPump (挠性和共形贴肤泵)”的共同未决并且共同转让的美国专利申请(代理人案卷号P-8678 (55581))中找到，上述申请通过引用被明确并入本文。 [0044] According to additional embodiments of the present invention attached to the skin of the pump to be used, the specific features and functions may be in U.S. Patent No. 6,589,229 commonly assigned Robert IConnelly et al., Copending and commonly assigned U.S. Pat. serial No. 12 / 458,807, and filed with the present application, entitled "flexible and conformal PatchPump (conformal and flexible skin attached pump)" in co-pending and commonly assigned U.S. Patent application (Attorney Docket No. P -8678 (55581)) found in the application is expressly incorporated herein by reference. 如图1B中所示可以在医疗装置100中提供的一个特定特征涉及在使用之前医疗装置的自动或半自动引动。 A particular feature may be provided in the medical device 100 shown in FIG 1B, it relates to the use of automatic or semi-automatic prior to priming the medical device. 设在医疗装置100的内部的药物流动通道112开始于药物储存器106并且终止于由输注针头部署机构108插入的输注针头。 Medical device 100 disposed within the medication flow path 112 starts at the drug reservoir 106 and terminates in an infusion needle deployment mechanism 108 by the insertion of the infusion needle. 在该实施例中，碟状的疏水薄膜107靠近输注针头部署机构108放置在流动通道112中。 In this embodiment, the plate-like hydrophobic film 107 near the infusion needle deployment mechanism 108 is placed in the flow channel 112. 当泵浦机构114初始被启动时疏水薄膜107允许从流动通道驱除陷在流动通道112的空隙容量内的任何空气。 When the pump mechanism 114 is actuated initially hydrophobic membrane 107 allows the purge any air trapped within the void capacity of the flow passage 112 from the flow channel. 流动通道112中的流体流动将驱动来自流动通道112的空气通过疏水薄膜107，所述疏水薄膜由于特定薄膜材料以及薄膜中的孔隙大小、分布和密度而阻止来自流动通道112的流体流动。 Fluid flow passage 112 will drive the air flow from the flow passage 112 through the hydrophobic membrane 107, the hydrophobic thin film material, and due to the specific pore size in the film, distribution and density while preventing fluid flow from the flow passage 112. 示例性医疗装置中的疏水薄膜107的使用是特别有效的，原因是输注需要很小的背压。 An exemplary medical device using a hydrophobic film 107 is particularly effective, because the infusion requires very little back pressure. 示例性疏水薄膜中的孔隙的特定分布、密度和尺寸可以基于将通过流动通道提供的特定药物或流体以及其它性能要求进行选择。 Certain distribution, density and size exemplary hydrophobic pores in the film may be selected based on the particular drug or fluid to be provided through the flow channel, and other performance requirements. 流动通道112中的流体流动的中止可以被感测并且通知用户，允许用户完成启动程序并且开始使用该医疗装置。 Fluid flow in the flow channel 112 may be aborted and notifies the user sensed, allowing the user to start using the startup program is completed and the medical device.
[0045] 根据本发明构造的医疗装置100的第一示例性实施例在图3C中示出。 [0045] In FIG. 3C shows a first exemplary embodiment of the present invention is constructed of the medical device 100. 如上所述，延长普通贴肤泵的使用持续时间的主要挑战之一是在延长的时间段内保持输注部位的可行性。 As mentioned above, one of the major challenges common to extend the use of the pump attached to the skin is to keep the duration of the infusion site over an extended period of time feasible. 输注部位可以被限定为输注针头进入用户皮肤所在的部位。 Infusion site may be defined where the user's skin entry site for the infusion needle. 保持可行的输注部位超过3天是困难的，原因在于胰岛素会在输注针头中结晶，因此阻塞胰岛素到患者体内的流动。 Possible to maintain more than three days infusion site is difficult, because the insulin infusion needle may crystallize, thereby blocking the flow of insulin to the patient. 另外，用户的身体可能响应身体中的异物而不利地反应。 In addition, the user's body may respond to foreign substances in the body and adversely react. 输注部位处的组织可能随时间变得发炎，导致输注的阻力增加。 Infusion at a tissue site over time can become inflamed, leading to increased resistance infusion. 如果输注针头保持插入组织中，则细胞生长可能发生在输注针头上并且很可能局部结瘢。 If the infusion needle is inserted into the tissue holder, the cell growth may occur on an infusion needle and probably localized scarring. 本发明的第一示例性实施例通过在输注循环期间推进或撤回输注针头122以改变在用户皮肤内的深度来保持输注部位的可行性。 A first exemplary embodiment of the present invention is withdrawn by advancing or infusion needle 122 to change to maintain the feasibility of the infusion site in depth within the user's skin during the infusion cycle. 通过在输注循环期间调节输注的深度，输注部位处的发炎和结瘢及其关联并发症的风险可以被减小或避免。 Depth adjustment by infusion during the infusion cycle, the risk of inflammation at the infusion site and scarring and associated complications can be reduced or avoided.
[0046] 用于本发明示例性实施例的输注针头122优选地是挠性的，用于允许延长使用和用户的舒适性，而且保持允许输注针头插入用户体内的合适裂断强度(column strength)。 [0046] The infusion needle of an exemplary embodiment of the present invention 122 preferably is flexible, allowing for prolonged use and user's comfort, but also to maintain suitable column strength to allow the infusion needle into the body of the user (column strength). 如图3A中所示,一个示例性实施例优选地包括不锈钢套管300,所述套管具有锐化尖端和沿着套管的轴激光切割或化学蚀刻的交替狭槽302。 As shown in Figure 3A, a preferred embodiment example embodiment comprises a stainless steel cannula 300, the cannula having a sharpened tip alternating slots and along the axis of the laser cutting or chemical etching of the sleeve 302. 交替狭槽302允许套管挠曲，而且提供插入用户皮肤所必需的刚性或裂断强度。 Alternately flex slot 302 allows the cannula, is inserted into the user's skin and to provide the necessary rigidity or column strength. 不锈钢套管300优选地是在远端具有锐化尖端的单体。 Stainless steel tube 300 is preferably a sharpened tip at the distal end of the monomer. 套管300优选地由Vialon⑧或Teflon ®套筒304覆盖或涂覆，所述套筒提供生物相容外部流体密封以用于允许药物流体通过套管的尖端进入用户体内。 304 sleeve 300 is preferably coated or covered by a Teflon ® Vialon⑧ or a sleeve to provide a fluid-tight outer biocompatible medical fluid for allowing the user to enter the body through the tip of the cannula. 示例性Vialon ®材料的附加公开可以在Min-Shiu Lee等人的共同转让的美国专利第5，226，899号和第5，453，099号以及Theo Onwunaka等人的美国专利第5，545，708号中找到，上述每个专利通过引用明确并入本文。 Additional exemplary disclosed exemplary Vialon ® material may U.S. Patent Nos. 5,226,899 and No. 5,453,099 Min-Shiu Lee et al., And commonly-assigned Theo Onwunaka et al in U.S. Patent No. 5,545, No. found 708, each of the above patents are expressly incorporated herein by reference. 当然任何合适的不透流体材料可以用于形成所述鞘或涂层。 Of course, any suitable fluid impervious materials may be used to form the sheath or coating. 在图3B中显示了挠性输注针头122的另一个示例性实施例。 It shows the flexibility of the infusion needle to another exemplary embodiment 122 in Figure 3B. 图3B中的示例性实施例优选地包括附连到扭转弹簧308的锐化不锈钢针头尖端306。 Preferably the exemplary embodiment of FIG. 3B includes sharpening the stainless steel is attached to the torsion spring 308 of the needle tip 306. 针头尖端306允许刺入用户的皮肤并且优选地焊接到扭转弹簧308，但是可以使用任何合适的方法附连。 Allow the needle tip 306 penetrates the user's skin and is preferably welded to the torsion spring 308, but any suitable method of attachment. 扭转弹簧308提供与图3A中所述的实施例类似的好处并且类似地也包括Vialon ®或Teflon ®套筒304以用于将流体密封在扭转弹簧的内腔之内。 Similar benefits embodiment the torsion spring 308 provided in the embodiment of FIG. 3A and similarly also comprises Vialon ® Teflon ® or sleeve 304 for sealing the fluid within the lumen of the torsion of the spring. 本领域普通技术人员将理解，扭转弹簧308和不锈钢套管300可以带有任何合适的横截面，并且可以备选地包括矩形横截面以最大化内径。 Those of ordinary skill in the art will appreciate the torsion springs 308 and 300 may be a stainless steel cannula with any suitable cross-section, and may alternatively comprise a rectangular cross-section to maximize the inner diameter. 另外，图3A和3B中所示的输注针头的尖端不需要包括供药物流动到用户体内的开口。 Further, FIGS. 3A and infusion needle tip shown in Figure 3B need not include an opening for the flow of medicament to the user's body. 可能期望的是实现具有闭合端部的输注针头，所述闭合端部具有位于尖端附近的侧端口以用于允许药物流动到用户体内。 It may be desirable to achieve an infusion needle having a closed end, said closed end portion having a side port located near the tip for allowing the drug to flow into the body of the user.
[0047] 用于其它示例性实施例中的输注针头122可以备选地包括具有相对于套管轴可选地硬化以用于进入用户皮肤内的硬化尖端的挠性套管、借助于刚性插入针头插入的挠性套管或任何其它合适的装置。 [0047] for infusion needle other exemplary embodiments may alternatively comprise 122 with respect to the sleeve shaft is selectively hardened tip for entering the hardening flexible sleeve within the user's skin, by means of a rigid flexible sleeve or any other suitable device is inserted into the needle insertion. 图1A中所示的输注针头部署机构108可以包括手动或自动机构以用于将输注针头122插入用户皮肤内或撤回输注针头。 FIG infusion needle deployment mechanism shown in FIG. 1A 108 may include a manual or automatic mechanism for the infusion needle 122 is inserted into the user's skin or infusion needle withdrawn. 另外，可以手动地或自动地致动针头部署机构108以将输注针头插入用户皮肤。 Further, it may be manually or automatically actuated needle deployment mechanism 108 to the infusion needle into the skin of the user. 控制器116可以在医疗装置初始化之后或基于某个其它的编程或感测条件自动地致动针头部署机构108。 After the controller 116 may initialize or medical device programming or based on some other sensed condition automatically actuating the needle deployment mechanism 108. 此外，可以经由从BGM、PDM或主机设备接收的适当命令来实现自动部署。 Further, via a suitable command received from the BGM, PDM or the host device automatically deployed.
[0048] 如图3C中所示，针头部署机构108包括驱动器118以用于致动输注针头122的插入和撤回。 [0048] As shown in FIG. 3C, the needle deployment mechanism 108 includes a driver 118 for actuating the infusion needle insertion and withdrawal 122. 适用于本发明的驱动器118的示例性机构提供马达，所述马达由控制器116电子控制以通过在顺时针或逆时针运动中旋转螺纹杆而在插入和撤回方向上驱动输注针头122，其中输注针头经由往复式螺纹结构或套筒沿着螺纹杆轴向地移动。 Exemplary suitable drive mechanism 118 of the present invention to provide a motor controlled by the controller 116 by electronic rotation of the threaded rod in a clockwise or counterclockwise driven movement in the infusion needle insertion and withdrawal direction 122, wherein infusion needle is axially movable along threaded rod via a threaded arrangement or the reciprocating sleeve. 备选实施例实现当施加电荷时收缩的形状记忆合金和/或压电致动器。 As an alternative embodiment to achieve the shape memory alloy contracts when charge is applied and / or piezoelectric actuators. 控制器116可以将可变电压施加于形状记忆合金或压电致动器以实现在插入或撤回方向上的期望运动距离，从而驱动输注针头122。 The controller 116 may be a variable voltage is applied to the shape memory alloys or piezoelectric actuators to effect insertion or withdrawal in the direction of desired movement distance, thereby driving the infusion needle 122. 适用于本发明的驱动器118的其它实施例可以包括多个机械或电子致动闩锁和/或弹簧以用于实现输注针头在插入和撤回方向上的运动，这是本领域普通技术人员可用的。 Is applicable to other embodiments of the present invention, the drive 118 may include a plurality of mechanical or electronically actuated latch and / or a spring for achieving motion in an infusion needle insertion and withdrawal direction, which is available to those of ordinary skill in the art of. 驱动器118优选地由控制器116电子控制，然而在某些实施例中驱动器118可以由拇指旋轮和机械拨盘中的至少一种或通过致动按钮、滑动闩锁或控制杆进行控制。 Drive electronics 118 are preferably controlled by the controller 116, but embodiments may be made of driver 118 and the mechanical dials thumb wheel in at least one or by actuating buttons or slide latch control lever in certain embodiments. 用于本发明的驱动器118不限于以上实施例。 Driver 118 for the present invention is not limited to the above embodiment. 本领域普通技术人员将认识到能够将针头插入用户和撤回针头的任何已知机构可以适用于本发明的实施例，例如在Lum等人的美国专利第6，391，005号和J.Christopher Flaherty等人的美国专利公开2004/0010207中所公开的实施例，上述每个专利通过引用明确地并入本文。 Those of ordinary skill in the art will recognize that any known mechanism capable of inserting the needle and withdrawal of the needle the user may be applied to the embodiment of the present invention, for example, in U.S. Patent No. 6,391,005 Lum and J.Christopher Flaherty et al. in the embodiment disclosed 2004/0010207 et al., U.S. Patent Publication, each of the above patents are incorporated herein expressly incorporated by reference.
[0049] 在图3D和3E中所示的本发明的示例性实施例中，使用以上讨论的任何合适方法将输注针头122手动地或自动地插入用户皮肤至期望深度，例如4_。 [0049] In an exemplary embodiment of the present invention and shown in FIG. 3D 3E, any suitable method discussed above infusion needle 122 is manually or automatically inserted into the user's skin to a desired depth, e.g. 4_. 医疗装置100然后开始对用户的药物输注或注射。 The medical device 100 and the user starts a drug infusion or injection. 在经过预定时间段(例如I或2天)之后，控制器116指示驱动器118将输注针头122进一步推进到第二深度，例如5_。 After a predetermined period of time (e.g. I or 2 days), the controller 116 instructs the drive 118 to the infusion needle 122 is further advanced to a second depth, e.g. 5_. 通过提供第二输注深度，输注针头122可以将药物有效地输注到潜在的未发炎组织中，因此延长输注部位的使用持续时间。 Providing a second depth by infusion, the infusion needle 122 may be a pharmaceutically effective infusion of a potential non-inflamed tissue, thus extending the duration of use of the infusion site. 在期望或需要时可以重复以上操作。 The above operation may be repeated when desired or needed. 因此，在经过第二预定时间段之后，控制器116进一步指示驱动器118将输注针头122推进到第三输注深度。 Thus, after a second predetermined period of time, the controller 116 instructs the drive 118 further infusion infusion needle 122 advanced to the third depth. 在另一个示例性实施例中，驱动器118初始将输注针头122插入到5mm的深度并且在经过预定时间段之后，控制器116指示驱动器118将输注针头122撤回到较浅的第二输注深度。 In another exemplary embodiment, the driver 118 is initially inserted into the infusion needle 122 5mm and depth after a predetermined period of time, the controller 116 instructs the drive 118 to the infusion needle 122 to withdraw a second infusion shallower depth. 本领域普通技术人员将认识到可以在本发明中组合以上的任意实施例。 Those of ordinary skill in the art will recognize that any of the above embodiments may be combined in the embodiment of the present invention. 例如，控制器116可以通过指示驱动器118将输注针头122插入到期望深度、在第一时间段之后撤回针头并且然后在第二时间段之后将针头驱动到初始输注深度或备选输注深度而可变地控制所述输注深度。 For example, controller 116 may be an infusion needle 118 instructs the drive 122 to be inserted through the desired depth, the needle withdrawn after the first period of time and then a second time period after the initial infusion needle driving depth depth infusion or alternatively variably controlling said infusion depth. 驱动器118可以被配置成实现输注深度的任意次变化。 Driver 118 may be configured to change any number of times to achieve the depth of the infusion. 备选地，驱动器118可以被配置成仅仅提供单次深度变化，这可以使用可能用于简单贴肤泵中的纯机械结构容易地执行。 Alternatively, the driver 118 may be configured to provide only a single depth change, which may be used for simple purely mechanical structure affixed to the skin of the pump easily performed.
[0050] 在另一个示例性实施例中，如在图3C中所见，在初始插入输注针头122并且开始药物输注之后，可以控制驱动器118以从输注部位完全或近似完全缩回输注针头122达预定时间段。 [0050] as seen in FIG. 3C In another exemplary embodiment, the infusion needle 122 is inserted in the initial and after the initiation of drug infusion can be controlled from the driver 118 to the infusion site completely or almost completely retracted lose injection needle 122 for a predetermined period of time. 在一个实施例中，驱动器118可以在用户睡眠时被致动以从用户缩回输注针头122达8小时，然后在用户清醒时将输注针头122重新插入或驱动到期望深度。 In one embodiment, the actuator 118 may be actuated to retract the infusion needle 122 for 8 hours from the user when the user is sleeping and waking the user when the infusion needle 122 is inserted or re-driven to the desired depth. 该实施例不仅将通过减小输注部位发炎的风险来增加输注部位的可行性，而且它也可以减小患者的组织结瘢。 This embodiment not only by reducing the risk of inflammation of the infusion site to increase the feasibility of the infusion site, and it is possible to reduce a patient's tissue scarring.
[0051] 图3C-3E中的每一个示出了驱动器108在垂直于用户皮肤的方向上驱动输注针头122。 [0051] in FIG. 3C-3E each shows a driver 108 driving in the direction perpendicular to the infusion user's skin needle 122. 在其它实施例中，优选的是输注针头可以成角度地可变插入用户体内和撤回。 In other embodiments, it is preferable that the infusion needle can be inserted into the body of the user angularly variable and withdrawal. 通过将输注针头122成角度地插入用户体内，输注针头穿过更大量的皮肤而不穿刺到更大深度。 By the infusion needle 122 inserted into the body of a user at an angle, a greater amount of the infusion needle through the skin to greater depths without puncturing. 考虑到以上实施例，这可以允许输注深度的距离增加，因此提供更为增加的输注部位可行性的持续时间以及改善的用户舒适度。 Considering the above embodiments, which may allow the depth of the infusion increased distance, thus providing a more increased duration of infusion site feasibility and improved user comfort.
[0052] 用于以上实施例中的医疗装置100还可以包括流量传感器120，如图2中所示，用于检测由泵机构114提供的药物的流速。 [0052] used in the above embodiment the medical device 100 may further comprise 120, as shown in FIG. 2, for detecting the flow rate of the drug provided by the pump mechanism of the flow rate sensor 114. 流量传感器120能够为泵机构114提供闭环流量控制以实现并保持期望流速。 The flow sensor 120 can provide a closed-loop flow control to achieve and maintain a desired flow rate of the pump mechanism 114. 另外，流量传感器120还可以具有检测输注针头122是否被阻塞或输注部位是否正阻止期望的药物输注速率的能力。 Further, the flow sensor 120 may also have the capability of detecting whether the rate of drug infusion infusion needle 122 is blocked or blocked positive if desired infusion site. 在示例性实施例中，当由流量传感器120检测到输注部位可能被阻塞时，控制器116优选地指示驱动器118将输注针头122撤回或推进到第二输注深度。 In an exemplary embodiment, when the flow rate is detected by the sensor 120 to the infusion site may be blocked, the controller 116 instructs the drive 118 preferably infusion needle 122 is withdrawn or advanced to the depth of the second infusion. 随后流量传感器120可以在潜在地警告用户之前检测是否在新的输注深度实现期望的流速。 Then the flow velocity sensor 120 may detect whether a new achieve the desired depth prior to infusion potentially alert the user. 该示例性实施例可以通过尝试可以具有提供期望的药物输注速率的能力的新输注深度来延长医疗装置100的使用持续时间，而不必警告用户更换医疗装置100。 The new infusion depth capacity according to this exemplary embodiment may be provided with a desired drug infusion rate by attempting to extend the duration of use of the medical device 100 without having to replace the medical device 100 to warn the user.
[0053] 用于本发明的医疗装置100的另一个示例性实施例在图4和图5中示出。 Another exemplary embodiment of the [0053] present invention for a medical device 100 is shown in FIGS. 4 and 5. 图4中的医疗装置100优选地包括第一输注针头部署机构108a和第二输注针头部署机构108b。 100 in FIG. 4 preferably comprises a first medical device 108a infusion needle deployment mechanism and the second infusion needle deployment mechanism 108b. 输注针头部署机构108a和108b可以被分开致动并且优选地(而非必须地)位于医疗装置100的相对端。 Infusion needle deployment mechanism 108a and 108b may be separately actuated and is preferably (but not necessarily) at the opposite end 100 of the medical device. 输注针头部署机构108a和108b可以在上面关于图3C中所示的输注针头部署机构108所述的任意实施例中实现。 Infusion needle deployment mechanism 108a and 108b can be implemented on any of the embodiments of the infusion needle deployment mechanism 108 shown in FIG. 3C, in the above embodiment. 该实施例中的医疗装置100也优选地包括至少一个流量传感器120a或120b以用于检测并且潜在地警告用户通过相应输注针头的药物流动被阻塞。 100 also preferably embodiment of the medical device comprises at least one embodiment of the flow sensor 120a or 120b for detecting and potentially alert the user by a corresponding flow of medication infusion needle is blocked. 在一个示例性实施例中，输注针头部署机构108a初始被手动地或自动地致动以将输注针头122插入用户达期望深度。 In one exemplary embodiment, the infusion needle deployment mechanism 108a is initially manually or automatically actuated to an infusion needle 122 is inserted into a desired depth of the user. 在该实施例中不要求(尽管可以是优选的)针头机构108a和108b被配置成将输注针头122如图3C-3E中所示可变地推进到用户体内和撤回输注针头。 Is not required (although preferred) needle bodies 108a and 108b are configured to variably infusion needle 122 as shown in FIG. 3C-3E advancing the body of a user and a withdrawal of the infusion needle in this embodiment. 在致动针头部署机构108a以将输注针头122插入到用户中之后，流量传感器120a优选地检测至用户的药物流动是否被阻塞。 Actuating the needle deployment mechanism 108a after the infusion needle 122 to be inserted into the user, the flow sensor 120a to detect whether the user is preferably a drug flow is blocked. 如果确定药物流动被阻塞，则控制器116可以优选地警告用户并且指示用户手动地致动输注针头部署机构108b。 If it is determined the drug flow is blocked, then the controller 116 may alert the user and preferably instructs the user to manually actuate the infusion needle deployment mechanism 108b. 备选地，控制器116可以自动地致动针头部署机构108b。 Alternatively, the controller 116 may automatically actuate the needle deployment mechanism 108b. 在致动针头部署机构108b之后,控制器116优选地指示泵机构114a停止通过针头部署机构108b的输注针头122的药物流动并且开始至针头部署机构108b所提供的第二输注部位的药物流动。 After actuation of the needle deployment mechanism 108b, the controller 116 preferably indicates the pump mechanism 114a is stopped by infusion needle deployment mechanism 108b of the needle 122 starts to flow and medicament to a second portion of the infusion needle deployment mechanism 108b provided pharmaceutical flows .
[0054] 在以上实施例中，由于利用两个针头部署机构108a和108b,因此可能不必利用输注针头122的可变撤回/插入。 [0054] In the above embodiment, since the two needle deployment mechanism 108a and 108b, and therefore may not be necessary the use of a variable infusion needle 122 withdrawal / insertion. 可以在该实施例中利用任何合适的(机械或自动致动)针头部署机构。 Using any suitable (automatically or mechanically actuated) a needle deployment mechanism in this embodiment. 可以在该实施例中利用简单的、手动致动的一次性部署针头机构108a和108b，例如图6A和6B中所示的利用卡扣圆盘或扭转弹簧的针头机构。 It can be utilized in the simple, one-time manual actuation of the needle deployment mechanism 108a and 108b in this embodiment, for example, needle mechanism with a snap discs or torsion spring shown in FIGS. 6A and 6B. 图6C和6D示出了用于本发明的另一个实施例，所述实施例尤其适合于图3A和3B中所示的输注针头122。 6C and 6D illustrate another embodiment of the present invention, the embodiment is particularly suited in FIG. 3A and 3B infusion needle 122. 如图6C中所示，输注针头122附连到针头滑座602。 As shown in FIG 6C, the infusion needle 122 attached to the needle carriage 602. 针头滑座602由固位闩锁构件604保持在撤回、预备位置，所述固位闩锁构件防止针头滑座602在插入方向上移动。 The needle is held by the carriage 602 604 retaining the latch member in the withdrawal, the ready position, the retention latch member prevents the needle carriage 602 moves in the insertion direction. 可以手动地或自动地致动输注针头部署以从阻塞位置移位固位闩锁元件604。 It may be manually or automatically actuated to displace the deployment of the infusion needle retention latch element 604 from the blocking position. 当固位闩锁604被致动时，压缩弹簧606在插入方向上驱动针头滑座602，如图6D中所示。 When the retention of the latch 604 is actuated, the compression spring 606 is driven in the direction of insertion of the needle carriage 602, as shown in FIG 6D. 在将输注针头122插入用户体内之后，针头滑座602的朝远侧移动由包含针头部署机构的底盘或外壳阻止。 After the infusion needle 122 is inserted into the body of a user, the needle carriage 602 to prevent distal movement by the chassis or housing comprising a needle deployment mechanism.
[0055] 图6E和6F示出了根据本发明实施例的用于医疗装置中的输注针头的另一个部署机构。 [0055] Figures 6E and 6F illustrate another deployment mechanism for a medical device according to an embodiment of the present invention, the infusion needle. 不同于如先前所述的机构中那样被触发，该针头部署可以是用户控制的。 As different from the previously described mechanism that is triggered, the needle deployment may be user controlled. 也就是说，滑座602在撤回位置由压缩弹簧606偏移。 That is, the carriage 602 by the compression spring 606 at the offset position withdrawn. 图6E显示了装置处于撤回位置，使得输注针头122不从底盘伸出。 Figure 6E shows the apparatus is in the retracted position, such that the infusion needle 122 does not protrude from the chassis. 滑座602包括用户可接近的手动致动器607。 Carriage 602 includes a user accessible manual actuator 607. 当用户在箭头'A'的方向上用足以克服弹簧偏压的力移动手动致动器时，滑座602连同输注针头122 —起在箭头'A'的方向上移动。 When a user moves the actuator by manual force sufficient to overcome the spring bias in the direction of arrow 'A' of the carriage 602 together with the infusion needle 122-- move together in the direction of arrow 'A' of. 滑座602还包括与固位闩锁610上的固位表面609相配合的指状闩锁608。 The carriage further includes a finger 602 of the latch 608 and the retaining surface 609 on the retainer 610 of the latch mating. 当滑座602在箭头'A'的方向上移动时，指状闩锁608和固位表面609之间的干涉导致固位闩锁610在箭头'B'的方向上移位。 When the carriage 602 is moved in the direction of arrow 'A', the interference between the finger-like latch retaining surface 608 and 609 cause the latch retainer 610 is displaced in the direction of arrow 'B' of. 指状闩锁608和固位表面609被成形为使得当指状闩锁移动经过每个固位表面609时，滑座602被阻止在撤回方向上向后移动。 The latch finger 608 and retaining surface 609 is shaped such that when the fingers of each latch moves past the retaining surface 609, the carriage 602 is prevented from moving backward in the withdrawal direction. 随着滑座在箭头'A'的方向上移动，输注针头从底盘伸出并且进入用户的皮肤表面。 As the carriage is moved in the direction of arrow 'A' of the infusion needle protrudes from the chassis and into the user's skin surface. 悬臂固位闩锁610可以在箭头'B'的方向上向下挠曲以释放滑座602并且撤回输注针头。 Cantilever retaining latch 610 can flex downwardly in the direction of arrow 'B' of the carriage 602 to release the infusion and withdrawal of the needle. 本领域普通技术人员将理解，可以利用通过向下挠曲固位R锁610来释放滑座602的任何合适布置。 One of ordinary skill in the art will appreciate that by using a flex downwardly R retainer 610 to release the lock slide 602 in any suitable arrangement of. 这样的布置可以包括经由设在底盘的外表面上的装置由用户手动移动或经由PDM上的适当命令的自动电子释放。 Such an arrangement may comprise an outer surface of the device via a chassis provided in an appropriate release or automatic electronic command on the PDM manually by the user via the mobile.
[0056] 图6G和6H示出了上述的图6C的针头部署机构，其带有引导套筒123以用于以期望的插入角将挠性输注针头122引导到用户中。 [0056] FIG. 6G and 6H illustrate a needle deployment mechanism described above in FIG. 6C, the guide sleeve 123 with a desired angle of insertion for the flexible guide the infusion needle 122 into the user. 另外，引导套筒123为挠性针头122提供附加完整性，从而防止部署期间的扭结或其它非期望偏转。 In addition, guide sleeve 123 provides additional integrity to the flexible needle 122, to prevent kinking during deployment or other undesirable deflection. 从图6G和6H应当理解，引导套筒123能够被配置在医疗装置内以允许相对于针头滑座602的运动以各种定向部署。 It will be appreciated from FIGS. 6G and 6H, guide sleeve 123 can be disposed within a medical device to allow movement of the carriage with respect to the needle 602 to deploy various orientations. 由此，示例性实施例中的引导套筒123的使用允许将输注针头122部署到皮肤中，同时通过允许滑座平行于皮肤移动而最小化针头部署机构对医疗装置的总体轮廓的影响。 Thus, using the example of embodiment guide sleeve 123 allows the deployment of the infusion needle into the skin 122 of the embodiment, while the carriage by allowing movement parallel to the skin and the needle deployment mechanism to minimize the impact on the overall profile of the medical device. [0057] 如图4和图5中所示，医疗装置100可以包括两个分开的泵机构114a和114b以控制在由针头部署机构108a和108b分别提供的输注部位对用户的输注。 [0057] As shown in FIG. 4 and the medical device 100 may include two 5 separate pump mechanisms 114a and 114b to control the infusion at the infusion site to the user by the needle deployment mechanism 108a and 108b are provided, respectively. 备选地，本领域普通技术人员应当理解单泵机构114可以被提供以在每个激励输注部位将药物泵浦至用户。 Alternatively, one of ordinary skill will appreciate that a single pump mechanism 114 may be provided to pump the drug to a user each excitation infusion site. 泵机构114可以优选地是在题为“Flexible and Conformal Patch Pump (挠性和共形贴肤泵)”的先前并入的共同未决美国专利申请中所描述的压电隔膜或热气泡微型泵以及任何其它合适的和周知的泵机构。 The pump mechanism 114 may preferably be entitled "Flexible and Conformal Patch Pump (conformal and flexible skin attached pump)" of the previously incorporated co-pending U.S. patent application described thermal bubble or piezoelectric membrane micropump and any other suitable and well-known pump mechanism. 本领域普通技术人员将认识到控制器116可以在警告用户或自动致动针头机构108b之前驱动针头部署机构108a以将输注针头122插入或撤回到第二输注深度，如先前实施例中所述。 Those of ordinary skill in the art will recognize that the controller 116 may drive the needle deployment mechanism 108a to the infusion needle 122 is inserted into or withdrawn prior to the second infusion depth warn the user or automatically actuating the needle mechanism 108b, as in the previous embodiments Example above. 在该示例性实施例中，输注针头机构108b提供多余输注针头以在至第一输注部位的流动被阻塞的情况下允许在第二输注部位继续疗法。 Embodiment, the infusion needle the infusion needle mechanism 108b provides redundant to allow further parts of the infusion therapy in a case where the second flow to the first infusion site is blocked in this exemplary embodiment. 本领域普通技术人员还可以理解，针头部署机构108b也可以在其它情况下被致动，例如在第一输注部位的预定使用期之后或者在第一输注部位变得刺激或发炎的情况下。 Under ordinary skill in the art can also be appreciated, the needle deployment mechanism 108b may be actuated in other cases, for example, after a first predetermined infusion site of use or become the first infusion site irritation or inflammation of the case .
[0058] 要被用于以上任意实施例中的附加特征提供用于肝素化输注针头122的途径。 [0058] The route for infusion of heparinized needle 122 to be used for any of the above additional features provided in the embodiment. 可以在初始插入用户皮肤之前或在可变插入和撤回运动期间执行输注针头122的肝素化。 Or may be performed heparinized infusion needle 122 during insertion and withdrawal of the variable before the initial insertion movement of the user's skin. 可以通过由本领域普通技术人员可用的任何方法用肝素涂覆输注针头122来执行肝素化。 It may be performed using a heparin-coated heparin infusion needle 122 by any method available to those of ordinary skill in the art. 肝素化输注针头可以便于通过防止输注部位的血液凝固而保护输注部位，血液凝固可能阻塞或以另外方式复杂化输注部位。 Heparin infusion needle the infusion site can be facilitated by preventing blood coagulation and protection of the site of infusion, blood coagulation may obstruct or otherwise complicate the infusion site. 药物肝素是抗凝血剂族中的一种。 Drug Heparin is an anticoagulant family. 本领域普通技术人员会理解类似的药物可以代替以获得相同的好处而不脱离本发明该实施例的范围和精神。 Those of ordinary skill in the art will appreciate that similar drugs may be used instead to obtain the same benefits without departing from the scope and spirit of the present invention to this embodiment.
[0059] 通过由单针头机构108、利用第二针头机构108b或其组合提供的对输注部位的保护，医疗装置100能够相比于本领域中的其它可用贴肤泵延长用户的药物治疗。 [0059] By means of a single needle 108, needle mechanism 108b by the second or a combination thereof to provide protection of the infusion site, other available 100 can be attached to the pump as compared to the skin in the art to extend the user's medical device therapy. 提供延长的功能性所必需的修改和增强并不明显地增加医疗装置100的复杂性并且可以带有简单的、成本可行的部件。 Provide extended functionality necessary modifications and enhancements not significantly increase the complexity of the medical device 100 and may be with a simple, cost feasible member. 尽管单个医疗装置100的单位成本可能略微增加，但是附加部件所提供的延长的使用持续时间必然减小通过医疗装置100将药物治疗提供给用户的每日成本，并且必然减少浪费。 Although the unit cost of a slight increase in the individual 100 may be a medical device, but the use of additional elongated member provided necessarily reduced by the duration of the medical device 100 to provide a daily drug treatment cost of the user, and the waste will be reduced.
[0060] 如上任意示例性实施例中所述，提供能够延长对用户的药物治疗的医疗装置100引入的唯一挑战是在医疗装置的延长使用期间将足够的药物容量供应给所述用户。 [0060] As in any embodiment of the exemplary embodiments, providing drug therapy can extend the user's medical device 100 is introduced only challenge during prolonged use of the medical device pharmaceutical sufficient capacity supplied to the user. 图1、图4和图5示出了用于提供容纳或存储药物供应的储存器106的优选实施例。 1, FIG. 4 and FIG. 5 shows a receiving or providing the drug storage reservoir 106 is preferably supplied embodiments.
[0061] 利用单输注针头机构108的医疗装置100的示例性实施例优选地包括如图1A中所示的单个储存器106。 [0061] using a single infusion needle mechanism exemplary embodiment of medical device 108 preferably includes 100 shown in FIG. 1A single reservoir 106. 在第一实施例中，储存器106能够容纳为延长的使用持续时间(例如5-7天)提供足够供应的药物容量。 In the first embodiment, the reservoir 106 can provide a sufficient supply for receiving an extended duration of use (e.g., 5-7 days) the capacity of the drug. 在该实施例中，储存器106可以作为包装在医疗装置100中的预填充储存器而被提供。 In this embodiment, the reservoir 106 can be packaged as a medical device 100 in a pre-filled reservoir is provided. 储存器106优选地与贴肤泵集成并且不需要附加步骤将药物供应转移或接合到医疗装置100。 The reservoir 106 is preferably integrated with a pump attached to the skin and no additional step of joining the drug supply or transferred to the medical device 100. 储存器106可以作为刚性或挠性结构被提供并且优选地由诸如TOPAS (R)(无定形结构的热塑性烯烃聚合物)、C0C (环烯烃共聚物)、C0P (环烯烃聚合物)或CCP (晶Ii透明的聚合物)的材料构造，所述材料是由Becton, Dickinsonand Company注册的材料,并且由美国食品和药品管理局作为DMF第16368号列出。 Reservoir 106 may be provided and is preferably made, such as TOPAS (R) (thermoplastic olefin polymer of amorphous structure), C0C (cyclic olefin copolymer), C0P (cycloolefin polymer), or CCP (as a rigid or flexible structure crystal clear polymer Ii) constructed of a material, the material is registered by Becton, Dickinsonand Company material, and by the US food and Drug Administration, as listed in DMF No. 16368. 用于容纳药物的任何其它公知的材料也可以用于本发明中。 Any other known material for receiving medicament in the present invention may also be used.
[0062] 在另一个实施例中，如图7a中所示，储存器106可以包括包含在医疗装置100中的可填充和/或可再填充储存器。 [0062] In another embodiment, as shown in FIG 7a 106 may include a reservoir filled may be included in the medical device 100 and / or refillable reservoir. 在该实施例中，用户可以通过优选地设在医疗装置100的外表面上的填充端口Iio或隔膜将药物转移到储存器106内。 In this embodiment, the user may be provided by fill port preferably Iio diaphragm or the outer surface of the medical device 100 will be transferred into the drug reservoir 106. 常规贴肤泵套件典型地包括注射器用以将药物从药瓶转移到储存器内。 Conventional skin paste typically comprises a syringe pump kit for the transfer of the drug from the vial into the reservoir. 备选地，本发明的示例性实施例提供了包含适合于储存器106的容量或根据用户需要定制的特定药物量的预填充注射器200或预填充注射筒。 Alternatively, an exemplary embodiment of the present invention provides a capacity suitable for storage comprising 106 or pre-filled syringe or pre-filled syringe according to the amount of a particular drug requires the user 200 to customize. 预填充注射器和注射筒可被包括作为贴肤泵套件的一部分或作为预填充注射器的包装的一部分。 Pre-filled syringe and syringe barrel may be included as part of a pump attached to the skin or the kit as a pre-filled syringe of the part of the package. 这类实施例必然减小使用医疗装置100的复杂度并且还可以降低使用这类装置的疗法的每日成本。 Such embodiments will inevitably reduce the complexity of using the medical device 100 and may also reduce the cost of therapy daily use such devices.
[0063] 如图7b中所示，另一个示例性实施例包括与医疗装置100分离的预填充储存器组件700或筒。 [0063] As shown in Figure 7b, another exemplary embodiment includes a pre-filled reservoir assembly separated from the cartridge 700 or medical device 100. 在该实施例中，用户可以将预填充储存器组件700接合到医疗装置100中，并且该动作可以将预填充储存器连接到医疗装置100的泵机构。 In this embodiment, a user may pre-filled reservoir assembly 700 is joined to the medical device 100, and the action may be pre-filled reservoir connected to the pump mechanism of the medical device 100. 在以上实施例中描述的可填充/可再填充储存器106或预填充储存器组件700的容量可由医疗装置100的构造及其特定用户的所需使用来确定。 Fillable / refillable reservoir capacity of the pre-filled reservoir 106 or assembly 700 may be configured to use a particular user and the desired medical device 100 to determine the above described embodiment. 由于这些实施例中的储存器是可再填充的或可更换的，因此它们的容量不需要足以在医疗装置100的整个使用持续时间期间供应药物。 Since these embodiments the reservoir is a refillable or replaceable, so they do not need a capacity enough to supply the drug during the entire duration of use of the medical device 100. 然而，优选的是储存器106具有足够的容量使得它可以在医疗装置100的使用持续时间期间仅仅需要再填充或更换一次。 However, it is preferred that the reservoir 106 has sufficient capacity so that it may only need to be filled or replaced once during the duration of use of the medical device 100.
[0064] 图4和图5示出了设在包括第一和第二输注针头部署机构108a和108b的医疗装置100中的储存器106的示例性实施例。 [0064] Figures 4 and 5 illustrate an exemplary embodiment is provided comprising a first and a second reservoir 100 in an infusion needle deployment mechanism 108a and 108b of the medical device 106. 图4中的储存器106可以与以上提供的实施例相同地实现以为针头部署机构108a和108b两者供应药物。 Example 4 FIG reservoir 106 may be provided above the same manner as the needle deployment mechanism to achieve that both the supply of drugs 108a and 108b. 然而，归因于第二输注针头部署机构108b所导致的部件的数量增加，为了节省空间，优选的是图4中的储存器106包含减小的容量并且如上所述，在医疗装置100的使用持续时间期间是可再填充的/可更换的。 However, due to the number of the second member infusion needle deployment mechanism 108b resulting increase in order to save space, it is preferable that in the reservoir 106 in FIG. 4 comprises a reduced capacity and as described above, the medical device 100 in during the duration of use of a refillable / replaceable. 图5中所示的实施例包括两个储存器106a和106b。 Embodiment illustrated in FIG. 5 comprises two reservoirs 106a and 106b. 在该实施例中，储存器106a被提供以将药物严格地供应到针头机构108a并且储存器106b被提供以用于将药物供应到针头机构108b。 In this embodiment, the reservoir 106a is provided to the drug supplied to the needle means strictly reservoir 108a and 106b are provided for supplying a medicament to the needle mechanism 108b. 储存器106a和106b优选地是预填充的，但是也可以如上所述是可填充的/可再填充的或可插入的/可更换的。 Reservoir 106a and 106b are preferably pre-filled, but as described above may be filled / or refillable insertable / replaceable.
[0065] 以上实施例通过延长可穿戴贴肤泵的使用持续时间而降低输注输送的每日成本，所述可穿戴贴肤泵典型地在它们的使用之后完全被丢弃。 [0065] The above embodiments may be worn attached to the skin by extending the duration of use and daily cost reduction of the infusion pump delivery, the wearable pumps are typically attached to the skin is completely discarded after their use. 在以上实施例中，医疗装置100包括可被安全地再使用的系统部件。 In the above embodiment, the system 100 includes a component may be safely re-use medical device. 因此，完全丢弃医疗装置导致了对可使用的、相对昂贵的部件的不必要浪费。 Thus, the medical device lead discarded completely unnecessary waste of relatively expensive components may be used. 可以通过在以上示例性实施例中提供再使用相对昂贵的部件的医疗装置而更进一步降低这类贴肤泵的输注输送的每日成本。 By providing re-use of relatively expensive components of a medical device in the above exemplary embodiment to further reduce the cost of such stickers skin daily infusion pump delivery. 仅是那些可被安全地再使用的部件被优选地包含在医疗装置的可再使用部分中，而任何非安全或单次使用部件则优选地被包含在一次性部分中。 Only those parts of the reusable components can be reused safely is preferably contained in the medical device, and any non-secure or single use component is preferably contained in the disposable part.
[0066] 如图8A中所示，本发明的一个示例性实施例提供了根据以上任意示例性实施例的部分可再使用和部分一次性的医疗装置100。 [0066] As shown in FIG. 8A, an exemplary embodiment of the present invention provides any of the above part according to an exemplary embodiment of the reusable part and the disposable medical device 100. 在一个示例性实施例中，医疗装置100被设计成使得在每次使用持续时间之后仅仅更换“无菌的”或“用过的”部件，如先前并入的Robert I Connelly等人的美国专利第6，589，229号中所述。 In one exemplary embodiment, the medical device 100 is designed such that only the replacement or "used" member "sterile" duration after each use, as previously incorporated Robert I Connelly et al., U.S. Pat. No. 6,589,229 in the. 例如,在每次使用之后应当更换的部件包括:输注针头122、药物储存器106、用于将医疗装置100附着到用户的粘合剂和可选的电池或电源109。 For example, should be replaced after each use of the component comprising: an infusion needle 122, the drug reservoir 106 for the medical device 100 is attached to the user's binder and optional battery or power source 109. 在一些实施例中，一次性外壳还可以包括根据上述示例性实施例的流量传感器120，用以检测药物流至用户的速率或输注部位流动的任何阻塞。 In some embodiments, the disposable housing may further comprise any of the above-described blocking flow sensor 120 of the exemplary embodiment, for detecting the flow of drug to the user's site or infusion flow rate. 这些部件优选地包封在两件式密封外壳中，所述外壳具有用于针头部署机构108、泵机构114和用于将流量传感器120和可选的电池109电子连接到控制器116的电接触111的暴露界面。 These components are preferably encapsulated in two-piece seal housing, the housing having a needle deployment mechanism 108, the pump mechanism 114 and the flow sensor 120 for optional battery 109 and an electronic controller electrically connected to the contact 116 interface 111 is exposed. 药物储存器106可以如以上任意示例性实施例所述实现。 The drug reservoir 106 may be implemented as any of the above exemplary embodiments. 如果储存器106是可填充的/可再填充的，则填充端口110或隔膜优选地设在一次性外壳上。 If the reservoir 106 is filled / re-filled, the fill port 110, or septum is preferably provided on the disposable housing.
[0067] 在一个示例性实施例中，控制器116、泵机构114和针头部署机构108优选地容纳在与一次性部分132类似设计的独立的可再使用结构130内。 [0067] In one exemplary embodiment, the controller 116, the pump mechanism 114 and a needle deployment mechanism 108 is preferably housed within the disposable part 132 and a similar design independent of the structure 130 may be reused. 一次性部分132优选地与可再使用部分130闩锁在一起，因此使控制器116、泵机构114和针头部署机构108分别与可选的电池109和流量传感器120、药物储存器106和输注针头122自动地接合。 Preferably, the disposable portion 132 and reusable portion 130 may be latched together, so that the controller 116, the pump mechanism 114 and a needle deployment mechanism 108 and an optional battery 109, respectively, and a flow sensor 120, a drug reservoir 106 and the infusion needles 122 automatically engaged. 本领域普通技术人员应当理解，医疗装置100的以上任意示例性实施例可以提供可再使用外壳部分和一次性外壳部分。 One of ordinary skill will appreciate, any of the above exemplary embodiments of medical device 100 may provide a reusable and a disposable housing portion housing portion. 为了保证医疗装置100的一次性部分132不使用超过预定持续时间，在本发明的一个示例性实施例中，可以允许控制器116警告用户该一次性部分应被更换。 In order to ensure that the disposable portion 132 of medical device 100 does not use more than a predetermined time duration, in one exemplary embodiment of the present invention, the controller 116 may allow the user is warned that the disposable part should be replaced. 在特定次数的警告之后，还可以允许控制器116禁用该一次性部分132。 After a certain number of warnings, it may also allow the controller 116 to disable the disposable portion 132. 可再使用部件可以包括针头部署机构、装置的电子电路或系统智能、流体计量器件或泵以及用于引导、对准、接合或闩锁和解锁一次性部分所必需的任何外壳部件。 Reusable component may include a needle deployment mechanism, a smart electronic circuit or system, or the fluid metering device and a pump means for guiding, aligning, engaging or latching the housing member and the disposable portion unlock any necessary. 需要时，可再充电电源或其它能量收集部件也可以包括在可再使用部分130内。 If desired, the rechargeable power source or other energy collecting part may also be included in the reusable part 130. 可再使用部分也可以配置有使用私域网或其它通信技术与任何其它灵巧装置通信所必需的部件，如先前并入的美国专利申请序列号12/458，807中所公开的。 The reusable portion may be configured with the use of personal area network or any other communication technology to communicate with other devices and components necessary dexterity, such as the previously incorporated U.S. Patent Application Serial No. 12 / 458,807 disclosed. 可以传送的信息包括任何系统诊断信息以及用户的输注速率和时间表信息的存储历史。 Information may include the transfer of any system diagnostic information, and storing the user's history infusion rate and schedule information. 包含在可再使用和一次性外壳中的特定部件依赖于医疗装置100的优选应用并且不受上述实施例所限。 Specific components contained in the reusable and disposable housing is dependent on the preferred application of the medical device 100 and is not limited by the above embodiments. 本领域普通技术人员将理解可以根据用户需要提供部件和特征的任一组合。 Those of ordinary skill in the art will appreciate that any combination of components and features may be provided according to user needs.
[0068] 在优选实施例中，可再使用部分130被配置并构造成重复与一次性部分132 —并使用达两年或以上的持续时间。 And the duration of use for two years or more - [0068] embodiment, the reusable portion 130 is arranged and configured to repeat the disposable portion 132 in the preferred embodiment. 在该期限内，可再使用部分和一次性部分之间的电互连111容易出故障。 Within that period, the reusable part 111 and the electrical interconnection between the disposable portion prone to failure. 典型的电连接是脆弱的并且可能无法经得起医疗装置旨在使用的类型或使用期。 A typical electrical connections are fragile and may not be able to withstand the type of medical device is intended for use or use of. 本发明的一个示例性实施例在无需该电连接111的情况下实现上述使用并且允许可再使用部分130使用以上讨论的私域网(PAN)与一次性部分132通信。 An exemplary embodiment of the present invention to achieve the above without the need to use the electrical connector 111 and allows the reusable part of a personal area network (PAN) section 130 uses to communicate with the above discussed 132 disposable. 在一次性部分132中提供PAN收发器的成本是可忽略的，尤其是在相较于提供医疗装置组件的更大耐用性和延长使用的折中的情况下。 The PAN transceiver 132 in the disposable portion of the cost is negligible, especially in the case of compromise in providing a medical device assembly as compared to greater durability and extended use.
[0069] 医疗装置100的可再使用部分130占整个装置成本的60% -70%。 [0069] The medical device 130 may be reusable part 60% -70% of the overall cost of the apparatus 100. 在预定时间段(例如360天或以上)内分摊成本将使药物输注疗法的每日成本基本上降至该装置的一次性部分的成本。 Cost per day cost sharing a predetermined time period (e.g., 360 days or more) will allow the drug infusion therapy substantially reduced the cost of the disposable portion of the device. 通过进一步延长根据以上实施例的装置的一次性部分132的使用持续时间，每日成本被进一步降低。 The disposable portion of the device by further extension of the embodiment according to the above embodiment using the duration 132, the daily cost is further reduced.
[0070] 图2和图9还示出了医疗装置100的另一个示例性实施例，该实施例并入了根据以上示例性实施例提供的由延长的使用持续时间所允许的可选的感测单元124。 [0070] FIG. 2 and FIG. 9 also shows another exemplary embodiment of medical device 100, which incorporates a sense of embodiment provided in accordance with the above exemplary alternative embodiment of a prolonged usage duration allowed sensing unit 124. 针对糖尿病护理，医疗行业正朝着胰岛素输注的闭环系统发展。 For diabetes care, the medical industry is moving in a closed-loop insulin delivery system development. 典型地被称为“人工胰”的理想系统包括连续葡萄糖监测仪以提供用于精确胰岛素输注控制的“实时”或“近实时”反馈。 Over systems are typically referred to as "artificial pancreas" includes a continuous glucose monitor to provide for accurate control of the insulin infusion "real time" or "near real time" feedback. 连续葡萄糖监测可以在感测单元124内实现，所述感测单元包括用于提供关于用户血糖水平数据的传感器126。 Continuous glucose monitoring may be implemented within sensing unit 124, the sensing unit comprises means for providing the user the blood glucose level data of the sensor 126.
[0071] 图2将感测单元124描绘成被包含在医疗装置100中。 [0071] FIG. 2 is depicted as the sensing unit 124 is included in the medical device 100. 尽管这是优选实施例，但是本领域普通技术人员将理解感测单元124可以独立于医疗装置100提供。 While this is a preferred embodiment, those of ordinary skill in the art will appreciate that the sensing unit 124 may provide a medical device 100 independently. 传感器126可以具体化为任何公知的感测或采样技术。 Sensor 126 may be embodied as any known sensing or sampling techniques. 例如，一些公知的感测技术利用电化学、比色、光学/光谱学或其它基于能量的检测方法来确定用户的血糖水平。 For example, some known sensing techniques using an electrochemical, colorimetric, optical / spectroscopic or other energy-based detection methods to determine the blood sugar level. 另外，存在也可以实现的公知采样技术的两个类，即，无创和有创。 Further, there are two classes known sampling techniques may also be implemented, i.e., invasive and non-invasive. 本发明的一个示例性实施例优选地利用感测葡萄糖结合蛋白(GBP)的比色传感器或电化学传感器,例如Brister等人在的美国专利第7，310, 544号中描述的葡萄糖氧化酶(GOx)传感器，以及Brauker等人在美国专利公告第2005/0245799号中公开的分析传感器，上述专利都被转让给DexCom Inc.并且通过引用明确地并入本文。 An exemplary embodiment of the present invention, preferred embodiments utilize the sensed glucose binding protein (GBP) colorimetric sensor or an electrochemical sensor, for example, Brister et al., In U.S. Patent No. 7,310, 544 described the glucose oxidase ( analyzing sensor GOx) sensor, Brauker et al., and disclosed in U.S. Patent Publication No. 2005/0245799, the above patents are assigned to DexCom Inc. and hereby expressly incorporated by reference herein. 其中所描述的可植入GOx已显示提供多达七天的使用持续时间。 The implantable GOx described therein has been shown to provide up to seven days in duration of use. 因此，迄今为止，由于与传感器相比贴肤泵的使用持续时间更短，因此在普通可穿戴贴肤泵中有效地实现这类感测技术方面存在悖论。 Thus, so far, since the use of a pump attached to the skin compared to the shorter duration of the sensor, and therefore in normal skin attached to the wearable pump effectively implement such sensing technology paradox. 以上讨论的示例性实施例提供能与领先的连续葡萄糖监测技术的性能相匹配的延长使用的医疗装置100。 Exemplary embodiments discussed above provide a medical device used to extend can be matched with the performance of the leading 100 continuous glucose monitoring technology.
[0072] 如图9中所示，感测单元124优选地包括以上讨论的传感器126、和传感器部署机构128。 As shown in Figure [0072] 9, the sensing unit 124 preferably includes a sensor 126, and a sensor deployment mechanism 128 discussed above. 部署机构128可以被手动地或自动地致动并且可以在输注针头部署机构108的上述任意系统中具体化。 Deployment mechanism 128 may be manually or automatically actuated and may be embodied in any of the above system, the infusion needle deployment mechanism 108. 当然应当理解自动部署可以经由从BGM、PDM或主机设备接收的适当命令实现。 Of course, it should be understood automatic deployment may be implemented via appropriate command received from the BGM, PDM or the host device. 可以容易地对以上讨论的针头部署机构108以及在题为'^Flexible and ConformalPatch Pump (挠性和共形贴肤泵)”的先前并入的美国专利申请中描述的实施例进行修改以提供传感器126的插入。例如，传感器126可以设在驱动针头或推杆的端部，在构造上类似于用于将传感器126插入用户皮肤内的输注针头。另外，传感器126可以借助于插入套筒定位在用户体内，一旦传感器放置在用户体内的期望深度，所述插入套筒被撤回。传感器部署机构128优选地提供用于插入和缩回传感器126的单插入运动和缩回运动。传感器部署机构128也可以备选地被提供以可变地插入和撤回传感器126，类似于以上关于输注针头部署机构108的示例性实施例中所述。传感器插入部位的炎症或对异物的其它身体反应可能阻止传感器126提供很精确的感测信息。因此，通过调节传感器126的插入深度，感测单 Example embodiments previously incorporated U.S. patent application can be easily needle deployment mechanism 108 discussed above, and entitled '^ Flexible and ConformalPatch Pump (conformal and flexible skin attached pump) "described in the sensor can be modified to provide insert 126. for example, sensor 126 may be provided at the needle end portion of the drive or push rod, similar in construction to the sensor 126 for the infusion needle is inserted into the user's skin. Further, by means of sensors inserted into the sleeve 126 may be positioned in the body of a user, once the sensor is placed in the body of the user a desired depth, the insertion sleeve is withdrawn. deployed sensor mechanism 128 preferably provides for a single insertion movement of the insertion and extraction and retraction movement sensor 126. the sensor mechanism 128 deployed may alternatively be provided to variably insertion and withdrawal sensor 126, similar to the above on the exemplary embodiment of an infusion needle deployment mechanism 108. inflammatory reactions sensor insertion site or other foreign matter may prevent the body sensor 126 provides a very accurate sensing information. Therefore, by adjusting the insertion depth, the sensing sensor 126 元124可以提供更精确的感测信息，导致输注速率的更大精度和改善的用户舒适度。在一个示例性实施例中，传感器部署机构128位于输注针头机构108的相对端。在另一个实施例中，传感器126与输注针头122共同定位。因此，在该实施例中，传感器部署机构和输注针头部署机构108可以在相同结构中具体化。 Element 124 may provide more accurate sensing information, leading to greater accuracy and improved infusion rate user comfort. In one embodiment, the opposite end 108 of the sensor means is located in an infusion needle deployment mechanism 128 the exemplary embodiment. In another embodiment, the sensor 126 is co-located with the infusion needle 122 in one embodiment. Thus, in this embodiment, the sensor infusion needle deployment mechanism and the deployment mechanism 108 may be embodied in the same structure.
[0073] 图1OA和IOB示出了在本发明一个示例性实施例中用于提供连续葡萄糖监测和输注速率控制的系统。 [0073] FIGS 1OA and IOB illustrates a system embodiment of the present invention to provide a continuous glucose monitoring and controlling the rate of infusion exemplary embodiment. 控制器116接收来自流量传感器120和传感器126的数据作为输入，并据此控制泵机构114提供期望的输注速率。 The controller 116 receives data from flow sensors 120 and 126 as input, and accordingly to control the pump mechanism 114 to provide a desired infusion rate. 根据本发明一个实施例的闭环输注控制系统在转让给Medtronic MiniMed, Inc.的Steil等人的美国专利第6，558，351中被描述,上述专利通过引用明确地并入本文。 The closed loop infusion system according to one embodiment of the control of the present invention are described in, assigned to Medtronic MiniMed, Inc. of Steil et al U.S. Patent 6,558,351, the aforementioned patents are incorporated herein expressly incorporated by reference. 其中描述的方法涉及闭环输注控制系统，其中葡萄糖传感器将输入信号提供给控制器，所述控制器又利用复制第一相胰岛素反应的比例/微分(PD)部件和提供第二相胰岛素反应的积分(I)部件。 Wherein the closed-loop process described relates to an infusion control system, wherein the glucose sensor input signal to the controller, and the controller using a first phase insulin response to replicate proportional / derivative (PD) and a member of a second phase insulin response integral (I) component. PID控制器在本领域中是公知的，其使用三个独立参数比例、积分和微分提供通用控制环反馈机制。 PID controllers are well known in the art, which uses three independent parameters proportional, integral and derivative feedback control loop to provide a common mechanism. 比例参数决定对系统中的即时误差的反应。 Ratio parameter determines the reaction of the instant system error. 积分参数根据系统中的最近误差的总和确定反应，而微分参数则基于系统误差率的变化来控制反应。 The sum of the integral parameter determines the reaction system in recent error, and differential parameter based on changes in the error rate to control the reaction system. PID控制器于是基于这些参数的加权和确定适当反应。 Thus the PID controller based on a weighted sum of these parameters to determine an appropriate response. 尽管以上讨论的PID控制器可以有效地控制胰岛素输注速率，但是在本发明的示例性实施例中每一个所述PID参数都不是必须的。 Although PID controllers discussed above can effectively control the rate of insulin infusion, but in an exemplary embodiment of the present invention, each of the PID parameter are not necessary.
[0074] 图1OB示出了用于本发明示例性实施例的比例-积分(PI)或比例-微分(PD)控制器。 [0074] FIG 1OB shows that the ratio for an exemplary embodiment of the present invention - integral (PI) or proportional - derivative (PD) controller. 因为基础输注的变化率典型地极小，所以PI和ro控制器有效地控制胰岛素输注。 Because basal infusion rate of change is typically extremely small, and ro PI controller effectively control insulin infusion. 因为在治疗II型糖尿病中的输注速率不需要瞬时变化到明显不同的水平，所以PI和ro控制器还可以为用于治疗II型糖尿病的医疗装置提供足够的控制。 Because the rate of infusion in the treatment of Type II diabetes is not required to change instantaneously distinct levels, the PI controller and ro may also be a medical device for the treatment of Type II diabetes providing adequate control. 医疗装置100的示例性实施例可以提供机动化泵机构114，例如具有整体齿轮减速的微型马达或线性致动器，其由于输注速率不需要瞬时变化到明显不同的水平而可使用PI或ro控制器有效地控制。 Exemplary embodiments of medical device 100 may provide a motorized pump mechanism 114, for example, a micromotor overall gear reduction or a linear actuator, which is not required since the temporal change to the infusion rate significantly different levels may be used or PI ro the controller effectively controlled. 另外，因为最大误差或超调可以是一个步进或环形增量，所以其中内部转子和定子被设计成允许轴或导螺杆的增量旋转的步进控制马达和感测轴的转数或部分转数的环形计数器是泵机构114的两种可行的控制选择。 Further, since the overshoot or the maximum error can be an annular step or increment, the number of revolutions of the control motor, and wherein the sense axis of the inner rotor and the stator are designed to allow incremental rotation of the shaft or lead screw or a stepping portion ring counter the number of revolutions of the pump mechanism 114 are two possible control options. 具有整体齿轮减速装置的这类高分辨率线性致动器和马达在本领域中是公知的并且是可用的，例如由Haydon Switch and Instrument和MicroMoElectronics提供的那些。 Such resolution linear gear reduction unit having integral actuator and motor are well known and available in the art, such as those provided by the Haydon Switch and Instrument and MicroMoElectronics. 然而，如本发明的示例性实施例中的那样，尺寸被确定成应用于小型、不显眼可穿戴医疗装置的这类系统典型地非常昂贵。 However, as an exemplary embodiment of the present invention as applied to a small sized, unobtrusive wearable medical device such systems are typically very expensive. 因此，对于在普通、一次性、可穿戴医疗装置中的使用，用于这类控制的成本目前是过高的。 Thus, for ordinary, disposable, wearable medical device is used, the cost for such control is now too high. 大量用户优选或需要在这类实施例中提供控制和精度。 Or need a large number of user-preferred embodiment provides control and accuracy in such embodiment. 因此，需要在实用的并且用户可负担的包装中用以上泵机构114提供连续葡萄糖监测。 Therefore, the above pump mechanism 114 to provide continuous glucose monitoring in a practical and affordable package by the user.
[0075] 如上关于图8A所讨论的，本发明的一个示例性实施例可以在能够持续若干年的医疗装置100的可再使用部分130中并入以上直接描述的泵机构114。 [0075] The pump mechanism as described above regarding an exemplary embodiment of the present invention can be used again as discussed in FIG. 8A can last several years the medical device 100 in section 130 is incorporated directly above described 114. 上述的高精度泵机构114能够执行适合于可再使用实施例中的重复使用。 Described above can be performed with high precision pump mechanism 114 is adapted to use the reusable repeated in this embodiment. 因此，提供专用泵机构114以及其它相对昂贵的系统部件的成本可被分摊至医疗装置100的整个使用期。 Thus, a dedicated pump mechanism 114 and other relatively expensive components of the system can be allocated to the cost of the entire medical device 100 is used.
[0076] 医疗装置100的示例性实施例优选地还包括以上讨论的用于连续葡萄糖监测的感测单兀124。 Preferred exemplary embodiment [0076] The medical device 100 further includes a sensing unit for continuous glucose monitoring Wu discussed above 124. 在该实施例中，可再使用外壳还包括传感器部署机构128,并且一次性外壳包含传感器126。 In this embodiment, the reusable sensor housing further comprises a deployment mechanism 128 includes a sensor 126 and the disposable housing. 在一个示例性实施例中，在一次性部分上的电接触111将优选地将传感器126连接到控制器单元116以用于提供连续葡萄糖监测。 In one exemplary embodiment, the electrical contacts on the disposable portion 111 will preferably connect the sensor 126 to the controller unit 116 for providing a continuous glucose monitoring. 备选地，如以上类似讨论地，可以使用PAN通信技术在传感器126和控制器单元116之间提供通信，因此电接触可以不是必须的。 Alternatively, as similarly discussed above, the PAN communication technology may be used to provide communication between the sensor 126 and controller unit 116, so the electrical contact may not be necessary. 由于传感器126如上所述能够嵌入用户体内持续达7天，因此在本发明的示例性实施例中在将传感器设于延长使用的医疗装置100的可再使用部分内的方面不存在部件或成本的非必要浪费。 Since the user can be embedded in the sensor body 126 as described above for 7 days duration, so in the exemplary embodiment of the present invention, the sensor is provided in the medical device to extend the reusable portion 100 in terms of the absence of components or cost unnecessary waste.
[0077] 当传感器技术继续发展时，传感器126可以能够提供更长的使用持续时间。 [0077] When the sensor technology continues to evolve, sensor 126 may be able to provide a longer duration of use. 由此，如图SB中所示，本发明的一个示例性实施例提供独立于容纳一次性胰岛素输注部件的一次性部分132的附加的第二一次性部分134，如结合图8A所讨论的那样。 Accordingly, as shown in FIG. SB, an exemplary embodiment of the present invention provides an additional independent second receiving portion 132 of the disposable portion of the disposable disposable insulin infusion member 134, as discussed in conjunction with FIG. 8A as. 在该实施例中，第二一次性部分可以包含传感器126、用于插入传感器的传感器部署机构128和可选的电池10%，如图所示。 In this embodiment, the disposable portion may comprise a second sensor 126 for optional battery 128 and the sensor insertion sensor 10% deployment mechanism, as shown in FIG. 优选的是第二一次性部分设在第一一次性部分132的输注针头机构的相对端，从而保证传感器被部署到可行组织中。 It preferred that the second portion of the disposable disposable infusion needle disposed in a first portion 132 of the mechanism opposite ends, so as to ensure the sensor is deployed into the viable tissue. 提供第二一次性部分134以用于允许传感器 Providing a second portion 134 for allowing the disposable sensor
126的更长使用持续时间，使得包含具有较短使用持续时间的部件的第--次性部分132 126 longer duration of use, so that the first member comprises a short duration of use of - 132 views moiety
可以被丢弃而无需不必要地缩短更持久的传感器126的使用跨度。 It can be discarded without unnecessarily shortened more durable sensor 126 using a span. 优选的是当第一一次性部分132附连到可再使用部分时可再使用部分130和第二一次性的部分134保持与用户接触。 Preferred is when the first disposable portion 132 is attached to the reusable portion of the reusable part 130 and a second disposable portion 134 is held in contact with the user. 如上所述，第二一次性部分134可以经由直接连接与可再使用部分130通信或者可以带有PAN通信部件以用于与可再使用部分130或其它外部设备通信。 As described above, the second disposable portion 134 may be directly connected via a communication section 130 may be reusable or may communicate with the PAN member for communication with the reusable part 130 or other external device.
[0078] 在图SB中，第一一次性部分132被显示为仅仅具有单针头部署机构，然而可能优选的是在与一次性部分相对的一角或一端提供第二针头部署机构，如关于图4和图5中所述的，用于增加第一一次性部分132的使用持续时间。 [0078] In FIG. SB, the first disposable portion 132 is shown as having only a single needle deployment mechanism, however, it may be preferred in a second needle deployment mechanism and a disposable portion to provide the opposite corner or at one end, as described with respect FIG. 4 and 5 in the FIG., the first disposable portion 132 for increasing duration of use. 优选的是第二针头部署机构设在与第一部署机构相对的一角或一端以在离第一输注部位一定距离处提供新的可行输注部位，从而降低第一输注部位刺激或发炎的潜在风险。 Preferably the second needle deployment mechanism disposed at a corner opposite to the first deployment mechanism or to provide an end portion of the new feasible infusion from the infusion site at a distance from the first, thereby reducing irritation or inflammation of the first portion of the infusion potential risks. 另外，在图8C-8F中所示的另一个实施例中，每个一次性部分132a-d通过将相应的针头部署机构定位在离在前针头部署机构一定距离处来获得可行的输注部位。 Further, in another illustrated embodiment in FIGS. 8C-8F embodiments, each of the disposable portions 132a-d by respective needle deployment mechanism is positioned at a distance from the first needle deployment mechanism to obtain a viable infusion site . 当可再使用部分130和第二一次性部分134保持附连到用户时，第一一次性部分132a-d在一次性外壳接合部位重复地附连到可再使用部分130。 When the reusable portion 130 and the second holding portion 134 when the disposable is attached to the user, a first portion 132a-d in the disposable disposable housing joint is repeatedly attached to the reusable part 130. 在图8C中所示的附连一次性部分132a的第一实例中，针头部署机构108设在一次性部分132a的一个所述角内。 Examples of disposable first attachment portion 132a shown in FIG. 8C, the needle deployment mechanism 108 is located in a disposable portion 132a of the corner. 在图8C中，针头部署机构108设在左下角。 In FIG. 8C, the needle deployment mechanism 108 is provided in the lower left. 当一次性部分132a的短期部件被用过时，新的、更换的、第一一次性部分132b被附连到可再使用部分130。 When the short-term disposable portion 132a of the member is used, a new, replacement, a first disposable portion 132b is attached to the reusable part 130. 在一次性部分132b中，针头部署机构设在一次性部分132b的另一角。 In the disposable portion 132b, the needle deployment mechanism disposed at the other corner of the disposable portion 132b. 如图8D中所示，针头部署机构108设在一次性部分132b的左上角。 As shown in FIG. 8D, the needle deployment mechanism 108 provided in the upper left corner of the disposable portion 132b. 一次性部分132a-132d中的每个针头部署机构的放置实现彼此分开0.5至2.5英寸之间并且优选地大约1.25至1.75英寸的输注部位。 Placing each needle deployment mechanism disposable portion 132a-132d are separated from one another and implemented preferably about 1.25 to 1.75 inches infusion site between 0.5 to 2.5 inches. 每个一次性部分132a-132d的使用的顺序可以由用户确定，只要一次性部分的针头部署机构实现新的输注部位。 Each sequential use disposable portions 132a-132d may be determined by the user, as long as the disposable part of the needle deployment mechanism to achieve a new infusion site. 一次性部分132a-132d优选地包括需要特定定向以将一个所述一次性部分附连至可再使用部分130的“键”特征135。 132a-132d disposable portion preferably includes a specific orientation required to connect the disposable portion is attached to a reusable "key" feature 135 of section 130. 因而，该键特征将阻止用户以要再次使用输注部位的定向而将一次性部分附连到该可再使用部分。 Thus, the key feature to prevent the user to orient the infusion site to be used again disposable portion attached to the reusable portion. [0079] 以上讨论的示例性医疗装置的特征被提供用于延长可穿戴医疗装置的使用持续时间。 [0079] The features of the exemplary medical device as discussed above is provided for the use of the wearable medical device extended duration. 普通的可穿戴医疗装置用大致覆盖外壳部分(附着至到用户)的整个表面面积或者典型地提供为医疗装置的周长轮廓的粘合剂层附着至用户皮肤。 The entire surface area of ​​the conventional wearable medical device to substantially cover the housing portion (to be attached to the user) or the medical device is typically provided as a perimeter contour of the adhesive layer is attached to the user's skin. 然而，粘合层的普通配置可能不适合于在以上示例性实施例中提供的延长使用的医疗装置。 However, the general configuration of the adhesive layer may not be appropriate to extend the medical device provided in the above exemplary embodiment in. 也就是说，普通的粘合技术在医疗装置和用户的柔软、可拉伸皮肤表面之间的界面处提供很小的运动自由度。 That is, in the conventional bonding technology medical device and the user's soft, stretchable at the interface between the skin surface provides little freedom of movement. 在延长使用期间，普通的粘合层可能无法经受该界面处的用户的皮肤的微小拉伸或者可能证明对于用户来说太不舒服。 During prolonged use, the ordinary adhesive layer is subjected to a slight stretching of the skin may not be the user interface or may prove too uncomfortable for the user. 由此，图1lA中所示的粘合层150提供图案(例如锯齿形图案)以用于允许增加在用户皮肤和示例性医疗装置之间的界面处的运动自由度。 Thus, as shown in FIG. 1lA adhesive layer 150 provided in the pattern (e.g., zigzag pattern) to allow for increased freedom of movement at the interface between the skin of the user and the exemplary medical device. 这类图案通过在正常身体活动期间允许微小运动在皮肤表面上发生而减小用户对伴随粘合表面的身体感觉的注意并且延长正常使用。 Such a pattern by allowing small movements of the body during normal user activity reduced attention to physical sensations associated adhesive surface and extending normal use occur on the skin surface. 优选的是粘合层包括连续图案，从而还提供密封以防止进水。 Preferred is an adhesive layer comprising a continuous pattern, thereby also providing a seal to prevent water ingress. 粘合层还优选地由允许如图1lA和IlB中所示的微小拉伸的挠性材料形成或制造。 The adhesive layer is also preferably formed or manufactured from a flexible material that allows a slight stretching As shown in the 1lA and IlB. 优选的是粘合剂150所提供的运动自由度是微小的并且不应当导致输注部位处的非期望运动。 150 freedom of movement provided by the preferred adhesive is that minor and should not result in undesired motion of the infusion site. 然而，在一个实施例中，用作锚固器的附加的挠性较小的粘合环或周边152可以设在输注部位153以用于防止该部位处的任何非期望运动，如图1lB和IlC中所示。 However, in one embodiment, the smaller additional anchor as a flexible adhesive ring 152 may be provided in or outside the infusion site 153 for preventing any undesired movement of the site, as 1lB and As shown in IlC. 在这类实施例中，优选的是粘合环152相对于粘合层150或154具有更高的粘性和减小的挠性。 In such embodiments, it is preferred that the adhesive ring 152 with respect to the adhesive layer 150 or 154 has a higher viscosity and reduced flexibility. 由此，能够保持沿医疗装置周长的粘合层的挠性和舒适性而不损害输注部位153。 Accordingly, it is possible to maintain the comfort and flexibility of the adhesive layer along a perimeter of the medical device 153 without impairing the infusion site. 附加实施例也可以包括不仅具有更低的粘性而且具有增加的厚度的粘合层150或154，或夹在粘合层和医疗装置之间以用于提供附加运动自由度的弹性体或泡沫层。 Additional embodiments may also include a lower viscosity and having only an adhesive layer having an increased thickness of 150 or 154, or sandwiched between the adhesive layer and the medical device for providing additional freedom of movement of an elastomeric or foam layer . 图1lA和IlB中所示的图案不是限制性的。 1lA pattern shown in FIG. IlB and not limiting. 可以提供粘合剂的任何这类锯齿形或曲线型图案以增强根据示例性实施例的医疗装置100的延长的可穿戴性。 Any such adhesive may be provided to a zigzag pattern curved or extended 100 to enhance the wearable medical device according to an exemplary embodiment. 此外，如图1lC中所示，沿医疗装置周长轮廓性布置的粘合层154也可以通过利用减小的粘性、增加的挠性和/或粘合层的厚度以及实现夹在粘合层和医疗装置之间的弹性体或泡沫层而获得以上讨论的期望挠性。 Further, as shown in FIG 1lC, the medical device along the perimeter contour of the adhesive layer 154 may be disposed by using a reduced viscosity, increased flexibility and / or the thickness of the adhesive layer and the adhesive layer sandwiched implemented and an elastomer or foam layer disposed between the medical device to obtain a desired flexibility discussed above. 在该实施例中，粘合层154不必采用锯齿形、曲线形或其它非均匀连续图案。 In this embodiment, the adhesive layer 154 need not serrated, curved or other non-uniform discontinuous pattern.
[0080] 在上述的任意示例性实施例中，医疗装置100也可以与可编程药物输送装置400结合使用，例如可编程胰岛素注射笔，如图12A-12B中所示。 [0080] In any of the above-described exemplary embodiment, the medical device 100 may also be programmable drug delivery device 400 used in combination, for example, a programmable insulin pens, as shown in FIG. 12A-12B. 在优选实施例中，可穿戴医疗装置被配置成仅仅提供预设的、可预编程的或可编程的基础输注速率，而可编程药物输送装置400被提供用于输注必要的单次剂量。 In a preferred embodiment, the wearable medical device is configured to only provide a predetermined, preprogrammed or programmable basal infusion rate and programmable drug delivery device 400 is provided in a single dose necessary for infusion . 尽管以上讨论的可穿戴医疗装置的某些实施例能够提供单次剂量，但是一些用户可能偏好使用熟悉的笔式注射装置并且感觉更舒服，例如图12A中所示的笔式注射装置。 Although the above discussion of certain embodiments of a wearable medical device capable of providing a single dose, but some users may prefer familiar pen injection devices and more comfortable to use, for example, a pen-type injection apparatus shown in FIG. 12A. 另外，对于一些用户，由胰岛素注射笔装置单独提供的药物治疗可能是有效治疗。 Additionally, for some users, insulin injection pen means for providing drug therapy alone may be an effective treatment. 普通的机械胰岛素笔式注射装置典型地需要用户交互以精确地设定期望的注射剂量。 Common mechanical insulin pen injection devices typically require a user to accurately set a desired interaction of the injected dose. 常规机械笔通常包括可能难以看到或精确设定的小剂量刻度。 Conventional mechanical pen typically includes may be difficult to see the exact setting or a small dose scale. 由此，在本发明的示例性实施例中，可编程胰岛素注射笔装置400将消除由用户不能正确地操作装置产生的剂量误差的潜在风险。 Accordingly, in an exemplary embodiment of the present invention, the programmable insulin pen device 400 to eliminate the potential risk of the user can not operate correctly dose means generates an error.
[0081] 在本发明的一个实施例中，当未使用时，药物输送装置400优选地保持附连到个人糖尿病管理器(PDM) 500、血糖监测仪(BGM)或用于计算单次剂量的其它装置。 [0081] In one embodiment of the present invention, when not in use, the drug delivery device 400 preferably remains attached to the personal diabetes manager (PDM) 500, a blood glucose monitor (BGM), or for calculating a single dose of other devices. 当用户指示PDM 500计算单次剂量需求时，PDM从基础速率输注历史、从标准测试条确定的或由身体功能传感器传送的用户的血糖水平或关于用户将消耗的膳食的信息来计算所述剂量，并且将所述剂量自动编程到药物输送装置400中而不需要用户进行任何进一步的计算、设定或调节。 When the user instructs PDM 500 calculates single dosage requirements, infusion history from the PDM basal rate, determined from a standard or user test strip transfer function of the sensor body by the blood glucose level information about the meal or the user to calculate the consumed dose, and the dose is automatically programmed into the drug delivery device 400 without requiring any further user computing, setting or adjusting. PDM 500可以优选地包括用于确定血糖水平的感测机构或其它系统，以被使用来计算针对该用户的期望单次剂量。 PDM 500 may preferably comprise means for determining blood glucose level sensing mechanism or other systems, to be used to calculate a desired for a single dose of the user. 本发明的该示例性实施例减少了输注所必需的步骤数并且减小了由用户不能正确地操作普通的机械胰岛素注射笔导致的剂量误差。 The exemplary embodiment of the present invention reduces the number of steps necessary for the infusion and reduces the dose error by the user can not operate correctly ordinary mechanical insulin injection pens caused. [0082] 在示例性实施例中，药物输送装置400优选地包括可更换的胰岛素筒402并且可以为圆柱形，类似于通常可用的胰岛素注射笔。 [0082] In an exemplary embodiment, the drug delivery device 400 preferably includes a replaceable insulin cartridge 402 and may be cylindrical, similar to insulin pens commonly available. 典型位于普通胰岛素注射笔上部内的剂量机械化优选地由环绕笔筒内径的挠性电路替换。 A typical dose is preferably located in the mechanization of the upper regular insulin injection pen is replaced by a flexible circuit around the inner diameter of the pen. 挠性电路用作控制器404以用于控制药物计量机构(例如微型泵406或马达)以将编程剂量输送给用户。 Flex circuit 404 serves as a controller for controlling the medicament metering means (e.g., a micro-pump or motor 406) to deliver doses to the user program. 可再充电电池408可以设在挠性电路内部的圆筒的中心线上。 A rechargeable battery center line 408 of the cylinder may be provided inside of the flexible circuit. 可更换胰岛素筒402将位于注射笔下部内，并且微型泵406优选地设在胰岛素筒402和输注针头410之间。 Replaceable cartridge insulin injection pen 402 will be located in portions, and the micropump 406 is preferably provided between the insulin infusion needle cylinder 402 and 410. 微型泵406可以由以上讨论的且在题为” Flexible and Conformal Patch Pump (挠性和共形贴肤泵)”的先前并入的共同未决申请(代理人案卷号P-8678 (55581))中提供的任意技术实现。 The micropump 406 may, and in the discussion above, entitled "Flexible and Conformal Patch Pump (conformal and flexible skin attached pump)" of the previously incorporated co-pending application (Attorney Docket No. P-8678 (55581)) provided any technology implementation. 在一些实施例中，微型泵406可由马达替换，所述马达设在胰岛素筒402的近侧以驱动可移动停止器将流体直接迫入输注针头410。 In some embodiments, the micropump 406 may replace the motor, the motor provided at the proximal barrel 402 to drive the insulin movable stop forcing fluid directly into the infusion needle 410. 在该实施例中，线性致动器可以与胰岛素瓶成直线地放置在挠性电路内部。 In this embodiment, the linear actuator may be a straight line with the insulin bottle placed inside the flexible circuit. 线性致动器施加力以驱动设在瓶中的柱塞或停止器，导致等于柱塞运动的排代容量的单次剂量。 Linear actuator applies a force to drive the plunger or provided on the bottle stopper, resulting in movement of the plunger is equal to the displacement capacity of the single dose. 很小的线性致动器是可用的并且可以有利地用于该目的。 Small linear actuator is available and can be advantageously used for this purpose. 一个例子是由NewScale Technologies制造的Squiggle ®线性致动器。 An example is manufactured by the NewScale Technologies Squiggle ® linear actuator. 注射笔的上部和下部优选地分离以便更换胰岛素筒，并且当被组装时，提供至微型泵406或马达的电连接。 The pen preferably separated from upper and lower portions to replace the insulin cartridge, and, when assembled, provide electrical connection to the motor of the micropump 406 or. 每当药物输送装置400附连到PDM 500时，输送装置400中的可再充电电池408可以被充电，并且存储在注射笔中的输注历史或血糖历史可以自动地上载到PDM 500。 Whenever the drug delivery device 400 is attached to the PDM 500, delivery device 400 may be a rechargeable battery 408 may be charged, and the glucose infusion history or the history stored in the injection pen can be automatically uploaded to PDM 500.
[0083] 本发明的一个示例性实施例可以为药物输送装置400提供经由私域网通信所必需的低成本部件，如先前并入的共同未决美国专利申请序列号12/458，807中所述。 [0083] An exemplary embodiment of the present invention to provide a low cost drug delivery device member 400 via a personal area network communication is necessary, as previously incorporated co-pending U.S. Patent Application Serial No. 12 / 458,807 as above. 该实施例允许药物输送装置400和PDM 500或如以上示例性实施例中公开的“灵巧”可穿戴医疗装置之间的连续通信。 This embodiment allows drug delivery device 400 and PDM 500 as described above in exemplary embodiments or embodiments disclosed in "smart" wearable continuous communications between the medical device. 每当计算单次剂量时，“灵巧”医疗装置或PDM可以自动地编程药物输送装置400，只要两者与用户的身体物理连接。 Whenever the calculation unit dose, "smart" medical device or may be automatically programmed PDM drug delivery device 400, both the user's body as long as the physical connection. 包含生物传感器或以其他方式与生物传感器通信的“灵巧”可穿戴医疗装置也可以能够将单次剂量需求提供给将由装置基于用户的血糖水平自动编程的药物输送装置400。 Comprising a biosensor or otherwise associated with "smart" communications wearable biosensor medical device may also be capable of providing a single dose to the demand by the device based on the user's blood glucose level automatic programming of drug delivery device 400. 另外，每当单次剂量被施予用户时，药物输送装置400可以经由私域网自动地更新PDM或“灵巧”医疗装置。 Further, whenever the user a single dose is administered, the drug delivery device 400 may automatically update the PDM or "smart" medical device via the personal area network. 以上实施例在容易使用且为需要胰岛素疗法的许多用户所熟悉的实施例中提供能够进一步增强以上公开的示例性可穿戴医疗装置的功能性的低成本、智能装置。 In the above embodiments is easy to use and need to provide a low cost exemplary wearable medical device functionality, smart devices disclosed above can be further enhanced by many users familiar embodiment of insulin therapy.
[0084] 尽管已参考特定的示例性实施例显示并描述了本发明,但是它不受示例性实施例限制，而仅由所附权利要求及其等效物限定。 [0084] Although exemplary embodiments with reference to specific exemplary embodiments shown and described the present invention, but it is not limiting the exemplary embodiments, but only of the appended claims and their equivalents defined by. 应当理解本领域技术人员能够改变或修改示例性实施例而不脱离本发明的范围和精神。 It should be understood that those skilled in the art can change or modify the exemplary embodiments without departing from the scope and spirit of the invention.
1.一种用于在延长的使用期向用户施予药物治疗的医疗装置，所述医疗装置包括: 泵机构，用于向用户施予药物； 第一和第二输送套管，用于在第一和第二输注部位将所述药物经皮输注到用户体内； 第一和第二机构，用于分开控制所述第一和第二套管在所述第一和第二输注部位进入所述用户体内的部署；以及流量感测单元，用于通过感测所述第一输送套管是否被阻塞或是否因其它原因无法将药物的期望流量输送至用户而检测所述第一输注部位是否不再可行， 其中，当所述流量感测单元检测到所述输注部位不再可行时从用户撤回所述第一输送套管。 CLAIMS 1. A medical device for the administration of drugs to a user over an extended period of use, the medical device comprising: a pump means for administering medication to a user; a first and a second delivery sheath for the first and second parts of the infusion of medicament percutaneously infused to the body of a user; first and second means for separately controlling the first and second sleeve in the first and second infusion the user enters the site of deployment in the body; and the flow sensing unit, whether blocked or if for some other reason can not deliver the desired flow rate of medication to a user by sensing the first conveyor to detect the first cannula if the infusion site is no longer feasible, wherein, when the sensing unit detects the flow rate of the infusion site to the user to withdraw from the first delivery sheath is no longer feasible.
2.根据权利要求1所述的医疗装置，其中在预定使用期之后从用户撤回所述第一输送套管。 2. The medical device according to claim 1, wherein the first delivery sheath to withdraw from a user after a predetermined lifetime.
3.根据权利要求1所述的医疗装置，其中当撤回所述第一输送套管时将所述第二输送套管部署到用户体内。 The medical device of claim 1, wherein the second delivery sheath to deploy the body of the user when withdrawing the first delivery sheath.
4.根据权利要求1所述的医疗装置，其中用于控制所述第一和第二输送套管的部署的所述第一和第二机构被手动致动。 4. The medical device of claim 1, wherein for controlling the deployment of the first and second delivery sheath first and second means are manually actuated.
5.根据权利要求1所述的医疗装置，其中用于控制所述第一和第二输送套管的部署的所述第一和第二机构被自动致动。 The medical device of claim 1, wherein the means for controlling the deployment of the first and second delivery sheath first and second means are automatically actuated.
6.根据权利要求1所述的医疗装置，还包括供应所述医疗装置的延长使用持续时间所必需的药物容量的储存器。 6. The medical device of claim 1, further comprising supplying the medical device to extend the duration of use of the drug required storage capacity.
7.根据权利要求1所述的医疗装置，还包括用于将药物供应到相应的第一和第二输送套管的第一和第二储存器。 The medical device of claim 1, further comprising means for supplying a drug to the respective first and second first and second reservoirs of the delivery sheath.
8.根据权利要求1所述的医疗装置，还包括供应输注到用户体内的药物的可再填充储存器，所述储存器包括用于接收药物的供应的端口或隔膜。 8. The medical device of claim 1, further comprising a supply of drug infusion into the body of the user may refill reservoir, the reservoir includes a port for supplying or receiving a diaphragm drug.
9.根据权利要求1所述的医疗装置，还包括用于接收预填充储存器组件的接收器。 9. The medical device of claim 1, further comprising a receiver for receiving a pre-filled reservoir assembly.
10.根据权利要求1所述的医疗装置，其中所述泵机构和用于控制所述第一和第二套管的部署的所述第一和第二机构被容纳在所述医疗装置的可再使用部分内。 10. The medical device of can according to claim 1, wherein the deployment mechanism and the pump for controlling the first and second first and second sleeve means are housed in the medical device reuse inner portion.
11.根据权利要求1所述的医疗装置，其中所述医疗装置用沿所述医疗装置的周长设置的挠性锯齿形粘合带附着至用户皮肤。 11. The medical device of claim 1, wherein the flexible zigzag along the perimeter of the medical device with the medical device attached to the adhesive tape provided the user's skin.
12.根据权利要求11所述的医疗装置，其中所述粘合带包括弹性体或泡沫层。 12. The medical device according to claim 11, wherein said adhesive tape comprises a layer of an elastomeric or foam.
13.根据权利要求1所述的医疗装置，其中所述泵机构被控制以将预编程药物输送分布施予用户。 13. The medical device of claim 1, wherein said pump means is controlled to the preprogrammed drug delivery administration user profile.
14.一种用于延长医疗装置的使用的方法，所述医疗装置包括用于向用户施予药物治疗的第一和第二输送套管，所述方法包括: 在输注部位将所述第一套管部署到用户体内以用于向用户施予药物； 从所述用户撤回所述第一套管；以及在第二输注部位将所述第二套管部署到所述用户体内以用于向所述用户施予药物， 其中，所述方法还包括以下步骤:通过检测所述第一套管被阻塞或无法将药物的期望流量输送至用户来确定所述输注部位是否不再可行，并且当确定所述输注部位不再可行时从所述用户撤回所述第一套管。 14. A method for extending the use of a medical device, the medical device includes means for administering drugs to a user a first and a second delivery sheath, said method comprising: said first portion of the infusion a sleeve for deployment into the body of the user administering the drug to a user; withdrawing the sleeve from the first user; and deployed to the body of the user in a second infusion site to the second sleeve with in administering the drug to a user, wherein said method further comprises the step of: blocked or not to deliver the desired flow rate of medication to a user is determined by detecting whether the first sleeve infusion site is no longer viable and when it is determined that the injection site is no longer possible to withdraw the sleeve from the first user.
15.根据权利要求14所述的方法，还包括在预定使用期之后从所述用户撤回所述第一套管。 15. The method of claim 14, further comprising withdrawing the cannula from the first user after a predetermined lifetime.
16.根据权利要求14所述的方法，其中所述部署的步骤还包括在相应的输注部位将相应的套管自动地部署到用户体内。 16. The method according to claim 14, wherein said step of deploying further comprises a respective infusion site corresponding to the sleeve body of the user is automatically deployed.
17.根据权利要求14所述的方法，其中所述部署的步骤还包括在相应的输注部位将相应的套管手动地部署到用户体内。 17. The method according to claim 14, wherein said step of deploying further comprises a respective infusion site corresponding to the sleeve body of the user manually deployed.
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