公开(公告)号：US6009343A

公开(公告)日：1999-12-28

申请号：US606506

申请日：1996-02-23

Applicant: Eric B. Shain ,  Tuan A. Elstrom ,  Thomas G. Schapira ,  Timothy P. Henning

Inventor： Eric B. Shain ,  Tuan A. Elstrom ,  Thomas G. Schapira ,  Timothy P. Henning

IPC: A61B5/00 ,  A61B5/145 ,  A61N1/30

CPC classification number: A61B5/14514 ,  A61B5/14532

Abstract: The present disclosure provides the use of vacuum to enhance the transdermal transport of fluids in sampling methods for the detection of analytes in a patient's blood.

Abstract translation: 本公开提供了在用于检测患者血液中的分析物的取样方法中使用真空来增强流体的透皮转运。

公开(公告)号：US20120296189A1

公开(公告)日：2012-11-22

申请号：US13458556

申请日：2012-04-27

Applicant: John Bhogal ,  Shridhara Alva Karinka ,  Timothy P. Henning ,  David Cunningham ,  Udo Hoss ,  Andrew H. Naegeli ,  John LaTour

Inventor： John Bhogal ,  Shridhara Alva Karinka ,  Timothy P. Henning ,  David Cunningham ,  Udo Hoss ,  Andrew H. Naegeli ,  John LaTour

IPC: G01N30/96 ,  G01N33/00 ,  A61B5/00

CPC classification number: A61B10/0045 ,  A61B5/14503 ,  A61B5/14514 ,  A61B5/14532 ,  A61B5/1459 ,  A61B5/1495 ,  A61B2010/008 ,  G01N30/96

Abstract: Provided are methods of measuring analyte concentrations in interstitial fluid samples, methods of determining accuracy of subcutaneously implantable analyte sensors, methods of manufacturing and determining calibration factors for subcutaneously implantable analyte sensors, as well as subcutaneously implantable analyte sensors manufactured according to the described methods and having a high level of accuracy. Methods of determining the concentration of an analyte in a bodily sample, and methods of extracting interstitial fluid are also provided.

Abstract translation: 提供了测量间质液样品中分析物浓度的方法，确定皮下可植入分析物传感器的准确性的方法，制备和确定皮下可植入分析物传感器的校准因子的方法，以及根据所述方法制造的皮下可植入分析物传感器，并具有 高精度。 还提供了确定身体样品中分析物浓度的方法和提取组织液的方法。

公开(公告)号：US06565738B1

公开(公告)日：2003-05-20

申请号：US09239200

申请日：1999-01-28

Applicant: Timothy P. Henning ,  Kristen L. Cousineau

Inventor： Timothy P. Henning ,  Kristen L. Cousineau

IPC: G01N27327

CPC classification number: G01N33/5438 ,  C12Q1/52

Abstract: A biosensor for determining the concentration of an analyte, such as, for example, ALT, in a sample of biological fluid, such as, for example, whole blood, comprising: (a) a base layer; (b) a detecting layer comprising a reference electrode and a working electrode, the surface of the electrically conductive portion of the working electrode being sufficiently smooth so that determination of the concentration of an analyte present in a low concentration, e.g., less than 1 mM, can be made; (c) a layer overlying said electrodes, said layer comprising dried reagents; and (d) an anticoagulant disposed in such a location that it will prevent the sample from coagulating during the determination. The biosensor preferably further includes a fluid-transporting layer to aid in delivering the sample from a sample application zone to the electrodes. The biosensor preferably further includes a covering layer overlying the electrode area to reduce evaporation of the sample during the assay and to help define the fluid transport path and the volume of fluid over the detecting layer.

Abstract translation: 一种生物传感器，用于在生物流体例如全血样品中测定分析物（例如ALT）的浓度，包括：（a）基底层;（b）检测层，包括 参考电极和工作电极，工作电极的导电部分的表面足够光滑，从而可以确定以低浓度（例如小于1mM）存在的分析物的浓度;（c ）覆盖所述电极的层，所述层包括干燥试剂; 和（d）设置在这样的位置的抗凝血剂，以防止样品在测定期间凝结。生物传感器优选地还包括流体输送层，以帮助将样品从样品施加区输送到电极。 生物传感器优选地还包括覆盖电极区域的覆盖层，以减少在测定期间样品的蒸发，并帮助限定流体输送路径和检测层上的流体体积。

公开(公告)号：US06537243B1

公开(公告)日：2003-03-25

申请号：US09689527

申请日：2000-10-12

Applicant: Timothy P. Henning ,  Michael G. Lowery

Inventor： Timothy P. Henning ,  Michael G. Lowery

IPC: A61N532

CPC classification number: A61B5/14514 ,  A61B5/150022 ,  A61B5/150061 ,  A61B5/150099 ,  A61B5/150389 ,  A61B5/150442 ,  A61B5/150503 ,  A61B5/150946 ,  A61B5/150969 ,  A61B5/15142 ,  A61B2010/008

Abstract: A device for obtaining a sample of interstitial fluid from a patient for use in monitoring the level of blood glucose in the patient. The device comprises a hollow tube having a wall surrounding a cavity, wherein the wall of the tube contains a multiplicity of pores.

Abstract translation: 一种用于从患者获得间质液样品用于监测患者血糖水平的装置。 该装置包括具有围绕空腔的壁的中空管，其中管的壁包含多个孔。

公开(公告)号：US6093156A

公开(公告)日：2000-07-25

申请号：US982721

申请日：1997-12-02

Applicant: David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young ,  Andrew J. Muetterties ,  Thomas G. Schapira ,  Geoffrey R. Chambers ,  Graham J. Hughes ,  Jared L. Watkin ,  Gary F. Prokop ,  Joshua P. Goldfarb

Inventor： David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young ,  Andrew J. Muetterties ,  Thomas G. Schapira ,  Geoffrey R. Chambers ,  Graham J. Hughes ,  Jared L. Watkin ,  Gary F. Prokop ,  Joshua P. Goldfarb

IPC: A61B5/151 ,  A61B5/00 ,  A61B5/145 ,  A61B5/1459 ,  A61B5/1473 ,  A61B5/15 ,  A61B5/154 ,  A61B5/157 ,  G01N33/48 ,  G01N33/66

CPC classification number: A61B5/15186 ,  A61B5/14532 ,  A61B5/1486 ,  A61B5/150022 ,  A61B5/150068 ,  A61B5/150076 ,  A61B5/150099 ,  A61B5/150221 ,  A61B5/150412 ,  A61B5/150503 ,  A61B5/150664 ,  A61B5/15113 ,  A61B5/15125 ,  A61B5/1519 ,  A61B5/15194 ,  A61B5/157 ,  A61B5/411 ,  A61B2562/0295 ,  A61B5/150358

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained,(b) forming a seal between said blood collection device and said surface of the skin,(c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood,(d) triggering a lancing assembly and causing a lancet to penetrate said skin,(e) retracting said lancet,(f) withdrawing blood toward and onto a fluid collector, and(g) releasing the vacuum.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with said sealable chamber,(b) a power source,(c) a vacuum pump operably connected to said power source, said vacuum pump in communication with said sealable chamber,(d) a lancing assembly positioned within said housing, said lancing assembly capable of moving a lancet towards said sealable opening, and(e) a fluid collector positioned in said sealable chamber, said fluid collector in fluid communication with said sealable opening.

公开(公告)号：US6027496A

公开(公告)日：2000-02-22

申请号：US823940

申请日：1997-03-25

Applicant: Neil W. Loomis ,  Peter M. Bojan ,  Timothy P. Henning ,  Mark R. Pope ,  Andrew J. Muetterties

Inventor： Neil W. Loomis ,  Peter M. Bojan ,  Timothy P. Henning ,  Mark R. Pope ,  Andrew J. Muetterties

IPC: A61F9/007 ,  A61B17/00 ,  A61B18/18 ,  A61B18/20 ,  A61B17/36

CPC classification number: A61B18/20 ,  A61B5/14514 ,  A61B5/150022 ,  A61B5/15136 ,  A61B2017/00765 ,  A61B2018/00636 ,  A61B2018/1807 ,  A61M2037/0007

Abstract: A method for increasing the permeability of the stratum corneum by means of a source of light, preferably a laser, more preferably a pulsed laser. By increasing the permeability of the stratum corneum, access to the interstitial fluid is achieved, thereby enabling measurement of analytes in the interstitial fluid. In one aspect, the method comprises the steps of:(a) providing a source of light having a wavelength of from about 930 nm to about 1040 nm; and(b) exposing a region of the stratum corneum of the patient to said source of light for a period of time sufficient to form an opening in the stratum corneum.Preferably, exposure of the region of the stratum corneum to the source of light is ceased when an amount of interstitial fluid fills the opening in the stratum corneum, which amount is sufficient to cause the scatter intensity of the light reflected from the surface of the interstitial fluid occupying the opening in the stratum corneum to differ from the scatter intensity of the light reflected from a region of the stratum corneum that is substantially free of interstitial fluid. The invention also involves an apparatus for carrying out the foregoing method.

Abstract translation: 通过光源，优选激光，更优选脉冲激光来提高角质层的透过性的方法。 通过增加角质层的渗透性，实现对间质液的接近，从而能够测量间质液中的分析物。 一方面，该方法包括以下步骤：（a）提供波长为约930nm至约1040nm的光源; 和（b）将患者的角质层的区域暴露于所述光源一段足以在角质层中形成开口的时间段。 优选地，当间质液体的量填充角质层中的开口时，角质层的区域暴露于光源将被停止，该量足以引起从间隙的表面反射的光的散射强度 占据角质层中的开口的流体不同于从基本上不含间质液的角质层区域反射的光的散射强度。 本发明还涉及一种用于执行上述方法的装置。

公开(公告)号：US5310469A

公开(公告)日：1994-05-10

申请号：US815423

申请日：1991-12-31

Applicant: David D. Cunningham ,  Susan B. Brontman ,  Jill M. Geist ,  R. Hayes Helgren ,  Timothy P. Henning ,  Kenneth S. Johnson ,  Laura S. Morici ,  Thomas G. Schapira ,  Neal T. Sleszynski

Inventor： David D. Cunningham ,  Susan B. Brontman ,  Jill M. Geist ,  R. Hayes Helgren ,  Timothy P. Henning ,  Kenneth S. Johnson ,  Laura S. Morici ,  Thomas G. Schapira ,  Neal T. Sleszynski

IPC: C12Q1/00 ,  G01N27/26

CPC classification number: C12Q1/001 ,  C12Q1/002 ,  Y10S435/817

Abstract: A sensor for measuring the concentration of an analyte in a solution is disclosed. The sensor may be adapted for use as either an amperometric or a potentiometric sensor. It includes a membrane having a biologically active protein immobilized within. The membrane is attached and reliably sealed to a housing by means of ultrasonic welding, either directly or indirectly. Further, the membrane may be compressed to a fraction of its original dimensions. Metallic parts of the device may, optionally, be physically isolated from the sample solution to reduce corrosion. These features operate synergistically so that the claimed device exhibits relatively fast response and recovery times, is reliably leak-proof, and may be constructed in relatively small sizes.

Abstract translation: 公开了一种用于测量溶液中分析物浓度的传感器。 传感器可以适用于电流计或电位传感器。 它包括固定有生物活性蛋白质的膜。 通过直接或间接的超声波焊接将膜附接并可靠地密封到外壳。 此外，膜可以被压缩到其原始尺寸的一部分。 设备的金属部分可以任选地与样品溶液物理隔离以减少腐蚀。 这些特征协同运作，使得所要求保护的装置表现出相对较快的响应和恢复时间，可靠地防漏，并且可以构造成相对较小的尺寸。

公开(公告)号：US06837858B2

公开(公告)日：2005-01-04

申请号：US09972444

申请日：2001-10-05

Applicant: David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young ,  Andrew J. Muetterties ,  Thomas G. Schapira ,  Geoffrey R. Chambers ,  Graham J. Hughes ,  Jared L. Watkin ,  Gary F. Prokop ,  Joshua P. Goldfarb

Inventor： David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young ,  Andrew J. Muetterties ,  Thomas G. Schapira ,  Geoffrey R. Chambers ,  Graham J. Hughes ,  Jared L. Watkin ,  Gary F. Prokop ,  Joshua P. Goldfarb

IPC: A61B5/151 ,  A61B5/00 ,  A61B5/145 ,  A61B5/1459 ,  A61B5/1473 ,  A61B5/15 ,  A61B5/154 ,  A61B5/157 ,  G01N33/48 ,  G01N33/66

CPC classification number: A61B5/15186 ,  A61B5/14532 ,  A61B5/1486 ,  A61B5/150022 ,  A61B5/150068 ,  A61B5/150076 ,  A61B5/150099 ,  A61B5/150221 ,  A61B5/150358 ,  A61B5/150412 ,  A61B5/150503 ,  A61B5/150664 ,  A61B5/15113 ,  A61B5/15125 ,  A61B5/1519 ,  A61B5/15194 ,  A61B5/157 ,  A61B5/411 ,  A61B2562/0295

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained, (b) forming a seal between said blood collection device and said surface of the skin, (c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood, (d) triggering a lancing assembly and causing a lancet to penetrate said skin, (e) retracting said lancet, (f) withdrawing blood toward and onto a fluid collector, and (g) releasing the vacuum. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with said sealable chamber, (b) a power source, (c) a vacuum pump operably connected to said power source, said vacuum pump in communication with said sealable chamber, (d) a lancing assembly positioned within said housing, said lancing assembly capable of moving a lancet towards said sealable opening, and (e) a fluid collector positioned in said sealable chamber, said fluid collector in fluid communication with said sealable opening.

Abstract translation: 用于从患者获得血样的方法和装置用于随后的诊断测试，例如葡萄糖监测。 在本发明的一个方面，所述方法包括以下步骤：（a）将血液收集装置放置在要获得所述样品的皮肤表面上的区域上，（b）在所述血液收集器之间形成密封 装置和皮肤表面，（c）产生足以导致皮肤表面变得伸展和凝结的真空的真空，（d）触发穿刺组件并使刺血针穿透所述皮肤，（e）缩回 所述刺血针，（f）朝向流体收集器排出血液，和（g）释放真空。在本发明的另一方面，提供一种用于执行前述方法的装置。 该设备包括：（a）壳体，其中具有位于其中的可密封腔室和与所述可密封腔室流体连通的可密封开口，（b）动力源，（c）可操作地连接到所述动力源的真空泵，所述真空泵 与所述可密封腔室连通，（d）位于所述壳体内的采血组件，所述穿刺组件能够将刺血针移向所述可密封开口，以及（e）定位在所述可密封腔室中的流体收集器，所述流体收集器处于流体连通 具有所述可密封的开口。

公开(公告)号：US06283926B1

公开(公告)日：2001-09-04

申请号：US09532729

申请日：2000-03-22

Applicant: David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young

Inventor： David D. Cunningham ,  Timothy P. Henning ,  Eric B. Shain ,  Douglas F. Young

IPC: A61B500

CPC classification number: A61B5/411 ,  A61B5/14532 ,  A61B5/150022 ,  A61B5/150068 ,  A61B5/150099 ,  A61B5/150221 ,  A61B5/150229 ,  A61B5/150358 ,  A61B5/150412 ,  A61B5/15136 ,  A61B5/157

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing.

Abstract translation: 用于从患者获得血样的方法和装置用于随后的诊断测试，例如葡萄糖监测。 在本发明的一个方面，所述方法包括以下步骤：（a）在要从其中提取血液样本的皮肤区域中形成无障碍的开口; 并且（b）借助于皮肤的真空和拉伸，从皮肤中的无障碍的开口提取血液样品。在本发明的另一方面，提供了一种用于执行前述方法的装置。 该装置包括：（a）用于在皮肤区域形成无障碍的开口的装置，所述皮肤区域将从所述皮肤区域中提取所述样品，优选为采血组件; 和（b）真空泵。优选地，该装置还包括壳体。

公开(公告)号：US06155992A

公开(公告)日：2000-12-05

申请号：US982449

申请日：1997-12-02

Applicant: Timothy P. Henning ,  Robert G. Hiltibran ,  David D. Cunningham ,  Eric B. Shain ,  Brian J. Tarkowski ,  Douglas F. Young

Inventor： Timothy P. Henning ,  Robert G. Hiltibran ,  David D. Cunningham ,  Eric B. Shain ,  Brian J. Tarkowski ,  Douglas F. Young

IPC: A61B5/151 ,  A61B5/00 ,  A61B5/1455 ,  A61B5/1477 ,  A61B5/15 ,  A61B10/00

CPC classification number: A61B5/14514 ,  A61B10/0045 ,  A61B5/14532 ,  A61B2010/008 ,  A61M2037/0007

Abstract: A method and apparatus for obtaining a sample of interstitial fluid from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of (a) treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (b) forming an opening in the treated area of the skin; and (c) extracting the sample of interstitial fluid from the opening in the skin, with the aid of vacuum and stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. Th apparatus comprises (a) a device for forming an unobstructed opening in the area of the skin from which the sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing.

Abstract translation: 一种从患者获得间质液样品的方法和装置，用于随后的诊断测试，例如葡萄糖监测。 在本发明的一个方面，该方法包括以下步骤：（a）用真空或热或真空和热处理皮肤区域，以增加皮肤区域间隙液的可用性; （b）在皮肤的处理区域中形成开口; 并且（c）借助真空和皮肤拉伸从皮肤开口提取间质液样品。 在本发明的另一方面，提供一种用于执行前述方法的装置。 Th装置包括（a）用于在要从其中提取样品的皮肤区域中形成无障碍的开口的装置，优选为采血组件; 和（b）真空泵。 优选地，该装置还包括壳体。