公开(公告)号：US09532741B2

公开(公告)日：2017-01-03

申请号：US14341468

申请日：2014-07-25

Applicant: DexCom, Inc.

Inventor： James H. Brauker ,  Mark C. Shults ,  Mark A. Tapsak

IPC: A61B5/145 ,  A61B5/1473 ,  A61B5/07 ,  A61B5/1486 ,  A61L31/10 ,  A61L31/14

CPC classification number: A61B5/14735 ,  A61B5/076 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/14865 ,  A61B2562/02 ,  A61L31/10 ,  A61L31/14 ,  Y10T428/249921

Abstract: The present invention provides a biointerface membrane for use with an implantable device that interferes with the formation of a barrier cell layer including; a first domain distal to the implantable device wherein the first domain supports tissue attachment and interferes with barrier cell layer formation and a second domain proximal to the implantable device wherein the second domain is resistant to cellular attachment and is impermeable to cells. In addition, the present invention provides sensors including the biointerface membrane, implantable devices including these sensors or biointerface membranes, and methods of monitoring glucose levels in a host utilizing the analyte detection implantable device of the invention. Other implantable devices which include the biointerface membrane of the present invention, such as devices for cell transplantation, drug delivery devices, and electrical signal delivery or measuring devices are also provided.

Abstract translation: 本发明提供了一种用于与可植入装置一起使用的生物界面膜，其干扰屏障细胞层的形成，包括： 远离植入装置的第一区域，其中第一结构域支持组织附着并干扰阻挡细胞层形成，以及邻近可植入装置的第二结构域，其中第二结构域对细胞附着有抗性并且对细胞是不可渗透的。 此外，本发明提供了包括生物界面膜，包括这些传感器或生物界面膜的可植入装置的传感器，以及利用本发明的分析物检测可植入装置监测宿主中的葡萄糖水平的方法。 还提供了包括本发明的生物界面膜的其它可植入装置，例如用于细胞移植的装置，药物递送装置和电信号传递或测量装置。

公开(公告)号：US09439589B2

公开(公告)日：2016-09-13

申请号：US14553382

申请日：2014-11-25

Applicant: DexCom, Inc.

Inventor： Mark C. Shults ,  Stuart J. Updike ,  Rathbun K. Rhodes ,  Barbara J. Gilligan ,  Mark A. Tapsak

IPC: A61B5/00 ,  A61B5/1486 ,  A61B5/145 ,  A61B5/1455 ,  C12Q1/00

CPC classification number: A61B5/14532 ,  A61B5/0031 ,  A61B5/1455 ,  A61B5/14558 ,  A61B5/1459 ,  A61B5/1486 ,  A61B5/14865 ,  A61B2562/17 ,  C12Q1/006

Abstract: Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices include unique architectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.

公开(公告)号：US20150351683A1

公开(公告)日：2015-12-10

申请号：US14830568

申请日：2015-08-19

Applicant: DexCom, Inc.

Inventor： James H. Brauker ,  Mark A. Tapsak ,  Sean T. Saint ,  Apurv Ullas Kamath ,  Paul V. Neale ,  Peter C. Simpson ,  Michael Robert Mensinger ,  Dubravka Markovic

IPC: A61B5/00 ,  A61M5/172 ,  A61M11/00 ,  A61B5/1486 ,  A61M15/00 ,  A61B5/145 ,  A61M5/315

CPC classification number: A61M5/31525 ,  A61B5/0002 ,  A61B5/14532 ,  A61B5/1486 ,  A61B5/14865 ,  A61B5/4839 ,  A61B2560/0443 ,  A61M5/1723 ,  A61M11/00 ,  A61M15/0001 ,  A61M2005/1726 ,  A61M2205/18 ,  A61M2205/3303 ,  A61M2205/502 ,  A61M2205/52 ,  A61M2230/201 ,  G06F19/00 ,  G06F19/3468 ,  G16H20/17 ,  G16H40/63

Abstract: Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.

公开(公告)号：US20140378798A1

公开(公告)日：2014-12-25

申请号：US14482458

申请日：2014-09-10

Applicant: DexCom, Inc.

Inventor： Mark A. Tapsak ,  Rathbun K. Rhodes ,  Mark C. Shults ,  Jason D. McClure

IPC: A61B5/1473 ,  B05D5/00 ,  B05D3/00 ,  A61B5/145

CPC classification number: A61B5/14865 ,  A61B5/14532 ,  A61B5/1473 ,  A61B5/1486 ,  A61B2562/028 ,  A61B2562/125 ,  A61L31/12 ,  B01D69/141 ,  B01D71/54 ,  B01D71/80 ,  B05D3/007 ,  B05D5/00 ,  C12Q1/002 ,  C12Q1/006 ,  Y10T428/31551

Abstract: The invention provides an implantable membrane for regulating the transport of analytes therethrough that includes a matrix including a first polymer; and a second polymer dispersed throughout the matrix, wherein the second polymer forms a network of microdomains which when hydrated are not observable using photomicroscopy at 400× magnification or less. In one aspect, the homogeneous membrane of the present invention has hydrophilic domains dispersed substantially throughout a hydrophobic matrix to provide an optimum balance between oxygen and glucose transport to an electrochemical glucose sensor.

Abstract translation: 本发明提供了一种用于调节分析物通过其的运输的可植入膜，其包括包含第一聚合物的基质; 和分散在整个基质中的第二种聚合物，其中第二种聚合物形成微区网络，当400×放大倍率或更小时，使用光学显微镜不能观察到水合。 在一个方面，本发明的均质膜具有基本上分散在疏水性基质上的亲水性畴，以提供氧和葡萄糖转运到电化学葡萄糖传感器之间的最佳平衡。

公开(公告)号：US20230139158A1

公开(公告)日：2023-05-04

申请号：US18089351

申请日：2022-12-27

Applicant: DexCom, Inc.

Inventor： Jiong Zou ,  Robert J. Boock ,  Andrew Trinin Dennis ,  Ted Tang Lee ,  Jeff T. Suri ,  David Sze ,  Mark A. Tapsak ,  Huashi Zhang ,  Shanger Wang

IPC: G01N27/327 ,  C12N11/089 ,  C12N11/093 ,  C12N11/08 ,  C08L39/06 ,  C08L69/00 ,  C08L75/04 ,  C12Q1/00 ,  A61B5/00 ,  A61B5/145 ,  A61B5/1486 ,  G01N33/66 ,  A61K31/045 ,  A61K31/137 ,  A61K31/46 ,  A61K31/465 ,  A61K31/485 ,  A61K31/515 ,  A61K31/56 ,  A61K33/00 ,  A61K36/185 ,  A61K38/28 ,  A61B5/1473

Abstract: Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The enzyme layer protects the enzyme and prevents it from leaching from the sensing membrane into a host or deactivating.

公开(公告)号：US20220111148A1

公开(公告)日：2022-04-14

申请号：US17556761

申请日：2021-12-20

Applicant: DexCom, Inc.

Inventor： James H. Brauker ,  Mark A. Tapsak ,  Sean T. Saint ,  Apurv Ullas Kamath ,  Paul V. Neale ,  Peter C. Simpson ,  Michael Robert Mensinger ,  Dubravka Markovic

IPC: A61M5/315 ,  A61B5/1486 ,  A61M15/00 ,  A61M11/00 ,  A61B5/00 ,  A61B5/145 ,  A61M5/172 ,  G16H40/63 ,  G16H10/40 ,  G16H20/17

Abstract: Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.

公开(公告)号：US20190239782A1

公开(公告)日：2019-08-08

申请号：US16388752

申请日：2019-04-18

Applicant: DexCom, Inc.

Inventor： Mark C. Shults ,  Stuart J. Updike ,  Rathbun K. Rhodes ,  Barbara J. Gilligan ,  Mark A. Tapsak

IPC: A61B5/145 ,  A61B5/1455 ,  C12Q1/00 ,  A61B5/1486 ,  A61B5/00

CPC classification number: A61B5/0031 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/14558 ,  A61B5/1459 ,  A61B5/1486 ,  A61B5/14865 ,  A61B2562/17 ,  C12Q1/006

Abstract: Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices include unique architectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.

公开(公告)号：US10039480B2

公开(公告)日：2018-08-07

申请号：US14619651

申请日：2015-02-11

Applicant: DexCom, Inc.

Inventor： James H. Brauker ,  Mark C. Shults ,  Mark A. Tapsak

IPC: A61B5/00 ,  A61F2/02 ,  G01N27/40 ,  A61B5/1473 ,  A61B5/07 ,  A61B5/1486 ,  A61L31/10 ,  A61L31/14 ,  A61B5/145

Abstract: The present invention provides a biointerface membrane for use with an implantable device that interferes with the formation of a barrier cell layer including; a first domain distal to the implantable device wherein the first domain supports tissue attachment and interferes with barrier cell layer formation and a second domain proximal to the implantable device wherein the second domain is resistant to cellular attachment and is impermeable to cells. In addition, the present invention provides sensors including the biointerface membrane, implantable devices including these sensors or biointerface membranes, and methods of monitoring glucose levels in a host utilizing the analyte detection implantable device of the invention. Other implantable devices which include the biointerface membrane of the present invention, such as devices for cell transplantation, drug delivery devices, and electrical signal delivery or measuring devices are also provided.

公开(公告)号：US09993186B2

公开(公告)日：2018-06-12

申请号：US15429022

申请日：2017-02-09

Applicant: DexCom, Inc.

Inventor： James R. Petisce ,  Mark A. Tapsak ,  Peter C. Simpson ,  Victoria Carr-Brendel ,  James H. Brauker

IPC: A61B5/1473 ,  A61B5/145 ,  A61B5/1486

CPC classification number: A61B5/1473 ,  A61B5/145 ,  A61B5/14503 ,  A61B5/14532 ,  A61B5/14546 ,  A61B5/1468 ,  A61B5/14735 ,  A61B5/14865

Abstract: The present invention relates generally to systems and methods for increasing oxygen availability to implantable devices. The preferred embodiments provide a membrane system configured to provide protection of the device from the biological environment and/or a catalyst for enabling an enzymatic reaction, wherein the membrane system includes a polymer formed from a high oxygen soluble material. The high oxygen soluble polymer material is disposed adjacent to an oxygen-utilizing source on the implantable device so as to dynamically retain high oxygen availability to the oxygen-utilizing source during oxygen deficits. Membrane systems of the preferred embodiments are useful for implantable devices with oxygen-utilizing sources and/or that function in low oxygen environments, such as enzyme-based electrochemical sensors and cell transplantation devices.

公开(公告)号：US20180024086A1

公开(公告)日：2018-01-25

申请号：US15720329

申请日：2017-09-29

Applicant: DexCom, Inc.

Inventor： Rathbun K. Rhodes ,  Mark A. Tapsak ,  James H. Brauker ,  Mark C. Shults

IPC: G01N27/327 ,  C12Q1/00 ,  A61B5/1486 ,  G01N33/487 ,  A61B5/145

CPC classification number: G01N27/3272 ,  A61B5/14532 ,  A61B5/14865 ,  C12Q1/002 ,  C12Q1/006 ,  G01N33/48707 ,  G01N33/48785

Abstract: The present invention provides a sensor head for use in an implantable device that measures the concentration of an analyte in a biological fluid which includes: a non-conductive body; a working electrode, a reference electrode and a counter electrode, wherein the electrodes pass through the non-conductive body forming an electrochemically reactive surface at one location on the body and forming an electronic connection at another location on the body, further wherein the electrochemically reactive surface of the counter electrode is greater than the surface area of the working electrode; and a multi-region membrane affixed to the nonconductive body and covering the working electrode, reference electrode and counter electrode. In addition, the present invention provides an implantable device including at least one of the sensor heads of the invention and methods of monitoring glucose levels in a host utilizing the implantable device of the invention.