WO2009026394A1 - Système d'échantillonnage de fluide corporel - Google Patents
Système d'échantillonnage de fluide corporel Download PDFInfo
- Publication number
- WO2009026394A1 WO2009026394A1 PCT/US2008/073765 US2008073765W WO2009026394A1 WO 2009026394 A1 WO2009026394 A1 WO 2009026394A1 US 2008073765 W US2008073765 W US 2008073765W WO 2009026394 A1 WO2009026394 A1 WO 2009026394A1
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- WIPO (PCT)
- Prior art keywords
- analyte
- connector
- analyte sensor
- contacts
- sensors
- Prior art date
Links
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- 239000010839 body fluid Substances 0.000 title description 7
- 238000005070 sampling Methods 0.000 title description 4
- 239000012491 analyte Substances 0.000 claims abstract description 179
- 230000000149 penetrating effect Effects 0.000 claims abstract description 44
- 238000004806 packaging method and process Methods 0.000 claims description 18
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- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 13
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150305—Packages specially adapted for piercing devices or blood sampling devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150358—Strips for collecting blood, e.g. absorbent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150503—Single-ended needles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
Definitions
- This invention relates generally to body fluid sampling and detecting systems, and more particularly to body fluid sampling and detecting systems with improved analyte sensor contacts
- Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis
- Biochemical analysis of blood samples is a diagnostic tool for determining clinical information
- Many po ⁇ nt-of- care tests are performed using whole blood, the most common being monitoring diabetic blood glucose level
- Other uses for this method include the analysis of oxygen and coagulation based on Prothrombin time measurement
- a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin
- Another problem frequently encountered by patients who must use lancing equipment to obtain and analyze blood samples is the amount of manual dexterity and hand-eye coordination required to properly operate the lancing and sample testing equipment due to retinopathies and neuropathies particularly, severe in elderly diabetic patients For those patients, operating existing lancet and sample testing equipment can be a challenge Once a blood droplet is created, that droplet must then be guided into a receiving channel of a small test strip or the like If the sample placement on the strip is unsuccessful, repetition of the entire procedure including re-lancing the skin to obtain a new blood droplet is necessary
- an object of the present invention is to provide an analyte measuring apparatus that provides for connecting sequential analyte sensors to glucose read electronics where there are multiple sample chambers that each have an analyte sensor
- an analyte measuring apparatus that has a housing, a plurality of penetrating members and a plurality of analyte sensors each associated with an analyte sensor pocket and with a penetrating member.
- a plurality of connector pins are coupled to the plurality of analyte sensors and configured to be coupled to contacts of an analyte sensing device that includes analyte read electronics.
- an analyte measuring apparatus has a housing with a shutter door, a plurality of penetrating members and a plurality of analyte sensors each in an analyte sensor pocket and each associated with a penetrating member.
- the analyte sensors are configured to be coupled to contacts of an analyte sensing device that has analyte read electronics.
- the connector is configured to be inserted into an analyte sensor pocket.
- an analyte measuring apparatus has a housing with a shutter door, a plurality of penetrating members and a plurality analyte sensors each in an analyte sensor pocket and each associated with a penetrating member.
- the analyte sensors are configured to be coupled to contacts of an analyte sensing device that has analyte read electronics.
- the connector is configured to be inserted into an analyte sensor pocket.
- Each connector has a first connector that makes connection with the housing, and a second connection coupled to an analyte sensor.
- an analyte measuring apparatus has a housing with a shutter door, a plurality of penetrating members and a plurality analyte sensors each in an analyte sensor pocket and each associated with a penetrating member. At least one seal maintains each of a penetrating member in a selected environment. One or more blades are provided to cut at least a portion of the seal prior to a penetrating member advancing to a tissue site.
- Figures 1-12 illustrate multiple pins that are in a triangular relationship.
- Figures 13 through 17 illustrated an embodiment of the present invention where the connector is disconnected from the pivoting mechanism and put on a cam track.
- Figures 18-21 illustrate an embodiment of the present invention with a new analyte sensor design.
- Figure 22 illustrates an embodiment of the analyte sensor with a carbon pad.
- Figure 23 illustrates analyte sensor pocket dimensions at a midline of the carbon pads.
- Figure 24 illustrates heat-seal flash dimensions of an analyte sensor of the present invention with carbon pads.
- Figure 25 illustrates an embodiment of the present invention of the dimensions after folding a foil seal into the analyte sensor pocket.
- Figure 26 illustrates a sensor-to-analyte sensor pocket alignment.
- Figure 27 illustrates one embodiment of a connector and analyte sensor with dimensions.
- Figure 28 illustrates the alignment of the connector to the analyte sensor pocket opening and the carbon pads.
- Figure 29 is a perspective view of the connector operation with the shutter of the present invention.
- Figures 30 and 31 illustrate embodiments of connectors with a flex cable.
- Figure 32 through 39 illustrate embodiments of a formed connector that are used in the fluid detecting system of the present invention.
- Figures 40-45 illustrate embodiments of the present invention that include blade elements to cut the foil/seal prior to the penetrating member advancing to the tissue site.
- Figure 46 illustrates an embodiment of the present invention where the size and pitch of the electrode contact pads on the analyte sensor strip are increased by linking one electrode from each analyte sensor onto a common electrode for all of the analyte sensors in the disposable.
- Figure 47 illustrates an embodiment of the present invention where each analyte sensor has its own set of three contacts.
- Figures 48-51 illustrate an embodiment of the present invention molded plastic packaging structures are used in packaging the analyte sensors where the electrical contacts are co-molded and positioned in a manner to establish contact with the electrical pads of the analyte sensors.
- Figures 52 to 57 illustrates embodiments of the present invention where interfaces are created between analyte sensor conductors to flex circuit conductors.
- the present invention provides a body fluid detecting system.
- the system includes a housing with a door, a disposable that is positionable and replaceable to and from the housing, a plurality of tissue penetrating members, a plurality of sample chambers that are in the disposable, analyte sensors and electrical contacts couple to the analyte sensors.
- Each sample chamber is associated with a tissue penetrating member.
- Analyte read electronics are coupled to the analyte sensors to provide a reading on the measured analyte, such as glucose. Electrical contacts are used for the coupling.
- a tissue penetrating driver is configured to be coupled to each penetrating member, which can be by way of a gripper. Upon action of a lancing event, the gripper is coupled to the penetrating member and a penetrating member driver. The penetrating member is advanced to the tissue site, creates a wound, and a body fluid sample, such as blood, enters a sample chamber.
- Each sample chamber has an analyte detecting member, or analyte sensor, that measures the amount of analyte in the blood or fluid sample.
- the analyte sensors may be designed for use with a variety of different sensing techniques. Analyte sensors can be in a well, or merely be placed on a support. In one embodiment, analyte sensors include chemistries that are utilized to measure and detect glucose, and other analytes. In another embodiment, analyte detecting members are utilized to detect and measure the amount of different analytes in a body fluid or sample. In one embodiment, the analyte detected is glucose.
- a plurality of sterility enclosures can be provided that at least cover tips of the penetrating members.
- One or more seals are provided to maintain each penetrating member in a sterile condition..
- Each analyte sensor needs to be maintained in a dry state and is sealed or covered.
- a cover sheet can be provided that is a flexible polymer sheet. It should be understood of course that the sheet may be made of a variety of materials useful for coupling an analyte detecting member. This allows the analyte sensor to be sterilized separately from each penetrating member and assembled together at a later time. This process may be used on certain analyte sensors that may be damaged if exposed to the sterilization process. Of course, some embodiments may also have the analyte sensor coupled to the penetrating members during sterilization.
- the cover sheet may also form part of the seal to maintain a sterile environment about portions of the penetrating member.
- the sterility enclosure is removed from their associated penetrating members prior to launch of the penetrating member.
- the enclosure may be peeled away. .
- the sterility barrier can be breached by a device other than a penetrating member or can be breached by a penetrating member itself.
- Each analyte sensor is positioned to receive fluid from a wound created by the penetrating member
- a punch is used to push down on the seal covering the port associated with a penetrating member. This breaks the seal and also pushes it downward, allowing the penetrating member to exit without contacting the seal.
- the seal protrudes outward and is broken off by the downward motion of the punch.
- Seals may be made from a variety of materials such as but not limited to metallic foil, aluminum foil, paper, polymeric material, or laminates combining any of the above.
- the seals may also be made of a fracturable material.
- the seals may be made of a material that can easily be broken when a device applies a force thereto.
- the seals alone or in combination with other barriers may be used to create a sterile environment about at least the tip of the penetrating member prior to lancing or actuation.
- the present invention provides methods and devices for connecting the analyte sensor to the analyte read electronics of the system.
- the width of the connector can be reduced if the connectors, pins, are placed at the corners of a triangle rather than on a line.
- multiple pins 10, e.g., three are in a triangular relationship.
- the connector is not a connector that wipes across the analyte sensor.
- a spring loaded pin is utilized.
- a leaf spring 12 is used to provide the force behind the spring loaded pins 10.
- the pins 10 can have a diameter of about 0.5 mm on a 1.0 mm equilateral triangle enabling leads 14 down to about 1.7 mm. Only a short length of the pins 10 is exposed and the leaf springs 12 can be about 0.8 mm wide.
- the leaf spring 12 contacts the door or shutter 16, there can be a rolling flexible pcb connection, a pivoting mechanism and a sliding mechanism.
- Figure 4 illustrates an inside view with three recesses that can be 0.9 mm wide, are enough to allow heat staking at the top to retain conductors 14. It is also deep enough to prevent contacts for shorting on the foil of the housing.
- Figure 5 illustrates an outside view showing three holes 18 and recesses to mount the pins 10 and provide access for the contacts. This region is wider to allow for improved strength and to prevent the recesses 18 from breaking out.
- Figure 6 shows one contact omitted for clarity.
- Figures 6 and 7 show the leaf spring contacts 12, mid contact in bending and side contact in torsion and bending.
- Figure 8 illustrates a pin 10.
- Figures 9 through 12 illustrates an embodiment of coil springs of the present invention, with exemplary dimensions.
- analyte measuring apparatus 100 that includes a shutter 110, housing door and connector 112 is provided and the connector 112 is inserted into an analyte sensor pocket 114.
- the connector 112 is disconnected from the pivoting mechanism, put on a cam track 116 and added to the shutter 110, the door, to drive the connector 112 into the analyte sensor pocket 114.
- the shutter opens 110 the shutter 110 forces the connector 112 into the analyte sensor pocket 114.
- the connector 112 is pulled out of the analyte sensor housing 114.
- Figures 18-21 illustrate an embodiment of the present invention with a another analyte sensor design 118
- Figure 22 illustrates an embodiment of the analyte sensor with a carbon pad 120
- Figure 23 illustrates analyte sensor pocket dimensions at a midline of the carbon pads 120
- Figure 24 illustrates heat-seal flash dimensions of an analyte sensor of the present invention with carbon pads 120
- Figure 25 illustrates an embodiment of the present invention of the dimensions after folding a foil seal into the analyte sensor pocket 114
- Figure 26 illustrates a sensor-to-analyte sensor pocket 114 alignment
- Figure 27 illustrates one embodiment of a connector 112 and analyte sensor with dimensions
- Figure 28 illustrates the alignment of the connector 112 to the analyte sensor pocket 114 opening and the carbon pads 120
- Figure 29 is a perspective view of the connector operation with the shutter 110 of the present invention
- the present invention provides methods and devices for connecting the analyte sensor to the analyte read electronics of a analyte read system configured to be coupled to the analyte measurement apparatus 200
- a connector 210 is provided that makes two connections One connection is with the housing 212
- the second connection is with the analyte sensor 214 This connects the system circuitry with the analyte read electronics system of the sensor circuitry
- the connector 210 is mounted off the shelf on the door
- the flex cable 216 is added to the connector 210 and is mounted on the housing 212
- the benefits are, there is compliance of motion that comes from the flex cable 216 and not a rubbing motion, there is no friction loads to deal with which alleviates power requirements of a carriage drive and there is less of a bad connection, or connector manning, due to increased friction loads over time
- a connector 210 is a formed connector based on a profile connector
- the profile connector 210 gives close spacing of the connectors themselves
- the shape of the wire is cut as a profile
- the profile has the desired curvature to give the a desired wiping connection that wipes across the surface of a carbon pad of the analyte sensor
- the metal of the connector 210 is not bent but is instead rotated, such as 90 degrees
- the features of the wires are then cut as a profile rather then bent as form
- the shape of the wire connectors 210 is changed to control the amount of wipe across the analyte sensor
- a plastic shield 218 can be placed on the outside of the connectors to shield them from electrical shorting a foil of the disposable In this embodiment, an ability is provided to use 0 15 mm thick contact, and to thicken walls to a mm of about 0 31 mm
- Figures 38 and 39 illustrate a wiping distance across the sensor by the connector 210
- blade elements 310 are provided cut the foil/seal, prior to the penetrating member advancing to the tissue site
- the foil web 312 left by the punch defines an opening that can be for purposes of an example, and without limiting the scope of the present invention, be about 2 396 plus or minus 0 050 mm wide Increasing the opening width to 2 860 plus or minus 0 080 mm, the pocket width with flashing, would require an excessive force
- the addition of the blades cuts the foil 312 and converts the web into a flag 314
- Figures 40-42 illustrate an embodiment that creates foil flags 314 on the side
- the blades are configured to create foil flags 314 on the top as well as on the sides
- the size and pitch of the electrode contact pads 316 on the analyte sensor strip are increased by linking one electrode from each analyte sensor onto a common electrode 318 for all of the analyte sensors in the disposable
- the common electrode 318 can be contacted at a separate convenient location, leaving only two remaining electrode pads 316 per analyte sensor to fit into the available analyte sensor space
- the analyte sensor pads 316 are connected to a meter 320 During the molding process of the disposable, wire, such as copper, is preformed and deposited in a mold Part of the wire is a connector pad at the bottom and front end of the disposable In this embodiment, each analyte sensor has its own set of three contacts This is a simpler approach for the meter 320 An advantage of this embodiment is that is solves a connector problem and is a simple, cost effective manner In one embodiment with bottom front connector pads, a jack connector is placed in the bottom of an analyte sensor chamber, the analyte sensor is placed in the analyte sensor chamber and the jack connector is crimped underneath This moves the analyte sensor into place with the molded wire This provides for a regular pick and place of the analyte sensor, followed by a connecting step through a hole molded in the bottom of the disposable This adds stability because it partially fixes the analyte sensor in the pocket
- molded plastic packaging structures 322 and foil seals 323 are used in packaging the analyte sensors while protecting them from moisture ingress from the ambient During use, it is necessary to open these packaging structures 322 by stripping the foil and providing access to the connector pads on the analyte sensor
- these connector contacts 324 are on external surface of the package 322 This can be achieved by insert molding, or co-molding, metal electrical conduits as integral parts of the packaging structure
- the electrical contacts 324 can be co-molded and positioned in a manner as to establish contact with the electrical pads of the analyte sensors, at one end of the conduits upon insertion of the analyte sensors into the packaging structures, and making the other end of the conduit available for connection to other devices external to the packaging structure.
- This embodiment also provides a method of using the external electrical contact 324 to read the analyte sensor signal during use with these same electrical contacts 324 to establish proper location of the analyte sensors within the packaging structure 322 by monitoring electrical signals. These electrical signals are produced when proper contacts between the analyte sensor pads and the inner end of the conduit are achieved during loading of the analyte sensors into the packaging structure 322.
- interfaces 326 are created between analyte sensor conductors to flex circuit conductors 328 with minimal costs, space and an avoidance of multiple mechanical and or thermal coefficient effects.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
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- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
L'invention concerne un appareil de mesure d'analyte qui comporte un logement, une pluralité d'éléments pénétrants et une pluralité de capteurs d'analyte chacun associé à une poche de capteur d'analyte et avec un élément pénétrant. Une pluralité de broches de connecteur est couplée à la pluralité de capteurs d'analyte et configurées pour être couplées à des contacts d'un dispositif de détection d'analyte qui comprend une électronique de lecture d'analyte.
Applications Claiming Priority (10)
Application Number | Priority Date | Filing Date | Title |
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US95685807P | 2007-08-20 | 2007-08-20 | |
US95687007P | 2007-08-20 | 2007-08-20 | |
US95687607P | 2007-08-20 | 2007-08-20 | |
US95686207P | 2007-08-20 | 2007-08-20 | |
US60/956,876 | 2007-08-20 | ||
US60/956,870 | 2007-08-20 | ||
US60/956,862 | 2007-08-20 | ||
US60/956,858 | 2007-08-20 | ||
US19393508A | 2008-08-19 | 2008-08-19 | |
US12/193,935 | 2008-08-19 |
Publications (1)
Publication Number | Publication Date |
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WO2009026394A1 true WO2009026394A1 (fr) | 2009-02-26 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2008/073765 WO2009026394A1 (fr) | 2007-08-20 | 2008-08-20 | Système d'échantillonnage de fluide corporel |
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WO (1) | WO2009026394A1 (fr) |
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