US2022287627A1PendingUtilityA1

Tactile sensing device for lumbar punctures

Assignee: Texas Medical CenterPriority: May 3, 2016Filed: Jun 2, 2022Published: Sep 15, 2022
Est. expiryMay 3, 2036(~9.8 yrs left)· nominal 20-yr term from priority
A61B 2017/3407A61B 17/3494A61B 5/0053A61B 5/066A61M 2210/1003A61B 17/3417A61B 2017/3405A61B 2017/00026A61B 17/3403A61B 5/4566A61B 17/3401A61B 17/3468A61M 5/427A61B 2017/3413A61B 5/4504A61B 5/4896A61B 2017/00022A61B 5/4887A61B 5/0006A61B 2090/065A61M 5/46
67
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Claims

Abstract

Tactile sensing devices, systems, and methods to image a target tissue location are disclosed. When force is applied to the tactile sensing device, voltage data is detected and visualized on a screen, indicating the target tissue location.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A tactile sensing device for imaging a target tissue location in an individual in need thereof, comprising:
 a) a needle guide having a proximal opening and a distal opening, configured for guiding a needle towards the individual; and   b) a sensor array comprising at least one sensor configured to detect applied pressure.   
     
     
         2 . A tactile sensing device for imaging a target tissue location in an individual in need thereof, comprising:
 a) a needle guide cartridge comprising at least two needle guides, wherein each needle guide has a side opening and a distal opening, and each needle guide is configured for guiding a needle towards the individual; and   b) a sensor array comprising at least one sensor configured to detect applied pressure.   
     
     
         3 . A tactile sensing device for imaging a target tissue location in an individual in need thereof, comprising:
 a) a sensor array comprising at least one sensor configured to detect applied pressure;   b) a display screen; and   c) a marking tool to mark the target tissue location.   
     
     
         4 . A tactile sensing device for imaging a target tissue location in an individual in need thereof, comprising:
 a) a sensor array comprising at least one sensor configured to detect applied pressure;   b) a connection to a display screen; and   c) a marking tool to mark the target tissue location.   
     
     
         5 . The tactile sensing device of  claim 2 , wherein the needle guide cartridge allows for the needle to be inserted into the individual at more than one level. 
     
     
         6 . The tactile sensing device of any of  claims 1 - 4 , and wherein the needle guide allows for the needle to be inserted into the individual at more than one angle. 
     
     
         7 . The tactile sensing device of  claim 6 , wherein the angle is a cephalad angle between about −45 degrees to about 45 degrees. 
     
     
         8 . The tactile sensing device of  claim 7 , wherein the angle is a 15 degree cephalad angle. 
     
     
         9 . The tactile sensing device of any one of  claims 1 - 4 , wherein the sensor array is configured to be loaded into a sensor array holder. 
     
     
         10 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a frame. 
     
     
         11 . The tactile sensing device of  claim 10 , wherein the frame further comprises an elongated portion carrying the needle guide, a downwardly elbowed portion serving as a handle, and a sensor array holder positioned distally away from the handle. 
     
     
         12 . The tactile sensing device of any one of  claims 1 - 2 , further comprising a display screen positioned directly above the sensor array. 
     
     
         13 . The tactile sensing device of any one of  claim 3 ,  4 , or  12 , wherein the display screen is configured to display the target tissue location and the needle to be inserted into the individual. 
     
     
         14 . The tactile sensing device of any one of  claim 3 ,  4 , or  12 , wherein the display screen is a computer screen, a mobile device screen, a liquid crystal display (LCD), a thin film transistor liquid crystal display (TFT-LCD), or an organic light emitting diode (OLED) display. 
     
     
         15 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a needle hub connector that connects to the needle, configured to be inserted through an opening of the needle guide. 
     
     
         16 . The tactile sensing device of  claim 15 , wherein the opening of the needle guide is the proximal opening of the needle guide or a knob opening of the needle guide. 
     
     
         17 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a knob that is coupled to a needle hub connector or extends from a needle hub connector. 
     
     
         18 . The tactile sensing device of  claim 17 , wherein the knob protrudes from a side opening or a slit. 
     
     
         19 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a valve. 
     
     
         20 . The tactile sensing device of  claim 19 , wherein the valve is a 3-way valve or a 3-way stopcock valve. 
     
     
         21 . The tactile sensing device of  claim 19 , wherein the valve is configured to be inserted through a knob opening of a needle guide. 
     
     
         22 . The tactile sensing device of  claim 19 , wherein the valve is fixed onto a needle guide cartridge. 
     
     
         23 . The tactile sensing device of  claim 19 , wherein the valve further comprises a needle hub connector, a fluid connector, a fluid port, a pressure gauge connector, a pressure gauge port, or a combination thereof. 
     
     
         24 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a fluid collection system. 
     
     
         25 . The tactile sensing device of  claim 24 , wherein the fluid collection system is a faucet fluid collection system, rail fluid collection system, diaphragm fluid collection system, or spoke fluid collection system. 
     
     
         26 . The tactile sensing device of  claim 25 , wherein the faucet fluid collection system comprises at least one collection tube, a central rod extending downwardly from a frame, a faucet base extending downwardly from the central rod, and a rotating handle for generating a rotational movement, said rotating handle coupled to the faucet base, wherein at least one collection tube sits on the faucet base. 
     
     
         27 . The tactile sensing device of  claim 25 , wherein the rail fluid collection system comprises a pair of guide rails extending beneath a needle guide cartridge, said guide rails configured to receive a sliding rail platform, said rail platform comprising at least one opening, said opening configured to hold at least one collection tube. 
     
     
         28 . The tactile sensing device of  claim 25 , wherein the diaphragm fluid collection system comprises at least one collection tube, at least one diaphragm, at least one rotating band allowing the diaphragm to be opened or closed, and a cap configured to be secured onto a first collection tube. 
     
     
         29 . The tactile sensing device of  claim 25 , wherein the spoke fluid collection system comprises a central hub; at least one central hub opening located on a side surface of the central hub, said central hub opening configured to connect to at least one collection tube; and a spoke connector extending outwardly from a front face of the central hub. 
     
     
         30 . The tactile sensing device of any one of  claims 1 - 4 , wherein the needle is a spinal needle, an epidural needle, or a biopsy needle. 
     
     
         31 . The tactile sensing device of any one of  claims 1 - 4 , wherein the sensor array is a 6×3 sensor array comprising eighteen sensors. 
     
     
         32 . The tactile sensing device of any one of  claims 1 - 4 , wherein the sensor array is an 8×4 array comprising thirty two sensors. 
     
     
         33 . The tactile sensing device of any one of  claims 1 - 4 , wherein the sensor array is secured onto a platform. 
     
     
         34 . The tactile sensing device of  claim 33 , wherein the platform comprises projections onto which the sensors are adhered to. 
     
     
         35 . The tactile sensing device of  claim 34 , wherein the projections are struts or connectors. 
     
     
         36 . The tactile sensing device of any one of  claims 1 - 4 , wherein the sensor is covered with a material configured to enhance force feedback. 
     
     
         37 . The tactile sensing device of any one of  claims 31 - 36 , wherein the sensor is a force-sensitive resistor. 
     
     
         38 . The tactile sensing device of any one of  claims 3 - 4 , wherein the marking tool is a light, an ink, a hydrogel, a nanoparticle. 
     
     
         39 . The tactile sensing device of  claim 38 , wherein the light is a laser light or a light emitting diode (LED). 
     
     
         40 . The tactile sensing device of  claim 38 , wherein the ink is a permanent ink, a gentian violent ink, a water-based ink, an oil-based in, a liquid ink, or a gel ink. 
     
     
         41 . The tactile sensing device of  claim 38 , wherein the hydrogel further comprises a contrast agent. 
     
     
         42 . The tactile sensing device of  claim 38 , wherein the nanoparticle further comprises a contrast agent. 
     
     
         43 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a multiplexer. 
     
     
         44 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a voltage divider. 
     
     
         45 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a voltage source. 
     
     
         46 . The tactile sensing device of any one of  claims 1 - 4 , further comprising a pressure sensor operatively connected to the tactile sensing device and configured to measure an intracranial pressure. 
     
     
         47 . The tactile sensing device of  claim 46 , wherein the pressure sensor is a piezoresistive pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a piezoelectric pressure sensor, an optical pressure sensor, or a potentiometric pressure sensor. 
     
     
         48 . A system for imaging a target tissue location in an individual in need thereof, comprising:
 a) a tactile sensing device of any one of  claims 1 - 47 ; and   b) a computing device comprising:
 i) at least one processor operatively coupled to the tactile sensing device; 
 ii) a memory device; and 
 iii) a non-transitory computer readable storage medium with a computer program including instructions executable by the processor causing the processor to convert a voltage signal into an image. 
   
     
     
         49 . The system of  claim 48 , wherein the computing device is a microcontroller. 
     
     
         50 . The system of  claim 48 , wherein the computing device further comprises a second computer program including instructions executable by the processor that cause the processor to encode the voltage signal into a first computer signal and a second computer signal. 
     
     
         51 . The system of  claim 50 , further comprising a transmitter configured to transmit the first computer signal to the computing device. 
     
     
         52 . The system of  claim 50 , further comprising a receiver configured to receive the second computer signal from the tactile sensing device. 
     
     
         53 . The system of  claim 50 , wherein the first and second computer signals are transmitted remotely, directly, wirelessly, or via a wire. 
     
     
         54 . The system of  claim 50 , wherein the first computer signal and the second computer signals are wireless signals. 
     
     
         55 . The system of  claim 48 , wherein the computing device is a mobile device. 
     
     
         56 . The system of  claim 50 , wherein the computing device further comprises a third computer program including instructions executable by the processor that cause the processor to calculate a projected needle position and display it on the display screen. 
     
     
         57 . The system of  claim 56 , wherein the computing device further comprises a fourth computer program including instructions executable by the processor causing the processor to:
 a) determine, as a first requirement, a location of a target tissue location detected by the tactile sensing device; and   b) perform predictive analysis based on application of machine learning to approximate the projected needle position.   
     
     
         58 . A method for imaging a target tissue location in an individual in need thereof, comprising:
 a) placing a tactile sensing device of any one of  claims 1 - 47  on the individual;   b) applying force to the tactile sensing device against the individual; and   c) viewing an image of the target tissue location, obtained from voltage signals generated by the tactile sensing device, resulting from the application of force to the tactile sensing device against an individual, on a display screen.   
     
     
         59 . A method for generating an image of a target tissue location in an individual in need thereof, comprising:
 a) collecting a plurality of voltage signals generated by a tactile sensing device of any one of  claims 1 - 47 , resulting from the application of force to the tactile sensing device against an individual;   b) converting the voltage signals into a mathematical array;   c) rescaling the mathematical array; and   d) transforming the rescaled mathematical array into the image of a target tissue location of the individual.   
     
     
         60 . The method of any one of  claim 58  or  59 , wherein the target tissue location is a bone structure. 
     
     
         61 . The method of  claim 60 , wherein the bone structure is an articular surface. 
     
     
         62 . The method of  claim 61 , wherein the articular surface is a vertebral articulation, an articulation of a first bone of a hand with a second bone of the hand, an elbow joint, a wrist joint, an axillary articulation of a first bone of a shoulder with a second bone of the shoulder, a sternoclavicular joint, a temporomandibular joint, a sacroiliac joint, a hip joint, a knee joint, or an articulation of a first bone of a foot with a second bone of the foot. 
     
     
         63 . The method of  claim 62 , wherein a vertebral articulation is a spinous process. 
     
     
         64 . The method of any one of  claim 58  or  59 , wherein the target tissue location is a subcutaneous tissue, a muscle, a ligament, an adipose tissue, a cyst, a cavity, or a tumor mass. 
     
     
         65 . The method of  claim 58 , wherein placing the tactile sensing device on the individual further comprises positioning the tactile sensing device on a bone structure. 
     
     
         66 . The method of  claim 65 , wherein the bone structure is a vertebral column of an individual. 
     
     
         67 . The method of  claim 59 , wherein collecting the plurality of voltage signals further comprises transmitting the data via a multiplexer. 
     
     
         68 . The method of  claim 59 , wherein collecting the plurality of the voltage signals further comprises transmitting the data via a voltage divider. 
     
     
         69 . The method of  claim 59 , wherein converting the plurality of the voltage signals comprises acquiring, processing, and transforming the plurality of voltage signals into the image using a computer processor. 
     
     
         70 . The method of  claim 69 , wherein the image is a pressure map representing the target tissue location. 
     
     
         71 . The method of  claim 70 , wherein the pressure map is overlaid on top of a structural spinal image. 
     
     
         72 . A method for performing a lumbar puncture in an individual in need thereof, comprising:
 a) placing a tactile sensing device of any one of  claims 1 - 47  on a lumbar region of the individual;   b) applying force to the tactile sensing device against the lumbar region;   c) viewing an image of vertebral articulations on a display screen; wherein the image is generated by the tactile sensing device resulting from the application of force to the tactile sensing device against the lumbar region;   d) localizing two spinous processes on the image;   e) identifying a gap between a first spinous process and a second spinous process of the individual;   f) using a needle guide to insert a needle between the first and second spinous processes of the individual and into a subarachnoid space; and   g) collecting cerebrospinal fluid or administering a therapeutic agent.   
     
     
         73 . The method of  claim 72 , wherein the therapeutic agent is an analgesic, an anesthetic, a chemotherapeutic agent, or a contrast agent or dye. 
     
     
         74 . A method for administering a therapeutic agent to an epidural space of an individual in need thereof, comprising:
 a) placing a tactile sensing device of any one of  claims 1 - 47  on a lumbar region of the individual;   b) applying force to the tactile sensing device against the lumbar region;   c) viewing an image of vertebral articulations on a display screen; wherein the image is detected by the tactile sensing device resulting from the application of force to the tactile sensing device against the lumbar region;   d) localizing two spinous processes on the image;   e) identifying a gap between a first spinous process and a second spinous process of the individual;   f) using a needle guide to insert a needle between the first and second spinous processes and into the epidural space of the individual; and   g) injecting a therapeutic agent into the epidural space.   
     
     
         75 . The method of  claim 74 , wherein the therapeutic agent is an analgesic, an anesthetic, a contrast agent or dye, a chemotherapeutic agent, or a steroid. 
     
     
         76 . The method of any one of  claim 72  or  74 , wherein the first spinous process is a part of L1, L2, L3, or L4 lumbar vertebrae and the second spinous process is a part of L2, L3, L4, or L5 lumbar vertebrae. 
     
     
         77 . The method of any one of  claim 72  or  74 , wherein the needle is a traumatic or an atraumatic needle. 
     
     
         78 . The method of any one of  claim 72  or  74 , further comprising using a stylet or a catheter in conjunction with the needle. 
     
     
         79 . A method for guiding a first individual performing a lumbar puncture on a second individual in need thereof, comprising:
 a) placing a tactile sensing device of any one of  claims 1 - 47  on a lumbar region of the individual;   b) applying force to the tactile sensing device against the lumbar region;   c) viewing an image of vertebral articulations on a display screen, wherein the image is generated by the tactile sensing device resulting from the application of force to the tactile sensing device against the lumbar region;   d) localizing two spinous processes on the image;   e) identifying a gap between a first spinous process and a second spinous process of the individual;   f) using a needle guide to insert a needle between the first and second spinous processes of the individual and into a subarachnoid space; and   g) collecting cerebrospinal fluid or administering a therapeutic agent.   
     
     
         80 . A method for guiding a first individual administering a therapeutic agent into an epidural space of a second individual in need thereof, comprising:
 a) placing a tactile sensing device of any one of  claims 1 - 47  on a lumbar region of the individual;   b) applying force to the tactile sensing device against the lumbar region;   c) viewing an image of vertebral articulations on a display screen, wherein the image is generated by the tactile sensing device resulting from the application of force to the tactile sensing device against the lumbar region;   d) localizing two spinous processes on the image;   e) identifying a gap between a first spinous process and a second spinous process of the individual;   f) using a needle guide to insert a needle between the first and second spinous processes and into the epidural space of the individual; and   g) injecting a therapeutic agent into the epidural space.   
     
     
         81 . A method for imaging a target tissue location in an individual in need thereof, comprising:
 a) placing a tactile sensing device on the individual;   b) applying force to the tactile sensing device against the individual; and   c) viewing an image of the target tissue location, obtained from voltage signals generated by the tactile sensing device, resulting from the application of force to the tactile sensing device against an individual, on a display screen.   
     
     
         82 . A method for generating an image of a target tissue location in an individual in need thereof, comprising:
 a) collecting a plurality of voltage signals generated by a tactile sensing device, resulting from the application of force to the tactile sensing device against an individual;   b) converting the voltage signals into a mathematical array;   c) rescaling the mathematical array; and   d) transforming the rescaled mathematical array into the image of a target tissue location of the individual.   
     
     
         83 . The method of any one of  claim 81  or  82 , wherein the target tissue location is a bone structure. 
     
     
         84 . The method of  claim 83 , wherein the bone structure is an articular surface. 
     
     
         85 . The method of  claim 84 , wherein the articular surface is a vertebral articulation, an articulation of a first bone of a hand with a second bone of the hand, an elbow joint, a wrist joint, an axillary articulation of a first bone of a shoulder with a second bone of the shoulder, a sternoclavicular joint, a temporomandibular joint, a sacroiliac joint, a hip joint, a knee joint, or an articulation of a first bone of a foot with a second bone of the foot. 
     
     
         86 . The method of  claim 85 , wherein a vertebral articulation is a spinous process. 
     
     
         87 . The method of any one of  claim 81  or  82 , wherein the target tissue location is a subcutaneous tissue, a muscle, a ligament, an adipose tissue, a cyst, a cavity, or a tumor mass. 
     
     
         88 . The method of  claim 81 , wherein placing the tactile sensing device on the individual further comprises positioning the tactile sensing device on a bone structure. 
     
     
         89 . The method of  claim 88 , wherein the bone structure is a vertebral column of an individual. 
     
     
         90 . The method of any one of  claim 81  or  82 , wherein the tactile sensing device comprises an array of force-sensitive resistors. 
     
     
         91 . The method of  claim 90 , wherein the array of force-sensitive resistors is a 6×3 array comprising eighteen force-sensitive resistors. 
     
     
         92 . The method of  claim 90 , wherein the array of force-sensitive resistors is an 8×4 array comprising thirty two force-sensitive resistors. 
     
     
         93 . The method of  claim 90 , wherein the array of force-sensitive resistors is secured onto a platform. 
     
     
         94 . The method of  claim 93 , wherein the platform comprises projections onto which the force-sensitive resistors are adhered to. 
     
     
         95 . The method of  claim 94 , wherein the projections are struts or connectors. 
     
     
         96 . The method of  claim 95 , wherein the force-sensitive resistors are covered with a material configured to enhance force feedback. 
     
     
         97 . The method of  claim 96 , wherein the material configured to enhance force feedback is a hemispherical rubber disk. 
     
     
         98 . The method of  claim 82 , wherein collecting the plurality of voltage signals further comprises transmitting the data via a multiplexer. 
     
     
         99 . The method of  claim 82 , wherein collecting the plurality of the voltage signals further comprises transmitting the data via a voltage divider. 
     
     
         100 . The method of  claim 82 , wherein converting the plurality of the voltage signals comprises acquiring, processing, and transforming the plurality of voltage signals into the image using a computer processor. 
     
     
         101 . The method of  claim 100 , wherein the image is a pressure map representing the target tissue location. 
     
     
         102 . The method of  claim 101 , wherein the pressure map is overlaid on top of a structural spinal image. 
     
     
         103 . A method for performing a lumbar puncture in an individual in need thereof, comprising:
 a) placing a tactile sensing device on a lumbar region of the individual;   b) applying force to the tactile sensing device against the lumbar region;   c) viewing an image of vertebral articulations on a display screen; wherein the image is generated by the tactile sensing device resulting from the application of force to the tactile sensing device against the lumbar region;   d) localizing two spinous processes on the image;   e) identifying a gap between a first spinous process and a second spinous process of the individual;   f) using a needle guide to insert a needle between the first and second spinous processes of the individual and into a subarachnoid space; and   g) collecting cerebrospinal fluid or administering a therapeutic agent.   
     
     
         104 . The method of  103 , wherein the therapeutic agent is an analgesic, an anesthetic, a chemotherapeutic agent, or a contrast agent or dye. 
     
     
         105 . A method for administering a therapeutic agent to an epidural space of an individual in need thereof, comprising:
 a) placing a tactile sensing device on a lumbar region of the individual;   b) applying force to the tactile sensing device against the lumbar region;   c) viewing an image of vertebral articulations on a display screen; wherein the image is detected by the tactile sensing device resulting from the application of force to the tactile sensing device against the lumbar region;   d) localizing two spinous processes on the image;   e) identifying a gap between a first spinous process and a second spinous process of the individual;   f) using a needle guide to insert a needle between the first and second spinous processes and into the epidural space of the individual; and   g) injecting a therapeutic agent into the epidural space.   
     
     
         106 . The method of  claim 105 , wherein the therapeutic agent is an analgesic, an anesthetic, a contrast agent or dye, a chemotherapeutic agent, or a steroid. 
     
     
         107 . The method of any one of  claims 103  and  105 , wherein the first spinous process is a part of L1, L2, L3, or L4 lumbar vertebrae and the second spinous process is a part of L2, L3, L4, or L5 lumbar vertebrae. 
     
     
         108 . The method of any one of  claims 103  and  105 , wherein the needle is a traumatic or an atraumatic needle. 
     
     
         109 . The method of any one of  claims 103  and  105 , further comprising using a stylet or a catheter in conjunction with the needle. 
     
     
         110 . The method of any one of  claims 103  and  105 , wherein the needle guide is oriented between −45° and 45° cephalad angle and terminating at an opening located on the center of the tactile sensing device, thereby controlling the angle at which the needle is inserted into a human body. 
     
     
         111 . The method of  claim 110 , wherein the opening located on the center of the tactile sensing device is an elongated slit. 
     
     
         112 . The method of any one of  claims 103  and  105 , wherein the needle guide is oriented at a 15° cephalad angle. 
     
     
         113 . The method of any one of  claims 103  and  105 , wherein the needle guide terminates at a plurality of openings formed by an elongated slit with a plurality of columns. 
     
     
         114 . The method of any one of  claims 103  and  105 , further comprising using a plurality of needle guides oriented between a −45° and 45° cephalad angle and terminating at a plurality of openings located along the midline of the tactile sensing device, thereby controlling the angle at which the needle is inserted into a human body. 
     
     
         115 . The method of any one of  claims 103  and  105 , further comprising using a plurality of needle guides oriented at a 15° cephalad angle. 
     
     
         116 . The method of  claim 115 , wherein the plurality of needle guides terminates at an opening. 
     
     
         117 . The method of  claim 116 , wherein the opening is an elongated slit. 
     
     
         118 . A method for guiding a first individual performing a lumbar puncture on a second individual in need thereof, comprising:
 a) placing a tactile sensing device on a lumbar region of the individual;   b) applying force to the tactile sensing device against the lumbar region;   c) viewing an image of vertebral articulations on a display screen, wherein the image is generated by the tactile sensing device resulting from the application of force to the tactile sensing device against the lumbar region;   d) localizing two spinous processes on the image;   e) identifying a gap between a first spinous process and a second spinous process of the individual;   f) using a needle guide to insert a needle between the first and second spinous processes of the individual and into a subarachnoid space; and   g) collecting cerebrospinal fluid or administering a therapeutic agent.   
     
     
         119 . A method for guiding a first individual administering a therapeutic agent into an epidural space of a second individual in need thereof, comprising:
 a) placing a tactile sensing device on a lumbar region of the individual;   b) applying force to the tactile sensing device against the lumbar region;   c) viewing an image of vertebral articulations on a display screen, wherein the image is generated by the tactile sensing device resulting from the application of force to the tactile sensing device against the lumbar region;   d) localizing two spinous processes on the image;   e) identifying a gap between a first spinous process and a second spinous process of the individual;   f) using a needle guide to insert a needle between the first and second spinous processes and into the epidural space of the individual; and   g) injecting a therapeutic agent into the epidural space.

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