JP2017225519A - Blood sampling device and blood sampling method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide blood sampling means and a blood sampling device capable of achieving blood sampling from a fingertip safely and easily in any subject.SOLUTION: A blood sampling device includes a perforator, a blood collection tube, a cartridge that holds an adhesive plaster, a drive mechanism for changing the position of the cartridge, and performing an operation to press the perforator, a container, and a seal against a fingertip, a fixing mechanism for fixing a part of the fingertip, and a pressing mechanism for pressing a finger root. After a finger root is pressed, a fingertip of a subject is perforated with the perforator, blood is collected into the collection tube from a puncture mark, and the bleeding from the puncture mark is stopped by an adhesive plaster after the pressure is released.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an apparatus for collecting blood from a finger of a subject.

  In order to lead a healthy life, it is important to have regular medical examinations. One of the tests commonly performed in a health checkup is a blood test that diagnoses the state of the tissues and organs of the whole body by collecting blood from a subject and analyzing blood components. A general blood test is often performed at a medical institution, but it is often performed at home as a self-test with limited measurement items such as blood glucose level.

  A blood collection method often performed as blood collection for self-test such as blood glucose level measurement is capillary blood collection. Capillary blood collection is a method of puncturing a capillary of a finger by pressing a dedicated skin puncture device against the subject's finger and collecting the blood that has flowed out. Capillary blood collection is simpler than venous blood collection, and can be carried out by not only medical professionals, but also by self-examination. However, since the amount of blood that can be secured is small, in order to secure a blood collection amount of several tens of μL, a complicated operation such as pressing and squeezing a finger at the time of blood collection is required.

  Patent Document 1 discloses a puncture device that realizes blood collection from a finger with a simple operation. This puncture device has a squeezing mechanism for pressing the fingertip with pressure means having a lid for accommodating the fingertip in the opening through which the puncture element enters and exits, and for sending blood from the base of the finger toward the fingertip. The blood is squeezed out by moving the squeezing mechanism in the direction from the base of the finger to the fingertip after the fingertip is punctured.

  Patent Document 2 discloses a blood collection device that collects an amount of blood necessary for examination. In this blood collection device, after the fingertip is punctured, blood is pushed out to the fingertip and blood is squeezed out from the puncture site by sequentially transferring the compression site from the clamp member far from the fingertip to the clamp member close to the puncture site.

JP 2010-057954 A JP 2005-278740 A

  The puncture device described in Patent Document 1 and the blood collection device described in Patent Document 2 are advantageous in that the subject can perform capillary blood collection from the fingertips without performing complicated operations. However, because there are individual differences in the finger length, thickness, blood pressure, etc. for each subject, in order to achieve stable blood collection for any subject, A blood collection device having robustness is required.

  The present invention has been achieved in view of the above-described problems of the prior art, and an object thereof is to provide a blood collection means and a blood collection apparatus that can realize blood collection from a fingertip safely and easily by any subject. There is to do.

  The configuration of the present invention for achieving the above object is as follows.

  That is, a puncture needle holder having a puncture needle for puncturing a puncture target site of a living body, a container holder having a container for collecting body fluid flowing out from the puncture mark of the puncture target site, and a seal having a seal for sealing the puncture mark A cartridge having a holder, and a cartridge case for movably holding the punch holder, the container holder, and the seal holder; and changing the relative position of the puncture target site and the cartridge in the horizontal direction; and the puncture target A drive mechanism for changing a vertical position of the part and the perforator, the container and the seal, a first fixing mechanism for fixing a part of the puncture target part, and another part of the puncture target part It has a compression mechanism for compressing a part and a second fixing mechanism whose position is variable.

  Other configurations of the present invention are as follows.

  A step of attaching a cartridge for movably holding a puncture needle, a container, and a seal to the device; a step of pressing the puncture target site; a step of pressing the puncture needle held by the cartridge against the puncture target site; and the cartridge A step of moving the cartridge horizontally, a step of pressing the container held by the cartridge against the puncture mark, collecting body fluid flowing out from the puncture mark, a step of moving the cartridge further in the horizontal direction, and a puncture target site And a step of pressing a seal held by the cartridge against the puncture mark and sealing the puncture mark with a seal.

  According to the present invention, by providing a blood collection device that uses a disposable cartridge equipped with a perforator, a blood collection container, and a bandage, any subject can safely and easily collect blood from the fingertip. Exhibits extremely excellent effects.

It is a figure which shows the structure of the blood collection apparatus which becomes Example 1 of this invention. It is a figure which shows the structure of the cartridge which becomes Example 1 of this invention. It is a flowchart of the blood collection by the blood collection apparatus which becomes Example 1 of this invention. It is the attachment method of the cartridge to the blood-collecting apparatus which becomes Example 1 of this invention. It is the fixing method of the finger | toe to the blood-collecting apparatus which becomes Example 1 of this invention. It is a figure which shows the positional relationship of each component of the blood collection apparatus which becomes Example 1 of this invention. It is a figure which shows the screen of the interface used as Example 1 of this invention. It is a figure which shows the mechanism of the pressure control of the finger clamping mechanism which becomes Example 1 of this invention. It is a figure which shows the structure of the drive mechanism used as Example 1 of this invention. It is a figure which shows the structure of the drive mechanism used as Example 1 of this invention. It is a figure which shows the structure of the drive mechanism used as Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows operation | movement of the drive mechanism which becomes Example 1 of this invention. It is a figure which shows the screen of the interface used as Example 1 of this invention. It is a figure which shows the clamping pressure at the time of the cuff internal pressure adjustment which becomes Example 1 of this invention. It is a figure which shows the structure of the punch holder which becomes Example 1 of this invention, a blood-collecting-tube holder, and a bandage holder. It is a figure which shows the structure of the blood-collecting tube holder which becomes Example 2 of this invention. It is a figure which shows the structure of the push rod component which becomes Example 2 of this invention. It is a figure which shows the positional relationship of each site | part in the blood collection process which becomes Example 2 of this invention. It is a figure which shows the structure of the finger tightening mechanism which becomes Example 3 of this invention. It is a figure which shows the structure of the cartridge which becomes Example 4 of this invention.

  Blood tests that can diagnose the condition of whole body tissues and organs are important tests for maintaining a healthy life, and it is thought that they will be performed more often in medical institutions and at home. . Since blood collection from a subject is indispensable for the implementation of a blood test, it is preferable that anyone can easily and safely collect blood for implementation at home. Accordingly, the inventors of the present invention have studied various methods and systems for automatic blood collection. It came to this invention. The preferred embodiment will be described below.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, embodiment mentioned later is an example, It cannot be overemphasized that the other aspect by the combination of each Example, the combination with well-known or a well-known technique, and substitution is also possible.

  First, the basic configuration of the blood collection device 1 according to the present invention will be described with reference to FIG.

  FIG. 1 is an external view of the blood collection device 1. In FIG. 1, the upper case 100 and the lower case 101 of the blood collection device 1 are shown in cross section to show the internal configuration of the blood collection device 1. The blood collection device 1 includes a punch 112 (FIG. 2), a disposable cartridge 11 containing a blood collection tube 114 (FIG. 2) and an adhesive plaster 116 (FIG. 2), a cartridge case 110 holding the cartridge 11, and a cartridge holder 11. A drive mechanism 12 for operating, a column 128 for holding the cartridge holder 11 and the drive mechanism 12, a motor 120 serving as a power source for the drive mechanism 12, and a finger presser for pressing and fixing the tip instep side of the finger A mechanism 13, a finger tightening mechanism 15 including a cuff 151 for tightening the periphery of the finger base side, a finger holding base 14 that holds the finger pressing mechanism 13 and the finger tightening mechanism 15, and serves as a base on which a finger is placed, and a cuff 151 A pressure adjustment mechanism 17 having a pump 174 (FIG. 8), a solenoid valve 173 (FIG. 8), and a pressure sensor 172 (FIG. 8) for adjusting the air pressure inside To the camera 162 (FIG. 8) for observing the abdominal side of the fingertip fixed to the finger pressing mechanism 13, the control mechanism 16 for controlling the operation of the motor 120, the pressure adjusting mechanism 17 and the camera 162, and the control mechanism 16. The interface 160 for displaying the instruction contents and the output result from the control mechanism 16, the interface holder 161 for holding the interface 160, and the external connection part 163 that is a connection part of a power supply or data communication cable. Has been.

  Next, the configuration of the cartridge 11 used by the blood collection device 1 according to the present invention will be described with reference to FIG. 2A, 2B, and 2C are an assembled view, an external view, and a sectional view of the cartridge 11, respectively.

  The cartridge 11 includes a punch holder 111 that holds the punch 112, a blood collection holder 113 that holds the blood collection tube 114, and a bandage holder 115 that holds the bandage 116, and a punch holder holding hole 1110 in the cartridge case 110. And holding hole 1130 for blood collection tube holder and holding hole 1150 for bandage holder. The perforator holder holding hole 1110, the blood collection tube holder holding hole 1130, and the bandage holder holding hole 1150 are through holes, but the bottom diameter is larger than the diameter of the punch holder 111, blood collection holder 113, and bandage holder 115. Since it is small, the punch holder 111, the blood collection tube holder 113, and the bandage holder 115 do not fall from the hole holder 1101 for the punch holder, the hole 1130 for the blood collection holder, and the hole 1150 for the bandage holder. Further, the cartridge case 110 is preferably light-transmitting in order to acquire an image of a perforated portion during blood collection.

  The perforator 112 is a single-use skin puncture device composed of a puncture needle and a holder incorporating the puncture needle. When the tip 1120 of the perforator 112 is pressed against a finger, the puncture needle pops out momentarily and the finger skin and Perforate capillaries. The blood collection tube 114 is a blood collection container composed of an absorption pad 1140 for absorbing blood and a container. By pressing the absorption pad 1140 against a finger puncture site, blood that has bleed is collected from the puncture site. . The adhesive bandage 116 includes an absorbent pad at the center of the adhesive sheet, and is attached to the adhesive bandage holder 115 with the adhesive surface facing upward.

  FIG. 3 is a flowchart of a blood collection process from a finger using the blood collection device 1. The flowchart shows the figure numbers corresponding to the respective steps. Blood collection by the blood collection device 1 includes (1) setting the cartridge 11, (2) fixing the finger, (3) inputting subject information and blood collection conditions, (4) reading the lot of the cartridge 11, and (5) the cartridge 11 and the finger 156. (6) Finger tightening by pressurizing the cuff 151, (7) Finger perforation by the punch 112, (8) Blood outflow confirmation, (9) Blood sampling by the blood collection tube 114, (10) Cuff The finger tightening is released by the pressure reduction of 151, and (11) hemostasis by the adhesive bandage 116 is performed in this order. The blood collection apparatus 1 can be operated by the subject himself or by a person other than the subject. The blood collection process of the blood collection device 1 will be described along the flowchart of FIG.

(1) Set of Cartridge 11 FIG. 4 shows a procedure for attaching the cartridge 11 to the blood collection device 1. The unused cartridge 11 is covered with a cartridge lid 1100 to prevent contamination during storage. At the time of use, the upper case 100 of the blood collection device 1 is opened, and the cartridge 11 with the cartridge lid 1100 removed is set in the cartridge holder 121. After the cartridge 11 is set, the upper case 100 is closed and the upper case 100 is fixed with the fixing component 1001.

(2) Finger Fixing FIG. 5 shows a procedure for fixing the finger 156 to the blood collection device 1. First, the finger pressing mechanism 13 is opened, the finger 156 is inserted into the hole of the finger tightening mechanism 15, and the fingertip is placed in the blood collection window 140 which is a hole in the finger fixing base 14. After placing the finger 156 on the blood collection window 140, the finger pressing mechanism 13 is closed to fix the fingertip to the blood collection window 140. Adsorption of the finger pressing mechanism magnet 135 of the finger pressing mechanism 13 and the finger fixing base magnet 141 of the finger fixing base 14 prevents the finger pressing mechanism 13 from opening in a later process.

  FIG. 6 is a top sectional view of the automatic analyzer 1 when the finger 156 is fixed. The details and positional relationship of each component of the automatic analyzer 1 when the finger 156 is fixed will be described with reference to FIG.

  The finger press mechanism 13 includes a first fingertip press 131 for fixing the tip (end node) of the finger 156, a second fingertip press 132 for fixing the vicinity of the first joint of the finger 156, and a first fingertip press 131. The first fingertip presser case 131 is configured to hold the second fingertip presser 132. The first fingertip presser 131 and the finger presser mechanism case 130 are connected by a first fingertip presser spring 133, and the second fingertip presser 132 and the finger presser are pressed. The mechanism case 130 is connected by a second fingertip pressing spring 134. When the finger 156 is fixed, the first fingertip presser 131 and the second fingertip presser 132 press the finger 156 against the finger fixing base 14 by the spring force of the first fingertip presser spring 133 and the second fingertip presser spring 134. Since the finger becomes thinner toward the tip, the spring constant of the first finger pressing spring 133 is preferably larger than the spring constant of the second fingertip pressing spring 134.

  The finger tightening mechanism 15 includes a cuff 151 that tightens the finger 156 by air pressure and a cuff case that holds the cuff 151. The finger tightening mechanism 15 can be moved back and forth on the finger fixing base 14 with respect to the insertion direction of the finger, and the finger fixing base 14 and the finger tightening mechanism 15 are connected by a finger tightening mechanism spring 152. Since the spring force of the finger tightening mechanism spring 152 pushes the finger tightening mechanism 15 toward the base of the finger 156, when the subject's finger 156 is fixed to the blood collection window 140, the finger tightening is performed regardless of the length of the subject's finger 156. The mechanism 15 moves to the base (base) of the finger 156. Further, the finger 156 can be pressed by the cuff 150 by increasing the internal pressure of the cuff 150 of the finger tightening mechanism 15.

  Further, the finger tightening mechanism 15 includes a microphone 157, and the blood flow sound of the finger 156 can be measured by the microphone 157. The measured blood flow sound can be displayed on the interface 160 described later.

  When the finger 156 is fixed to the finger fixing base 14 by the finger pressing mechanism 13, the belly of the fingertip of the finger 156 protrudes from the blood collection window 140, and the cartridge 11 is disposed under the belly of the protruding finger 156. The cartridge case 110 has a shape having a helicopter that protrudes about several millimeters upward. By setting the distance between the cartridge case 110 of the cartridge 11 and the finger fixing base 14 to be several mm or less, the belly of the finger 156 is positioned in the space covered with the finger fixing base and the cartridge 11. In actual blood collection, blood squirts during fingertip puncture or blood collection, and bleeding from the puncture site may not stop even after blood collection, so the inside of the blood collection device may be contaminated with the blood of the subject However, contamination by blood is prevented by the cartridge case 110. Since the cartridge itself is disposable, it is replaced after every measurement, so that the inside of the blood collection device is not contaminated with blood.

  Further, since the cartridge case 110 is light transmissive, it is possible to observe the belly of the fingertip of the finger 156 and the state of the cartridge 11 with the camera 162 fixed to the upper case 100. Note that the light-transmitting region may be only a part of the cartridge case 110. In other words, it is only necessary to be configured so that the positional relationship between the cartridge and the finger 156 and the puncture state of the finger 156 can be confirmed from the outside of the cartridge case 110 by means such as a camera.

(3) Input of Subject Information and Blood Collection Conditions FIG. 7 is a display screen of the interface 160 after the finger 156 is fixed. The operator of the blood collection apparatus 1 can perform (a) subject information and blood collection condition input from the interface 160, (b) confirmation of the state of the finger 156 and the cartridge 11, (c) operation of the blood collection process, pause, stop, and (d ) The blood flow status of the finger can be checked. In FIG. 7, the interface 160 is shown in the form of a tablet PC. However, a PC, a tablet PC, or a smartphone may be used, or the interface 160 may be installed on the blood collection device 1. An advantage of using a tablet PC or a smartphone as the interface 160 is that the interface 160 can be used separately from the blood collection device 1. When a subject other than the subject operates the blood collection device 1, the subject can see how blood is collected. Inadvertent viewing can be prevented.

  The operator inputs subject information 1604 and blood collection conditions 1605 from the interface 160. The subject information 1604 is personal information at the time of blood collection such as the subject's age, blood type, blood pressure, and the like, and the blood collection condition is information related to the blood collection process such as finger tightening pressure, perforation, blood collection timing, and the like.

(4) Lot Reading of Cartridge 11 By recording lot information of the cartridge 11 on the cartridge case 110 as a barcode 117, it is possible to read the lot information of the cartridge 11 from the image 1620 acquired by the camera 162. By this process, the subject information and blood collection conditions input in the previous process can be linked to the lot information of the cartridge 11.

(5) Confirmation of initial positions of cartridge 11 and finger 156 In order to confirm the initial positions of cartridge 11 and finger 156, an image 1620 photographed by camera 162 is displayed on interface 160. Confirmation of the initial position of the cartridge 11 is carried out by confirming that the punch 112 is directly under the finger 156. Further, it may be confirmed that the barcode 117 is visible when the cartridge 11 is in the initial position. Confirmation of the initial position of the finger 156 is confirmed by seeing the finger 156 through the blood collection window 140. Note that a moving image may be captured by the camera 162 and displayed on the interface 160. After confirming the initial position, the driver can be controlled by pressing the execution button 1601, the pause button 1602, and the stop button 1603 of the control button 1600, and the blood sampling can be performed / paused / stopped.

(6) The blood flow sound of the finger tightening finger 156 due to pressurization of the cuff 151 (FIG. 6) is acquired by the microphone 157 (FIG. 6), and the blood flow sound in the temporal change 1550 of the blood flow sound in the screen of the interface 160 is obtained. Can be confirmed. When the internal pressure of the cuff 151 (FIG. 6) is increased and the finger tightening force is increased, the blood flow flowing through the finger 156 stops at a certain point in time and the blood flow sound is also eliminated. The point at which the blood flow noise disappears is regarded as the optimum tightening pressure, and the process proceeds to the subsequent drilling process. The subject's confidence may be determined by referring to the interface 160 for timing control, or the computer may determine based on a preset criterion.

  FIG. 8 shows a cuff internal pressure adjusting mechanism for adjusting the internal pressure of the cuff 151. The cuff internal pressure adjusting mechanism is a cuff pressure sensor 152, a cuff electromagnetic valve 153, a cuff pump 154, a cuff 151, and a cuff pressure sensor. 152, a cuff solenoid valve 153, and a cuff pump 154 that connects the cuff pump 154. By constantly measuring the internal pressure of the cuff 151 with the cuff pressure sensor 152, the internal pressure of the cuff 151 can be adjusted under specified conditions, and abnormal pressurization of the cuff 151 can be prevented.

(7) From finger perforation by the perforator 112 (11) After tightening the hemostatic finger 156 by the bandage 116, the finger perforation, blood sampling, and hemostasis are performed by the mechanical mechanism of the drive mechanism 12. 9, FIG. 10 and FIG. 11 are an assembled view, a front view and a right side view of the drive mechanism 12, respectively. The configuration and mechanical mechanism of the drive mechanism 12 will be described with reference to these drawings.

  The drive mechanism 12 includes a rack gear 122, a toothless gear 123, a groove cam 124, a push rod part 125, a cartridge holder 121, a column 128, and a rail 1210. The cartridge holder 121 includes a rack gear 122 and is arranged to move on the rail 1210. The toothless gear 123 and the groove cam 124 have a shaft 129 as a common rotation axis, and the shaft 129 is fixed to the column 128. The toothless gear 123 and the rack gear 122 have a rack-and-pinion positional relationship. When the rack gear 122 and the toothless gear 123 are in a positional relationship in which the perforation-blood collection gear 1230 or the blood collection-hemostatic gear 1231 is engaged, the motor 120 ( When the shaft 129 is rotated according to FIG. 1, the rack gear 122 receives a force in the direction of the rail 1210 due to the rotation of the toothless gear 123, and the cartridge holder 121 moves on the rail 1210 due to the force received by the rack gear 122.

  Further, the center convex part 1241 of the groove cam 124 and the center hole part 1251 of the push rod part 125 are configured to overlap each other, and the groove projection 1250 of the push rod part 125 is configured to fit into the groove 1241 of the groove cam 124. Therefore, the groove cam 124 acts as a groove cam of the push rod part 125. Further, the push rod component 125 is disposed on a plane including the central axes of the punch holder 111, the blood collection tube holder 113, and the bandage holder 115.

  When the shaft 129 is rotated by the motor 120 (FIG. 1), the push rod part 125 moves up and down by the rotation of the groove cam 124, and the punch holder 111, the blood collection holder 113, or the bandage holder depending on the position of the cartridge holder 121. Move 115 up and down.

  12 to 20 are front views of the drive mechanism 12 in each process of finger perforation, blood collection, and hemostasis. In order to show the positional relationship between the push rod part 125, the groove cam 124, and the toothless gear 123, a front view including the push rod part 125 and the groove cam 124 is shown in FIG. The figure is shown as (b).

  12 to 13 show the state of the drive mechanism 12 from before the finger is drilled to when the finger is drilled. As the shaft 129 rotates, the groove cam 124 and the toothless gear 123 rotate. At this time, since the distance between the central axis of the shaft 129 and the groove projection 1250 of the push rod part 125 is widened, the push rod part 125 moves upward and pushes the punch holder 111. When the perforator 112 and the finger 156 come into contact with each other and the perforator 112 receives a certain load, the perforation needle of the perforator 112 pops out and punctures the skin and capillaries of the finger 156. At this time, since the rack gear 122 faces the missing tooth portion 1233 of the missing gear 123 during drilling, the cartridge holder 121 does not move.

  FIG. 14 shows the state of the drive mechanism 12 from the time when the finger is punched until just before blood collection. Due to the rotation of the groove cam 124 and the toothless gear 123, the gear 1230 between the punching and blood collection of the toothless gear 123 and the rack gear 122 are engaged, and the cartridge holder 121 moves from right to left in the figure. Since the length of the punch-blood collection gear 1230 is equal to the distance between the central axes of the punch holder 111 and the blood collection holder 113, this movement causes the central axis of the blood collection holder 113 and the push rod 1252 of the push rod component 125 to overlap. become. At this time, the distance between the central axis of the shaft 129 and the groove projection 1250 of the push rod part 125 does not change while maintaining the narrowest distance, so that the push rod part 125 does not push the punch holder 111 or the blood collection tube holder 113.

  15 to 16 show the state of the drive mechanism 12 from before blood collection to blood collection. Since the gap between the central axis of the shaft 129 and the groove projection 1250 of the push rod component 125 is widened by the rotation of the groove cam 124 and the toothless gear 123, the push rod component 125 moves upward and pushes the blood collection tube holder 113. Do. By contacting the blood collection tube 114 and the finger 156, blood 1560 is collected in the blood collection tube 114. At this time, since the rack gear 122 is opposed to the missing tooth portion 1234 during blood collection of the missing gear 123, the cartridge holder 121 does not move.

  Further, after blood collection is completed, the cuff 151 (FIGS. 6 and 8) is decompressed to release finger tightening, thereby preventing further bleeding.

  FIG. 17 shows the state of the drive mechanism 12 from after blood collection until just before hemostasis. By rotation of the groove cam 124 and the missing tooth gear 123, the blood collection-hemostatic gear 1232 of the missing tooth gear 123 and the rack gear 122 are engaged, and the cartridge holder 121 moves from right to left in the figure. Since the length of the blood collection-hemostatic gear 1232 is equal to the distance between the central axes of the blood collection tube holder 113 and the adhesive bandage holder 115, this movement causes the central axis of the adhesive bandage holder 115 and the push bar 1252 of the push bar part 125 to overlap. . At this time, the distance between the central axis of the shaft 129 and the groove projection 1250 of the push rod part 125 remains the smallest and does not change, so the push rod part 125 does not push the blood collection tube holder 113 or the bandage holder 115.

  18 to 20 show the state of the drive mechanism 12 from before hemostasis to hemostasis. Since the gap between the central axis of the shaft 129 and the groove projection 1250 of the push rod part 125 is widened by the rotation of the groove cam 124 and the toothless gear 123, the push rod part 125 moves upward and pushes the adhesive bandage holder 115. . When the bandage 116 and the finger 156 come into contact with each other, the bandage 116 is attached to the finger 156 to stop bleeding. At this time, since the rack gear 122 faces the missing tooth portion 1235 at the time of hemostasis of the missing gear 123, the cartridge holder 121 does not move.

  In the blood collection device 1, it is possible to adjust the processing time and the transition timing of each process from perforation to hemostasis by controlling the rotation of the motor 120. For example, after the finger 156 is pierced, it is possible to confirm the presence or absence of blood 1560 from the image 1620 (FIG. 21) of the finger 156 and confirm the sufficient blood volume before proceeding to the blood collection process. When the blood 1560 cannot be confirmed, the cuff 151 is pressurized and the finger 156 is tightened to promote bleeding.

  FIG. 22 shows one example of a method for adjusting the internal pressure of the cuff 151 for increasing the amount of blood collected. Before the finger 156 (FIG. 8) is pierced, the finger 156 is pressed by increasing the internal pressure of the cuff 151. The internal pressure of the cuff 156 at this time is P. After the finger 156 is compressed, the finger 156 is pierced with the lancet 112 (FIG. 2). After the finger 156 is pierced, the internal pressure of the cuff 156 is returned to 0, and the internal pressure of the cuff 151 is repeatedly increased and decreased at regular intervals, thereby repeatedly pressing and releasing the finger. By this operation, it is possible to increase the amount of blood flowing out from the perforated portion of the finger 156. After blood collection, the internal pressure of the cuff 156 is returned to 0 and the finger is released, thereby suppressing bleeding after blood collection.

  FIG. 23 is a cross-sectional view of the punch holder 111, the blood collection tube holder 113, and the bandage holder 115. In the process from blood collection to hemostasis, when the distance between each holder 113, 114, 115 and the bottom surface of the finger fixing base 14 is shorter than the amount of movement of the push rod part 125 by the drive mechanism 12, each holder 113, 114, 115 inhibits rotation of the shaft 129 (FIG. 9). Therefore, each holder 113, 114, 115 needs a function for absorbing excessive movement of the push rod part 125. Each holder will be described below. FIG. 23A is a sectional view of the punch holder 111. The punch holder 111 includes a punch holder case 1110, a punch holder bottom part 1111 and a punch holder spring 1112. FIG. The punch holder spring 1112 contracts to absorb excessive movement of the push rod part 125. FIG. 23B is a cross-sectional view of the blood collection tube holder 113, which is composed of a blood collection tube holder upper case 1130, a blood collection tube holder lower case 1131, a blood collection tube holder spring 1132, and a blood collection tube holder buffer 1133. The blood collection tube holder cushioning material 1133 is an absorbent material such as foaming urethane, and has a property of contracting with a force smaller than that of the blood collection tube holder spring 1132. Even if the blood collection tube 114 moves further upward after the contact between the blood collection tube 114 and the finger 156, an extra load is not applied to the finger 156 due to the contraction of the buffer material 1133 for the blood collection tube holder. In addition, excessive movement of the push rod component 125 that cannot be absorbed by the buffer tube holder buffer 1133 is absorbed by the spring 1132 for blood collection tube holder. FIG. 23C is a cross-sectional view of the adhesive bandage holder 115, which includes an adhesive bandage holder upper case 1150, an adhesive bandage holder lower case 1151, an adhesive bandage holder spring 1152, and an adhesive bandage holder cushioning material 1153. When the bandage holder 115 moves upward after the contact between the bandage 116 and the finger 156, the bandage holder cushioning material 1153 is deformed along the shape of the finger 156. By this deformation, the adhesive bandage 115 can be attached to the entire surface of the finger 156.

  Since the amount of blood collected from the finger increases by increasing the difference between the pressure inside the finger and the pressure outside the finger, in the previous embodiment, the amount of blood collected can be reduced by pressing the root of the finger 156 with the cuff 151. Increased. This embodiment shows a method for further increasing the amount of blood collected by reducing the pressure outside the finger.

  FIG. 24 is an external view and a cross-sectional view of the blood collection tube holder 213. The blood collection tube holder 213 includes a blood collection tube holder case 2130, a blood collection tube holder lower cushioning material 2133, and a blood collection tube holder upper cushioning material 2134, and a blood collection tube from between the blood collection tube 114 and the blood collection tube holder 213. An intake passage 2135 extending to the bottom surface of the holder is provided.

  FIG. 25 is an external view and a cross-sectional view of the push rod part 225. The push rod part 225 includes a pipe line 2253 inside, and further includes a push rod cushioning material 2254 at the tip of the push rod 2252.

  FIG. 26 is a diagram showing the positional relationship of each part in the blood collection process. The mechanism of pressure reduction outside the finger by the blood collection tube holder 213 and the push rod part 225 will be described with reference to FIG.

  At the time of blood collection, after the blood collection tube holder 213 is pushed up by the push rod component 225 until the upper buffer material 2134 for the blood collection tube holder contacts the bottom surface of the finger fixing base 14, the operation of the drive mechanism 12 is temporarily stopped. At this time, the blood collection tube holder upper cushioning material 2134 is brought into close contact with the bottom surface of the finger fixing base 14 by deformation, and the push rod cushioning material 2254 is also brought into close contact with the bottom surface of the blood collection tube holder 213 by deformation. Furthermore, since the pipe line 2253 inside the push rod part 225 is connected to the intake flow path 2254 and is connected to the intake pump 2256 and the electromagnetic valve 2257 via the pipe line 2253 and the intake flow path 2254, the state of FIG. When the intake pump 2256 is operated, the atmospheric pressure around the finger 156 can be lowered via the conduit 2253. By this operation, the difference between the pressure inside the finger and the pressure outside the finger can be further increased, and the amount of blood collected from the finger can be increased.

  After the blood collection is completed, the operation of the intake pump 2256 is stopped and the electromagnetic valve 2257 is released, so that the pressure outside the finger and the pressure in the pipe line 2253 inside the push rod part 225 also return to the atmospheric pressure. Thereby, the blood collection tube holder 225 is detached from the bottom surface of the finger fixing base 14, and the push rod cushioning material 2254 is also detached from the bottom surface of the blood collection tube holder 213.

  Since other processes are the same as those in the first embodiment, detailed description thereof is omitted. According to the present embodiment, blood can be quickly collected from the puncture mark by pressure change.

  In the previous example, the cuff 151 pressed the entire periphery of the finger 156 to stop the blood flow, and blood was collected (FIGS. 6, 7, and 8). In the present embodiment, a method of stopping blood flow of a finger by tightening a part around the finger and collecting blood is shown.

  FIG. 27A is an external view of the finger tightening mechanism 25 that can tighten only the half circumferential surface on the back side of the finger 156, and FIG. 27B shows the finger tightening effect by the cuff 251. It is sectional drawing of the finger compression mechanism 25 and the finger | toe 156. FIG. The finger tightening mechanism 25 includes a cuff 251 that wraps the half-side surface on the back side of the finger 156 and a cuff case 250 that holds the cuff 251. The finger 156 has a structure in which a bone 1560 and a finger flexor muscle 1561 are in the center, and the surrounding area is covered with a subcutaneous tissue 1562. Further, the finger artery 1563 is located on the palm side of the finger, and the finger vein 1564 is located on the back side of the finger.

  When the cuff 251 compresses the back half of the finger 156, the cross-sectional area of the finger artery 1563 does not change, but the cross-sectional area of the finger vein 1564 is reduced by the cuff 251 and the blood flow stops. When the fingertip is punctured in this state, the finger vein 1564 is blocked, but the finger artery 1563 is not blocked. Therefore, compared to the case where the entire periphery of the finger 156 is compressed, blood is hard to stop and the amount of blood collected increases. Is possible.

  In the previous embodiment, an apparatus and method for automatically performing finger drilling, blood collection, and hemostasis processes have been shown. In this embodiment, an apparatus and a method for automatically performing the steps of finger disinfection, finger perforation, blood collection, and hemostasis are shown.

  FIGS. 28A and 28B are an assembled view and an external view of the cartridge 21, respectively.

  The cartridge 21 holds a sterilizer holder 218 that holds the sterilizer 219, a piercer holder 211 that holds the piercer 212, a blood collection holder 213 that holds the blood collection tube 214, and a bandage holder 215 that holds the bandage 216. To do.

  The sterilizer 219 is an instrument provided with absorbent cotton containing sterilizing ethanol at its tip, and is sterilized by pressing the tip against a finger hole with the blood collection device 1.

  Since other processes are the same as those in the first embodiment, detailed description thereof is omitted. According to this embodiment, finger disinfection with a disinfector can be performed before finger perforation.

1: blood collection device, 11: cartridge, 12: drive mechanism, 13: finger pressing mechanism, 14: finger fixing base, 15: finger tightening mechanism, 16: control mechanism, 17: pressure adjustment mechanism, 100: upper case, 101: Lower case, 110: cartridge case, 111: punch holder, 112: punch, 113: blood collection holder, 114: blood collection holder, 115: adhesive bandage holder, 116: adhesive bandage, 120: motor, 121: cartridge holder, 122: Rack gear, 123: Missing gear, 124: Groove cam, 125: Push rod part, 128: Column, 129: Shaft, 131: First finger press, 132: Second finger press, 1333: First finger press spring, 134: Spring for holding second finger, 140: Blood collection window, 151: Cuff, 152: Pressure sensor for cuff, 153: Solenoid valve for cuff, 154: Cuff Pump: 156: Finger, 157: Microphone, 160: Interface, 161: Interface holder, 163: External connection, 162: Camera, 172: Pressure sensor, 173: Electromagnetic valve, 174: Pump 213: Blood collection holder, 225: Push rod parts

Claims (22)

A puncture needle holder having a puncture needle for puncturing a puncture target site of a living body, a container holder having a container for collecting body fluid flowing out from the puncture mark of the puncture target site, a seal holder having a seal for sealing the puncture mark, And a cartridge having a cartridge case for movably holding the punch holder, the container holder and the seal holder;
A drive mechanism for changing a horizontal relative position of the puncture target site and the cartridge, and changing a vertical relative position of the puncture target site and the perforator, the container and the seal;
A first fixing mechanism for fixing a part of the puncture target site;
A blood collecting apparatus comprising a second fixing mechanism having a compression mechanism for compressing another part of the puncture target site and having a variable position. The blood collection device according to claim 1, wherein
A blood collecting apparatus comprising biasing means for biasing the second fixing mechanism in a direction away from the first fixing mechanism. The blood collection device according to claim 1, wherein
A table having a hole for exposing a part of the puncture target portion held by the first fixing mechanism;
The first fixation mechanism is a blood collection device having pressing means for pressing the puncture target site toward the hole in a state where the puncture target site is fixed. The blood collection device according to claim 1, wherein
The puncture target site is the belly of the last node of the finger,
The first fixing mechanism and the second fixing mechanism are arranged side by side in the finger length direction,
The blood collection apparatus, wherein the second fixing mechanism is movable in the finger length direction. The blood collection device according to claim 4,
A table having a hole for exposing a part of the finger held by the first fixing mechanism;
The first fixing mechanism includes a blood collection device having pressing means for pressing the finger toward the hole while the finger is fixed. The blood collection device according to claim 5,
A plurality of spring members connecting the pressing means to the first fixing mechanism;
The blood collecting apparatus, wherein the spring member that connects the pressing means at a position close to the tip of the finger to be fixed has a larger spring constant than the spring member that connects the pressing means at a position far from the tip of the finger to be fixed. The blood collection device according to claim 1, wherein
The blood collection apparatus, wherein the cartridge is disposable. The blood collection device according to claim 1, wherein
The cartridge case has an open bottom surface,
The blood collection device, wherein the drive mechanism includes a punching needle holder, a container holder, and a push-up member that pushes up the seal holder from below. The blood collection device according to claim 1, wherein
A blood collection apparatus comprising a sound collector that collects blood flow sound of the puncture target site. The blood collection device according to claim 1, wherein
A base having a hole for exposing a part of the finger held by the first fixing mechanism;
A blood collection apparatus comprising image acquisition means for imaging the puncture target part exposed from the hole. The blood collection device according to claim 1, wherein
A blood collection device having an interface for displaying a control button for controlling the operation of the drive mechanism. The blood collection device according to claim 11,
The interface is a blood collection device that displays at least one of subject information, blood collection condition information, puncture target site and cartridge state information, and blood flow state information. The blood collection device according to claim 1, wherein
A table having a hole exposing a part of the puncture target portion held by the first fixing mechanism;
The cartridge case has a helicopter protruding upward,
A blood collecting apparatus, wherein a part of the puncture target part exposed from the hole is positioned in a space surrounded by the table and the cartridge case. Attaching a puncture needle, a container and a cartridge movably holding the seal to the device;
Pressing the puncture target site;
Pressing the puncture needle held in the cartridge against the puncture target site;
Moving the cartridge in a horizontal direction;
Pressing the container held by the cartridge against the puncture mark and collecting body fluid flowing out from the puncture mark;
Further moving the cartridge in a horizontal direction;
Releasing the pressure on the puncture target site;
And a step of pressing a seal held by the cartridge against the puncture mark and sealing the puncture mark with a seal. The blood collection method according to claim 14,
A blood collection method of measuring blood flow sound of a puncture target site while compressing the puncture target site and controlling timing of pressing a puncture needle so as to puncture the puncture target site with a pressure at which the blood flow sound disappears. The blood collection method according to claim 14,
After attaching the cartridge, confirm the position of the puncture target site and the cartridge with an image or a video,
A blood collection method in which after the puncture target site is punctured, the outflow of body fluid from the puncture mark is confirmed by the image acquisition means, and then the container is pressed against the puncture mark. The blood collection device according to claim 8,
The container holder has a through-passage through the inside of the container holder on the bottom surface,
The push-up member has an internal flow path that connects the first port and the second port whose ends are open,
A suction pump connectable to the second port via a flow path;
When the push-up member pushes up the container holder from below, the first port and the through-passage provided in the container holder are connected to each other, and the second port is disposed through the flow path. A blood collection device connected to a suction pump. The blood collection device according to claim 17,
A table having a hole for exposing a part of the finger held by the first fixing mechanism;
A cushioning material capable of compressive deformation at the upper end of the container holder and the upper end of the push-up member;
When the push-up member presses the container holder against the table, the periphery of the puncture target site is sealed by the container holder and the table, and the sealed space further passes through the bottom passage of the container holder. A blood collection device connected to the suction pump. The blood collection device according to claim 17,
A blood collection apparatus that controls the amount of body fluid flowing out from the puncture mark by decompressing the sealed space with the pump. The blood collection device according to claim 1, wherein
A blood collection apparatus comprising: a control mechanism that controls the compression mechanism so as to repeatedly compress and release another part of the puncture target site after the puncture needle punctures the puncture target site. The blood collection device according to claim 4,
The blood pressure collection device that compresses the dorsal side of the finger joint. The blood collection device according to claim 1, wherein
The cartridge case further includes a sterilizer holder having a sterilizer for disinfecting a puncture target portion of a living body.

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