Body insertion device and method of controlling the same

Abstract

The automatic body puncture device according to the present application includes: a tilt direction control unit for adjusting a tilt direction of a syringe needle of a syringe needle unit; and a syringe needle unit operator for supporting the syringe needle unit and orienting the syringe needle unit to a position that allows puncturing of a body and performing the puncture, the tilt direction of the syringe needle unit having been adjusted by the tilt direction control unit.

Description

Technical Field

[0001] This invention relates to a body insertion device and a method for controlling the device. Specifically, this invention relates to a device for adjusting the bevel orientation of a venous puncture needle or blood collection needle to be inserted into the body, and a method for controlling the device. Background Technology

[0002] In hospitals and clinics, medical procedures involving the insertion of medical devices into the body are frequently performed for various purposes. Currently, insertions are performed by doctors, nurses, or pathologists trained to locate insertion sites in vessels such as superficial veins. The current system requires lengthy training periods for medical personnel and incurs labor costs. Furthermore, if the needle is not inserted correctly, the medical personnel may attempt to insert it further, potentially causing unnecessary pain to the person receiving the needle. Even when specialists insert needles into individuals with poorly positioned blood vessels, such as infants, the elderly, patients undergoing chemotherapy, or people with darker skin tones, difficulties arise.

[0003] Repetitive blood collection can cause significant fatigue and numerous discomforts, even for experienced medical personnel. Furthermore, during the blood collection process, medical personnel are at risk of infection when blood splashes onto them or enters their bodies.

[0004] The applicant filed Korean Patent Application 10-2020-0010302 on January 29, 2020, which discloses a method for accurately detecting the location of body targets such as superficial veins using machine learning. The applicant also filed Korean Patent Application 10-2020-0040097 on April 2, 2020, which discloses a body insertion device. All of these applications are incorporated herein by reference.

[0005] [Existing Technology Reference]

[0006] Korean Patent No. 10-1601421 (published on March 10, 2016) Summary of the Invention

[0007] Technical goals

[0008] The object of the present invention is to provide a body insertion device in which the bevel orientation of a needle can be adjusted and a method for controlling the device.

[0009] Technical solution

[0010] The present invention provides a body insertion device for the body, the device comprising: an adjustment unit for adjusting the bevel orientation of a needle; and a moving unit for the needle. The moving unit supports a needle unit having the needle; adjusts the needle unit to an orientation suitable for body insertion; and moves the needle unit for body insertion, the bevel orientation of the needle being adjusted by the adjustment unit.

[0011] The apparatus of the present invention may further include a transfer unit for moving the needle unit from a first position to a second position.

[0012] The adjustment unit may include: a support arm for supporting the needle unit; a drive module for rotating the support arm; and a detector for detecting the bevel orientation of the needle.

[0013] The adjustment unit may include: at least one roller configured to contact the needle unit; a seventh drive module for rotating the roller to rotate the needle unit; and a detector for detecting the bevel orientation of the needle.

[0014] The transfer unit may include a movable arm that supports the needle unit, the movable arm moving between the first position and the second position.

[0015] The adjustment unit can be located at at least one of the first position and the second position, or close to that position.

[0016] The adjustment unit may also include a movement inhibiter to prevent the needle unit from moving in a direction different from the rotation direction caused by the roller.

[0017] The device of the present invention may further include a probe unit for detecting a target, wherein the probe unit includes a probe, a probe holder, and a pressing module for pressing the target.

[0018] The probe unit may also include an elastic member for connecting the probe holder and the pressing module.

[0019] The roller may include teeth that contact the outer periphery of the needle unit or mesh with the teeth of the needle unit.

[0020] The method for controlling the device according to the present invention includes: a first step of supporting a needle unit by a moving unit; a second step of adjusting the bevel orientation of the needle by an adjusting unit; a third step of adjusting the orientation of the needle unit to a suitable orientation for body insertion by the moving unit; and a fourth step of performing body insertion by the moving unit.

[0021] According to another aspect of the invention, a method for controlling a device includes: a first step of adjusting the bevel orientation of a needle by means of an adjustment unit; a second step of moving a needle unit from a first position to a second position by means of a transfer unit; a third step of receiving and supporting the needle unit at the second position by means of a moving unit; a fourth step of adjusting the needle unit to a suitable orientation for body insertion by means of the moving unit; and a fifth step of moving the needle unit by means of the moving unit for body insertion.

[0022] According to another aspect of the present invention, a method for controlling a device includes: a first step of supporting a needle unit by a moving unit; a second step of adjusting the bevel orientation of the needle by an adjusting unit; a third step of moving a pressing module on a target body while pressing the body; a fourth step of adjusting the orientation of the needle unit to a suitable orientation for body insertion by the moving unit; and a fifth step of moving the needle unit by the moving unit to insert the body.

[0023] A method for a control device according to another aspect of the present invention includes: a first step of adjusting the bevel orientation of a needle by means of an adjustment unit; a second step of moving a needle unit from a first position to a second position by means of a transfer unit; a third step of receiving and supporting the needle unit at the second position by means of a moving unit; a fourth step of moving a pressing module on a target body while pressing the body; and a fifth step of moving the needle unit by means of the moving unit for body insertion.

[0024] The pressing module can move linearly on the body.

[0025] The pressing module can move on the body beyond a predetermined distance.

[0026] The adjustment device of the present invention includes: a support member for supporting at least one of the inner and outer sides of the needle unit; and a drive module for rotating the support member to adjust the bevel orientation of the needle.

[0027] Another aspect of the adjustment device of the present invention includes: a support member for supporting at least one of the inner and outer sides of the needle unit; at least one roller that contacts the needle unit; and a drive module for rotating the roller to adjust the bevel orientation of the needle.

[0028] The roller may include teeth that contact or mesh with the outer periphery of the needle unit.

[0029] The drive module can be a rotary drive module or a linear drive module.

[0030] Effects of the present invention

[0031] According to the present invention, the bevel of the needle can be adjusted to have the desired orientation, thereby allowing the needle to be smoothly inserted into the body. Furthermore, according to the present invention, blood vessels are linearized, thereby facilitating the detection of blood vessels and blood collection. Attached Figure Description

[0032] Figure 1 This is a block diagram of a body insertion device according to the present invention.

[0033] Figure 2 This is a front view of the adjustment unit of the body insertion device according to the present invention.

[0034] Figure 3 This is a side view of the adjustment unit of the body insertion device according to the present invention.

[0035] Figure 4 This is a side view of the transfer unit of the body insertion device according to the present invention.

[0036] Figure 5 This is a plan view of the transfer unit of the body insertion device according to the present invention.

[0037] Figure 6 This is a plan view of an adjustment unit according to another embodiment of the present invention.

[0038] Figure 7 This is a front view of the needle moving unit of the body insertion device according to the present invention.

[0039] Figure 8 This is a side view of the needle moving unit of the body insertion device according to the present invention.

[0040] Figure 9 This is a side view of the probe unit of the body insertion device according to the present invention.

[0041] Figure 10 This is a flowchart of the body insertion method according to the present invention.

[0042] Figure 11 It is used in Figure 10 The flowchart shown illustrates the method for determining body targets during the process.

[0043] Figures 12 to 15 This is a diagram used to describe in detail the methods for determining body targets. Detailed Implementation

[0044] The invention will now be described in detail with reference to the accompanying drawings.

[0045] In this specification, essential elements of the invention will be described, while non-essential elements will not. However, the scope of the invention should not be limited to inventions that only include the described components. Furthermore, it should be understood that inventions that include additional elements or do not have non-essential elements may be within the scope of this invention.

[0046] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of the structure, function, manufacture, and use of the apparatuses and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the apparatuses and methods specifically described herein and illustrated in the drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined only by the claims. Features shown or described in conjunction with one exemplary embodiment may be combined with features of other embodiments. These modifications and variations are intended to be included within the scope of the invention.

[0047] In this specification, the transmission / reception of information (data) may be performed via encryption / decryption if necessary. It should be understood that, although not specifically mentioned, the transmission / reception described herein can be performed using encryption / decryption. Furthermore, sending (forwarding) from A to B or receiving from B by A includes processes via additional media, and is not limited to direct transmission or reception. The order of each step should be understood in a non-limiting manner, unless the preceding step must be performed logically and temporally before the next step. That is, except as otherwise provided above, although a process described as the next step precedes a process described as the preceding step, it does not affect the nature of the invention, and the scope of the claim should be defined as independent of the order of steps. Furthermore, in this specification, "A or B" is not only defined as selectively referring to A or B, but is defined as including both A and B. Moreover, in this specification, the term "comprising" has the meaning of including other components besides those listed.

[0048] The method of the present invention can be an electronic computing device. An electronic computing device can be a device such as a computer, tablet computer, mobile phone, portable computing device, fixed computing device, server computer, etc. Furthermore, it should be understood that one or more different methods or aspects thereof can be executed by at least one processor. The processor can be implemented on a computer, tablet computer, mobile device, portable computing device, etc. A memory configured to store program instructions can also be implemented in the device, in which case the processor is specifically programmed to execute the stored program instructions to perform one or more processes, as will be further described below. Furthermore, it should be understood that the following information, methods, etc., can be executed by a computer, tablet computer, mobile device, portable computing device, etc., including a processor, in conjunction with one or more additional components, as described in detail below. In addition, control logic can be implemented as a non-transient computer-readable medium on a computer-readable medium containing executable program instructions that are executed by a processor, controller / control unit, etc. Examples of computer-readable media include, but are not limited to, ROM, RAM, optical disc (CD)-ROM, magnetic tape, floppy disk, flash drive, smart card, and optical data storage device. Computer-readable recording media can also be distributed across a network-coupled computer system, such that the computer-readable medium is stored and executed in a distributed manner, for example, via a telematics server or controller area network (CAN).

[0049] Figure 1 This is a block diagram of a body insertion device according to the present invention. Figure 1 As shown, the body insertion device includes a controller 100, a slope orientation adjustment unit 22, a transfer unit 20, a needle movement unit 30, and a probe unit 40.

[0050] The controller 100 controls the inclined plane orientation adjustment unit 22, the transfer unit 20, the needle movement unit 30, and the probe unit 40. The controller 100 may be part of an electronic computing device and may be a logical combination of general-purpose hardware and software designed to perform specific functions. Control commands for the controller 100 may be generated by a computer program stored in a computer-readable recording medium.

[0051] Figure 2 This is a front view of the inclined plane orientation adjustment unit 22. Figure 3 This is its side view.

[0052] The bevel orientation adjustment unit 22 includes a first drive module 16, a first direction-changing module 18, a first rotation axis 17, a body 19, a second hydraulic module 145, support arms 14, support columns 15, and a detector 222 (e.g., a vision sensor). The first rotation axis 17 may be parallel to the longitudinal direction of the needle unit. The support arms 14 may be at least a pair of arms arranged parallel to each other and may be driven by the second hydraulic module 145 to move toward or away from each other. The support arms 14 may be driven to move away from each other, such that a radial force is applied outward to the inner wall of the needle unit 200, thereby supporting the needle unit 200. The bevel orientation of the needle located at the needle unit 200 may be detected by the detector 222.

[0053] If the bevel orientation of the needle in needle unit 200 is not desired, the first drive module 16 rotates the body 19 about the first rotation axis 17 according to a command from the controller 100, thereby adjusting the bevel orientation of the needle in needle unit 200 supported by support arm 14 to the desired orientation. The first reversing module 18 converts the driving force of the first drive module 16 into a force capable of rotating the body 19 about the first rotation axis 17. The first reversing module 18 may include a reducer and can be implemented using various known motion mechanisms. The reversing module described below may also include a reducer. The first drive module 16 may be a rotary drive, such as a conventional motor, or a linear drive, such as a linear motor. In the case of using a linear motor, the first reversing module 18 converts linear motion into a direction capable of rotating the support arm 14.

[0054] However, the direction-changing module and the inclined plane orientation adjustment unit are not necessary for this invention and can be removed depending on the design of the drive module.

[0055] Figure 4 and Figure 5 These are, respectively, a side view and a plan view of the transfer unit 20. According to another embodiment of the present invention, Figure 4 and Figure 5 The transfer unit 20 shown may be equipped with a slope orientation adjustment unit. Figure 6 The diagram shows a plan view of the inclined plane orientation adjustment unit.

[0056] The transfer unit 20 includes a second drive module 23, a movable arm 24, a second rotating shaft 25, a first body 26, and a second direction-changing module 27. The movable arm 24 may be equipped with a slope orientation adjustment unit according to another embodiment of the present invention. The slope orientation adjustment unit may include at least one roller 214 in contact with the needle unit 200, a seventh drive module 223 for rotating the roller 214 to rotate the needle unit 200, and a detector 222. Figures 4 to 6(Not shown in the image). The periphery of the needle unit 200 is supported by a first retainer 211 to hold it in a predetermined position. The first retainer 211 may include at least a pair of arms spaced parallel to each other and driven by a third hydraulic module 215 to move toward or away from each other. The arms move toward each other to contact the outer periphery of the needle unit, thereby applying a force toward the needle unit 200 and holding the needle unit. The first retainer 211 is capable of supporting the needle unit 200 on its inner side, similar to the support arm 14.

[0057] The outer periphery of roller 214 may be provided with teeth to contact the outer periphery of needle unit 200. Needle unit 200 may be provided with complementary teeth on its outer periphery, which can mesh with the teeth of roller. Roller 214 may be made of silicon, synthetic resin, metal, etc.

[0058] Figure 6 The inclined plane orientation adjustment unit shown may also include movement inhibitors 212 and 213, which prevent the needle unit 200 from moving in a direction different from the direction in which the needle unit 200 can move via the roller 214. Multiple movement inhibitors 212 and 213 may be arranged around the outer periphery of the needle unit 200.

[0059] The movable arm 24 can be driven by the second drive module 23 to move between a first position and a second position. In this specification, the "first position" refers to the position where the needle unit 200 is supplied to the transfer unit 20, and the "second position" refers to the position where the needle unit 200 is transferred from the transfer unit 20 to the needle moving unit 30. The bevel orientation adjustment unit 22 can be located at the first position or the second position, or a position close to it. Alternatively, the bevel orientation adjustment unit 22 can be located at a third position. In this case, the movable arm 24 moves the needle unit 200 from the first position to the third position; adjusts the bevel orientation at the third position; and then moves the needle unit 200 from the third position to the second position. In these embodiments, the movable arm that moves the needle unit 200 from the first position to the third position can be separate from the movable arm that moves the needle unit 200 from the third position to the second position.

[0060] The position of the inclined plane orientation adjustment unit 22 is not necessary for this invention. Multiple inclined plane orientation adjustment units can be provided. If the inclined plane orientation adjustment unit is located in a second position, the movable arm 24 may be unnecessary.

[0061] Figure 7 This is a front view of the needle moving unit 30 of the body insertion device according to the present invention. Figure 8 This is its side view.

[0062] The needle moving unit 30 includes a second body 31, a first hydraulic module 32, a third drive module 33, a fourth drive module 34, a connecting member 35, a third rotating shaft 36, and a third reversing module 37.

[0063] The connecting member 35 supports the pin unit 200 via at least a pair of second retainers 321 driven by the first hydraulic module 32.

[0064] The movable arm 24 moves the needle unit 200 from a first position to a second position, and then the second retainer 321 is driven by the first hydraulic module 32 to support the needle unit 200 in the second position. Subsequently, the holding state between the first retainer 211 and the needle unit 200 is released by the third hydraulic module 215, causing the needle unit 200 to be transferred. After the needle unit 200 is transferred, the movable arm 24 returns to the first position.

[0065] The connecting member 35 may be provided with Figures 4 to 6 The inclined plane orientation adjustment unit is shown. Within it, as in... Figure 7 In the embodiment shown where the needle unit 200 is supplied to the needle moving unit 30 and a slope orientation adjustment unit is provided in the needle moving unit 30, the transfer unit 20 may be unnecessary.

[0066] With the needle unit 200, which has been transferred to the needle moving unit 30, supported by the second retainer 321, the needle unit is aligned by the third drive module 33 and the fourth drive module 34 to have an orientation in which the needle can be inserted into the body.

[0067] First, the third drive module 33 rotates the second body 31 about the third rotation axis 36 to an angle at which the needle can be inserted into the body. The third reversing module 37 converts the driving force of the third drive module 33 into a rotational force relative to the third rotation axis 36. With the second body 31 rotated to an angle, the fourth drive module 34 moves the connecting member 35 in the longitudinal direction of the second body 31 to perform insertion into the body. The connecting member 35 can be moved by a ball screw arranged in the longitudinal direction of the second body 31.

[0068] The second body 31 can be configured to further extend along Figure 7 and Figure 8 It can move in at least one of the left and right directions or any other direction, but not shown in the figure.

[0069] Figure 9 A side view of the probe unit 40 according to the present invention is shown.

[0070] The probe unit 40 of the present invention includes a probe 41, a probe holder 42, a fifth drive module 43, a sixth drive module 44, a track 45, a moving module 46, a fourth reversing module 47, a pressing module 48 configured to press a target body, and a holder for the pressing module 48. The probe may be an ultrasonic probe. The pressing module 48 may be rotatably supported by the holder of the pressing module 48. The pressing module 48 may be a roller. The pressing module 48 and the probe holder 42 are connected to each other via an elastic member 49 (e.g., a spring) so that the pressing module 48 can press the body with a predetermined force.

[0071] The probe holder 42 can be rotated around the fourth rotation axis 475 via the fifth drive module 43. The fourth reversing module 47 can convert the driving force of the fifth drive module 43 into a rotational force that causes the probe holder 42 to rotate around the fourth rotation axis 475.

[0072] The moving module 46 can move along the longitudinal direction of the track 45 via the sixth drive module 44. The track 45 may be equipped with a ball screw.

[0073] The probe unit 40 is movable in the longitudinal direction of the body portion 400. An example method for detecting the location of a target body (e.g., a superficial vein) will be described in detail below. In the case where the target body is a blood vessel, linearization of the target body facilitates location detection. Linearization can be achieved by moving the probe unit in the longitudinal direction of the body portion 400 (e.g., the lower arm) while pressing the pressing module 48 against the body portion placed in the body support 300. The pressing module 48 can press the body portion 400 at a distance determined to be important for detection.

[0074] refer to Figures 1 to 9 , Figure 10 and Figure 11 The operation and control of the device according to the present invention are described below.

[0075] In step 1100, the needle unit 200 is supplied to, for example, the bevel orientation adjustment unit 22. Figure 2 and Figure 3 As shown, the needle unit 200 can be supplied supported by the support post 15. Alternatively, as Figures 4 to 6 As shown, the needle unit 200 can be supplied supported by a first retainer 211 and arranged between rollers 214. As described above, the bevel orientation adjustment unit can be located at at least one of the first and second positions, or in or near that position. Alternatively, the bevel orientation adjustment unit can be located at or near a third position.

[0076] After supplying the needle unit 200, in step 1110, the detector 222 identifies the bevel orientation and end position of the needle. If the bevel orientation differs from a predetermined orientation, in step 1120, either the first drive module 16 or the seventh drive module 223 receives a command from the controller 100 to adjust the bevel orientation by rotating the needle unit 200. When the first drive module 16 operates, the body 19 rotates about the first rotation axis 17, thereby rotating the needle unit 200 supported by the support arm 14.

[0077] exist Figures 4 to 6 In the embodiment shown, when the seventh drive module 223 is operated, the roller 214 rotates, thereby causing the needle unit 200 to rotate to adjust the inclined plane orientation to a predetermined orientation.

[0078] In step 1130, after the inclined plane orientation is adjusted to the predetermined orientation, the first drive module 16 or the seventh drive module 223 stops working and then synchronizes the adjusted inclined plane orientation information with the value recorded in the controller 100.

[0079] Subsequently, the location of the target body is determined in step 1140. Figure 11 The process for determining whether a target body is a superficial vein is illustrated.

[0080] In step 1141, probe 41 is moved to a position close to the blood vessel. Subsequently, in step 1142, probe unit 40 is moved to linearize the blood vessel while compression module 48 compresses the blood vessel. Compression module 48 can be configured to move over a predetermined distance on the target body. Ultrasound scanning and blood collection can be easily performed on the blood vessel linearized by compression module 48. The compression force of compression module 48 can be an optimized uniform force between 0 and 19.6 N (inclusive).

[0081] In step 1143, after the linearization of the blood vessel is completed, probe 41 contacts the target body and acquires its ultrasound image. In step 1144, the location of the target blood vessel is determined by image processing of the acquired ultrasound image.

[0082] refer to Figures 12 to 15 The method for determining the location of superficial veins is described below.

[0083] In step 1150, the needle unit 200 moves to the second position. If the bevel orientation adjustment unit is located in or near the first position, the needle unit 200 can be transferred from the first position to the second position via the movable arm 24, which is rotated by the second drive module 23 receiving commands from the controller, while the movable arm 24 supports the needle unit 200, thereby adjusting the bevel orientation of the needle unit 200. The transfer from the first position to the second position can also be achieved by other known motion mechanisms or variations thereof.

[0084] If the bevel orientation adjustment unit is located in or near the second position, step 1150 may be unnecessary. In this embodiment, the bevel orientation is adjusted while the needle unit 200 is supported by the needle movement unit 30, such as... Figures 2 to 6 As shown.

[0085] If the inclined plane orientation adjustment unit is set in the third position, the movable arm 24 moves from the first position to the third position; the inclined plane orientation is adjusted in the third position; and then the movable arm 24 moves from the third position to the second position.

[0086] With the needle unit 200 supported in a second position by the needle moving unit 30, the second body 31 rotates to an appropriate angle for body insertion via a third drive module 33 receiving commands from the controller 100. Subsequently, a fourth drive module 34 moves the connecting member 35 in the longitudinal direction of the second body 31 according to commands from the controller 100, thereby inserting the needle into the body. If the target body is a superficial vein, blood collection can be performed after needle insertion. The second body 31 can be configured to... Figure 7 and Figure 8 Move in at least one of the left and right directions or in any other direction.

[0087] The following describes a method for determining the insertion location of a needle based on image processing of images obtained by the ultrasound probe 41. This description is an example for superficial veins. This method is disclosed in Korean Patent 10-2246966 and is for illustrative purposes only. It should be understood that the method described below does not limit the scope of the invention.

[0088] Figure 12 The procedure for determining the location of superficial veins using an ultrasound probe is shown.

[0089] In step 1200, the subject places their upper arm into a unit (not shown) for pressing the upper arm, which then presses down on the upper arm. This unit may include an annular band with a width of 1 cm to 5 cm. The band presses the upper arm 3 cm to 12 cm above the elbow, preferably 6 cm to 8 cm above the elbow. The pressure applied to the upper arm can be 10 mmHg to 60 mmHg, preferably 20 mmHg to 30 mmHg. The following treatment can be performed even without pressing the upper arm.

[0090] Although Figure 12 The diagram shows pressing the upper arm before the ultrasound probe 41 moves, but it is also possible to press the upper arm after the ultrasound probe 41 has moved and begun acquiring image data. If the upper arm is pressed after the ultrasound probe begins acquiring first image data, the first image data may include image data acquired before pressing the upper arm and image data acquired after pressing the upper arm.

[0091] In step 1205, after pressing the upper arm, the ultrasound probe 41 is moved to a position spaced apart from the body part by a predetermined distance (e.g., 1 mm).

[0092] The ultrasound probe 41 can move from the elbow crease toward the hand to the middle cubital vein, which is 0 to 8 cm, preferably 1 to 3 cm.

[0093] In step 1210, first image data is acquired as the ultrasound probe 41 moves toward the body part. The first image data is acquired before the ultrasound probe 41 contacts the body part. The first image data may include image data acquired before pressing the upper arm and image data acquired after pressing the upper arm.

[0094] Second image data is acquired while the ultrasonic probe 41 contacts and presses against the body part. According to an alternative aspect of the invention, the body can be pressed by an alternative device.

[0095] The first and second image data may include image data analyzed by the Doppler effect in the acoustic signal of blood flow. According to another embodiment of the invention, only one of the first and second image data may be used.

[0096] In step 1220, the image data processing module converts the first image data and the second image data into data with a format and size that can be processed by the program code of the present invention. Alternatively, the image data can be processed without conversion.

[0097] In step 1225, the machine learning server uses, for example, a convolutional neural network to analyze the transformed image data; then, it identifies the pixels of the target and the objects to be avoided.

[0098] In this specification, a target can be a blood vessel, such as a superficial vein or artery; an object to be avoided can be an artery, nerve, bone tissue, etc. The target and object to be avoided are defined differently depending on the purpose of finding the target. When the purpose is to find a superficial vein, arteries, nerves, or bone tissue considered objects to be avoided can be classified as targets for another purpose.

[0099] The target and evasion object can be displayed as pixels or bounding boxes. The bounding box can be generated using a center value, boundaries, and distances. Information defining the shape of the target or evasion object can also be stored. This information can be a center value, information about the shape of the target or evasion object, such as a circle / ellipse, rectangle, etc. This information can also include the radius, the distance between at least two points, the length of one side, etc.

[0100] The present invention, which uses convolutional neural network learning (hereinafter referred to as "CNN learning"), is described below.

[0101] For CNN learning to be performed, data learning should be conducted beforehand. The image data used in CNN learning can be preprocessed to increase its versatility using data augmentation techniques such as random cropping, size transformation, and horizontal flipping of the first and second image data.

[0102] The machine learning server learns and stores the feature information of the target and the object to be avoided through CNN.

[0103] The feature information may include at least one of the following: the echo intensity of the component identified in the ultrasound image data; the distribution pattern of the echo component; the relative position information of the component distribution; height, weight, sex, age, morbidity, and information about past and / or present treatment of the person; information obtained by ultrasound probes and other devices during compression; and real-time blood flow information analyzed by the Doppler effect.

[0104] Unlike arteries, veins decrease in size directly or swell due to pressure on their proximal portion when pressed with an ultrasound probe or other device. Information obtained during the pressure process by the ultrasound probe and other devices can include information about changes in the state of veins, etc.

[0105] The Doppler signal from arteries is strong because arteries pulsate periodically and their blood flow is rapid. Therefore, real-time blood flow information is useful for detecting targets such as superficial veins or arteries.

[0106] Training via CNN can be performed based on feature information to display pixels at the locations of the target and the object to be avoided.

[0107] Learning (training) can be supervised learning, unsupervised learning, or semi-supervised learning.

[0108] In supervised learning, training can be performed using images with correct answers. If the target and avoidance objects identified in the image are different from the correct answer, training can be performed, thus reducing the loss function. The loss function can be BCE loss (binary cross-entropy loss), cross-entropy, etc. The optimizer can be Adam optimizer, RMSprop, stochastic gradient descent, etc. Evaluation can be done using dice coefficient loss, etc.

[0109] After identifying the target and / or evasive object through machine learning (e.g., CNN learning), step 1230 is performed to determine the final target based on the identified object.

[0110] Figure 13 A flowchart is shown, including the detailed process in step 1230.

[0111] In step 1300, it is determined whether the target to be searched was identified in a previous step. If the target exists, the number of targets is counted in step 1305.

[0112] If the number of identified targets is one, then in step 1335 it is determined whether the target's boundary intersects with the image boundary. If they do not intersect, step 1310 is performed. Otherwise, in step 1355, the ultrasound probe 41 is moved to another location, such as the center of the image, so that the coordinates of the target boundary are inside the image. The process then returns to step 1210, and the steps following step 1210 are performed. Instead of moving the ultrasound probe 41, the patient's body can be moved.

[0113] In step 1310, the diameter of the largest inscribed circle, which is one of the size-based information of the target, is calculated. The largest inscribed circle is the largest circle that includes only the target pixels. The size-based information of the object may include the maximum / minimum length of horizontal and vertical lines that can be drawn within the object, the maximum / minimum distance between the object's centroid and the object's boundary, the object's area, etc., and further to the diameter of the largest inscribed circle.

[0114] In step 1315, the depth of the target is calculated as one of the depth-based information. In step 1320, it is determined whether the target meets a first determination criterion and a second determination criterion. The depth-based information includes various information related to depth.

[0115] If the target is a superficial vein, the first determination criterion is whether the diameter of the largest inscribed circle is greater than or equal to a predetermined value (first value). For example, if the diameter of the largest inscribed circle of the identified target is less than 2 mm, the target can be classified as an avoidance target in step 1375. If the diameter of the largest inscribed circle is greater than or equal to the first value, the first determination criterion is satisfied. The first value can be determined with reference to the device's operating error range.

[0116] If the size-based information involves horizontal and vertical lines that can be drawn in the object, the first determination criterion may be whether the maximum and / or minimum length of the horizontal / vertical lines is greater than or equal to a predetermined value. For example, if the minimum length of the horizontal and vertical lines of the identified target is less than 2 mm, the target is classified as an avoidance object. If there are not singular targets that meet the first determination criterion, in step 1370, the object with the maximum value among the sum, product, average, etc. of length can be identified as a candidate for the final target.

[0117] If the size-based information is the maximum and minimum distances between the center of gravity and the boundary line, the first determination criterion is whether these distances are greater than or equal to a predetermined value. For example, if the minimum distance between the target's center of gravity and the target's boundary line is less than 2 mm, the target can be classified as an avoidance target. If there are multiple targets that meet the first determination criterion, in step 1370, the target with the maximum value among the sum, product, average, etc., of the distances can be identified as a candidate for the final target.

[0118] If the size-based information is the area of ​​the object, the first determining criterion is whether that area is greater than or equal to a predetermined value. For example, if the area of ​​the target is less than 10 mm². 2 If the target satisfies the first determination criterion, then the target can be classified as an avoidance target. If there are not multiple targets that meet the first determination criterion, then in step 1370, the object with the largest area can be identified as a candidate for the final target.

[0119] The second determination criterion is whether the depth of the target is less than or equal to a predetermined value (the second value), such as 1 cm. If the depth of the target is greater than the second value, the target can be classified as an avoidance target in step 1375. This is to exclude deep veins, as hemostasis of deep veins is more difficult than that of superficial veins, and to exclude arteries as avoidance targets. Furthermore, if the depth of the target is greater than the second value, the needle may create a deep wound upon insertion into the body, and important anatomical structures or nerves may be present along the insertion path. This is why the second determination criterion is necessary. If the depth of the target is less than or equal to the second value, the second determination criterion is determined to be met.

[0120] If the first and second determination criteria are met, then in step 1325, it is determined whether another object exists in the straight path between the candidate and the skin surface. This is referred to as the third determination criterion. The other object present in the path could be a nerve of an evasive object.

[0121] If the result is determined to be "no" in step 1325, then the candidate is determined as the final target in step 1330.

[0122] Alternatively, the objective that satisfies at least one of the first determination criteria, the second determination criteria, and the third determination criteria may be determined as the final objective.

[0123] The following describes an implementation of identifying multiple targets in step 1225.

[0124] If multiple targets are identified, the size of the largest inscribed circle of each target is calculated in step 1360. In step 1365, the sizes of the largest inscribed circles of each target are compared with each other, and then in step 1370, candidates for the final targets are determined according to a fourth determination criterion. Other size-based information can be calculated and compared with each other as described above in alternative embodiments of the invention.

[0125] The fourth determination criterion is as follows. In principle, the target with the largest size of its largest inscribed circle is selected as a candidate for the final target. However, if the difference between the largest size and the second largest size is within a predetermined value (the third value), such as 10%, a target that is closer to the contact surface of the ultrasonic probe, such as the target closest to the center of the contact surface, can be selected as a candidate for the final target.

[0126] Even in embodiments where the first information is other size-based information, the fourth determination criterion can still be applied as described above. That is, if the difference in the compared dimensions is within a predetermined value, a target closer to the contact surface of the ultrasonic probe, such as the target closest to the center of the contact surface, can be selected as a candidate for the final target.

[0127] After selecting a candidate for the final target in step 1370, step 1315 and subsequent steps are performed, and the candidate is then identified as the final target or the object to be evaded.

[0128] If it is determined in step 1300 that the target does not exist, it is then determined whether a target search has been performed more than or equal to a predetermined number of times. If it is determined that a search has been performed more than or equal to the predetermined number of times, such as 2 or 3 times, a target search is performed on the opposite arm in step 1380. If it is determined that fewer than the predetermined number of searches has been performed, the ultrasonic probe 41 is moved to a position different from the previous search, and then the first image data is obtained in step 1210.

[0129] After determining the final target according to the above steps, the coordinates of the center of the final target are calculated in step 1235. The needle unit 200 is then inserted into the center of the final target.

[0130] The center of the final target is defined by point x, which has the maximum distance to any point xi within the largest inscribed circle containing only the pixels of the final target.

[0131] If the number of times the straight line between the center and the skin surface crosses the surface of the blood vessel is greater than or equal to the predetermined number, such as twice, then the candidate for the final target can be excluded from the final target.

[0132] According to an optional embodiment of the invention, a circle with a predetermined diameter (e.g., 1 mm) is drawn for all pixels within the final target; then, if a predetermined proportion of the pixels within the circle, for example 30% to 95%, preferably 50% to 70%, is within the final target, the pixel is determined to be included in the final target. Otherwise, the pixel is excluded from the final target.

[0133] like Figure 15 As shown, since all pixels in the circle 1520 drawn relative to pixel 1510 are within the final target, pixel 1510 is determined to be a pixel of the final target. Since the predetermined portion of the pixels in the circle 1511 drawn relative to pixel 1530 is not within the final target, the corresponding pixel 1530 is excluded from the final target.

[0134] These processes are used to soften the boundaries of the final target and eliminate the possibility of misclassified pixels in the final target. However, these processes are optional and not required in this invention.

[0135] Although the invention has been described with reference to the accompanying drawings, the scope of the invention is determined by the appended claims and should not be construed as being limited by the embodiments described above and / or the drawings. It should be clearly understood that improvements, variations, and modifications of the invention disclosed in the claims and which are obvious to those skilled in the art also fall within the scope of the invention. Therefore, this specification is by way of example only and is not intended to otherwise limit the scope of the embodiments described herein.

Claims

1. A body insertion device comprising: an adjustment unit for adjusting a bevel orientation of a needle unit (200); a moving unit for the needle unit (200), the moving unit being provided with the needle unit; and an ultrasound probe unit (42) configured to obtain an image of a body based on at least one of first information related to a size of an identified target, second information related to a depth of the identified target, and third information that a straight path between the identified target and a skin surface is present with an evasive object, identify a target including a blood vessel and the evasive object in the body based on a trained neural network model, determine a position of a final target including the blood vessel, and wherein the adjustment unit (22) comprises a support arm (14) for supporting the needle unit (200), the support arm (14) comprising a pair of arms disposed parallel to each other, a hydraulic module (145) for driving the support arm (14), a driving module (16) for rotating the support arm (14), and a detector (222) for detecting the bevel orientation of a needle of the needle unit (200), wherein the pair of arms of the support arm are configured to be moved away from each other by the hydraulic module and to support the needle unit (200) by applying a force outwardly to an inner wall of the needle unit, wherein the driving module (16) is configured to adjust the bevel orientation of the needle of the needle unit (200) by rotating the support arm (14) based on the bevel orientation of the needle of the needle unit (200) detected by the detector (222), wherein the moving unit supports the needle unit having the needle, adjusts the needle unit to an orientation suitable for body insertion, and moves the needle unit into the final target in the body, the bevel orientation of the needle is adjusted by the adjustment unit, and wherein the ultrasound probe unit is further configured to determine whether a boundary of the target overlaps with a boundary of the image, and when it is determined that the boundary of the target overlaps with the boundary of the image, move so that coordinates of a boundary surface of the target are located within the image, and reacquire an image of a body part.

2. The body insertion device of claim 1, further comprising a transfer unit for moving the needle unit from a first position to a second position. The transfer unit comprises a movable arm supporting the needle unit, the movable arm being moved between the first position and the second position.

3. The body-insertable device according to claim 2, wherein The adjustment unit is disposed in at least one of the first position and the second position, or close to the position.

4. The body-insertable device according to claim 2, wherein The probe unit comprises a probe, a probe holder, a pressing module for pressing the target body.

5. The body-insertable device according to claim 1, further comprising a probe unit for probing a target object, wherein, The probe unit further comprises an elastic member for connecting the probe holder and the pressing module.

6. The body-insertable device according to claim 5, wherein ​

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