Medical puncture device and catheter assembly

Abstract

To provide a medical puncture device capable of puncturing, for example, only a front wall of a blood vessel of a biological tissue and further reliably securing the biological tissue, and catheter assembly.SOLUTION: A medical puncture device 1 includes a needle 10 to be punctured into a biological tissue, a needle hub 20 fixed to a proximal end 13 of the needle 10 and holding the needle 10, a body part 30 capable of storing and holding the needle hub 20, and an operation mechanism 50 when external force is applied thereto, executing operation of moving the needle 10 in an advancing direction X2 and a retraction direction X1 with respect to the body part 30. When a position of the needle 10 punctured and positioned in the biological tissue is an initial position M, the operation mechanism 50 pulls back the needle 10 in the retraction direction Z1 from the initial position M, then makes the needle 10 advance again in the advancing direction X2 and positioning it at the initial position M.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a medical puncture device and catheter assembly for use under ultrasonic echo. [Background technology]

[0002] Patent Document 1 discloses a medical puncture needle for injecting a liquid medicine. The medical puncture needle described in Patent Document 1 is punctured into a human body or an animal under ultrasonic imaging. Patent Document 2 discloses a medical expansion device for expanding a puncture hole. The medical expansion device described in Patent Document 2 is provided with a puncture needle having a blade surface for puncturing the skin. A second slider fixed to the base end of the puncture needle is biased by a coil spring in a direction in which the tip of the puncture needle retracts. Patent Document 3 discloses a puncture device that instantaneously protrudes a needle body to puncture the skin. The needle body of the puncture device described in Patent Document 3 is pushed out from an initial position toward the tip of the needle body, and then pulled back toward the base end of the needle body.

[0003] A high level of skill is required for an operator to secure venous and arterial blood vessels under ultrasonic echo using a puncture needle as disclosed in, for example, Patent Documents 1 to 3. The following two phenomena are cited as reasons why high level of skill is required. First, the first phenomenon is blood vessel collapse. Blood vessel collapse is a phenomenon in which the blood vessel is deformed by the force applied from the needle, causing the blood vessel diameter to become minute and the cross-sectional area of ​​the blood vessel in the short axis direction to become smaller. When blood vessel collapse occurs, it becomes impossible to insert the needle into the blood vessel, and there is a high risk of puncturing the back wall as a result of trying to penetrate the front wall of the blood vessel. If the back wall is punctured, there is a risk of hematoma or other veins, arteries, or nerves running parallel to the blood vessel to be punctured and being punctured incorrectly, causing injury. One of the reasons for blood vessel collapse is low internal pressure of the blood vessel. Blood vessel collapse occurs particularly notably in veins. The second phenomenon is blood vessel escape. Blood vessel escape is a phenomenon in which the force applied by the needle causes the blood vessel to move in a direction away from the position of the needle tip. When blood vessel escape occurs, there is a problem in that the needle tip cannot be inserted into the blood vessel. One of the reasons for blood vessel escape is that before the puncture needle breaks the body surface, the muscle and fatty tissue between the body surface and the vein deform, and the vein is pushed aside by the deformation of the muscle and fatty tissue.

[0004] As one technique for avoiding the above-mentioned blood vessel collapse and blood vessel escape, and improving the needle puncture success rate and blood vessel securing rate, it is considered that the operator should puncture the needle quickly. According to the clinical knowledge obtained by the present inventor, the faster the needle is inserted into the blood vessel, the higher the puncture success rate. On the other hand, if the operator tries to puncture the needle quickly, the needle tip may go too far and puncture both the front wall and the back wall of the blood vessel. If the needle tip penetrates the back wall of the blood vessel, other veins, arteries, and nerves running parallel to the blood vessel to be punctured may be damaged, or a hematoma may occur at the puncture mark caused by the operator returning the needle tip that penetrated the back wall into the blood vessel. In this way, it is an extremely precise and difficult task for the operator to secure the blood vessel by puncturing only the front wall of the blood vessel under ultrasonic echo. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 3171525 [Patent Document 2] Patent No. 6412483 [Patent Document 3] Patent No. 5015699 Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention has been made to solve the above-mentioned problems, and aims to provide a medical puncture device and catheter assembly that can puncture only the front wall of biological tissue, for example, a blood vessel, and more reliably secure the biological tissue. [Means for solving the problem]

[0007] The problem is to provide a needle capable of puncturing biological tissue, a needle hub fixed to the base end of the needle and holding the needle, a main body portion that houses the needle hub and can be held, and an operation mechanism that operates an action of moving the needle in an advancing direction and a retreating direction relative to the main body portion by applying an external force, the operation mechanism being configured such that, when the position of the needle that has been punctured and positioned in the biological tissue is set as an initial position, the operation mechanism retracts the needle from the initial position in the retreating direction, and then advances the needle again in the advancing direction to position it at the initial position. The operating mechanism has a biasing means disposed between an end face of the needle hub and an inner surface of the main body, and the needle hub holding the needle receives a biasing force from the biasing means and advances again in the advancing direction. The above-mentioned problems are solved by a medical puncture device, which is characterized by:

[0008] According to the medical puncture device of the present invention, when the position of the needle punctured and positioned in the biological tissue is set as the initial position, the operation mechanism retracts the needle from the initial position in the needle retraction direction, and then re-advances the needle in the advancement direction to position it at the initial position. As a result, the needle is located at the initial position when it re-advances in the advancement direction after being retracted in the retraction direction. Therefore, the operator can quickly puncture the biological tissue at the initial position, that is, the position where only the front wall of the blood vessel, which is the wall part located on the front side of the blood vessel, can be punctured, and the biological tissue can be secured more reliably. In other words, the medical puncture device of the present invention can prevent blood vessel collapse and blood vessel escape, improve the needle puncture success rate, and improve the blood vessel securing rate. In addition, since the operator can puncture only the front wall of the blood vessel, for example, of the biological tissue, it is possible to prevent the formation of a puncture hole (i.e., a puncture mark) in the rear wall of the blood vessel, for example, of the biological tissue, and to prevent the occurrence of a hematoma at the puncture mark. In addition, it is possible to prevent the operator from erroneously puncturing another vein, artery, or nerve running parallel to the biological tissue to be punctured. This prevents problems such as nerve damage and hematoma from occurring, and reduces the effort required for post-treatment due to erroneous puncture. Furthermore, it is possible to reduce stress on the operator during puncture and shorten the puncture time. When inserting the needle tip into a blood vessel in a biological tissue, the needle is pulled back from the initial position in the needle retraction direction, and then advanced again in the advance direction to the initial position. Therefore, the needle tip can puncture the blood vessel forcefully to expand the puncture area of ​​the needle tip, that is, the needle tip can puncture the central position of the blood vessel, and even if the needle tip is offset from the central position of the blood vessel, the blood vessel can be punctured reliably without escaping. It is possible to prevent the blood vessel from escaping, in which the force applied from the needle causes the blood vessel to move away from the position of the needle tip, and the needle tip can be inserted reliably into the blood vessel. Furthermore, according to the medical puncture device of the present invention, the operating mechanism can use the biasing force of the biasing means to advance the needle hub holding the needle in the advancement direction again. This allows the medical puncture device of the present invention to quickly advance the needle in the advancement direction again to reliably puncture only the front wall of the biological tissue, for example, a blood vessel, with a constant force, and more reliably secure the biological tissue. Even if it is difficult to secure power, for example, because power used for robot puncture is not required, the medical puncture device of the present invention can quickly advance the needle in the advancement direction again to puncture only the front wall of the biological tissue, for example, a blood vessel, and more reliably secure the biological tissue.

[0009] In the medical puncture device of the present invention, the operating mechanism preferably has a locking mechanism that is capable of fixing the position of the needle hub relative to the main body when the needle is pulled back in the retreating direction from the initial position and is capable of releasing the fixed position of the needle hub relative to the main body. According to the medical puncture device of the present invention, the locking mechanism can fix the position of the needle hub relative to the main body when the needle is retracted in the retracting direction from the initial position. That is, the locking mechanism can maintain the state in which the needle is retracted in the retracting direction from the initial position. The locking mechanism can release the state in which the position of the needle hub is fixed relative to the main body. This allows the operator to stably perform the operation of re-advancing the needle, which has been retracted in the retracting direction, in the advancing direction at any timing. This can improve the usability of the medical puncture device of the present invention.

[0010] In the medical puncture device according to the present invention, the operation mechanism preferably has a tab provided on the needle hub and capable of operating the position of the needle hub. According to the medical puncture device of the present invention, the operator can easily perform the operation of pulling back the position of the needle hub that holds the needle in the retracting direction by manually operating the tab.

[0011] In the medical puncture device according to the present invention, the operating mechanism is preferably capable of being used multiple times. According to the medical puncture device of the present invention, the technician can use the operating mechanism multiple times. Therefore, even if the technician is unable to puncture as desired the first time, the technician can try again, thereby more reliably securing the biological tissue.

[0012] In the medical puncture device according to the present invention, the speed at which the needle advances again in the advancing direction is preferably faster than the speed at which the needle is retracted in the retreating direction from the initial position. With the medical puncture device according to the present invention, the operator can prevent the needle from shifting from its initial position when pulling the needle back in the retreating direction, and can quickly puncture only the front wall of the biological tissue, for example, a blood vessel, when advancing the needle back in the advancing direction. This allows the medical puncture device according to the present invention to secure the biological tissue more reliably.

[0014] In the medical puncture device of the present invention, the operating mechanism preferably comprises an actuation initiation member, a first biasing means which, when the actuation initiation member is operated, applies a biasing force in the retraction direction to the needle hub holding the needle, thereby retracting the needle from the initial position in the retraction direction, and a second biasing means which, after the needle has been retracted from the initial position in the retraction direction, applies a biasing force in the advancement direction to the needle hub holding the needle, thereby advancing the needle again in the advancement direction. According to the medical puncture device of the present invention, when the operator operates the actuation start member, the first biasing means applies a biasing force in the retracting direction to the needle hub holding the needle, and pulls the needle back from the initial position in the retracting direction. Then, after the needle is once pulled back from the initial position in the retracting direction, the second biasing means applies a biasing force in the advancing direction to the needle hub holding the needle, and advances the needle in the advancing direction again. As a result, the operator can operate the actuation start member to once pull the needle back from the initial position in the retracting direction, and then advance the needle in the advancing direction again to position it at the initial position. As a result, the operator can operate the actuation start member to quickly advance the needle in the advancing direction again to reliably puncture only the front wall of the biological tissue, for example, a blood vessel, with a constant force, and more reliably secure the biological tissue. Furthermore, even if it is difficult to secure power, for example, power used for robotic puncture is not required, so the medical puncture device of the present invention can quickly advance the needle in the advancing direction again to puncture only the front wall of the biological tissue, for example, a blood vessel, based on the operation of the actuation start member, and more reliably secure the biological tissue.

[0015] The above problem is also solved by a catheter assembly according to the present invention, which comprises any of the above medical puncture devices, a catheter through which the needle of the medical puncture device can be inserted, and a catheter hub attached to the main body and fixed to the base end of the catheter.

[0016] According to the catheter assembly of the present invention, when the position of the needle punctured and positioned in the biological tissue is set as the initial position, the operating mechanism of the medical puncture device pulls the needle back from the initial position in the needle retraction direction, and then advances the needle again in the advance direction to position it at the initial position. Therefore, the operator can quickly puncture only the front wall of the biological tissue, for example, a blood vessel, and can secure the biological tissue more reliably. In other words, the catheter assembly of the present invention can prevent the occurrence of blood vessel collapse and blood vessel escape, and can improve the needle puncture success rate and blood vessel securing rate. Furthermore, since the operator can puncture only the front wall of the biological tissue, for example, a blood vessel, it is possible to prevent the formation of a puncture hole (i.e., a puncture mark) in the rear wall of the biological tissue, for example, a blood vessel, and to prevent the occurrence of a hematoma at the puncture mark. Furthermore, it is possible to prevent the operator from erroneously puncturing another vein, artery, or nerve that runs parallel to the biological tissue to be punctured. This prevents the occurrence of problems such as nerve damage and hematoma, and reduces the effort required for post-treatment due to erroneous puncture. Furthermore, it is possible to reduce the stress on the operator during puncture and shorten the puncture time. Effect of the Invention

[0017] According to the present invention, it is possible to provide a medical puncture device and a catheter assembly that can puncture only the front wall of a blood vessel, for example, of biological tissue and secure the biological tissue more reliably. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a cross-sectional view showing a medical puncture device according to a first embodiment of the present invention. [Diagram 2] 1 is a cross-sectional view showing an example of ultrasonic echo-guided puncture using a medical puncture device. FIG. [Diagram 3] 1A to 1C are cross-sectional views showing an example of an operating procedure for using a medical puncture device. [Figure 4] 1 is a cross-sectional view showing a catheter assembly according to an embodiment of the present invention. [Diagram 5] FIG. 4 is a cross-sectional view showing a medical puncture device according to a second embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings. The embodiments described below are preferred specific examples of the present invention, and therefore various technically preferable limitations are applied to them, but the scope of the present invention is not limited to these aspects unless otherwise specified in the following description to the effect that the present invention is limited to them. In addition, in each drawing, similar components are given the same reference numerals, and detailed descriptions thereof are omitted as appropriate.

[0020] (First embodiment) <Overview of Medical Puncture Device 1> FIG. 1 is a cross-sectional view showing a medical puncture device according to a first embodiment of the present invention. FIG. 1(A) shows a medical puncture device with the needle tip pulled out from the main body. FIG. 1(B) shows the state immediately before the needle tip is pulled back once and is about to advance again into the blood vessel. 1 is applicable to vein puncture, arterial puncture, and other punctures such as egg collection needles and biopsy needles, on the assumption that it will be used under ultrasonic echo. As shown in FIG. 1, the medical puncture device 1 has a needle 10, a needle hub 20, a main body 30, and an operation mechanism 50.

[0021] <Needle 10> Needle 10 shown in Fig. 1(A) is capable of puncturing biological tissue. Needle 10 has tip 11, middle section 12, and base end 13. Tip 11 of needle 10 is the end on the side having a needle opening formed at an angle. Base end 13 is the end opposite tip 11. Needle 10 is a needle used for puncturing under ultrasonic echo, and therefore has a predetermined blade face length and blade face angle (regular bevel or short bevel). The material of the needle 10 may be, for example, stainless steel such as medical SUS304 or SUS316L (with molybdenum added and low carbon content for corrosion resistance), aluminum, aluminum alloy, titanium, or other metal material, or hard resin. The needle 10 is used, for example, in catheter procedures under ultrasonic echo. The biological tissue to be punctured may be, for example, blood vessels of veins and arteries, or ovaries or other organs. In the embodiment of the present invention, the biological tissue is described as a blood vessel.

[0022] <Needle hub 20> The needle hub 20 shown in FIG. 1(A) is, for example, a cylindrical member made of plastic, and is fixed to the base end 13 of the needle 10. The needle hub 20 has an insertion hole 21. The base end 13 of the needle 10 is inserted and fixed in the insertion hole 21 of the needle hub 20. In other words, the needle hub 20 holds the needle 10 in a state where it is fixed to the base end 13 of the needle 10. The needle hub 20 has an engagement portion 22 that is substantially triangular in cross section. The engagement portion 22 is formed so as to protrude in the radial direction in the whole or part of the circumferential direction of the needle hub 20. A tab 23 for manual operation is provided on the needle hub 20. The tab 23 of the needle hub 20 is provided so as to protrude radially outward. The operation tip portion 23D of the tab 23 is formed at an angle. This allows the operator to easily perform a pull-back operation by holding the tab 23 with his / her fingers and pulling the tab 23 toward the backward direction (also called the "pull-back direction") X1.

[0023] <Main body 30> The main body 30 shown in FIG. 1(A) is a gripping portion that can be gripped by the operator's fingers, and houses the needle hub 20. The main body 30 is made of, for example, plastic, and has a tip portion 31, an intermediate portion 32, and a terminal portion 33. The intermediate portion 32 and the terminal portion 33 are formed, for example, in a cylindrical shape having a predetermined diameter so that the operator can easily grip them. The tip portion 31 is formed thinner than the intermediate portion 32. A tapered portion 34 that tapers toward the tip portion 31 side is formed between the tip portion 31 and the intermediate portion 32. A housing space portion 37 having a circular cross section is formed between the intermediate portion 32 and the terminal portion 33.

[0024] The intermediate portion 32 shown in FIG. 1 is provided with a guide groove 32G. The guide groove 32G can guide the tab 23 of the needle hub 20 along the retraction direction X1 and the advancement direction (also called the "advancement direction") X2 opposite to the retraction direction X1. The needle hub 20 is accommodated in the accommodation space 37 of the main body 30, and can move back and forth in the retraction direction X1 and the advancement direction X2 along the central axis CL of the main body 30 while being guided by the guide groove 32G. The tip portion 31 has a through hole 35 along the central axis CL. The intermediate portion 32 has a through hole 36 along the central axis CL. The intermediate portion 12 of the needle 10 passes through the through hole 35 and the through hole 36, and can slide back and forth along the central axis CL.

[0025] <Operation mechanism 50> Next, the operation mechanism 50 will be described. The operation mechanism 50 shown in FIG. 1(A) operates the action of moving the needle 10 in the backward direction X1 and the forward direction X2 relative to the main body part 30 by applying an external force by manual operation of the operator. The operation mechanism 50 includes a spring 51, a lock mechanism 52, and the above-mentioned tab 23 for manual operation. The spring 51 of this embodiment is an example of the "biasing means" of the present invention. The spring 51 of the operation mechanism 50 is, for example, a coil spring made of metal or plastic, and is arranged along the central axis CL together with the needle hub 20 in the housing space part 37 of the main body part 30. As shown in FIG. 1(A) and FIG. 1(B), the needle hub 20 and the spring 51 are arranged in series with each other along the central axis CL.

[0026] 1(A), the tip 11 of the needle 10 protrudes furthest from the tip portion 31 of the main body 30. The first end face 26 of the needle hub 20 abuts against the end face 32A of the intermediate portion 32 of the main body 30 due to the biasing force of the spring 51. The second end face 24 of the needle hub 20 abuts against the first end portion 51A of the spring 51. The inner surface of the terminal portion 33 of the main body 30 abuts against the second end portion 51B of the spring 51. Therefore, the needle hub 20 and the spring 51 are held in the accommodation space 37 of the main body 30 with respect to the central axis CL.

[0027] The locking mechanism 52 of the operating mechanism 50 is, for example, a cylindrical member made of resin and capable of elastic deformation. The locking mechanism 52 is provided between the intermediate portion 32 and the terminal end portion 33 of the main body portion 30. The locking mechanism 52 can fix the position of the needle hub 20 relative to the main body portion 30, and can release the state in which the position of the needle hub 20 relative to the main body portion 30 is fixed. The locking mechanism 52 has a cylindrical portion 53, a pressing portion 54, and an engaging protrusion portion 55. The cylindrical portion 53 forms the accommodation space portion 37 together with the intermediate portion 32 and the terminal end portion 33 of the main body portion 30.

[0028] As shown in FIG. 1(A), the outer dimensions of the cylindrical portion 53 of the locking mechanism 52 are set to be the same as the outer dimensions of the main body 30. The cylindrical portion 53 of the locking mechanism 52 is elastically deformable. A plurality of engagement protrusions 55 are formed on the inner peripheral surface of the cylindrical portion 53 so as to protrude radially inward. The engagement protrusions 55 are formed at arbitrary intervals from one another along the central axis CL. Each engagement protrusion 55 is formed on the entire or part of the inner peripheral surface of the cylindrical portion 53 in the circumferential direction. In the state shown in FIG. 1(A), the engagement portion 22 of the needle hub 20 is not engaged with the engagement protrusion 55. On the other hand, in the state shown in FIG. 1(B), the engagement portion 22 of the needle hub 20 is engaged with the engagement protrusion 55 while receiving a biasing force in the advancing direction X2 from the spring 51.

[0029] When the operator manually operates the tab 23 with, for example, a finger to pull the tab 23 back in the backward direction X1 against the biasing force of the spring 51, the engagement portion 22 of the needle hub 20 comes into contact with the engagement protrusion 55 of the locking mechanism 52 and pushes the cylindrical portion 53 radially outward. As a result, the cylindrical portion 53 is elastically deformed in the direction of the arrow Q shown in FIG. 1(B). Then, as shown in FIG. 1(B), the engagement portion 22 of the needle hub 20 engages with the engagement protrusion 55 in a hooked manner. In the state of FIG. 1(B), the engagement portion 22 of the needle hub 20 engages with the engagement protrusion 55, so that the needle hub 20 holding the needle 10 is held in a state of being pulled back in the backward direction X1. In other words, the position of the needle hub 20 is fixed with respect to the cylindrical portion 53 of the locking mechanism 52. At this time, the spring 51 is in a compressed state between the needle hub 20 and the terminal end portion 33, and applies a biasing force in the forward direction X2 to the needle hub 20.

[0030] The cylindrical portion 53 has a pressing portion 54. The pressing portion 54 is formed on the outside of the cylindrical portion 53 so as to protrude radially outward in a direction perpendicular to the central axis CL. In order to enable the operator to reliably press the pressing portion 54 with his / her fingers, the pressing portion 54 is formed, for example, in a semicircular cross section. The pressing portion 54 may be formed over the entire circumference of the cylindrical portion 53, or may be formed on a part of the circumference of the cylindrical portion 53. As shown in FIG. 1(B), when the operator pinches the pressing portion 54 by manual operation using, for example, his / her fingers and presses the pressing portion 54 radially inward with a pressing force P, the release portion 56 of the cylindrical portion 53 opens outward as shown by the arrow Q. This allows the operator to release the state in which the engagement portion 22 of the needle hub 20 is engaged with the engagement protrusion 55. Therefore, the needle 10 and the needle hub 20 are subjected to the urging force of the spring 51 that was held in a compressed state, and move together along the advance direction X2. As a result, the tip 11 of the needle 10 is advanced by the retraction amount W of the needle 10. Examples of materials for the needle hub 20, main body 30 and operating mechanism 50 include resin materials such as fluorine-based resins such as polytetrafluoroethylene (PTFE) and ethylene-tetrafluoroethylene copolymers, olefin-based resins such as polyethylene and polypropylene, or mixtures of these, polyurethane, polyester, polyamide, etc.

[0031] <Example of operating procedure when using the medical puncture device 1> Next, an example of an operating procedure when using the above-mentioned medical puncture device 1 will be described with reference to Figs. FIG. 2 is a cross-sectional view showing an example of ultrasonic echo-guided puncture using a medical puncture device. As shown in Figure 2, when the technician inserts tip 11 of needle 10 into a blood vessel 100, such as a vein, present inside skin 90, the technician checks the state of insertion of tip 11 of needle 10 while observing the echo image obtained from ultrasonic probe 95 on a monitor or the like under ultrasonic echo from ultrasonic probe 95.

[0032] FIG. 3 is a cross-sectional view showing an example of an operating procedure for using the medical puncture device. In Fig. 3(A) to Fig. 3(D), the four upper figures show the short-axis image of ultrasonic echo-guided puncture, and the four lower figures show the long-axis image of ultrasonic echo-guided puncture. Fig. 3(A) shows the state before the tip 11 of the needle 10 is punctured into the blood vessel 100. Fig. 3(B) shows the state in which the tip 11 of the needle 10 is punctured into the apex of the front wall 101 of the blood vessel 100 and the initial position M of the tip 11 of the needle 10 is determined. Fig. 3(C) shows the state in which the tip 11 of the needle 10 is pulled back from the initial position M by the pullback amount W. Fig. 3(D) shows the state in which the tip 11 of the needle 10 advances again to the initial position M by the pullback amount W. In the state shown in Fig. 3(D), the tip 11 of the needle 10 is punctured only into the front wall 101 of the blood vessel 100 to form a puncture hole 103, and no puncture hole is formed in the rear wall 102. The pullback amount W is, for example, about 1 mm to 10 mm. As shown in the long axis images of Figs. 3(A) to 3(D), the tip 11 of the needle 10 is inserted into the blood vessel 100 at a predetermined inclination angle. The initial position M is set at the center of the blood vessel 100 in the diameter direction E, for example, as shown in Fig. 3(B). However, the initial position M is not limited to this.

[0033] First, when the puncture of the tip 11 of the needle 10 starts under ultrasonic echo, as shown in FIG. 1(A), the tip 11 of the needle 10 of the medical puncture device 1 is in a state of being fully extended from the main body 30. In this state, the first end surface 26 of the needle hub 20 abuts against the end surface 32A of the middle part 32 of the main body 30. The second end surface 24 of the needle hub 20 abuts against the first end 51A of the spring 51. The inner surface of the terminal part 33 of the main body 30 abuts against the second end 51B of the spring 51. As shown in FIG. 3(A) to FIG. 3(B), the operator holds the main body 30 of the medical puncture device 1 and punctures the apex 109 of the front wall 101 of the blood vessel 100 at a predetermined inclination angle while observing the echo image under ultrasonic echo, and positions the tip 11 of the needle 10 at the initial position M. At this time, as shown in FIG. 3(B), the blood vessel 100 is pushed by the tip 11 of the needle 10 and is deformed and collapsed.

[0034] Next, the operator grasps the tab 23 shown in FIG. 1(A) with, for example, a finger, and pulls the tab 23 back in the retraction direction X1 against the biasing force of the spring 51 relative to the main body 30. Then, as shown in FIG. 1(B), the engagement portion 22 of the needle hub 20 engages with the engagement protrusion 55. In the state shown in FIG. 1(B), the position of the needle hub 20 is fixed relative to the cylindrical portion 53 of the locking mechanism 52. Moreover, the spring 51 is compressed between the needle hub 20 and the terminal end portion 33. As a result, as shown in FIG. 3(C), the tip 11 of the needle 10 is retracted from the initial position M in the retraction direction X1. In addition, as the tip 11 of the needle 10 separates from the front wall 101 of the blood vessel 100, the wall of the blood vessel 100 receives the internal pressure of the blood vessel 100 and returns to its original shape.

[0035] Next, as shown in FIG. 1(B), the operator pinches the pressing portion 54 by manual operation using, for example, fingers, and presses the pressing portion 54 radially inward with a pressing force P. This causes the release portion 56 of the cylindrical portion 53 to open outward as shown by the arrow Q. This causes the engagement portion 22 of the needle hub 20 to be released from the state of being hooked on the engagement protrusion 55. Therefore, the needle 10 and the needle hub 20 are subjected to the urging force of the spring 51 that was held in a compressed state, and move together quickly along the advancing direction X2. Since the needle hub 20 holding the needle 10 moves in the advancing direction X2 under the urging force of the spring 51 that was held in a compressed state, the speed at which the needle 10 advances again in the advancing direction X2 is faster than the speed at which the needle 10 is pulled back from the initial position M to the retreating direction X1. Then, the tip 11 of the needle 10 advances (is advanced) by the retraction amount W. In this way, the operating mechanism 50 pulls the tip 11 of the needle 10 back from the initial position M in the retreating direction X1, and then advances it again in the advancing direction X2 to position it at the initial position M. Therefore, the tip 11 of the needle 10 does not advance from the initial position M to the rear wall 102.

[0036] The operator can use the operating mechanism 50 multiple times. That is, the operator can use the tab 23 to pull the needle hub 20 back in the retracting direction X1 relative to the main body 30 again, and then manually pinch the pressing portion 54 to release the state in which the engaging portion 22 of the needle hub 20 is engaged with the engaging protrusion 55, thereby advancing the needle 10 again in the advancing direction X2.

[0037] According to the medical puncture device 1 of this embodiment, when the position of the needle 10 punctured and positioned in the blood vessel 100 is set as the initial position M, the operation mechanism 50 retracts the needle 10 from the initial position M in the retracting direction X1 of the needle 10, and then advances the needle 10 again in the advancing direction X2 to position it at the initial position M. As a result, the needle 10 is positioned at the initial position M when it advances again in the advancing direction X2 after being retracted once in the retracting direction X1. Therefore, the operator can quickly puncture the positioned initial position M, that is, a position where only the front wall 101 of the blood vessel 100 can be punctured, and the blood vessel 100 can be secured more reliably. In other words, the medical puncture device 1 of this embodiment can prevent the blood vessel 100 from being crushed or the blood vessel 100 from escaping, and can improve the puncture success rate of the needle 10 and the blood vessel securing rate. In addition, since the operator can puncture only the front wall 101 of the blood vessel 100, it is possible to prevent the formation of a puncture hole (i.e., a puncture mark) in the rear wall 102 of the blood vessel 100 and prevent the occurrence of a hematoma at the puncture mark. In addition, it is possible to prevent the operator from erroneously puncturing another vein, artery, or nerve running parallel to the blood vessel 100 to be punctured. This prevents problems such as nerve damage and hematoma from occurring, and reduces the effort required for post-treatment due to erroneous puncture. Furthermore, it is possible to reduce stress on the operator during puncture and shorten the puncture time. In general, if the needle punctures, for example, the center position of the blood vessel 100, the blood vessel 100 can be punctured without escaping in many cases. On the other hand, if the needle punctures the blood vessel 100 in a state where it is offset from the center position of the blood vessel 100, the blood vessel 100 moves in a direction that escapes from the needle tip, for example, in a lateral or downward direction. In contrast, in the medical puncture device 1 of this embodiment, the tip 11 of the needle 10 punctures the blood vessel 100 with force, thereby expanding the puncture area of ​​the tip 11 of the needle 10. In other words, not only can the tip 11 of the needle 10 puncture the central position of the blood vessel 100, but even if the tip 11 of the needle 10 is offset from the central position of the blood vessel 100, the blood vessel 100 can be punctured reliably without slipping out.

[0038] As described above, the locking mechanism 52 can fix the position of the needle hub 20 relative to the main body 30 in a state in which the needle 10 is retracted from the initial position M in the retracting direction X1. That is, the locking mechanism 52 can maintain the state in which the needle 10 is retracted from the initial position M in the retracting direction. The locking mechanism 52 can release the state in which the position of the needle hub 20 is fixed relative to the main body 30. This allows the operator to stably perform the operation of advancing the needle 10, which has been retracted once in the retracting direction X1, again in the advancing direction X2 at any timing. This can improve the usability of the medical puncture device 1 according to this embodiment.

[0039] Furthermore, since the operating mechanism 50 has a tab 23 provided on the needle hub 20, the operator can easily manually operate the tab 23 to pull back the position of the needle hub 20 holding the needle 10 in the backward direction X1.

[0040] Furthermore, since the operator can use the operation mechanism 50 multiple times, even if the operator is unable to puncture as desired the first time, the operator can puncture again, thereby enabling the operator to secure the blood vessel 100 more reliably.

[0041] As described above, the speed at which the needle 10 advances again in the advancing direction X2 is faster than the speed at which the needle 10 is pulled back from the initial position M in the retracting direction X1. Therefore, the operator can perform the pull-back operation of the needle 10 slowly and carefully when temporarily pulling back the needle 10 in the retracting direction X1 to prevent the initial position M from shifting. Then, the operator can quickly puncture only the front wall 101 of the blood vessel 100 when advancing the needle 10 again in the advancing direction X2. This allows the medical puncture device 1 according to this embodiment to secure the blood vessel 100 even more reliably.

[0042] Furthermore, as described above, the needle hub 20 holding the needle 10 receives the biasing force from the spring 51 and advances again in the advancing direction X2. Therefore, the operating mechanism 50 can use the biasing force of the spring 51 to advance the needle hub 20 holding the needle 10 again in the advancing direction X2. As a result, the medical puncture device 1 according to this embodiment can quickly advance the needle 10 again in the advancing direction X2 to reliably puncture only the front wall 101 of the blood vessel 100 with a constant force, and more reliably secure the blood vessel 100. Even if it is difficult to secure power, for example, since power used for robot puncture is not required, the medical puncture device 1 according to this embodiment can quickly advance the needle 10 again in the advancing direction X2 to puncture only the front wall 101 of the blood vessel 100, and more reliably secure the blood vessel 100.

[0043] FIG. 4 is a cross-sectional view showing a catheter assembly according to an embodiment of the present invention. The catheter assembly 200 shown in FIG. 4 includes a medical puncture device 1B having the same structure as the medical puncture device 1 described above with reference to FIGS. 1 to 3, a catheter 201, and a catheter hub 202. The catheter 201 and the catheter hub 202 are, for example, resin or metal tubes, through which the needle 10 is inserted slidably in the retreat direction X1 and the advance direction X2. As shown in FIG. 4, the tip 11 of the needle 10 is drawn out from the tip 203 of the catheter 201. The base end 206 of the catheter hub 202 is detachably attached to the middle part 32 of the main body 30B of the medical puncture device 1B. The tip 205 of the catheter hub 202 is fixed to the outer circumferential surface of the base end 204 of the catheter 201. As shown in FIG. 4, for example, the tip 203 of the catheter 201 has a tapered shape tapered toward the tip 11 of the needle 10.

[0044] Second embodiment Next, a medical puncture device according to a second embodiment of the present invention will be described with reference to FIG. FIG. 5 is a cross-sectional view showing a medical puncture device according to a second embodiment of the present invention. Where the components of the medical puncture device 1A according to the second embodiment shown in Figure 5 are similar to the components of the medical puncture device 1 according to the first embodiment described above with reference to Figures 1 to 3, the same symbols are used and explanations are omitted as appropriate, and the following explanation will focus on the differences.

[0045] As described above with reference to Figs. 1 to 3, in the operating mechanism 50 of the medical puncture device 1 shown in Fig. 1(A), the engaging portion 22 of the needle hub 20 does not engage with the engaging protrusion 55. When the operator manually operates the tab 23 with, for example, a finger to pull the tab 23 back in the retraction direction X1 against the biasing force of the spring 51, the engaging portion 22 of the needle hub 20 engages with the engaging protrusion 55 as shown in Fig. 1(B). This causes the needle hub 20 holding the needle 10 to be fixed at a position where it has been pulled back in the retraction direction X1. In addition, the spring 51 is held in a compressed state.

[0046] In contrast, in the operating mechanism 50A of the medical puncture device 1A shown in Fig. 5, as shown in Fig. 5(A) and Fig. 5(B), the needle hub 20 holding the needle 10 is automatically pulled back in the retraction direction X1 with a single touch using the biasing force of the spring 80, rather than being manually operated by the operator. Then, as shown in Fig. 5(B), the needle hub 20 holding the needle 10 is fixed at the position where it has been pulled back in the retraction direction X1.

[0047] As shown in FIG. 5(A), the main body 30 is provided with an outer cylinder portion 77 centered on the central axis CL. A spring 80 is disposed between the inner peripheral surface of the outer cylinder portion 77 and the outer peripheral surface of the intermediate portion 32 of the main body 30. The spring 80 of this embodiment is an example of the "first biasing means" of the present invention. In the state shown in FIG. 5(A), the spring 80 is held in a compressed state. The needle hub 20 has an abutment portion 25. The abutment portion 25 is formed so as to protrude radially outward. In this way, since the abutment portion 25 is formed so as to protrude radially outward, the operator can easily confirm the position of the needle hub 20 in the direction along the central axis CL by visually checking the abutment portion 25. Note that the abutment portion 25 does not necessarily have to protrude radially outward. One end 81 of the spring 80 is fixed to the inner surface of the outer cylinder portion 77. The other end 82 of the spring 80 abuts against the abutment portion 25 and the operation start button 70. The activation button 70 of the present embodiment is an example of the "activation initiation member" of the present invention.

[0048] A guide hole 39 is formed in the radial direction in the middle part 32 of the main body part 30. An operation start button 70 is inserted into the guide hole 39. The operation start button 70 is a stopper that prevents the other end 82 of the spring 80 in a compressed state from extending in the backward direction X1. The operation start button 70 has a through hole 71. The through hole 71 allows the other end 82 of the spring 80 to pass through.

[0049] In the state shown in FIG. 5(A), the activation button 70 prevents the other end 82 of the spring 80 from extending in the backward direction X1. When the operator presses the activation button 70 with, for example, a finger in the direction N shown in FIG. 5(A), the activation button 70 is further inserted into the guide hole 39, and the other end 82 of the spring 80 passes through the through hole 71 of the activation button 70, as shown in FIG. 5(B). Therefore, the compression force of the spring 80 is released, and the spring 80 applies a biasing force in the backward direction X1 to the abutment portion 25 of the needle hub 20. As a result, the needle hub 20 is pulled back in the backward direction X1, and the engagement portion 22 of the needle hub 20 engages with the engagement protrusion 55 so as to be caught thereon, as shown in FIG. 5(B).

[0050] On the other hand, the spring 130 is disposed between another engagement protrusion 120 of the lock mechanism 52 and the terminal end 33 of the main body 30. The spring 130 of this embodiment is an example of the "second biasing means" of the present invention. One end 131 of the spring 130 abuts against the other engagement protrusion 120 of the lock mechanism 52. The other end 132 of the spring 130 abuts against the inner surface of the terminal end 33. In the state shown in FIG. 5(B), the spring 130 is held in a compressed state. The biasing force of the spring 130 is greater than that of the spring 80. For example, the spring constant of the spring 130 is greater than that of the spring 80. The one end 131 of the spring 130 is provided with an operating lever 133 for pulling the one end 131 of the spring 130 back in the backward direction X1, for example, with a finger.

[0051] When the medical puncture device 1A is started to be used, the springs 80 and 130 are both held in a compressed state as shown in FIG. 5(A). When the operator presses the activation button 70 in the N direction, for example, with a finger, the activation button 70 is further inserted into the guide hole 39 as shown in FIG. 5(B). This action triggers the other end 82 of the spring 80 to pass through the through hole 71 of the activation button 70. This releases the compression force of the spring 80. Then, the spring 80 applies a biasing force in the backward direction X1 to the butting portion 25 of the needle hub 20, and the needle hub 20 is automatically pulled back in the backward direction X1. As shown in FIG. 5(B), when the needle hub 20 is pulled back in the backward direction X1, the engagement portion 22 of the needle hub 20 engages with the engagement protrusion 55 so as to be caught thereon. In this state, the tip 11 of the needle 10 is pulled back from the initial position M by the amount of pulling back W of the needle 10.

[0052] Next, as shown in Fig. 1(B), the operator manually pinches the pressing portion 54 with, for example, his / her fingers, and presses the pressing portion 54 radially inward with a pressing force P. This causes the release portion 56 of the cylindrical portion 53 to open outward as shown by the arrow Q. This allows the operator to release the state in which the engagement portion 22 of the needle hub 20 is caught and engaged with the engagement protrusion 55. Moreover, the engagement state between one end 131 of the spring 130 and the engagement protrusion 120 is released. This releases the urging force of the spring 130 that was held in a compressed state, and the needle 10 and the needle hub 20 are subjected to the urging force of the spring 130 that was held in a compressed state and move together quickly along the advancing direction X2. This causes the tip 11 of the needle 10 to advance by the retraction amount W. In this case, since the urging force of the spring 130 is greater than that of the spring 80, the spring 130 overcomes the urging force of the spring 80 and can quickly advance the needle hub 20 holding the needle 10 in the advancing direction X2.

[0053] When the operator uses the operation mechanism 50A again, the operator pushes back the needle hub 20 shown in FIG. 5(B) in the advancing direction X2 with, for example, a finger, and then pulls out the actuation start button 70 from the guide hole 39. The operator can then stop the movement of the other end 82 of the spring 80 with the actuation start button 70, thereby maintaining the compressed state of the spring 80. In addition, the operator can pull back the operation lever 133 in the retreating direction X1 with, for example, a finger, so that the one end 131 of the spring 130 engages with the engagement protrusion 120 again. This maintains the spring 130 in a compressed state. This allows the medical puncture device 1A to return to the state shown in FIG. 5(A). In this way, the operator can use the operation mechanism 50A multiple times. This allows the operator to puncture again even if the operator is unable to puncture as desired the first time, and the blood vessel 100 can be secured more reliably.

[0054] According to the medical puncture device 1A of this embodiment, when the operator operates the activation start button 70, the spring 80 applies a biasing force in the backward direction X1 to the needle hub 20 holding the needle 10, and the needle 10 is pulled back in the backward direction X1 from the initial position M. Then, after the needle 10 is temporarily pulled back in the backward direction X1 from the initial position M, the operator presses the pressing portion 54, and the spring 130 applies a biasing force in the advancing direction X2 to the needle hub 20 holding the needle 10, and the needle 10 is advanced again in the advancing direction X2. Thus, by operating the activation start button 70, the operator can temporarily pull the needle 10 back from the initial position M in the backward direction X1, and then advance the needle 10 again in the advancing direction X2 to position it at the initial position M. As a result, in the medical puncture device 1A according to this embodiment, when the operator operates the operation start button 70, the needle 10 is quickly advanced again in the advancement direction X2 to reliably puncture only the front wall 101 of the blood vessel 100 with a constant force, and the blood vessel 100 can be more reliably secured. Even if it is difficult to secure power, for example, because power used for robotic puncture is not required, the medical puncture device 1A according to this embodiment can quickly advance the needle 10 again in the advancement direction X2 to puncture only the front wall 101 of the blood vessel 100, and the blood vessel 100 can be more reliably secured. Also, the same effects as those described above for the medical puncture device 1 according to the first embodiment can be obtained.

[0055] The scope of application of the medical puncture device and catheter assembly according to the embodiment of the present invention includes, on the premise that they are used under ultrasonic echo, general puncture devices under ultrasonic echo such as vein puncture devices, arterial puncture devices, and other puncture devices under ultrasonic echo such as egg collection needles and biopsy needles. Examples of puncture devices for vein puncture include metal needles and indwelling needles such as CICC (Centrally Inserted Central Catheter inserted through the internal jugular vein, subclavian vein, femoral vein, etc.), PICC (Peripherally Inserted Central Catheter inserted into the upper arm vein and placed), and midline catheters.

[0056] Examples of puncture devices for arterial puncture include metal needles and indwelling needles for PTCA (Percutaneous Transluminal Coronary Angioplasty) catheter treatment. In addition, the medical puncture device and catheter assembly can be used as an ultrasonic echo-guided puncture device such as an egg collection needle or a biopsy needle. In the explanation of this embodiment, a blood vessel 100 is taken as an example of biological tissue. However, the biological tissue is not limited to the blood vessel 100, and may be any target site other than a blood vessel that is difficult to puncture.

[0057] The above describes the embodiments of the present invention. However, the present invention is not limited to the above embodiments, and various modifications can be made without departing from the scope of the claims. The configurations of the above embodiments can be partially omitted or arbitrarily combined in a manner different from the above. For example, the spring 51 as the biasing means of the operation mechanism 50 and the springs 80 and 130 as the biasing means of the operation mechanism 50A are coil springs made of metal or plastic, for example. However, each biasing means is not limited to this and may be a columnar or cylindrical structure made of elastically deformable material such as resin or rubber. [Explanation of symbols]

[0058] 1, 1A, 1B: medical puncture device, 10: needle, 11: tip, 12: middle part, 13: base end, 20: needle hub, 21: hole, 22: engagement part, 23: tab, 23D: operation tip part, 24: second end face, 25: butting part, 26: first end face, 30: main body part, 30B: main body part, 31: tip part, 32: middle part, 32A: end face, 32G: guide groove, 33: terminal part, 34: tapered part, 35, 36: through hole, 37: storage space part, 39: guide hole, 50, 50A: operation mechanism, 51: spring, 51A: first end part, 51B: second end part, 52: lock mechanism, 53: cylindrical part, 54: pressing part, 55: engagement protrusion, 56: release portion, 70: operation start button, 71: through hole, 77: outer cylinder portion, 80: spring, 81: one end, 82: other end, 90: skin, 95: ultrasound probe, 100: blood vessel, 101: front wall, 102: rear wall, 103: puncture hole, 109: apex, 120: engagement protrusion, 130: spring, 131: one end, 132: other end, 133: operation lever, 200: catheter assembly, 201: catheter, 202: catheter hub, 203: tip, 204: base end, 205: tip portion, 206: base end, CL: central axis, E: diameter direction, M: initial position, P: pushing force, W: pull-back amount, X1: retreating direction, X2: advancing direction

Claims

1. A needle capable of puncturing biological tissue; a needle hub secured to the base end of the needle and holding the needle; a grippable main body portion that houses the needle hub; an operating mechanism that operates an action of moving the needle in an advancing direction and a retreating direction relative to the main body by applying an external force; Equipped with when a position of the needle that has been punctured and positioned in the biological tissue is set as an initial position, the operation mechanism retracts the needle from the initial position in the retreating direction, and then advances the needle again in the advancing direction to position it at the initial position; The operating mechanism has a biasing means disposed between an end surface of the needle hub and an inner surface of the body portion, The needle hub holding the needle is biased by the biasing means and advances again in the advancing direction.

2. 2. The medical puncture device according to claim 1, wherein the operating mechanism has a locking mechanism capable of fixing the position of the needle hub relative to the main body when the needle is pulled back in the retraction direction from the initial position and releasing the fixed position of the needle hub relative to the main body.

3. 3. The medical puncture device according to claim 1, wherein the operation mechanism has a tab provided on the needle hub for operating the position of the needle hub.

4. 4. The medical puncture device according to claim 1, wherein the operating mechanism is reusable multiple times.

5. The medical puncture device according to any one of claims 1 to 4, characterized in that the speed at which the needle advances again in the advancing direction is faster than the speed at which the needle is retracted in the retreating direction from the initial position.

6. The operating mechanism comprises: An actuation initiation member; a first biasing means for applying a biasing force in the retracting direction to the needle hub holding the needle when the actuation initiation member is operated, thereby pulling the needle back in the retracting direction from the initial position; a second biasing means for applying a biasing force in the advancing direction to the needle hub holding the needle after the needle is pulled back in the retreating direction from the initial position, thereby causing the needle to advance again in the advancing direction; The medical puncture device according to any one of claims 1 to 5, further comprising:

7. A medical puncture device according to any one of claims 1 to 6, a catheter through which the needle of the medical puncture device can be inserted; a catheter hub attached to the body and secured to a proximal end of the catheter; A catheter assembly comprising:

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