Automatic puncture device and puncture needle holding part

Abstract

Provided are an automatic puncture device and a puncture needle holding part capable of moving the needle tip of an inner needle to a desired position and performing puncturing, without being affected by axial misalignment caused by the tolerance between the inner needle and an inner needle hub.　The automatic puncture device comprises: a puncture needle holding part (40) for holding a puncture needle (30); a drive part (50) for driving the puncture needle holding part (40) at least along a puncture direction in which the puncture needle (30) extends; an acquisition part (22) for acquiring a cross-sectional image of a target object; and a control part (60) for controlling the drive part (50). The puncture needle holding part (40) includes: an inner needle hub holding part (83) that holds an inner needle hub (34) positioned at a proximal end part of an inner needle (31) of the puncture needle (30); an outer cylinder hub holding part (94) that holds an outer cylinder hub (35) positioned at a proximal end part of an outer cylinder (33) that houses the inner needle (31); and an outer cylinder clamping part (97) that is provided on the distal end side of the outer cylinder hub holding part (94) and clamps the outer cylinder (33).

Description

Automatic puncture device and puncture needle holder

[0001] The present invention relates to an automatic puncture device and a puncture needle holder that automatically punctures a blood vessel.

[0002] To secure an access route to a blood vessel for drug administration or intravascular treatment, vascular puncture is performed by inserting a flexible outer tube into the human body over an inner needle with a sharp needle tip. After the inner needle and the outer tube reach the blood vessel, the inner needle can be removed to secure the access route by the outer tube. Recently, there have been devices that automatically perform vascular puncture (see, for example, Patent Document 1).

[0003] International Publication No. 2023 / 121860

[0004] To precisely puncture at coordinates determined from information such as ultrasound, the automatic puncture device must move the tip of the inner needle to the correct position. When fixing the inner needle to the device, the hub located at the base end of the inner needle is grasped. However, the cannula (needle portion) and hub of the inner needle are glued or fused together, and the axis may be misaligned. Even if the axis misalignment is slight, there is a length from the hub to the needle tip, so the positional deviation of the needle tip is in the order of 1 mm. When the target blood vessel is the brachial artery, which typically has a diameter of 2 to 4 mm, a deviation of 1 mm can lead to a puncture failure.

[0005] The present invention has been made to solve the above-mentioned problems, and aims to provide an automatic puncture device and a puncture needle holding unit that can move the tip of the inner needle to a desired position for puncture without being affected by axial misalignment caused by the tolerance between the inner needle and the inner needle hub.

[0006] (1) To achieve the above-mentioned object, an automatic puncture device includes a puncture needle holding section that holds a puncture needle, a drive section that drives the puncture needle holding section at least along the puncture direction in which the puncture needle extends, an acquisition section that acquires a cross-sectional image of the object, and a control section that controls the drive section, wherein the puncture needle holding section includes an inner needle hub holding section that holds an inner needle hub located at the base end of the inner needle of the puncture needle, an outer tube hub holding section that holds an outer tube hub located at the base end of an outer tube that houses the inner needle, and an outer tube clamping section that is provided on the tip side of the outer tube hub holding section and clamps the outer tube.

[0007] The automatic puncture device described above in (1) can clamp the outer tube with the outer tube clamping portion, and therefore can move the tip of the inner needle to the desired position for puncture without being affected by axial misalignment caused by the tolerance between the inner needle and the inner needle hub.

[0008] (2) In the automatic puncture device described in (1) above, the outer tube clamping part may have a groove part and a pressing part that is movable toward and away from the groove part. As a result, by pressing the outer tube placed in the groove part with the pressing part, the outer tube can be accurately positioned at a predetermined position in the groove part, and therefore the needle tip of the inner needle can be positioned at a desired position without being affected by axial misalignment between the inner needle and the inner needle hub.

[0009] (3) In the automatic puncture device described in (1) or (2) above, the puncture needle holding section may include an inner needle hub housing having the inner needle hub holding section, and an outer tube hub housing having the outer tube hub holding section and detachably connected to the inner needle hub housing. This allows the inner needle held by the inner needle hub housing to be housed in the outer tube held by the outer tube hub housing by separating the inner needle hub housing from the outer tube hub housing after puncture with the inner needle is completed. This allows the automatic puncture device to remove the inner needle from inside the outer tube after puncture is completed.

[0010] (4) The automatic puncture device described in (3) above may have a separation mechanism that separates the inner needle hub housing from the outer tubular hub housing, whereby the automatic puncture device can automatically separate the inner needle hub housing from the outer tubular hub housing using the separation mechanism after puncturing is completed.

[0011] (5) In the automatic puncture device described above in (4), the inner needle hub housing may have a first restricting portion that is a hole or a groove, the outer cylindrical hub housing may have a second restricting portion that is a hole or a groove, and the separation mechanism may have a fixing pin that fits into the first restricting portion and the second restricting portion, and a pressing shaft that can fit into the first restricting portion and / or the second restricting portion and press the fixing pin. This allows the automatic puncture device to automatically release the connection between the inner needle hub housing and the outer cylindrical hub housing that is formed by the fixing pin by using the pressing shaft to push the fixing pin out of the first restricting portion and / or the second restricting portion.

[0012] (6) In the automatic puncture device described in (4) or (5) above, the puncture needle holding section may have an elastic member that generates a force in a direction that separates the inner needle hub housing from the outer cylindrical hub housing. This allows the automatic puncture device to automatically separate the needle hub housing from the outer cylindrical hub housing using the force of the elastic member.

[0013] (7) In the automatic lancing device according to any one of (1) to (6) above, the puncture needle holding unit may be detachable from the automatic lancing device, thereby enabling the puncture needle holding unit to be replaceable, thereby reducing the possibility of contamination.

[0014] (8) In the automatic puncture device described in any one of (3) to (7) above, the puncture needle holding section may include an inner needle hub housing having the inner needle hub holding section, and an outer cylindrical hub housing having the outer cylindrical hub holding section and detachably connected to the inner needle hub housing, and the inner needle hub housing may have a cover section fixed to its surface. This allows the cover section to separate a clean field from an unclean field of the automatic puncture device.

[0015] (9) In the automatic puncture device described in any one of (1) to (8) above, the puncture needle holding unit may include a housing holding unit that is movable when driven by the drive unit, a guide member that is connectable to the housing holding unit, and an outer tube hub housing that is detachably connected to the guide member and has the outer tube hub holding unit. This allows the automatic puncture device to indirectly connect the outer tube hub housing to the housing holding unit via the guide member, thereby improving operability.

[0016] (10) In the automatic lancing device described in (9) above, the guide member and the outer tubular hub housing may have a retaining portion that uses magnetic force to maintain the connected state, thereby facilitating connection and separation of the guide member and the outer tubular hub housing and improving workability.

[0017] (11) The automatic lancing device described in (10) above may have a cover portion sandwiched between the guide member and the outer cylindrical hub housing. This allows the cover portion to be sandwiched between the guide member and the outer cylindrical hub housing, which can be connected in a non-contact manner by magnetic force, and the cover portion can reliably separate the clean field and the unclean field of the automatic lancing device.

[0018] (12) A puncture needle holding part that achieves the above object is a puncture needle holding part that can be attached to an external device and can hold a puncture needle, and is characterized by including an outer tube hub holding part that holds an outer tube hub located at the base end of an outer tube that houses the inner needle of the puncture needle, and an outer tube clamping part that is provided on the tip side of the outer tube hub holding part and clamps the outer tube.

[0019] The puncture needle holding portion described in (12) above can clamp the outer tube with the outer tube clamping portion, so that the tip of the inner needle can be moved to the desired position for puncture without being affected by axial misalignment caused by the tolerance between the inner needle and the inner needle hub.

[0020] 1 is a side view of an automatic puncture device according to an embodiment; 2 is a perspective view showing the puncture needle holding portion and the puncture needle; 3 is a cross-sectional view of the puncture needle holding portion, where (A) shows the outer tube hub housing and the inner needle hub housing connected together, and (B) shows the outer tube hub housing separated from the inner needle hub housing; 4 is a cross-sectional view showing the outer tube clamping portion and the puncture needle; 5 is a cross-sectional view taken along line A-A in FIG. 4, where (A) shows this embodiment, (B) shows a first modified example, (C) shows a second modified example, and (D) shows a third modified example; 6 is a side view illustrating a method of using the automatic puncture device, where (A) shows before puncturing, (B) shows during puncturing, and (C) shows after puncturing; and 7 is a front view of a fourth modified example, where (A) shows the clamping member of the outer tube clamping portion in an open state, and (B) shows the clamping member of the outer tube clamping portion in a closed state. 10 is a perspective view showing a fifth modified example, (A) showing a state in which the clamping members of the outer tube clamping part are open, and (B) showing a state in which the clamping members of the outer tube clamping part are closed. FIG. 11 is a perspective view of an outer tube clamping part showing a sixth modified example. FIG. 12 is a side view of a puncture needle holding part showing a seventh modified example. FIG. 13 is a rear view of the automatic puncture device according to the seventh modified example, viewed from the base end side. FIG. 14 is a cross-sectional view of a puncture needle holding part in an eighth modified example, (A) showing a state in which the outer tube hub housing and the inner needle hub housing are connected, and (B) showing a state in which the outer tube hub housing is separated from the inner needle hub housing. FIG. 15 is a cross-sectional view of a puncture needle holding part in a ninth modified example, (A) showing a state in which the outer tube hub housing and the inner needle hub housing are connected, and (B) showing a state in which the outer tube hub housing is separated from the inner needle hub housing. FIG. 16 is a perspective view of an outer tube hub housing and a puncture needle in a tenth modified example. FIG. 17 is a side view of an outer tube hub housing in a tenth modified example. 10 is a front view showing an outer cylindrical hub housing in a tenth modified example, (A) showing a state in which the clamping member is closed, and (B) showing a state in which the clamping member is open. FIG. 11 is a perspective view showing an outer cylindrical hub housing, a puncture needle, and a guide member in a tenth modified example. FIG. 12 is a perspective view showing a puncture needle holding portion in a tenth modified example. FIG. 13 is a perspective view showing a tenth modified example, (A) showing a guide member, and (B) showing a state in which the guide member is connected to a housing holding portion. FIG. 14 is a front view showing a puncture needle holding portion in a tenth modified example.

[0021] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Note that the dimensional proportions in the drawings may be exaggerated for the sake of explanation and may differ from the actual proportions. In addition, in this specification, the needle tip side of the puncture needle will be referred to as the "distal side" and the hub side will be referred to as the "proximal side."

[0022] The automatic puncture device 10 according to an embodiment of the present invention is used to puncture a human arm (target object), acquires a cross-sectional image of the arm, detects the position of the artery to be punctured, and automatically punctures that artery.

[0023] As shown in Figures 1 and 2, the automatic puncture device 10 has a probe main body 20 having an acquisition unit 22 that contacts the skin surface to acquire a cross-sectional image of the human body, a puncture needle 30 that performs the puncture, a puncture needle holding unit 40 that holds the puncture needle 30, a drive unit 50 that moves the puncture needle holding unit 40, a display unit 70 that can display the cross-sectional image, and a control unit 60 that performs image analysis of the cross-sectional image and controls the drive unit 50.

[0024] The probe main body 20 has a vertically long handle portion 21 that is held by the surgeon, and an acquisition portion 22 that is located at the bottom end of the handle portion 21. The probe main body 20 is disposed integrally with the automatic puncture device 10 and is configured to be inseparable from the automatic puncture device 10. However, the probe main body 20 may also be configured to be separable from the automatic puncture device 10.

[0025] The acquisition unit 22 is provided at the center of the underside of the probe body 20 so as to span substantially the entire width. The acquisition unit 22 is an ultrasound device that has a transducer that generates ultrasound waves and obtains cross-sectional images of the inside of the human body by detecting the reflected waves. In this embodiment, cross-sectional images that are substantially perpendicular to the axial direction of the blood vessels are obtained, and therefore the acquisition unit 22 is positioned so that the scanning direction is substantially perpendicular to the longitudinal direction of the arm.

[0026] The puncture needle 30 includes a metal inner needle 31 having a sharp needle tip 32 formed at its tip, and a flexible tubular outer cylinder 33 arranged to cover the outer peripheral surface of the inner needle 31. The inner needle 31 may be solid or hollow.

[0027] The needle tip 32 is a portion having a cutting edge that is inclined with respect to the axis, located distally of the portion of the inner needle 31 where the outer diameter is constant. Alternatively, the needle tip 32 may be a portion whose outer diameter decreases toward the sharp tip.

[0028] With the outer tube 33 covering the outside of the inner needle 31, the needle tip 32 protrudes from the outer tube 33. An inner needle hub 34 is fixed to the proximal end of the inner needle 31. A cylindrical outer tube hub 35 is fixed to the proximal end of the outer tube 33.

[0029] The driving unit 50 includes a first linear motion unit 51 that holds the puncture needle holding unit 40 and moves it linearly, a tilting unit 52 that tilts the first linear motion unit 51, a second linear motion unit 53 that moves the tilting unit 52 in the height direction from one end where the acquisition unit 22 of the probe main body 20 is located to the other end on the opposite side, and a rotating unit 54 that rotates the second linear motion unit 53 about a predetermined rotation axis P. Note that the driving unit 50 is only required to include at least the first linear motion unit 51, and may not include, for example, the tilting unit 52, the second linear motion unit 53, or the rotating unit 54.

[0030] The first linear motion part 51 holds a housing holding part 41 (described later) of the puncture needle holding part 40, and can move the puncture needle holding part 40 linearly back and forth along the extension direction (puncture direction) of the inner needle 31. The first linear motion part 51 adjusts the position of the puncture needle 30 and is used to puncture a blood vessel with the puncture needle 30. The first linear motion part 51 includes, for example, a rotary drive source such as a motor whose drive can be controlled by the control part 60, and a structure (for example, a feed screw mechanism) that converts the rotary motion of the rotary drive source into linear motion. The first linear motion part 51 may also hold the outer cylindrical hub housing 90.

[0031] The tilting unit 52 can tilt the first linear motion unit 51. The tilting unit 52 is used to change the puncture angle of the puncture needle 30 relative to the surface of the patient's skin. The tilting unit 52 includes, for example, a hinge whose angle can be changed, and a rotary drive source such as a motor whose drive can be controlled by the control unit 60 to change the angle of the hinge.

[0032] The second linear motion unit 53 is used to move the puncture needle 30 toward or away from the patient's skin. The second linear motion unit 53 can move the tilting unit 52 linearly forward and backward along the height direction of the probe body 20. The second linear motion unit 53 includes, for example, a rotary drive source such as a motor whose drive can be controlled by the control unit 60, and a structure (for example, a feed screw mechanism) that converts the rotary motion of the rotary drive source into linear motion.

[0033] The rotating unit 54 is used to change the direction of the inner needle 31 when the second linear motion unit 53 is viewed approximately perpendicular to the surface of the patient's skin. The rotating unit 54 can rotate the tilting unit 52 around a rotation axis P that is parallel to the height direction of the probe main body 20. The rotating unit 54 includes a rotation drive source such as a motor, the drive of which can be controlled by the control unit 60, for example.

[0034] The drive sources used for the first linear motion unit 51, the second linear motion unit 53, the tilting unit 52, and the rotating unit 54 are preferably configured to be able to control rotation and displacement with high precision while being monitored by the control unit 60, and are, for example, servo motors. In this embodiment, the drive unit 50 uses the rotating unit 54 to move the puncture needle 30 in a direction perpendicular to the extension direction of the puncture needle 30 and perpendicular to the height direction of the probe main body 20 (the depth direction in the plane of FIG. 1 ), but the drive unit 50 may also be configured to move the puncture needle 30 linearly in the depth direction.

[0035] The control unit 60 transmits a signal to the acquisition unit 22 to cause the acquisition unit 22 to output ultrasound. The control unit 60 can also form a cross-sectional image from the signal obtained from the acquisition unit 22. The control unit 60 can also display the obtained cross-sectional image on a display unit 70 such as a monitor. The control unit 60 can also perform arithmetic processing such as image analysis based on the cross-sectional image information to identify the position of blood vessels in the image. The control unit 60 can also control the operation of the drive unit 50, which performs puncture. The control unit 60 is physically configured with a memory circuit and an arithmetic circuit. The memory circuit can store programs and various parameters. The arithmetic circuit can perform arithmetic processing. The control unit 60 and the display unit 70 may be disposed in the probe main body 20, the drive unit 50, or the puncture needle holding unit 40, or may be configured separately from the probe main body 20, the drive unit 50, or the puncture needle holding unit 40.

[0036] As shown in Figures 1 to 3, the puncture needle holding portion 40 has a housing holding portion 41 held by the first linear moving portion 51, an inner needle hub housing 80 that holds the inner needle hub 34, an outer tube hub housing 90 that holds the outer tube hub 35, and a separation mechanism 110 that separates the inner needle hub housing 80 and the outer tube hub housing 90.

[0037] The housing holding part 41 is held by the first linear motion part 51 and has a storage part 42 that can store the inner needle hub housing 80 and the outer tube hub housing 90, and a support part 43 that supports a part of the separation mechanism 110. The storage part 42 is a recess that removably stores the inner needle hub housing 80 and the outer tube hub housing 90, which are aligned in the puncture direction of the inner needle 31. The storage part 42 stores the inner needle hub housing 80 so that it cannot move in the puncture direction, and stores the outer tube hub housing 90 so that it can slide in the puncture direction. The storage part 42 has an outer receiving part 44 that is a through hole through which a pressing shaft (described later) of the separation mechanism 110 can pass. Note that the outer receiving part 44 may not be a through hole but may be a groove extending in the extension direction of the inner needle 31. The support part 43 protrudes from the storage part 42 in a direction perpendicular to the puncture direction.

[0038] The inner needle hub housing 80 is removably housed in the housing portion 42 on the proximal end side of the housing holding portion 41. The inner needle hub housing 80 housed in the housing portion 42 is housed so as not to move in the puncture direction relative to the housing holding portion 41. The inner needle hub housing 80 has an inner needle hub housing main body 81 that holds the inner needle hub 34, and a protruding portion 82 that protrudes from the inner needle hub housing main body 81 in the distal direction.

[0039] The inner needle hub housing main body 81 has an inner needle hub holding portion 83 which is a recessed portion in which the inner needle hub 34 is held, and a first storage portion 84 which stores a part of the elastic member 114 described below. The first storage portion 84 is formed from the distal end surface of the inner needle hub housing main body 81 toward the proximal end.

[0040] A first restricting portion 85, which is a groove or hole (groove in this embodiment) extending in a direction perpendicular to the puncture direction, is formed in the protruding portion 82. The inner needle hub holding portion 83 restricts the inner needle hub 34 it holds from moving distally (the puncture direction) and proximally relative to the inner needle hub holding portion 83. For example, the inner needle hub holding portion 83 has a puncture force transmitting portion 86 that abuts against the proximal end surface of the outer tube hub 35, and can effectively transmit a distal-direction force to the inner needle hub 34 during puncture. This allows the inner needle 31 to be punctured without any problems even if the outer tube 33 slips relative to the outer tube clamping portion 97.

[0041] The sheath hub housing 90 is removably housed in the housing portion 42 on the distal side of the housing holding portion 41. The sheath hub housing 90 housed in the housing portion 42 is disposed adjacent to the distal side of the inner needle hub housing 80 and is housed so as to be movable (slidable) in the distal and proximal directions relative to the housing holding portion 41. The sheath hub housing 90 has an sheath hub housing main body 91 that holds the sheath hub 35, a clamping member 92 that rotates relative to the distal end of the sheath hub housing main body 91, and a hinge portion 93 that rotatably connects the clamping member 92 to the sheath hub housing main body 91.

[0042] The sheath hub housing main body 91 has an sheath hub holding portion 94 which is a recess that holds the sheath hub 35, a second storage portion 95 that stores a portion of the elastic member 114 described below, and a second restricting portion 96. The second restricting portion 96 is a groove or hole that extends in a direction perpendicular to the puncture direction, and is formed so as to communicate with the first restricting portion 85 when the sheath hub housing 90 and the inner needle hub housing 80 are connected. The second storage portion 95 is disposed on the distal side of the first storage portion 84. The second storage portion 95 is formed from the proximal end surface of the sheath hub housing main body 91 toward the distal end.

[0043] The distal end of the outer tube hub housing main body 91 and the clamping member 92 form an outer tube clamping portion 97 that clamps the outer tube 33. The outer tube hub holding portion 94 prevents the held outer tube hub 35 from moving distally or proximally relative to the outer tube hub holding portion 94. For example, the outer tube hub holding portion 94 has a portion that abuts against the proximal end surface of the outer tube hub 35, and can effectively transmit distal force to the outer tube hub 35 during puncture. This allows for smooth puncture even if the outer tube 33 slips relative to the outer tube clamping portion 97.

[0044] The tip of the outer tube hub housing main body 91 has a first groove 98 extending in the puncture direction and first magnets 99 on either side of the first groove 98. The clamping member 92 has a second groove 100 extending in the puncture direction and second magnets 101 located on either side of the second groove 100 and capable of attracting the first magnet 99. When the clamping member 92 closes and overlaps the outer tube hub housing main body 91, the first groove 98 and the second groove 100 are arranged to overlap. As shown in Figures 4 and 5(A), the first groove 98 and the second groove 100 are arc-shaped in a cross section perpendicular to the puncture direction, and it is preferable that the groove width W is greater than twice the groove depth D. This allows the first groove 98 and the second groove 100 to clamp the outer peripheral surface of the outer tube 33, which has a circular cross section. When the clamping member 92 is closed around the outer tube hub housing main body 91, the first magnet 99 and the second magnet 101 approach each other and attract each other, generating a clamping force in the outer tube clamping portion 97. The clamping force of the outer tube clamping portion 97 is preferably equal to or less than a force that does not damage the outer tube 33 or the inner needle 31, for example, 20 N or less. The outer tube hub housing main body 91 and the clamping member 92 do not necessarily have to include magnets. For example, the outer tube hub housing main body 91 and the clamping member 92 may have a structure that fits together and are coupled by fitting together to generate a clamping force.

[0045] The shape of the outer tube clamping portion 97 is not limited. For example, as in a first modified example shown in FIG. 5B , a first groove portion 98 having a V-shaped cross section perpendicular to the puncture direction may be formed in the outer tube hub housing main body 91, and a pressing portion 102 that can enter the first groove portion 98 may be formed in the clamping member 92. The top of the pressing portion 102 is formed, for example, as a flat surface. This allows the outer tube 33 placed in the first groove portion 98 to be pressed by the pressing portion 102, thereby accurately positioning the outer tube 33 at a predetermined position in the first groove portion 98. The first groove portion 98 may be, for example, arc-shaped rather than V-shaped.

[0046] 5(C), in order to reduce damage to the outer cylinder 33 with which it comes into contact, a soft member 103 made of a soft material such as rubber or elastomer may be disposed on the surface of the first groove portion 98 and the surface of the top of the pressing portion 102. Furthermore, as in a third modified example shown in FIG. 6(D), the soft member 103 may be disposed only in the first groove portion 98 without being disposed in the pressing portion 102, or, although not shown, may be disposed only in the pressing portion 102 without being disposed in the first groove portion 98. The soft member 103 can reduce damage to the surface of the outer cylinder 33 with which it comes into contact.

[0047] 5, the length L in the puncture direction of the portion of the outer tube clamping portion 97 that contacts the outer tube 33 is, but is not limited to, 3 mm or more, and preferably 5 mm or more. A long length L can prevent the puncture needle 30 from rotating around the outer tube clamping portion 97 as a fulcrum.

[0048] It is noted that grooves do not necessarily have to be formed in the outer tube hub housing main body 91 and the clamping member 92 of the outer tube clamping portion 97. For example, by controlling the distance between the clamping surfaces with high precision, the outer tube 33 can be gripped between the outer tube hub housing main body 91 and the clamping member 92. For example, the distance between the clamping surfaces can be set to be the same as the outer diameter of the outer tube 33, or slightly larger or smaller than the outer diameter. This allows the outer tube 33 to be clamped by the outer tube clamping portion 97 without damaging the surface of the outer tube 33.

[0049] The outer tube clamping unit 97 clamps the outer tube 33 from both sides (the front and back sides of the page in FIG. 1 ) that sandwich the blood vessel extending along the skin. That is, when the acquisition unit 22 is in contact with the skin of the patient's arm and the skin is viewed from above (when viewed from above the page in FIG. 1 ), the puncture direction of the puncture needle 30 coincides with the direction in which the blood vessel extends, and the outer tube clamping unit 97 clamps the outer tube 33 from both sides that sandwich the blood vessel. Therefore, the outer tube clamping unit 97 aligns the puncture direction of the puncture needle 30 with the direction in which the blood vessel extends, making it easy to position the puncture needle 30 at a position that allows it to accurately puncture the blood vessel.

[0050] When the outer tube clamping portion 97 clamps the outer tube 33 at a position close to the outer tube hub 35, it can prevent the needle tip 32 from being damaged by the outer tube clamping portion 97 while also preventing the needle tip 32 from shifting out of position.

[0051] 1 to 3, the separation mechanism 110 has a separation drive unit 111, a pressing shaft 112, a fixing pin 113, and an elastic member 114. The separation drive unit 111 is a drive source that is supported by the support unit 43 and linearly moves the pressing shaft 112. The separation drive unit 111 is, for example, a solenoid that operates by electromagnetic force, but may also be a motor or the like. The pressing shaft 112 is a long member that can be linearly moved by the separation drive unit 111 to press and move the fixing pin 113. The pressing shaft 112 extends approximately perpendicular to the puncture direction and can enter the storage unit 42 from the outside of the housing holding unit 41 through the outer receiving unit 44.

[0052] The fixing pin 113 is arranged across both the first restricting portion 85 of the inner needle hub housing 80 and the second restricting portion 96 of the outer tube hub housing 90. The fixing pin 113 prevents the inner needle hub housing 80 and the outer tube hub housing 90 from moving relative to each other in the puncture direction.

[0053] The elastic member 114 is stored in the first storage section 84 and the second storage section 95 in a state where it is contracted in the puncture direction. Therefore, the elastic member 114 biases the inner needle hub housing 80 and the outer tube hub housing 90 so as to move them apart in the puncture direction.

[0054] Next, a method of using the automatic puncture device 10 according to this embodiment will be described. First, with the clamping members 92 open relative to the sheath tube hub housing main body 91, the surgeon places the inner needle hub 34 in the inner needle hub holding portion 83 and the sheath tube hub 35 in the sheath tube hub holding portion 94. Next, the surgeon closes the clamping members 92 to clamp the sheath tube 33 between the first groove portion 98 of the sheath tube hub housing main body 91 and the second groove portion 100 of the clamping members 92. The fixing pin 113 is positioned across both the first restricting portion 85 of the inner needle hub housing 80 and the second restricting portion 96 of the sheath tube hub housing 90. The surgeon places the sheath tube hub housing 90 and the inner needle hub housing 80 in the accommodation portion 42 of the housing holding portion 41.

[0055] Next, the surgeon contacts the skin of the patient's arm with the acquisition unit 22. The control unit 60 acquires a cross-sectional image from the acquisition unit 22 and operates the drive unit 50 based on instructions from the surgeon or a preset calculation method, thereby placing the puncture needle holding unit 40 in a desired position and posture for puncturing the blood vessel, as shown in FIG.

[0056] Next, the control unit 60 activates the first linear motion unit 51 to perform puncture with the puncture needle 30, as shown in Figure 6(B) . This causes both the inner needle hub housing 80 and the outer tube hub housing 90 held by the housing holding unit 41 to move, and the inner needle 31 and the outer tube 33 are inserted into the blood vessel.

[0057] Next, the control unit 60 activates the separation drive unit 111 to push the pressing shaft 112 into the outer receiving portion 44. As shown in FIGS. 3 and 6C , the pressing shaft 112 pushes the fixing pins 113, which are arranged in the first restricting portion 85 and the second restricting portion 96, until they pass through the first restricting portion 85 and are arranged only in the second restricting portion 96. Thereafter, the operation of the separation drive unit 111 is deactivated to return the pressing shaft 112 to its position before activation. This releases the connection between the inner needle hub housing 80 and the outer tube hub housing 90. Therefore, the outer tube hub housing 90 and the clamping member 92 move distally relative to the inner needle hub housing 80 due to the biasing force of the elastic member 114. As a result, the outer tube 33 moves distally while the position of the inner needle 31 is fixed, and the needle tip 32 is retracted into the outer tube 33.

[0058] Next, the control unit 60 activates the first linear motion unit 51 to retract the housing holding unit 41 to the position before puncture. This allows the inner needle 31 to be removed from the outer tube 33, leaving the outer tube 33 in the blood vessel. Thereafter, the surgeon opens the clamping members 92 relative to the outer tube hub housing main body 91, and removes the outer tube hub 35 and inner needle hub 34 from the outer tube hub housing 90 and inner needle hub housing 80.

[0059] As described above, the automatic puncture device 10 according to this embodiment comprises a puncture needle holding section 40 that holds the puncture needle 30, a drive section 50 that drives the puncture needle holding section 40 at least along the puncture direction in which the puncture needle 30 extends, an acquisition section 22 that acquires cross-sectional images of the object, and a control section 60 that controls the drive section 50. The puncture needle holding section 40 comprises an inner needle hub holding section 83 that holds the inner needle hub 34 located at the base end of the inner needle 31 of the puncture needle 30, an outer tube hub holding section 94 that holds the outer tube hub 35 located at the base end of the outer tube 33 that houses the inner needle 31, and an outer tube clamping section 97 that is provided on the tip side of the outer tube hub holding section 94 and clamps the outer tube 33. As a result, the automatic puncture device 10 can clamp the outer tube 33 using the outer tube clamping portion 97, so that the needle tip 32 of the inner needle 31 can be moved to the desired position to perform puncture without being affected by axial misalignment caused by the tolerance between the inner needle 31 and the inner needle hub 34.

[0060] The outer tube clamping portion 97 may have a first groove portion 98 (groove portion) and a pressing portion 102 that is movable toward and away from the first groove portion 98. In this way, by pressing the outer tube 33 placed in the first groove portion 98 with the pressing portion 102, the outer tube 33 can be accurately positioned at a predetermined position in the first groove portion 98, and therefore the needle tip 32 of the inner needle 31 can be positioned at a desired position without being affected by axial misalignment between the inner needle 31 and the inner needle hub 34.

[0061] The puncture needle holding section 40 has an inner needle hub housing 80 having an inner needle hub holding section 83, and an outer tube hub housing 90 having an outer tube hub holding section 94 and detachably connected to the inner needle hub housing 80. By separating the inner needle hub housing 80 from the outer tube hub housing 90 after puncturing with the inner needle 31 is completed, the inner needle 31 held in the inner needle hub housing 80 can be housed in the outer tube 33 held in the outer tube hub housing 90. Therefore, the automatic puncture device 10 can remove the inner needle 31 from inside the outer tube 33 after puncturing is completed. The inner needle hub holding section 83 may be integral with the automatic puncture device 10 and inseparable from the automatic puncture device 10.

[0062] The automatic puncture device 10 has a separation mechanism 110 that separates the inner needle hub housing 80 and the outer barrel hub housing 90. This allows the automatic puncture device 10 to automatically separate the inner needle hub housing 80 and the outer barrel hub housing 90 using the separation mechanism 110 after puncture is completed.

[0063] The inner needle hub housing 80 has a first restricting portion 85 which is a hole or groove, the outer cylindrical hub housing 90 has a second restricting portion 96 which is a hole or groove, and the separation mechanism 110 has a fixing pin 113 which enters the first restricting portion 85 and the second restricting portion 96, and a pressing shaft 112 which can enter the first restricting portion 85 and / or the second restricting portion 96 and press the fixing pin 113. In this way, the automatic puncture device 10 can automatically release the connection between the inner needle hub housing 80 and the outer cylindrical hub housing 90 which has been made by the fixing pin 113, by using the pressing shaft 112 to push the fixing pin 113 out of the first restricting portion 85 and / or the second restricting portion 96.

[0064] The puncture needle holding section 40 has an elastic member 114 that generates a force in a direction that separates the inner needle hub housing 80 and the outer tube hub housing 90. This allows the automatic puncture device 10 to automatically separate the needle hub housing and the outer tube hub housing 90 using the force of the elastic member 114.

[0065] The puncture needle holding part 40 is removable from the automatic puncture device 10. This allows the automatic puncture device 10 to have a replaceable puncture needle holding part 40, making it a disposable part and reducing the possibility of contamination.

[0066] Furthermore, the puncture needle holding part 40 in this embodiment is attachable to an external device and capable of holding the puncture needle 30, and includes an outer tube hub holding part 94 that holds the outer tube hub 35 located at the base end of the outer tube 33 that houses the inner needle 31 of the puncture needle 30, and an outer tube clamping part 97 that is provided on the tip side of the outer tube hub holding part 94 and clamps the outer tube 33. As a result, the puncture needle holding part 40 can clamp the outer tube 33 using the outer tube clamping part 97, and therefore the needle tip 32 of the inner needle 31 can be moved to a desired position for puncture without being affected by axial misalignment caused by tolerances between the inner needle 31 and the inner needle hub 34.

[0067] The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical spirit of the present invention. For example, the form of the drive unit 50 is not particularly limited, and it may be a robot arm or the like.

[0068] The outer tube clamping portion 97 may clamp two points spaced apart in the puncture direction of the outer tube 33. The distance between the two points is, for example, 3 mm or more, and preferably 5 mm or more. This makes it possible to prevent the outer tube 33 from rotating around the outer tube clamping portion 97 as a fulcrum.

[0069] Furthermore, the configuration of the outer tube clamping portion 97 is not limited. For example, as in a fourth modified example shown in FIG. 7 , the outer tube clamping portion 97 may have a toggle 120 connected to the clamping member 92, the toggle 120 being capable of opening and closing the clamping member 92. The toggle 120 is a long member that can be operated by the surgeon. The toggle 120 has, at one end, a connecting hole 121 that is rotatably connected to a connecting shaft 115 formed at a position away from the hinge portion 93 of the clamping member 92, and at the other end, an operating portion 122 that can be operated by the surgeon. Note that the connecting shaft 115 may be formed in the toggle 120, and the connecting hole 121 may be formed in the clamping member 92. The toggle 120 slidably passes through a toggle holding hole 124 of a toggle holding portion 123 extending from the outer tube hub housing 90, between the connecting hole 121 and the operating portion 122. This allows the surgeon to operate the operating portion 122 to rotate the clamping member 92 and open or close the outer cylinder clamping portion 97 .

[0070] 8 , the outer tube clamping unit 97 may have a structure in which the clamping member 92 is operated by a link mechanism. The outer tube clamping unit 97 has the clamping member 92 in which the second groove portion 100 is formed, a guide rail 150 that supports the clamping member 92 so that it can move linearly, an input shaft 130 for inputting a force to open or close the clamping member 92, and a link 140 that transmits the force between the clamping member 92 and the input shaft 130.

[0071] The guide rail 150 is a member extending from the outer cylindrical hub housing 90. The guide rail 150 extends perpendicular to the puncture direction so that the surface of the supporting clamping member 92, on which the second groove portion 100 is formed, can move toward and away from the surface of the outer cylindrical hub housing main body 91, on which the first groove portion 98 is formed. The clamping member 92 has a sliding portion 116 that can slide along the guide rail 150 and a first connecting shaft 117 that is connected to the link 140. The input shaft 130 has an input portion 131 that receives force at one end and a second connecting shaft 132 that is connected to the link 140 at the other end. The input shaft 130 slidably passes through an input shaft holding hole 133 formed in a member extending from the outer cylindrical hub housing 90, between the input portion 131 and the second connecting shaft 132.

[0072] The link 140 has a first connecting hole 141 at one end that is rotatably connected to the first connecting shaft 117 of the clamping member 92, and a second connecting hole 142 at the other end that is rotatably connected to the second connecting shaft 132 of the input shaft 130. The link 140 also has an elongated hole 143 between the first connecting hole 141 and the second connecting hole 121, into which a support shaft 151 formed in a member extending from the outer cylindrical hub housing 90 slidably fits. Because the hole into which the support shaft 151 fits is the elongated hole 143, the rotating link 140 can move the surface of the clamping member 92 on which the second groove portion 100 is formed toward or away from the surface of the outer cylindrical hub housing main body 91 on which the first groove portion 98 is formed, while keeping the surface parallel to the surface.

[0073] When using the automatic puncture device 10 according to the fifth modification, the surgeon places the inner needle hub 34 in the inner needle hub holding portion 83 and places the outer tube hub 35 in the outer tube hub holding portion 94 with the clamping member 92 open relative to the outer tube hub housing main body 91. Next, the surgeon places the outer tube hub housing 90 and the inner needle hub housing 80 in the accommodation portion 42 of the housing holding portion 41. This causes the input portion 131 of the input shaft 130 to abut against the housing holding portion 41 and be pressed by the housing holding portion 41. As a result, the link 140 is pressed and tilted by the input shaft 130, and the surface on which the second groove portion 100 of the clamping member 92 is formed approaches the surface on which the first groove portion 98 of the outer tube hub housing main body 91 is formed. This allows the outer tube 33 to be clamped by the outer tube clamping portion 97 in conjunction with the action of placing the outer tube hub housing 90 and the inner needle hub housing 80 in the accommodation portion 42 of the housing holding portion 41. The input unit 131 may be manually pressed by the surgeon.

[0074] 9 , the outer tube clamping unit 97 may have two rotatable first rollers 161 aligned to form a first groove 98 and two rotatable second rollers 162 aligned to form a second groove 100. This allows the outer tube clamping unit 97 to change the clamping position of the outer tube 33 along the puncture direction. Therefore, the roller support unit 163 to which the first rollers 161 and the second rollers 162 are rotatably connected does not necessarily move together with the outer tube hub housing 90. The outer tube clamping unit 97 may also have a configuration in which the outer tube 33 is clamped between two opposing flat surfaces or two opposing curved surfaces.

[0075] 10 and 11 , the inner needle hub housing 80 may have a flexible cover section 170 fixed to the surface on which the inner needle hub holding section 83 is formed, in order to ensure a clean field. In FIG. 10 , the fixing section 171 (fused section) for the surface on which the inner needle hub holding section 83 is formed is indicated by diagonal lines. The cover section 170 is fixed to the inner needle hub housing 80, for example, by fusion. The method for fixing the cover section 170 is not limited to fusion and may be, for example, adhesive bonding. This allows the side of the inner needle hub housing 80 on which the cover section 170 is fixed to be a clean field, while the opposite rear and side surfaces are unclean fields, which can come into direct contact with the housing holding section 41 of the device. The sheath hub housing 90 is placed in the clean field along its entire circumference and comes into contact with the clean surface of the inner needle hub housing 80.

[0076] As described above, the inner needle hub housing 80 has a cover part 170 fixed to its surface. This allows the cover part 170 to separate the clean area and the unclean area of ​​the automatic puncture device 10. Alternatively, the outer tube hub housing 90 may have a cover part fixed to its surface by fusion bonding or the like, similar to the inner needle hub housing 80 described above.

[0077] Furthermore, the configuration of the separation mechanism 110 is not limited. For example, as in an eighth modified example shown in Fig. 12(A), the outer cylindrical hub housing 90 may have an inclined surface 180 inclined with respect to a plane perpendicular to the movement direction of the pressing shaft 112, at a position where the tip of the pressing shaft 112 moved by the separation drive unit 111 abuts against the inclined surface 180. It is preferable that the tip surface of the pressing shaft 112 that abuts against the inclined surface 180 is also inclined so as to be able to make surface contact with the inclined surface 180. When the separation drive unit 111 is activated and the pressing shaft 112 moves, the pressing shaft 112 presses against the inclined surface 180, as shown in Fig. 12(B). This allows the outer cylindrical hub housing 90 to move in the distal direction away from the inner needle hub housing 80.

[0078] 13(A), the separation mechanism 110 may include a separation drive unit 111 that generates rotational force from a motor or the like, a threaded portion 190 that is rotated by the separation drive unit 111, and a pressing shaft 112 that has a female thread 191 that threads into the male thread of the threaded portion 190. The sheath hub housing 90 has an abutment portion 192 against which the pressing shaft 112 can abut. When the separation drive unit 111 is actuated to rotate the threaded portion 190, the pressing shaft 112 that has a female thread 191 that threads into the male thread of the threaded portion 190 moves in the distal direction, as shown in FIG. 13(B). This allows the sheath hub housing 90 to move in the distal direction away from the inner needle hub housing 80.

[0079] Furthermore, as in the tenth modified example shown in Figures 14 to 20, the puncture needle holding portion 200 may have a structure in which an outer tube hub housing 230 that holds an outer tube hub 35 is connected to a housing holding portion 220 via another member, a guide member 210.

[0080] As shown in Figures 14 to 16, the outer tube hub housing 230 has an outer tube hub housing main body 231, a clamping member 232 that rotates relative to the outer tube hub housing main body 231, a hinge portion 233 that rotatably connects the clamping member 232 to the outer tube hub housing main body 231, a fixing screw 234 that fixes the clamping member 232 to the outer tube hub housing main body 231, and a first maintaining portion 235 that maintains the state held by the guide member 210.

[0081] The outer tube hub housing main body 231 is formed with a first groove 236 that grips the outer tube 33 and a threaded hole 237 into which the fixing screw 234 can be threaded. The first retaining portion 235 is a magnet located on the bottom surface of the outer tube hub housing main body 231 and on the back surface facing the housing holding portion 220. The clamping member 232 is formed with a second groove 238 that grips the outer tube 33 and a screw insertion groove 239 into which the fixing screw 234 can be inserted. As shown in FIG. 16(B) , when the clamping member 232 rotates relative to the outer tube hub housing main body 231 via the hinge portion 233, the second groove 238 moves away from the first groove 236, allowing the outer tube 33 to be positioned in the first groove 236. In this state, as shown in FIGS. 14 and 16(A) , the clamping member 232 is rotated relative to the outer tube hub housing main body 231 to bring the second groove 238 closer to the first groove 236. Furthermore, the fixing screw 234 is threaded into the screw hole 237 through the screw insertion groove 239 to fix the clamping member 232 to the outer tube hub housing main body 231. This allows the outer tube 33 to be clamped well between the first groove portion 236 and the second groove portion 238.

[0082] The housing holding part 220 holds the above-mentioned outer cylindrical hub housing 230 and the inner needle hub housing that holds the inner needle hub 34 so that they can be relatively movable by the drive part 50. As shown in Figures 18 to 20, the housing holding part 220 has two support protrusions 221 that protrude from the lower end towards the outer cylindrical hub housing 230 and guide member 210 and support the guide member 210. The two support protrusions 221 are aligned in the extension direction of the puncture needle 30.

[0083] As shown in Figures 17 to 20, the guide member 210 has a back support portion 211 that supports the back surface of the outer cylindrical hub housing 230 on the housing holding portion 220 side, a bottom support portion 212 that supports the bottom surface of the outer cylindrical hub housing 230, a connecting portion 213 that can be connected to the housing holding portion 220, and a second holding portion 214 that maintains the outer cylindrical hub housing 230 in a held state.

[0084] The bottom support portion 212 extends substantially perpendicularly from the lower end of the back support portion 211. The connecting portion 213 protrudes downward from the bottom support portion 212 and extends from the protruding end toward the back support portion 211. The second retaining portion 214 is a magnet that attracts the magnet of the first retaining portion 235 by being opposite in polarity, and is disposed on each of the back support portion 211 and the bottom support portion 212. The guide member 210 is detachably connected to the housing holding portion 220 by inserting the connecting portion 213 between the two support protrusions 221 of the housing holding portion 220.

[0085] As shown in FIG. 20 , the outer cylindrical hub housing 230 is placed on the bottom support portion 212 of the guide member 210. The second retaining portion 214, which is a magnet of the outer cylindrical hub housing 230, attracts the first retaining portion 235, which is a magnet of the guide member 210, by magnetic force, thereby maintaining the outer cylindrical hub housing 230 connected to the guide member 210. Because the guide member 210 and the outer cylindrical hub housing 230 can be connected without contact by magnetic force, the connected state can be maintained by sandwiching the cover portion 240 between them. The cover portion 240 can maintain the device side where the guide member 210 and the housing retaining portion 220 are arranged as an unclean area, and the side where the outer cylindrical hub housing 230 and the puncture needle 30 are arranged as a clean area. The cover portion 240 may be fixed to the surface of the guide member 210. The cover portion 240 is fixed to the guide member 210 by fusion bonding. The method for fixing the cover portion 240 is not limited to fusion bonding, and may be, for example, adhesive bonding.

[0086] As described above, in the automatic lancing device 10 of the tenth modified example, the puncture needle holding unit 200 has a housing holding unit 220 that is movable when driven by the drive unit 50, a guide member 210 that is connectable to the housing holding unit 220, and an outer tube hub housing 230 that is detachably connected to the guide member 210 and has an outer tube hub holding unit 94. This allows the automatic lancing device 10 to indirectly connect the outer tube hub housing 230 to the housing holding unit 220 via the guide member 210, thereby improving operability.

[0087] Furthermore, guide member 210 and outer cylindrical hub housing 230 have retaining portions (first retaining portion 235, second retaining portion 214) that use magnetic force to maintain their connected state, making it easy to connect and separate guide member 210 and outer cylindrical hub housing 230, improving workability.

[0088] Furthermore, automatic lancing device 10 has cover part 240 that is sandwiched between guide member 210 and outer cylindrical hub housing 230. This allows cover part 240 to be sandwiched between guide member 210 and outer cylindrical hub housing 230, which can be connected without contact by magnetic force, and cover part 240 can reliably separate the clean field and unclean field of automatic lancing device 10.

[0089] This application is based on Japanese Patent Application No. 2024-031100, filed on March 1, 2024, the disclosures of which are incorporated herein by reference in their entirety.

[0090] REFERENCE SIGNS LIST 10 Automatic puncture device 22 Acquisition unit 30 Puncture needle 31 Inner needle 32 Needle tip 33 Outer tube 34 Inner needle hub 35 Outer tube hub 40, 200 Puncture needle holding unit 41, 220 Housing holding unit 50 Drive unit 60 Control unit 80 Inner needle hub housing 83 Inner needle hub holding unit 85 First restriction unit 86 Puncture force transmission unit 90, 230 Outer tube hub housing 92, 232 Clamping member 94 Outer tube hub holding unit 96 Second restriction unit 97 Outer tube clamping unit 98, 236 First groove (groove) 102 Pressing unit 100, 238 Second groove (groove) 110 Separation mechanism 112 Pressing shaft 113 Fixing pin 114 Elastic member 170, 240 Cover part 210 Guide member 214 Second retaining part 235 First retaining part

Claims

1. An automatic puncture device comprising: a puncture needle holding section that holds a puncture needle; a drive section that drives the puncture needle holding section at least along the puncture direction in which the puncture needle extends; an acquisition section that acquires cross-sectional images of an object; and a control section that controls the drive section, wherein the puncture needle holding section includes: an inner needle hub holding section that holds an inner needle hub located at the base end of the inner needle of the puncture needle; an outer tube hub holding section that holds an outer tube hub located at the base end of an outer tube that houses the inner needle; and an outer tube clamping section that is provided on the tip side of the outer tube hub holding section and clamps the outer tube.

2. The automatic lancing device according to claim 1, wherein the outer tube clamping portion has a groove portion and a pressing portion that can move toward and away from the groove portion.

3. An automatic puncture device as described in claim 1 or 2, characterized in that the puncture needle holding portion comprises an inner needle hub housing having the inner needle hub holding portion, and an outer tube hub housing having the outer tube hub holding portion and detachably connected to the inner needle hub housing.

4. The automatic puncture device according to claim 3, further comprising a separation mechanism for separating the inner needle hub housing from the outer barrel hub housing.

5. The automatic puncture device according to claim 4, characterized in that the inner needle hub housing has a first restricting portion which is a hole or groove, the outer barrel hub housing has a second restricting portion which is a hole or groove, and the separation mechanism has a fixing pin which fits into the first restricting portion and the second restricting portion, and a pressing shaft which fits into the first restricting portion and / or the second restricting portion and can press the fixing pin.

6. The automatic puncture device according to claim 4 or 5, characterized in that the puncture needle holding portion has an elastic member that generates a force in a direction that separates the inner needle hub housing and the outer tube hub housing.

7. The automatic lancing device according to claim 1 or 2, wherein the lancing needle holding portion is removable from the automatic lancing device.

8. The automatic lancing device according to claim 3, wherein the inner needle hub housing has a cover portion fixed to its surface.

9. The automatic puncture device according to claim 1 or 2, characterized in that the puncture needle holding section comprises: a housing holding section that is movable when driven by the drive section; a guide member that can be connected to the housing holding section; and an outer tube hub housing that is detachably connected to the guide member and has the outer tube hub holding section.

10. The automatic lancing device according to claim 9, wherein the guide member and the outer cylindrical hub housing have a retaining portion that retains the connected state by magnetic force.

11. The automatic lancing device according to claim 10, further comprising a cover portion sandwiched between said guide member and said outer cylindrical hub housing.

12. A puncture needle holding unit that can be attached to an external device and can hold a puncture needle, comprising: an outer tube hub holding unit that holds an outer tube hub located at the base end of an outer tube that houses the inner needle of the puncture needle; and an outer tube clamping unit that is provided on the tip side of the outer tube hub holding unit and clamps the outer tube.

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