Puncture needle

Abstract

[Problem] To provide a puncture needle, which is satisfactory in terms of insertion in biological tissue and is capable of efficiently injecting a liquid medicine even when the diameter of the puncture needle is reduced. [Solution] A puncture needle 110 having a needle tube part 130, which comprises a needle tube part lumen 135 extending in the axial direction, a cutting edge part 120, which comprises a plurality of blade surfaces 121 formed at different positions around the axial direction and a plurality of ridge lines 123 positioned at respective boundaries of the plurality of blade surfaces and which is disposed on the distal side of the needle tube part, and a hole part 136, which is formed in the side surface of the needle tube part and connects the lumen of the needle tube part with the outside, wherein the hole part is disposed on an extension of a ridge line in the axial direction, and there are at least two hole parts.

Description

puncture needle

[0001] The present invention relates to a puncture needle.

[0002] BACKGROUND ART In the medical field, development of puncture needles has been underway to realize not only puncture of biological tissue but also local administration of a medicinal solution to a target site within the living body.

[0003] It is desirable for a puncture needle to have a thinner diameter structure in order to improve delivery to various parts of the body. However, when the diameter of the puncture needle is reduced, the lumen diameter of the puncture needle narrows, and injection resistance increases when administering a medicinal solution to a target site. Therefore, when the diameter of the puncture needle is reduced, the medicinal solution cannot be administered efficiently to the target site. Furthermore, when the diameter of the puncture needle is reduced, the pushability of the puncture needle decreases, and therefore the ability to penetrate biological tissue also decreases.

[0004] For example, Patent Document 1 listed below discloses a puncture needle (puncture device) having a cutting edge portion with multiple tapered surfaces tapering toward the tip and ridges extending between each tapered surface, a side hole positioned offset toward the base end from the tip of the cutting edge portion, and a lumen for administering a drug solution that communicates with the side hole.

[0005] Special table number 2010-512863

[0006] The puncture needle of Patent Document 1 is configured with a cutting edge having multiple tapered surfaces and ridges extending between the tapered surfaces, as described above. When the cutting edge is inserted into biological tissue, the multiple tapered surfaces and ridges allow the cutting edge to cut open the biological tissue. Therefore, the cutting edge is considered to have good penetration properties into biological tissue. However, even if the cutting edge structure disclosed in Patent Document 1 is adopted, if the diameter of the puncture needle is reduced, it is difficult to avoid an increase in injection resistance when administering a medicinal solution, making it difficult to achieve a sufficiently small diameter for the puncture needle.

[0007] The present invention has been made in consideration of the above-mentioned problems, and aims to provide a puncture needle that can efficiently inject medicinal solutions even when the diameter of the puncture needle is reduced, and that has high penetration ability into biological tissue.

[0008] The present invention can be achieved by any one of the following means (1) to (8).

[0009] (1) A puncture needle comprising: a needle tube portion having a needle tube portion lumen extending in the axial direction; a plurality of blade faces formed at different positions around the axial direction; and a plurality of ridge lines located at the boundaries of each of the plurality of blade faces; a cutting edge portion located at the tip side of the needle tube portion; and a hole portion formed on the side surface of the needle tube portion that connects the needle tube portion lumen of the needle tube portion to the outside, the hole portion being located on an extension of the ridge line in the axial direction, and there are two or more of the hole portions.

[0010] (2) The puncture needle described in (1) above, characterized in that, at least on the base end side of the hole, the inner wall of the needle tube portion on the inside of which the hole portion is formed intersects with the outer surface of the needle tube portion at an obtuse angle.

[0011] (3) The puncture needle according to (1) or (2) above, characterized in that the hole has a substantially rectangular shape in plan view with long sides extending along the axial direction.

[0012] (4) The puncture needle according to (3) above, characterized in that the corners of the hole are chamfered.

[0013] (5) A puncture needle described in any one of (1) to (4) above, characterized in that a groove portion extending from the hole portion toward the ridge line is formed on the outer surface of the needle tube portion.

[0014] (6) The puncture needle according to (5) above, characterized in that the groove portion extends at least to the boundary position between the cutting edge portion and the needle tube portion.

[0015] (7) A puncture needle according to any one of (1) to (6) above, characterized in that the cutting edge portion has a solid structure and is fixed to the needle tube portion at the tip side of the needle tube portion.

[0016] (8) The puncture needle according to any one of (1) to (7) above, wherein the cutting edge has a number of ridges corresponding to the number of holes.

[0017] According to the invention described in (1) above, it is possible to provide a puncture needle that can efficiently inject medicinal liquid even when the diameter of the puncture needle is reduced, and that has high penetration ability into biological tissue.

[0018] 6A-6C are perspective views of a medical device according to an embodiment. A perspective view of a medical device according to an embodiment. A partial cross-sectional view along the axial direction of a medical device according to an embodiment. A partial cross-sectional view showing an enlarged portion of a medical device according to an embodiment. A partial cross-sectional view showing an enlarged portion of a medical device according to an embodiment. A cross-sectional view orthogonal to the axis of a medical device taken along arrows 6A-6A in FIG. 3. A perspective view showing the vicinity of the tip of a puncture device. A perspective view showing the vicinity of the tip of a puncture device. A perspective view showing the vicinity of the tip of a puncture device. A perspective cross-sectional view along the axial direction of the tip of a puncture device. A plan view of a puncture needle. A front view of a puncture needle. A cross-sectional view schematically showing a usage example of a medical device according to an embodiment ... perspective view for explaining a medical device according to a modified example. A perspective view for explaining a locking mechanism added to a medical device according to a modified example.

[0019] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional proportions in the drawings are exaggerated for the sake of explanation and may differ from the actual proportions.

[0020] Figures 1 to 6 are diagrams showing the overall configuration of a medical device 10 according to an embodiment, Figures 7 to 12 are diagrams for explaining a puncture device 100 according to an embodiment, and Figures 13 to 17 are diagrams for explaining a procedure using the medical device 10.

[0021] In this specification, the directions related to the medical device 10 are defined as follows. The side of the medical device 10 that is introduced into a living body (the side indicated by arrow X1 in the figure) is the distal side, and the end of each member and component located on the distal side is referred to as the "distal portion." The side on which the grip portion 350 of the proximal handle portion 300 of the medical device 10 is located (the side indicated by arrow X2 in the figure) is referred to as the proximal side, and the end of each member and component located on the proximal side is referred to as the "proximal portion." The direction from the distal portion toward the proximal portion (or from the proximal portion toward the distal portion) is referred to as the "axial direction (direction indicated by arrow X1-X2)." In each figure, arrows Y1-Y2 indicate the width direction perpendicular to the axial direction, and arrows Z1-Z2 indicate the height direction perpendicular to both the axial direction and the width direction.

[0022] (Medical Device 10) As shown in Figs. 13 to 17, the medical device 10 incorporating the puncture needle 110 according to this embodiment is inserted into a delivery device so as to be able to advance and retract when in use.

[0023] In this embodiment, an endoscopic device 500 known in the medical field is exemplified as the delivery device. When the medical device 10 is delivered to a target site E in a living body, it can be inserted retractably into a channel 511 of an insertion section 510 provided in the endoscopic device 500. The endoscopic device 500 is, for example, a known ultrasound endoscope in which an ultrasound imaging section 520 is disposed at the tip of the insertion section 510. However, there are no particular limitations on the specific structure, product specifications, product type, etc. of the endoscopic device 500.

[0024] The delivery device is not particularly limited in terms of product specifications or specific structure, as long as it has a passage (lumen) through which the medical device 10 is inserted so as to be movable back and forth. For example, the delivery device may be a catheter or the like having a lumen through which the medical device 10 is inserted so as to be movable back and forth.

[0025] As shown in Figures 1 to 3, the medical device 10 has a puncture device 100 equipped with a puncture needle 110, an outer sheath 200 through which the puncture device 100 is inserted, and a proximal handle portion 300 arranged on the proximal end side of the puncture device 100 and the outer sheath 200.

[0026] In the medical device 10, the puncture device 100, the inner sheath 140, and the outer sheath 200 are connected to the respective parts of the proximal handle portion 300, and the relative axial positions of the above three components can be changed and adjusted by operating the proximal handle portion 300. Note that Fig. 1 illustrates a state in which the inner sheath 140 and the puncture device 100 are housed in the outer sheath 200, and Fig. 2 illustrates a state in which the inner sheath 140 and the puncture device 100 are protruded toward the distal end of the outer sheath 200.

[0027] (Outer Sheath 200) As shown in Figs. 4, 5 and 6, the outer sheath 200 is made up of a member with a multi-tube structure having predetermined lumens 203 and 204 therein.

[0028] 6, the outer sheath 200 has a first surface 201a defining a first lumen 203 therein through which the puncture device 100 can be inserted, and a second surface 201b defining at least one second lumen 204 between the first surface 201a and the second surface 201b. Note that Fig. 6 is an orthogonal cross-sectional view taken along arrows 6A-6A in Fig. 3.

[0029] The outer sheath 200 has an inner tube 210 having a first surface 201a and a first lumen 203, an outer tube 220 having a second surface 201b and a second lumen 204, and a fixing member 250 disposed between the inner tube 210 and the outer tube 220 and fixing the inner tube 210 and the outer tube 220.

[0030] The first surface 201a is formed by the inner surface (inner surface) of the inner tube 210. The second surface 201b is formed by the inner surface (inner surface) of the outer tube 220. The first lumen 203 is formed inside the inner tube 210 and extends over substantially the entire length of the inner tube 210 in the axial direction. The second lumen 204 is defined between the outer surface of the inner tube 210 and the inner surface of the outer tube 220 and extends over substantially the entire length of the inner tube 210 and the outer tube 220 in the axial direction.

[0031] 6 , in this embodiment, four second lumens 204 are formed inside the outer tube 220, spaced equally in the circumferential direction (axially symmetrically). Furthermore, each second lumens 204 is partitioned by a fixing member 250 so as to have substantially the same cross-sectional area at a different position in the circumferential direction based on the central axes C1 and C2 of the inner tube 210 and the outer tube 220. Therefore, each second lumen 204 is partitioned by the outer surface of the inner tube 210, the inner surface of the outer tube 220, and the exposed surface of the fixing member 250. The number of second lumens 204 is not particularly limited.

[0032] The fixing member 250 fixes the inner tube 210 and the outer tube 220, thereby maintaining the relative positional relationship between the inner tube 210 and the outer tube 220 (the positional relationship on the cross section perpendicular to the axis shown in FIG. 6).

[0033] In this embodiment, as shown in Fig. 6, the inner tube 210 and the outer tube 220 are concentrically arranged by the fixing member 250. That is, in the cross-sectional view perpendicular to the axis shown in Fig. 6, the central axis C1 of the inner tube 210 and the central axis C2 of the outer tube 220 are arranged to overlap each other.

[0034] 6, four fixing members 250 are arranged at equal intervals in the circumferential direction of the outer sheath 200, with reference to the central axis (synonymous with each of the central axes C1 and C2) of the outer sheath 200. The angular difference between the fixing members 250 in the circumferential direction is approximately 90°.

[0035] The number, arrangement, cross-sectional shape (cross-sectional shape shown in FIG. 6 ), etc. of the fixing members 250 are not particularly limited as long as they function to fix the inner tube 210 and the outer tube 220. For example, the fixing members 250 may be configured as a single member that extends spirally around the central axis of the outer sheath 200.

[0036] As shown in FIG. 3 , the distal end of the outer sheath 200 is provided with a distal end opening 207 that allows the pricking device 100 to protrude from the outer sheath 200 .

[0037] 5 , the proximal end 206 of the outer sheath 200 is connected to a first connecting section 320, which will be described later. Therefore, when the first connecting section 320 is moved forward or backward in the axial direction, the outer sheath 200 moves forward or backward in the axial direction in conjunction with the forward or backward movement of the first connecting section 320. Note that the proximal end of the outer sheath 200 refers to the proximal end of the inner tube 210 and the proximal end of the outer tube 220.

[0038] The outer sheath 200 (the inner tube 210 and the outer tube 220) and the inner sheath 140 described below can be made of, for example, the same materials as those used as constituent materials for catheters, etc. known in the medical field. Examples of such materials include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer; thermoplastic resins such as soft polyvinyl chloride; various elastomers such as polyurethane elastomer, polyamide elastomer, and polyester elastomer; and crystalline plastics such as polyamide, crystalline polyethylene, and crystalline polypropylene.

[0039] The fixing member 250 is preferably made of a relatively flexible resin material so as not to excessively increase the rigidity of the outer sheath 200. Examples of such materials include polyolefin (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these), polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, and polyimide.

[0040] (Puncture device 100) As shown in Figures 3 and 7 to 9, the puncture device 100 has a puncture needle 110 having a cutting edge portion 120 and a needle tube portion 130, and an inner sheath 140 having a third lumen 143 into which the puncture needle 110 is inserted so as to be able to move forward and backward.

[0041] Fig. 7 shows a state in which the cutting edge portion 120 and the needle tube portion 130 are housed in the third lumen 143 of the inner sheath 140. Fig. 8 shows a state in which the cutting edge portion 120 protrudes from the third lumen 143 of the inner sheath 140. Fig. 9 shows a state in which the cutting edge portion 120 and the vicinity of the distal end of the needle tube portion 130 protrude from the third lumen 143 of the inner sheath 140.

[0042] (Inner Sheath 140) As shown in Figures 8, 9, and 10, a tip member 145 is attached to the distal end of the inner sheath 140. The tip member 145 can be made of, for example, a metal or the like with radiopaque properties. Alternatively, the tip member 145 may be configured with grooves, depressions, or protrusions to provide high ultrasound reflectivity. When the tip member 145 is made of a metal or the like with radiopaque properties, the distal position of the inner sheath 140 (the position of the tip member 145) can be visually confirmed and grasped under X-ray fluoroscopy. Furthermore, when the tip member 145 is configured to have high ultrasound reflectivity, the distal position of the inner sheath 140 (the position of the tip member 145) can be visually confirmed and grasped using an ultrasound device. Note that a similar effect can be achieved by providing an X-ray-opaque marker or an ultrasonic marker on the tip member 145. A tip opening 145a is provided at the distal end of the tip member 145, allowing the puncture needle 110 to protrude.

[0043] 5 , the proximal end 146 of the inner sheath 140 is connected to the proximal handle portion 300 at a second connecting portion 330, which will be described later. Therefore, when the second connecting portion 330 is moved forward or backward in the axial direction, the inner sheath 140 moves forward or backward in the axial direction in conjunction with the forward or backward movement of the second connecting portion 330. Here, the proximal end 146 of the inner sheath 140 may be composed of a tubular member that can connect the inner sheath 140 within a lumen, and a cylindrical member through which the tubular member passes and is fixed.

[0044] 5, the proximal end 146 of the inner sheath 140 connected to the second connecting part 330 is disposed closer to the proximal end than the proximal end 206 of the outer sheath 200 connected to the first connecting part 320. The inner sheath 140 is inserted into the first lumen 203 (see FIG. 6) from a position closer to the proximal end than the proximal end 206 of the outer sheath 200.

[0045] 3 , the base end 113 of the puncture needle 110 (the base end of the needle tube portion 130) is connected to a third connecting portion 340, which will be described later. The third connecting portion 340 is also connected to a gripping portion 350, which will be described later. Therefore, when the third connecting portion 340 is moved forward or backward in the axial direction together with the gripping portion 350, the puncture needle 110 moves forward or backward in the axial direction in conjunction with the forward or backward movement of the third connecting portion 340.

[0046] 3 and 5 , the proximal end 113 of the puncture needle 110 connected to the third connecting part 340 is disposed closer to the proximal end than the proximal end 146 of the inner sheath 140 connected to the second connecting part 330. The puncture needle 110 is inserted into the third lumen 143 (see FIG. 6 ) from a position closer to the proximal end than the proximal end 146 of the inner sheath 140.

[0047] (Puncture Needle 110 ) As shown in FIGS. 7 , 8 , and 9 , the puncture needle 110 includes a needle tube portion 130 and a cutting edge portion 120 .

[0048] The needle tube portion 130 includes a needle tube portion lumen 135 extending in the axial direction. The outer diameter of the needle tube portion 130 is not particularly limited, but is preferably 0.51 mm or less, and more preferably 0.41 mm or less, from the viewpoint of suppressing unintended perforation during puncture.

[0049] The cutting edge portion 120 is disposed on the distal end side of the needle tube portion 130 .

[0050] The cutting edge portion 120 has a plurality of cutting surfaces 121 formed at different positions around the axial direction, and a plurality of ridge lines 123 located at the boundaries between the plurality of cutting surfaces 121 .

[0051] The puncture needle 110 has a hole 136 formed on the side surface of the needle tube portion 130, which connects the needle tube portion lumen 135 of the needle tube portion 130 with the outside.

[0052] The hole 136 is disposed on an extension of the ridge line 123 in the axial direction. The number of the hole 136 provided in the needle tube portion 130 is two or more.

[0053] 12, the cutting edge 120 can be configured to have, for example, four blade surfaces 121 and four ridge lines 123 located at the boundaries between the blade surfaces 121. The ridge lines 123 are arranged at different positions in the circumferential direction relative to the central axis C3 of the puncture needle 110, at equal intervals of approximately 90°.

[0054] As shown in Figure 12, each of the four blade surfaces 121 provided on the cutting edge portion 120 is composed of a tapered surface that extends in an approximately linear manner from the tip of the puncture needle 110 toward the base end (needle tube portion 130 side) so as to gradually move away from the central axis C3 of the puncture needle 110.

[0055] 12 , the needle tube portion 130 can be configured to have hole portions 136, the number of which corresponds to the number of ridge lines 123. In this embodiment, four hole portions 136, the same number as the number of ridge lines 123, are provided on the side surface of the needle tube portion 130.

[0056] The holes 136 can be arranged at positions corresponding to the ridge lines 123 in the circumferential direction based on the central axis C3 of the puncture needle 110. In this embodiment, the holes 136 are arranged at different positions in the circumferential direction based on the central axis C3 of the puncture needle 110, with equal angular differences of approximately 90°.

[0057] 10, the cutting edge portion 120 has a solid structure. That is, the needle tube portion lumen 135 is not formed inside the cutting edge portion 120.

[0058] As shown in FIG. 10 , the cutting edge portion 120 is fixed to the needle tube portion 130 on the distal end side of the needle tube portion 130 .

[0059] The puncture needle 110 is configured such that the portion that constitutes the cutting edge portion 120 and the portion that constitutes the needle tube portion 130 are separate members. In other words, the puncture needle 110 is configured from two members.

[0060] The cutting edge portion 120 has a first fixing portion 124 provided at the base end of the cutting edge portion 120. The needle tube portion 130 has a second fixing portion 134 provided at the distal end of the needle tube portion 130. The second fixing portion 134 is located closer to the distal end than the hole portion 136.

[0061] The second fixing portion 134 has a recessed space into which the first fixing portion 124 can be fitted. The cutting edge portion 120 is connected to the needle tube portion 130 by fitting the first fixing portion 124 into the second fixing portion 134. The connection between the first fixing portion 124 and the second fixing portion 134 can be reinforced as appropriate by adhesive, welding, or the like.

[0062] As shown in FIG. 3 , the puncture needle 110 has a proximal end opening (not shown) formed at the proximal end 133. The proximal end opening of the puncture needle 110 is arranged to communicate with a first port 351 that is integrally connected to the third connecting portion 340. When a predetermined drug solution supplying instrument (e.g., a syringe pump known in the medical field) is connected to the first port 351 and drug solution is supplied, the drug solution flows into the needle tube lumen 135 via the first port 351 and the proximal end opening of the puncture needle 110. Note that the drug solution may flow into the needle tube lumen 135 via a hole 136, which will be described later. That is, the drug solution may flow into the needle tube lumen 135 via the hole 136 by connecting an instrument capable of suction to the first port 351 and aspirating the instrument with the hole 136 protruding from the inner sheath 140 (with the hole 136 not covered by the inner sheath 140).

[0063] 10 and 11 , the needle tube lumen 135 is connected to a hole 136 formed near the distal end of the needle tube 130. The medicinal solution that has flowed into the needle tube lumen 135 moves axially toward the distal end along the needle tube lumen 135, and when it reaches the vicinity of the distal end of the needle tube 130, it is released to the outside of the needle tube 130 (outside the puncture needle 110) through the hole 136. By inserting the puncture device 100 into the third lumen 143 of the inner sheath 140 so as to be able to advance and retract, leakage of the medicinal solution from the hole 136 of the puncture device 100 can be prevented when the cutting edge 120 and the needle tube 130 are housed in the third lumen 143 of the inner sheath 140.

[0064] In a procedure using the medical device 10, as shown in Figure 9, by supplying a medicinal liquid to the needle tube portion lumen 135 while the hole portion 136 formed in the needle tube portion 130 is protruding from the inner sheath 140 (the hole portion 136 is not covered by the inner sheath 140), the medicinal liquid can be locally administered to the target site E (see Figure 16) through the hole portion 136.

[0065] As shown in FIG. 10, at least on the proximal side of the hole 136, the inner wall 130a of the needle tube 130, inside which the hole 136 is formed, intersects with the outer surface 130b of the needle tube 130 at an obtuse angle.

[0066] The above phrase "the inner wall 130a of the needle tube portion 130 intersects with the outer surface 130b of the needle tube portion 130 at an obtuse angle" means that, as shown in Fig. 10, the angle θ formed between an imaginary line L parallel to the inner wall 130a of the needle tube portion 130 and the central axis C3 of the puncture needle 110 is an acute angle. Note that the angle θ is not particularly limited as long as it is an acute angle, but is preferably 45° to 60°, for example.

[0067] The hole 136 can be configured to have a generally rectangular shape with long sides extending along the axial direction in the plan view shown in FIG.

[0068] 11, corners 136a (corners located at the four corners) of the hole 136 can be chamfered. That is, each corner 136a of the hole 136, which is formed in a substantially rectangular shape, can be formed into a rounded shape in the plan view shown in FIG.

[0069] As shown in FIGS. 9 and 11 , a groove 138 is formed in the outer surface 130b of the needle tube portion 130, extending coaxially with the ridge line 123 from the distal end of the hole 136 toward the ridge line 123. An X-ray opaque marker or an ultrasonic marker may be provided on the outer surface 130b of the needle tube portion 130 around the groove 138. Here, the X-ray opaque marker is provided by forming the outer surface 130b of the needle tube portion 130 around the groove 138 from a metal or the like having X-ray contrast properties, or by providing a metal or the like having X-ray contrast properties on the outer surface 130b of the needle tube portion 130. The ultrasonic marker is provided by providing a slope on the edge of the groove 138 or by providing another groove, depression, or protrusion around the groove 138. By providing such a marker, the position of the hole 136 can be visually confirmed and grasped under X-ray fluoroscopy (CT scanner) or ultrasound scanner.

[0070] The puncture needle 110 has four grooves 138 that connect to four holes 136 that are arranged to correspond to four ridges 123 that are arranged at different circumferential positions based on the central axis C3 of the puncture needle 110.

[0071] As shown in FIG. 11 , the distal end of the groove 138 can be provided so as to extend at least to the boundary position 105 between the cutting edge 120 and the needle tube 130 .

[0072] The above-mentioned “boundary position 105 ” is the boundary position between the base end of the cutting edge portion 120 and the tip end of the needle tube portion 130 .

[0073] Groove 138 may extend further toward cutting edge 120 (tip side) than boundary position 105, for example. Specifically, in the plan view shown in FIG. 11 , groove 138 can be extended to any position on base end 125 located near the base end of cutting edge 120. By providing groove 138 in this manner, the medicinal solution released from hole 136 is more smoothly guided through groove 138 to ridge line 123. Note that base end 125 is located closer to the base end of ridge line 123 and constitutes a portion where ridge line 123 is not formed.

[0074] 11 , groove 138 extends in a substantially linear manner from hole 136 toward ridge 123. Groove 138 is configured to have substantially the same width along the axial direction (length dimension in a direction perpendicular to the axial direction). Groove 138 also extends continuously from hole 136 to boundary position 105 without interruption.

[0075] For example, groove 138 may have a width that varies midway from hole 136 toward ridge line 123, or may extend in a meandering manner. Furthermore, groove 138 may not be continuously connected in the axial direction, but may instead have a plurality of intermittently spaced portions. However, as shown in FIG. 11 , if groove 138 is configured to extend substantially linearly with the same width from hole 136 toward ridge line 123 and to be continuously connected without interruption from hole 136 toward ridge line 123, the medicinal solution released from hole 136 can be more efficiently guided toward ridge line 123.

[0076] The puncture needle 110 (cutting edge portion 120 and needle tube portion 130) may be made of, for example, a metal needle, such as stainless steel, aluminum, an aluminum alloy, titanium, a titanium alloy, or other metals.

[0077] Note that there are no particular limitations on the specific structure of the cutting edge 120 (e.g., the number and shape of the cutting edges 121, the number and shape of the ridges 123, etc.) as long as the cutting edge 120 has a plurality of ridges 123 and a plurality of cutting surfaces 121. For example, the cutting edge 120 may have a hollow structure in which a lumen is formed to allow a chemical solution to flow inside the cutting edge 120, or may have a tip opening that allows a chemical solution to be released from the tip of the cutting edge 120.

[0078] Furthermore, the cutting edge portion 120 and the needle tube portion 130 can also be configured as a single, integrated member.

[0079] Furthermore, the needle tube portion 130 does not need to be provided with the groove portion 138 .

[0080] Furthermore, there are no particular limitations on the shape of the hole 136 in plan view, and it may be, for example, a circle, an oval, a square, a diamond, or the like.

[0081] (Proximal handle portion 300) As shown in Figures 3, 4, and 5, the proximal handle portion 300 has a first connecting portion 320 connected to the outer sheath 200, and a second connecting portion 330 connected to at least a part of the puncture device 100 and moving back and forth relative to the first connecting portion 320, thereby causing the tip of the puncture device 100 to protrude from the tip of the outer sheath 200.

[0082] As shown in FIGS. 3 and 4 , the tip end of the first connecting portion 320 is connected to the tip end side connecting portion 310 .

[0083] The distal end connection portion 310 has a receptacle portion 311 disposed near the distal end thereof. The receptacle portion 311 is configured to be connectable to the endoscopic device 500. The receptacle portion 311 can be configured, for example, as a known luer lock connector that can be locked and unlocked to a device insertion port (not shown) provided in the endoscopic device 500.

[0084] The distal connection portion 310 includes a lumen 313 through which the outer sheath 200 and the puncture device 100 are inserted.

[0085] 3 and 4, a first stopper 360 is disposed on the distal end side of the first connecting portion 320. The first stopper 360 is configured to be movable along the outer surface of the distal connecting portion 310.

[0086] The first stopper 360 has a fastener 361 for fixing the first stopper 360 to the tip-side connecting portion 310 , and a support portion 362 for supporting the fastener 361 .

[0087] The fastener 361 may be, for example, a screw having a male thread portion. The support portion 362 may be, for example, configured to have a female thread portion into which the fastener 361 can be screwed.

[0088] An operator operating the medical device 10 can fix the first stopper 360 at any position in the axial direction of the tip-side connecting portion 310 by screwing the fastener 361 into the support portion 362 and abutting the fastener 361 against the outer surface of the tip-side connecting portion 310. In addition, the operator can move the first stopper 360 along the outer surface of the tip-side connecting portion 310 by operating the fastener 361 to weaken the fixing force of the first stopper 360 to the tip-side connecting portion 310.

[0089] The first connecting portion 320 is movable forward and backward in the axial direction along the tip-side connecting portion 310. The maximum axial forward position (advance limit position) of the first connecting portion 320 is determined by the position of the first stopper 360. In other words, when the operator moves the first connecting portion 320 in the axial direction, the operator can advance the first connecting portion 320 to a position where the tip of the first connecting portion 320 abuts against the first stopper 360. In addition, the exposed length of the tip-side connecting portion 310 exposed from the first connecting portion 320 is adjusted by the position of the first stopper 360.

[0090] There are no particular limitations on the specific configuration of the first stopper 360, as long as it is capable of determining the maximum forward position of the first connecting portion 320 as described above. The same applies to the second stopper 370 and the third stopper 380 described below. In this embodiment, the second stopper 370 and the third stopper 380 have substantially the same configuration as the first stopper 360. Therefore, in the following description, the description of the configuration of the second stopper 370 and the third stopper 380 will be omitted as appropriate.

[0091] 4, a large diameter portion 316 for preventing slippage is provided near the base end of the tip side connecting portion 310. When the tip side connecting portion 310 is moved toward the tip side, the large diameter portion 316 for preventing slippage comes into contact with the support portion 362 of the first stopper 360, thereby preventing the tip side connecting portion 310 from moving further distally than the first stopper 360. The large diameter portion 316 for preventing slippage prevents the tip side connecting portion 310 from slipping out toward the tip side of the medical device 10.

[0092] As shown in FIG. 4 , a first protrusion 315 that can be fitted into a first recess 327 formed on the inner wall of the first connection part 320 is provided near the base end of the distal connection part 310 .

[0093] In the medical device 10, when the first convex portion 315 is fitted into the first concave portion 327, axial movement of the distal connection portion 310 is restricted. For example, by keeping the first convex portion 315 fitted into the first concave portion 327 during a preparation stage (such as a product shipping stage after manufacture or a storage stage) before the medical device 10 is used in a medical setting, the distal connection portion 310 and the first connection portion 320 can be held in predetermined initial positions. In this embodiment, the first convex portion 315 is provided on the distal connection portion 310 axially closer to the base end than the large diameter portion 316, but the large diameter portion 316 may also be provided on the distal connection portion 310 axially closer to the base end than the first convex portion 315.

[0094] It is preferable that the first recess 327 and the first protrusion 315 are configured to generate a fixing force that allows the first protrusion 315 to relatively easily come out of the first recess 327 when an operator applies a force that moves one of the tip-side connecting portion 310 and the first connecting portion 320 in the axial direction relative to the other. The same applies to the second recess 337 and the second protrusion 325 described below.

[0095] 4 and 5 , the first connecting part 320 is configured as a tubular member having a lumen 323 through which the puncture device 100 and the outer sheath 200 are inserted. A part of the base end side of the tip-side connecting part 310 is inserted into the lumen 323.

[0096] 4 and 5 , the second connecting part 330 is configured as a tubular member having a lumen 333 through which the inner sheath 140 and the outer sheath 200 are inserted. A portion of the proximal end side of the first connecting part 320 is inserted into the lumen 333.

[0097] 5 , a large diameter portion 326 for preventing slippage is provided at the proximal end of the first connecting portion 320. When the first connecting portion 320 is moved toward the distal end, the large diameter portion 326 for preventing slippage comes into contact with the support portion 362 of the second stopper 370, thereby preventing the first connecting portion 320 from moving toward the distal end beyond the second stopper 370. The large diameter portion 326 for preventing slippage prevents the first connecting portion 320 from slipping out toward the distal end of the medical device 10.

[0098] As shown in FIG. 5 , a second protrusion 325 that can be fitted into a second recess 337 formed on the inner wall of the second connection part 330 is provided near the base end of the first connection part 320 .

[0099] In the medical device 10, when the second protrusion 325 is fitted into the second recess 337, axial movement of the first connecting portion 320 is restricted. By leaving the second protrusion 325 fitted into the second recess 337 during a preparation stage before using the medical device 10 in a medical setting, the first connecting portion 320 and the second connecting portion 330 can be held in predetermined initial positions. In this embodiment, the second protrusion 325 is provided on the first connecting portion 320 axially closer to the base end than the large diameter portion 326, but the large diameter portion 326 may also be provided on the first connecting portion 320 axially closer to the base end than the second protrusion 325.

[0100] 5, a large diameter portion 336 for preventing slippage is provided at the proximal end of the second connecting portion 330. When the third connecting portion 340 is moved toward the distal end, the large diameter portion 336 for preventing slippage comes into contact with the distal end portion 354 of the gripping portion 350, thereby preventing the second connecting portion 330 from moving distally beyond the distal end portion 354 of the gripping portion 350. The large diameter portion 336 for preventing slippage prevents the second connecting portion 330 from slipping out toward the distal end of the medical device 10.

[0101] 4 and 5 , a second stopper 370 is disposed on the tip side of the second connecting portion 330. The second stopper 370 is configured to be movable along the outer surface of the first connecting portion 320.

[0102] The second connecting part 330 is movable forward and backward in the axial direction along the outer surface of the first connecting part 320. The maximum axial forward position (advance limit position) of the second connecting part 330 is determined by the position of the second stopper 370. When the operator moves the second connecting part 330 in the axial direction, the operator can advance the second connecting part 330 to a position where the tip end of the second connecting part 330 abuts against the second stopper 370. Furthermore, the length by which the inner sheath 140 connected to the first connecting part 320 protrudes from the outer sheath 200 is adjusted by the position of the second stopper 370.

[0103] As shown in Fig. 3 , at least a portion of the proximal handle portion 300 has a third connecting portion 340. The third connecting portion 340 is located closer to the proximal end than the second connecting portion 330, and is connected to the proximal end portion 113 of the puncture needle 110. As shown in Figs. 8 and 9 , the third connecting portion 340 is configured to move forward and backward relative to the second connecting portion 330, thereby causing the cutting edge portion 120 to protrude from the distal end of the inner sheath 140.

[0104] The proximal handle portion 300 has a grip portion 350 that can be held by the operator with the fingers, etc. The third connecting portion 340 is disposed near the proximal end of the internal space 353 of the grip portion 350. A proximal end opening (not shown) located at the proximal end 113 of the puncture needle 110 connected to the third connecting portion 340 is in fluid communication with the first port 351.

[0105] The third connector 340 is connected to the grip 350 together with the first port 351. The puncture needle 110 is connected to the grip 350 via the third connector 340.

[0106] The gripping portion 350 is movable back and forth in the axial direction along the outer surface of the second connecting portion 330. When the gripping portion 350 moves in the axial direction along the outer surface of the second connecting portion 330, the third connecting portion 340 and the puncture needle 110 connected to the gripping portion 350 move in the axial direction in conjunction with the movement of the gripping portion 350.

[0107] A protective member (protective sheath) for covering and protecting the portion of the needle tube portion 130 of the puncture needle 110 that is exposed from the inner sheath 140 can be appropriately placed in the internal space 353 of the grip portion 350. Furthermore, a protective member (protective sheath) for covering and protecting the portion of the inner sheath 140 that is exposed from the outer sheath 200 can be appropriately placed in the internal space of the lumen 333 through which the inner sheath 140 and the outer sheath 200 are inserted. The configuration of the protective member is not particularly limited as long as it can prevent the puncture needle 110 from being bent in the internal space 353 by operating the forward and backward movement of the proximal handle portion 300. For example, the protective member may be configured in the internal space 353 of the gripping portion 350 to include a small-diameter tubular body covering the outer surface 130b of the needle tube portion 130 and a large-diameter tubular body, and the small-diameter tubular body, one end of which is fixed to the wall on the proximal end side of the internal space 353 of the gripping portion 350, can be inserted into the large-diameter tubular body, one end of which is fixed to the wall on the proximal end side of the proximal end 146 of the inner sheath 140 connected to the second connecting portion 330. Alternatively, the protective member may be configured to include two tubular bodies of the same diameter that cover the outer surface 130b of the needle tube portion 130 and have engaging portions (e.g., grooves or notches) for engaging with each other, and the tubular bodies are fixed at one end each as described above and engage with each other at the engaging portions. In the internal space of the lumen 333 through which the inner sheath 140 and the outer sheath 200 are inserted, one end of each of the two tubular bodies is fixed to a wall on the proximal end side of the proximal end 206 of the outer sheath 200 and a wall on the distal end side of the proximal end 146 of the inner sheath 140 connected to the second connecting part 330. Here, the protective member may be fixed so as to axially penetrate the proximal end 146 of the inner sheath 140 connected to the second connecting part 330 and the proximal end 206 of the outer sheath 200.

[0108] 3 and 5, a third stopper 380 is disposed on the tip side of the gripping portion 350. The third stopper 380 is configured to be movable along the outer surface of the second connecting portion 330.

[0109] The maximum axial forward position (forward limit position) of the gripping portion 350 is determined by the position of the third stopper 380. In other words, when the operator moves the gripping portion 350 in the axial direction, the operator can advance the gripping portion 350 to a position where the tip portion 354 of the gripping portion 350 abuts against the third stopper 380. Furthermore, the projection length of the puncture needle 110 connected to the gripping portion 350 via the third connecting portion 340 from the inner sheath 140 is adjusted by the position of the third stopper 380.

[0110] It is preferable that the tip 354 of the gripping portion 350 be made of a resin or metal material that is hard enough to prevent damage to the gripping portion 350 when it comes into contact with the third stopper 380.

[0111] As shown in FIG. 3, the medical device 10 has a first port 351 that is arranged to communicate with the needle tube lumen 135 via the third connection portion 340 of the proximal handle portion 300 and enables fluid to be supplied into the needle tube lumen 135.

[0112] The first port 351 can be configured with a known connector to which, for example, a drug solution supplying device or a device capable of suction can be connected.

[0113] <Example of Use of Medical Device 10> Next, a method of administering a medicinal solution using the medical device 10 will be described. The method of administering a medicinal solution described below is an example, and the procedure for using the medical device 10 is not limited to the following.

[0114] The following describes a procedure for administering a medicinal solution to a target site E (e.g., a region containing biological tissue in which cancer cells are present) of the pancreas M using the medical device 10. Here, as shown in Fig. 13 , a procedure is described in which an endoscopic device 500 is used to deliver the medical device 10 transgastrically and deliver a puncture needle 110 to the pancreas M via the stomach wall W.

[0115] When starting administration of a medicinal solution using the medical device 10, the operator inserts the endoscopic device 500 into the patient's living body. After delivering the insertion section 510 of the endoscopic device 500 to a predetermined position in the stomach, the operator uses the ultrasound imaging section 520 to check the condition of the target site E.

[0116] The operator primes the medical device 10 by connecting a medicinal solution supplying tool to the first port 351 (see FIG. 3 ) and feeding the medicinal solution to the proximal handle portion 300 .

[0117] The operator operates the first stopper 360 and the distal end connecting portion 310 to adjust the effective length of the medical device 10 so that it corresponds to the effective length of the insertion portion 510 of the endoscopic device 500 .

[0118] The operator inserts the medical device 10 into the channel 511 of the insertion section 510 of the endoscopic device 500 and delivers the medical device 10 to the stomach via the insertion section 510. While moving the medical device 10 within the channel 511, the operator maintains a state in which the cutting edge 120 of the puncture needle 110 protrudes from the inner sheath 140 and the hole 136 is covered by the inner sheath 140 (the state shown in FIG. 8 ). Furthermore, while delivering the medical device 10 to the stomach, the operator maintains a state in which the cutting edge 120 of the puncture needle 110 and the tip of the inner sheath 140 are housed in the first lumen 203 of the outer sheath 200 (a state in which the cutting edge 120 of the puncture needle 110 and the tip of the inner sheath 140 do not protrude from the outer sheath 200).

[0119] With the puncture device 100 covered with the outer sheath 200 as described above, the operator can deliver the medical device 10 to a desired position in a living body through the channel 511 of the endoscopic device 500. Compared to a medical device 10 not provided with the outer sheath 200, the outer diameter of the portion of the medical device 10 inserted into the channel 511 is increased by an amount corresponding to the outer diameter of the outer sheath 200. Therefore, as shown in Fig. 6 , the operator can narrow the clearance formed between the medical device 10 and the inner wall of the insertion section 510 while moving the medical device 10 within the channel 511. Note that in Fig. 6 , the insertion section 510 of the endoscopic device 500 is illustrated by an imaginary line.

[0120] If excessive clearance is formed between the medical device 10 and the inner wall of the insertion section 510 while the medical device 10 is being moved within the channel 511, the medical device 10 is likely to twist or bend. If twisting or bending occurs in the medical device 10, the distal end of the medical device 10 protruding from the insertion section 510 of the endoscopic device 500 will be in a state of protruding from the distal end of the insertion section 510 so as to be separated significantly from the central axis of the channel 511. This causes a radial positional deviation, based on the central axis of the insertion section 510, between the base end of the puncture device 100 located near the proximal side of the endoscopic device 500 (near the insertion port of the endoscopic device 500) and the vicinity of the distal end of the medical device 10 protruding from the insertion section 510 of the endoscopic device 500. If such misalignment occurs, the operability of the medical device 10 will decrease (torque transmission will be insufficient), it will become difficult for the ultrasonic imaging unit 520 to grasp the position of the cutting edge 120 located at the tip of the puncture device 100, and the pushability of the puncture device 100 will decrease, making it impossible to sufficiently transmit the pushing force applied at the base end side of the medical device 10 to the cutting edge 120. As described above, the medical device 10 according to this embodiment can prevent excessive clearance from occurring between the medical device 10 and the inner wall of the insertion section 510, and therefore can preferably prevent the above-mentioned problems from occurring.

[0121] Furthermore, by moving the second connecting portion 330 of the proximal handle portion 300 forward or backward relative to the first connecting portion 320 of the proximal handle portion 300 connected to the outer sheath 200, the medical device 10 can operate to protrude the puncture device 100 from the first lumen 203 (see FIG. 6 ) of the outer sheath 200 and to accommodate the puncture device 100 in the first lumen 203 of the outer sheath 200. This allows the operator to smoothly proceed with a predetermined treatment using the medical device 10 (delivery of the medical device 10 to the target site E or local administration of a medicinal solution to the target site E).

[0122] The outer sheath 200 also has two lumens: a first lumen 203 through which the puncture device 100 can be inserted, and a second lumen 204 located radially outward of the first lumen 203. The outer sheath 200 is configured to have appropriate flexibility by having the two lumens 203, 204. This allows the operator to smoothly deliver the medical device 10 to a desired position in a living body through the channel 511 of the insertion portion 510.

[0123] As shown in Fig. 14 , the operator moves the medical device 10 to the distal end of the endoscopic device 500, thereby causing the puncture needle 110 and the inner sheath 140 to protrude from the insertion section 510 through a distal opening (not shown) of the insertion section 510. As shown in Fig. 16 , the operator moves the puncture device 100 toward the target site E of the pancreas M, with the cutting edge 120 of the puncture needle 110 protruding from the inner sheath 140. At this time, the operator punctures the stomach wall W with the cutting edge 120 of the puncture needle 110 protruding from the inner sheath 140, with the hole 136 covered by the inner sheath 140 (the state shown in Fig. 8 ). By covering the hole 136 with the inner sheath 140 as described above, the operator can prevent biological tissue from entering the hole 136 and blocking (clogging) the hole 136 with biological tissue.

[0124] The cutting edge 120 of the puncture needle 110 is formed with a plurality of blade surfaces 121 and a plurality of ridges 123 located at the boundaries between the plurality of blade surfaces 121. Therefore, by operating the cutting edge 120 so as to push it into the biological tissue, the operator can smoothly insert the cutting edge 120 while cutting open the biological tissue with the plurality of blade surfaces 121 and the plurality of ridges 123.

[0125] The hole 136 of the puncture needle 110 is formed on the side surface of the needle tube portion 130. Therefore, when the cutting edge portion 120 is inserted into biological tissue, it is possible to prevent biological tissue from entering the hole 136 and clogging the hole 136. Therefore, the puncture needle 110 can prevent an increase in the injection resistance of the medicinal solution due to clogging of the hole 136.

[0126] 15 , the operator penetrates the stomach wall W with the cutting edge 120 and the needle tube portion 130, and then advances the cutting edge 120 and the needle tube portion 130 relative to the inner sheath 140, thereby causing the cutting edge 120 and the portion of the needle tube portion 130 where the hole 136 is formed to protrude from the inner sheath 140 (the state shown in FIG. 9 ). By protruding the cutting edge 120 and the needle tube portion 130 from the inner sheath 140 as described above, the operator inserts a certain range on the distal end side of the puncture needle 110 (a certain range including at least the portion proximal to the position where the hole 136 is formed in the needle tube portion 130) into the target site E of the pancreas M.

[0127] 16 , with the hole 136 of the needle tube portion 130 positioned at the target site E, the operator supplies a medicinal solution to the needle tube portion lumen 135 via the first port 351. The operator can locally administer the medicinal solution to the target site E by releasing the medicinal solution supplied to the needle tube portion lumen 135 to the outside of the needle tube portion 130 via the hole 136. Examples of medicinal solutions used in the procedures described here include CAR-T cells, mRNA drugs, anticancer drugs, immune checkpoint inhibitors, etc. The medicinal solution to be administered can be selected arbitrarily depending on the type of procedure using the medical device 10, the biological organ to be used, the disease to be treated, etc.

[0128] The puncture needle 110 has two or more holes 136 formed on the side surface of the needle tube portion 130 (see FIG. 12 ). Therefore, the operator can efficiently administer a medicinal solution to the target site E through the needle tube portion lumen 135 and the two or more holes 136.

[0129] Furthermore, the hole 136 of the puncture needle 110 is disposed on an extension of the ridge line 123 in the axial direction (see FIG. 9 ). The medicinal solution released from the hole 136 travels along the outer surfaces of the needle tube portion 130 and the cutting edge portion 120 in the axial direction, reaching the ridge line 123. The ridge line 123 of the cutting edge portion 120 functions to incise biological tissue when the cutting edge portion 120 is inserted into the biological tissue. Therefore, the medicinal solution that travels from the hole 136 to the ridge line 123 is efficiently diffused along the incision plane formed by the ridge line 123. This allows the operator to administer the medicinal solution to the target site E more efficiently.

[0130] After the administration of the medicinal liquid to the target site E is completed, the operator removes the puncture needle 110 from the pancreas M.

[0131] The operator retracts the puncture needle 110, which has been removed from the pancreas M, into the inner sheath 140, to obtain the state shown in Fig. 7. With the puncture needle 110 retracted into the inner sheath 140, the operator retracts the puncture needle 110 and the inner sheath 140 into the outer sheath 200.

[0132] With the puncture needle 110 and the inner sheath 140 housed in the outer sheath 200, the operator houses the medical device 10 in the insertion section 510 of the endoscopic device 500 and removes it from the living body via the channel 511 of the insertion section 510. After inserting the puncture needle 110 into the target site E, the operator houses the puncture needle 110 in the inner sheath 140 and then removes the medical device 10 from the living body with the inner sheath 140 housed in the outer sheath 200, thereby preventing biological tissue (e.g., biological tissue of a diseased area) adhering to the puncture needle 110 that has been inserted into the target site E from being seeded in the living body.

[0133] By following the above-described procedure, the operator can locally administer a medicinal solution to the target site E using the medical device 10.

[0134] The effects of the puncture needle 110 according to this embodiment will be described below.

[0135] The puncture needle 110 has a needle tube portion 130 with a needle tube portion lumen 135 extending in the axial direction, a plurality of blade surfaces 121 formed at different positions around the axial direction, and a plurality of ridge lines 123 located at the boundaries of each of the plurality of blade surfaces 121, a cutting edge portion 120 arranged on the tip side of the needle tube portion 130, and a hole portion 136 formed on the side of the needle tube portion 130 and connecting the needle tube portion lumen 135 of the needle tube portion 130 to the outside, the hole portion 136 being arranged on the extension of the ridge line 123 in the axial direction, and there are at least two hole portions 136.

[0136] The puncture needle 110 has two or more holes 136 formed on the side surface of the needle tube portion 130, and therefore can efficiently administer a medicinal solution to the target site E through the two or more holes 136. Furthermore, the holes 136 of the puncture needle 110 are arranged on extensions of the ridge lines 123 in the axial direction, and therefore the medicinal solution that has traveled from the holes 136 to the ridge lines 123 can be efficiently diffused along the incision surface formed by the ridge lines 123. Therefore, even when the puncture needle 110 is configured with a reduced diameter, it can efficiently inject a medicinal solution into the target site E and can have high penetration ability into biological tissue.

[0137] Furthermore, in the puncture needle 110, at least on the base end side of the hole 136, the inner wall of the needle tube portion 130, inside which the hole 136 is formed, intersects with the outer surface 130b of the needle tube portion 130 at an obtuse angle.

[0138] As described above, the puncture needle 110 has an inner wall of the needle tube portion 130, on the inside of which the hole 136 is formed, that intersects with the outer surface 130b of the needle tube portion 130 at an obtuse angle at least on the proximal side of the hole 136. This prevents the biological tissue from getting caught on the inner wall around the hole 136 of the needle tube portion 130 when the needle tube portion 130 is inserted into the biological tissue. This more effectively prevents the biological tissue from clogging the hole 136. Furthermore, at least on the proximal side of the hole 136, the medicinal solution that has flowed into the needle tube portion lumen 135 can flow along the inner wall of the needle tube portion 130, thereby reducing injection resistance during administration of the medicinal solution and allowing the medicinal solution to be efficiently released to the outside of the needle tube portion 130 (outside the puncture needle 110) through the hole 136.

[0139] In addition, the hole 136 has a generally rectangular shape in plan view with long sides extending along the axial direction.

[0140] The puncture needle 110 has a hole 136 configured in a substantially rectangular shape with its long side in the axial direction, so that the medicinal solution can be released over a relatively wide range in the axial direction when administering the medicinal solution to the target site E. This reduces the injection resistance when administering the medicinal solution and allows the medicinal solution to be released efficiently.

[0141] The corners 136a of the hole 136 are chamfered.

[0142] Because the corners 136a of the hole 136 of the puncture needle 110 are chamfered, when the medicinal solution is released from the hole 136, the medicinal solution diffuses around the corners 136a. This reduces injection resistance while increasing the amount of medicinal solution administered. Furthermore, when the needle tube portion 130 is inserted into biological tissue, the biological tissue is less likely to get caught on the chamfered corners 136a of the hole 136, which more effectively prevents the hole 136 from becoming clogged with biological tissue.

[0143] Furthermore, a groove 138 extending from the hole 136 toward the ridge line 123 is formed on the outer surface 130 b of the needle tube portion 130 .

[0144] In the puncture needle 110, the medicinal solution released from the hole 136 is guided toward the ridge 123 via the groove 138. Therefore, the puncture needle 110 can diffuse the medicinal solution over a wide area from the periphery of the hole 136 toward the tip side where the ridge 123 is located. Therefore, the puncture needle 110 can administer the medicinal solution to the target site E more efficiently.

[0145] The distal end of the groove 138 extends at least to the boundary position 105 between the cutting edge 120 and the needle tube 130 .

[0146] Since the groove portion 138 of the puncture needle 110 extends to the boundary position 105 between the cutting edge portion 120 and the needle tube portion 130, the medicinal solution released from the hole portion 136 can be more efficiently guided toward the ridge line 123.

[0147] The cutting edge portion 120 has a solid structure and is fixed to the needle tube portion 130 on the distal end side of the needle tube portion 130 .

[0148] The cutting edge portion 120 has a central shaft structure, which can improve the penetrability of the cutting edge portion 120 into biological tissue. Furthermore, the puncture needle 110 is composed of two members, a needle tube portion 130 having a needle tube portion lumen 135 formed therein, and a cutting edge portion 120 having no needle tube portion lumen 135 fixed therein, so different functions can be added to the cutting edge portion 120 and the needle tube portion 130 (the cutting edge portion 120 can be given the function of improving penetration, and the needle tube portion 130 can be given the function of delivering a medicinal solution).

[0149] The cutting edge 120 has ridges 123 the number of which corresponds to the number of holes 136 .

[0150] The puncture needle 110 can guide the medicinal solution from each of the holes 136 toward the corresponding number of ridges 123. Therefore, the puncture needle 110 can administer the medicinal solution to the target site E more efficiently.

[0151] Next, a modified example of the above-described embodiment will be described. In the description of the modified example, the explanation of the already-described components and the procedure for using the puncture needle will be omitted as appropriate. Furthermore, the content of the modified example that is not specifically explained can be the same as the above-described embodiment.

[0152] <Modification> FIG. 18 shows a medical device 10A according to a modification.

[0153] The puncture needle 110 according to this embodiment is not particularly limited in terms of the specific manner of use, etc., as long as it is used for the purpose of administering a medicinal solution to a predetermined target site E. For example, in the above-described embodiment, an example of an apparatus configuration was shown in which the puncture device 100 equipped with the puncture needle 110 can be delivered to a desired position in a living body using a delivery device (endoscopic device 500). However, the puncture device 100 is not limited to one that is intended for use in a procedure that also uses a delivery device.

[0154] A medical device 10A according to a modified example shown in FIG. 18 is configured as a device for percutaneous puncture administration to achieve local administration of a medicinal solution to a predetermined target site E in a living body.

[0155] In a procedure using the medical device 10A of this modified example, an operator can use, for example, a known diagnostic image acquisition device such as a CT scanner instead of the imaging unit of the delivery device to confirm the lesion and the puncture route.

[0156] The medical device 10A is intended for percutaneous puncture, and therefore does not include an outer sheath 200 (see FIG. 1) that can be inserted into the insertion portion 510 of a delivery device such as the endoscopic device 500.

[0157] The medical device 10A includes a proximal handle portion 300A that allows the puncture needle 110 to be protruded from the inner sheath 140 and the puncture needle 110 to be retracted into the inner sheath 140.

[0158] The proximal handle unit 300A includes a rectangular parallelepiped grip portion 350. The grip portion 350 is provided with a knob portion 463 for controlling the axial advancement and retreat of the puncture needle 110. The knob portion 463 is connected to the puncture needle 110 and is configured to slide along a slide hole 413 provided in the grip portion 350. When advancing and retreating the puncture needle 110, the operator can control the movement of the knob portion 463 by grasping the knob portion 463 with the fingers or the like. While the grip portion 350 of this modification is rectangular parallelepiped in shape, its shape is not particularly limited as long as it allows the puncture needle 110 to protrude from and retract into the inner sheath 140. For example, the grip portion 350 may be cylindrical or tapered.

[0159] A first port 351 configured to be fluidically connected to the needle tube lumen 135 of the puncture needle 110 is provided at the proximal end of the gripping portion 350. The first port 351 in this modification is provided at the proximal end of the gripping portion 350, but may be provided on a side surface of the gripping portion 350 closer to the tip than the proximal end, as long as it is configured to be fluidically connected to the needle tube lumen 135 of the puncture needle 110.

[0160] The operator can control the axial movement of the puncture needle 110 by gripping the knob 463 with the fingers or the like and moving it back and forth in the axial direction. In a procedure using the puncture needle 110, the operator can appropriately switch between protruding the puncture needle 110 from the inner sheath 140 and retracting the puncture needle 110 into the inner sheath 140, thereby preferably preventing the biological tissue of the target site E attached to the puncture needle 110 from being seeded in the living body, as in the above-described embodiment.

[0161] A locking mechanism 460 shown in FIG. 19 can be added to the proximal handle portion 300A according to the modified example, as appropriate.

[0162] The locking mechanism 460 can be provided in a predetermined protective sheath 470. The inner sheath 140 can be inserted inside the protective sheath 470. The protective sheath 470 has a first groove 461 and a second groove 462. A knob 463a that is movable along the grooves 461, 462 and connected to the puncture needle 110 is provided near the base end 113 of the puncture needle 110 housed in the inner sheath 140. The locking mechanism 460 is composed of the first groove 461, the second groove 462, and the knob 463a. The protective sheath 470 can be disposed near the base end of the puncture needle 110 disposed in the grip 350.

[0163] The first groove portion 461 extends linearly in the axial direction of the protective sheath 470, and the second groove portion 462 extends in a direction (the circumferential direction of the inner sheath 140) intersecting the first groove portion 461. A plurality of second groove portions 462 are arranged at intervals in the axial direction of the protective sheath 470.

[0164] When the knob 463a is located at the proximal end of the protective sheath 470, the cutting edge 120 is located at a position where it is housed in the inner sheath 140. To maintain a state in which the cutting edge 120 does not protrude from the inner sheath 140, the operator grasps the knob 463 with the fingers or the like and moves the knob 463a into the second groove 462 to establish a locked state. By establishing the locked state, the knob 463a can be restricted from moving in the axial direction along the first groove 461. Therefore, the operator can prevent the cutting edge 120 from inadvertently protruding from the inner sheath 140.

[0165] When the operator causes the cutting edge 120 to protrude from the inner sheath 140, the operator grasps the knob 463a with the fingers or the like and moves the knob 463a, which is in the locked state, from the second groove 462 to the first groove 461. By further moving the knob 463a along the first groove 461, the operator can move the puncture needle 110 in the axial direction in conjunction with the knob 463a.

[0166] A plurality of second grooves 462 are arranged at intervals in the axial direction in the protective sheath 470. Therefore, the operator can adjust the length by which the cutting edge 120 protrudes from the inner sheath 140 in multiple stages by using any of the second grooves 462 to enter a locked state.

[0167] In the above example, a configuration in which the locking mechanism 460 controls the axial movement of the puncture needle 110 was illustrated, but it is also possible to add a mechanism for controlling the axial movement of the puncture needle 110 and / or the inner sheath 140 to the medical device 10, for example, by incorporating a similar configuration into the medical device 10 of the above-mentioned embodiment (see Figure 1).

[0168] The medical device of the present invention has been described above through embodiments and modifications, but the present invention is not limited to the configurations described in the embodiments and modifications, and can be modified as appropriate based on the claims.

[0169] This application is based on Japanese Patent Application No. 2023-170000, filed on September 29, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0170] DESCRIPTION OF SYMBOLS 10 Medical device 10A Medical device 100 Puncture device 105 Boundary position 110 Puncture needle 113 Base end of puncture needle 120 Cutting edge 121 Blade surface 123 Ridge line 125 Cylindrical portion 130 Needle tube portion 130a Inner wall of needle tube portion 130b Outer surface of needle tube portion 135 Needle tube portion lumen 136 Hole portion 136a Corner portion of hole portion 138 Groove portion 140 Inner sheath 200 Outer sheath 210 Inner tube 220 Outer tube 250 Fixing member 300 Proximal handle portion 460 Locking mechanism 500 Endoscopic device (delivery device) 510 Insertion section 511 Channel 520 Ultrasound imaging section C1 Central axis of inner sheath C2 Central axis of outer sheath C3 Central axis of the needle g Clearance E Target site M Pancreas W Stomach wall

Claims

1. A puncture needle comprising: a needle tube portion having a needle tube portion lumen extending in the axial direction; a blade tip portion arranged at the tip side of the needle tube portion, the blade tip portion having a plurality of blade faces formed at different positions around the axial direction and a plurality of ridge lines located at the boundaries between the plurality of blade faces; and a hole portion formed on a side surface of the needle tube portion and connecting the needle tube portion lumen of the needle tube portion to the outside, the hole portion being arranged on an extension of the ridge line in the axial direction, and there are two or more holes.

2. The puncture needle according to claim 1, characterized in that, at least on the base end side of the hole, the inner wall of the needle tube portion on the inside of which the hole is formed intersects with the outer surface of the needle tube portion at an obtuse angle.

3. The puncture needle according to claim 1, characterized in that the hole has a generally rectangular shape in a plan view with its long sides extending along the axial direction.

4. The puncture needle according to claim 3, characterized in that the corners of the hole are chamfered.

5. The puncture needle according to claim 1, characterized in that a groove extending from said hole toward said ridge line is formed on the outer surface of said needle tube portion.

6. The puncture needle according to claim 5, wherein the tip end of said groove portion extends at least to the boundary between said cutting edge portion and said needle tube portion.

7. The puncture needle according to claim 1, characterized in that the cutting edge portion has a solid structure and is fixed to the needle tube portion on the tip side of the needle tube portion.

8. The puncture needle according to claim 1, wherein said cutting edge portion has a number of ridges corresponding to the number of said holes.

Images