Medical device

Abstract

[Problem] To provide a medical device that can prevent an excessive clearance with an inner wall of a delivery device from being formed when delivering a puncture device to a target site in a living body, and makes it possible to easily and smoothly project the puncture device from a first lumen of an outer sheath and accommodate the puncture device inside the first lumen of the outer sheath by manipulating the forward / backward movement of a handle part. [Solution] This medical device 10 is configured to be inserted into a channel 511 of an insertion part 510 of an endoscope device 500 so as to be capable of moving forward and backward. The medical device includes: a puncture device 100; an outer sheath 200 into which the puncture device is inserted; and a handle part 300 disposed on the proximal end side of the puncture device and the outer sheath. The handle part includes: a first connection part 320 connected to the outer sheath; and a second connection part 330 that is connected to at least a portion of the puncture device and moves forward and backward relative to the first connection part, thereby projecting the tip of the puncture device from the tip of the outer sheath.

Description

medical devices

[0001] The present invention relates to medical devices.

[0002] BACKGROUND ART In the medical field, development of medical devices used for puncturing biological tissue and administering a liquid drug to a target site in a living body is underway.

[0003] In the development of such medical devices, various innovations have been attempted to realize more efficient procedures. One such approach, for example, is to adopt a structure similar to that of a conventional biopsy needle in order to ensure the ability to puncture biological tissue. However, biopsy needles tend to have a large outer diameter in order to achieve their original purpose of extracting tissue samples. Therefore, if a structure similar to that of a biopsy needle is adopted for the above medical devices, issues arise, such as an increased risk of bleeding and leakage during drug administration.

[0004] One possible solution to this problem is to configure the device with a smaller outer diameter than that of a typical biopsy needle. However, if the device outer diameter is made smaller, excessive clearance may occur between the narrow-diameter medical device and the inner wall of the delivery device when performing a procedure using a delivery device such as an endoscopic device. This excessive clearance, combined with the relatively long lengths of the delivery device and medical device, can cause the medical device to twist or bend as it navigates through numerous bends within the body. Furthermore, this twisting or bending of the medical device can result in radial misalignment between the proximal end (handle end) of the medical device and the distal end (cutting edge) of the medical device relative to the central axis of the lumen (channel) of the delivery device. As a result, problems arise such as the position of the tip of the medical device being difficult to grasp from diagnostic images (e.g., ultrasound images obtained by an ultrasound endoscope), reduced operability of the medical device (insufficient torque transmission), and reduced pushability of the medical device, making it impossible to fully transmit the pushing force applied at the base end to the tip end.

[0005] In relation to the above-mentioned problems, Patent Document 1 below discloses a multi-lumen drug solution administration device that includes a flexible catheter body that is inserted into a living body, a needle portion that can move back and forth within the lumen of the catheter body, and a connector portion that is located at the base end of the catheter body and is connected to the needle portion.

[0006] In the procedure using the drug solution administration device of Patent Document 1, after the catheter body is delivered to the periphery of a target site in a living body, the needle portion is protruded toward the living tissue through a hole (side hole) provided in the catheter body. After the needle portion is inserted into the living tissue, the operator (a medical professional such as a doctor) administers the drug solution to the target site by operating a syringe connected to the connector portion.

[0007] JP 2004-329487 A

[0008] In the drug solution administration device of Patent Document 1, the catheter body that houses the needle portion has an outer diameter larger than that of the needle portion. Therefore, it is thought that various problems caused by excessive clearance between the medical device and the inner wall of the delivery device can be prevented. However, the drug solution administration device of Patent Document 1 has the following concerns.

[0009] In the procedure using the drug solution administration device of Patent Document 1, as described above, the needle portion is delivered to a predetermined position in the living body via the long catheter body, and then the needle portion is protruded toward the target site. Therefore, after delivering the needle portion together with the catheter body to the vicinity of the target site, the operator must appropriately and precisely control the advancement and retraction of the needle portion.

[0010] In procedures involving puncturing biological tissue with a needle, it is desirable to insert and remove the needle as quickly and smoothly as possible, taking into consideration the burden on the patient. However, the medical device of Patent Document 1 does not particularly consider a structure or device for advancing and retracting the needle within the lumen of the catheter body. For example, in procedures using the drug solution administration device of Patent Document 1, when inserting or removing the needle into or from biological tissue, the operator must directly grasp the proximal end of the needle, which extends from the connector disposed outside the living body, with their fingers or the like, and move the entire needle along with the proximal end of the needle. Therefore, in procedures using the medical device of Patent Document 1, it is not easy to insert and remove the needle smoothly into or from biological tissue.

[0011] The present invention has been made in consideration of the above-mentioned problems, and aims to provide a medical device that can prevent excessive clearance from being formed between the inner wall of a delivery device when delivering a puncture device to a target site in a living body, and that can easily and smoothly protrude the puncture device from the first lumen of the outer sheath and store the puncture device in the first lumen of the outer sheath by operating the forward and backward movement of the handle at the hand.

[0012] The present invention can be achieved by any one of the following means (1) to (9).

[0013] (1) A medical device that is inserted into a delivery device so as to be able to move back and forth, comprising: a puncture device; an outer sheath through which the puncture device is inserted; and a proximal handle portion arranged on the proximal end side of the puncture device and the outer sheath, wherein the outer sheath has a first surface that defines a first lumen inside through which the puncture device can be inserted; and a second surface that defines at least one second lumen between the first surface and the outer sheath, and the proximal handle portion has a first connecting portion connected to the outer sheath; and a second connecting portion that is connected to at least a part of the puncture device and moves back and forth relative to the first connecting portion, thereby causing the tip of the puncture device to protrude from the tip of the outer sheath.

[0014] (2) The medical device described in (1) above, characterized in that the puncture device has a puncture needle having a cutting edge portion and a needle tube portion, and an inner sheath having a third lumen into which the puncture needle is inserted so as to be able to move back and forth.

[0015] (3) The medical device described in (2) above, characterized in that the inner sheath is connected to the proximal handle portion at the second connection portion, at least a portion of the proximal handle portion is located closer to the base end than the second connection portion, and further has a third connection portion to which the base end of the puncture needle is connected and which moves back and forth relative to the second connection portion, causing the cutting edge portion to protrude from the tip of the inner sheath.

[0016] (4) A medical device described in any one of (1) to (3) above, characterized in that the puncture needle has a puncture lumen that enables fluid to be delivered to the tip side.

[0017] (5) A medical device as described in (4) above, characterized in that it has a first port arranged to communicate with the puncture lumen through the third connection portion of the hand handle portion, enabling fluid to be supplied into the puncture lumen.

[0018] (6) A medical device described in any one of (1) to (5) above, characterized in that the first connection portion has a second port arranged to communicate with the inside of the first lumen of the outer sheath and enabling fluid communication between the inside and outside of the first lumen.

[0019] (7) A medical device described in any one of (1) to (6) above, characterized in that the outer sheath has an inner tube having the first surface and the first lumen, an outer tube having the second surface and the second lumen, and a fixing member disposed between the inner tube and the outer tube and fixing the inner tube and the outer tube.

[0020] (8) The medical device described in (7) above, characterized in that the inner tube and the outer tube are concentrically arranged by the fixing member.

[0021] (9) The medical device described in (8) above, characterized in that the fixing member extends spirally around the central axis of the inner tube and the outer tube.

[0022] The medical device described in (1) above can prevent excessive clearance from being formed between the puncture device and the inner wall of the delivery device when delivering the puncture device to a target site in a living body. Furthermore, the medical device described in (1) above can easily and smoothly protrude the puncture device from the first lumen of the outer sheath and retract the puncture device into the first lumen of the outer sheath by operating the forward and backward movement of the proximal handle.

[0023] 20A is a perspective view of a medical device according to an embodiment; FIG. 20B is a perspective view of a medical device according to an embodiment; FIG. 20C is a partial cross-sectional view of a medical device according to an embodiment; FIG. 20D is a partial cross-sectional view of a medical device according to an embodiment; FIG. 20E is a partial cross-sectional view of a medical device according to an embodiment; FIG. 20F is a partial cross-sectional view of a medical device according to an embodiment; FIG. 20G is a partial cross-sectional view of a medical device according to an embodiment; FIG. 11 is a partial cross-sectional view along the axial direction of a medical device according to Modification 3.

[0024] 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.

[0025] Figures 1 to 6 are figures showing the overall configuration of a medical device 10 according to an embodiment, Figures 7 to 13 are figures for explaining a puncture device 100 according to an embodiment, and Figures 14 to 18 are figures for explaining a procedure using the medical device 10.

[0026] 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.

[0027] (Medical Device 10) As shown in Figs. 14 to 18, the medical device 10 is configured as a medical device that is inserted into a delivery device so as to be able to advance and retract.

[0028] 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.

[0029] As shown in Figures 1 to 3, the medical device 10 has a puncture device 100, 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.

[0030] 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.

[0031] (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.

[0032] 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 3A-3A in Fig. 3.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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).

[0037] 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.

[0038] 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°.

[0039] Note that there are no particular limitations on the number, arrangement, cross-sectional shape (cross-sectional shape shown in FIG. 6 ) and the like of the fixing members 250, as long as they function to fix the inner tube 210 and the outer tube 220. For example, as shown in a modified example described later, the fixing member can be configured as a single member that extends spirally in the axial direction (see FIGS. 20 and 21 ).

[0040] 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 .

[0041] 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.

[0042] 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, polyether ether ketone, polyimide, 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.

[0043] 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.

[0044] (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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] As shown in FIGS. 10 and 11, the puncture needle 110 has a puncture lumen 135 that allows fluid to be delivered to the distal side.

[0052] In this embodiment, the puncture lumen 135 of the puncture needle 110 is formed only in the needle tube portion 130. The cutting edge portion 120 of the puncture needle 110 has a solid structure in which the puncture lumen 135 is not formed inside.

[0053] As shown in FIG. 3 , the puncture needle 110 has a proximal end opening (not shown) formed at the proximal end 113. 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 puncture 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 puncture lumen 135 via a hole 136, which will be described later. That is, the drug solution may flow into the puncture lumen 135 via the hole 136 by connecting a suction-capable instrument 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).

[0054] 10 and 11 , the puncture lumen 135 is connected to a hole 136 formed near the distal end of the needle tube portion 130. The medicinal solution that has flowed into the puncture lumen 135 moves axially toward the distal end along the puncture lumen 135, and when it reaches near the distal end of the needle tube portion 130, it is released to the outside of the needle tube portion 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 portion 120 and the needle tube portion 130 are housed in the third lumen 143 of the inner sheath 140.

[0055] In a procedure using the medical device 10, as shown in Figure 9, by supplying a medicinal liquid to the puncture lumen 135 with the hole 136 formed in the needle tube portion 130 protruding from the inner sheath 140 (with the hole 136 not covered by the inner sheath 140), the medicinal liquid can be locally administered to the target site E (see Figure 17) through the hole 136.

[0056] As shown in FIGS. 10 and 11, in this embodiment, the puncture needle 110 is made up of two members: a cutting edge portion 120 and a needle tube portion 130.

[0057] 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 tip end of the needle tube portion 130.

[0058] 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.

[0059] As shown in FIG. 13 , the cutting edge 120 has four cutting surfaces 121 and four ridges 123 located at the boundaries between the cutting surfaces 121 .

[0060] There are no particular limitations on the specific structure of the cutting edge portion 120 (e.g., the number and shape of the cutting surfaces 121, the number and shape of the ridges 123, etc.). For example, the cutting edge portion 120 may have a hollow structure in which a lumen is formed to allow a medicinal solution to flow inside the cutting edge portion 120, or may have a tip opening that allows the medicinal solution to be released from the tip of the cutting edge portion 120. Furthermore, the cutting edge portion 120 and the needle tube portion 130 may be configured as an integrated single member.

[0061] The hole 136 formed in the needle tube portion 130 may be formed, for example, in a substantially circular shape in the plan view shown in Fig. 12. Furthermore, for example, four holes 136 may be provided at different positions in the circumferential direction based on the central axis C3 of the puncture needle 110, spaced apart by equal angles (approximately 90°), as shown in Fig. 13. However, there are no particular limitations on the shape and number of the holes 136, the positions at which the holes 136 are arranged in the needle tube portion 130, etc.

[0062] 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.

[0063] (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.

[0064] 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 .

[0065] 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.

[0066] The distal connection portion 310 includes a lumen 313 through which the outer sheath 200 and the puncture device 100 are inserted.

[0067] 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.

[0068] 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 .

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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 .

[0075] In the medical device 10, when the first convex portion 315 is fitted into the first concave portion 327, axial movement of the distal connecting 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 connecting portion 310 and the first connecting portion 320 can be held in a predetermined initial position. Note that, in this embodiment, the first convex portion 315 is provided on the distal connecting 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 connecting portion 310 axially closer to the base end than the first convex portion 315.

[0076] The first recess 327 and the first protrusion 315 are preferably 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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 .

[0081] 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. Note that in this embodiment, the second protrusion 325 is provided on the first connecting portion 320 closer to the base end in the axial direction than the large diameter portion 326, but the large diameter portion 326 may be provided on the first connecting portion 320 closer to the base end in the axial direction than the second protrusion 325.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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 bending 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.

[0090] 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.

[0091] 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.

[0092] It is preferable that the tip 354 of the gripping portion 350 be made of a resin material or a metal material that is hard enough to prevent damage to the gripping portion 350 when it comes into contact with the third stopper 380.

[0093] As shown in FIG. 3, the medical device 10 has a first port 351 that is arranged to communicate with the puncture lumen 135 via the third connection portion 340 of the proximal handle portion 300 and enables fluid to be supplied into the puncture lumen 135.

[0094] 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.

[0095] <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.

[0096] The following describes a procedure for administering a medicinal solution to a target site E (e.g., a specific region containing biological tissue in which cancer cells are present) of the pancreas M using the medical device 10. Here, as shown in Fig. 14 , 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.

[0097] 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.

[0098] The operator connects a medicinal solution supplying tool to the first port 351 (see FIG. 3 ) and primes the medical device 10 by feeding medicinal solution into the proximal handle portion 300 .

[0099] 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 .

[0100] 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).

[0101] 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.

[0102] 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.

[0103] 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).

[0104] 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.

[0105] 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. 15 , 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.

[0106] 16 , 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.

[0107] 17 , with the hole 136 of the needle tube portion 130 positioned at the target site E, the operator supplies a medicinal liquid to the puncture lumen 135 via the first port 351. The operator can locally administer the medicinal liquid to the target site E by releasing the medicinal liquid supplied to the puncture lumen 135 to the outside of the needle tube portion 130 via the hole 136. Examples of medicinal liquids used in the procedures described here include CAR-T cells, mRNA drugs, anticancer drugs, immune checkpoint inhibitors, etc. The medicinal liquid 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] By following the above-described procedure, the operator can locally administer a medicinal solution to the target site E using the medical device 10.

[0112] The effects of the medical device 10 according to this embodiment will be described below.

[0113] The medical device 10 is configured as a medical device that is movably inserted into a channel 511 of an insertion section 510 of an endoscopic device 500. The medical device 10 has a puncture device 100, an outer sheath 200 through which the puncture device 100 is inserted, and a proximal handle section 300 that is arranged on the proximal end side of the puncture device 100 and the outer sheath 200. The outer sheath 200 has a first surface 201a that defines a first lumen 203 therein through which the puncture device 100 can be inserted, and a second surface 201b that defines at least one second lumen 204 between the first surface 201a and the second surface 201b. The proximal handle portion 300 has a first connection portion 320 connected to the outer sheath 200, and a second connection portion 330 connected to at least a part of the puncture device 100 and moving back and forth relative to the first connection portion 320, thereby causing the tip of the puncture device 100 to protrude from the tip of the outer sheath 200.

[0114] The medical device 10 configured as described above can prevent excessive clearance from being formed between the puncture device 100 and the inner wall of the endoscopic device 500 (the inner wall of the insertion section 510) when delivering the puncture device 100 to the target site E in a living body. Furthermore, the medical device 10 can easily and smoothly protrude the puncture device 100 from the first lumen 203 of the outer sheath 200 and retract the puncture device 100 into the first lumen 203 of the outer sheath 200 by operating the forward and backward movement of the proximal handle section 300.

[0115] The puncture device 100 also 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 advance and retract.

[0116] The puncture device 100 can accommodate the cutting edge 120 of the puncture needle 110 that has punctured the biological tissue in the third lumen 143 of the inner sheath 140. Therefore, when the puncture device 100 is removed from the living body, the biological tissue of the target site E (e.g., the biological tissue of a diseased area) that has adhered to the puncture needle 110 can be prevented from being seeded in the living body.

[0117] In addition, the inner sheath 140 is connected to the proximal handle portion 300 at the second connection portion 330, and at least a portion of the proximal handle portion 300 is located closer to the base end than the second connection portion 330, and has a third connection portion 340 to which the base end portion 113 of the puncture needle 110 is connected and which moves back and forth relative to the second connection portion 330, causing the cutting edge portion 120 to protrude from the tip of the inner sheath 140.

[0118] The puncture device 100 can easily and smoothly protrude the inner sheath 140 from the outer sheath 200 and retract the inner sheath 140 into the outer sheath 200 by advancing and retracting the second connecting part 330 to which the inner sheath 140 is connected. Furthermore, the puncture device 100 can easily and smoothly protrude the puncture needle 110 from the inner sheath 140 and retract the puncture needle 110 into the inner sheath 140 by advancing and retracting the third connecting part 340 to which the puncture needle 110 is connected.

[0119] The needle 110 also has a lumen 135 that allows fluid to be delivered to the distal end.

[0120] The medical device 10 has a puncture lumen 135 formed in the puncture needle 110, and therefore can be suitably used in procedures for locally administering a medicinal solution to a target site E.

[0121] The medical device 10 also has a first port 351 that is arranged to communicate with the puncture lumen 135 via the third connection portion 340 of the proximal handle portion 300 and that allows fluid to be supplied into the puncture lumen 135.

[0122] The operator can supply various fluids (e.g., a medicinal solution to be administered to the target site E) to the puncture lumen 135 via the first port 351. Therefore, the operator can use the medical device 10 to perform a procedure of locally administering the medicinal solution to the target site E.

[0123] The outer sheath 200 also 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 to fix the inner tube 210 and the outer tube 220.

[0124] The medical device 10 has a multi-tube structure in which the outer sheath 200 is made up of multiple tubular members including the inner tube 210 and the outer tube 220, thereby improving the kink resistance and breakage resistance of the outer sheath 200. Furthermore, a second lumen 204 in the form of a space partitioned by the fixing member 250 is formed between the inner tube 210 and the outer tube 220, which prevents the outer sheath 200 from becoming excessively rigid and allows the outer sheath 200 to have appropriate flexibility.

[0125] The inner tube 210 and the outer tube 220 are concentrically arranged by a fixing member 250 .

[0126] Because the inner tube 210 and the outer tube 220 of the outer sheath 200 are concentrically arranged by the fixing member 250, the kink resistance and breakage resistance of the outer sheath 200 can be uniformly enhanced in the circumferential direction of the outer sheath 200. This more reliably prevents the outer sheath 200 from being damaged while the medical device 10 is being moved within the channel 511 of the insertion section 510 of the endoscopic device 500. Furthermore, because the second lumen 204 is divided into sections of uniform size in the circumferential direction of the outer sheath 200, the flexibility of the second lumen 204 can be made uniform throughout the circumferential direction. This allows the outer sheath 200 to deform so as to conform to bending portions within a living body, thereby improving the operability of the medical device 10.

[0127] Next, a modified example of the above-described embodiment will be described. In the description of the modified example, the explanation of the already explained components and the procedure for using the medical device 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.

[0128] <Modification 1> Fig. 19 shows a medical device 10A according to Modification 1. Fig. 19 is a partial cross-sectional view along the axial direction of the medical device 10A corresponding to Fig. 3 shown in the above-described embodiment.

[0129] As shown in FIG. 19 , in the medical device 10A according to the first modification, the first connection portion 320 is arranged to communicate with the inside of the first lumen 203 (see FIG. 6 ) of the outer sheath 200, and has a second port 410 that enables fluid communication between the inside and outside of the first lumen 203.

[0130] The second port 410 can be configured, for example, by a connector portion that is connected to a predetermined tube 420 in a liquid-tight and air-tight manner.

[0131] Each of the first connecting portion 320 and the second connecting portion 330 may be provided with holes 411, 413 to prevent interference with the tube 420 when the first connecting portion 320 and the second connecting portion 330 move axially.

[0132] In a procedure using the medical device 10, an operator can connect the second port 410 to a predetermined fluidic device 430 (e.g., a suction pump capable of generating negative pressure) via the tube 420. When inserting the puncture needle 110 into biological tissue (see FIGS. 15 and 16 ), the operator can fix the distal end of the outer sheath 200 to the biological organ to be punctured by operating the fluidic device 430 to generate negative pressure in the first lumen 203. With the distal end of the outer sheath 200 fixed to the biological organ to be punctured, the operator can protrude the puncture needle 110 from the outer sheath 200, thereby enabling the cutting edge 120 of the puncture needle 110 to more reliably puncture the desired puncture position.

[0133] The second port 410 may be arranged to provide fluid communication between the inside and outside of the first lumen 203 and the inside and outside of the second lumen 204. By generating negative pressure in the second lumen 204, the operator can fix the tip portion 354 of the outer sheath 200 to the biological organ or the like to be punctured, in the same way as when negative pressure is generated in the first lumen 203.

[0134] <Modification 2> Fig. 20 shows a perspective view of an outer sheath 200A according to Modification 2. Fig. 21 is an orthogonal cross-sectional view of the outer sheath 200A taken along arrows 21A-21A shown in Fig. 20 .

[0135] As shown in FIGS. 20 and 21, the fixing member 450 can be configured to have a shape that extends spirally around the central axes C1 and C2 of the inner tube 210 and outer tube 220 of the outer sheath 200A.

[0136] 21, the cross-sectional shape of the fixing member 450 is, for example, circular. However, there are no particular limitations on the cross-sectional shape of the fixing member 450, and it may be, for example, rectangular, elliptical, or other shapes.

[0137] As in the above-described embodiment, the fixing member 450 is preferably made of a relatively soft resin material from the viewpoint of preventing the outer sheath 200 from becoming excessively rigid.

[0138] The fixing member 450 may be formed of, for example, one member or two or more members. There are also no particular limitations on the spiral shape of the fixing member 450 (such as the width of the gap in the axial direction).

[0139] In the outer sheath 200A according to Modification 2, the fixing member 450 extends spirally around the central axes C1, C2 of the inner tube 210 and the outer tube 220, thereby making the rigidity of the outer sheath 200A uniform at each axial portion. Furthermore, as shown in Fig. 21 , the area where the fixing member 450 exists between the inner tube 210 and the outer tube 220 (the area occupied on a cross section perpendicular to the axis) is small at each axial portion of the outer sheath 200A, improving the flexibility of the outer sheath 200A. Therefore, the outer sheath 200A has even better ability to follow curved portions and the like within a living body.

[0140] <Modification 3> Fig. 22 shows a medical device 10B according to Modification 3. Fig. 22 is a partial cross-sectional view along the axial direction of the medical device 10B corresponding to Fig. 3 shown in the above-described embodiment.

[0141] 22 , the third connecting part 340 can be configured to be movable forward and backward along a slide hole 355 formed in the gripping part 350. By moving forward and backward along the slide hole 355, the third connecting part 340 can move forward and backward along the extension direction of the gripping part 350, which is the same direction as the axial direction of the medical device 10B. The puncture needle 110 connected to the third connecting part 340 moves in the axial direction of the medical device 10B in conjunction with the movement of the gripping part 350.

[0142] A first port 351, which is arranged so that a portion of it protrudes, can be connected to the third connection part 340 through a slide hole 355. The operator can move the third connection part 340 and the puncture needle 110 back and forth by gripping and operating the first port 351 with the fingers or the like.

[0143] 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.

[0144] The medical device may be configured as a device intended only for puncturing biological tissue. In such a configuration, the puncture needle may not have a puncture lumen, and the proximal handle may not have a first port.

[0145] The outer sheath does not have to be composed of two tubes (an inner tube and an outer tube). In other words, the outer sheath can be composed of a single hollow member with a first lumen and a second lumen formed therein. When the outer sheath is configured in this manner, the installation of the fixing member can be omitted.

[0146] 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 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 is inserted so as to be movable back and forth.

[0147] There are no particular limitations on the content of the procedure to which the medical device is applied, or on the biological organs, diseases, etc. to which it is applied, and it is not limited to the content explained in the specification.

[0148] This application is based on Japanese Patent Application No. 2023-169994, filed on September 29, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0149] 10 Medical device 10A Medical device 10B Medical device 100 Puncture device 110 Puncture needle 120 Cutting edge portion 121 Blade surface 123 Ridge line 130 Needle tube portion 135 Puncture lumen 136 Hole portion 140 Inner sheath 143 Third lumen 200 Outer sheath 200A Outer sheath 201a First surface 201b Second surface 203 First lumen 204 Second lumen 210 Inner tube 220 Outer tube 250 Fixing member 300 Proximal handle portion 310 Tip side connecting portion 320 First connecting portion 330 Second connecting portion 350 Grip portion 351 First port 360 First stopper 370 Second stopper 380 Third stopper 410 Second port 450 Fixing member 460 Locking mechanism 470 Protective sheath 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 puncture needle g Clearance E Target site M Pancreas W Gastric wall

Claims

1. A medical device that is movably inserted into a delivery device, comprising: a puncture device; an outer sheath through which the puncture device is inserted; and a proximal handle portion arranged on the base end side of the puncture device and the outer sheath, wherein the outer sheath has a first surface that defines a first lumen on the inside through which the puncture device can be inserted, and a second surface that defines at least one second lumen between the first surface and the second surface, and the proximal handle portion has a first connecting portion connected to the outer sheath, and a second connecting portion connected to at least a part of the puncture device and that moves forward and backward relative to the first connecting portion, causing the tip of the puncture device to protrude from the tip of the outer sheath.

2. The medical device according to claim 1, characterized in that the puncture device comprises a puncture needle having a cutting edge portion and a needle tube portion, and an inner sheath having a third lumen into which the puncture needle is inserted so as to be movable forward and backward.

3. The medical device of claim 2, characterized in that the inner sheath is connected to the proximal handle portion at the second connection portion, at least a portion of the proximal handle portion is located on the base end side of the second connection portion, and further has a third connection portion to which the base end of the puncture needle is connected and which moves forward and backward relative to the second connection portion, causing the cutting edge portion to protrude from the tip of the inner sheath.

4. The medical device according to claim 3, wherein the puncture needle has a puncture lumen that enables fluid to be delivered to the tip side.

5. The medical device of claim 4, characterized in that it has a first port arranged to communicate with the puncture lumen via the third connection portion of the hand handle portion and capable of supplying fluid into the puncture lumen.

6. The medical device of claim 1, characterized in that the first connection portion has a second port arranged to communicate with the inside of the first lumen of the outer sheath and enabling fluid communication between the inside and outside of the first lumen.

7. The medical device of claim 1, characterized in that the outer sheath comprises: an inner tube having the first surface and the first lumen; an outer tube having the second surface and the second lumen; and a fixing member disposed between the inner tube and the outer tube for fixing the inner tube and the outer tube.

8. The medical device according to claim 7, wherein the inner tube and the outer tube are concentrically arranged by the fixing member.

9. The medical device according to claim 8, wherein the fixing member extends helically around the central axis of the inner tube and the outer tube.

Images