Medical device

Abstract

Provided is a medical device comprising a handle part capable of linearly moving a puncture part by a simple operation.　This medical device (100) includes: a puncture part (110) that can puncture biological tissue; a syringe (120) connected to the proximal end side of the puncture part; and a handle part (130) that is disposed so as to cover the proximal end side of the puncture part and the proximal end side of the syringe. The handle part comprises: a first handle part (140) having a first internal space (145) and a first connection part (146) which is provided on the proximal end side of the first internal space and to which the syringe (120) is fixed; and a second handle part (150) which is disposed on the distal end side of the first handle part and has a second internal space (155). The first handle part and the second handle part can move forward and backward relative to each other in a central axis direction, and the puncture part and the syringe can move forward and backward in the central axis direction in the second internal space in conjunction with the relative forward and backward movement of the first handle part and the second handle part in the central axis direction.

Description

medical devices

[0001] The present invention relates to medical devices.

[0002] BACKGROUND ART In the medical field, development is underway of medical devices equipped with a puncture section (needle tube) that enables administration of a substance to be administered to a diseased area such as a tumor present in a living body.

[0003] In a procedure using a medical device equipped with a puncture part as described above, a syringe holding an administration substance such as a medicinal solution is used. For example, Patent Document 1 listed below discloses a medical device in which a syringe is integrally connected to a handle portion located on the proximal side where a medical professional such as a surgeon (hereinafter referred to as "the surgeon") operates the device. The puncture part is attached so as to be in fluid communication with the syringe via the internal space of the handle portion.

[0004] In the procedure using the medical device of Patent Document 1, the surgeon grasps the handle with fingers or the like outside the living body and moves the entire medical device toward a predetermined biological organ inside the patient's living body, thereby puncturing the puncture part into the target site of the biological organ. With the puncture part punctured into the target site, the surgeon can administer the administration object to the target site by operating the syringe.

[0005] US Patent Application Publication No. 2010 / 0185156

[0006] In a procedure using a medical device with a puncture portion, a "percutaneous approach" is sometimes performed, in which the inside of the living body is accessed from outside the living body and the puncture portion is moved toward the target site. In such a procedure, the surgeon is required to properly and quickly insert the puncture portion into the target site and remove the puncture portion from the living body.

[0007] For example, if it were possible to control the puncture part so that it moves linearly when moving it inside a living body or when inserting it into a target site, it would be possible to smoothly perform the procedure. Based on this knowledge, the inventors of the present invention have invented a medical device that is easier to operate than conventional devices.

[0008] An object of the present invention is to provide a medical device having a handle portion at hand that allows the puncture portion to be moved linearly with a simple operation.

[0009] The present invention is achieved by any one of the following means (1) to (10).

[0010] (1) A medical device comprising: a puncturing section capable of puncturing biological tissue; a syringe connected to a base end side of the puncturing section; and a proximal handle section arranged to cover the base end side of the puncturing section and the base end side of the syringe, wherein the proximal handle section comprises: a first proximal handle section having a first internal space and a first connection section provided on the base end side of the first internal space and to which the syringe is fixed; and a second proximal handle section arranged on the distal end side of the first proximal handle section and having a second internal space, wherein each of the first proximal handle section and the second proximal handle section is movable forward and backward relative to each other in a central axis direction, and wherein the puncturing section and the syringe are movable forward and backward in the second internal space in conjunction with the relative forward and backward movement of the first proximal handle section and the second proximal handle section in the central axis direction.

[0011] (2) The medical device according to (1), further comprising an inner sheath having a lumen through which the puncture portion can be inserted, and the second proximal handle portion has a second connecting portion to which the inner sheath is connected.

[0012] (3) The medical device according to (2), wherein the second handle portion has: a first locking mechanism that can fix and release the first handle portion and the second handle portion and determine the length of protrusion of the puncture portion from the inner sheath; and a first scale that allows the length of protrusion to be confirmed.

[0013] (4) The medical device according to (2) or (3), further comprising a support sheath that covers the puncture portion and the inner sheath at a position distal to the first connection portion.

[0014] (5) The medical device according to (4), wherein the second proximal handle portion has a third connection portion to which the support sheath is connected, and the third connection portion is configured to be movable back and forth in the central axis direction, and by moving back and forth, the length of the support sheath covering the puncture portion and the inner sheath can be determined.

[0015] (6) The medical device according to (5), wherein the second proximal handle portion has a second locking mechanism that enables the length of the support sheath to be fixed, and a second scale that enables the length of the support sheath to be confirmed.

[0016] (7) The medical device according to (6), wherein the second proximal handle portion has an adjustment mechanism that allows the third connection portion to be moved at regular intervals in accordance with the second scale.

[0017] (8) The medical device according to any one of (1) to (7), wherein the first proximal handle portion has: a third scale indicating the amount of fluid in the syringe; and a window portion that makes the syringe visible from the outside.

[0018] (9) The medical device according to any one of (1) to (8), wherein the puncture portion and the syringe are integrally connected, and the inner surface of the connection portion at the tip end side of the syringe that is connected to the base end side of the puncture portion has a tapered shape.

[0019] (10) The medical device according to (2), wherein the second proximal handle portion has an auxiliary support sheath that covers the puncture portion at a position closer to the base end than the second connecting portion.

[0020] According to the medical device described in (1) above, when the surgeon moves the first handle portion back and forth along the central axis, the movement of the first handle portion can be guided by the second handle portion. Therefore, by moving the first handle portion back and forth along the extension direction of the second handle portion, the surgeon can linearly move the syringe connected to the first handle portion and the puncture portion connected to the syringe. By linearly moving the puncture portion, the surgeon can properly and quickly puncture the target site of the biological organ with the puncture portion.

[0021] 1 is a diagram (side view) showing a medical device according to an embodiment. FIG. 3 is a partial cross-sectional view in the coaxial direction of the medical device. FIG. 4 is an enlarged view of portion 3A of FIG. 1. FIG. 5 is an enlarged perspective view of the distal end of the puncture portion and the distal end of the inner sheath. FIG. 6 is an enlarged perspective view of the distal end of the puncture portion and the distal end of the inner sheath. FIG. 7 is a partial cross-sectional view in the coaxial direction of the second proximal handle. FIG. 8 is a partial cross-sectional view in the coaxial direction of the first proximal handle. FIG. 9 is an enlarged view of portion 8A of FIG. 7. FIG. 9A is an enlarged view of portion 9A of FIG. 6. FIG. 10A is an enlarged view of portion 10A of FIG. 9, and a view showing an orthogonal cross section of the puncture portion, inner sheath, and support sheath located at the second locking mechanism. FIG. 11A is an enlarged view of portion 11A of FIG. 6. FIG. 12A is an enlarged view of portion 11, and a view showing an orthogonal cross section of the puncture portion, inner sheath, and support sheath located at the third connecting portion. FIG. 13A is an enlarged view of portion 14A of FIG. 13, and a view showing an orthogonal cross section of the puncture portion, inner sheath, and support sheath located at the second connecting portion. FIG. 14B is an enlarged view of portion 14B of FIG. 13, and a view showing an orthogonal cross section of the puncture portion, inner sheath, and support sheath located at the second connecting portion. FIG. 15 is a plan view showing a portion of the second proximal handle. FIG. 16 is a side view showing a portion of the second FIG. 1 is a plan view showing an example of the structure of the first proximal handle portion. FIG. 2 is a plan view showing an example of the structure of the first proximal handle portion. FIG. 3 is a diagram schematically showing an example of use of the medical device according to an embodiment. FIG. 4 is a diagram schematically showing an example of use of the medical device according to an embodiment. FIG. 5 is a diagram schematically showing an example of use of the medical device according to an embodiment. FIG. 6 is a diagram schematically showing an example of use of the medical device according to an embodiment. FIG. 7 is a diagram for explaining an adjustment mechanism according to a modified example. FIG. 8 is a diagram for explaining an auxiliary support sheath according to a modified example.

[0022] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that in some of the drawings, the dimensional proportions are exaggerated for the sake of convenience and are different from the actual proportions.

[0023] 1 to 18 are diagrams for explaining a medical device 100 according to an embodiment. Figures 19 to 24 are diagrams for explaining a procedure using the medical device 100.

[0024] In this specification, the directions of the medical device 100 are defined as follows: The side of the medical device 100 that is introduced into a living body (the side indicated by the arrow X1 in the figure) is the distal side, and the end portion of each member and each component located on the distal side is referred to as the "distal portion." Furthermore, the side of the medical device 100 where the proximal handle portion 130 is located (the side indicated by the arrow X2 in the figure) is referred to as the proximal side, and the end portion of each member and each component located on the proximal side is referred to as the "proximal portion." Furthermore, the direction from the distal portion toward the proximal portion (or from the proximal portion toward the distal portion) is referred to as the "central axis direction (direction indicated by the arrows X1-X2)."

[0025] <Medical device 100> As shown in Figures 1, 2, and 22, the medical device 100 has a puncture section 110 that can puncture biological tissue, a syringe 120 connected to the base end side of the puncture section 110, and a proximal handle section 130 arranged to cover the base end side of the puncture section 110 and the base end side of the syringe 120.

[0026] In this embodiment, the medical device 100 is used in a procedure for administering a predetermined medicinal liquid to a target site E (e.g., a specific region containing biological tissue in which cancer cells are present) in a biological organ, the pancreas M (see FIGS. 19 to 24). The medical device 100 may also be used in biological organs such as the gallbladder, biliary tract, liver, and lungs, which serve as biological tissue in which cancer cells are present. Examples of medicinal liquids used in this procedure include cellular medicines (such as CAR-T cells), nucleic acid medicines (such as mRNA therapeutic agents), anticancer drugs, and immune checkpoint inhibitors. The use of the medical device 100 and the type of medicinal liquid to be administered are not limited to these examples.

[0027] <Puncture Section 110> As shown in FIGS. 3 to 5 and 8, the puncture section 110 includes a distal end section 111, a proximal end section 113, and a lumen 115 extending between the distal end section 111 and the proximal end section 113.

[0028] FIG. 4 shows a state in which the puncture section 110 is housed in the inner sheath 180, and FIG. 5 shows a state in which the tip section 111 of the puncture section 110 protrudes from the tip section 181 of the inner sheath 180.

[0029] 2 and 3, a needle tip 111a that can puncture and penetrate the biological tissue to be punctured is formed at the tip 111 of the puncturing unit 110. Note that the needle tip 111a may be sharp or blunt as long as it can puncture and penetrate the biological tissue to be punctured.

[0030] An outlet hole 117 that communicates between the lumen 115 and the outside of the puncture portion 110 is formed at a position on the tip side of the puncture portion 110. The outlet hole 117 can be configured, for example, as one or more side holes provided at any position in the circumferential direction of the puncture portion 110 based on the central axis O. In this embodiment, the tip portion 111 is solid, and the outlet holes 117 are provided as side holes (two in total, one at each opposing position in the circumferential direction of the puncture portion 110 based on the central axis O), but the lumen 115 may also extend to the tip portion 111, and one outlet hole 117 may be provided at the needle tip 111 a.

[0031] The puncturing unit 110 can be made of, for example, a metal needle, such as stainless steel, aluminum, an aluminum alloy, titanium, a titanium alloy, a cobalt-chromium alloy, or other metals.

[0032] The shape and specific structure of the puncturing unit 110 are not particularly limited as long as the puncturing unit 110 can puncture biological tissue and can administer a medicinal solution to a target site E of a biological organ via the lumen 115. For example, the puncturing unit 110 may have a tip opening that allows the medicinal solution to be released from the tip of the needle tip 111a, or may have a cutting edge portion consisting of multiple ridges and cutting surfaces.

[0033] <Syringe 120> As shown in FIGS. 2, 7, and 8, syringe 120 has a main body (cylinder) 125 having an internal space 125a capable of holding a medicinal solution, and a plunger 126 capable of sliding within main body 125.

[0034] The base end 123 of the syringe 120 and the base end 128 of the plunger 126 can be arranged so as to be exposed to the outside from the base end side of the proximal handle portion 130 (first proximal handle portion 140). However, the base end 123 of the syringe 120 may be arranged so as to coincide with the base end 143 of the first proximal handle portion 140. By advancing the plunger 126 outside the proximal handle portion 130, the surgeon can eject the medicinal liquid through the puncture portion 110 connected to the syringe 120.

[0035] As shown in FIG. 8, the puncture part 110 and the syringe 120 are integrally connected.

[0036] A part of the base end 113 of the puncture part 110 can be inserted into the tip end 121 of the syringe 120 and connected to it as a single unit. The base end 113 of the puncture part 110 can be fixed to the tip end 121 of the syringe 120 by fitting, adhesion, or the like.

[0037] The connecting portion on the tip side of syringe 120 (tip portion 121 of syringe 120) that is connected to the base end side of puncture portion 110 has tapered outer and inner surfaces.

[0038] The cross-sectional shape of the tip portion 121 of the syringe 120 (the cross-sectional shape of the internal space 125a) gradually decreases in cross-sectional area toward the tip side where the base end 113 of the puncture portion 110 is connected. Therefore, the puncture portion 110 and the syringe 120 are connected so that the difference in inner diameter between the lumen 115 of the puncture portion 110 and the tip portion 121 of the syringe 120 gradually decreases toward the tip side. This prevents injection resistance from increasing near the boundary between the two components 110, 120 when transferring the medicinal solution from the syringe 120 to the puncture portion 110. This allows the surgeon to smoothly advance the plunger 126 by manually operating it when administering the medicinal solution.

[0039] Syringe 120 can be made transparent (including translucent or colored transparent) so that internal space 125a can be seen from the outside. A seal member or the like can be attached to plunger 126 to closely contact the inner circumferential surface of main body 125 of syringe 120 and enhance liquid-tightness. Furthermore, the tip of plunger 126 may have a tapered shape so as to closely contact the tapered inner circumferential surface of tip 121 of syringe 120.

[0040] <Proximal handle portion 130> As shown in Figures 2, 6 and 7, the proximal handle portion 130 includes a first proximal handle portion 140 having a first internal space 145 and a first connection portion 146 provided on the base end side of the first internal space 145 and to which the syringe 120 is fixed, and a second proximal handle portion 150 arranged on the tip side of the first proximal handle portion 140 and having a second internal space 155.

[0041] The first proximal handle portion 140 and the second proximal handle portion 150 are each capable of moving relatively forward and backward in a central axis direction. A central axis O, which serves as a reference for the central axis direction during forward and backward movement, can be defined by the central axis of the lancing portion 110.

[0042] The puncture portion 110 and the syringe 120 can move back and forth in the central axis direction at the base end region 155b located on the base end side of the second proximal handle portion 150 in conjunction with the relative forward and backward movement in the central axis direction of the first proximal handle portion 140 and the second proximal handle portion 150.

[0043] In this embodiment, the syringe 120 is inserted into and connected to the proximal end region 155b of the second proximal handle portion 150, and the puncture portion 110 is connected to the syringe 120. The puncture portion 110 is disposed so as to pass through the internal spaces 145, 155 of the handle portions 140, 150, but is not fixed so as to restrict its position relative to the handle portions 140, 150. Therefore, the surgeon can move the syringe 120 and the puncture portion 110 forward and backward in conjunction with the movement of the first proximal handle portion 140 by relatively moving the first proximal handle portion 140 and the second proximal handle portion 150 forward and backward in the central axis direction (for example, by moving the first proximal handle portion 140 forward or backward with the position of the second proximal handle portion 150 fixed).

[0044] When the surgeon moves the first handle portion 140 back and forth in the central axis direction, the movement of the first handle portion 140 can be guided by the second handle portion 150. Therefore, by moving the first handle portion 140 back and forth along the extension direction of the second handle portion 150, the surgeon can linearly move the syringe 120 and the puncture portion 110 connected to the syringe 120.

[0045] In particular, in the medical device 100 according to this embodiment, a portion of the base end 153 of the second proximal handle portion 150 is inserted into the first internal space 145 of the first proximal handle portion 140, and the two members 140, 150 are connected in a positional relationship in which their central axes overlap each other, as shown in Fig. 7. Therefore, by moving the first proximal handle portion 140 back and forth in the direction of the central axis, the surgeon can guide the movement of the first proximal handle portion 140 by the second proximal handle portion 150, which extends in a substantially straight line, and move the first proximal handle portion 140 linearly.

[0046] 7, a locking portion 149 can be provided on the outer surface near the distal end 141 of the first handle portion 140 and / or the inner surface near the proximal end 153 of the second handle portion 150 to prevent the first handle portion 140 and the second handle portion 150 from moving back and forth in the coaxial direction unintentionally by the surgeon. The locking portion 149 can be configured, for example, as a concave-convex stopper with a fitting force that allows the lock to be released relatively easily when the surgeon moves the first handle portion 140 and the second handle portion 150 by, for example, pushing one handle portion against the other handle portion with a force greater than or equal to a predetermined force.

[0047] 7 , the first connector 146 can be disposed near the base end 143 of the first proximal handle portion 140. The first connector 146 can be formed of, for example, an adhesive. However, there are no particular limitations on the specific configuration of the first connector 146, as long as it can fix the syringe 120 to the first proximal handle portion 140.

[0048] The syringe 120 and a part of the base end 113 of the puncture section 110 can be placed in the first internal space 145 of the first proximal handle section 140 .

[0049] The second internal space 155 of the second proximal handle portion 150 has a tip region 155a located at the tip side of the second proximal handle portion 150 and a base region 155b located at the base end side of the second proximal handle portion 150.

[0050] In the distal end region 155a, a part of the puncture section 110 and parts of each of the sheaths 180 and 190 described below are disposed. In the proximal end region 155b, a part of the distal end side of the syringe 120 and a part of the proximal end side of the puncture section 110 are disposed.

[0051] The second proximal handle portion 150 includes a hollow tip member 157 extending from the tip region 155a toward the tip side. The second proximal handle portion 150 includes a second locking mechanism 170 (described later) attached to a position toward the tip side of the tip member 157.

[0052] <Inner Sheath 180> As shown in FIGS. 3, 4, 5, 13, and 14, the medical device 100 has an inner sheath 180 that is provided with a lumen 185 through which the puncture portion 110 can be inserted.

[0053] As shown in Figures 6, 13 and 14, the second proximal handle portion 150 has a second connecting portion 158 to which an inner sheath 180 is connected.

[0054] The second connecting portion 158 is disposed between the distal end region 155 a and the proximal end region 155 b of the second proximal handle portion 150 .

[0055] 13 , the proximal end 183 of the inner sheath 180 can be disposed at a position closer to the proximal end than the second connecting portion 158. The proximal end 183 of the inner sheath 180 can be disposed, for example, near the tip of the proximal end region 155 b. The puncture section 110 is inserted into the lumen 185 of the inner sheath 180 through a proximal end opening (not shown) provided in the proximal end 183 of the inner sheath 180.

[0056] 13 and 14 , the second connecting portion 158 has an internal space through which the inner sheath 180 can be inserted. The outer surface of the inner sheath 180 is fixed to the inner surface of the second connecting portion 158 via a fixing portion f1. The fixing portion f1 can be formed of, for example, an adhesive or the like that is filled in the internal space of the second connecting portion 158.

[0057] 6 and 7 , the puncture portion 110 is arranged to be inserted coaxially through the proximal handle portion 130. The puncture portion 110 also passes through an inner sheath 180 connected to a second proximal handle portion 150 arranged on the distal side of the first proximal handle portion 140. Therefore, in the medical device 100, when the puncture portion 110 moves forward or backward, the coaxial movement of the puncture portion 110 can be supported by the inner sheath 180. Therefore, in a procedure using the medical device 100, when the puncture portion 110 punctures biological tissue with the puncture portion 110, bending of the puncture portion 110 can be prevented within the second internal space 155 of the second proximal handle portion 150.

[0058] Furthermore, when the puncturing portion 110 has a discharge hole 117 (see FIGS. 4 and 5 ) configured as a side hole formed in the medical device 100 of this embodiment, the distal end 111 of the puncturing portion 110 can be covered with the inner sheath 180 until the vicinity of the needle tip 111 a of the puncturing portion 110 is punctured into the target site E. This prevents clogging of the side hole with biological tissue and also prevents leakage of the medicinal solution from the lumen 115 of the puncturing portion 110 into the lumen 185 of the inner sheath 180 and the medicinal solution from the distal end 181 of the inner sheath 180 into surrounding tissue other than the target site E (see FIGS. 22 and 23 ). Preventing such clogging and leakage of the medicinal solution allows the medicinal solution to be administered smoothly and appropriately through the side hole of the puncturing portion 110 that has been punctured into the target site E.

[0059] As shown in Figures 1, 6 and 7, the second proximal handle portion 150 has a first locking mechanism 160 that can fix and release the first proximal handle portion 140 and the second proximal handle portion 150 and determine the protrusion length of the puncture portion 110 from the inner sheath 180, and a first scale 164 that makes it possible to check the protrusion length of the puncture portion 110 from the inner sheath 180.

[0060] 1 and 6, the first locking mechanism 160 is disposed on the outer surface of the second proximal handle portion 150. Also, as shown in Figures 6 and 7, the first locking mechanism 160 is disposed on the distal side of the distal end portion 141 of the first proximal handle portion 140. The first locking mechanism 160 is configured to be prevented from moving distally in the central axial direction from the protrusion (rib) 159a provided between a distal end region 155a located on the distal side of the second proximal handle portion 150 and a proximal end region 155b located on the proximal end side of the second proximal handle portion 150.

[0061] The first locking mechanism 160 has a gripping portion 161 that can be grasped by the surgeon's fingers, etc., a tubular portion 161a having one end connected to the gripping portion 161, a movable portion 162 that can be connected to the gripping portion 161, and a window portion 163 provided in the movable portion 162.

[0062] The first locking mechanism 160 can be configured to be operable to lock and unlock relative to the second handle portion 150, for example, by pinching the gripping portion 161 with fingers or the like and rotating it clockwise or counterclockwise, thereby pressing the other end of the tubular portion 161a against the second handle portion 150. By unlocking the first locking mechanism 160, the surgeon can move the gripping portion 161 and the movable portion 162 along the outer surface of the second handle portion 150. Note that a groove 156b is provided axially at any circumferential position of the second handle portion 150 to enable smooth sliding movement of the first locking mechanism 160.

[0063] As shown in Figures 6 and 7, when the first locking mechanism 160 is positioned near the base end 153 of the second proximal handle portion 150, the distal end 141 of the first proximal handle portion 140 interferes with (butts against) the movable portion 162 of the first locking mechanism 160. Therefore, the first proximal handle portion 140 is locked and restricted from moving distally. To move the first proximal handle portion 140 distally, the first locking mechanism 160 is unlocked and moved to a predetermined distal position. By performing this operation, the first proximal handle portion 140 is allowed to move distally by the distance the first locking mechanism 160 has moved distally. Moving the first proximal handle portion 140 distally moves the syringe 120 connected to the first proximal handle portion 140 and the puncture portion 110 connected to the syringe 120 distally. By moving the puncture section 110 toward the distal end, a portion of the distal end of the puncture section 110 can be protruded toward the distal end of the inner sheath 180, which is disposed so as to protrude a predetermined length from the second proximal handle section 150. The surgeon can adjust the protrusion length (maximum protrusion length) of the puncture section 110 from the inner sheath 180 by operating the first locking mechanism 160 as described above and adjusting the position of the first locking mechanism 160.

[0064] The surgeon can check the protruding length of the puncture portion 110 from the inner sheath 180 based on the first scale 164 provided on the first proximal handle portion 140 .

[0065] 1, the first scale 164 can be arranged on the side surface of the first proximal handle portion 140. In addition, various symbols (numbers, letters, designs, etc.) can be attached to the first scale 164 to enable the surgeon to more easily visually check the protrusion length of the puncture portion 110. As described above, the movable portion 162 of the first locking mechanism 160 has a window portion 163, so the surgeon can easily check the first scale 164 through the window portion 163.

[0066] <Support Sheath 190 > As shown in FIGS. 3 , 9 , and 10 , the medical device 100 has a support sheath 190 that covers the puncture section 110 and the inner sheath 180 at a position distal to the first connecting section 146 .

[0067] In a procedure using the medical device 100, when the surgeon punctures the pancreas M with the puncture unit 110, the surgeon can support the movement of the puncture unit 110 with the support sheath 190 (see FIGS. 21 and 22 ). This makes it possible to prevent the puncture unit 110 from bending due to the load when puncturing the pancreas M with the puncture unit 110. This improves the reach of the puncture unit 110 to the target site E located within the pancreas M and the efficiency of administering the medicinal solution.

[0068] As shown in FIGS. 6 and 11, the second proximal handle portion 150 has a third connecting portion 159 to which the support sheath 190 is connected.

[0069] The third connecting portion 159 is located closer to the tip of the second proximal handle portion 150 than the second connecting portion 158 .

[0070] The third connecting part 159 is configured to be movable back and forth in the central axial direction. By moving the third connecting part 159 back and forth in the central axial direction, it is possible to determine the length of the support sheath 190 that covers the puncture part 110 and the inner sheath 180 (the length by which the support sheath 190 protrudes toward the distal end of the second locking mechanism 170, which is located at the distal end of the second proximal handle part 150).

[0071] 11 , the proximal end 193 of the support sheath 190 can be disposed near the proximal end of the third connecting section 159. The inner sheath 180, through which the puncture section 110 is inserted, is inserted into the lumen 195 of the support sheath 190 via a proximal end opening (not shown) formed in the proximal end 193 of the support sheath 190.

[0072] 12 , an internal space is formed in the third connecting portion 159, through which the support sheath 190 can be inserted. The outer surface of the support sheath 190 is fixed to the inner surface of the third connecting portion 159 via a fixing portion f2. The fixing portion f2 can be formed, for example, by an adhesive or the like that is filled in the internal space of the third connecting portion 159.

[0073] As shown in FIG. 15 , the second proximal handle portion 150 is formed with a through-hole 156 a that allows the third connecting portion 159 to project out of the second proximal handle portion 150 .

[0074] With the second locking mechanism 170 (described later) released, the surgeon can grasp the third connecting part 159 with their fingers or the like and move the third connecting part 159 forward or backward along the through hole 156a. Figures 15 and 16 show a state in which the third connecting part 159 has been advanced to the most distal position along the through hole 156a formed in the second proximal handle part 150. When the surgeon moves the third connecting part 159 forward or backward in the coaxial direction, the support sheath 190 connected to the third connecting part 159 also moves forward or backward in the coaxial direction in conjunction with the third connecting part 159. Therefore, by adjusting the position of the third connecting part 159 in the coaxial direction, the length of protrusion of the support sheath 190 from the second proximal handle part 150 can be easily adjusted.

[0075] As shown in Figures 9, 10, 15, and 16, the second proximal handle portion 150 has a second locking mechanism 170 that enables the length of the support sheath 190 to be fixed, and a second scale 174 that enables the length of the support sheath 190 to be confirmed.

[0076] The second locking mechanism 170 has an internal space 171 through which the support sheath 190 can be inserted.

[0077] The second locking mechanism 170 can be configured, for example, by a known chuck mechanism (e.g., a three-jaw chuck mechanism) that can grip and release the support sheath 190 in accordance with the expansion and contraction of the inner diameter (cross-sectional area) near the distal end of the internal space 171. When the second locking mechanism 170 transitions to the locked state, the distal end of the second locking mechanism 170 is pressed against the outer surface of the support sheath 190, restricting the forward and backward movement of the support sheath 190 in the coaxial direction. Note that the specific structure of the second locking mechanism 170 is not limited as long as it has a configuration that allows the support sheath 190 to be locked and unlocked.

[0078] The surgeon can check the protruding length of the support sheath 190 based on the second scale 174 shown in Figures 15 and 16. The second scale 174 can be arranged, for example, on the top surface and side surface of the second proximal handle portion 150. Various symbols (numbers, letters, designs, etc.) can be attached to the second scale 174 to enable the surgeon to more easily visually check the protruding length of the support sheath 190.

[0079] The inner sheath 180 and the support sheath 190 can be made of materials similar to 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, crystalline plastics such as polyamide, crystalline polyethylene, and crystalline polypropylene, and metals such as stainless steel (SUS: Steel Use Stainless Steel), titanium alloy, and cobalt-chromium alloy.

[0080] 17 , the first proximal handle portion 140 has a third scale 147 that indicates the amount of fluid (amount of medicinal solution held) in the syringe 120 and a window 148 that allows the syringe 120 to be viewed from the outside. The third scale 147 and the window 148 are preferably provided in a different direction (angle) from the first scale 164 with respect to the central axis O. For example, the third scale 147 and the window 148 may be provided at a position that is 90 degrees different from the first scale 164 with respect to the central axis O. Although not shown, the second proximal handle portion 150 may also be configured to have a window that allows the syringe 120 to be viewed from the outside, at a different direction (angle) from the first scale 164 with respect to the central axis O.

[0081] While performing a procedure using the medical device 100, the surgeon can visually check the medicinal liquid in the syringe 120 and the position of the plunger 126 inserted into the syringe 120 (such as the position of the tip of the plunger 126) through the window 148 formed in the first proximal handle portion 140, thereby making it possible to easily check the remaining amount of medicinal liquid in the syringe 120.

[0082] 18 , for example, when a window 148 is provided in the first proximal handle portion 140, the scale 127a may be provided on the plunger 126 without providing the third scale 147 on the first proximal handle portion 140. Furthermore, the scale 127a may be provided on the outer surface of the syringe 120 instead of on the plunger 126. In these configurations, the surgeon can easily check the remaining amount of medicinal liquid in the syringe 120 by visually checking the scale 127a on the plunger 126 or the syringe 120 through the window 148 formed in the first proximal handle portion 140. Furthermore, for example, when a window is provided in the second proximal handle portion 150, the scale 127a may be provided on the plunger 126 without providing a scale on the second proximal handle portion 150. When configured in this manner, the surgeon can easily check the remaining amount of medicinal liquid in the syringe 120 by visually checking the scale 127a on the plunger 126 through the window formed in the second handle portion 150.

[0083] <Example of Use of Medical Device 100> Next, a description will be given of a method for administering a medicinal solution using the medical device 100. The method for administering a medicinal solution described here is an example, and the procedure for using the medical device 100 is not limited to the following.

[0084] The following description explains a procedure for administering a medicinal liquid to a target site E of the pancreas M via a percutaneous approach using the medical device 100.

[0085] Before starting administration of a medicinal solution using the medical device 100, the surgeon uses a device for acquiring diagnostic images to photograph and identify the target site E. Note that the procedure using the medical device 100 can be performed under CT guidance or ultrasound guidance, for example.

[0086] Based on the acquired diagnostic image, the surgeon determines the distance to the target site E, the puncture angle of the puncture section 110, and an appropriate puncture route to the target site E (for example, a puncture route that avoids the trachea and large blood vessels).

[0087] The surgeon fills the syringe 120, which is connected to the proximal handle portion 130 (first proximal handle portion 140) via the first connecting portion 146, with a medicinal liquid. Note that the syringe 120 may be a prefilled syringe in which the main body portion 125 is prefilled with the medicinal liquid.

[0088] The surgeon can fix the medical device 100 at a predetermined angle to the patient's body surface (for example, the abdominal or chest surface) so that the puncture unit 110 can move and puncture along the determined puncture path. This procedure may be performed as needed or may be omitted.

[0089] The surgeon administers anesthesia (e.g., local anesthesia) to the patient and inserts the medical device 100 into the body surface. When inserting the medical device 100 into the body surface, the surgeon operates the proximal handle 130 to project the inner sheath 180 a predetermined length toward the distal end of the support sheath 190 and to project the puncturing portion 110 a predetermined length toward the distal end of the inner sheath 180. Note that it is preferable that the discharge hole 117 of the puncturing portion 110 is covered by the inner sheath 180 until the puncturing portion 110 is inserted into the target site E (see FIG. 4 ).

[0090] With the positional relationship of the members 110, 180, and 190 adjusted as described above, the surgeon punctures the medical device 100 from the body surface, and then moves the medical device 100 inside the living body toward the pancreas M as shown in Fig. 19. Note that the puncturing unit 110 may be arranged so as to be covered by the support sheath 190 from the time the medical device 100 is punctured from the body surface until the time the puncturing unit 110 is inserted into the pancreas M. By arranging it in this manner, it is possible to prevent the puncturing unit 110 from damaging the organ inside the living body.

[0091] As shown in Figure 20, the surgeon moves the medical device 100 to the vicinity of the pancreas M, and then temporarily stops the movement of the medical device 100. With the movement of the medical device 100 stopped, the surgeon releases the second locking mechanism 170. The surgeon operates the second proximal handle portion 150 (third connecting portion 159) to position the tip portion 191 of the support sheath 190 near the puncture position of the pancreas M, as shown in Figure 21.

[0092] 22 , the surgeon punctures the pancreas M with the puncture unit 110 while checking the direction of travel of the puncture unit 110 under the guidance of an imaging device (for example, under CT guidance), and inserts the puncture unit 110 until the tip 181 of the inner sheath 180 reaches the interface with the target site E. When the surgeon punctures the pancreas M with the puncture unit 110, the surgeon can support the puncture unit 110 with the support sheath 190, thereby preventing the puncture unit 110 from bending or the like.

[0093] Furthermore, when the surgeon moves the puncturing portion 110 within the pancreas M, the surgeon can support the puncturing portion 110 with the inner sheath 180. This prevents the puncturing portion 110 from bending while being moved within the pancreas M. Furthermore, by covering the discharge hole 117 of the puncturing portion 110 with the inner sheath 180 until the puncturing portion 110 punctures the target site E, the surgeon can prevent the discharge hole 117 from being clogged with biological tissue such as the pancreas M. This allows the medicinal solution to be smoothly released from the discharge hole 117 after the puncturing portion 110 has punctured the target site E.

[0094] Next, the surgeon operates the first locking mechanism 160 to set the projection length of the puncture section 110 projecting from the inner sheath 180 .

[0095] After setting the protrusion length of the puncture portion 110, the surgeon operates the first proximal handle portion 140 to protrude the puncture portion 110 from the distal end portion 181 of the inner sheath 180 by the predetermined protrusion length.

[0096] As shown in Figure 23, the surgeon punctures the target site E with the puncture section 110, and while a certain range on the tip side of the puncture section 110 including the discharge hole 117 is positioned within the target site E, the surgeon operates the plunger 126 to administer the medicinal liquid into the target site E.

[0097] After the surgeon has finished administering the medicinal solution to the target site E, he or she operates the proximal handle portion 130 ex vivo to house the puncture portion 110 in the inner sheath 180. By housing the puncture portion 110 in the inner sheath 180, it is possible to prevent the biological tissue near the target site E from being seeded.

[0098] After accommodating the puncture portion 110 in the inner sheath 180, the surgeon unlocks the second locking mechanism 170 and then operates the proximal handle portion 130 ex vivo to accommodate the puncture portion 110 and the inner sheath 180 in the support sheath 190, and removes the medical device 100 ex vivo. By removing the medical device 100 ex vivo with the puncture portion 110 and the inner sheath 180 accommodated in the support sheath 190, the surgeon can prevent tissues and cells from being seeded from the biological tissue near the target site E or the biological tissue containing cancer (tumor) cells of the pancreas M into surrounding normal biological tissue.

[0099] In the above procedure, when inserting the puncturing unit 110 into the pancreas M or when moving the puncturing unit 110 within the pancreas M, the operator can move the puncturing unit 110 linearly by using the proximal handle unit 130 (the first proximal handle unit 140 and the second proximal handle unit 150) to guide the movement of the puncturing unit 110. This allows the operator to smoothly and quickly perform the puncturing operation using the puncturing unit 110.

[0100] As described above, the medical device 100 of this embodiment has a puncturing portion 110 that can puncture biological tissue, a syringe 120 connected to the base end side of the puncturing portion 110, and a proximal handle portion 130 that is arranged to cover the base end side of the puncturing portion 110 and the base end side of the syringe 120. The proximal handle portion 130 has a first internal space 145 and a first connecting portion 146 that is provided on the base end side of the first internal space 145 and to which the syringe 120 is fixed, and a second proximal handle portion 150 that is arranged on the tip side of the first proximal handle portion 140 and has a second internal space 155. The puncturing portion 110 and the syringe 120 can move forward and backward in the central axial direction in the second internal space 155 in conjunction with the relative forward and backward movement of the first proximal handle portion 140 and the second proximal handle portion 150 in the central axial direction.

[0101] According to the medical device 100, when the surgeon moves the first proximal handle portion 140 back and forth in the central axis direction, the movement of the first proximal handle portion 140 can be guided by the second proximal handle portion 150. Therefore, the surgeon can linearly move the syringe 120 connected to the first proximal handle portion 140 and the puncture portion 110 connected to the syringe 120 by moving the first proximal handle portion 140 back and forth along the extension direction of the second proximal handle portion 150. By linearly moving the puncture portion 110, the surgeon can cause the puncture portion 110 to puncture the target site E of the biological organ appropriately and quickly.

[0102] 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.

[0103] <Modification 1> Fig. 25 shows a part of a medical device according to Modification 1. Fig. 25 is a plan view corresponding to Fig. 15 shown in the above-described embodiment.

[0104] The second proximal handle portion 150 can be configured to have an adjustment mechanism 210 that allows the third connecting portion 159 to move at regular intervals in accordance with the second scale 174 .

[0105] The adjustment mechanism 210 can be configured, for example, by convex portions 211 and concave portions 212 arranged alternately in the central axis direction.

[0106] The protrusion 211 is configured to partially narrow the width of the through hole 156 a for pulling the third connection part 159 out of the second proximal handle part 150 .

[0107] The recess 212 is configured to partially widen the width of the through hole 156a compared to the portion where the protrusion 211 is arranged.

[0108] A base 159a that allows the projection 211 and the recess 212 to move in the central axis direction is provided at a portion of the third connection portion 159 that passes through the through hole 156a.

[0109] When adjusting the length of the support sheath 190 by manipulating the third connecting portion 159, the surgeon can restrict movement of the third connecting portion 159 in the central axis direction by placing the base portion 159a of the third connecting portion 159 in the recess 212. Furthermore, with the second locking mechanism 170 unlocked, the surgeon can adjust the length of the support sheath 190 by moving the base portion 159a of the third connecting portion 159 so that it passes over the portion where the protrusion 211 is provided. By using the adjustment mechanism 210, the surgeon can adjust the length of the support sheath 190 at regular intervals to match the position of the protrusion 211, which allows the procedure using the medical device to proceed more smoothly.

[0110] The adjustment mechanism 210 can be modified as desired as long as it is possible to move the third connection portion 159 at regular intervals in the central axis direction, and is not limited to the shape of the convex portion 211 and concave portion 212 shown in the figure.

[0111] <Modification 2> Fig. 26 shows a part of a medical device according to Modification 2. Fig. 26 is a cross-sectional view corresponding to Fig. 6 shown in the above-described embodiment.

[0112] The second proximal handle portion 150 can be configured to have an auxiliary support sheath 220 that covers the puncture portion 110 at a position more proximal than the second connecting portion 158 .

[0113] The auxiliary support sheath 220 can be disposed, for example, within the proximal end region 155b of the second proximal handle unit 150 located on the proximal end side of the second connecting portion 158. The auxiliary support sheath 220 may be disposed, for example, so as to pass through a space formed between the outer surface of the inner sheath 180 and the lumen 195 of the support sheath 190. The auxiliary support sheath 220 may also have a bellows structure, thereby being configured to be foldable in the direction of its central axis. Such an arrangement or design can prevent the proximal end of the auxiliary support sheath 220 from coming into contact with the distal end 121 of the syringe 120, thereby preventing restriction of movement of the syringe 120 toward the side where the medical device is introduced into the living body.

[0114] The medical device according to the second modification includes the auxiliary support sheath 220, which allows the support of a portion of the puncture portion 110 at a position closer to the proximal end than the second connecting portion 158 to which the inner sheath 180 is connected. This makes it possible to more effectively guide the linear movement of the puncture portion 110 and more effectively prevent the puncture portion 110 from being bent or otherwise damaged within the second internal space 155 of the second proximal handle portion 150.

[0115] 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.

[0116] This application is based on Japanese Patent Application No. 2024-043201, filed on March 19, 2024, the disclosure of which is incorporated herein by reference in its entirety.

[0117] 100 Medical device 110 Puncture portion 115 Lumen of puncture portion 120 Syringe 126 Plunger 130 Proximal handle portion 140 First proximal handle portion 145 First internal space 146 First connecting portion 147 Third scale 148 Window portion 150 Second proximal handle portion 155 Second internal space 155a Distal end region 155b Base end region 158 Second connecting portion 159 Third connecting portion 160 First locking mechanism 164 First scale 170 Second locking mechanism 174 Second scale 180 Inner sheath 185 Lumen of inner sheath 190 Support sheath 195 Lumen of support sheath 210 Adjustment mechanism 220 Auxiliary support sheath M Pancreas (biological organ) E Target site O Central axis

Claims

1. A medical device having: a puncture section capable of puncturing biological tissue; a syringe connected to the base end side of the puncture section; and a proximal handle section arranged to cover the base end side of the puncture section and the base end side of the syringe, wherein the proximal handle section comprises: a first proximal handle section having a first internal space and a first connection section provided at the base end side of the first internal space and to which the syringe is fixed; and a second proximal handle section arranged at the tip side of the first handle section and having a second internal space, wherein each of the first and second handle sections is movable forward and backward relative to each other in a central axis direction, and wherein the puncture section and the syringe are movable forward and backward in the second internal space in accordance with the relative forward and backward movement of the first and second handle sections in the central axis direction.

2. The medical device according to claim 1, further comprising an inner sheath having a lumen through which the puncture portion can be inserted, and the second proximal handle portion having a second connecting portion to which the inner sheath is connected.

3. The medical device according to claim 2, wherein the second handle portion has a first locking mechanism that can fix and release the first and second handle portions and determine the length of protrusion of the puncture portion from the inner sheath, and a first scale that makes it possible to check the length of protrusion.

4. The medical device according to claim 2, further comprising a support sheath that covers the puncture portion and the inner sheath at a position distal to the first connection portion.

5. A medical device as described in claim 4, wherein the second proximal handle portion has a third connecting portion to which the support sheath is connected, and the third connecting portion is configured to be movable back and forth in the central axis direction, and by moving back and forth, the length of the support sheath covering the puncture portion and the inner sheath can be determined.

6. The medical device according to claim 5, wherein the second proximal handle portion has a second locking mechanism that enables the length of the support sheath to be fixed, and a second scale that enables the length of the support sheath to be confirmed.

7. The medical device according to claim 6, wherein the second proximal handle portion has an adjustment mechanism that allows the third connection portion to be moved at regular intervals in accordance with the second scale.

8. The medical device of claim 1, wherein the first handle portion has a third scale indicating the amount of fluid in the syringe, and a window portion that allows the syringe to be viewed from the outside.

9. The medical device according to claim 1, wherein the puncture portion and the syringe are integrally connected, and the inner surface of the connecting portion at the tip side of the syringe that connects to the base end side of the puncture portion has a tapered shape.

10. A medical device as described in claim 2, wherein the second proximal handle portion has an auxiliary support sheath that covers the puncture portion at a position proximal to the second connection portion.

Images