Catheter and puncture catheter

Abstract

A catheter (100) has a metal tube (4) having a longitudinal direction (x) and having a lumen extending in the longitudinal direction (x), and a tip member (2) connected to the distal end of the metal tube (4). A plurality of grooves (410) extending spirally are formed in the metal tube (4), and the plurality of grooves (410) are arranged in the longitudinal direction (x) of the metal tube (4).

Description

Catheters and puncture catheters

[0001] The present invention relates to a catheter and a puncture catheter.

[0002] Treatments such as direct administration of a medicinal solution such as a cardiac regenerative cell preparation to cardiac muscle cells that are losing function due to myocardial infarction or the like are being performed to regenerate cardiac muscle cells. When administering a medicinal solution directly to an internal organ, a catheter with a needle must be inserted into a body cavity and the needle must be inserted into the organ. For example, the following needles and catheters have been developed for use in such treatments.

[0003] Patent Document 1 describes a drug solution injection needle that is a hollow needle for puncturing a patient's myocardium to inject a drug solution, and that comprises a sharp metal tip member, an electrically insulating connecting tube connected to the base end of the tip member, a metal tube connected to the base end of the connecting tube, and an insulating layer covering the outer surface of the base end portion of the metal tube, and the connecting tube and / or tip member have at least one hole (a drug solution outflow path) that communicates with the lumen of the needle and opens on the outer surface of the connecting tube or tip member, and the tip portion of the metal tube that is not covered by the insulating layer forms an electrode for measuring electrical potential.

[0004] Patent Document 2 describes a catheter with a helical needle for puncturing a patient's myocardium and injecting a medicinal solution, the catheter including a catheter body having a distal end and a proximal end and a delivery lumen passing therethrough, and a helical needle having a helical delivery lumen connected to receive an injectable substance from the delivery lumen of the catheter body. Patent Document 2 also describes that the myocardium is punctured by rotating the helical needle.

[0005] International Publication No. 2021 / 192283 Special Publication No. 2016-537040

[0006] However, there is still room for improvement in the operability of catheters equipped with a needle or other member at the tip, such as those described in Patent Documents 1 and 2.

[0007] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a catheter and a puncture catheter that are easy to operate.

[0008] Catheters according to embodiments of the present invention that can solve the above problems are as follows: [1] A catheter comprising: a metal tube having a longitudinal direction and a lumen extending in the longitudinal direction; and a tip member connected to a distal end of the metal tube, wherein a plurality of grooves extending spirally are formed in the metal tube, and the plurality of grooves are aligned in the longitudinal direction.

[0009] The metal tube has a plurality of spirally extending grooves formed therein, which makes it possible to impart flexibility to the metal tube. Furthermore, the distal end member is connected to the metal tube having a plurality of spirally extending grooves formed therein, which makes it possible to easily transmit torque to the distal end member. This makes it possible to easily improve the operability of the catheter.

[0010] A catheter according to an embodiment of the present invention is preferably any one of the following [2] to

[11] . [2] The catheter according to [1], wherein the groove is a bottomed groove or a through groove. [3] The catheter according to [1] or [2], which has an outer resin layer provided on the outer surface of the metal tube, and wherein the groove is a through groove that penetrates the metal tube in the radial direction from the lumen of the metal tube to the inner surface of the outer resin layer. [4] The catheter according to [1] or [2], which has an inner resin layer provided on the inner surface of the metal tube, and wherein the groove is a through groove that penetrates the metal tube in the radial direction from the outside of the metal tube to the outer surface of the inner resin layer. [5] The catheter according to any one of [1] to [4], wherein no tubes with grooves formed therein are provided radially inward or radially outward of the metal tube. [6] The catheter according to any one of [1] to [5], wherein the plurality of grooves are arranged in a spiral at a pitch smaller than the length of the grooves. [7] The catheter according to any one of [1] to [6], wherein the metal tube has a first portion and a second portion located proximal to the first portion, wherein the plurality of grooves are arranged in a spiral pattern in the first portion, and wherein the plurality of grooves are arranged in a spiral pattern at a pitch greater than that in the first portion in the second portion. [8] The catheter according to [7], wherein, when observed from a direction perpendicular to the longitudinal direction, the angle between the extension direction of the grooves formed in the first portion and the longitudinal direction is 70° or more and 85° or less. [9] The catheter according to [7] or [8], wherein, when observed from a direction perpendicular to the longitudinal direction, the angle between the extension direction of the grooves formed in the second portion and the longitudinal direction is 55° or more and 65° or less.

[10] The catheter according to any one of [7] to [9], wherein the first portion is formed by a first tube, and the second portion is formed by a second tube connected to a proximal end of the first tube.

[11] The catheter according to any one of [1] to

[10] , wherein the tip member is a medical puncture needle, and the puncture needle has a tubular member having an inner cavity extending in the longitudinal direction, and a spiral member in which a wire is wound spirally around the tubular member.

[0011] The puncture catheter according to the embodiment of the present invention that can solve the above problems is as follows:

[12] A puncture catheter comprising: a medical puncture needle having a longitudinal direction, a first tube having an inner lumen extending in the longitudinal direction, with a plurality of grooves formed therein, and connected to a proximal end of the puncture needle, and a second tube having an inner lumen extending in the longitudinal direction, with a plurality of grooves formed therein, and connected to a proximal end of the first tube, wherein the total length of the grooves formed in the first tube per unit area is greater than the total length of the grooves formed in the second tube per unit area.

[0012] The formation of multiple grooves in the first tube and the second tube can impart flexibility to the first tube and the second tube. The total length of the grooves per unit area formed in the first tube is greater than the total length of the grooves per unit area formed in the second tube, which facilitates increasing flexibility on the distal side. Furthermore, the connection of the first tube and the second tube with multiple grooves formed therein to the puncture needle facilitates transmission of torque to the puncture needle.

[0013] The puncture catheter according to the embodiment of the present invention is preferably any one of the following

[13] to

[19] .

[13] The puncture catheter according to

[12] , wherein the plurality of grooves provided in the first tube are bottomed grooves or through grooves, and the plurality of grooves provided in the second tube are bottomed grooves or through grooves.

[14] The puncture catheter according to

[12] or

[13] , wherein the first tube and the second tube are made of metal.

[15] The puncture catheter according to any one of

[12] to

[14] , wherein an outer resin layer is provided on the outer surface of the first tube and the outer surface of the second tube.

[16] The puncture catheter according to any one of

[12] to

[15] , wherein an inner resin layer is provided on the inner surface of the first tube and the inner surface of the second tube.

[17] The puncture catheter according to any one of

[12] to

[16] , wherein the shortest distance between adjacent grooves formed in the first tube in the longitudinal direction is shorter than the shortest distance between adjacent grooves formed in the second tube in the longitudinal direction.

[18] The puncture catheter according to any one of

[12] to

[17] , wherein the grooves formed in the first tube are arranged in a spiral pattern, and the grooves formed in the second tube are arranged in a spiral pattern at a pitch greater than that of the first tube.

[19] The puncture catheter according to any one of

[12] to

[18] , wherein the puncture needle includes a tubular member having a lumen extending in the longitudinal direction, and a helical member formed by helically winding a wire around the tubular member.

[0014] The catheter and puncture catheter of the present invention have improved operability due to improved flexibility and torque transmission.

[0015] FIG. 1 is a side view showing an example of a catheter according to an embodiment of the present invention. FIG. 2 is a cross-sectional view of the catheter shown in FIG. 1. FIG. 3 is a cross-sectional view showing a modified example of the catheter shown in FIG. 2. FIG. 4 is a cross-sectional view showing a modified example of the catheter shown in FIG. 2. FIG. 5 is a side view (partial cross-sectional view) showing a modified example of a catheter according to an embodiment of the present invention. FIG. 6 is a side view showing an example of a puncture catheter according to an embodiment of the present invention. FIG. 7 is a cross-sectional view of the puncture catheter shown in FIG. 6. FIG. 8 is a cross-sectional view showing a modified example of the puncture catheter shown in FIG. 7. FIG. 9 is a cross-sectional view showing a modified example of the puncture catheter shown in FIG. 7. FIG. 10 is a side view (partial cross-sectional view) showing a modified example of a puncture catheter according to an embodiment of the present invention.

[0016] The present invention will be described in detail below with reference to the drawings. However, the present invention is not limited to the illustrated examples, and appropriate modifications can be made within the scope of the above and below-described purpose, and all such modifications are within the technical scope of the present invention. In each drawing, hatching, symbols, etc. may be omitted for convenience. In such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various parts in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0017] (Catheter) First, a catheter according to an embodiment of the present invention will be described.

[0018] One embodiment of a catheter according to the present invention is a catheter having a metal tube having a longitudinal direction and a lumen extending in the longitudinal direction, and a tip member connected to the distal end of the metal tube, wherein the metal tube has a plurality of spirally extending grooves formed therein, and the plurality of grooves are aligned in the longitudinal direction of the metal tube.

[0019] The overall configuration of a catheter according to an embodiment of the present invention will be described with reference to Figures 1 to 5. Figures 1 to 5 show a catheter 100 having a metal tube 4 and a tip member 2. In these figures, the longitudinal direction of the metal tube 4 is indicated by x, and the radial direction of the metal tube 4 is indicated by y. The radial direction y is a direction perpendicular to the longitudinal direction x. The longitudinal direction x of the metal tube 4 can also be said to be the extension direction of the metal tube 4. In addition, the metal tube 4 has a circumferential direction.

[0020] In the description of the catheter, the proximal side refers to the direction toward the user's hand in the longitudinal direction x of the metal tube 4, and the distal side refers to the opposite side of the proximal side, i.e., the direction toward the treatment target. Furthermore, when each component is divided into two equal parts in the longitudinal direction x of the metal tube 4, the part of each component located on the distal side is referred to as the distal section, and the part of each component located on the proximal side is referred to as the proximal section. The distal end of each component is the end located most distally of each component. The proximal end of each component is the end located most proximal of each component. The end of each component refers to the portion including the end of each component and its periphery. In other words, the distal end of each component refers to the portion including the distal end of each component and its periphery, and the proximal end of each component refers to the portion including the proximal end of each component and its periphery.

[0021] Fig. 1 is a side view showing an example of a catheter according to an embodiment of the present invention. Fig. 2 is a cross-sectional view of the catheter shown in Fig. 1. Figs. 3 and 4 are cross-sectional views showing modified examples of the catheter shown in Fig. 2. More specifically, Figs. 2 to 4 are cross-sectional views taken along the longitudinal direction of a metal tube, passing through the central axis of the metal tube. Fig. 5 is a side view (partial cross-sectional view) showing a modified example of a catheter according to an embodiment of the present invention.

[0022] As shown in FIGS. 1 to 5, the catheter 100 has a metal tube 4 and a tip member 2 .

[0023] The metal tube 4 has a longitudinal direction x and an inner cavity 4c extending in the longitudinal direction x. The metal tube 4 has a plurality of grooves 410 formed therein.

[0024] The groove 410 extends in a spiral shape. In the description relating to the catheter, a groove that extends in the circumferential direction of the metal tube 4 for at least 1 / 6 of the circumference of the metal tube 4 is defined as a groove 410 that extends in a spiral shape.

[0025] The grooves 410 are aligned in the longitudinal direction x of the metal tube 4 .

[0026] The tip member 2 is connected to the distal end of the metal tube 4. As the tip member 2, for example, a medical tool such as a puncture needle, a knife, a balloon, a basket, or a stent can be used.

[0027] The metal tube 4 has a plurality of spirally extending grooves 410 formed therein, thereby imparting flexibility to the metal tube 4. Furthermore, the distal end member 2 is connected to the metal tube 4 having a plurality of spirally extending grooves 410 formed therein, thereby facilitating the transmission of torque to the distal end member 2. This makes it easier to improve the operability of the catheter 100.

[0028] The catheter 100 is preferably used when delivering the tip member 2 to a region to be treated. In particular, when a puncture needle is used as the tip member 2, it is preferably used when administering a liquid such as a cell preparation or a medicinal solution to a target tissue. Specifically, the catheter 100 can be used when directly administering to an internal organ, such as the heart, kidney, or liver. For example, the catheter 100 can be used when directly administering an iPS cell suspension to the liver or kidney, or when directly administering a cardiac regenerative cell preparation to the heart, or more specifically, the myocardium. Note that internal organs refer to organs located within the body, particularly in the abdominal or thoracic region, and are also referred to as internal organs.

[0029] 2, the metal tube 4 can have an inner surface 4g facing the lumen 4c of the metal tube 4 and an outer surface 4h facing the outside of the metal tube 4. In the longitudinal direction x of the metal tube 4, the metal tube 4 has a distal end 4d and a proximal end 4p. The lumen 4c of the metal tube 4 passes through the metal tube 4 in the longitudinal direction x, and it is preferable that both the distal end 4d and the proximal end 4p of the metal tube 4 are open.

[0030] The metal tube 4 may have a hollow cylindrical shape, a hollow polygonal prism shape, or the like.

[0031] The length of the metal tube 4 in the longitudinal direction x of the metal tube 4 can be 1100 mm or more, 1330 mm or more, 1560 mm or more, etc. The length of the metal tube 4 in the longitudinal direction x of the metal tube 4 can be 2300 mm or less, 2070 mm or less, 1840 mm or less, etc. The length of the metal tube 4 in the longitudinal direction x of the metal tube 4 refers to the longest length of the metal tube 4 in the longitudinal direction x.

[0032] The length of the metal tube 4 in the radial direction y of the metal tube 4 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the metal tube 4 in the radial direction y of the metal tube 4 can be 20 mm or less, 15 mm or less, 10 mm or less, etc. The length of the metal tube 4 in the radial direction y of the metal tube 4 refers to the longest length of the metal tube 4 in the radial direction y.

[0033] Examples of metals that can be used to form the metal tube 4 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni—Ti alloys, Co—Cr alloys, and combinations thereof.

[0034] The grooves 410 formed in the metal tube 4 may be bottomed grooves as shown in Fig. 2 or through grooves as shown in Fig. 3 and Fig. 4. Furthermore, both through grooves and bottomed grooves may be formed in the metal tube 4. By combining through grooves and bottomed grooves or selecting either one of them for the grooves 410 formed in the metal tube 4, it becomes easier to obtain a metal tube 4 with the desired flexibility and rigidity.

[0035] The length of one groove 410 in the extension direction of the groove 410 may be shorter or longer than the outer circumferential length of the metal tube 4. The length of one groove 410 in the extension direction of the groove 410 refers to the longest length of the lengths of the groove 410 in the extension direction of the groove 410.

[0036] 1 to 4, the grooves 410 may be arranged in a spiral shape. As shown in Figures 1 to 4, one groove 410 may exist on an extension line of another groove. As shown in Figures 1 to 4, an end of one groove 410 in the extension direction of the groove 410 may face an end of another groove 410 in the extension direction of the groove 410.

[0037] As shown in Fig. 1, the plurality of grooves 410 are preferably arranged in a spiral shape at a pitch smaller than the length of the grooves 410. The plurality of grooves 410 are preferably arranged in a spiral shape at a pitch smaller than the length of the grooves 410 in the extension direction of the grooves 410. This makes it easier to transmit torque to the tip member 2. Note that Fig. 1 shows the spiral pitch P.

[0038] As shown in Fig. 5, the multiple grooves 410 do not have to be arranged in a spiral shape. As shown in Fig. 5, one groove 410 does not have to be on an extension line of another groove 410. As shown in Fig. 5, the end of one groove 410 in the extension direction of the groove 410 does not have to face the end of the other groove 410 in the extension direction of the groove 410.

[0039] 3, the catheter 100 preferably has an outer resin layer 4e provided on the outer surface 4h of the metal tube 4. This makes it possible to transport liquids such as cell preparations and medicinal solutions to the tip member 2 via the lumen 4c of the metal tube 4, regardless of whether the groove 410 formed in the metal tube 4 is a through groove or a bottomed groove. It is more preferable that the groove 410 is a through groove that penetrates the metal tube 4 in the radial direction y from the lumen 4c of the metal tube 4 to the inner surface of the outer resin layer 4e.

[0040] The outer resin layer 4e may be provided so as to cover the entire outer surface 4h of the metal tube 4, or may be provided so as to cover only a part of the outer surface 4h of the metal tube 4. As shown in Fig. 3, the outer resin layer 4e may also be provided on the groove 410.

[0041] 4, the catheter 100 preferably has an inner resin layer 4f provided on the inner surface 4g of the metal tube 4. This makes it possible to transport liquids such as cell preparations and medicinal solutions to the tip member 2 via the inner lumen 4c of the metal tube 4, regardless of whether the groove 410 formed in the metal tube 4 is a through groove or a bottomed groove. It is more preferable that the groove 410 is a through groove that penetrates the metal tube 4 in the radial direction y from the outside of the metal tube 4 to the outer surface of the inner resin layer 4f.

[0042] Although not shown, the catheter 100 may have an outer resin layer 4e provided on the outer surface 4h of the metal tube 4 and an inner resin layer 4f provided on the inner surface 4g of the metal tube 4. This makes it possible to transport liquids such as cell preparations and medicinal solutions to the tip member 2 via the lumen 4c of the metal tube 4, regardless of whether the groove 410 formed in the metal tube 4 is a through groove or a bottomed groove. The groove 410 is preferably a through groove that penetrates the metal tube 4 in the radial direction y from the inner surface of the outer resin layer 4e to the outer surface of the inner resin layer 4f.

[0043] The outer resin layer 4e and the inner resin layer 4f can be made of synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyether ketone resins (e.g., PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, fluororesins (e.g., PTFE, PFA, ETFE), etc. The resins constituting the outer resin layer 4e and the resins constituting the inner resin layer 4f may be the same or different.

[0044] 1 to 5 , it is not necessary for tubes with grooves to be provided radially inward and radially outward of the metal tube 4. Grooves may not be provided in tubes or layers in contact with the metal tube 4 or in tubes or layers stacked on the metal tube 4. Note that it is also permissible to provide tubes with grooves radially inward and radially outward of the metal tube 4, or to provide grooves in tubes or layers in contact with the metal tube 4 or in tubes or layers stacked on the metal tube 4.

[0045] 1, the metal tube 4 has a first portion 4a and a second portion 4b located proximal to the first portion 4a, and it is preferable that the grooves 410 are arranged spirally in the first portion 4a, and that the grooves 410 are arranged spirally at a pitch greater than that in the first portion 4a in the second portion 4b. This makes it easier to transmit torque to the distal end member 2.

[0046] 1 , when observed from a direction perpendicular to the longitudinal direction x of the metal tube 4, the angle α between the extension direction of the groove 410 formed in the first portion 4a and the longitudinal direction x of the metal tube 4 is preferably larger than the angle β between the extension direction of the groove 410 formed in the second portion 4b and the longitudinal direction x of the metal tube 4. This makes it easier to transmit torque to the tip member 2.

[0047] 1 , when observed from a direction perpendicular to the longitudinal direction x of the metal tube 4, the angle α between the extension direction of the groove 410 formed in the first portion 4a and the longitudinal direction x of the metal tube 4 is preferably 70° or more, more preferably 73° or more, and even more preferably 75° or more. When observed from a direction perpendicular to the longitudinal direction x of the metal tube 4, the angle α between the extension direction of the groove 410 formed in the first portion 4a and the longitudinal direction x of the metal tube 4 is preferably 85° or less, more preferably 83° or less, and even more preferably 80° or less. By setting the angle α within the above range, torque can be easily transmitted to the tip member 2.

[0048] 1 , when observed from a direction perpendicular to the longitudinal direction x of the metal tube 4, the angle β between the extension direction of the groove 410 formed in the second portion 4 b and the longitudinal direction x of the metal tube 4 is preferably 55° or more, more preferably 57° or more, and even more preferably 59° or more. When observed from a direction perpendicular to the longitudinal direction x of the metal tube 4, the angle β between the extension direction of the groove 410 formed in the second portion 4 b and the longitudinal direction x of the metal tube 4 is preferably 65° or less, more preferably 63° or less, and even more preferably 61° or less. By setting the angle β within the above range, torque can be easily transmitted to the tip member 2.

[0049] Preferably, the first portion 4a is formed by a first tube 41, and the second portion 4b is formed by a second tube 42 connected to the proximal end of the first tube 41. This makes it easier to manufacture a metal tube 4 having the first portion 4a and the second portion 4b, each having grooves 410 formed in a spiral pattern with different pitches. Note that the first portion 4a and the second portion 4b may be formed from a single tube. More specifically, a portion of a single tube may be the first portion 4a, and another portion of the tube may be the second portion 4b.

[0050] The material forming the first tube 41 and the material forming the second tube 42 may be the same or different.

[0051] The length of the second portion 4b is preferably longer than the length of the first portion 4a in the longitudinal direction x of the metal tube 4. The length of the second tube 42 is preferably longer than the length of the first tube 41 in the longitudinal direction x of the metal tube 4. With the above configuration, torque can be easily transmitted to the tip member 2.

[0052] 2, the first tube 41 may have an inner surface 412 facing the lumen 411 of the first tube 41 and an outer surface 413 facing the outside of the first tube 41. In the longitudinal direction x of the metal tube 4, the first tube 41 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the first tube 41 are open.

[0053] The first tube 41 may have a hollow cylindrical shape, a hollow polygonal prism shape, or the like.

[0054] The length of the first tube 41 in the longitudinal direction x of the metal tube 4 can be 100 mm or more, 130 mm or more, 160 mm or more, etc. The length of the first tube 41 in the longitudinal direction x of the metal tube 4 can be 300 mm or less, 270 mm or less, 240 mm or less, etc. The length of the first tube 41 in the longitudinal direction x of the metal tube 4 refers to the longest length of the first tube 41 in the longitudinal direction x of the metal tube 4.

[0055] The length of the first tube 41 in the radial direction y of the metal tube 4 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the first tube 41 in the radial direction y of the metal tube 4 can be 20 mm or less, 15 mm or less, 10 mm or less, etc. The length of the first tube 41 in the radial direction y of the metal tube 4 refers to the longest length of the first tube 41 in the radial direction y of the metal tube 4.

[0056] 2 , the lumen 411 of the first tube 41 preferably communicates with the lumen of the tip member 2. This makes it possible to transport liquids such as cell preparations and drug solutions to the tip member 2 via the lumen 411 of the first tube 41. When a puncture needle 3 (described later) is used as the tip member 2, the lumen 411 of the first tube 41 preferably communicates with the lumen 11 of the tubular member 10.

[0057] 2, the second tube 42 may have an inner surface 422 facing the lumen 421 of the second tube 42 and an outer surface 423 facing the outside of the second tube 42. In the longitudinal direction x of the metal tube 4, the second tube 42 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the second tube 42 are open.

[0058] The second tube 42 may have a shape such as a hollow cylinder or a hollow polygonal column.

[0059] The length of the second tube 42 in the longitudinal direction x of the metal tube 4 can be 1000 mm or more, 1200 mm or more, 1400 mm or more, etc. The length of the second tube 42 in the longitudinal direction x of the metal tube 4 can be 2000 mm or less, 1800 mm or less, 1600 mm or less, etc. The length of the second tube 42 in the longitudinal direction x of the metal tube 4 refers to the longest length of the second tube 42 in the longitudinal direction x of the metal tube 4.

[0060] The length of the second tube 42 in the radial direction y of the metal tube 4 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the second tube 42 in the radial direction y of the metal tube 4 can be 20 mm or less, 15 mm or less, 10 mm or less, etc. The length of the second tube 42 in the radial direction y of the metal tube 4 refers to the longest length of the second tube 42 in the radial direction y of the metal tube 4.

[0061] It is preferable that the distal end of the second tube 42 is connected to the proximal end of the first tube 41. It is also preferable that the lumen 421 of the second tube 42 is in communication with the lumen 411 of the first tube 41. This makes it possible to transport liquids such as cell preparations and medicinal solutions to the tip member 2 via the lumen 411 of the first tube 41 and the lumen 421 of the second tube.

[0062] The tip member 2 is preferably a medical puncture needle 3 .

[0063] The puncture needle 3 is preferably one that is inserted into an internal organ.

[0064] The puncture needle 3 can have various shapes, such as a hollow cylinder or a hollow polygonal prism. However, as shown in FIGS. 1 to 5 , the puncture needle 3 preferably includes a tubular member 10 having a lumen 11 extending in the longitudinal direction x of the metal tube 4, and a helical member 20 in which a wire rod 21 is helically wound around the tubular member 10. The puncture needle 3 included in the catheter 100 includes the helical member 20 disposed around the tubular member 10. By rotating the puncture needle 3 around the tubular member 10, the puncture needle 3 can be easily threaded into the target tissue. This makes it easier to insert the puncture needle 3 into the target tissue. Furthermore, the wire rod 21 constituting the helical member 20 bites into the tissue, making it difficult for the puncture needle 3 to come out of the tissue. Furthermore, adjusting the rotation of the puncture needle 3 makes it easier to adjust the puncture depth.

[0065] The puncture needle 3 can be made of, for example, metal or resin. The puncture needle 3 may be made entirely of metal, or entirely of resin. The puncture needle 3 may be partly made of metal and the other partly made of resin.

[0066] The puncture needle 3 can be made of, for example, metal or resin. The puncture needle 3 may be made entirely of metal, or entirely of resin. The puncture needle 3 may be partially made of metal and other portions made of resin. The cylindrical member 10 and the spiral member 20 may be made of the same material, or may be made of different materials.

[0067] The puncture needle 3 is preferably made of only metal. Examples of metals that can be used to make the puncture needle 3 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni—Ti alloy, Co—Cr alloy, and combinations thereof.

[0068] Examples of resins that can be used to form the puncture needle 3 include polyether ether ketone (PEEK) and polycarbonate (PC). By forming the puncture needle 3 using only resin, without using any metal, the puncture needle 3 can be used by patients who are allergic to metals.

[0069] The length of the puncture needle 3 in the longitudinal direction x of the metal tube 4 can be 2 mm or more, 3 mm or more, 4 mm or more, etc. The length of the puncture needle 3 in the longitudinal direction x of the metal tube 4 can be 50 mm or less, 30 mm or less, 10 mm or less, etc. The length of the puncture needle 3 in the longitudinal direction x of the metal tube 4 refers to the longest length of the puncture needle 3 in the longitudinal direction x of the metal tube 4. When used as a catheter to puncture the myocardium, the length of the puncture needle 3 in the longitudinal direction x of the metal tube 4 is preferably 5 mm.

[0070] The length of the puncture needle 3 in the radial direction y of the metal tube 4 can be 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, etc. The length of the puncture needle 3 in the radial direction y of the metal tube 4 can be 10 mm or less, 5 mm or less, 1 mm or less, etc. The length of the puncture needle 3 in the radial direction y of the metal tube 4 refers to the longest length of the puncture needle 3 in the radial direction y of the metal tube 4. When used as a catheter to puncture the myocardium, the length of the puncture needle 3 in the radial direction y of the metal tube 4 is preferably 0.45 mm.

[0071] The tubular member 10 may have an inner surface 12 facing the lumen 11 of the tubular member 10 and an outer surface 13 facing the outside of the tubular member 10. In the longitudinal direction x of the metal tube 4, the tubular member 10 has a distal end 10d and a proximal end 10p. It is preferable that the distal end 10d of the tubular member 10 is closed and the proximal end 10p is open.

[0072] 1 to 5, the tubular member 10 preferably has a tapered section 15 whose outer diameter decreases toward the distal side, and a straight tube section 16 located proximal to the tapered section 15. In particular, it is preferable that the tapered section 15 is provided in a portion including the distal end 10d of the tubular member 10. This makes it easier to puncture the distal end of the tubular member 10 into the target tissue. In addition, this reduces wobble of the rotation axis when the puncture needle 3 is rotated in the circumferential direction of the metal tube 4, which tends to improve stability when the puncture needle 3 is punctured.

[0073] 1 and 2, it is preferable that a hole 14 is formed in the tubular member 10, which connects the inner cavity 11 of the tubular member 10 with the outside of the puncture needle 3. A liquid such as a cell preparation or a drug solution carried through the inner cavity 11 is carried to the target tissue through this hole 14.

[0074] It is preferable that the hole 14 be capable of discharging liquid from the lumen 11 of the tubular member 10 radially outward of the tubular member 10. For this reason, it is preferable that the hole 14 be located proximal to the distal end 10d of the tubular member 10 and distal to the proximal end 10p of the tubular member 10.

[0075] Only one hole 14 may be formed in the tubular member 10, or multiple holes 14 may be formed. When only one hole 14 is formed in the tubular member 10, it becomes easier to administer a liquid such as a cell preparation or a drug solution in a pinpoint manner. When multiple holes 14 are formed in the tubular member 10, it becomes easier to administer a liquid such as a cell preparation or a drug solution over a wide area.

[0076] The outer shape of the hole 14 when observed from a direction perpendicular to the longitudinal direction x of the metal tube 4 can be a polygonal shape such as a triangle, a rectangle, or a pentagon, a circle, an ellipse, or a combination of these. Note that polygons include polygons with clear corner vertices and straight sides, as well as rounded polygons with rounded corners and polygons with at least some curved sides.

[0077] The helical member 20 is formed by winding a wire 21 in a helical shape. By winding the wire 21, the wire 21 has an inner surface located on the inside and an outer surface located on the outside. The lumen formed on the inner surface side of the wire 21 is the lumen of the helical member 20. The helical member 20 can be configured to have an inner surface 22 facing the lumen of the helical member 20, and an outer surface 23 facing the outside of the helical member 20. In the longitudinal direction x of the metal tube 4, the helical member 20 has a distal end 20d and a proximal end.

[0078] The puncture needle 3 may be provided with only one spiral member 20 or with a plurality of spiral members 20 .

[0079] The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the metal tube 4 can be a polygonal shape such as a triangle, a rectangle, or a pentagon, a circle, an ellipse, or a combination thereof. In a cross section perpendicular to the longitudinal direction x of the metal tube 4, the cross-sectional shape of the wire 21 is preferably a polygonal shape, and more preferably a rectangle. The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the metal tube 4 may be the same from the distal end 21d to the proximal end of the wire 21. When the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the metal tube 4 is the same from the distal end 21d to the proximal end of the wire 21, the sizes of the cross-sectional shapes may be the same (congruent) or different (similar) depending on the position in the longitudinal direction x of the metal tube 4.

[0080] The cross-sectional shape of the wire rod 21 in a cross section perpendicular to the longitudinal direction x of the metal tube 4 may vary depending on the position in the longitudinal direction x of the metal tube 4. For example, the cross-sectional shape of the wire rod 21 in a cross section perpendicular to the longitudinal direction x of the metal tube 4 that passes through a midpoint of the metal tube 4 in the longitudinal direction x may be rectangular, and the cross-sectional shape of the wire rod 21 in a cross section perpendicular to the longitudinal direction x of the metal tube 4 that passes through a distal end of the wire rod 21 may be elliptical. Furthermore, the cross-sectional shape of the wire rod 21 in a cross section perpendicular to the longitudinal direction x of the metal tube 4 that passes through a midpoint of the metal tube 4 in the longitudinal direction x may be rectangular with two long sides that are arc-shaped.

[0081] As shown in Figures 2 to 4, the wire 21 preferably has a solid structure. The entire wire 21 may have a solid structure, or only a portion of the wire 21 may have a solid structure. In particular, it is more preferable that the entire distal end of the wire 21 has a solid structure. A solid structure makes it easier to reduce the diameter of the wire 21. Although not shown, a mode in which the wire 21 has a hollow structure is also acceptable. For example, the wire 21 may have an inner cavity extending along the central axis of the wire 21.

[0082] The wire 21 may be a solid wire or a stranded wire.

[0083] The distal end 20d of the spiral member 20 is preferably located proximal to the distal end 10d of the tubular member 10. The distal end 20d of the spiral member 20 may be located distal to the proximal end of the tapered portion 15 of the tubular member 10, but is more preferably located proximal to the proximal end of the tapered portion 15 of the tubular member 10. The wire rod 21 may be disposed only radially outward from the straight tube portion 16 of the tubular member 10, and the wire rod 21 may not be disposed radially outward from the tapered portion 15 of the tubular member 10. This configuration allows the distal end of the tubular member 10 to abut against the target tissue before the distal end of the spiral member 20. This makes it easier to rotate the puncture needle 3 around the tubular member 10 as an axis when rotating it circumferentially around the metal tube 4, thereby reducing wobble of the rotation axis and improving stability when inserting the puncture needle 3.

[0084] A portion of the tubular member 10 and a portion of the spiral member 20 may be fixed. More specifically, it is preferable that the proximal portion of the spiral member 20 be fixed to the proximal portion of the tubular member 10, and it is more preferable that the proximal end portion of the spiral member 20 be fixed to the proximal portion of the tubular member 10. This prevents the position of the spiral member 20 relative to the tubular member 10 from changing, making it easier to stably screw the puncture needle 3 into tissue. The tubular member 10 and the spiral member 20 may be indirectly fixed via another member, but it is preferable that a portion of the tubular member 10 and a portion of the spiral member 20 are directly fixed without via another member.

[0085] Direct fixation of the cylindrical member 10 and the spiral member 20 refers to the cylindrical member 10 and the spiral member 20 being fixed to each other without any other member in between. For example, fixing of the cylindrical member 10 and the spiral member 20 with an adhesive or fixing of the cylindrical member 10 and the spiral member 20 by welding falls under the category of direct fixation.

[0086] The indirect fixation of the cylindrical member 10 and the spiral member 20 refers to the fact that the cylindrical member 10 and the spiral member 20 are fixed via another member. For example, the fixation of the cylindrical member 10 and the spiral member 20 via a connecting member that connects the outer surface 13 of the cylindrical member 10 and the inner surface 22 of the spiral member 20 corresponds to the indirect fixation.

[0087] The proximal end of the helical member 20 refers to a portion of the helical member 20 that includes the proximal end and its surrounding area. The range of the proximal end of the helical member 20 may be, for example, the range described below. The range of the proximal end of the helical member 20 may be a range from the proximal end of the helical member 20 to a point one-third of the way distal to the proximal end of the helical member 20 when the helical member 20 is divided into thirds in the longitudinal direction x of the metal tube 4. The range of the proximal end of the helical member 20 may be a range from the proximal end of the helical member 20 to a point one-quarter of the way distal to the proximal end of the helical member 20 when the helical member 20 is divided into fourths in the longitudinal direction x of the metal tube 4. The range of the proximal end of the spiral member 20 may be from the proximal end of the spiral member 20 to a point 1 / 5 of the way distal to the proximal end of the spiral member 20 when the spiral member 20 is divided into five equal parts in the longitudinal direction x of the metal tube 4.

[0088] The inner diameter of the spiral member 20 may be four times or less, or may be three times or less, but is preferably two times or less, the outer diameter of the tubular member 10. This configuration tends to reduce the gap between the tubular member 10 and the spiral member 20, making it easier to screw the puncture needle 3 into the target tissue by rotating the puncture needle 3 around the tubular member 10 as an axis. The inner diameter of the spiral member 20 is preferably larger than the outer diameter of the tubular member 10, and can be 1.1 times or more, 1.2 times or more, 1.3 times or more, the outer diameter of the tubular member 10, etc.

[0089] In a cross section perpendicular to the longitudinal direction x of the metal tube 4 and passing through the midpoint of the metal tube 4 in the longitudinal direction x, the length of the wire rod 21 in the radial direction of the tubular member 10 is preferably shorter than the length of the wire rod 21 in the circumferential direction of the tubular member 10. The longer the length of the wire rod 21 in the radial direction of the tubular member 10, the easier it is to adjust the puncture depth; however, this may make it more difficult to insert the puncture needle 3 into the tissue, resulting in a longer puncture time. By adopting the above configuration, the length of the wire rod 21 in the radial direction of the tubular member 10 can be made relatively short, making it easier to adjust the puncture depth without making it too difficult to insert the puncture needle 3 into the tissue. The length of the wire rod 21 in the radial direction of the tubular member 10 refers to the longest length of the wire rod 21 in the radial direction of the tubular member 10. The length of the wire rod 21 in the circumferential direction of the tubular member 10 refers to the longest length of the wire rod 21 in the circumferential direction of the tubular member 10.

[0090] 1, the wire 21 preferably has a tapered shape extending from the distal end 21d of the wire 21 to a position that is half the length of the pitch of the spiral member 20 toward the proximal side from the distal end 21d of the wire 21. By having a tapered shape extending to the above position, the wire 21 can easily penetrate into the target tissue, making it easier to screw the puncture needle 3 into the target tissue.

[0091] 1, the outer diameter of the cylindrical member 10 is preferably smaller than the outer diameter of the metal tube 4. This allows the distal end of the metal tube 4 to hit the tissue and act as a stopper, making it easier for only the puncture needle 3 to puncture the tissue. This prevents the puncture needle 3 from puncturing the tissue too deeply.

[0092] It is preferable that the distal end of the metal tube 4 is connected to the puncture needle 3. The metal tube 4 and the puncture needle 3 may be connected via a reducing-diameter member 30. The reducing-diameter member 30 is a member whose outer diameter decreases toward the distal side. More specifically, as shown in Figures 1 and 2, it is preferable that the proximal end of the tubular member 10 and the distal end of the metal tube 4 are connected by the reducing-diameter member 30.

[0093] The reducing member 30 preferably has a lumen 31 penetrating the metal tube 4 in the longitudinal direction x. The reducing member 30 may have an inner surface facing the lumen 31 of the reducing member 30 and an outer surface facing the outside of the reducing member 30. In the longitudinal direction x of the metal tube 4, the reducing member 30 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the reducing member 30 are open. It is preferable that the lumen 31 of the reducing member 30 communicates with the lumen 11 of the tubular member 10 and the lumen 4c of the metal tube 4.

[0094] The reducing member 30 can be made of, for example, any of the materials exemplified as materials that can be used to make the puncture needle 3, but it is preferable that the reducing member 30 be made of metal. The material that makes up the puncture needle 3 and the material that makes up the reducing member 30 may be the same or different.

[0095] The shape of the diameter reducing member 30 may be, for example, a hollow polygonal truncated cone or a hollow truncated cone.

[0096] 5 , the catheter 100 may have a sheath 5 having an inner cavity into which the tip member 2 and the metal tube 4 can be inserted. It is preferable that the tip member 2 and the metal tube 4 are movable in the inner cavity of the sheath 5 in the longitudinal direction x of the metal tube 4.

[0097] The sheath 5 is preferably flexible because it is inserted into the body, allowing the sheath 5 to be deformed to conform to the shape of the body cavity. In addition, the sheath 5 is preferably elastic so as to maintain its shape.

[0098] Examples of the sheath 5 include a hollow body formed by arranging one or more wires in a predetermined pattern; a hollow body coated with a resin on at least one of the inner and outer surfaces; a resin tube; or a combination of these, such as a combination of these connected in the longitudinal direction. Examples of hollow bodies in which wires are arranged in a predetermined pattern include a tubular body having a mesh structure formed by simply crossing or weaving wires, and a coil formed by winding wires. The wires may be one or more solid wires or one or more twisted wires. The resin tube can be manufactured, for example, by extrusion molding. When the sheath 5 is a resin tube, the sheath 5 can be composed of a single layer or multiple layers. A portion of the sheath 5 in the longitudinal or circumferential direction may be composed of a single layer, and the other portion may be composed of multiple layers.

[0099] The sheath 5 can be made of, for example, a synthetic resin such as polyolefin resin (e.g., polyethylene or polypropylene), polyamide resin (e.g., nylon), polyester resin (e.g., PET), aromatic polyether ketone resin (e.g., PEEK), polyether polyamide resin, polyurethane resin, polyimide resin, or fluororesin (e.g., PTFE, PFA, or ETFE), or a metal such as stainless steel, carbon steel, or nickel-titanium alloy. These may be used alone or in combination of two or more.

[0100] 5, the catheter 100 may have a handle 6 having a lumen into which the metal tube 4 is inserted. The handle 6 is a part that is held by the user, and is preferably shaped to be easily held by the user. The handle 6 is preferably connected to the proximal end of the sheath 5.

[0101] The material of which the handle 6 is made is not particularly limited, but examples thereof include polyolefin resins such as polypropylene (PP) and polyethylene (PE), polyester resins such as polyethylene terephthalate (PET), polycarbonate resin, ABS resin, and polyurethane resin.

[0102] 5, the distal end member 2 is preferably delivered to the internal organ to be treated while being placed in the lumen of the sheath 5. After delivery, it is preferable to move the position of the distal end member 2 distally relative to the sheath 5, protrude the distal end of the sheath 5, and perform treatment with the distal end member 2.

[0103] (Puncture Catheter) Next, a puncture catheter according to an embodiment of the present invention will be described.

[0104] One embodiment of the puncture catheter according to the present invention comprises a medical puncture needle having a longitudinal direction, a first tube having an inner lumen extending in the longitudinal direction of the puncture needle, with multiple grooves formed therein, and connected to the proximal end of the puncture needle, and a second tube having an inner lumen extending in the longitudinal direction of the puncture needle, with multiple grooves formed therein, and connected to the proximal end of the first tube, wherein the sum of the lengths of the grooves per unit area formed in the first tube is greater than the sum of the lengths of the grooves per unit area formed in the second tube.

[0105] The overall configuration of a puncture catheter according to an embodiment of the present invention will be described with reference to Figures 6 to 10. Figures 6 to 10 show a puncture catheter 200 having a puncture needle 3, a first tube 41, and a second tube 42. In these drawings, the longitudinal direction of the puncture needle 3 is indicated by s, and the radial direction of the puncture needle 3 is indicated by t. The radial direction t is a direction perpendicular to the longitudinal direction s. The longitudinal direction s of the puncture needle 3 can also be said to be the extension direction of the puncture needle 3. In addition, the puncture needle 3 has a circumferential direction.

[0106] In the description of the puncture catheter, the proximal side refers to the direction toward the user's hand relative to the longitudinal direction s of the puncture needle 3, and the distal side refers to the opposite side of the proximal side, i.e., the direction toward the treatment target. Furthermore, when each component is divided into two equal parts along the longitudinal direction s of the puncture needle 3, the distal portion of each component is referred to as the distal section, and the proximal portion of each component is referred to as the proximal section. The distal end of each component is the end located most distally of each component. The proximal end of each component is the end located most proximal of each component. The end of each component refers to the portion including the end of each component and its periphery. In other words, the distal end of each component refers to the portion including the distal end of each component and its periphery, and the proximal end of each component refers to the portion including the proximal end of each component and its periphery.

[0107] Fig. 6 is a side view showing an example of a puncture catheter according to an embodiment of the present invention. Fig. 7 is a cross-sectional view of the puncture catheter shown in Fig. 6. Figs. 8 and 9 are cross-sectional views showing modified examples of the puncture catheter shown in Fig. 7. More specifically, Figs. 7 to 9 show cross sections passing through the central axis of the puncture needle and along the longitudinal direction of the puncture needle. Fig. 10 is a side view (partial cross-sectional view) showing a modified example of the puncture catheter according to an embodiment of the present invention.

[0108] As shown in FIGS. 6 to 10, the puncture catheter 200 has a puncture needle 3, a first tube 41, and a second tube .

[0109] The puncture needle 3 is for medical use and has a longitudinal direction s.

[0110] The first tube 41 is connected to the proximal end of the puncture needle 3. The first tube 41 has an inner cavity 411 extending in the longitudinal direction s of the puncture needle 3. A plurality of grooves 410 are formed in the first tube 41.

[0111] The second tube 42 is connected to the proximal end of the first tube 41. The second tube 42 has an inner cavity 421 extending in the longitudinal direction s of the puncture needle 3. A plurality of grooves 410 are formed in the second tube 42.

[0112] The total length of the grooves 410 per unit area formed in the first tube 41 is greater than the total length of the grooves 410 per unit area formed in the second tube 42. The length of the groove 410 refers to the length of the longest portion of the length of one groove 410 in the extension direction of that groove 410.

[0113] Forming the plurality of grooves 410 in the first tube 41 and the second tube 42 imparts flexibility to the first tube 41 and the second tube 42. The total length of the grooves 410 per unit area formed in the first tube 41 is greater than the total length of the grooves 410 per unit area formed in the second tube 42, which makes it easier to increase flexibility on the distal side. Furthermore, connecting the first tube 41 and the second tube 42, in which the plurality of grooves 410 are formed, to the puncture needle 3 makes it easier to transmit torque to the puncture needle 3.

[0114] The puncture catheter 200 is used to administer a liquid such as a cell preparation or a medicinal solution to a target tissue. Specifically, the puncture catheter 200 can be used to administer the liquid directly to an internal organ, such as the heart, kidney, or liver. For example, the puncture catheter 200 can be used to administer an iPS cell suspension directly to the liver or kidney, or to administer a cardiac regenerative cell preparation directly to the heart, or more specifically, to the myocardium.

[0115] The puncture needle 3 is preferably one that is inserted into an internal organ of the body. The internal organ refers to an organ located inside the body, particularly in the abdominal or thoracic region, and is also called an internal organ.

[0116] The puncture needle 3 can be of various shapes, such as a hollow cylinder or a hollow polygonal prism. However, as shown in FIGS. 6 to 10 , the puncture needle 3 preferably comprises a tubular member 10 having a lumen 11 extending in the longitudinal direction s and a spiral member 20 in which a wire rod 21 is spirally wound around the tubular member 10. The puncture needle 3 included in the puncture catheter 200 has the spiral member 20 disposed around the tubular member 10. By rotating the puncture needle 3 around the tubular member 10, the puncture needle 3 can be easily threaded into the target tissue. This makes it easier to insert the puncture needle 3 into the target tissue. Furthermore, the wire rod 21 constituting the spiral member 20 bites into the tissue, making it difficult for the puncture needle 3 to slip out of the tissue. Furthermore, adjusting the rotation of the puncture needle 3 makes it easier to adjust the puncture depth.

[0117] The puncture needle 3 can be made of, for example, metal or resin. The puncture needle 3 may be made entirely of metal, or entirely of resin. The puncture needle 3 may be partially made of metal and other portions made of resin. The cylindrical member 10 and the spiral member 20 may be made of the same material, or may be made of different materials.

[0118] The puncture needle 3 is preferably made of only metal. Examples of metals that can be used to make the puncture needle 3 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni—Ti alloy, Co—Cr alloy, and combinations thereof.

[0119] Examples of resins that can be used to form the puncture needle 3 include polyether ether ketone (PEEK) and polycarbonate (PC). By forming the puncture needle 3 using only resin, without using any metal, the puncture needle 3 can be used by patients who are allergic to metals.

[0120] The length of the puncture needle 3 in the longitudinal direction s of the puncture needle 3 can be 2 mm or more, 3 mm or more, 4 mm or more, etc. The length of the puncture needle 3 in the longitudinal direction s of the puncture needle 3 can be 50 mm or less, 30 mm or less, 10 mm or less, etc. The length of the puncture needle 3 in the longitudinal direction s of the puncture needle 3 refers to the longest length of the puncture needle 3 in the longitudinal direction s. When used as a puncture catheter to puncture the myocardium, the length of the puncture needle 3 in the longitudinal direction s of the puncture needle 3 is preferably 5 mm.

[0121] The length of the puncture needle 3 in the radial direction t of the puncture needle 3 can be 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, etc. The length of the puncture needle 3 in the radial direction t of the puncture needle 3 can be 10 mm or less, 5 mm or less, 1 mm or less, etc. The length of the puncture needle 3 in the radial direction t of the puncture needle 3 refers to the longest length of the puncture needle 3 in the radial direction t. When used as a puncture catheter to puncture the myocardium, the length of the puncture needle 3 in the radial direction t of the puncture needle 3 is preferably 0.45 mm.

[0122] The tubular member 10 can be configured to have an inner surface 12 facing the lumen 11 of the tubular member 10 and an outer surface 13 facing the outside of the tubular member 10. In the longitudinal direction s of the puncture needle 3, the tubular member 10 has a distal end 10d and a proximal end 10p. It is preferable that the distal end 10d of the tubular member 10 is closed and the proximal end 10p is open.

[0123] 6 to 10, the tubular member 10 preferably has a tapered section 15 whose outer diameter decreases toward the distal side, and a straight tube section 16 located proximal to the tapered section 15. In particular, it is preferable that the tapered section 15 is provided in a portion including the distal end 10d of the tubular member 10. This makes it easier to puncture the distal end of the tubular member 10 into the target tissue. In addition, this reduces wobble of the rotation axis when the puncture needle 3 is rotated in the circumferential direction of the puncture needle 3, which tends to improve stability when puncturing with the puncture needle 3.

[0124] 6 and 7, it is preferable that a hole 14 is formed in the tubular member 10, which connects the inner cavity 11 of the tubular member 10 with the outside of the puncture needle 3. Liquids such as cell preparations and drug solutions carried through the inner cavity 11 are carried to the target tissue through this hole 14.

[0125] It is preferable that the hole 14 be capable of discharging liquid from the lumen 11 of the tubular member 10 radially outward of the tubular member 10. For this reason, it is preferable that the hole 14 be located proximal to the distal end 10d of the tubular member 10 and distal to the proximal end 10p of the tubular member 10.

[0126] Only one hole 14 may be formed in the tubular member 10, or multiple holes 14 may be formed. When only one hole 14 is formed in the tubular member 10, it becomes easier to administer a liquid such as a cell preparation or a drug solution in a pinpoint manner. When multiple holes 14 are formed in the tubular member 10, it becomes easier to administer a liquid such as a cell preparation or a drug solution over a wide area.

[0127] The outer shape of the hole 14 when observed from a direction perpendicular to the longitudinal direction s of the puncture needle 3 can be a polygonal shape such as a triangle, a rectangle, or a pentagon, or a circle, an ellipse, or a combination of these. Note that polygons include polygons with clear corner vertices and straight sides, as well as rounded polygons with rounded corners and polygons with at least some of the sides curved.

[0128] The helical member 20 is formed by winding a wire 21 in a helical shape. By winding the wire 21, the wire 21 has an inner surface located on the inside and an outer surface located on the outside. The lumen formed on the inner surface side of the wire 21 is the lumen of the helical member 20. The helical member 20 can be configured to have an inner surface 22 facing the lumen of the helical member 20, and an outer surface 23 facing the outside of the helical member 20. In the longitudinal direction s of the puncture needle 3, the helical member 20 has a distal end 20d and a proximal end.

[0129] The puncture needle 3 may be provided with only one spiral member 20 or with a plurality of spiral members 20 .

[0130] The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction s of the puncture needle 3 can be a polygonal shape such as a triangle, a rectangle, or a pentagon, a circle, an ellipse, or a combination of these. In a cross section perpendicular to the longitudinal direction s of the puncture needle 3, the cross-sectional shape of the wire 21 is preferably a polygonal shape, and more preferably a rectangle. The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction s of the puncture needle 3 may be the same from the distal end 21d to the proximal end of the wire 21. When the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction s of the puncture needle 3 is the same from the distal end 21d to the proximal end of the wire 21, the sizes of the cross-sectional shapes may be the same (congruent) or different (similar) depending on the position in the longitudinal direction s of the puncture needle 3.

[0131] The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction s of the puncture needle 3 may vary depending on the position in the longitudinal direction s of the puncture needle 3. For example, the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction s of the puncture needle 3 and passing through the midpoint of the puncture needle 3 in the longitudinal direction s may be rectangular, and the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction s of the puncture needle 3 and passing through the distal end of the wire 21 may be elliptical. Furthermore, the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction s of the puncture needle 3 and passing through the midpoint of the puncture needle 3 in the longitudinal direction s may be rectangular with two long sides that are arc-shaped.

[0132] As shown in Figures 7 to 9, the wire 21 preferably has a solid structure. The entire wire 21 may have a solid structure, or only a portion of the wire 21 may have a solid structure. In particular, it is more preferable that the entire distal end of the wire 21 has a solid structure. A solid structure makes it easier to reduce the diameter of the wire 21. Although not shown, a mode in which the wire 21 has a hollow structure is also acceptable. For example, the wire 21 may have an inner cavity extending along the central axis of the wire 21.

[0133] The wire 21 may be a solid wire or a stranded wire.

[0134] The distal end 20d of the spiral member 20 is preferably located proximal to the distal end 10d of the tubular member 10. The distal end 20d of the spiral member 20 may be located distal to the proximal end of the tapered portion 15 of the tubular member 10, but is more preferably located proximal to the proximal end of the tapered portion 15 of the tubular member 10. The wire rod 21 may be disposed only radially outward from the straight tube portion 16 of the tubular member 10, and the wire rod 21 may not be disposed radially outward from the tapered portion 15 of the tubular member 10. With the above configuration, the distal end of the tubular member 10 can be brought into contact with the target tissue before the distal end of the spiral member 20. This makes it easier to rotate the puncture needle 3 around the tubular member 10 as an axis when rotating it in the circumferential direction of the puncture needle 3, thereby reducing wobble of the rotation axis and improving stability when inserting the puncture needle 3.

[0135] A portion of the tubular member 10 and a portion of the spiral member 20 may be fixed. More specifically, it is preferable that the proximal portion of the spiral member 20 be fixed to the proximal portion of the tubular member 10, and it is more preferable that the proximal end portion of the spiral member 20 be fixed to the proximal portion of the tubular member 10. This prevents the position of the spiral member 20 relative to the tubular member 10 from changing, making it easier to stably screw the puncture needle 3 into tissue. The tubular member 10 and the spiral member 20 may be indirectly fixed via another member, but it is preferable that a portion of the tubular member 10 and a portion of the spiral member 20 are directly fixed without via another member.

[0136] Direct fixation of the cylindrical member 10 and the spiral member 20 refers to the cylindrical member 10 and the spiral member 20 being fixed to each other without any other member in between. For example, fixing of the cylindrical member 10 and the spiral member 20 with an adhesive or fixing of the cylindrical member 10 and the spiral member 20 by welding falls under the category of direct fixation.

[0137] The indirect fixation of the cylindrical member 10 and the spiral member 20 refers to the fact that the cylindrical member 10 and the spiral member 20 are fixed via another member. For example, the fixation of the cylindrical member 10 and the spiral member 20 via a connecting member that connects the outer surface 13 of the cylindrical member 10 and the inner surface 22 of the spiral member 20 corresponds to the indirect fixation.

[0138] The proximal end of the helical member 20 refers to a portion of the helical member 20 that includes the proximal end and its surrounding area. The range of the proximal end of the helical member 20 may be, for example, the range described below. The range of the proximal end of the helical member 20 may be a range from the proximal end of the helical member 20 to a point one-third of the way distal to the proximal end of the helical member 20 when the helical member 20 is divided into three equal parts in the longitudinal direction s of the puncture needle 3. The range of the proximal end of the helical member 20 may be a range from the proximal end of the helical member 20 to a point one-quarter of the way distal to the proximal end of the helical member 20 when the helical member 20 is divided into four equal parts in the longitudinal direction s of the puncture needle 3. The range of the proximal end of the spiral member 20 may be from the proximal end of the spiral member 20 to a point 1 / 5 of the way distal to the proximal end of the spiral member 20 when the spiral member 20 is divided into five equal parts in the longitudinal direction s of the puncture needle 3.

[0139] The inner diameter of the spiral member 20 may be four times or less, or may be three times or less, but is preferably two times or less, the outer diameter of the tubular member 10. This configuration tends to reduce the gap between the tubular member 10 and the spiral member 20, making it easier to screw the puncture needle 3 into the target tissue by rotating the puncture needle 3 around the tubular member 10 as an axis. The inner diameter of the spiral member 20 is preferably larger than the outer diameter of the tubular member 10, and can be 1.1 times or more, 1.2 times or more, 1.3 times or more, the outer diameter of the tubular member 10, etc.

[0140] In a cross section perpendicular to the longitudinal direction s of the puncture needle 3 and passing through the midpoint of the longitudinal direction s of the puncture needle 3, the length of the wire rod 21 in the radial direction of the tubular member 10 is preferably shorter than the length of the wire rod 21 in the circumferential direction of the tubular member 10. The longer the length of the wire rod 21 in the radial direction of the tubular member 10, the easier it is to adjust the puncture depth; however, this may make it more difficult to insert the puncture needle 3 into the tissue, resulting in a longer puncture time. By adopting the above configuration, the length of the wire rod 21 in the radial direction of the tubular member 10 can be made relatively short, making it easier to adjust the puncture depth without making it too difficult to insert the puncture needle 3 into the tissue. The length of the wire rod 21 in the radial direction of the tubular member 10 refers to the longest length of the wire rod 21 in the radial direction of the tubular member 10. The length of the wire rod 21 in the circumferential direction of the tubular member 10 refers to the longest length of the wire rod 21 in the circumferential direction of the tubular member 10.

[0141] 6, the wire 21 preferably has a tapered shape extending from the distal end 21d of the wire 21 to a position that is half the length of the pitch of the spiral member 20 toward the proximal side from the distal end 21d of the wire 21. By having a tapered shape extending to the above position, the wire 21 can easily penetrate into the target tissue, making it easier to screw the puncture needle 3 into the target tissue.

[0142] 6, the outer diameter of the tubular member 10 is preferably smaller than the outer diameter of the first tube 41. This allows the distal end of the first tube 41 to hit the tissue and act as a stopper, making it easier for only the puncture needle 3 to puncture the tissue. This prevents the puncture needle 3 from puncturing the tissue too deeply.

[0143] It is preferable that the distal end of the first tube 41 is connected to the puncture needle 3. The first tube 41 and the puncture needle 3 may be connected via a reducing-diameter member 30. The reducing-diameter member 30 is a member whose outer diameter decreases toward the distal side. More specifically, as shown in Figures 6 and 7, it is preferable that the proximal end of the tubular member 10 and the distal end of the first tube 41 are connected by the reducing-diameter member 30.

[0144] The reducing diameter member 30 preferably has a lumen 31 that penetrates the puncture needle 3 in the longitudinal direction s. The reducing diameter member 30 can be configured to have an inner surface facing the lumen 31 of the reducing diameter member 30 and an outer surface facing the outside of the reducing diameter member 30. In the longitudinal direction s of the puncture needle 3, the reducing diameter member 30 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the reducing diameter member 30 are open. It is preferable that the lumen 31 of the reducing diameter member 30 communicates with the lumen 11 of the tubular member 10 and the lumen 411 of the first tube 41.

[0145] The reducing member 30 can be made of, for example, any of the materials exemplified as materials that can be used to make the puncture needle 3, but it is preferable that the reducing member 30 be made of metal. The material that makes up the puncture needle 3 and the material that makes up the reducing member 30 may be the same or different.

[0146] The shape of the diameter reducing member 30 may be, for example, a hollow polygonal truncated cone or a hollow truncated cone.

[0147] 7, the first tube 41 can be configured to have an inner surface 412 facing the lumen 411 of the first tube 41 and an outer surface 413 facing the outside of the first tube 41. In the longitudinal direction s of the puncture needle 3, the first tube 41 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the first tube 41 are open.

[0148] The first tube 41 may have a hollow cylindrical shape, a hollow polygonal prism shape, or the like.

[0149] The length of the first tube 41 in the longitudinal direction s of the puncture needle 3 can be 100 mm or more, 130 mm or more, 160 mm or more, etc. The length of the first tube 41 in the longitudinal direction s of the puncture needle 3 can be 300 mm or less, 270 mm or less, 240 mm or less, etc. The length of the first tube 41 in the longitudinal direction s of the puncture needle 3 refers to the longest length of the first tube 41 in the longitudinal direction s of the puncture needle 3.

[0150] The length of the first tube 41 in the radial direction t of the puncture needle 3 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the first tube 41 in the radial direction t of the puncture needle 3 can be 20 mm or less, 15 mm or less, 10 mm or less, etc. The length of the first tube 41 in the radial direction t of the puncture needle 3 refers to the longest length of the first tube 41 in the radial direction t of the puncture needle 3.

[0151] 7 , the lumen 411 of the first tube 41 preferably communicates with the lumen 11 of the puncture needle 3. This makes it possible to transport liquids such as cell preparations and medicinal solutions to the puncture needle 3 via the lumen 411 of the first tube 41.

[0152] 7, the second tube 42 can be configured to have an inner surface 422 facing the lumen 421 of the second tube 42 and an outer surface 423 facing the outside of the second tube 42. In the longitudinal direction s of the puncture needle 3, the second tube 42 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the second tube 42 are open.

[0153] The second tube 42 may have a shape such as a hollow cylinder or a hollow polygonal column.

[0154] The length of the second tube 42 in the longitudinal direction s of the puncture needle 3 can be 1000 mm or more, 1200 mm or more, 1400 mm or more, etc. The length of the second tube 42 in the longitudinal direction s of the puncture needle 3 can be 2000 mm or less, 1800 mm or less, 1600 mm or less, etc. The length of the second tube 42 in the longitudinal direction s of the puncture needle 3 refers to the longest length of the second tube 42 in the longitudinal direction s of the puncture needle 3.

[0155] The length of the second tube 42 in the radial direction t of the puncture needle 3 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the second tube 42 in the radial direction t of the puncture needle 3 can be 20 mm or less, 15 mm or less, 10 mm or less, etc. The length of the second tube 42 in the radial direction t of the puncture needle 3 refers to the longest length of the second tube 42 in the radial direction t of the puncture needle 3.

[0156] It is preferable that the distal end of the second tube 42 is connected to the proximal end of the first tube 41. It is also preferable that the lumen 421 of the second tube 42 is in communication with the lumen 411 of the first tube 41. This makes it possible to transport liquids such as cell preparations and medicinal solutions to the puncture needle 3 via the lumen 411 of the first tube 41 and the lumen 421 of the second tube.

[0157] The plurality of grooves 410 provided in the first tube 41 may be bottomed grooves as shown in FIG. 7 or through grooves as shown in FIGS. 8 and 9 . The first tube 41 may be provided with both through grooves and bottomed grooves. The plurality of grooves 410 provided in the second tube 42 may be bottomed grooves as shown in FIG. 7 or through grooves as shown in FIGS. 8 and 9 . The second tube 42 may be provided with both through grooves and bottomed grooves. By combining through grooves and bottomed grooves or selecting either one of them for the grooves 410 provided in the first tube 41 or the second tube 42, the first tube 41 or the second tube 42 can be easily provided with desired flexibility and rigidity.

[0158] The first tube 41 and the second tube 42 may be made of metal or resin. The first tube 41 and the second tube 42 may be partially made of metal and the other portion made of resin. The first tube 41 and the second tube 42 may be made of the same material or may be made of different materials.

[0159] Examples of resins that can be used to form the first tube 41 and the second tube 42 include polyether ether ketone (PEEK) and polycarbonate (PC). The resin that forms the first tube 41 and the resin that forms the second tube 42 may be the same or different.

[0160] The first tube 41 and the second tube 42 are preferably made of metal. Examples of metals that can be used to make the first tube 41 and the second tube 42 include stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, Co-Cr alloys, and combinations thereof. The metals that make up the first tube 41 and the second tube 42 may be the same or different.

[0161] The length of one groove 410 formed in the first tube 41 in the extension direction of the groove 410 may be shorter or longer than the outer circumferential length of the first tube 41. The length of one groove 410 in the extension direction of the groove 410 refers to the longest length of the one groove 410 in the extension direction of the groove 410.

[0162] The length of one groove 410 formed in the second tube 42 in the extension direction of the groove 410 may be shorter or longer than the outer circumferential length of the second tube 42. The length of one groove 410 in the extension direction of the groove 410 refers to the longest length of the lengths of the groove 410 in the extension direction.

[0163] As shown in Figures 6 to 9, the multiple grooves 410 may be arranged in a spiral shape. As shown in Figures 6 to 9, one groove 410 may exist on an extension line of another groove. As shown in Figures 6 to 9, an end of one groove 410 in the extension direction of the groove 410 may face an end of another groove 410 in the extension direction of the groove 410.

[0164] As shown in Fig. 6, the plurality of grooves 410 are preferably arranged in a spiral shape at a pitch smaller than the length of the grooves 410. The plurality of grooves 410 are preferably arranged in a spiral shape at a pitch smaller than the length of the grooves 410 in the extension direction of the grooves 410. This makes it easier to transmit torque to the puncture needle 3. Note that Fig. 6 shows the spiral pitch P.

[0165] As shown in Fig. 10 , the multiple grooves 410 do not have to be arranged in a spiral shape. As shown in Fig. 10 , one groove 410 does not have to be on an extension line of another groove 410. As shown in Fig. 10 , the end of one groove 410 in the extension direction of the groove 410 does not have to face the end of the other groove 410 in the extension direction of the groove 410.

[0166] 8, an outer resin layer 4e is preferably provided on the outer surface 413 of the first tube 41 and the outer surface 423 of the second tube 42. This allows liquids such as cell preparations and medicinal solutions to be transported to the puncture needle 3 via the lumen 411 of the first tube 41 and the lumen 421 of the second tube 42, regardless of whether the grooves 410 formed in the first tube 41 and the second tube 42 are through grooves or bottomed grooves. It is more preferable that the grooves 410 are through grooves that penetrate from the lumen 411 of the first tube 41 and the lumen 421 of the second tube 42 to the inner surface of the outer resin layer 4e in the radial direction t of the puncture needle 3.

[0167] The outer resin layer 4e may be provided so as to cover the entire outer surface 413 of the first tube 41 and the outer surface 423 of the second tube 42, or may be provided so as to cover only a portion of the outer surface 413 of the first tube 41 and the outer surface 423 of the second tube 42. As shown in Fig. 8 , the outer resin layer 4e may also be provided on the groove 410.

[0168] 9 , an inner resin layer 4f is preferably provided on the inner surface 412 of the first tube 41 and the inner surface 422 of the second tube 42. This allows liquids such as cell preparations and medicinal solutions to be transported to the puncture needle 3 via the lumen 411 of the first tube 41 and the lumen 421 of the second tube 42, regardless of whether the grooves 410 formed in the first tube 41 and the second tube 42 are through grooves or bottomed grooves. It is more preferable that the grooves 410 are through grooves that penetrate from the outside of the first tube 41 and the second tube 42 to the outer surface of the inner resin layer 4f in the radial direction t of the puncture needle 3.

[0169] Although not shown, the puncture catheter 200 may be provided with an outer resin layer 4e and an inner resin layer 4f. That is, the outer resin layer 4e may be provided on the outer surface 413 of the first tube 41 and the outer surface 423 of the second tube 42, and the inner resin layer 4f may be provided on the inner surface 412 of the first tube 41 and the inner surface 422 of the second tube 42. This allows liquids such as cell preparations and medicinal solutions to be transported to the puncture needle 3 via the lumen 411 of the first tube 41 and the lumen 421 of the second tube 42, regardless of whether the grooves 410 formed in the first tube 41 and the second tube 42 are through grooves or bottomed grooves. The grooves 410 are preferably through grooves that penetrate from the inner surface of the outer resin layer 4e to the outer surface of the inner resin layer 4f in the radial direction t of the puncture needle 3.

[0170] The outer resin layer 4e and the inner resin layer 4f can be made of synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyether ketone resins (e.g., PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, fluororesins (e.g., PTFE, PFA, ETFE), etc. The resins constituting the outer resin layer 4e and the resins constituting the inner resin layer 4f may be the same or different.

[0171] 6 to 10 , it is not necessary for grooves to be formed on the radially inner side of the first tube 41, the radially inner side of the second tube 42, the radially outer side of the first tube 41, or the radially outer side of the second tube 42. Grooves may not be formed in tubes or layers in contact with the first tube 41 or the second tube 42, or in tubes or layers stacked on the first tube 41 or the second tube 42. It is also permissible to provide a configuration in which grooves are formed on at least one of the radially inner side of the first tube 41, the radially inner side of the second tube 42, the radially outer side of the first tube 41, or the radially outer side of the second tube 42, or to provide grooves in tubes or layers in contact with the first tube 41 or the second tube 42, or in tubes or layers stacked on the first tube 41 or the second tube 42.

[0172] It is preferable that the shortest distance between adjacent grooves 410 formed in the first tube 41 in the longitudinal direction s of the puncture needle 3 is shorter than the shortest distance between adjacent grooves 410 formed in the second tube 42 in the longitudinal direction s of the puncture needle 3. This makes it easier to increase the flexibility of the first tube 41, which is located distal to the second tube 42, and therefore makes it easier to improve the operability of the puncture catheter 200.

[0173] 6, the plurality of grooves 410 formed in the first tube 41 are preferably arranged in a spiral pattern. The plurality of grooves 410 formed in the second tube 42 are preferably arranged in a spiral pattern with a larger pitch than the first tube 41. This makes it easier to transmit torque to the puncture needle 3.

[0174] 6 , when observed from a direction perpendicular to the longitudinal direction s of the puncture needle 3, the angle α between the extension direction of the groove 410 formed in the first tube 41 and the longitudinal direction s of the puncture needle 3 is preferably larger than the angle β between the extension direction of the groove 410 formed in the second tube 42 and the longitudinal direction s of the puncture needle 3. This makes it easier to transmit torque to the puncture needle 3.

[0175] 6 , when observed from a direction perpendicular to the longitudinal direction s of the puncture needle 3, the angle α between the extension direction of the groove 410 formed in the first tube 41 and the longitudinal direction s of the puncture needle 3 is preferably 70° or more, more preferably 73° or more, and even more preferably 75° or more. When observed from a direction perpendicular to the longitudinal direction s of the puncture needle 3, the angle α between the extension direction of the groove 410 formed in the first tube 41 and the longitudinal direction s of the puncture needle 3 is preferably 85° or less, more preferably 83° or less, and even more preferably 80° or less. Setting the angle α within the above range makes it easier to transmit torque to the puncture needle 3.

[0176] 6 , when observed from a direction perpendicular to the longitudinal direction s of the puncture needle 3, the angle β between the extension direction of the groove 410 formed in the second tube 42 and the longitudinal direction s of the puncture needle 3 is preferably 55° or more, more preferably 57° or more, and even more preferably 59° or more. When observed from a direction perpendicular to the longitudinal direction s of the puncture needle 3, the angle β between the extension direction of the groove 410 formed in the second tube 42 and the longitudinal direction s of the puncture needle 3 is preferably 65° or less, more preferably 63° or less, and even more preferably 61° or less. By setting the angle β within the above range, torque can be easily transmitted to the puncture needle 3.

[0177] In the longitudinal direction s of the puncture needle 3, the length of the second tube 42 is preferably longer than the length of the first tube 41. With the above configuration, torque can be easily transmitted to the puncture needle 3.

[0178] 10 , the puncture catheter 200 may have a sheath 5 having an inner cavity into which the puncture needle 3, the first tube 41, and the second tube 42 can be inserted. It is preferable that the puncture needle 3, the first tube 41, and the second tube 42 be movable in the inner cavity of the sheath 5 in the longitudinal direction s of the puncture needle 3.

[0179] The sheath 5 is preferably flexible because it is inserted into the body, allowing the sheath 5 to be deformed to conform to the shape of the body cavity. In addition, the sheath 5 is preferably elastic so as to maintain its shape.

[0180] Examples of the sheath 5 include a hollow body formed by arranging one or more wires in a predetermined pattern; a hollow body coated with a resin on at least one of the inner and outer surfaces; a resin tube; or a combination of these, such as a combination of these connected in the longitudinal direction. Examples of hollow bodies in which wires are arranged in a predetermined pattern include a tubular body having a mesh structure formed by simply crossing or weaving wires, and a coil formed by winding wires. The wires may be one or more solid wires or one or more twisted wires. The resin tube can be manufactured, for example, by extrusion molding. When the sheath 5 is a resin tube, the sheath 5 can be composed of a single layer or multiple layers. A portion of the sheath 5 in the longitudinal or circumferential direction may be composed of a single layer, and the other portion may be composed of multiple layers.

[0181] The sheath 5 can be made of, for example, a synthetic resin such as polyolefin resin (e.g., polyethylene or polypropylene), polyamide resin (e.g., nylon), polyester resin (e.g., PET), aromatic polyether ketone resin (e.g., PEEK), polyether polyamide resin, polyurethane resin, polyimide resin, or fluororesin (e.g., PTFE, PFA, or ETFE), or a metal such as stainless steel, carbon steel, or nickel-titanium alloy. These may be used alone or in combination of two or more.

[0182] 10, the puncture catheter 200 may have a handle 6 having a lumen into which the second tube 42 is inserted. The handle 6 is a part that is held by the user, and is preferably shaped to be easily held by the user. The handle 6 is preferably connected to the proximal end of the sheath 5.

[0183] The material of which the handle 6 is made is not particularly limited, but examples thereof include polyolefin resins such as polypropylene (PP) and polyethylene (PE), polyester resins such as polyethylene terephthalate (PET), polycarbonate resin, ABS resin, and polyurethane resin.

[0184] 10 , the puncture needle 3 is preferably delivered to the internal organ to be treated while being placed in the lumen of the sheath 5. After delivery, it is preferable to move the position of the puncture needle 3 distally relative to the sheath 5, and then project the puncture needle 3 from the distal end of the sheath 5 to puncture the organ.

[0185] This application claims the benefit of priority based on Japanese Patent Application Nos. 2024-005415 and 2024-005416, filed on January 17, 2024. The entire contents of the specifications of Japanese Patent Application Nos. 2024-005415 and 2024-005416, filed on January 17, 2024, are incorporated herein by reference.

[0186] 2: Tip member 3: Puncture needle 4: Metal tube 4a: First portion 4b: Second portion 4c: Lumen of metal tube 4d: Distal end of metal tube 4e: Outer resin layer 4f: Inner resin layer 4g: Inner surface of metal tube 4h: Outer surface of metal tube 4p: Proximal end of metal tube 5: Sheath 6: Handle 10: Cylindrical member 10d: Distal end of tubular member 10p: Proximal end of tubular member 11: Lumen of tubular member 12: Inner surface of tubular member 13: Outer surface of tubular member 14: Hole 15: Tapered portion 16: Straight tube portion 20: Helical member 20d: Distal end of helical member 21: Wire 21d: Distal end of wire 22: Inner surface of helical member 23: Outer surface of helical member 30: Reducing member 31: Lumen of reducing member 41: First tube 410: Groove 411: Lumen of first tube 412: Inner surface of first tube 413: Outer surface of first tube 42: Second tube 421: Lumen of second tube 422: Inner surface of second tube 423: Outer surface of second tube 100: Catheter 200: Puncture catheter

Claims

1. A catheter having a metal tube with a longitudinal direction and a lumen extending in the longitudinal direction, and a tip member connected to the distal end of the metal tube, wherein a plurality of helically extending grooves are formed in the metal tube, and the plurality of grooves are arranged in the longitudinal direction.

2. The catheter according to claim 1, wherein the groove is a bottomed groove or a through groove.

3. The catheter according to claim 1, having an outer resin layer provided on the outer surface of the metal tube, and the groove is a through groove that penetrates in the radial direction of the metal tube from the lumen of the metal tube to the inner surface of the outer resin layer.

4. The catheter according to claim 1, having an inner resin layer provided on the inner surface of the metal tube, and the groove is a through groove that penetrates in the radial direction of the metal tube from the outside of the metal tube to the outer surface of the inner resin layer.

5. The catheter according to any one of claims 1 to 4, wherein no tube having grooves formed radially inward and radially outward of the metal tube is provided.

6. The catheter according to any one of claims 1 to 4, wherein the plurality of grooves are arranged helically at a pitch smaller than the length of the groove.

7. The metal tube has a first portion and a second portion located proximal to the first portion, wherein in the first portion, the plurality of grooves are arranged helically, and in the second portion, the plurality of grooves are arranged helically at a pitch larger than that of the first portion. The catheter according to any one of claims 1 to 4.

8. The catheter according to claim 7, wherein when observed from a direction perpendicular to the longitudinal direction, the angle at which the extending direction of the groove formed in the first portion intersects the longitudinal direction is 70° or more and 85° or less.

9. The catheter according to claim 7, wherein when observed from a direction perpendicular to the longitudinal direction, the angle at which the extending direction of the groove formed in the second portion intersects the longitudinal direction is 55° or more and 65° or less.

10. The catheter according to claim 7, wherein the first portion is constituted by a first tube, and the second portion is constituted by a second tube connected to the proximal end of the first tube.

11. The tip member is a medical puncture needle, and the puncture needle includes a tubular member having a lumen extending in the longitudinal direction, and a helical member in which a wire is helically wound around the tubular member. The catheter according to any one of claims 1 to 4.

12. A medical puncture needle having a longitudinal direction, a first tube having a lumen extending in the longitudinal direction, a plurality of grooves formed therein, and connected to the proximal end of the puncture needle, and a second tube having a lumen extending in the longitudinal direction, a plurality of grooves formed therein, and connected to the proximal end of the first tube. The total length of the grooves per unit area formed in the first tube is greater than the total length of the grooves per unit area formed in the second tube. A puncture catheter.

13. The plurality of grooves provided in the first tube are bottomed grooves or through grooves, and the plurality of grooves provided in the second tube are bottomed grooves or through grooves. The puncture catheter according to claim 12.

14. The first tube and the second tube are made of metal. The puncture catheter according to claim 12.

15. An outer resin layer is provided on the outer surface of the first tube and on the outer surface of the second tube. The puncture catheter according to claim 14.

16. An inner resin layer is provided on the inner surface of the first tube and on the inner surface of the second tube. The puncture catheter according to claim 14.

17. The shortest distance between adjacent grooves in the longitudinal direction formed in the first tube is shorter than the shortest distance between adjacent grooves in the longitudinal direction formed in the second tube. The puncture catheter according to claim 12.

18. The plurality of grooves formed in the first tube are arranged helically, and the plurality of grooves formed in the second tube are arranged helically with a pitch larger than that of the first tube. The puncture catheter according to claim 12.

19. The puncture needle includes a tubular member having a lumen extending in the longitudinal direction, and a helical member in which a wire is helically wound around the tubular member. The puncture catheter according to any one of claims 12 to 18.

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