Puncture needle, and puncture catheter provided with puncture needle

Abstract

Provided is a medical puncture needle (3) having a longitudinal direction (x), the puncture needle (3) having a cylindrical part (1) having a lumen extending in the longitudinal direction (x) of the puncture needle (3), and a protrusion (2) protruding radially outwards from the cylindrical part (1) in a cross section perpendicular to the longitudinal direction (x) of the puncture needle (3), the protrusion (2) spirally extending around the cylindrical part (1). Also provided is a puncture catheter (100) provided with the puncture needle (3).

Description

Puncture needle and puncture catheter equipped with the needle

[0001] The present invention relates to a medical puncture needle and a puncture catheter equipped with the puncture needle.

[0002] Treatments such as direct administration of a medicinal solution such as a myocardial regenerative cell preparation to cardiomyocytes that are losing function due to myocardial infarction or the like are being performed to regenerate cardiomyocytes. 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 have been developed as needles 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 comprising 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. The catheter 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, the needle described in Patent Document 1 has problems such as the needle easily coming out of the tissue after puncturing, and it being difficult to finely adjust the puncture depth.

[0007] The needle described in Patent Document 2 has a problem in that the central axis is unstable when rotated, making it difficult to puncture the target tissue.

[0008] The present invention has been made in consideration of the above circumstances, and its purpose is to provide a puncture needle that is easy to puncture target tissue, is difficult to remove from the target tissue, and allows easy adjustment of the puncture depth, and a puncture catheter equipped with the puncture needle.

[0009] Puncture needles according to embodiments of the present invention that can solve the above problems are as follows: [1] A medical puncture needle having a longitudinal direction, comprising: a tubular portion having an inner cavity extending in the longitudinal direction, and a ridge portion that protrudes radially outward from the tubular portion in a cross section perpendicular to the longitudinal direction, and the ridge portion extends spirally around the tubular portion.

[0010] The above-mentioned puncture needle has a ridge portion provided around the cylindrical portion, so that the puncture needle can be easily screwed into the target tissue by rotating the puncture needle around the cylindrical portion as an axis. This makes it easier to insert the puncture needle into the target tissue. In addition, the ridge portion bites into the tissue, making it difficult for the puncture needle to come out of the tissue. Furthermore, adjusting the rotation of the puncture needle makes it easier to adjust the puncture depth.

[0011] The puncture needle according to the embodiment of the present invention is preferably any one of the following [2] to

[18] . [2] The puncture needle according to [1], wherein the convex rib portion is formed by a helical member in which a wire is wound helically, and the tubular portion is formed by a tubular member arranged inside the helical member. [3] The puncture needle according to [2], wherein the inner surface of the helical member and the outer surface of the tubular member abut each other. [4] The puncture needle according to [2], wherein the inner surface of the helical member and the outer surface of the tubular member are fixed by adhesive or welding. [5] The puncture needle according to [2], wherein the convex rib portion is formed by the helical member and a connecting member connected to the inner surface of the helical member, and the outer surface of the tubular member is connected to the inner surface of the helical member via the connecting member. [6] The puncture needle according to any one of [2] to [5], wherein the tubular member has a wire-arranged region in which the wire is arranged radially outward of the tubular member and a wire-free region in which the wire is not arranged radially outward of the tubular member, and a hole connecting the inner cavity of the tubular member to the outside of the puncture needle is formed in the wire-free region of the tubular member. [7] The puncture needle according to [6], wherein the hole is not formed in the wire-arranged region of the tubular member. [8] The puncture needle according to any one of [2] to [7], wherein the inner diameter of the spiral member is no more than twice the outer diameter of the tubular member. [9] The puncture needle according to any one of [2] to [8], wherein the distal end of the wire has a tapered shape.

[10] The puncture needle according to any one of [2] to [9], wherein, in a cross section perpendicular to the longitudinal direction and passing through a midpoint in the longitudinal direction of the puncture needle, the length of the wire material in the radial direction of the tubular member is shorter than the length of the wire material in the circumferential direction of the tubular member.

[11] The puncture needle according to any one of [2] to

[10] , wherein the wire material has a section in which the value obtained by dividing the length of the wire material in the circumferential direction of the tubular member measured in the cross section perpendicular to the longitudinal direction by the length of the wire material in the radial direction of the tubular member measured in the cross section decreases toward the distal side.

[12] The puncture needle according to [9], wherein the tapered shape extends from the distal end of the wire to a position proximally away from the distal end of the wire by a length equal to half the pitch of the helical member.

[13] The puncture needle according to [1], wherein the tubular portion and the ridge portion are integrally molded.

[14] The puncture needle according to any one of [1] to

[13] , wherein, in a cross section perpendicular to the longitudinal direction, the cross-sectional shape of the ridge portion is polygonal, triangular, or tapered, becoming smaller radially outward from the tubular portion.

[15] The puncture needle according to any one of [1] to

[14] , wherein the distal end of the ridge portion is located proximal to the distal end of the tubular portion.

[16] The puncture needle according to any one of [1] to

[15] , wherein the tubular portion has a hole communicating the lumen of the tubular portion with the outside of the puncture needle.

[17] The puncture needle according to any one of [1] to

[16] , wherein the tubular portion has a tapered portion whose outer diameter decreases toward the distal side and a straight portion located proximal to the tapered portion.

[18] The puncture needle according to any one of [1] to

[17] , wherein the entire convex rib portion has a solid structure.

[0012] The present invention also includes the following puncture catheters.

[19] A puncture catheter having the puncture needle according to any one of [1] to

[18] .

[20] The puncture catheter according to

[19] , comprising a first tube having an inner lumen extending in the longitudinal direction and connected to the proximal end of the puncture needle, the first tube having a plurality of grooves formed therein.

[21] The puncture catheter according to

[20] , wherein the first tube is made of metal.

[22] The puncture catheter according to

[20] or

[21] , wherein a first resin layer made of resin is provided on the outer surface of the first tube.

[23] The puncture catheter according to any one of

[20] to

[22] , wherein, when observed from a direction perpendicular to the longitudinal direction, the extension direction of the grooves intersects with the longitudinal direction at an angle α.

[24] The puncture catheter according to

[23] , wherein the angle α is 70° or more and 85° or less.

[25] The puncture catheter according to any one of

[20] to

[24] , wherein the plurality of grooves includes a first groove and a second groove located at a position different from that of the first groove, and wherein the second groove is located in the extension direction of the first groove when observed from a direction perpendicular to the longitudinal direction.

[26] The puncture catheter according to

[25] , wherein the maximum length between the first groove and the second groove in the extension direction of the first groove is shorter than the maximum length of the first groove in the extension direction of the first groove.

[27] The puncture catheter according to

[25] or

[26] , wherein the plurality of grooves includes a third groove located adjacent to the first groove in the longitudinal direction, and wherein the maximum length between the first groove and the third groove in the longitudinal direction is shorter than the length of the helical pitch of the ridge portion.

[0013] The puncture needle according to the embodiment of the present invention has a ridged portion around the tubular portion. This makes it easy to puncture the target tissue, makes it difficult for the needle to slip out of the target tissue, and makes it easy to adjust the puncture depth. A puncture catheter equipped with this puncture needle also has the same effects.

[0014] FIG. 1 is a side view showing an example of a puncture needle according to an embodiment of the present invention. FIG. 2 is a cross-sectional view of the puncture needle shown in FIG. 1. FIG. 3 is a cross-sectional end view taken along line III-III in FIG. 1. FIG. 4 is a cross-sectional end view showing a modified example of the puncture needle shown in FIG. 3. FIG. 5 is a cross-sectional end view showing a modified example of the puncture needle shown in FIG. 3. FIG. 6 is a side view showing a modified example of the puncture needle shown in FIG. 1. FIG. 7 is a cross-sectional view of the puncture needle shown in FIG. 6. FIG. 8 is a cross-sectional end view taken along line VIII-VIII in FIG. 6. FIG. 9 is a side view (partially cross-sectional) showing an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 10 is a side view showing a tubular member of the puncture needle of FIG. 1. FIG. 11 is a side view showing an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 12 is a cross-sectional view of the puncture catheter shown in FIG. 11. Fig. 13 is a cross-sectional view showing a modified example of the puncture catheter shown in Fig. 12. Fig. 14 is a side view (partial cross-sectional view) showing a modified example of the puncture catheter equipped with a puncture needle according to an embodiment of the present invention. Fig. 15 is a cross-sectional end view taken along line XV-XV shown in Fig. 1.

[0015] 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.

[0016] One embodiment of the puncture needle of the present invention is a medical puncture needle having a longitudinal direction, and has a tubular portion with an inner cavity extending in the longitudinal direction of the puncture needle, and a convex rib portion that protrudes radially outward from the tubular portion in a cross section perpendicular to the longitudinal direction of the puncture needle, and the convex rib portion extends spirally around the tubular portion.

[0017] The overall configuration of a puncture needle and a puncture catheter equipped with the puncture needle according to an embodiment of the present invention will be described with reference to FIGS. 1 to 15. FIG.

[0018] 1 to 8 show a puncture needle 3 having a cylindrical portion 1 and a ridge portion 2. Fig. 9 shows a puncture catheter 100 having the puncture needle 3, a tube 4, a sheath 5, and a handle 6.

[0019] FIG. 10 shows only the cylindrical member 10 of the puncture needle 3 of FIG.

[0020] 11 to 13 show a puncture catheter 100 having a puncture needle 3 and a first tube 41. Fig. 14 shows a puncture catheter 100 having a puncture needle 3, a first tube 41, a second tube 42, a sheath 5, and a handle 6.

[0021] FIG. 15 shows a puncture needle 3 having a cylindrical member 10 and a spiral member 20 .

[0022] In the drawings, the longitudinal direction of the puncture needle 3 is indicated by x, the radial direction of the puncture needle 3 by y, and the circumferential direction of the puncture needle 3 by c. The radial direction y is perpendicular to the longitudinal direction x. In other words, the longitudinal direction x of the puncture needle 3 can also be referred to as the extension direction of the puncture needle 3. For ease of understanding, the drawings show an embodiment in which the longitudinal direction x of the puncture needle 3 coincides with the longitudinal direction of the tubular portion 1, the radial direction y of the puncture needle 3 coincides with the radial direction of the tubular portion 1, and the circumferential direction c of the puncture needle 3 coincides with the circumferential direction of the tubular portion 1; however, the present invention is not limited to this embodiment. Furthermore, the longitudinal direction x of the puncture needle 3 coincides with the longitudinal direction of the tubular member 10, the radial direction y of the puncture needle 3 coincides with the radial direction of the tubular member 10, and the circumferential direction c of the puncture needle 3 coincides with the circumferential direction of the tubular member 10; however, the present invention is not limited to this embodiment.

[0023] In this specification, the proximal side refers to the direction toward the user's hand in the longitudinal direction x 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 part or component is divided into two equal parts in the longitudinal direction x of the puncture needle 3, the distal part of each part or component is referred to as the distal portion, and the proximal part of each part or component is referred to as the proximal portion. The distal end of each part or component is the most distal end of each part or component. The proximal end of each part or component is the most proximal end of each part or component. The end of each part or component refers to the end of each part or component and its periphery. In other words, the distal end of each part or component refers to the distal end of each part or component and its periphery, and the proximal end of each part or component refers to the proximal end of each part or component and its periphery.

[0024] FIG. 1 is a side view showing an example of a puncture needle according to an embodiment of the present invention. FIG. 2 is a cross-sectional view of the puncture needle shown in FIG. 1. More specifically, it is a cross-section passing through the central axis of the puncture needle and along the longitudinal direction of the puncture needle. FIG. 3 is a cross-sectional end view taken along line III-III in FIG. 1. FIGS. 4 and 5 are cross-sectional end views showing modified examples of the puncture needle shown in FIG. 3. FIG. 6 is a side view showing modified examples of the puncture needle shown in FIG. 1. FIG. 7 is a cross-sectional view of the puncture needle shown in FIG. 6. More specifically, it is a cross-section passing through the central axis of the puncture needle and along the longitudinal direction of the puncture needle. FIG. 8 is a cross-sectional end view taken along line VIII-VIII in FIG. 6. FIG. 9 is a side view (partially cross-sectional) showing an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 10 is a side view showing a tubular member of the puncture needle of FIG. 1. Here, the boundary between the region where the wire is disposed radially outward of the tubular member and the region where the wire is not disposed radially outward of the tubular member is indicated by a dashed line. FIG. 11 is a side view showing an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 12 is a cross-sectional view of the puncture catheter shown in FIG. 11. FIG. 13 is a cross-sectional view showing a modified example of the puncture catheter shown in FIG. 12. More specifically, FIGS. 12 and 13 show cross sections passing through the central axis of the puncture needle and along the longitudinal direction of the puncture needle. FIG. 14 is a side view (partial cross-sectional view) showing a modified example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 15 is a cross-sectional end view of a section taken along line XV-XV shown in FIG. 1. More specifically, it shows the cross-sectional end view passing through the midpoint of the puncture needle in the longitudinal direction and perpendicular to the longitudinal direction of the puncture needle.

[0025] First, a puncture needle 3 according to an embodiment of the present invention will be described with reference to Figures 1 to 15. The puncture needle 3 is for medical use and is inserted into target tissue. As shown in Figures 1, 2, 6, 7, 9, and 11 to 14, the puncture needle 3 has a longitudinal direction x. The puncture needle 3 has a cylindrical portion 1 and a ridge portion 2.

[0026] 1, 2, 6, 7, 12 and 13, the cylindrical portion 1 is a cylindrical portion of the puncture needle 3 and has a lumen 11 extending in the longitudinal direction x of the puncture needle 3. A liquid such as a cell preparation or a drug solution can be delivered to the target tissue via this lumen 11.

[0027] As shown in Figures 1 to 9 and 11 to 15, the puncture needle 3 has a ridge portion 2. As shown in Figures 3 to 5 and 8, the ridge portion 2 protrudes radially outward from the cylindrical portion 1 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3. The ridge portion 2 is the portion located radially outward from the cylindrical portion 1 relative to the cylindrical portion 1. As shown in Figures 1, 2, 6, 7, 9, and 11 to 14, the ridge portion 2 extends spirally around the cylindrical portion 1.

[0028] The puncture needle 3 has a ridge portion 2 provided around the cylindrical portion 1, so that the puncture needle 3 can be easily screwed into the target tissue by rotating the puncture needle 3 around the cylindrical portion 1. This makes it easier to insert the puncture needle 3 into the target tissue. In addition, the ridge portion 2 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.

[0029] The puncture needle 3 is used when administering a liquid such as a cell preparation or a drug solution to a target tissue. Specifically, the puncture needle 3 can be used when directly administering the liquid to an internal organ, such as the heart, kidney, or liver. For example, the puncture needle 3 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.

[0030] 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.

[0031] 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 made partially of metal and other portions of resin. The cylindrical portion 1 and the ridge portion 2 may be made of the same material, or may be made of different materials.

[0032] 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.

[0033] 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.

[0034] The length of the puncture needle 3 in the longitudinal direction x 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 x 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 x of the puncture needle 3 refers to the longest length of the puncture needle 3 in the longitudinal direction x. When used as a puncture needle for puncturing myocardium, the length of the puncture needle 3 in the longitudinal direction x of the puncture needle 3 is preferably 5 mm.

[0035] The length of the puncture needle 3 in the radial direction y 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 y 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 y of the puncture needle 3 refers to the longest length of the puncture needle 3 in the radial direction y. When used as a puncture needle for puncturing myocardium, the length of the puncture needle 3 in the radial direction y of the puncture needle 3 is preferably 0.45 mm.

[0036] The cylindrical portion 1 has a distal end 1d and a proximal end 1p in the longitudinal direction x of the puncture needle 3. It is preferable that the distal end 1d of the cylindrical portion 1 is closed and the proximal end 1p is open.

[0037] The tubular portion 1 preferably has a tapered portion 7 whose outer diameter decreases toward the distal side, and a straight portion 8 located proximal to the tapered portion 7. In particular, it is preferable that the tapered portion 7 is provided in a portion including the distal end 1d of the tubular portion 1. This makes it easier to puncture the distal end of the tubular portion 1 into the target tissue. In addition, this reduces wobble of the rotation axis when the puncture needle 3 is rotated in the circumferential direction c of the puncture needle 3, which tends to improve stability when puncturing with the puncture needle 3.

[0038] 1, 2, 6, 7, and 9 to 14, it is preferable that a hole 14 is formed in the cylindrical portion 1, connecting the inner cavity 11 of the cylindrical portion 1 with the outside of the puncture needle 3. A liquid such as a cell preparation or a drug solution carried via the inner cavity 11 is carried to the target tissue via this hole 14.

[0039] It is preferable that the hole 14 be capable of discharging liquid from the inner cavity 11 of the tubular portion 1 toward the radially outward direction of the tubular portion 1. For this reason, it is preferable that the hole 14 be located proximal to the distal end 1d of the tubular portion 1 and distal to the proximal end 1p of the tubular portion 1.

[0040] Only one hole 14 may be formed in the cylindrical portion 1, or multiple holes 14 may be formed. When only one hole 14 is formed in the cylindrical portion 1, 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 cylindrical portion 1, it becomes easier to administer a liquid such as a cell preparation or a drug solution over a wide area.

[0041] The outer shape of the hole 14 when observed from a direction perpendicular to the longitudinal direction x 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. 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.

[0042] The ridge portion 2 has a distal end 2d and a proximal end in the longitudinal direction x of the puncture needle 3. The puncture needle 3 may be provided with only one ridge portion 2, or may be provided with multiple ridge portions 2.

[0043] As shown in Figures 1 and 6, the distal end 2d of the ridge portion 2 is preferably located proximal to the distal end 1d of the tubular portion 1. The distal end 2d of the ridge portion 2 may be located distal to the proximal end of the tapered portion 7 of the tubular portion 1, but is more preferably located proximal to the proximal end of the tapered portion 7 of the tubular portion 1. The ridge portion 2 may be provided only on the straight tube portion 8 of the tubular portion 1, and the ridge portion 2 may not be provided on the tapered portion 7 of the tubular portion 1. With the above configuration, the distal end of the tubular portion 1 can abut against the target tissue before the distal end of the ridge portion 2. This makes it easier to rotate the puncture needle 3 around the tubular portion 1 as an axis when rotating it in the circumferential direction c of the puncture needle 3, thereby reducing wobble of the rotation axis and improving stability when puncturing with the puncture needle 3.

[0044] As shown in Figures 2 and 7, the ridges 2 preferably have a solid structure. The entire ridges 2 may be solid, or only a portion of the ridges 2 may be solid. A solid structure makes it easier to reduce the diameter of the puncture needle 3 including the ridges 2. Although not shown, a hollow ridge 2 may also be acceptable. For example, the ridges 2 may have an inner cavity extending along the central axis of the ridges 2.

[0045] When observed from a direction perpendicular to the longitudinal direction x of the puncture needle 3, it is preferable that adjacent convex rib portions 2 in the longitudinal direction x of the puncture needle 3 are not in contact with each other but are spaced apart. Furthermore, when observed from a direction perpendicular to the longitudinal direction x of the puncture needle 3, it is more preferable that adjacent convex rib portions 2 in the longitudinal direction x of the puncture needle 3 are spaced apart by the presence of a gap therebetween.

[0046] The cylindrical portion 1 and the ridge portion 2 may be separate members. For example, as shown in FIGS. 1 to 5 , the ridge portion 2 may be formed by a helical member 20 in which a wire rod 21 is wound helically, and the cylindrical portion 1 may be formed by a cylindrical member 10 disposed inside the helical member 20. That is, the puncture needle 3 preferably includes the cylindrical member 10 and the helical member 20. By disposing the helical member 20 around the cylindrical member 10, the puncture needle 3 can be easily screwed into the target tissue by rotating the puncture needle 3 around the cylindrical member 10 as an axis. 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, the puncture depth can be easily adjusted by adjusting the rotation of the puncture needle 3.

[0047] The cylindrical member 10 and the spiral member 20 may be made of the same material, or may be made of different materials.

[0048] 1 and 2, the lumen 11 is preferably provided in the tubular member 10. The tubular member 10 is a cylindrical member and preferably has the lumen 11 extending in the longitudinal direction x of the puncture needle 3. Liquids such as cell preparations and medicinal solutions can be delivered to the target tissue via this lumen 11.

[0049] The tubular member 10 can have an inner surface 12 facing the lumen 11 and an outer surface 13 facing the outside. In the longitudinal direction x 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.

[0050] As shown in Figures 1, 2, 6, 7, and 9 to 14, 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.

[0051] 1, 2, 11, and 12, the hole 14 preferably connects the inner cavity 11 of the tubular member 10 to the outside of the puncture needle 3. Liquids such as cell preparations and drug solutions carried through the inner cavity 11 are delivered to the target tissue through this hole 14.

[0052] 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.

[0053] 1 and 2, the holes 14 are preferably formed in the straight tube portion 16 of the tubular member 10. This makes it easier for liquids such as cell preparations and drug solutions carried through the lumen 11 to be discharged radially outward from the tubular member 10.

[0054] 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.

[0055] 1 and 10 , the tubular member 10 preferably has a wire arrangement region 17 in which the wire 21 is arranged radially outward of the tubular member 10, and a wire-free region 18 in which the wire 21 is not arranged radially outward of the tubular member 10. The holes 14 are preferably formed in the wire-free region 18 of the tubular member 10. By forming the holes 14 in the wire-free region 18, it is possible to prevent the liquid ejected from the holes 14 from colliding with the wire 21 and moving in an unintended direction. Note that, from the viewpoint of further enhancing the effect of preventing the liquid ejected from the holes 14 from colliding with the wire 21 and moving in an unintended direction, it is particularly preferable that the holes 14 connecting the lumen 11 of the tubular member 10 and the outside of the puncture needle 3 are not formed in the wire arrangement region 17 of the tubular member 10.

[0056] The helical member 20 is preferably formed by helically winding a wire 21. 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 tubular member 10 is preferably disposed in 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. In the longitudinal direction x of the puncture needle 3, the helical member 20 has a distal end 20d and a proximal end.

[0057] The puncture needle 3 may be provided with only one spiral member 20 or with a plurality of spiral members 20 .

[0058] The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x 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 x 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 x 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 x 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 x of the puncture needle 3.

[0059] The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 may vary depending on the position in the longitudinal direction x of the puncture needle 3. For example, as shown in Figures 1 and 15, the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the midpoint of the puncture needle 3 in the longitudinal direction x may be polygonal, quadrangular, or rectangular, and the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the distal end of the wire 21 may be elliptical as shown in Figures 1 and 3. Furthermore, the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the midpoint of the puncture needle 3 in the longitudinal direction x may be rectangular, with two long sides arcuate, as shown in Figure 15.

[0060] The distal end of the wire 21 refers to a portion including the distal end 21d of the wire 21 and its surrounding area. The range of the distal end of the wire 21 may be, for example, as follows: When the wire 21 is divided into three equal parts in the longitudinal direction x of the puncture needle 3, the range of the distal end of the wire 21 may be from the distal end 21d of the wire 21 to a point one-third of the way proximal to the distal end 21d of the wire 21. When the wire 21 is divided into four equal parts in the longitudinal direction x of the puncture needle 3, the range of the distal end of the wire 21 may be from the distal end 21d of the wire 21 to a point one-fourth of the way proximal to the distal end 21d of the wire 21. When the wire 21 is divided into five equal parts in the longitudinal direction x of the puncture needle 3, the range of the distal end of the wire 21 may be from the distal end 21d of the wire 21 to a point one-fifth of the way proximal to the distal end 21d of the wire 21.

[0061] As shown in Figures 1 to 5 and 11 to 15, 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.

[0062] The wire 21 may be a solid wire or a stranded wire.

[0063] The distal end 21d of the wire 21 is preferably located proximal to the distal end 10d of the tubular member 10. The distal end 21d of the wire 21 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 21 may be located only radially outward from the straight tube portion 16 of the tubular member 10, and the wire 21 may not be located 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 the puncture needle 3 in the circumferential direction c of the puncture needle 3, thereby reducing wobble of the rotation axis and improving stability when puncturing with the puncture needle 3.

[0064] The distal end of the helical member 20 refers to a portion of the helical member 20 that includes the distal end 20d and its surrounding area. The range of the distal end of the helical member 20 may be, for example, as follows: The range of the distal end of the helical member 20 may be from the distal end 20d of the helical member 20 to a point one-third of the way proximal to the distal end 20d of the helical member 20 when the helical member 20 is divided into three equal parts in the longitudinal direction x of the puncture needle 3. The range of the distal end of the helical member 20 may be from the distal end 20d of the helical member 20 to a point one-quarter of the way proximal to the distal end 20d of the helical member 20 when the helical member 20 is divided into four equal parts in the longitudinal direction x of the puncture needle 3. The range of the distal end of the spiral member 20 may be from the distal end 20d of the spiral member 20 to a point 1 / 5 of the way proximal to the distal end 20d of the spiral member 20 when the spiral member 20 is divided into five equal parts in the longitudinal direction x of the puncture needle 3.

[0065] As shown in FIG. 3 , the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 may be in contact with each other. Furthermore, the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 may be fixed to each other while they are in contact with each other. In this case, the fixed portions may be bonded with an adhesive. Furthermore, the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 may not be fixed to each other while they are in contact with each other. A configuration in which the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 are not fixed to each other refers to a configuration other than one in which the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 are fixed to each other. For example, this refers to a configuration in which the inner surface 22 of the spiral member 20 and the outer surface 13 of the tubular member 10 are not fixed together via an adhesive or other material, and the inner surface 22 of the spiral member 20 and the outer surface 13 of the tubular member 10 are not welded together.

[0066] In the section where the distal portion of the spiral member 20 is located in the longitudinal direction x of the puncture needle 3, it is preferable that a gap exists between the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20, as shown in Figures 3 and 4. In the section where the distal portion of the spiral member 20 is located in the longitudinal direction x of the puncture needle 3, a member other than the gap may be disposed between the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20, as shown in Figure 4. In the section where the distal portion of the spiral member 20 is located in the longitudinal direction x of the puncture needle 3, only a gap may exist between the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20, as shown in Figure 3. This configuration makes it easier for tissue to be wedged between the tubular member 10 and the wire 21. This makes it difficult for the puncture needle 3 to be removed from the target tissue after it has been punctured.

[0067] The gap 19 between the outer surface 13 of the cylindrical member 10 and the inner surface 22 of the helical member 20 is a portion located in the radial direction of the cylindrical member 10 between the outer surface 13 of the cylindrical member 10 and the inner surface 22 of the helical member 20. In Figures 3 to 5, a half line extending in the radial direction of the cylindrical member 10 with the central axis of the cylindrical member 10 as one end is indicated by a two-dot chain line.

[0068] The convex rib portion 2 may include a helical member 20 and other members. More specifically, as shown in FIG. 4 , the convex rib portion 2 may be configured to include a helical member 20 and a connecting member 24 connected to the inner surface 22 of the helical member 20, and the outer surface 13 of the tubular member 10 may be connected to the inner surface 22 of the helical member 20 via the connecting member 24. In this case, it is more preferable that the length of the connecting member 24 in the circumferential direction c of the puncture needle 3 is shorter than the length of the wire 21 in the circumferential direction c of the puncture needle 3. It is even more preferable that a gap exists between the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20 in addition to the connecting member 24. This configuration makes it easier for tissue to be wedged between the tubular member 10 and the wire 21. This makes it less likely for the puncture needle 3 to be removed from the target tissue after puncturing the tissue. The length of the connecting member 24 in the circumferential direction c of the puncture needle 3 refers to the longest length of the connecting member 24 in the circumferential direction c of the puncture needle 3. The length of the wire 21 in the circumferential direction c of the puncture needle 3 refers to the longest length of the wire 21 in the circumferential direction c of the puncture needle 3.

[0069] The connecting member 24 is, for example, a long, linear, or strip-shaped member, and is preferably provided along the wire 21. In this case, it is more preferable that the length of the connecting member 24 in its axial direction is shorter than the length of the wire 21 in its axial direction. In the longitudinal direction x of the puncture needle 3, the connecting member 24 may be provided only in the section where the distal portion of the wire 21 is located, or only in the section where the distal end portion of the wire 21 is located. The connecting member 24 may be provided only in the section where the proximal portion of the wire 21 is located, or only in the section where the proximal end portion of the wire 21 is located. The tubular member 10, the spiral member 20, and the connecting member 24 may be made of the same material, or may be made of different materials.

[0070] The proximal end of the wire 21 refers to a portion of the wire 21 that includes the proximal end and its surrounding area. The range of the proximal end of the wire 21 may be, for example, as follows: The range of the proximal end of the wire 21 may be a range from the proximal end of the wire 21 to a point one-third of the way distal to the proximal end of the wire 21 when the wire 21 is divided into three equal parts in the longitudinal direction x of the puncture needle 3. The range of the proximal end of the wire 21 may be a range from the proximal end of the wire 21 to a point one-fourth of the way distal to the proximal end of the wire 21 when the wire 21 is divided into four equal parts in the longitudinal direction x of the puncture needle 3. The range of the proximal end of the wire 21 may be a range from the proximal end of the wire 21 to a point one-fifth of the way distal to the proximal end of the wire 21 when the wire 21 is divided into five equal parts in the longitudinal direction x of the puncture needle 3.

[0071] The inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 may be adhesively or welded together. For example, a portion of the inner surface 22 of the helical member 20 and a portion of the outer surface 13 of the tubular member 10 may be melted and bonded together. As shown in Figure 5, the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 may be spaced apart, and the inner surface 13 of the helical member 20 and the outer surface 13 of the tubular member 10 may be fixed together by an adhesive 25 disposed between the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 in a space 19. In this case, the convex rib portion 2 is composed of the helical member 20 and the adhesive 25.

[0072] The adhesive 25 may be, for example, a polyurethane-based, epoxy-based, cyano-based, fluorine-based, or silicone-based adhesive.

[0073] 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.

[0074] 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, the fixation of the cylindrical member 10 and the spiral member 20 using the adhesive 25 as described above, or the fixation of the cylindrical member 10 and the spiral member 20 by welding, etc., corresponds to direct fixation.

[0075] The indirect fixation of the cylindrical member 10 and the spiral member 20 refers to the fixation of the cylindrical member 10 and the spiral member 20 via another member. For example, the fixation of the cylindrical member 10 and the spiral member 20 via the connecting member 24 as described above corresponds to the indirect fixation.

[0076] 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 x 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 x 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 x of the puncture needle 3.

[0077] 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.

[0078] As shown in Figure 15, in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the midpoint of the puncture needle 3 in the longitudinal direction x, the length 21y of the wire 21 in the radial direction of the tubular member 10 is preferably shorter than the length 21c of the wire 21 in the circumferential direction of the tubular member 10. The longer the length 21y of the wire 21 in the radial direction of the tubular member 10, the easier it is to adjust the puncture depth, but this may make it more difficult to insert the puncture needle 3 into the tissue, resulting in a longer puncture time. With the above configuration, the length 21y of the wire 21 in the radial direction of the tubular member 10 can be 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 21y of the wire 21 in the radial direction of the tubular member 10 refers to the longest length of the wire 21 in the radial direction of the tubular member 10. The length 21c of the wire 21 in the circumferential direction of the tubular member 10 refers to the longest length of the wire 21 in the circumferential direction of the tubular member 10 .

[0079] 1 and 11, the distal end of the wire 21 preferably has a tapered shape. The tapered shape makes it easier to screw the wire 21 into tissue.

[0080] 1 and 11 , the tapered shape preferably extends from the distal end 21d of the wire 21 to a position that is a distance from the distal end 21d of the wire 21 toward the proximal side that is half the length of the pitch 20P of the spiral member 20. Having a tapered shape that extends to the above position makes it easier for the wire 21 to penetrate into the target tissue, facilitating the threading of the puncture needle 3 into the target tissue. The tapered shape preferably becomes narrower toward the distal end 21d of the wire 21.

[0081] It is preferable that the wire 21 has a section in which the value obtained by dividing the length 21y of the wire 21 in the circumferential direction of the tubular member 10 measured in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 by the length 21c of the wire 21 in the radial direction of the tubular member 10 measured in the cross section decreases toward the distal side. This can enhance the effect of making the wire 21 easier to screw in.

[0082] The cylindrical portion 1 and the ridge portion 2 may be formed from a single member, or the cylindrical portion 1 and the ridge portion 2 may be integrally molded. For example, a puncture needle 3 having the cylindrical portion 1 and the ridge portion 2 as shown in Figures 6 and 7 may be cut out by cutting a single cylindrical member. A mold for molding the puncture needle 3 having the cylindrical portion 1 and the ridge portion 2 as shown in Figures 6 and 7 may be prepared, and the puncture needle 3 may be molded by pouring material into the mold.

[0083] In a cross section perpendicular to the longitudinal direction x of the puncture needle 3, the cross-sectional shape of the ridge portion 2 may be polygonal, triangular, or tapered, becoming smaller radially outward of the tubular portion 1. In particular, when the tubular portion 1 and the ridge portion 2 are integrally molded, it is preferable that the cross-sectional shape of the ridge portion 2 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 be polygonal, triangular, or tapered, becoming smaller radially outward of the tubular portion 1. This configuration makes it easier for the ridge portion 2 to bite into tissue, making it difficult for the puncture needle 3 to slip out of the tissue. From the perspective of enhancing this effect, it is preferable that the cross-sectional shape of the ridge portion 2 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 be tapered, becoming smaller radially outward of the tubular portion 1, as shown in FIG.

[0084] 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.

[0085] 11 , the pitch 20P of the spiral member 20 is preferably larger than the inner diameter of the hole 14. This makes it easier to form the hole 14 even when the hole 14 is formed in the non-wire-placement region 18 that exists between the wire-placement regions 17.

[0086] 11 , the holes 14 are preferably located distal to the distal ends 21 d of the wires 21. This makes it easier to form the holes 14 in the wire-free regions 18 even when the pitch 20P of the helical member 20 is relatively short.

[0087] Next, a puncture catheter 100 having a puncture needle 3 according to an embodiment of the present invention will be described with reference to Figures 1 to 15. Note that the same reference numerals will be used to designate components that have already been described above, and descriptions thereof may be omitted.

[0088] The puncture catheter 100 has a puncture needle 3 having any of the above-described features.

[0089] 9, the puncture catheter 100 may have a tube 4 connected to the proximal end of the puncture needle 3 and having a lumen extending in the longitudinal direction x of the puncture needle 3. It is preferable that the proximal end of the puncture needle 3 and the distal end of the tube 4 are connected.

[0090] The tube 4 can be made of, for example, any of the materials exemplified as materials that can be used to make the puncture needle 3 .

[0091] The tube 4 may be made up of only one cylindrical member, or may be made up of a plurality of cylindrical members.

[0092] 9 , the puncture catheter 100 may have a sheath 5 having a lumen into which the puncture needle 3 can be inserted. A tube 4 may also be insertable into the lumen of the sheath 5. It is preferable that the puncture needle 3 and the tube 4 be movable in the lumen of the sheath 5 in the longitudinal direction x of the puncture needle 3.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 9, the puncture catheter 100 may have a handle 6. The handle 6 may have an inner cavity into which the 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.

[0097] 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.

[0098] 9 and 14, 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.

[0099] 11, the puncture catheter 100 may have a first tube 41. It is preferable that the above-mentioned tube 4 has the first tube 41.

[0100] 11 to 13, the first tube 41 preferably has an inner cavity 401 extending in the longitudinal direction x of the puncture needle 3, and is connected to the proximal end of the puncture needle 3. The first tube 41 preferably has a plurality of grooves 410 formed therein.

[0101] The puncture needle 3 included in the puncture catheter 100 has a ridge portion 2 formed around the cylindrical portion 1. This makes it easier to screw the puncture needle 3 into the target tissue by rotating the puncture needle 3 around the cylindrical portion 1. This makes it easier to insert the puncture needle 3 into the target tissue. Furthermore, the ridge portion 2 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. Additionally, the first tube 41 connected to the puncture needle 3 has multiple grooves 410 formed therein, which provides flexibility to the first tube 41. Furthermore, the first tube 41 with the grooves 410 formed therein is connected to the puncture needle 3, which makes it easier to transmit torque to the puncture needle 3. This improves the flexibility and operability of the puncture catheter 100.

[0102] 12 and 13 , the first tube 41 can be configured to have an inner surface 402 facing the lumen 401 and an outer surface 403 facing the outside. In the longitudinal direction x 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.

[0103] The first tube 41 may have a hollow cylindrical shape, a hollow polygonal prism shape, or the like.

[0104] The length of the first tube 41 in the longitudinal direction x 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 x 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 x of the puncture needle 3 refers to the longest length of the first tube 41 in the longitudinal direction x of the puncture needle 3. When used as a puncture catheter to puncture the myocardium, the length of the first tube 41 in the longitudinal direction x of the puncture needle 3 is preferably 200 mm.

[0105] The length of the first tube 41 in the radial direction y 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 y 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 y of the puncture needle 3 refers to the longest length of the first tube 41 in the radial direction y of the puncture needle 3. When used as a puncture catheter to puncture the myocardium, the length of the first tube 41 in the radial direction y of the puncture needle 3 is preferably 0.9 mm.

[0106] 12 and 13 , the lumen 11 of the tubular member 10 is preferably in communication with the lumen 401 of the first tube 41. This allows liquids such as cell preparations and medicinal solutions to be transported to the puncture needle 3 via the lumen 401 of the first tube 41.

[0107] The first tube 41 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 first tube 41 be made of metal.

[0108] The plurality of grooves 410 formed in the first tube 41 may be through grooves as shown in Fig. 13 or bottomed grooves as shown in Fig. 12. Furthermore, both through grooves and bottomed grooves may be formed in the first tube 41. By combining through grooves and bottomed grooves or selecting either one of them for the grooves 410 formed in the first tube 41, it becomes easier to obtain the first tube 41 with the desired flexibility and rigidity.

[0109] 13 , a first resin layer 404 made of resin is preferably provided on the outer surface 403 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 401 of the first tube 41, regardless of whether the groove 410 formed in the first tube 41 is a through groove or a bottomed groove. Note that when the groove 410 is a through groove, it is more preferable that the first resin layer 404 is provided on the outer surface 403 of the first tube 41.

[0110] The first resin layer 404 may be provided so as to cover the entire outer surface 403 of the first tube 41, or may be provided so as to cover only a portion of the outer surface 403 of the first tube 41. As shown in Fig. 13 , the first resin layer 404 may also be provided on a groove 410.

[0111] The first resin layer 404 can be made of a synthetic resin such as a polyolefin resin (e.g., polyethylene or polypropylene), a polyamide resin (e.g., nylon), a polyester resin (e.g., PET), an aromatic polyether ketone resin (e.g., PEEK), a polyether polyamide resin, a polyurethane resin, a polyimide resin, or a fluororesin (e.g., PTFE, PFA, ETFE).

[0112] 11 , when observed from a direction perpendicular to the longitudinal direction x of the puncture needle 3, the extension direction of the groove 410 and the longitudinal direction x of the puncture needle 3 preferably intersect at an angle α. The angles α at which the extension direction of each groove 410 intersects with the longitudinal direction x of the puncture needle 3 may all be the same angle or may be different angles. The angle α is preferably 70° or greater, more preferably 73° or greater, and even more preferably 75° or greater. The angle α 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.

[0113] The length of one groove 410 in the extension direction of the groove 410 is preferably shorter 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 lengths of the groove 410 in the extension direction of the groove 410.

[0114] 11 , the plurality of grooves 410 include a first groove 411 and a second groove 412 that is located at a different position from the first groove 411, and when observed from a direction perpendicular to the longitudinal direction x of the puncture needle 3, it is preferable that the second groove 412 is located in the extension direction of the first groove 411. This makes it easier to transmit torque to the puncture needle 3.

[0115] 11 , the maximum length between the first groove 411 and the second groove 412 in the extension direction of the first groove 411 is preferably shorter than the maximum length of the first groove 411 in the extension direction of the first groove 411. This allows the distance between the first groove 411 and the second groove 412 to be relatively short, making it easier to impart flexibility to the first tube 41.

[0116] 11 , the plurality of grooves 410 includes a third groove 413 located adjacent to the first groove 411 in the longitudinal direction x of the puncture needle 3, and the maximum length between the first groove 411 and the third groove 413 in the longitudinal direction x of the puncture needle 3 is preferably shorter than the length of the spiral pitch 2P of the ridge portion 2. This allows the distance between the first groove 411 and the third groove 413 to be relatively short, making it easier to impart flexibility to the first tube 41.

[0117] 11, 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.

[0118] 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 11 to 14, 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.

[0119] The reducing diameter member 30 preferably has a lumen 31 that penetrates the puncture needle 3 in the longitudinal direction x. The reducing diameter member 30 can be configured to have an inner surface facing the lumen 31 and an outer surface facing the outside. In the longitudinal direction x 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 401 of the first tube 41.

[0120] 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 first tube 41 and the material that makes up the reducing member 30 may be the same or different.

[0121] The shape of the diameter reducing member 30 may be, for example, a hollow polygonal truncated pyramid or a hollow truncated cone.

[0122] 14 , the puncture catheter 100 may have a second tube 42 that has an inner cavity extending in the longitudinal direction x of the puncture needle 3 and is connected to the proximal end of the first tube 41. A preferred embodiment is one in which the above-mentioned tube 4 has the first tube 41 and the second tube 42.

[0123] The second tube 42 may have an inner surface facing the lumen and an outer surface facing the outside. The second tube 42 has a distal end and a proximal end in the longitudinal direction x of the puncture needle 3. It is preferable that both the distal end and the proximal end of the second tube 42 are open.

[0124] The second tube 42 may have a shape such as a hollow cylinder or a hollow polygonal column.

[0125] The length of the second tube 42 in the longitudinal direction x 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 x 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 x of the puncture needle 3 refers to the longest length of the second tube 42 in the longitudinal direction x of the puncture needle 3. When used as a puncture catheter to puncture the myocardium, the length of the second tube 42 in the longitudinal direction x of the puncture needle 3 is preferably 1300 mm.

[0126] The length of the second tube 42 in the radial direction y 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 puncture needle 3 in the radial direction y 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 y of the puncture needle 3 refers to the longest length of the second tube 42 in the radial direction y of the puncture needle 3. When used as a puncture catheter to puncture the myocardium, the length of the second tube 42 in the radial direction y of the puncture needle 3 is preferably 0.9 mm.

[0127] 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 of the second tube 42 is in communication with the lumen 401 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 401 of the first tube 41 and the lumen of the second tube.

[0128] The second tube 42 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 second tube 42 be made of metal. The material that makes up the first tube 41 and the material that makes up the second tube 42 may be the same or different.

[0129] 14 , the puncture catheter 100 may have a sheath 5. It is preferable that the puncture needle 3, the first tube 41, and the second tube 42 can be inserted into the inner cavity of the sheath 5. It is preferable that the puncture needle 3, the first tube 41, and the second tube 42 can be moved in the longitudinal direction x of the puncture needle 3 within the inner cavity of the sheath 5.

[0130] 14, the puncture catheter 100 may have a handle 6. A second tube 42 may be inserted into the lumen of the handle 6.

[0131] This application claims the benefit of priority based on Japanese Patent Applications Nos. 2023-145175, 2023-145176, 2023-145177, and 2023-145178, filed on September 7, 2023. The entire contents of the specifications of Japanese Patent Applications Nos. 2023-145175, 2023-145176, 2023-145177, and 2023-145178, filed on September 7, 2023, are incorporated herein by reference.

[0132] 1: Cylindrical portion 1d: Distal end of cylindrical portion 1p: Proximal end of cylindrical portion 7: Tapered portion of cylindrical portion 8: Straight tube portion of cylindrical portion 10: Cylindrical member 11: Lumen 10d: Distal end of cylindrical member 10p: Proximal end of cylindrical member 12: Inner surface of cylindrical member 13: Outer surface of cylindrical member 14: Hole 15: Tapered portion of cylindrical member 16: Straight tube portion of cylindrical member 17: Wire-arranged region 18: Wire-free region 2: Convex portion 2d: Distal end of convex portion 2P: Helical pitch of convex portion 20: Helical member 20d: Distal end of helical member 20P: Pitch of helical member 21: Wire 21d: Distal end of wire 22: Inner surface of helical member 23: Outer surface of helical member 24: Connecting member 25: Adhesive 3: Puncture needle 30: Diameter-reducing member 31: Inner cavity of diameter-reducing member 4: Tube 41: First tube 401: Inner cavity of first tube 402: Inner surface of first tube 403: Outer surface of first tube 404: First resin layer 410: Groove 411: First groove 412: Second groove 413: Third groove 42: Second tube 5: Sheath 6: Handle 100: Puncture catheter

Claims

1. A medical puncture needle having a longitudinal direction, comprising: a tubular portion having an inner cavity extending in the longitudinal direction; and a ridge portion protruding radially outward from the tubular portion in a cross section perpendicular to the longitudinal direction, wherein the ridge portion extends in a spiral shape around the tubular portion.

2. The puncture needle according to claim 1, wherein the convex portion is formed of a spiral member in which wire is wound in a spiral shape, and the tubular portion is formed of a cylindrical member arranged inside the spiral member.

3. The puncture needle according to claim 2, wherein the inner surface of the spiral member and the outer surface of the cylindrical member abut against each other.

4. The puncture needle according to claim 2, wherein the inner surface of the spiral member and the outer surface of the cylindrical member are fixed to each other by adhesive or welding.

5. The puncture needle according to claim 2, wherein the convex rib portion is constituted by the helical member and a connecting member connected to the inner surface of the helical member, and the outer surface of the tubular member is connected to the inner surface of the helical member via the connecting member.

6. The puncture needle according to claim 2, wherein the tubular member has a wire arrangement region in which the wire is arranged radially outward of the tubular member, and a non-wire arrangement region in which the wire is not arranged radially outward of the tubular member, and a hole connecting the inner cavity of the tubular member to the outside of the puncture needle is formed in the non-wire arrangement region of the tubular member.

7. The puncture needle according to claim 6, wherein the hole is not formed in the wire arrangement area of ​​the tubular member.

8. The puncture needle according to claim 2, wherein the inner diameter of said spiral member is not more than twice the outer diameter of said tubular member.

9. The puncture needle according to claim 2, wherein the distal end of the wire is tapered.

10. The puncture needle as described in claim 2, wherein in a cross section perpendicular to the longitudinal direction passing through the midpoint of the longitudinal direction of the puncture needle, the length of the wire in the radial direction of the tubular member is shorter than the length of the wire in the circumferential direction of the tubular member.

11. The puncture needle according to claim 2, wherein the wire has a section in which the value obtained by dividing the length of the wire in the circumferential direction of the tubular member measured in a cross section perpendicular to the longitudinal direction by the length of the wire in the radial direction of the tubular member measured in the cross section decreases toward the distal side.

12. The puncture needle according to claim 9, wherein the tapered shape extends from the distal end of the wire to a position that is 1 / 2 the length of the pitch of the helical member proximally away from the distal end of the wire.

13. The puncture needle according to claim 1, wherein the cylindrical portion and the ridge portion are integrally formed.

14. The puncture needle according to claim 1, wherein in a cross section perpendicular to the longitudinal direction, the cross-sectional shape of the convex rib portion is polygonal, triangular, or tapered so as to become smaller radially outward of the tubular portion.

15. The puncture needle according to claim 1, wherein the distal end of the convex portion is located proximal to the distal end of the cylindrical portion.

16. The puncture needle according to claim 1, wherein a hole communicating the inner cavity of the tubular portion with the outside of the puncture needle is formed in the tubular portion.

17. The puncture needle according to claim 1, wherein the tubular portion has a tapered portion whose outer diameter decreases toward the distal side, and a straight portion located proximal to the tapered portion.

18. The puncture needle according to claim 1, wherein the entire convex portion is of solid structure.

19. A puncture catheter having a puncture needle according to any one of claims 1 to 18.

20. The puncture catheter of claim 19, further comprising a first tube having an inner lumen extending in the longitudinal direction and connected to a proximal end of the puncture needle, the first tube having a plurality of grooves formed therein.

21. The puncture catheter of claim 20, wherein said first tube is constructed from metal.

22. The puncture catheter according to claim 21, wherein a first resin layer made of resin is provided on the outer surface of the first tube.

23. The puncture catheter according to claim 20, wherein, when observed from a direction perpendicular to the longitudinal direction, the extension direction of the groove intersects with the longitudinal direction at an angle α.

24. The puncture catheter according to claim 23, wherein the angle α is between 70° and 85°.

25. The puncture catheter according to claim 20, wherein the plurality of grooves include a first groove and a second groove located at a position different from that of the first groove, and when observed from a direction perpendicular to the longitudinal direction, the second groove is located in the extension direction of the first groove.

26. The puncture catheter according to claim 25, wherein the maximum length between the first groove and the second groove in the extension direction of the first groove is shorter than the maximum length of the first groove in the extension direction of the first groove.

27. The puncture catheter according to claim 25, wherein the plurality of grooves includes a third groove located adjacent to the first groove in the longitudinal direction, and the maximum length between the first groove and the third groove in the longitudinal direction is shorter than the length of the spiral pitch of the convex rib portion.

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