Puncture needle, puncture catheter provided with puncture needle, and catheter system provided with puncture catheter

Abstract

Provided is a medical puncture needle (3) having a longitudinal direction (x), wherein: the puncture needle (3) has a cylindrical member (10) having a lumen extending in the longitudinal direction (x) of the puncture needle (3), and a spiral member (20) in which a wire (21) is spirally wound around the cylindrical member (10); and the distal end of the wire (21) and the cylindrical member (10) are not fixed to each other, or the distal end of the wire (21) and the cylindrical member (10) are not in contact with each other. Also provided are a puncture catheter (100) provided with the puncture needle (3), and a catheter system (200) provided with the puncture catheter (100).

Description

Puncture needle, puncture catheter equipped with puncture needle, and catheter system equipped with puncture catheter

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

[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, a puncture catheter equipped with the puncture needle, and a catheter system equipped with the puncture catheter.

[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 member having an inner cavity extending in the longitudinal direction; and a spiral member in which a wire is spirally wound around the tubular member, wherein the distal end of the wire and the tubular member are not fixed to each other, or the distal end of the wire and the tubular member are not in contact with each other.

[0010] The above-mentioned puncture needle has a spiral member disposed around a cylindrical member, so that the puncture needle can be easily screwed into the target tissue by rotating the puncture needle around the cylindrical member as an axis. This makes it easier to insert the puncture needle into the target tissue. In addition, the wire constituting the spiral member 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 outer surface of the tubular member and the inner surface of the helical member are separated in the longitudinal section where the distal portion of the helical member is located. [3] The puncture needle according to [2], wherein the outer surface of the tubular member and the inner surface of the helical member are separated in the longitudinal section where the distal portion of the helical member is located by the presence of a gap between the outer surface of the tubular member and the inner surface of the helical member. [4] The puncture needle according to any one of [1] to [3], wherein the cross-sectional shape of the wire rod is polygonal in a cross section perpendicular to the longitudinal direction. [5] The puncture needle according to any one of [1] to [4], wherein, in a cross section perpendicular to the longitudinal direction and passing through the midpoint in the longitudinal direction of the puncture needle, the relationship of 2h<H and H-h<W is satisfied, where H is the length between the part of the wire rod that is located most radially outward in the radial direction of the tubular member and the outer surface of the tubular member, h is the separation distance between the outer surface of the tubular member and the inner surface of the helical member, and W is the width of the wire rod in the circumferential direction of the puncture needle. [6] The puncture needle according to any one of [1] to [5], wherein the distal end of the helical member is located proximal to the distal end of the tubular member. [7] The puncture needle according to any one of [1] to [6], wherein the tubular member has a hole that communicates between the lumen of the tubular member and the outside of the puncture needle. [8] The puncture needle according to any one of [1] to [7], wherein the tubular member has a tapered section whose outer diameter decreases toward the distal side and a straight section located proximal to the tapered section. [9] The puncture needle according to any one of [1] to [8], wherein the wire rod has a solid structure.

[10] The puncture needle according to any one of [1] to [9], which is configured to puncture an organ inside the body.

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

[10] , wherein a part of the tubular member and a part of the spiral member are directly fixed to each other.

[12] The puncture needle according to [7], 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 the hole is formed in the wire-free region of the tubular member.

[13] The puncture needle according to

[12] , wherein the hole is not formed in the wire-arranged region of the tubular member.

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

[13] , wherein the inner diameter of the spiral member is not more than twice the outer diameter of the tubular member.

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

[14] , wherein the distal end of the wire has a tapered shape.

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

[15] , wherein, in a cross section perpendicular to the longitudinal direction passing through a midpoint in 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.

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

[16] , 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 the 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.

[18] The puncture needle according to

[15] , wherein the tapered shape extends from the distal end of the wire to a position that is half the length of the pitch of the helical member away from the distal end of the wire toward the proximal side.

[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 the first groove, and 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 next 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 pitch length of the helical member.

[0013] The present invention also includes the following catheter system:

[28] A catheter system comprising the puncture catheter according to any one of

[20] to

[27] , further comprising a sheath having a lumen into which the puncture needle and the first tube are inserted, wherein the catheter system satisfies the relationship D>d>s+2H, where H is the length between the outer surface of the tubular member and the part of the wire rod that is located furthest outward in the radial direction of the tubular member, d is the maximum outer diameter of the first tube, s is the maximum outer diameter of the tubular member, and D is the inner diameter of the sheath.

[0014] The puncture needle according to the embodiment of the present invention has a spiral member disposed around a cylindrical member. 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 and a catheter system equipped with this puncture needle also have the same effects.

[0015] 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 cross-sectional end view showing a modified example of the puncture needle shown in FIG. 3. FIG. 7 is a cross-sectional end view taken along line VII-VII in FIG. 1. FIG. 8 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. 9 is a side view showing an example of a puncture needle according to an embodiment of the present invention. FIG. 10 is a cross-sectional view of the puncture needle shown in FIG. 9. FIG. 11 is a side view showing a tubular member included in the puncture needle of FIG. 9. FIG. 12 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. 13 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. 14 is a cross-sectional view of the puncture catheter shown in FIG. 13. FIG. 15 is a cross-sectional view showing a modified example of the puncture catheter shown in FIG. 14. FIG. 16 is a side view (partial cross-sectional view) showing an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 17 is a side view showing an example of a puncture needle according to an embodiment of the present invention. FIG. 18 is a cross-sectional view of the puncture needle shown in FIG. 17. FIG. 19 is a cross-sectional end view taken along line XIX-XIX shown in FIG. 17. FIG. 20 is a cross-sectional end view showing a modified example of the puncture needle shown in FIG. 19. FIG. 21 is a cross-sectional end view showing a modified example of the puncture needle shown in FIG. 19. FIG. 22 is a cross-sectional end view showing a modified example of the puncture needle shown in FIG. 19. FIG. 23 is a cross-sectional end view taken along line XXIII-XXIII shown in FIG. 17. Fig. 24 is a side view (partial cross-sectional view) showing an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. Fig. 25 is a side view (partial cross-sectional view) showing an example of a catheter system equipped with a puncture catheter having a puncture needle according to an embodiment of the present invention. Fig. 26 is a side view showing an example of a puncture needle and a first tube provided in a catheter system equipped with a puncture catheter having a puncture needle according to an embodiment of the present invention. Fig. 27 is a cross-sectional view of the puncture needle and the first tube shown in Fig. 26.FIG. 28 is a cross-sectional view showing a modification of the puncture needle and the first tube shown in FIG.

[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] One embodiment of the puncture needle of the present invention is a medical puncture needle having a longitudinal direction, and comprises a tubular member having an inner cavity extending in the longitudinal direction of the puncture needle, and a spiral member in which a wire is wound spirally around the tubular member, and the gist is that the distal end of the wire and the tubular member are not fixed to each other, or the distal end of the wire and the tubular member are not in contact with each other.

[0018] The overall configuration of a puncture needle, a puncture catheter equipped with the puncture needle, and a catheter system equipped with the puncture catheter according to an embodiment of the present invention will be described with reference to FIGS. 1 to 28.

[0019] 1 to 7 show a puncture needle 3 having a tubular member 10 and a spiral member 20. Fig. 8 shows a puncture catheter 100 having the puncture needle 3, a tube 4, a sheath 5, and a handle 6.

[0020] 9, 10, and 12 show a puncture needle 3 having a tubular member 10 and a spiral member 20. Fig. 12 shows a puncture catheter 100 having the puncture needle 3, a tube 4, a sheath 5, and a handle 6.

[0021] 13 to 15 show a puncture catheter 100 having a puncture needle 3 and a first tube 41. Fig. 16 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.

[0022] 17 to 23 show a puncture needle 3 having a tubular member 10 and a spiral member 20. Fig. 24 shows a puncture catheter 100 having a puncture needle 3, a tube 4, a sheath 5, and a handle 6.

[0023] Figure 25 shows a puncture catheter 100 having a puncture needle 3, a first tube 41, a sheath 5, and a handle 6, and a catheter system 200 having the puncture catheter 100. Figures 26 to 28 show the puncture needle 3 and the first tube 41 that the catheter system 200 has.

[0024] 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 a direction perpendicular to the longitudinal direction x. In other words, the longitudinal direction x of the puncture needle 3 can also be said to be 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 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, but the present invention is not limited to this embodiment.

[0025] 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 component is divided into two equal halves in the longitudinal direction x 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.

[0026] 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 along the longitudinal direction of the puncture needle, passing through the central axis of the puncture needle. FIG. 3 is a cross-sectional end view taken along line III-III shown in FIG. 1. FIGS. 4 to 6 are cross-sectional end views showing modified examples of the puncture needle shown in FIG. 3. More specifically, FIGS. 3 to 6 are cross-sectional end views passing through the distal end of the wire rod. FIG. 7 is a cross-sectional end view taken along line VII-VII shown in FIG. 1. More specifically, it is a 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. FIG. 8 is a side view (partial cross-sectional view) showing an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 9 is a side view showing an example of a puncture needle according to an embodiment of the present invention. FIG. 10 is a cross-sectional view of the puncture needle shown in FIG. 9. More specifically, FIG. 11 shows a cross section passing through the central axis of the puncture needle and along the longitudinal direction of the puncture needle. FIG. 11 shows a side view of the tubular member included in the puncture needle of FIG. 9. 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. 12 shows a side view (partial cross-sectional view) of an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 13 shows a side view of an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 14 shows a cross-sectional view of the puncture catheter shown in FIG. 13. FIG. 15 shows a cross-sectional view of a modified example of the puncture catheter shown in FIG. 14. More specifically, FIGS. 14 and 15 show cross sections passing through the central axis of the puncture needle and along the longitudinal direction of the puncture needle. FIG. 16 shows a side view (partial cross-sectional view) of an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. FIG. 17 shows a side view of an example of a puncture needle according to an embodiment of the present invention. Fig. 18 is a cross-sectional view of the puncture needle shown in Fig. 17. More specifically, it shows a cross-section passing through the central axis of the puncture needle along the longitudinal direction of the puncture needle. Fig. 19 is a cross-sectional end view taken along line XIX-XIX shown in Fig. 17. Figs. 20 to 22 are cross-sectional end views showing modified examples of the puncture needle shown in Fig. 19. More specifically, Figs. 19 to 22 are cross-sectional end views taken through the distal end of the wire. Fig. 23 is a cross-sectional end view taken along line XXIII-XXIII shown in Fig. 17.More specifically, the figure shows a cross-sectional end surface of the puncture needle, passing through the midpoint in the longitudinal direction of the puncture needle and perpendicular to the longitudinal direction of the puncture needle. Fig. 24 shows a side view (partially cross-sectional) of an example of a puncture catheter equipped with a puncture needle according to an embodiment of the present invention. Fig. 25 shows a side view (partially cross-sectional) of an example of a catheter system equipped with a puncture catheter having a puncture needle according to an embodiment of the present invention. Fig. 26 shows a side view of an example of a puncture needle and a first tube provided in a catheter system equipped with a puncture catheter having a puncture needle according to an embodiment of the present invention. Fig. 27 shows a cross-sectional view of the puncture needle and the first tube shown in Fig. 26. Fig. 28 shows a cross-sectional view of a modified example of the puncture needle and the first tube shown in Fig. 27. More specifically, Figs. 27 and 28 show cross sections passing through the central axis of the puncture needle and along the longitudinal direction of the puncture needle.

[0027] First, a puncture needle 3 according to an embodiment of the present invention will be described with reference to Figures 1 to 28. The puncture needle 3 is for medical use and is inserted into target tissue. As shown in Figures 1, 2, 8 to 10, 12 to 18, and 24 to 28, the puncture needle 3 has a longitudinal direction x. The puncture needle 3 has a cylindrical member 10 and a spiral member 20.

[0028] 1, 2, 9, 10, 17, 18, 26, and 27, the tubular member 10 is a tubular member having 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.

[0029] As shown in Figures 1, 2, 9, 10, 17, 18, 26, and 27, the puncture needle 3 has a spiral member 20 in which a wire 21 is wound spirally around a tubular member 10.

[0030] As shown in Figures 3, 5, 19, and 21, the puncture needle 3 is configured such that the distal end of the wire 21 and the tubular member 10 are not fixed to each other, or such that the distal end of the wire 21 and the tubular member 10 do not come into contact with each other, as shown in Figures 3, 4, 6, 19, 20, and 22. In other words, the puncture needle 3 has at least one of a configuration in which the distal end of the wire 21 and the tubular member 10 are not fixed to each other, and a configuration in which the distal end of the wire 21 and the tubular member 10 do not come into contact with each other. As shown in Figures 5 and 21, the puncture needle 3 may have a configuration in which the distal end of the wire 21 and the tubular member 10 are in contact with each other, but the distal end of the wire 21 and the tubular member 10 are not fixed to each other. As shown in Figures 4, 6, 20 and 22, the puncture needle 3 has the distal end of the wire 21 and the tubular member 10 fixed to each other, but may have a configuration in which the distal end of the wire 21 and the tubular member 10 do not contact each other. As shown in Figures 3 and 19, the puncture needle 3 has the distal end of the wire 21 and the tubular member 10 not fixed to each other, and may not contact each other.

[0031] The configuration in which the distal end of the wire 21 and the tubular member 10 are not fixed to each other refers to a configuration other than the configuration in which the distal end of the wire 21 and the tubular member 10 are fixed to each other. For example, the distal end of the wire 21 and the tubular member 10 are not fixed to each other via an adhesive or other member, and the distal end of the wire 21 and the tubular member 10 are not fixed by welding.

[0032] The configuration in which the distal end of the wire 21 does not come into contact with the tubular member 10 refers to a configuration other than the configuration in which the distal end of the wire 21 comes into contact with the tubular member 10. For example, there is a configuration in which the inner surface of the distal end of the wire 21 and the outer surface 13 of the tubular member 10 are separated from each other by a gap or another member.

[0033] The distal end of the wire 21 refers to a portion of the wire 21 including the distal end 21d and its surrounding area. The range of the distal end of the wire 21 may be, for example, as follows: 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 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-fourth 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-fifth 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.

[0034] The puncture needle 3 has the spiral member 20 disposed around the tubular member 10, so that by rotating the puncture needle 3 around the tubular member 10 as an axis, the puncture needle 3 can be easily screwed into the target tissue. This makes it easier to insert the puncture needle 3 into the target tissue. Furthermore, the wire rod 21 that constitutes the spiral member 20 bites into the tissue, making it difficult for the puncture needle 3 to come out of the tissue. Furthermore, by adjusting the rotation of the puncture needle 3, the puncture depth can be easily adjusted.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] As shown in Figures 1, 2, 8 to 18, and 24 to 28, the tubular member 10 preferably has a tapered section 15 whose outer diameter decreases distally, 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 c of the puncture needle 3, which tends to improve stability when puncturing with the puncture needle 3.

[0044] 1, 2, 8 to 18, and 24 to 28, 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 via the inner cavity 11 is carried to the target tissue via this hole 14.

[0045] 1, 2, 8 to 18, and 24 to 28, the holes 14 are preferably formed in the straight tube portion 16. 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 9 and 11 , 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 connecting the lumen 11 of the tubular member 10 to the outside of the puncture needle 3 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. 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 to the outside of the puncture needle 3 are not formed in the wire arrangement region 17 of the tubular member 10.

[0050] The helical member 20 is 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 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.

[0051] The puncture needle 3 may be provided with only one spiral member 20 or with a plurality of spiral members 20 .

[0052] 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.

[0053] 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, 7, 17, and 23, 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, and as shown in Figures 1, 3, 17, and 19, 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. 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 Figures 7 and 23.

[0054] As shown in Figures 2 to 7, 10, 14, 15, 18 to 23, 25, 27, and 28, 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.

[0055] The wire 21 may be a solid wire or a stranded wire.

[0056] As shown in Figures 1, 8, 9, 12, 13, 16, 17, 24, and 26, the distal end of the wire 21 preferably has a tapered shape. The tapered shape of the wire 21 makes it easier to screw the wire 21 into tissue.

[0057] 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.

[0058] In the section where the distal end of the wire 21 is located in the longitudinal direction x of the puncture needle 3, it is preferable that the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20 are spaced apart. 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 more preferable that the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20 are spaced apart, as shown in Figures 3, 4, 6, 19, 20, and 22. 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 come out of the target tissue after it has punctured the tissue.

[0059] 3, 4, 6, 19, 20, and 22, it is preferable that the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20 are spaced apart in the section where the tapered shape of the wire rod 21 is located in the longitudinal direction x of the puncture needle 3. This configuration makes it easier for tissue to be wedged between the tubular member 10 and the wire rod 21. This makes it difficult for the puncture needle 3 to come out of the target tissue after it has been inserted into the tissue.

[0060] In the section where the distal portion of the helical member 20 is located in the longitudinal direction x of the puncture needle 3, it is preferable that the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20 are separated by a gap 19 between the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20, as shown in Figures 3, 4, 19, and 20. In the section where the distal portion of the helical member 20 is located in the longitudinal direction x of the puncture needle 3, a member other than a gap may be disposed between 19 between the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20, as shown in Figures 4 and 20. In the section where the distal portion of the helical member 20 is located in the longitudinal direction x of the puncture needle 3, it is more preferable that only a gap exists between 19 between the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20, as shown in Figures 3 and 19. The above configuration makes it easier for tissue to be bitten into between the tubular member 10 and the wire 21. This makes it difficult for the puncture needle 3 to come out of the target tissue after the puncture needle 3 has punctured the tissue.

[0061] In the section where the tapered shape of the wire rod 21 is located in the longitudinal direction x of the puncture needle 3, it is preferable that the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20 are separated by a gap 19 between the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20, as shown in Figures 3, 4, 19 and 20. In the section where the tapered shape of the wire rod 21 is located in the longitudinal direction x of the puncture needle 3, a member other than the gap may be disposed in the section 19 between the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20, as shown in Figures 4 and 20. It is more preferable that only a gap exists between the outer surface 13 of the tubular member 10 and the inner surface 22 of the helical member 20, as shown in Figures 3 and 19. The above configuration makes it easier for tissue to be bitten into between the tubular member 10 and the wire 21. This makes it difficult for the puncture needle 3 to come out of the target tissue after the puncture needle 3 has punctured the tissue.

[0062] 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, 4, 7, 19, 20, and 23, 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.

[0063] As shown in FIGS. 4 and 20, the puncture needle 3 may have a connecting member 24.

[0064] More specifically, in the section of the puncture needle 3 where the distal portion of the spiral member 20 is located in the longitudinal direction x, the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20 can be connected via a connecting member 24. In the section of the puncture needle 3 where the distal end of the wire 21 is located in the longitudinal direction x, the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20 can also be connected via a connecting member 24. 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 spiral 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 that the puncture needle 3 will come out of the target tissue after puncturing it. 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.

[0065] In the section where the tapered shape of the wire 21 is located in the longitudinal direction x of the puncture needle 3, the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20 can be connected via a 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 in addition to the connecting member 24 between the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20 in the space 19 between the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20. 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 inserted into the tissue. Note that 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 .

[0066] 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 the axial direction of the wire 21. 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 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.

[0067] 5 and 21 , in the section where the distal portion of the helical member 20 is located in the longitudinal direction x of the puncture needle 3, the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 are in contact with each other, but the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 may be configured not to be fixed to 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, for example, an embodiment in which the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 are not bonded to each other with an adhesive, and 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 by welding.

[0068] As shown in Figures 5 and 21 , the inner surface 22 of the distal end of the helical member 20 and the outer surface 13 of the tubular member 10 may be in contact with each other. When the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 are in contact with each other, the inner surface 22 of the helical member 20 and the outer surface 13 of the tubular member 10 do not have to be fixed to 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 a configuration 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 configuration refers to 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 via an adhesive or other member, and 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 by welding. In the section where the tapered shape of the wire 21 is located in the longitudinal direction x of the puncture needle 3, the inner surface 22 of the spiral member 20 and the outer surface 13 of the tubular member 10 abut against each other, as shown in Figures 5 and 21, but it is also acceptable for the inner surface 22 of the spiral member 20 and the outer surface 13 of the tubular member 10 to be configured not to be fixed to each other.

[0069] 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.

[0070] In the section where the distal portion of the spiral member 20 is located in the longitudinal direction x of the puncture needle 3, as shown in Figures 6 and 22, the inner surface 22 of the spiral member 20 and the outer surface 13 of the tubular member 10 are not in contact with each other, but the inner surface 22 of the spiral member 20 and the outer surface 13 of the tubular member 10 may be fixed together by adhesive 25.

[0071] The inner surface 22 of the distal end of the spiral member 20 and the outer surface 13 of the tubular member 10 may be adhesively fixed. In this case, the inner surface 22 of the distal end of the spiral member 20 and the outer surface 13 of the tubular member 10 can be bonded together with an adhesive 25, as shown in Figures 6 and 22 . The inner surface 22 of the distal end of the spiral member 20 and the outer surface 13 of the tubular member 10 do not need to be in contact with each other. In the section where the tapered shape of the wire 21 is located in the longitudinal direction x of the puncture needle 3, the inner surface 22 of the spiral member 20 and the outer surface 13 of the tubular member 10 do not contact each other, as shown in Figures 6 and 22 , but the inner surface 22 of the spiral member 20 and the outer surface 13 of the tubular member 10 may be fixed together with an adhesive 25.

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

[0073] 7 , in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the midpoint in the longitudinal direction x of the puncture needle 3, the length between the outer surface 13 of the tubular member 10 and the part of the wire rod 21 located most radially outward in the radial direction of the tubular member 10 is H, the distance 19 between the outer surface 13 of the tubular member 10 and the inner surface 22 of the spiral member 20 is h, and the width of the wire rod 21 in the circumferential direction c of the puncture needle 3 is W. The puncture needle 3 preferably satisfies the relationship 2h<H and H-h<W. This configuration makes it easier for tissue to be wedged between the tubular member 10 and the wire rod 21. This makes it difficult for the puncture needle 3 to be removed from the target tissue after it has been punctured.

[0074] 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 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 the puncture needle 3.

[0075] 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.

[0076] 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.

[0077] 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 that connects the outer surface 13 of the cylindrical member 10 and the inner surface 22 of the spiral member 20 as described above corresponds to the indirect fixation.

[0078] 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.

[0079] 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.

[0080] As shown in Figure 23, 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 .

[0081] 1 and 26, 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 P 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, making it easier to screw the puncture needle 3 into the target tissue. The tapered shape preferably becomes narrower toward the distal end 21d of the wire 21.

[0082] 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.

[0083] 26 , the pitch P 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.

[0084] 26, it is preferable that the holes 14 are located distal to the distal ends 21d of the wires 21. This makes it easier to form the holes 14 in the wire-free regions 18 even when the pitch P of the helical member 20 is relatively short.

[0085] 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 28. Note that the same reference numerals will be used to designate components that have already been described above, and descriptions thereof may be omitted.

[0086] As shown in FIGS. 8, 12 to 16, 24 and 25, the puncture catheter 100 preferably has a puncture needle 3 having any of the above-described aspects.

[0087] 8, 12, and 24, 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.

[0088] 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 .

[0089] The tube 4 may be made up of only one cylindrical member, or may be made up of a plurality of cylindrical members.

[0090] 8, 12, and 24, 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 are movable in the lumen of the sheath 5 in the longitudinal direction x of the puncture needle 3.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] As shown in Figures 8, 12, 16, 24, and 25, 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.

[0095] 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.

[0096] 8, 12, 16, 24, and 25, 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.

[0097] 13, the puncture catheter 100 may have a first tube 41. It is preferable that the above-mentioned tube 4 has the first tube 41.

[0098] 13 to 15 and 25 to 28, 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.

[0099] The puncture needle 3 included in the puncture catheter 100 has a cylindrical member 10 and a spiral member 20 disposed around it. By rotating the puncture needle 3 around the cylindrical 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 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. 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, connecting the first tube 41 with the grooves 410 formed therein to the puncture needle 3 makes it easier to transmit torque to the puncture needle 3. This improves the flexibility and operability of the puncture catheter 100.

[0100] 14, 15, 27, and 28, 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.

[0101] The first tube 41 may have a hollow cylindrical shape, a hollow polygonal prism shape, or the like.

[0102] 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.

[0103] 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.

[0104] 14, 15, 27, and 28, the lumen 11 of the tubular member 10 preferably communicates 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.

[0105] 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.

[0106] The plurality of grooves 410 formed in the first tube 41 may be through grooves as shown in Figures 15 and 28, or may be bottomed grooves as shown in Figures 14 and 27. 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.

[0107] 15 and 28 , 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.

[0108] 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 Figures 15 and 28, the first resin layer 404 may also be provided on the groove 410.

[0109] 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).

[0110] As shown in Figures 13 and 26, 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.

[0111] 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.

[0112] 13 and 26 , the multiple grooves 410 include a first groove 411 and a second groove 412 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.

[0113] 13 and 26, 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.

[0114] 13 and 26 , 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 pitch P of the spiral member 20. 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.

[0115] 13, 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.

[0116] 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 13 to 16 and 25 to 28, 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.

[0117] 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.

[0118] 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.

[0119] The shape of the diameter reducing member 30 may be, for example, a hollow polygonal truncated pyramid or a hollow truncated cone.

[0120] 16 and 25, 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.

[0121] 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.

[0122] The second tube 42 may have a shape such as a hollow cylinder or a hollow polygonal column.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 16 and 25 , 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.

[0128] 16 and 25, the puncture catheter 100 may have a handle 6. A second tube 42 may be inserted into the lumen of the handle 6.

[0129] 25 to 28, a catheter system 200 including a puncture catheter 100 having a puncture needle 3 according to an embodiment of the present invention will be described. Note that the same reference numerals will be used to designate components already described above, and descriptions thereof will be omitted in some cases.

[0130] As shown in FIG. 25, the catheter system 200 preferably includes a puncture catheter 100 having a puncture needle 3 , a first tube 41 and a sheath 5 .

[0131] As shown in Figure 25, the sheath 5 preferably has a lumen 51 into which the puncture needle 3 and the first tube 41 are inserted. The sheath 5 may have an inner surface 52 facing the lumen 51 and an outer surface 53 facing the outside. In the longitudinal direction x of the puncture needle 3, the sheath 5 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the sheath 5 are open. As shown in Figure 25, the puncture needle 3, the first tube 41, and the second tube 42 may be inserted into the lumen 51 of the sheath 5. It is preferable that the puncture needle 3, the first tube 41, and the second tube 42 be movable in the longitudinal direction x of the puncture needle 3 within the lumen 51 of the sheath 5.

[0132] As shown in Figure 25, when the length between the part of the wire 21 that is located most radially outward of the tubular member 10 and the outer surface 13 of the tubular member 10 in the radial direction of the tubular member 10 is H, the maximum outer diameter of the first tube 41 is d, the maximum outer diameter of the tubular member 10 is s, and the inner diameter of the sheath is D, it is preferable that the catheter system 200 satisfy the relationship D > d > s + 2H.

[0133] The puncture needle 3 included in the catheter system 200 has a cylindrical member 10 and a spiral member 20 disposed around it. By rotating the puncture needle 3 around the cylindrical 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 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. Additionally, since the catheter system 200 satisfies the relationship D > d > s + 2H, the outer diameter of the first tube 41 is larger than the outer diameter of the puncture needle 3. This causes the distal end of the first tube 41 to strike the tissue, making it easier for only the puncture needle 3 to puncture the tissue, preventing the tissue from being inserted too deeply.

[0134] As shown in Figure 25, the puncture catheter 100 included in the catheter system 200 may have a second tube 42 that has an inner lumen extending in the longitudinal direction x of the puncture needle 3 and is connected to the proximal end of the first tube 41, as described above.

[0135] This application claims the benefit of priority based on Japanese Patent Application Nos. 2023-145174, 2023-145176, 2023-145177, 2023-145178, and 2023-145179, filed on September 7, 2023. The entire contents of the specifications of Japanese Patent Application Nos. 2023-145174, 2023-145176, 2023-145177, 2023-145178, and 2023-145179, filed on September 7, 2023, are incorporated herein by reference.

[0136] 10: Cylindrical member 10d: Distal end of cylindrical member 10p: Proximal end of cylindrical member 11: Lumen of cylindrical member 12: Inner surface of cylindrical member 13: Outer surface of cylindrical member 14: Hole 15: Tapered portion 16: Straight tube portion 17: Wire-arranged region 18: Wire-free region 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 24: Connecting member 25: Adhesive P: Pitch of helical member 3: Puncture needle 30: Reducing diameter member 31: Lumen of reducing diameter member 4: Tube 41: First tube 401: Lumen 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 51: Inner cavity of sheath 52: Inner surface of sheath 53: Outer surface of sheath 6: Handle 100: Puncture catheter 200: Catheter system

Claims

1. A medical puncture needle having a longitudinal direction, comprising: 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, wherein the distal end of the wire and the tubular member are not fixed to each other, or the distal end of the wire and the tubular member are not in contact with each other.

2. The puncture needle according to claim 1, wherein in the section in the longitudinal direction where the distal portion of the helical member is located, the outer surface of the tubular member and the inner surface of the helical member are spaced apart.

3. A puncture needle as described in claim 2, wherein in the section in the longitudinal direction in which the distal portion of the helical member is located, the outer surface of the tubular member and the inner surface of the helical member are separated by the presence of a gap between the outer surface of the tubular member and the inner surface of the helical member.

4. The puncture needle according to claim 1, wherein the cross section of the wire perpendicular to the longitudinal direction is polygonal.

5. The puncture needle according to claim 1, wherein, in a cross section perpendicular to the longitudinal direction passing through the midpoint in the longitudinal direction of the puncture needle, the relationship 2h<H and H-h<W is satisfied, where H is the length between the part of the wire that is located most radially outward in the radial direction of the tubular member and the outer surface of the tubular member, h is the separation distance between the outer surface of the tubular member and the inner surface of the spiral member, and W is the width of the wire in the circumferential direction of the puncture needle.

6. The puncture needle according to claim 1, wherein the distal end of the spiral member is located proximal to the distal end of the tubular member.

7. The puncture needle according to claim 1, wherein said tubular member has a hole communicating the inner cavity of said tubular member with the outside of said puncture needle.

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

9. The puncture needle according to claim 1, wherein the wire is of solid structure.

10. The puncture needle according to claim 1, which is inserted into an internal organ.

11. The puncture needle according to claim 1, wherein a portion of said cylindrical member and a portion of said spiral member are directly fixed to each other.

12. The puncture needle as described in claim 7, 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 the hole is formed in the non-wire arrangement region of the tubular member.

13. The puncture needle according to claim 12, wherein the hole is not formed in the wire arrangement region of the tubular member.

14. The puncture needle according to claim 1, wherein the inner diameter of the spiral member is not more than twice the outer diameter of the cylindrical member.

15. The puncture needle according to claim 1, wherein the distal end of the wire has a tapered shape.

16. The puncture needle according to claim 1, wherein in a cross section perpendicular to the longitudinal direction passing through the midpoint of the puncture needle in the longitudinal direction, 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.

17. The puncture needle according to claim 1, 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.

18. The puncture needle according to claim 15, 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.

19. A puncture catheter having the puncture needle according to claim 1.

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 of 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 pitch length of the spiral member.

28. A catheter system comprising the puncture catheter according to any one of claims 20 to 27, further comprising a sheath having an inner cavity into which the puncture needle and the first tube are inserted, wherein the catheter system satisfies the relationship D>d>s+2H, where H is the length between the part of the wire that is located most radially outward of the tubular member in the radial direction of the tubular member and the outer surface of the tubular member, d is the maximum outer diameter of the first tube, s is the maximum outer diameter of the tubular member, and D is the inner diameter of the sheath.

Images