Puncture catheter
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- KANEKA CORP
- Filing Date
- 2025-12-23
- Publication Date
- 2026-07-16
AI Technical Summary
Existing puncture catheters used for administering chemical solutions to myocardial tissue have a high liquid retention issue, leading to excessive liquid usage.
The puncture catheter incorporates a spacer, helical member, or sliding member within the lumen of the connecting member to minimize liquid retention, reducing the amount of liquid used.
The design effectively reduces the amount of liquid remaining in the catheter, making it easier to administer precise doses of cell-containing solutions to target tissues like the heart, kidneys, or liver.
Smart Images

Figure JP2025045013_16072026_PF_FP_ABST
Abstract
Description
Puncture catheter
[0001] The present invention relates to a puncture catheter.
[0002] For myocardial tissue having cardiomyocytes that are losing function due to myocardial infarction or the like, treatment such as regenerating cardiomyocytes is performed by directly administering a chemical solution such as a cardiomyocyte regeneration cell-containing solution. Thus, when directly administering a chemical solution to an organ in the body, it is necessary to insert a catheter having a needle into the body cavity and puncture the organ with the needle. As a catheter having a needle used in such treatment, for example, the following have been developed.
[0003] Patent Document 1 describes a catheter provided with a fixed piercing element having a spiral structure. This catheter is operated so that the spiral structure of the piercing element is twisted into the heart wall.
[0004] Japanese Patent Translation of PCT International Publication No. 2003-529409
[0005] However, in the catheter described in Patent Document 1, there is a problem that the amount of liquid remaining in the catheter is large, resulting in an increase in the amount of liquid used.
[0006] The present invention has been made in view of the above circumstances, and an object thereof is to provide a puncture catheter that can easily reduce the amount of liquid used.
[0007] The puncture catheter according to the embodiment of the first invention that has solved the above problems is as follows. [1] A puncture catheter having a needle member with a medical puncture needle and a connection member having a lumen and connected to the proximal portion of the needle member, wherein the connection member has a spacer disposed in the lumen on the proximal side of the needle member.
[0008] By disposing a spacer in the lumen of the connection member of the puncture catheter, the amount of liquid remaining in the connection member can be reduced, so that the amount of liquid used can be easily reduced.
[0009] A puncture catheter according to an embodiment of the first invention is preferably any of the following [2] to
[11] . [2] A puncture catheter according to [1], further comprising a syringe whose distal end is inserted into the lumen of the connecting member, wherein the distal end of the syringe abuts against the proximal end of the spacer when the syringe is inserted into the lumen of the connecting member. [3] A puncture catheter according to [2], wherein the length of the spacer in the insertion direction of the syringe, as measured when the syringe is inserted into the lumen of the connecting member, is shorter than the length of the spacer in the insertion direction of the syringe, as measured when the syringe is not inserted into the lumen of the connecting member. [4] A puncture catheter according to any one of [1] to [3], wherein the spacer is cylindrical. [5] A puncture catheter according to [4], wherein the spacer has a section in which its inner diameter decreases toward the distal side. [6] The puncture catheter according to any one of [1] to [5], wherein the proximal end of the spacer is located in the proximal part of the connecting member. [7] The puncture catheter according to any one of [1] to [6], wherein the connecting member has a housing having a lumen, and the spacer is located in the lumen of the housing. [8] The puncture catheter according to [7], wherein the Shore D hardness of the spacer is lower than the Shore D hardness of the housing. [9] The puncture catheter according to [7] or [8], wherein the connecting member has a needle member connecting member located in the lumen of the housing distal to the spacer.
[10] The puncture catheter according to [9], wherein the spacer is made of a material with lower rigidity than the needle member connecting member.
[11] The puncture catheter according to [9] or
[10] , wherein the needle member comprises a first cylindrical member connected to the puncture needle and a second cylindrical member connected to the puncture needle and positioned in the lumen of the first cylindrical member, and the needle member connecting member comprises a first needle member connecting portion to which the first cylindrical member is connected and a second needle member connecting portion to which the second cylindrical member is connected.
[0010] A puncture catheter according to a second embodiment of the invention that has solved the above problems is as follows:
[12] A puncture catheter comprising: a needle member having a medical puncture needle; and a connecting member having a lumen and connected to the proximal part of the needle member, wherein the connecting member has a helical member located in the lumen and proximal to the needle member.
[0011] By arranging a helical member in the lumen of the connecting member of the above-mentioned puncture catheter, the amount of fluid remaining in the connecting member can be reduced, making it easier to reduce the amount of fluid used.
[0012] A puncture catheter according to an embodiment of the second invention is preferably any of the following
[13] to
[20] .
[13] A puncture catheter according to
[12] , further comprising a syringe whose distal end is inserted into the lumen of the connecting member, wherein the distal end of the syringe abuts against the proximal end of the helical member when the syringe is inserted into the lumen of the connecting member.
[14] A puncture catheter according to
[13] , wherein the length of the helical member in the insertion direction of the syringe, as measured when the syringe is inserted into the lumen of the connecting member, is shorter than the length of the helical member in the insertion direction of the syringe, as measured when the syringe is not inserted into the lumen of the connecting member.
[15] A puncture catheter according to any one of
[12] to
[14] , wherein the helical member has a section in which the wire diameter of the wire constituting the helical member increases toward the distal side.
[16] The puncture catheter according to any one of
[12] to
[15] , wherein the helical member has a section in which its inner diameter decreases toward the distal side.
[17] The puncture catheter according to any one of
[12] to
[16] , wherein the proximal end of the helical member is located in the proximal part of the connecting member.
[18] The puncture catheter according to any one of
[12] to
[17] , wherein the connecting member has a housing having a lumen, and the helical member is disposed in the lumen of the housing.
[19] The puncture catheter according to
[18] , wherein the connecting member has a needle member connecting member disposed in the lumen of the housing distal to the helical member.
[20] The puncture catheter according to
[19] , wherein the needle member comprises a first cylindrical member connected to the puncture needle and a second cylindrical member connected to the puncture needle and positioned in the lumen of the first cylindrical member, and the needle member connecting member comprises a first needle member connecting portion to which the first cylindrical member is connected and a second needle member connecting portion to which the second cylindrical member is connected.
[0013] A puncture catheter according to a third embodiment of the invention that has solved the above problems is as follows:
[21] A puncture catheter comprising: a needle member having a medical puncture needle; and a connecting member having a housing having a lumen and connected to the proximal part of the needle member, wherein the connecting member has a sliding member disposed in the lumen of the housing and movable in the longitudinal direction of the puncture catheter relative to the housing.
[0014] By positioning a sliding member within the lumen of the puncture catheter housing, the amount of fluid remaining in the connecting member can be reduced, making it easier to reduce the amount of fluid used.
[0015] A puncture catheter according to an embodiment of the third invention is preferably any of the following
[22] to
[36] .
[22] A puncture catheter according to
[21] , further comprising a syringe whose distal end is inserted into the lumen of the housing, wherein the distal end of the syringe abuts against the proximal end of the slide member when the syringe is inserted into the lumen of the housing.
[23] A puncture catheter according to
[22] , wherein the position of the slide member when the syringe is inserted into the lumen of the housing is distal to the position of the slide member when the syringe is not inserted into the lumen of the housing.
[24] A puncture catheter according to any one of
[21] to
[23] , wherein the proximal end of the slide member is located at the proximal part of the connecting member.
[25] A puncture catheter according to any one of
[21] to
[24] , wherein an elastic member is disposed distal to the slide member in the lumen of the housing.
[26] The puncture catheter according to
[25] , wherein the distal end of the slide member is capable of contacting the elastic member.
[27] The puncture catheter according to
[25] or
[26] , wherein the elastic member is a coil.
[28] The puncture catheter according to any one of
[21] to
[27] , wherein the needle member is connected to the slide member.
[29] The puncture catheter according to
[28] , wherein the needle member comprises a first cylindrical member connected to the puncture needle and a second cylindrical member connected to the puncture needle and positioned in the lumen of the first cylindrical member, and the first cylindrical member and the second cylindrical member are connected to the slide member.
[30] The puncture catheter according to any one of
[21] to
[27] , wherein the connecting member is positioned in the lumen of the housing distal to the slide member and has a needle member connecting member to which the needle member is connected.
[31] The puncture catheter according to
[30] , wherein the needle member comprises a first cylindrical member connected to the puncture needle and a second cylindrical member connected to the puncture needle and positioned in the lumen of the first cylindrical member, and the first cylindrical member and the second cylindrical member are connected to the needle member connecting member.
[32] The puncture catheter according to any one of
[21] to
[31] , wherein the slide member has a lumen.
[33] The puncture catheter according to
[32] , wherein the sliding member has a section in which its inner diameter decreases toward the distal side.
[34] The puncture catheter according to any one of
[21] to
[33] , wherein the connecting member has an engaging portion into which the sliding member can engage.
[35] The puncture catheter according to
[34] , wherein the connecting member has an engaging member disposed in the lumen of the housing and having the engaging portion, and the engaging member is immovable in the longitudinal direction of the puncture catheter relative to the housing.
[36] The puncture catheter according to
[35] , wherein the engaging member has a lumen.
[0016] In the first invention, by arranging a spacer in the lumen of the connecting member of the puncture catheter, the amount of liquid remaining in the connecting member can be reduced, making it easier to reduce the amount of liquid used.
[0017] In the second invention, since a helical member is arranged in the lumen of the connecting member of the puncture catheter, the amount of liquid remaining in the connecting member can be reduced, making it easier to reduce the amount of liquid used.
[0018] In the third invention, since a sliding member is arranged in the lumen of the housing of the puncture catheter, the amount of liquid remaining in the connecting member can be reduced, making it easier to reduce the amount of liquid used.
[0019] Figure 1 shows a side view of a puncture catheter according to an embodiment of the first invention. Figure 2 shows a cross-sectional view of the puncture catheter shown in Figure 1. Figure 3 shows a cross-sectional view of the puncture catheter shown in Figure 2 along the line III-III. Figure 4 shows a cross-sectional view showing a modified example of the puncture catheter shown in Figure 3. Figure 5 shows a side view of a puncture catheter according to an embodiment of the first invention. Figure 6 shows a cross-sectional view of the puncture catheter shown in Figure 5. Figure 7 shows a side view of a puncture catheter according to an embodiment of the second invention. Figure 8 shows a cross-sectional view of the puncture catheter shown in Figure 7. Figure 9 shows a side view of a puncture catheter according to an embodiment of the second invention. Figure 10 shows a cross-sectional view of the puncture catheter shown in Figure 9. Figure 11 shows a side view of a puncture catheter according to an embodiment of the third invention. Figure 12 shows a cross-sectional view of the puncture catheter shown in Figure 11. Figure 13 shows a cross-sectional view of the puncture catheter shown in Figure 12 along the line XIII-XIII. Figure 14 shows a cross-sectional view of a modified puncture catheter shown in Figure 12. Figure 15 shows a cross-sectional view of a modified puncture catheter shown in Figure 12. Figure 16 shows a side view of a puncture catheter according to an embodiment of the third invention. Figure 17 shows a cross-sectional view of the puncture catheter shown in Figure 16. Figure 18 shows a cross-sectional view of a modified puncture catheter shown in Figure 17. Figure 19 shows a cross-sectional view of a modified puncture catheter shown in Figure 17. Figure 20 shows a cross-sectional view of a modified puncture catheter shown in Figure 17. Figure 21 shows a cross-sectional view of the puncture catheter shown in Figure 20 before a syringe is attached.
[0020] 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 it is possible to implement it with appropriate modifications within the scope that is consistent with the spirit described above and below, and all such modifications are included within the technical scope of the present invention. In each drawing, hatching and reference numerals may be omitted for convenience, in which case refer to the specification or other drawings. Also, the dimensions of various parts in the drawings may differ from the actual dimensions, as priority is given to helping to understand the features of the present invention.
[0021] (First Invention) One embodiment of the puncture catheter of the first invention is a puncture catheter having a needle member having a medical puncture needle and a connecting member having a lumen and being connected to the proximal part of the needle member, wherein the connecting member has a spacer which is located in the lumen and is positioned proximal to the needle member.
[0022] The overall configuration of the puncture catheter according to an embodiment of the first invention will be described with reference to Figures 1 to 6. Figures 1 and 5 show side views of the puncture catheter according to an embodiment of the first invention. Figure 2 shows a cross-sectional view of the puncture catheter shown in Figure 1. More specifically, it shows a cross-section passing through the central axis of the puncture needle and parallel to the longitudinal direction of the puncture needle. Figure 3 shows a cross-sectional view of the puncture catheter shown in Figure 2 along the line III-III. Figure 4 shows a cross-sectional view showing a modified example of the puncture catheter shown in Figure 3. Figure 6 shows a cross-sectional view of the puncture catheter shown in Figure 5. More specifically, it shows a cross-section passing through the central axis of the puncture needle and parallel to the longitudinal direction of the puncture needle. Figures 1 to 6 show a puncture catheter 100 having a needle member 70 and a connecting member 40.
[0023] In this drawing, the longitudinal direction of the puncture needle 1 is indicated by x, the radial direction by y, and the circumferential direction by c. The radial direction y is perpendicular to the longitudinal direction x. In other words, the longitudinal direction x of the puncture needle 1 can also be said to be the direction of extension of the puncture needle 1.
[0024] In this specification, the proximal side refers to the direction toward the user's hand relative to the longitudinal direction x of the puncture needle 1, and the distal side refers to the opposite side of the proximal side, i.e., the direction toward the treatment target. Furthermore, when each component is divided into two equal parts along the longitudinal direction x of the puncture needle 1, the portion located on the distal side of each component is called the distal part, and the portion located on the proximal side of each component is called the proximal part. The distal end of each component is the end located furthest distally from each component. The proximal end of each component is the end located furthest proximal from each component. The end of each component refers to the portion including the end of each component and its surroundings. That is, the distal end of each component refers to the portion including the distal end of each component and its surroundings, and the proximal end of each component refers to the portion including the proximal end of each component and its surroundings.
[0025] The puncture catheter 100 includes a needle member 70 and a connecting member 40.
[0026] As shown in Figures 1, 2, 5, and 6, the needle member 70 has a puncture needle 1.
[0027] The puncture needle 1 is for medical use and is intended to puncture target tissue. As shown in Figures 1, 2, 5, and 6, the puncture needle 1 preferably has a longitudinal direction x and a lumen 1e extending in the longitudinal direction x. Through this lumen 1e, liquids such as cell-containing fluid or drug solutions can be delivered to the target tissue.
[0028] The connecting member 40 has a lumen 40e and is connected to the proximal part of the needle member 70.
[0029] The connecting member 40 has a spacer 43 located in the lumen 40e and proximal to the needle member 70. Preferably, the distal end 43a of the spacer 43 is located proximal to the proximal end 70b of the needle member 70.
[0030] By placing the spacer 43 in the lumen 40e of the connecting member 40 of the puncture catheter 100, the amount of liquid remaining in the connecting member 40 can be reduced, making it easier to reduce the amount of liquid used.
[0031] The puncture catheter 100 is used to administer liquids such as cell-containing solutions or drug solutions to target tissues. Specifically, the puncture catheter 100 is preferably used for direct administration to internal organs, such as the heart, kidneys, or liver. The liquid administered using the puncture catheter 100 is preferably a cell-containing solution. For example, the puncture catheter 100 can be used to directly administer iPS cell-containing solutions to the liver or kidneys, or to directly administer myocardial regeneration cell-containing solutions to the heart, or more specifically, the myocardium.
[0032] As shown in Figures 1, 2, 5, and 6, the puncture catheter 100 preferably further includes a syringe 80 whose distal end is inserted into the lumen 40e of the connecting member 40. The syringe 80 has a distal end 80a and a proximal end, and it is preferable that the syringe 80 is filled with liquid. By inserting the syringe 80 into the lumen 40e of the connecting member 40 and pushing the plunger, the liquid in the syringe 80 can be supplied into the connecting member 40. When the syringe 80 is inserted into the lumen 40e of the connecting member 40, it is preferable that the distal end 80a of the syringe 80 abuts against the proximal end 43b of the spacer 43.
[0033] Preferably, the length of the spacer 43 in the insertion direction of the syringe 80, measured when the syringe 80 is inserted into the lumen 40e of the connecting member 40, is shorter than the length of the spacer 43 in the insertion direction of the syringe 80, measured when the syringe 80 is not inserted into the lumen 40e of the connecting member 40. By changing the length of the spacer 43 in the insertion direction of the syringe 80 in this way, the impact received by the distal end of the syringe 80 is more easily absorbed, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0034] When the syringe 80 is inserted into the lumen 40e of the connecting member 40, it is preferable that the position of the proximal end 43b of the spacer 43 is distal to the position of the proximal end 43b of the spacer 43 when the syringe 80 is not inserted into the lumen 40e of the connecting member 40. By changing the position of the proximal end 43b of the spacer 43 in this way, the impact received by the distal end of the syringe 80 is more easily absorbed, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0035] It is preferable that the syringe 80 is inserted into the lumen 40e of the connecting member 40, and the syringe 80 pushes the proximal end of the spacer 43, causing the position of the proximal end 43b of the spacer 43 to move distally. As the position of the proximal end 43b of the spacer 43 moves distally, it becomes easier to absorb the impact received by the distal end of the syringe 80, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0036] When the syringe 80 is inserted into the lumen 40e of the connecting member 40, it is preferable that the position of the distal end 43a of the spacer 43 is the same as the position of the distal end 43a of the spacer 43 when the syringe 80 is not inserted into the lumen 40e of the connecting member 40.
[0037] The needle member 70 may have a distal end 70a and a proximal end 70b.
[0038] The needle member 70 may have other members in addition to the puncture needle 1. Specifically, as shown in Figures 1, 2, 5, and 6, the needle member 70 may have cylindrical members such as the first cylindrical member 10 and the second cylindrical member 20, which will be described later. Although not shown, the needle member 70 may consist only of the puncture needle 1.
[0039] The puncture needle 1 is preferably designed to puncture internal organs. Internal organs refer to organs located inside the body, particularly in the abdomen and chest, and are also known as viscera.
[0040] The puncture needle 1 can be made of, for example, metal or resin. The puncture needle 1 may be made entirely of metal, or entirely of resin. The puncture needle 1 may be made partly of metal and the other part of resin.
[0041] The puncture needle 1 is preferably made of metal only. Examples of metals that make up the puncture needle 1 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0042] Examples of resins that make up the puncture needle 1 include polyether ether ketone (PEEK) and polycarbonate (PC). By constructing the puncture needle 1 using only resin and no metal, the puncture needle 1 can be used even for patients with metal allergies.
[0043] The puncture needle 1 may have a distal end 1a and a proximal end 1b. The puncture needle 1 may have an inner surface 1c facing the inner cavity 1e of the puncture needle 1 and an outer surface 1d facing the outside of the puncture needle 1.
[0044] The length of the puncture needle 1 in the longitudinal direction x of the puncture needle 1 can be 2 mm or more, 3 mm or more, 4 mm or more, etc. The length of the puncture needle 1 in the longitudinal direction x of the puncture needle 1 can be 50 mm or less, 30 mm or less, 10 mm or less, etc. The length of the puncture needle 1 in the longitudinal direction x of the puncture needle 1 refers to the longest length among the lengths of the puncture needle 1 in the longitudinal direction x that the puncture needle 1 has. When used as a puncture catheter for puncturing the myocardium, the length of the puncture needle 1 in the longitudinal direction x of the puncture needle 1 is preferably 5 mm.
[0045] The length of the puncture needle 1 in the radial direction y of the puncture needle 1 can be 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, etc. The length of the puncture needle 1 in the radial direction y of the puncture needle 1 can be 10 mm or less, 5 mm or less, 1 mm or less, etc. The length of the puncture needle 1 in the radial direction y of the puncture needle 1 refers to the longest length among the lengths of the puncture needle 1 in the radial direction y that the puncture needle 1 has. When used as a puncture catheter for puncturing the myocardium, the length of the puncture needle 1 in the radial direction y of the puncture needle 1 is preferably 0.45 mm.
[0046] As shown in FIGS. 5 and 6, the puncture needle 1 may have a cylindrical member 2 and a helical member 3.
[0047] The cylindrical member 2 is a cylindrical member and may have an inner cavity 2e extending in the longitudinal direction x of the puncture needle 1. This inner cavity 2e corresponds to the inner cavity 1e of the puncture needle 1. Through this inner cavity 2e, liquids such as cell-containing fluid and drug solution can be transported to the target tissue. The cylindrical member 2 may have a distal end 2a and a proximal end 2b.
[0048] The helical member 3 is preferably a member in which a wire 4 is helically wound. The wire 4 is preferably wound around the cylindrical member 2.
[0049] Regarding the puncture needle 1, by adopting a design in which a spiral member 3 is arranged around a cylindrical member 2, it becomes easier to screw the puncture needle 1 into the target tissue by rotating the puncture needle 1 around the cylindrical member 2 as an axis. This makes it easier to puncture the target tissue with the puncture needle 1. In addition, the wire 4 constituting the spiral member 3 bites into the tissue, making it difficult for the puncture needle 1 to come out of the tissue. Furthermore, the puncture depth can be easily adjusted by adjusting the rotation of the puncture needle 1.
[0050] It is preferable that a hole 5 is formed in the puncture needle 1, connecting the lumen 1e of the puncture needle 1 to the outside of the puncture needle 1. Liquids such as cell-containing fluid or drug solution that have been transported through the lumen 1e are delivered to the target tissue through this hole 5.
[0051] The puncture needle 1 may have only one hole 5 or multiple holes 5. If only one hole 5 is formed on the puncture needle 1, it becomes easier to administer liquids such as cell-containing fluid or drug solutions to a specific point. If multiple holes 5 are formed on the puncture needle 1, it becomes easier to administer liquids such as cell-containing fluid or drug solutions to a wider area.
[0052] When observed from a direction perpendicular to the longitudinal direction x of the puncture needle 1, the outer shape of the hole 5 can be a polygon such as a triangle, square, or pentagon, or a circle, an ellipse, or a combination thereof. Polygons include not only those with clearly defined corner vertices and straight sides, but also rounded polygons with rounded corners, and those with at least some of their sides being curved.
[0053] The needle member 70 may include a first cylindrical member 10 connected to the puncture needle 1, and a second cylindrical member 20 connected to the puncture needle 1 and positioned in the lumen 10e of the first cylindrical member 10.
[0054] As shown in Figures 1 to 6, the first cylindrical member 10 is a cylindrical member having a lumen 10e extending in the longitudinal direction x of the puncture needle 1 and is connected to the puncture needle 1. The first cylindrical member 10 may have a tapered portion in which the outer diameter decreases toward the distal end.
[0055] The first cylindrical member 10 may have a distal end 10a and a proximal end 10b. Preferably, the first cylindrical member 10 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the first cylindrical member 10 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the first cylindrical member 10 is fixed in contact with the proximal end of the puncture needle 1.
[0056] It is preferable that the lumen 1e of the puncture needle 1 and the lumen 10e of the first cylindrical member 10 are not in communication with each other.
[0057] Preferably, the first cylindrical member 10 has an inner surface 10c facing the inner lumen 10e of the first cylindrical member 10 and an outer surface 10d facing the outside of the first cylindrical member 10.
[0058] The method of connecting the first cylindrical member 10 and the puncture needle 1 is not particularly limited. Examples include fixing by welding, welding, bonding, crimping, etc. Among these, it is preferable that the first cylindrical member 10 and the puncture needle 1 are welded together.
[0059] The first cylindrical member 10 may consist of only one cylindrical member, or it may consist of multiple cylindrical members.
[0060] The first cylindrical member 10 can be made of resin, metal, or the like. The first cylindrical member 10 may be made entirely of metal, or entirely of resin. The first cylindrical member 10 may be made partly of metal and the other part of resin.
[0061] Examples of metals that make up the first cylindrical member 10 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0062] Examples of resins constituting the first cylindrical member 10 include synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyetherketone resins (e.g., PEEK), polyetherpolyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, ETFE), or combinations thereof.
[0063] Preferably, the first cylindrical member 10 includes a portion made of a material containing metal. Only a portion of the first cylindrical member 10 may be made of metal, or the entire first cylindrical member 10 may be made of metal.
[0064] As shown in Figures 2 and 6, it is preferable that the first cylindrical member 10 has a metal layer 11 made of metal. Having a metal layer 11 in the first cylindrical member 10 makes it easier to create a puncture catheter 100 with high torque transmission capabilities.
[0065] Preferably, the metal layer 11 has an inner surface 11c located on the radially inward side of the first cylindrical member 10 and an outer surface 11d located on the radially outward side of the first cylindrical member 10.
[0066] The metal layer 11 may consist of a pipe, a coil around which wire is wound, a braid in which wire is woven, a pipe with holes or grooves formed therein, or a combination thereof.
[0067] It is preferable that the metal layer 11 has a plurality of grooves 11f formed therein. The grooves 11f may be closed grooves or through grooves. Both through grooves and closed grooves may be formed in the metal layer 11. By combining through grooves and closed grooves, or by selecting one or the other, it becomes easier to create a metal layer 11 with the desired flexibility and rigidity.
[0068] As shown in Figure 2, it is preferable that the first cylindrical member 10 has an outer resin layer 12 disposed on the outer surface 11d of the metal layer 11. This makes it less likely for the first cylindrical member 10 to get caught on the body cavity wall, even if holes or grooves 11f are formed in the metal layer 11, and makes it easier to ensure insertion within the body cavity.
[0069] The outer resin layer 12 may be arranged to cover only a portion of the outer surface 11d of the metal layer 11. Alternatively, the outer resin layer 12 may be arranged to cover the entire outer surface 11d of the metal layer 11.
[0070] As shown in Figure 6, the first cylindrical member 10 may have an inner resin layer 13 arranged on the inner surface 11c of the metal layer 11.
[0071] The inner resin layer 13 may be arranged to cover only a portion of the inner surface 11c of the metal layer 11. Alternatively, the inner resin layer 13 may be arranged to cover the entire inner surface 11c of the metal layer 11.
[0072] Although not shown in the figures, the first cylindrical member 10 may have both an outer resin layer 12 disposed on the outer surface 11d of the metal layer 11 and an inner resin layer 13 disposed on the inner surface 11c of the metal layer 11.
[0073] As shown in Figures 2 and 6, the second cylindrical member 20 is preferably a cylindrical member that is positioned in the lumen 10e of the first cylindrical member 10. The second cylindrical member 20 is connected to the puncture needle 1 and has a lumen 20e that extends in the longitudinal direction x of the puncture needle 1. A liquid such as a cell-containing solution or a drug solution passes through this lumen 20e.
[0074] The second cylindrical member 20 may have a distal end 20a and a proximal end 20b. Preferably, the second cylindrical member 20 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the second cylindrical member 20 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the second cylindrical member 20 is fixed in contact with the proximal end of the puncture needle 1.
[0075] It is preferable that the lumen 1e of the puncture needle 1 and the lumen 20e of the second cylindrical member 20 are in communication.
[0076] Preferably, the second cylindrical member 20 has an inner surface 20c facing the inner lumen 20e of the second cylindrical member 20 and an outer surface 20d facing the outside of the second cylindrical member 20.
[0077] It is preferable that the inner surface 10c of the first cylindrical member 10 and the outer surface 20d of the second cylindrical member 20 are separated. A void exists between the inner surface 10c of the first cylindrical member 10 and the outer surface 20d of the second cylindrical member 20, and no other members are required to be placed in this void.
[0078] The method of connecting the second cylindrical member 20 and the puncture needle 1 is not particularly limited. Examples include fixing by welding, welding, adhesive, crimping, etc. Among these, it is preferable that the second cylindrical member 20 and the puncture needle 1 are bonded together with an adhesive.
[0079] For example, polyurethane-based, epoxy-based, cyano-based, fluorine-based, and silicone-based adhesives can be used.
[0080] The second cylindrical member 20 may consist of only one cylindrical member, or it may consist of multiple cylindrical members.
[0081] The second cylindrical member 20 can be made of resin, metal, or the like. The second cylindrical member 20 may be made entirely of metal, or entirely of resin. The second cylindrical member 20 may be made partly of metal and the other part of resin.
[0082] Examples of metals that make up the second cylindrical member 20 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0083] Examples of resins constituting the second cylindrical member 20 include synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyetherketone resins (e.g., PEEK), polyetherpolyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, ETFE), or combinations thereof.
[0084] The second cylindrical member 20 preferably includes a portion made of a resin-containing material. Only a portion of the second cylindrical member 20 may be made of resin, or the entire second cylindrical member 20 may be made of resin. The second cylindrical member 20 is preferably made of an elastically deformable material.
[0085] As shown in Figures 2 and 6, it is preferable that the second cylindrical member 20 has a tapered portion 22 in which the outer diameter increases toward the distal end. It is even more preferable that the second cylindrical member 20 has a tapered portion 22 in which the outer diameter increases toward the distal end.
[0086] The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 can be 1100 mm or more, 1330 mm or more, 1560 mm or more, etc. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 can be 2300 mm or less, 2070 mm or less, 1840 mm or less, etc. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1. The length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, it is preferable that the length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 are 1500 mm. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 may be the same or different.
[0087] The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 can be 20.0 mm or less, 15.0 mm or less, 10.0 mm or less, etc. The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 refers to the longest length of the first cylindrical member 10 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, it is preferable that the length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 be 0.9 mm.
[0088] The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 can be 0.1 mm or more, 0.2 mm or more, 0.3 mm or more, etc. The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 can be 15.0 mm or less, 10.0 mm or less, 5.0 mm or less, etc. The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 refers to the longest length of the second cylindrical member 20 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 is preferably 0.5 mm.
[0089] As shown in Figures 2 and 6, it is preferable that the second cylindrical member 20 has a tapered portion 23 whose outer diameter increases towards the proximal side. It is even more preferable that the second cylindrical member 20 has a tapered portion 23 at its proximal end, where the outer diameter increases towards the proximal side. This makes it easier to connect the proximal end of the second cylindrical member 20 to the connecting member 40.
[0090] The second cylindrical member 20 may have multiple sections with different inner diameters in the longitudinal direction of the second cylindrical member 20. The inner diameter of the second cylindrical member 20 may be constant for a length from the distal end 20a to the proximal end 20b of the second cylindrical member 20.
[0091] As shown in Figures 2 and 6, it is preferable that the distal end of the first connection portion 31, which is the part where the first cylindrical member 10 and the puncture needle 1 are connected, is located distal to the distal end of the second connection portion 32, which is the part where the second cylindrical member 20 and the puncture needle 1 are connected. It is preferable that the first cylindrical member 10 and the puncture needle 1 are in contact at the first connection portion 31. It is preferable that the second cylindrical member 20 and the puncture needle 1 are in contact at the second connection portion 32.
[0092] The connecting member 40 may have a distal end 40a and a proximal end 40b. Preferably, the connecting member 40 is connected to the proximal end of the needle member 70. More preferably, the distal end of the connecting member 40 is connected to the proximal end of the needle member 70. Preferably, the connecting member 40 is fixed in contact with the needle member 70.
[0093] The method of connecting the connecting member 40 and the needle member 70 is not particularly limited. Examples include fixing by welding, welding, bonding, crimping, etc.
[0094] The connecting member 40 may consist of only one member or may consist of multiple members.
[0095] The connecting member 40 can be made of resin, metal, or the like. The connecting member 40 may be made entirely of metal, or entirely of resin. The connecting member 40 may be made partly of metal and the other part of resin.
[0096] Examples of metals that make up the connecting member 40 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0097] Examples of resins that make up the connecting member 40 include synthetic resins such as polyolefin resin (e.g., polyethylene and polypropylene), polyamide resin (e.g., nylon), polyester resin (e.g., PET), aromatic polyetherketone resin (e.g., PEEK), polyetherpolyamide resin, polyurethane resin, polyimide resin, fluororesin (e.g., PTFE, PFA, ETFE), polycarbonate resin, ABS resin, or combinations thereof.
[0098] The connecting member 40 preferably includes a portion made of a material containing resin. Only a portion of the connecting member 40 may be made of resin, or the entire connecting member 40 may be made of resin.
[0099] The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 can be 2.0 mm or more, 3.0 mm or more, 4.0 mm or more, etc. The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 can be 30.0 mm or less, 20.0 mm or less, 10.0 mm or less, etc. The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the connecting member 40 in the longitudinal direction x of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 is preferably 5.5 mm.
[0100] The length of the connecting member 40 in the radial direction y of the puncture needle 1 can be 1.0 mm or more, 2.0 mm or more, 3.0 mm or more, etc. The length of the connecting member 40 in the radial direction y of the puncture needle 1 can be 6.0 mm or less, 5.0 mm or less, 4.0 mm or less, etc. The length of the connecting member 40 in the radial direction y of the puncture needle 1 refers to the longest length of the connecting member 40 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the connecting member 40 in the radial direction y of the puncture needle 1 is preferably 3.2 mm.
[0101] As shown in Figures 1 to 6, the connecting member 40 preferably has a housing 45 having a lumen 45e, and the spacer 43 is preferably positioned in the lumen 45e of the housing 45.
[0102] The housing 45 may have a distal end 45a and a proximal end 45b. Preferably, the housing 45 is connected to the proximal end of the needle member 70. More preferably, the distal end of the housing 45 is connected to the proximal end of the needle member 70. Preferably, the housing 45 is fixed in contact with the needle member 70.
[0103] Preferably, the housing 45 has an inner surface 45c facing the inner cavity 45e of the housing 45 and an outer surface 45d facing the outside of the housing 45.
[0104] The housing 45 can be made of resin, metal, or other materials listed as capable of constituting the connecting member 40. The housing 45 may be made entirely of metal, or entirely of resin. The housing 45 may be made partly of metal and the other parts of resin.
[0105] The spacer 43 may have a distal end 43a and a proximal end 43b.
[0106] The shape of the spacer 43 can be, for example, cylindrical, columnar, hollow columnar, or hollow polygonal columnar. As shown in Figure 4, multiple columnar spacers 43 may be arranged on the inner surface 45c of the housing 45. As shown in Figure 3, it is preferable that the spacer 43 is cylindrical or hollow columnar and has a lumen. A cylindrical spacer 43 may be placed in the lumen 45e of the housing 45.
[0107] As shown in Figure 2, the spacer 43 is preferably cylindrical or hollow columnar, with an inner diameter smaller than the inner diameter of the distal end of the syringe 80. This reduces the amount of liquid remaining in the connecting member 40, making it easier to reduce the amount of liquid used. Although not shown, the spacer 43 may also be cylindrical or hollow columnar, with an inner diameter larger than the inner diameter of the distal end of the syringe 80.
[0108] As shown in Figure 2, the spacer 43 is preferably cylindrical or hollow columnar, with an inner diameter smaller than the inner diameter of the proximal end 20b of the second cylindrical member 20. This reduces the amount of liquid remaining in the connecting member 40, making it easier to reduce the amount of liquid used. However, it is also acceptable for the spacer 43 to be cylindrical or hollow columnar, with an inner diameter larger than the inner diameter of the distal end 20b of the second cylindrical member 20.
[0109] As shown in Figure 6, the spacer 43 is preferably cylindrical or hollow columnar, and its lumen has a section that narrows toward the distal end. As shown in Figure 6, the spacer 43 is preferably having a section 44 whose inner diameter decreases toward the distal end. This reduces the amount of liquid remaining in the connecting member 40, making it easier to reduce the amount of liquid used.
[0110] As shown in Figures 2 and 6, the proximal end 43b of the spacer 43 may be located on the proximal part of the connecting member 40. Although not shown, the proximal end 43b of the spacer 43 may be located on the distal part of the connecting member 40.
[0111] As shown in Figures 2 and 6, the distal end 43a of the spacer 43 may be located on the distal part of the connecting member 40. Although not shown, the distal end 43a of the spacer 43 may be located on the proximal part of the connecting member 40.
[0112] The spacer 43 can be made of resin, metal, or other materials listed as capable of constituting the connecting member 40. The spacer 43 may be made entirely of metal, or entirely of resin. The spacer 43 may be made partly of metal and the other part of resin.
[0113] The Shore D hardness of the spacer 43 is preferably lower than that of the housing 45. This makes it easier to absorb the impact received by the distal end of the syringe 80, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0114] As shown in Figures 2 and 6, the connecting member 40 may have a needle member connecting member 46 located in the lumen 45e of the housing 45 distal to the spacer 43. The needle member connecting member 46 is the member to which the needle member 70 is connected. Preferably, the proximal end of the needle member connecting member 46 is in contact with or fixed to the distal end 43b of the spacer 43. The proximal end of the needle member connecting member 46 may be located distal to the distal end 43b of the spacer 43. The proximal end of the needle member connecting member 46 and the distal end 43b of the spacer 43 may be separated.
[0115] The needle member connecting member 46 can be made of resin, metal, or other materials listed as materials that can constitute the connecting member 40. The needle member connecting member 46 may be made entirely of metal, or entirely of resin. The needle member connecting member 46 may be made partly of metal and the other part of resin.
[0116] The needle member connecting member 46 preferably has a lumen through which liquid can pass.
[0117] As shown in Figures 2 and 6, the proximal end of the third connection portion 33, where the first cylindrical member 10 and the connecting member 40 are connected, may be located distal to the proximal end of the fourth connection portion 34, where the second cylindrical member 20 and the connecting member 40 are connected. Although not shown, the proximal end of the third connection portion 33, where the first cylindrical member 10 and the connecting member 40 are connected, may be located proximal to the proximal end of the fourth connection portion 34, where the second cylindrical member 20 and the connecting member 40 are connected. In the third connection portion 33, it is preferable that the first cylindrical member 10 and the connecting member 40 are in contact. In the fourth connection portion 34, it is preferable that the second cylindrical member 20 and the connecting member 40 are in contact.
[0118] The spacer 43 may be made of a material with lower rigidity than the needle member connecting member 46. This makes it easier to absorb the impact received by the distal end of the syringe 80, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0119] As shown in Figures 2 and 6, the needle member connecting member 46 may have a first needle member connecting portion 461 to which the first cylindrical member 10 is connected, and a second needle member connecting portion 462 to which the second cylindrical member 20 is connected. The first needle member connecting portion 461 may have a lumen. The second needle member connecting member 462 may have a lumen.
[0120] As shown in Figures 2 and 6, the outer surface 10d of the first cylindrical member 10 may be fixed to the first needle member connection portion 461. The outer surface 10d of the first cylindrical member 10 may be fixed in contact with the first needle member connection portion 461. The inner surface 20c of the second cylindrical member 20 may be fixed to the second needle member connection portion 462. The inner surface 20c of the second cylindrical member 20 may be fixed in contact with the second needle member connection portion 462. Although not shown, the inner surface 10c of the first cylindrical member 10 may be fixed to the first needle member connection portion 461. The outer surface 20d of the second cylindrical member 20 may be fixed to the second needle member connection portion 462.
[0121] The lumen of the spacer 43, the lumen of the second needle member connecting member 462, the lumen 20e of the second cylindrical member 20, and the lumen 1e of the puncture needle 1 are arranged in this order from proximal to distal, and it is preferable that the lumen of the spacer 43, the lumen of the second needle member connecting member 462, the lumen 20e of the second cylindrical member 20, and the lumen 1e of the puncture needle 1 are in communication with each other. This allows the liquid in the syringe 80, such as cell-containing fluid or drug solution, to be delivered to the target tissue.
[0122] (Second Invention) One embodiment of the puncture catheter of the second invention is a puncture catheter having a needle member having a medical puncture needle and a connecting member having a lumen and being connected to the proximal part of the needle member, wherein the connecting member has a helical member that is located in the lumen and is positioned proximal to the needle member.
[0123] Referring to Figures 7 to 10, the overall configuration of the puncture catheter according to an embodiment of the second invention will be described. Figures 7 and 9 show side views of the puncture catheter according to an embodiment of the second invention. Figure 8 shows a cross-sectional view of the puncture catheter shown in Figure 7. Figure 10 shows a cross-sectional view of the puncture catheter shown in Figure 9. In more detail, Figures 8 and 10 show a cross-section passing through the central axis of the puncture needle and parallel to the longitudinal direction of the puncture needle. Figures 7 to 10 show a puncture catheter 100 having a needle member 70 and a connecting member 40.
[0124] In this drawing, the longitudinal direction of the puncture needle 1 is indicated by x, and the radial direction of the puncture needle 1 is indicated by y. The radial direction y is perpendicular to the longitudinal direction x. In other words, the longitudinal direction x of the puncture needle 1 can also be said to be the direction of extension of the puncture needle 1.
[0125] In this specification, the proximal side refers to the direction toward the user's hand relative to the longitudinal direction x of the puncture needle 1, and the distal side refers to the opposite side of the proximal side, i.e., the direction toward the treatment target. Furthermore, when each component is divided into two equal parts along the longitudinal direction x of the puncture needle 1, the portion located on the distal side of each component is called the distal part, and the portion located on the proximal side of each component is called the proximal part. The distal end of each component is the end located furthest distally from each component. The proximal end of each component is the end located furthest proximal from each component. The end of each component refers to the portion including the end of each component and its surroundings. That is, the distal end of each component refers to the portion including the distal end of each component and its surroundings, and the proximal end of each component refers to the portion including the proximal end of each component and its surroundings.
[0126] The puncture catheter 100 includes a needle member 70 and a connecting member 40.
[0127] As shown in Figures 7, 8, 9, and 10, the needle member 70 has a puncture needle 1.
[0128] The puncture needle 1 is for medical use and is intended to puncture target tissue. As shown in Figures 7, 8, 9, and 10, the puncture needle 1 preferably has a longitudinal direction x and a lumen 1e extending in the longitudinal direction x. Through this lumen 1e, liquids such as cell-containing fluid or drug solutions can be delivered to the target tissue.
[0129] The connecting member 40 has a lumen 40e and is connected to the proximal part of the needle member 70.
[0130] The connecting member 40 has a helical member 90 located in the lumen 40e and positioned proximal to the needle member 70. Preferably, the distal end 90a of the helical member 90 is located proximal to the proximal end 70b of the needle member 70.
[0131] By arranging the spiral member 90 in the lumen 40e of the connecting member 40 of the above-mentioned puncture catheter 100, the amount of liquid remaining in the connecting member 40 can be reduced, making it easier to reduce the amount of liquid used.
[0132] The puncture catheter 100 is used to administer liquids such as cell-containing solutions or drug solutions to target tissues. Specifically, the puncture catheter 100 is preferably used for direct administration to internal organs, such as the heart, kidneys, or liver. The liquid administered using the puncture catheter 100 is preferably a cell-containing solution. For example, the puncture catheter 100 can be used to directly administer iPS cell-containing solutions to the liver or kidneys, or to directly administer myocardial regeneration cell-containing solutions to the heart, or more specifically, the myocardium.
[0133] As shown in Figures 7, 8, 9, and 10, the puncture catheter 100 preferably further includes a syringe 80 whose distal end is inserted into the lumen 40e of the connecting member 40. The syringe 80 has a distal end 80a and a proximal end, and it is preferable that the syringe 80 is filled with liquid. By inserting the syringe 80 into the lumen 40e of the connecting member 40 and pushing the plunger, the liquid in the syringe 80 can be supplied into the connecting member 40. When the syringe 80 is inserted into the lumen 40e of the connecting member 40, it is preferable that the distal end 80a of the syringe 80 abuts against the proximal end 90b of the helical member 90.
[0134] Preferably, the length of the helical member 90 in the insertion direction of the syringe 80, as measured when the syringe 80 is inserted into the lumen 40e of the connecting member 40, is shorter than the length of the helical member 90 in the insertion direction of the syringe 80, as measured when the syringe 80 is not inserted into the lumen 40e of the connecting member 40. By changing the length of the helical member 90 in the insertion direction of the syringe 80 in this way, the impact received by the distal end of the syringe 80 is more easily absorbed, thereby making it easier to suppress damage to the distal end of the syringe 80. For example, by the syringe 80 directly or indirectly pushing the helical member 90 from the distal end 90b side of the helical member 90, the length of the helical member 90 in the insertion direction of the syringe 80, as measured when the syringe 80 is inserted into the lumen 40e of the connecting member 40, can be made shorter than the length of the helical member 90 in the insertion direction of the syringe 80, as measured when the syringe 80 is not inserted into the lumen 40e of the connecting member 40.
[0135] When the syringe 80 is inserted into the lumen 40e of the connecting member 40, it is preferable that the position of the proximal end 90b of the helical member 90 is distal to the position of the proximal end 90b of the helical member 90 when the syringe 80 is not inserted into the lumen 40e of the connecting member 40. By changing the position of the proximal end 90b of the helical member 90 in this way, the impact received by the distal end of the syringe 80 is more easily absorbed, thereby making it easier to suppress damage to the distal end of the syringe 80. For example, by directly or indirectly pushing the helical member 90 from the distal end 90b side of the helical member 90 with the syringe 80, the position of the proximal end 90b of the helical member 90 when the syringe 80 is inserted into the lumen 40e of the connecting member 40 can be moved distal to the position of the proximal end 90b of the helical member 90 when the syringe 80 is not inserted into the lumen 40e of the connecting member 40.
[0136] For example, the spiral member 90 may have a predetermined pitch when the syringe 80 is not inserted into the lumen 40e of the connecting member 40, and the pitch of the spiral member 90 may be smaller than the predetermined pitch when the syringe 80 is inserted into the lumen 40e of the connecting member 40. This makes it possible to change the length of the spiral member 90 in the insertion direction of the syringe 80, or to change the position of the proximal end 90b of the spiral member 90, before and after inserting the syringe 80 into the lumen 40e of the connecting member 40.
[0137] When the syringe 80 is inserted into the lumen 40e of the connecting member 40, it is preferable that the position of the distal end 90a of the helical member 90 is the same as the position of the distal end 90a of the helical member 90 when the syringe 80 is not inserted into the lumen 40e of the connecting member 40.
[0138] The needle member 70 may have a distal end 70a and a proximal end 70b.
[0139] The needle member 70 may have other members in addition to the puncture needle 1. Specifically, as shown in Figures 7, 8, 9, and 10, the needle member 70 may have cylindrical members such as the first cylindrical member 10 and the second cylindrical member 20, which will be described later. Although not shown, the needle member 70 may consist only of the puncture needle 1.
[0140] The puncture needle 1 is preferably designed to puncture internal organs. Internal organs refer to organs located inside the body, particularly in the abdomen and chest, and are also known as viscera.
[0141] The puncture needle 1 can be made of, for example, metal or resin. The puncture needle 1 may be made entirely of metal, or entirely of resin. The puncture needle 1 may be made partly of metal and the other part of resin.
[0142] The puncture needle 1 is preferably made of metal only. Examples of metals that make up the puncture needle 1 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0143] Examples of resins that make up the puncture needle 1 include polyether ether ketone (PEEK) and polycarbonate (PC). By constructing the puncture needle 1 using only resin and no metal, the puncture needle 1 can be used even for patients with metal allergies.
[0144] The puncture needle 1 may have a distal end 1a and a proximal end 1b. The puncture needle 1 may have an inner surface 1c facing the lumen 1e of the puncture needle 1 and an outer surface 1d facing the outside of the puncture needle 1.
[0145] The length of the puncture needle 1 in the longitudinal direction x can be 2 mm or more, 3 mm or more, 4 mm or more, etc. The length of the puncture needle 1 in the longitudinal direction x can be 50 mm or less, 30 mm or less, 10 mm or less, etc. The length of the puncture needle 1 in the longitudinal direction x refers to the longest length of the puncture needle 1 in the longitudinal direction x. When used as a puncture catheter for puncturing the myocardium, the length of the puncture needle 1 in the longitudinal direction x is preferably 5 mm.
[0146] The length of the puncture needle 1 in the radial direction y can be 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, etc. The length of the puncture needle 1 in the radial direction y can be 10 mm or less, 5 mm or less, 1 mm or less, etc. The length of the puncture needle 1 in the radial direction y refers to the longest length of the puncture needle 1 in the radial direction y. When used as a puncture catheter for puncturing the myocardium, the length of the puncture needle 1 in the radial direction y is preferably 0.45 mm.
[0147] As shown in Figures 9 and 10, the puncture needle 1 may have a cylindrical member 2 and a spiral member 3.
[0148] The tubular member 2 is a tubular member and may have a lumen 2e extending in the longitudinal direction x of the puncture needle 1. This lumen 2e corresponds to the lumen 1e of the puncture needle 1. Through this lumen 2e, liquids such as cell-containing fluid or drug solutions can be delivered to the target tissue. The tubular member 2 may have a distal end 2a and a proximal end 2b.
[0149] The helical member 3 is preferably a member in which a wire 4 is wound in a helical shape. The wire 4 is preferably wound around the cylindrical member 2.
[0150] Regarding the puncture needle 1, by adopting a design in which a spiral member 3 is arranged around a cylindrical member 2, it becomes easier to screw the puncture needle 1 into the target tissue by rotating the puncture needle 1 around the cylindrical member 2 as an axis. This makes it easier to puncture the target tissue with the puncture needle 1. In addition, the wire 4 constituting the spiral member 3 bites into the tissue, making it difficult for the puncture needle 1 to come out of the tissue. Furthermore, the puncture depth can be easily adjusted by adjusting the rotation of the puncture needle 1.
[0151] It is preferable that a hole 5 is formed in the puncture needle 1, connecting the lumen 1e of the puncture needle 1 to the outside of the puncture needle 1. Liquids such as cell-containing fluid or drug solution that have been transported through the lumen 1e are delivered to the target tissue through this hole 5.
[0152] The puncture needle 1 may have only one hole 5 or multiple holes 5. If only one hole 5 is formed on the puncture needle 1, it becomes easier to administer liquids such as cell-containing fluid or drug solutions to a specific point. If multiple holes 5 are formed on the puncture needle 1, it becomes easier to administer liquids such as cell-containing fluid or drug solutions to a wider area.
[0153] When observed from a direction perpendicular to the longitudinal direction x of the puncture needle 1, the outer shape of the hole 5 can be a polygon such as a triangle, square, or pentagon, or a circle, an ellipse, or a combination thereof. Polygons include not only those with clearly defined corner vertices and straight sides, but also rounded polygons with rounded corners, and those with at least some of their sides being curved.
[0154] The needle member 70 may include a first cylindrical member 10 connected to the puncture needle 1, and a second cylindrical member 20 connected to the puncture needle 1 and positioned in the lumen 10e of the first cylindrical member 10.
[0155] As shown in Figures 7 to 10, the first cylindrical member 10 is a cylindrical member having a lumen 10e extending in the longitudinal direction x of the puncture needle 1 and is connected to the puncture needle 1. The first cylindrical member 10 may have a tapered portion in which the outer diameter decreases toward the distal end.
[0156] The first cylindrical member 10 may have a distal end 10a and a proximal end 10b. Preferably, the first cylindrical member 10 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the first cylindrical member 10 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the first cylindrical member 10 is fixed in contact with the proximal end of the puncture needle 1.
[0157] It is preferable that the lumen 1e of the puncture needle 1 and the lumen 10e of the first cylindrical member 10 are not in communication with each other.
[0158] Preferably, the first cylindrical member 10 has an inner surface 10c facing the inner lumen 10e of the first cylindrical member 10 and an outer surface 10d facing the outside of the first cylindrical member 10.
[0159] The method of connecting the first cylindrical member 10 and the puncture needle 1 is not particularly limited. Examples include fixing by welding, welding, bonding, crimping, etc. Among these, it is preferable that the first cylindrical member 10 and the puncture needle 1 are welded together.
[0160] The first cylindrical member 10 may consist of only one cylindrical member, or it may consist of multiple cylindrical members.
[0161] The first cylindrical member 10 can be made of resin, metal, or the like. The first cylindrical member 10 may be made entirely of metal, or entirely of resin. The first cylindrical member 10 may be made partly of metal and the other part of resin.
[0162] Examples of metals that make up the first cylindrical member 10 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0163] Examples of resins constituting the first cylindrical member 10 include synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyetherketone resins (e.g., PEEK), polyetherpolyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, ETFE), or combinations thereof.
[0164] Preferably, the first cylindrical member 10 includes a portion made of a material containing metal. Only a portion of the first cylindrical member 10 may be made of metal, or the entire first cylindrical member 10 may be made of metal.
[0165] As shown in Figures 8 and 10, it is preferable that the first cylindrical member 10 has a metal layer 11 made of metal. Having a metal layer 11 in the first cylindrical member 10 makes it easier to create a puncture catheter 100 with high torque transmission capabilities.
[0166] Preferably, the metal layer 11 has an inner surface 11c located on the radially inward side of the first cylindrical member 10 and an outer surface 11d located on the radially outward side of the first cylindrical member 10.
[0167] The metal layer 11 may consist of a pipe, a coil around which wire is wound, a braid in which wire is woven, a pipe with holes or grooves formed therein, or a combination thereof.
[0168] It is preferable that the metal layer 11 has a plurality of grooves 11f formed therein. The grooves 11f may be closed grooves or through grooves. Both through grooves and closed grooves may be formed in the metal layer 11. By combining through grooves and closed grooves, or by selecting one or the other, it becomes easier to create a metal layer 11 with the desired flexibility and rigidity.
[0169] As shown in Figure 8, it is preferable that the first cylindrical member 10 has an outer resin layer 12 disposed on the outer surface 11d of the metal layer 11. This makes it less likely for the first cylindrical member 10 to get caught on the body cavity wall, even if holes or grooves 11f are formed in the metal layer 11, and makes it easier to ensure insertion within the body cavity.
[0170] The outer resin layer 12 may be arranged to cover only a portion of the outer surface 11d of the metal layer 11. Alternatively, the outer resin layer 12 may be arranged to cover the entire outer surface 11d of the metal layer 11.
[0171] As shown in Figure 10, the first cylindrical member 10 may have an inner resin layer 13 disposed on the inner surface 11c of the metal layer 11.
[0172] The inner resin layer 13 may be arranged to cover only a portion of the inner surface 11c of the metal layer 11. Alternatively, the inner resin layer 13 may be arranged to cover the entire inner surface 11c of the metal layer 11.
[0173] Although not shown in the figures, the first cylindrical member 10 may have both an outer resin layer 12 disposed on the outer surface 11d of the metal layer 11 and an inner resin layer 13 disposed on the inner surface 11c of the metal layer 11.
[0174] As shown in Figures 8 and 10, the second cylindrical member 20 is preferably a cylindrical member that is positioned in the lumen 10e of the first cylindrical member 10. The second cylindrical member 20 is connected to the puncture needle 1 and has a lumen 20e that extends in the longitudinal direction x of the puncture needle 1. A liquid such as a cell-containing solution or a drug solution passes through this lumen 20e.
[0175] The second cylindrical member 20 may have a distal end 20a and a proximal end 20b. Preferably, the second cylindrical member 20 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the second cylindrical member 20 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the second cylindrical member 20 is fixed in contact with the proximal end of the puncture needle 1.
[0176] It is preferable that the lumen 1e of the puncture needle 1 and the lumen 20e of the second cylindrical member 20 are in communication.
[0177] Preferably, the second cylindrical member 20 has an inner surface 20c facing the inner lumen 20e of the second cylindrical member 20 and an outer surface 20d facing the outside of the second cylindrical member 20.
[0178] It is preferable that the inner surface 10c of the first cylindrical member 10 and the outer surface 20d of the second cylindrical member 20 are separated. A void exists between the inner surface 10c of the first cylindrical member 10 and the outer surface 20d of the second cylindrical member 20, and no other members are required to be placed in this void.
[0179] The method of connecting the second cylindrical member 20 and the puncture needle 1 is not particularly limited. Examples include fixing by welding, welding, adhesive, crimping, etc. Among these, it is preferable that the second cylindrical member 20 and the puncture needle 1 are bonded together with an adhesive.
[0180] For example, polyurethane-based, epoxy-based, cyano-based, fluorine-based, and silicone-based adhesives can be used.
[0181] The second cylindrical member 20 may consist of only one cylindrical member, or it may consist of multiple cylindrical members.
[0182] The second cylindrical member 20 can be made of resin, metal, or the like. The second cylindrical member 20 may be made entirely of metal, or entirely of resin. The second cylindrical member 20 may be made partly of metal and the other part of resin.
[0183] Examples of metals that make up the second cylindrical member 20 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0184] Examples of resins constituting the second cylindrical member 20 include synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyetherketone resins (e.g., PEEK), polyetherpolyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, ETFE), or combinations thereof.
[0185] The second cylindrical member 20 preferably includes a portion made of a resin-containing material. Only a portion of the second cylindrical member 20 may be made of resin, or the entire second cylindrical member 20 may be made of resin. The second cylindrical member 20 is preferably made of an elastically deformable material.
[0186] As shown in Figures 8 and 10, it is preferable that the second cylindrical member 20 has a tapered portion 22 in which the outer diameter increases toward the distal end. It is even more preferable that the second cylindrical member 20 has a tapered portion 22 in which the outer diameter increases toward the distal end.
[0187] The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 can be 1100 mm or more, 1330 mm or more, 1560 mm or more, etc. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 can be 2300 mm or less, 2070 mm or less, 1840 mm or less, etc. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1. The length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, it is preferable that the length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 are 1500 mm. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 may be the same or different.
[0188] The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 can be 20.0 mm or less, 15.0 mm or less, 10.0 mm or less, etc. The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 refers to the longest length of the first cylindrical member 10 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, it is preferable that the length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 be 0.9 mm.
[0189] The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 can be 0.1 mm or more, 0.2 mm or more, 0.3 mm or more, etc. The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 can be 15.0 mm or less, 10.0 mm or less, 5.0 mm or less, etc. The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 refers to the longest length of the second cylindrical member 20 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 is preferably 0.5 mm.
[0190] As shown in Figures 8 and 10, it is preferable that the second cylindrical member 20 has a tapered portion 23 whose outer diameter increases towards the proximal side. It is even more preferable that the second cylindrical member 20 has a tapered portion 23 at its proximal end, where the outer diameter increases towards the proximal side. This makes it easier to connect the proximal end of the second cylindrical member 20 to the connecting member 40.
[0191] The second cylindrical member 20 may have multiple sections with different inner diameters in the longitudinal direction of the second cylindrical member 20. The inner diameter of the second cylindrical member 20 may be constant for a length from the distal end 20a to the proximal end 20b of the second cylindrical member 20.
[0192] As shown in Figures 8 and 10, it is preferable that the distal end of the first connection portion 31, which is the part where the first cylindrical member 10 and the puncture needle 1 are connected, is located distal to the distal end of the second connection portion 32, which is the part where the second cylindrical member 20 and the puncture needle 1 are connected. It is preferable that the first cylindrical member 10 and the puncture needle 1 are in contact at the first connection portion 31. It is preferable that the second cylindrical member 20 and the puncture needle 1 are in contact at the second connection portion 32.
[0193] The connecting member 40 may have a distal end 40a and a proximal end 40b. Preferably, the connecting member 40 is connected to the proximal end of the needle member 70. More preferably, the distal end of the connecting member 40 is connected to the proximal end of the needle member 70. Preferably, the connecting member 40 is fixed in contact with the needle member 70.
[0194] The method of connecting the connecting member 40 and the needle member 70 is not particularly limited. Examples include fixing by welding, welding, bonding, crimping, etc.
[0195] The connecting member 40 may consist of only one member or may consist of multiple members.
[0196] The connecting member 40 can be made of resin, metal, or the like. The connecting member 40 may be made entirely of metal, or entirely of resin. The connecting member 40 may be made partly of metal and the other part of resin.
[0197] Examples of metals that make up the connecting member 40 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0198] Examples of resins that make up the connecting member 40 include synthetic resins such as polyolefin resin (e.g., polyethylene and polypropylene), polyamide resin (e.g., nylon), polyester resin (e.g., PET), aromatic polyetherketone resin (e.g., PEEK), polyetherpolyamide resin, polyurethane resin, polyimide resin, fluororesin (e.g., PTFE, PFA, ETFE), polycarbonate resin, ABS resin, or combinations thereof.
[0199] The connecting member 40 preferably includes a portion made of a material containing resin. Only a portion of the connecting member 40 may be made of resin, or the entire connecting member 40 may be made of resin.
[0200] The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 can be 2.0 mm or more, 3.0 mm or more, 4.0 mm or more, etc. The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 can be 30.0 mm or less, 20.0 mm or less, 10.0 mm or less, etc. The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the connecting member 40 in the longitudinal direction x of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 is preferably 5.5 mm.
[0201] The length of the connecting member 40 in the radial direction y of the puncture needle 1 can be 1.0 mm or more, 2.0 mm or more, 3.0 mm or more, etc. The length of the connecting member 40 in the radial direction y of the puncture needle 1 can be 6.0 mm or less, 5.0 mm or less, 4.0 mm or less, etc. The length of the connecting member 40 in the radial direction y of the puncture needle 1 refers to the longest length of the connecting member 40 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the connecting member 40 in the radial direction y of the puncture needle 1 is preferably 3.2 mm.
[0202] As shown in Figures 7 to 10, the connecting member 40 preferably has a housing 45 having a lumen 45e, and the helical member 90 is preferably positioned in the lumen 45e of the housing 45.
[0203] The housing 45 may have a distal end 45a and a proximal end 45b. Preferably, the housing 45 is connected to the proximal end of the needle member 70. More preferably, the distal end of the housing 45 is connected to the proximal end of the needle member 70. Preferably, the housing 45 is fixed in contact with the needle member 70.
[0204] Preferably, the housing 45 has an inner surface 45c facing the inner cavity 45e of the housing 45 and an outer surface 45d facing the outside of the housing 45.
[0205] The housing 45 can be made of resin, metal, or other materials listed as capable of constituting the connecting member 40. The housing 45 may be made entirely of metal, or entirely of resin. The housing 45 may be made partly of metal and the other parts of resin.
[0206] The helical member 90 preferably has a distal end 90a and a proximal end 90b. The helical member 90 is a member in which a wire 91 is wound in a helical shape. By winding the wire 91, the wire 91 comes to have 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 91 is the lumen of the helical member 90. It is preferable that there is a void in the lumen of the helical member 90.
[0207] As shown in Figure 10, it is preferable that the helical member 90 has a section 92 in which the diameter of the wire 91 constituting the helical member 90 increases toward the distal end. This reduces the amount of liquid remaining in the connecting member 40, making it easier to reduce the amount of liquid used.
[0208] As shown in Figure 10, the helical member 90 may have a section in which its lumen narrows toward the distal end. Preferably, as shown in Figure 10, the helical member 90 has a section 93 in which its inner diameter decreases toward the distal end. This reduces the amount of liquid remaining in the connecting member 40, making it easier to reduce the amount of liquid used.
[0209] As shown in Figures 8 and 10, the proximal end 90b of the helical member 90 may be located at the proximal part of the connecting member 40. Although not shown, the proximal end 90b of the helical member 90 may be located at the distal part of the connecting member 40.
[0210] The helical member 90 can be made of resin, metal, or other materials listed as capable of constituting the connecting member 40. The helical member 90 may be made entirely of metal, or entirely of resin. The helical member 90 may be made partly of metal and the other part of resin.
[0211] The Shore D hardness of the helical member 90 is preferably lower than that of the housing 45. This makes it easier to absorb the impact received by the distal end of the syringe 80, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0212] The helical pitch of the helical member 90 may increase towards the distal end or towards the proximal end. The helical pitch of the helical member 90 may be constant from the distal end 90a to the proximal end 90b of the helical member 90, or it may vary depending on the location.
[0213] The cross-sectional shape of the wire 91 in a section parallel to the longitudinal direction x of the puncture needle 1 can be a polygon such as a triangle, square, or pentagon, or a circle, an ellipse, or a combination thereof. The cross-sectional shape of the wire 91 in a section parallel to the longitudinal direction x of the puncture needle 1 is preferably a polygon, and more preferably a square, as shown in Figures 8 and 10. The cross-sectional shape of the wire 91 in a section parallel to the longitudinal direction x of the puncture needle 1 may be the same from the distal end to the proximal end of the wire 91, or it may be different. If the cross-sectional shape of the wire 91 in a section parallel to the longitudinal direction x of the puncture needle 1 is the same from the distal end to the proximal end of the wire 91, the size of the cross-sectional shape may be the same (congruent) or different (similar) depending on the position in the longitudinal direction x of the puncture needle 1.
[0214] The wire 91 may be hollow or solid. The entire wire 91 may be hollow or solid. Only a part of the wire 91 may be hollow, and the rest of the wire 91 may be solid.
[0215] As shown in Figures 8 and 10, the connecting member 40 may have a needle member connecting member 46 located in the lumen 45e of the housing 45, distal to the helical member 90. The needle member connecting member 46 is the member to which the needle member 70 is connected. Preferably, the proximal end of the needle member connecting member 46 is in contact with or fixed to the distal end 90b of the helical member 90. The proximal end of the needle member connecting member 46 may be located distal to the distal end 90a of the helical member 90. The proximal end of the needle member connecting member 46 and the distal end 90a of the helical member 90 may be separated.
[0216] The needle member connecting member 46 can be made of resin, metal, or other materials listed as materials that can constitute the connecting member 40. The needle member connecting member 46 may be made entirely of metal, or entirely of resin. The needle member connecting member 46 may be made partly of metal and the other part of resin.
[0217] The needle member connecting member 46 preferably has a lumen through which liquid can pass.
[0218] As shown in Figures 8 and 10, the proximal end of the third connection portion 33, where the first cylindrical member 10 and the connecting member 40 are connected, may be located distal to the proximal end of the fourth connection portion 34, where the second cylindrical member 20 and the connecting member 40 are connected. Although not shown, the proximal end of the third connection portion 33, where the first cylindrical member 10 and the connecting member 40 are connected, may be located proximal to the proximal end of the fourth connection portion 34, where the second cylindrical member 20 and the connecting member 40 are connected. In the third connection portion 33, it is preferable that the first cylindrical member 10 and the connecting member 40 are in contact. In the fourth connection portion 34, it is preferable that the second cylindrical member 20 and the connecting member 40 are in contact.
[0219] The helical member 90 may be made of a material with lower rigidity than the needle member connecting member 46. This makes it easier to absorb the impact received by the distal end of the syringe 80, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0220] As shown in Figures 8 and 10, the needle member connecting member 46 may have a first needle member connecting portion 461 to which the first cylindrical member 10 is connected, and a second needle member connecting portion 462 to which the second cylindrical member 20 is connected. The first needle member connecting portion 461 may have a lumen. The second needle member connecting member 462 may have a lumen.
[0221] As shown in Figures 8 and 10, the outer surface 10d of the first cylindrical member 10 may be fixed to the first needle member connection portion 461. The outer surface 10d of the first cylindrical member 10 may be fixed in contact with the first needle member connection portion 461. The inner surface 20c of the second cylindrical member 20 may be fixed to the second needle member connection portion 462. The inner surface 20c of the second cylindrical member 20 may be fixed in contact with the second needle member connection portion 462. Although not shown, the inner surface 10c of the first cylindrical member 10 may be fixed to the first needle member connection portion 461. The outer surface 20d of the second cylindrical member 20 may be fixed to the second needle member connection portion 462.
[0222] The lumen of the helical member 90, the lumen of the second needle member connecting member 462, the lumen 20e of the second cylindrical member 20, and the lumen 1e of the puncture needle 1 are arranged in this order from proximal to distal, and it is preferable that the lumen of the helical member 90, the lumen of the second needle member connecting member 462, the lumen 20e of the second cylindrical member 20, and the lumen 1e of the puncture needle 1 are in communication with each other. This allows the liquid in the syringe 80, such as cell-containing fluid or drug solution, to be delivered to the target tissue.
[0223] (Third Invention) One embodiment of the third invention of a puncture catheter comprises a needle member having a medical puncture needle and a connecting member having a housing with a lumen and connected to the proximal part of the needle member, wherein the connecting member has a sliding member disposed in the lumen of the housing and movable in the longitudinal direction of the puncture catheter relative to the housing.
[0224] Referring to Figures 11 to 21, the overall configuration of the puncture catheter according to an embodiment of the third invention will be described. Figures 11 and 16 show side views of the puncture catheter according to an embodiment of the third invention. Figure 12 shows a cross-sectional view of the puncture catheter shown in Figure 11. More specifically, it shows a cross-section passing through the central axis of the puncture needle and parallel to the longitudinal direction of the puncture needle. Figure 13 shows a cross-sectional view of the puncture catheter shown in Figure 12 along the line XIII-XIII. Figures 14 and 15 show cross-sectional views showing modified examples of the puncture catheter shown in Figure 12. Figure 17 shows a cross-sectional view of the puncture catheter shown in Figure 16. More specifically, it shows a cross-section passing through the central axis of the puncture needle and parallel to the longitudinal direction of the puncture needle. Figures 18 to 20 show cross-sectional views showing modified examples of the puncture catheter shown in Figure 17. Figure 21 shows a cross-sectional view of the puncture catheter shown in Figure 20 before the syringe is attached. Figures 11 to 21 show a puncture catheter 100 having a needle member 70 and a connecting member 40.
[0225] In this drawing, the longitudinal direction of the puncture needle 1 is denoted by x, the radial direction of the puncture needle 1 by y, and the circumferential direction of the puncture needle 1 by c. The radial direction y is perpendicular to the longitudinal direction x. In other words, the longitudinal direction x of the puncture needle 1 can also be said to be the direction of extension of the puncture needle 1. For ease of understanding, this drawing shows an embodiment in which the longitudinal direction x of the puncture needle 1 coincides with the longitudinal direction of the puncture catheter 100, the radial direction y of the puncture needle 1 coincides with the radial direction of the puncture catheter 100, and the circumferential direction c of the puncture needle 1 coincides with the circumferential direction of the puncture catheter 100. However, the present invention is not limited to this embodiment.
[0226] In this specification, the proximal side refers to the direction toward the user's hand relative to the longitudinal direction x of the puncture needle 1, and the distal side refers to the opposite side of the proximal side, i.e., the direction toward the treatment target. Furthermore, when each component is divided into two equal parts along the longitudinal direction x of the puncture needle 1, the portion located on the distal side of each component is called the distal part, and the portion located on the proximal side of each component is called the proximal part. The distal end of each component is the end located furthest distally from each component. The proximal end of each component is the end located furthest proximal from each component. The end of each component refers to the portion including the end of each component and its surroundings. That is, the distal end of each component refers to the portion including the distal end of each component and its surroundings, and the proximal end of each component refers to the portion including the proximal end of each component and its surroundings.
[0227] The puncture catheter 100 includes a needle member 70 and a connecting member 40.
[0228] As shown in Figures 11, 12, 14 to 21, the needle member 70 has a puncture needle 1.
[0229] The puncture needle 1 is for medical use and is intended to puncture target tissue. As shown in Figures 11, 12, 14 to 21, the puncture needle 1 preferably has a longitudinal direction x and a lumen 1e extending in the longitudinal direction x. Through this lumen 1e, liquids such as cell-containing fluid or drug solutions can be delivered to the target tissue.
[0230] The connecting member 40 is connected to the proximal portion of the needle member 70. The connecting member 40 also has a housing 45 which has a lumen 45e.
[0231] The connecting member 40 is positioned in the lumen 45e of the housing 45 and has a sliding member 95 that is movable relative to the housing 45 in the longitudinal direction of the puncture catheter 100.
[0232] Since the sliding member 95 is positioned in the lumen 45e of the housing 45 of the above-mentioned puncture catheter 100, the amount of liquid remaining in the connecting member 40 can be reduced, making it easier to reduce the amount of liquid used.
[0233] The puncture catheter 100 is used to administer liquids such as cell-containing solutions or drug solutions to target tissues. Specifically, the puncture catheter 100 is preferably used for direct administration to internal organs, such as the heart, kidneys, or liver. The liquid administered using the puncture catheter 100 is preferably a cell-containing solution. For example, the puncture catheter 100 can be used to directly administer iPS cell-containing solutions to the liver or kidneys, or to directly administer myocardial regeneration cell-containing solutions to the heart, or more specifically, the myocardium.
[0234] As shown in Figures 11, 12, and 14-20, the puncture catheter 100 preferably further includes a syringe 80 whose distal end is inserted into the lumen 45e of the housing 45. The syringe 80 has a distal end 80a and a proximal end, and it is preferable that the syringe 80 is filled with liquid. By inserting the syringe 80 into the lumen 45e of the housing 45 and pressing the plunger, the liquid inside the syringe 80 can be supplied into the housing 45. When the syringe 80 is inserted into the lumen 45e of the housing 45, it is preferable that the distal end 80a of the syringe 80 contacts the proximal end 95b of the slide member 95.
[0235] As shown in Figures 20 and 21, it is preferable that the position of the slide member 95 when the syringe 90 is inserted into the lumen 45e of the housing 45 is distal to the position of the slide member 95 when the syringe 80 is not inserted into the lumen 45e of the housing 45. By changing the position of the slide member 95 in this way, the impact received by the distal end of the syringe 80 is more easily absorbed, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0236] The needle member 70 may have a distal end 70a and a proximal end 70b.
[0237] The needle member 70 may have other members in addition to the puncture needle 1. Specifically, as shown in Figures 11, 12, 14 to 21, the needle member 70 may have cylindrical members such as the first cylindrical member 10 and the second cylindrical member 20, which will be described later. Although not shown, the needle member 70 may consist only of the puncture needle 1.
[0238] The puncture needle 1 is preferably designed to puncture internal organs. Internal organs refer to organs located inside the body, particularly in the abdomen and chest, and are also known as viscera.
[0239] The puncture needle 1 can be made of, for example, metal or resin. The puncture needle 1 may be made entirely of metal, or entirely of resin. The puncture needle 1 may be made partly of metal and the other part of resin.
[0240] The puncture needle 1 is preferably made of metal only. Examples of metals that make up the puncture needle 1 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0241] Examples of resins that make up the puncture needle 1 include polyether ether ketone (PEEK) and polycarbonate (PC). By constructing the puncture needle 1 using only resin and no metal, the puncture needle 1 can be used even for patients with metal allergies.
[0242] The puncture needle 1 may have a distal end 1a and a proximal end 1b. The puncture needle 1 may have an inner surface 1c facing the lumen 1e of the puncture needle 1 and an outer surface 1d facing the outside of the puncture needle 1.
[0243] The length of the puncture needle 1 in the longitudinal direction x can be 2 mm or more, 3 mm or more, 4 mm or more, etc. The length of the puncture needle 1 in the longitudinal direction x can be 50 mm or less, 30 mm or less, 10 mm or less, etc. The length of the puncture needle 1 in the longitudinal direction x refers to the longest length of the puncture needle 1 in the longitudinal direction x. When used as a puncture catheter for puncturing the myocardium, the length of the puncture needle 1 in the longitudinal direction x is preferably 5 mm.
[0244] The length of the puncture needle 1 in the radial direction y can be 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, etc. The length of the puncture needle 1 in the radial direction y can be 10 mm or less, 5 mm or less, 1 mm or less, etc. The length of the puncture needle 1 in the radial direction y refers to the longest length of the puncture needle 1 in the radial direction y. When used as a puncture catheter for puncturing the myocardium, the length of the puncture needle 1 in the radial direction y is preferably 0.45 mm.
[0245] As shown in Figures 16 to 21, the puncture needle 1 may have a cylindrical member 2 and a spiral member 3.
[0246] The tubular member 2 is a tubular member and may have a lumen 2e extending in the longitudinal direction x of the puncture needle 1. This lumen 2e corresponds to the lumen 1e of the puncture needle 1. Through this lumen 2e, liquids such as cell-containing fluid or drug solutions can be delivered to the target tissue. The tubular member 2 may have a distal end 2a and a proximal end 2b.
[0247] The helical member 3 is preferably a member in which a wire 4 is wound in a helical shape. The wire 4 is preferably wound around the cylindrical member 2.
[0248] Regarding the puncture needle 1, by adopting a design in which a spiral member 3 is arranged around a cylindrical member 2, it becomes easier to screw the puncture needle 1 into the target tissue by rotating the puncture needle 1 around the cylindrical member 2 as an axis. This makes it easier to puncture the target tissue with the puncture needle 1. In addition, the wire 4 constituting the spiral member 3 bites into the tissue, making it difficult for the puncture needle 1 to come out of the tissue. Furthermore, the puncture depth can be easily adjusted by adjusting the rotation of the puncture needle 1.
[0249] It is preferable that a hole 5 is formed in the puncture needle 1, connecting the lumen 1e of the puncture needle 1 to the outside of the puncture needle 1. Liquids such as cell-containing fluid or drug solution that have been transported through the lumen 1e are delivered to the target tissue through this hole 5.
[0250] The puncture needle 1 may have only one hole 5 or multiple holes 5. If only one hole 5 is formed on the puncture needle 1, it becomes easier to administer liquids such as cell-containing fluid or drug solutions to a specific point. If multiple holes 5 are formed on the puncture needle 1, it becomes easier to administer liquids such as cell-containing fluid or drug solutions to a wider area.
[0251] When observed from a direction perpendicular to the longitudinal direction x of the puncture needle 1, the outer shape of the hole 5 can be a polygon such as a triangle, square, or pentagon, or a circle, an ellipse, or a combination thereof. Polygons include not only those with clearly defined corner vertices and straight sides, but also rounded polygons with rounded corners, and those with at least some of their sides being curved.
[0252] The needle member 70 may include a first cylindrical member 10 connected to the puncture needle 1, and a second cylindrical member 20 connected to the puncture needle 1 and positioned in the lumen 10e of the first cylindrical member 10.
[0253] As shown in Figures 11, 12, 14 to 21, the first cylindrical member 10 is a cylindrical member having a lumen 10e extending in the longitudinal direction x of the puncture needle 1 and is connected to the puncture needle 1. The first cylindrical member 10 may have a tapered portion in which the outer diameter decreases toward the distal side.
[0254] The first cylindrical member 10 may have a distal end 10a and a proximal end 10b. Preferably, the first cylindrical member 10 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the first cylindrical member 10 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the first cylindrical member 10 is fixed in contact with the proximal end of the puncture needle 1.
[0255] It is preferable that the lumen 1e of the puncture needle 1 and the lumen 10e of the first cylindrical member 10 are not in communication with each other.
[0256] Preferably, the first cylindrical member 10 has an inner surface 10c facing the inner lumen 10e of the first cylindrical member 10 and an outer surface 10d facing the outside of the first cylindrical member 10.
[0257] The method of connecting the first cylindrical member 10 and the puncture needle 1 is not particularly limited. Examples include fixing by welding, welding, bonding, crimping, etc. Among these, it is preferable that the first cylindrical member 10 and the puncture needle 1 are welded together.
[0258] The first cylindrical member 10 may consist of only one cylindrical member, or it may consist of multiple cylindrical members.
[0259] The first cylindrical member 10 can be made of resin, metal, or the like. The first cylindrical member 10 may be made entirely of metal, or entirely of resin. The first cylindrical member 10 may be made partly of metal and the other part of resin.
[0260] Examples of metals that make up the first cylindrical member 10 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0261] Examples of resins constituting the first cylindrical member 10 include synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyetherketone resins (e.g., PEEK), polyetherpolyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, ETFE), or combinations thereof.
[0262] Preferably, the first cylindrical member 10 includes a portion made of a material containing metal. Only a portion of the first cylindrical member 10 may be made of metal, or the entire first cylindrical member 10 may be made of metal.
[0263] As shown in Figures 12, 14, 15, 17 to 21, it is preferable that the first cylindrical member 10 has a metal layer 11 made of metal. Having a metal layer 11 in the first cylindrical member 10 makes it easier to create a puncture catheter 100 with high torque transmission capabilities.
[0264] Preferably, the metal layer 11 has an inner surface 11c located on the radially inward side of the first cylindrical member 10 and an outer surface 11d located on the radially outward side of the first cylindrical member 10.
[0265] The metal layer 11 may consist of a pipe, a coil around which wire is wound, a braid in which wire is woven, a pipe with holes or grooves formed therein, or a combination thereof.
[0266] It is preferable that the metal layer 11 has a plurality of grooves 11f formed therein. The grooves 11f may be closed grooves or through grooves. Both through grooves and closed grooves may be formed in the metal layer 11. By combining through grooves and closed grooves, or by selecting one or the other, it becomes easier to create a metal layer 11 with the desired flexibility and rigidity.
[0267] As shown in Figures 12, 14, and 15, it is preferable that the first cylindrical member 10 has an outer resin layer 12 disposed on the outer surface 11d of the metal layer 11. This makes it less likely for the first cylindrical member 10 to get caught on the body cavity wall, even if holes or grooves 11f are formed in the metal layer 11, and makes it easier to ensure insertion within the body cavity.
[0268] The outer resin layer 12 may be arranged to cover only a portion of the outer surface 11d of the metal layer 11. Alternatively, the outer resin layer 12 may be arranged to cover the entire outer surface 11d of the metal layer 11.
[0269] As shown in Figures 17 to 21, the first cylindrical member 10 may have an inner resin layer 13 arranged on the inner surface 11c of the metal layer 11.
[0270] The inner resin layer 13 may be arranged to cover only a portion of the inner surface 11c of the metal layer 11. Alternatively, the inner resin layer 13 may be arranged to cover the entire inner surface 11c of the metal layer 11.
[0271] Although not shown in the figures, the first cylindrical member 10 may have both an outer resin layer 12 disposed on the outer surface 11d of the metal layer 11 and an inner resin layer 13 disposed on the inner surface 11c of the metal layer 11.
[0272] As shown in Figures 12, 14, 15, 17 to 21, the second cylindrical member 20 is preferably a cylindrical member that is positioned in the lumen 10e of the first cylindrical member 10. The second cylindrical member 20 is connected to the puncture needle 1 and has a lumen 20e that extends in the longitudinal direction x of the puncture needle 1. Liquids such as cell-containing fluid or drug solution pass through this lumen 20e.
[0273] The second cylindrical member 20 may have a distal end 20a and a proximal end 20b. Preferably, the second cylindrical member 20 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the second cylindrical member 20 is connected to the proximal end of the puncture needle 1. More preferably, the distal end of the second cylindrical member 20 is fixed in contact with the proximal end of the puncture needle 1.
[0274] It is preferable that the lumen 1e of the puncture needle 1 and the lumen 20e of the second cylindrical member 20 are in communication.
[0275] Preferably, the second cylindrical member 20 has an inner surface 20c facing the inner lumen 20e of the second cylindrical member 20 and an outer surface 20d facing the outside of the second cylindrical member 20.
[0276] It is preferable that the inner surface 10c of the first cylindrical member 10 and the outer surface 20d of the second cylindrical member 20 are separated. A void exists between the inner surface 10c of the first cylindrical member 10 and the outer surface 20d of the second cylindrical member 20, and no other members are required to be placed in this void.
[0277] The method of connecting the second cylindrical member 20 and the puncture needle 1 is not particularly limited. Examples include fixing by welding, welding, adhesive, crimping, etc. Among these, it is preferable that the second cylindrical member 20 and the puncture needle 1 are bonded together with an adhesive.
[0278] For example, polyurethane-based, epoxy-based, cyano-based, fluorine-based, and silicone-based adhesives can be used.
[0279] The second cylindrical member 20 may consist of only one cylindrical member, or it may consist of multiple cylindrical members.
[0280] The second cylindrical member 20 can be made of resin, metal, or the like. The second cylindrical member 20 may be made entirely of metal, or entirely of resin. The second cylindrical member 20 may be made partly of metal and the other part of resin.
[0281] Examples of metals that make up the second cylindrical member 20 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0282] Examples of resins constituting the second cylindrical member 20 include synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyetherketone resins (e.g., PEEK), polyetherpolyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, ETFE), or combinations thereof.
[0283] The second cylindrical member 20 preferably includes a portion made of a resin-containing material. Only a portion of the second cylindrical member 20 may be made of resin, or the entire second cylindrical member 20 may be made of resin. The second cylindrical member 20 is preferably made of an elastically deformable material.
[0284] As shown in Figures 12, 14, 15, 17 to 21, it is preferable that the second cylindrical member 20 has a tapered portion 22 in which the outer diameter increases toward the distal end. It is even more preferable that the second cylindrical member 20 has a tapered portion 22 in which the outer diameter increases toward the distal end.
[0285] The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 can be 1100 mm or more, 1330 mm or more, 1560 mm or more, etc. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 can be 2300 mm or less, 2070 mm or less, 1840 mm or less, etc. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1. The length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, it is preferable that the length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 are 1500 mm. The length of the first cylindrical member 10 in the longitudinal direction x of the puncture needle 1 and the length of the second cylindrical member 20 in the longitudinal direction x of the puncture needle 1 may be the same or different.
[0286] The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 can be 20.0 mm or less, 15.0 mm or less, 10.0 mm or less, etc. The length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 refers to the longest length of the first cylindrical member 10 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, it is preferable that the length of the first cylindrical member 10 in the radial direction y of the puncture needle 1 be 0.9 mm.
[0287] The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 can be 0.1 mm or more, 0.2 mm or more, 0.3 mm or more, etc. The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 can be 15.0 mm or less, 10.0 mm or less, 5.0 mm or less, etc. The length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 refers to the longest length of the second cylindrical member 20 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the second cylindrical member 20 in the radial direction y of the puncture needle 1 is preferably 0.5 mm.
[0288] As shown in Figures 12, 14, 15, 17 to 21, it is preferable that the second cylindrical member 20 has a tapered portion 23 whose outer diameter increases towards the proximal side. It is even more preferable that the second cylindrical member 20 has a tapered portion 23 at its proximal end, where the outer diameter increases towards the proximal side. This makes it easier to connect the proximal end of the second cylindrical member 20 to the connecting member 40.
[0289] The second cylindrical member 20 may have multiple sections with different inner diameters in the longitudinal direction of the second cylindrical member 20. The inner diameter of the second cylindrical member 20 may be constant for a length from the distal end 20a to the proximal end 20b of the second cylindrical member 20.
[0290] As shown in Figures 12, 14, 15, 17 to 21, it is preferable that the distal end of the first connection portion 31, which is the part where the first cylindrical member 10 and the puncture needle 1 are connected, is located distal to the distal end of the second connection portion 32, which is the part where the second cylindrical member 20 and the puncture needle 1 are connected. It is preferable that the first cylindrical member 10 and the puncture needle 1 are in contact at the first connection portion 31. It is preferable that the second cylindrical member 20 and the puncture needle 1 are in contact at the second connection portion 32.
[0291] The connecting member 40 may have a distal end 40a and a proximal end 40b. Preferably, the connecting member 40 is connected to the proximal end of the needle member 70. More preferably, the distal end of the connecting member 40 is connected to the proximal end of the needle member 70. Preferably, the connecting member 40 is fixed in contact with the needle member 70.
[0292] The method of connecting the connecting member 40 and the needle member 70 is not particularly limited. Examples include fixing by welding, welding, bonding, crimping, etc.
[0293] The connecting member 40 can be made of resin, metal, or the like. The connecting member 40 may be made entirely of metal, or entirely of resin. The connecting member 40 may be made partly of metal and the other part of resin.
[0294] Examples of metals that make up the connecting member 40 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or combinations thereof.
[0295] Examples of resins that make up the connecting member 40 include synthetic resins such as polyolefin resin (e.g., polyethylene and polypropylene), polyamide resin (e.g., nylon), polyester resin (e.g., PET), aromatic polyetherketone resin (e.g., PEEK), polyetherpolyamide resin, polyurethane resin, polyimide resin, fluororesin (e.g., PTFE, PFA, ETFE), polycarbonate resin, ABS resin, or combinations thereof.
[0296] The connecting member 40 preferably includes a portion made of a material containing resin. Only a portion of the connecting member 40 may be made of resin, or the entire connecting member 40 may be made of resin.
[0297] The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 can be 2.0 mm or more, 3.0 mm or more, 4.0 mm or more, etc. The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 can be 30.0 mm or less, 20.0 mm or less, 10.0 mm or less, etc. The length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 refers to the longest length of the connecting member 40 in the longitudinal direction x of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the connecting member 40 in the longitudinal direction x of the puncture needle 1 is preferably 5.5 mm.
[0298] The length of the connecting member 40 in the radial direction y of the puncture needle 1 can be 1.0 mm or more, 2.0 mm or more, 3.0 mm or more, etc. The length of the connecting member 40 in the radial direction y of the puncture needle 1 can be 6.0 mm or less, 5.0 mm or less, 4.0 mm or less, etc. The length of the connecting member 40 in the radial direction y of the puncture needle 1 refers to the longest length of the connecting member 40 in the radial direction y of the puncture needle 1. When used as a puncture catheter for puncturing the myocardium, the length of the connecting member 40 in the radial direction y of the puncture needle 1 is preferably 3.2 mm.
[0299] The housing 45 may have a distal end 45a and a proximal end 45b. Preferably, the housing 45 is connected to the proximal end of the needle member 70. More preferably, the distal end of the housing 45 is connected to the proximal end of the needle member 70. Preferably, the housing 45 is fixed in contact with the needle member 70.
[0300] Preferably, the housing 45 has an inner surface 45c facing the inner cavity 45e of the housing 45 and an outer surface 45d facing the outside of the housing 45.
[0301] The housing 45 can be made of resin, metal, or other materials listed as capable of constituting the connecting member 40. The housing 45 may be made entirely of metal, or entirely of resin. The housing 45 may be made partly of metal and the other parts of resin.
[0302] The slide member 95 may have a distal end 95a and a proximal end 95b.
[0303] As shown in Figures 12 to 15 and Figures 17 to 21, it is preferable that the slide member 95 has a lumen 95e. The shape of the slide member 95 can be, for example, cylindrical, columnar, hollow cylindrical, hollow polygonal prism, etc.
[0304] Preferably, the slide member 95 has an inner surface facing its inner lumen 95e and an outer surface facing the outside of the slide member 95.
[0305] As shown in Figure 19, the slide member 95 is preferably cylindrical or hollow columnar, with an inner diameter smaller than the inner diameter of the distal end of the syringe 80. This reduces the amount of liquid remaining in the connecting member 40, making it easier to reduce the amount of liquid used. Although not shown, the slide member 95 may also be cylindrical or hollow columnar, with an inner diameter larger than the inner diameter of the distal end of the syringe 80.
[0306] As shown in Figure 19, the slide member 95 is preferably cylindrical or hollow columnar, and its inner diameter is smaller than the inner diameter of the proximal end 20b of the second cylindrical member 20. This reduces the amount of liquid remaining in the connecting member 40, making it easier to reduce the amount of liquid used. However, it is also acceptable for the slide member 95 to be cylindrical or hollow columnar, and its inner diameter to be larger than the inner diameter of the proximal end 20b of the second cylindrical member 20.
[0307] As shown in Figures 20 and 21, the slide member 95 may have a section in which its lumen 95e narrows toward the distal end. As shown in Figures 20 and 21, the slide member 95 may have a section 96 in which its inner diameter decreases toward the distal end. This reduces the amount of liquid remaining in the connecting member 40, making it easier to reduce the amount of liquid used.
[0308] As shown in Figures 12, 14, 15, 17 to 21, the proximal end 95b of the slide member 95 may be located at the proximal part of the connecting member 40. Although not shown, the proximal end 95b of the slide member 95 may be located at the distal part of the connecting member 40.
[0309] As shown in Figures 12, 14, 15, 17 to 20, the distal end 95a of the slide member 95 may be located on the distal part of the connecting member 40. More specifically, when the syringe 80 is inserted into the lumen 45e of the housing 45, the distal end 95a of the slide member 95 may be located on the distal part of the connecting member 40. As shown in Figure 21, the distal end 95a of the slide member 95 may be located on the proximal part of the connecting member 40. More specifically, when the syringe 80 is not inserted into the lumen 45e of the housing 45, the distal end 95a of the slide member 95 may be located on the proximal part of the connecting member 40.
[0310] The slide member 95 can be made of resin, metal, or other materials listed as suitable for forming the connecting member 40. The slide member 95 may be made entirely of metal, or entirely of resin. The slide member 95 may be made partly of metal and the rest of the slide member of resin.
[0311] The Shore D hardness of the slide member 95 is preferably lower than that of the housing 45. This makes it easier to absorb the impact received by the distal end of the syringe 80, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0312] As shown in Figures 14, 17, 18, 20, and 21, the connecting member 40 is located in the lumen 45e of the housing 45, distal to the slide member 95, and may have a needle member connecting member 46 to which the needle member 70 is connected. As shown in Figures 14, 18, 20, and 21, the proximal end of the needle member connecting member 46 may be able to contact the slide member 95. As shown in Figure 17, the proximal end of the needle member connecting member 46 may not be able to contact the distal end 95a of the slide member 95.
[0313] The needle member connecting member 46 can be made of resin, metal, or other materials listed as materials that can constitute the connecting member 40. The needle member connecting member 46 may be made entirely of metal, or entirely of resin. The needle member connecting member 46 may be made partly of metal and the other part of resin.
[0314] The needle member connecting member 46 preferably has a lumen through which liquid can pass.
[0315] As shown in Figures 12, 14, 15, 17 to 21, the proximal end of the third connection portion 33, where the first cylindrical member 10 and the connecting member 40 are connected, may be located distal to the proximal end of the fourth connection portion 34, where the second cylindrical member 20 and the connecting member 40 are connected. Although not shown, the proximal end of the third connection portion 33, where the first cylindrical member 10 and the connecting member 40 are connected, may be located proximal to the proximal end of the fourth connection portion 34, where the second cylindrical member 20 and the connecting member 40 are connected. It is preferable that the first cylindrical member 10 and the connecting member 40 are in contact at the third connection portion 33. It is preferable that the second cylindrical member 20 and the connecting member 40 are in contact at the fourth connection portion 34.
[0316] The slide member 95 may be made of a material with lower rigidity than the needle member connecting member 46. This makes it easier to absorb the impact received by the distal end of the syringe 80, thereby making it easier to suppress damage to the distal end of the syringe 80.
[0317] As shown in Figures 14, 17, 18, 20, and 21, the first cylindrical member 10 and the second cylindrical member 20 may be connected to the needle member connecting member 46. More specifically, the needle member connecting member 46 may have a first needle member connecting portion 461 to which the first cylindrical member 10 is connected, and a second needle member connecting portion 462 to which the second cylindrical member 20 is connected. The first needle member connecting portion 461 may have a lumen. The second needle member connecting member 462 may have a lumen.
[0318] As shown in Figures 14, 17, 18, 20, and 21, the outer surface 10d of the first cylindrical member 10 may be fixed to the first needle member connection portion 461. The outer surface 10d of the first cylindrical member 10 may be fixed in contact with the first needle member connection portion 461. The inner surface 20c of the second cylindrical member 20 may be fixed to the second needle member connection portion 462. The inner surface 20c of the second cylindrical member 20 may be fixed in contact with the second needle member connection portion 462. Although not shown, the inner surface 10c of the first cylindrical member 10 may be fixed to the first needle member connection portion 461. The outer surface 20d of the second cylindrical member 20 may be fixed to the second needle member connection portion 462.
[0319] As shown in Figure 15, the elastic member 97 may be positioned in the lumen 45e of the housing 45, distal to the slide member 95. In this case, it is preferable that the slide member 95 can contact the elastic member 97. As shown in Figure 15, it is even more preferable that the distal end 95a of the slide member 95 can contact the elastic member 97. By positioning the elastic member 97 distal to the slide member 95, it can act as a stopper for the slide member 95. Furthermore, the presence of the elastic member 97 allows it to absorb the impact when the slide member 95 moves distally.
[0320] The elastic member 97 can be made of resin, metal, or other materials listed as suitable for forming the connecting member 40. The elastic member 97 may be made entirely of metal, or entirely of resin. The elastic member 97 may be made partly of metal and the other part of resin.
[0321] The shape of the elastic member 97 can be cylindrical, columnar, helical, or the like. The elastic member 97 may be a porous material or a coil 971 as shown in Figure 15.
[0322] In a natural state where no external force is applied to the puncture catheter 100, it is preferable that the pitch of the coil 971 is greater than or equal to the wire diameter of the wire material constituting the coil 971. It is preferable that, as the slide member 95 moves distally, a force is applied to the elastic member 97, causing the pitch of the coil 971 to become smaller than the pitch of the coil 971 before the force was applied.
[0323] As shown in Figure 15, it is preferable that the elastic member 97 is positioned between the needle member 70 and the connecting member 40.
[0324] As shown in Figures 12, 15, and 19, the needle member 70 may be connected to the slide member 95. More specifically, the slide member 95 may be fixed to the proximal end of the needle member 70.
[0325] As shown in Figures 14, 17, 18, 20, and 21, the slide member 95 is not fixed to the needle member 70 and may be movable relative to the needle member 70.
[0326] The first cylindrical member 10 and the second cylindrical member 20 may be connected to the slide member 95, or they may be fixed to the slide member 95. As shown in Figures 12, 15, and 19, the outer surface 10d of the first cylindrical member 10 may be fixed to the slide member 95. Also, the inner surface 20c of the second cylindrical member 20 may be fixed to the slide member 95. Although not shown, the inner surface 10c of the first cylindrical member 10 may be fixed to the slide member 95. The outer surface 20d of the second cylindrical member 20 may be fixed to the slide member 95.
[0327] As shown in Figures 17 to 19, the connecting member 40 may have an engaging portion 98 into which the sliding member 95 can engage.
[0328] As shown in Figure 17, the connecting member 40 may have an engaging member 981 positioned in the lumen 45e of the housing 45. The engaging member 981 is a member having an engaging portion 98. The engaging member 981 may be movable relative to the housing 45 in the longitudinal direction of the puncture catheter 100, but it is preferable that the engaging member 981 is not movable relative to the housing 45 in the longitudinal direction of the puncture catheter 100.
[0329] As shown in Figure 17, it is preferable that the engaging member 981 has a lumen 981e.
[0330] The engaging member 981 can be made of resin, metal, or other materials listed as capable of constituting the connecting member 40. The engaging member 981 may be made entirely of metal, or entirely of resin. The engaging member 981 may be made partly of metal and the other part of resin.
[0331] As shown in Figure 18, the needle member connecting member 46 may have an engaging portion 98 into which the slide member 95 can engage.
[0332] As shown in Figure 19, the housing 45 may have an engaging portion 98 into which the sliding member 95 can engage.
[0333] It is preferable that the lumen 95e of the slide member 95, the lumen 20e of the second needle member connecting member 462, the lumen 20e of the second cylindrical member 20, and the lumen 1e of the puncture needle 1 are arranged in this order from proximal to distal, and in addition, the lumen 95e of the slide member 95, the lumen 20e of the second needle member connecting member 462, the lumen 20e of the second cylindrical member 20, and the lumen 1e of the puncture needle 1 are in communication. Furthermore, it is preferable that the lumen 95e of the slide member 95, the lumen 981e of the engaging member 981, the lumen of the second needle member connecting member 462, the lumen 20e of the second cylindrical member 20, and the lumen 1e of the puncture needle 1 are arranged in this order from proximal to distal, and in addition, the lumen 95e of the slide member 95, the lumen 981e of the engaging member 981, the lumen of the second needle member connecting member 462, the lumen 20e of the second cylindrical member 20, and the lumen 1e of the puncture needle 1 are in communication with each other. This makes it possible to deliver the liquid in the syringe 80, such as cell-containing fluid or drug solution, to the target tissue.
[0334] This application claims the benefit of priority based on Japanese Patent Application No. 2025-003374, filed on January 9, 2025; the benefit of priority based on Japanese Patent Application No. 2025-003375, filed on January 9, 2025; and the benefit of priority based on Japanese Patent Application No. 2025-003376, filed on January 9, 2025. The entire contents of the specifications of Japanese Patent Application No. 2025-003374, Japanese Patent Application No. 2025-003375, and Japanese Patent Application No. 2025-003376 are incorporated herein by reference.
[0335] 1: Puncture needle 10: First cylindrical member 100: Puncture catheter 10a: Distal end 10b: Proximal end 10c: Inner surface 10d: Outer surface 10e: Lumen 11: Metal layer 11c: Inner surface 11d: Outer surface 11f: Groove 12: Outer resin layer 13: Inner resin layer 1a: Distal end 1b: Proximal end 1c: Inner surface 1d: Outer surface 1e: Lumen 2: Cylindrical member 20: Second cylindrical member 20a: Distal end 20b: Proximal end 20c: Inner surface 20d: Outer surface 20e: Lumen 22: Tapered section 23: Tapered section 2a: Distal end 2b: Proximal end 2e: Lumen 3: Helical member 31: First connection section 32: Second connection section 33: Third connection part 34: Fourth connection part 4: Wire 40: Connecting member 40a: Distal end 40b: Proximal end 40e: Lumen 43: Spacer 43a: Distal end 43b: Proximal end 44: Section 45: Housing 45a: Distal end 45b: Proximal end 45c: Inner surface 45d: Outer surface 45e: Lumen 46: Needle member connecting member 461: First needle member connecting part 462: Second needle member connecting part 5: Hole 70: Needle member 70a: Distal end 70b: Proximal end 80: Syringe 80a: Distal end 90: Helical member 90a: Distal end 90b: Proximal end 91: Wire 92: Section 93: Section 95: Slide member 95a: Distal end 95b: Proximal end 95e: Lumen 96: Section 97: Elastic member 971: Coil 98: Engaging part 981: Engaging member 981e: Lumen
Claims
1. A puncture catheter comprising: a needle member having a medical puncture needle; and a connecting member having a lumen and connected to the proximal part of the needle member, wherein the connecting member has a spacer located in the lumen and proximal to the needle member.
2. The puncture catheter according to claim 1, further comprising a syringe whose distal end is inserted into the lumen of the connecting member, wherein when the syringe is inserted into the lumen of the connecting member, the distal end of the syringe abuts against the proximal end of the spacer.
3. The puncture catheter according to claim 2, wherein the length of the spacer in the insertion direction of the syringe, as measured when the syringe is inserted into the lumen of the connecting member, is shorter than the length of the spacer in the insertion direction of the syringe, as measured when the syringe is not inserted into the lumen of the connecting member.
4. The puncture catheter according to any one of claims 1 to 3, wherein the spacer is cylindrical.
5. The puncture catheter according to claim 4, wherein the spacer has a section in which its inner diameter decreases toward the distal end.
6. The puncture catheter according to any one of claims 1 to 3, wherein the proximal end of the spacer is located at the proximal portion of the connecting member.
7. The puncture catheter according to any one of claims 1 to 3, wherein the connecting member has a housing having a lumen, and the spacer is disposed in the lumen of the housing.
8. The puncture catheter according to claim 7, wherein the Shore D hardness of the spacer is lower than the Shore D hardness of the housing.
9. The puncture catheter according to claim 7, wherein the connecting member is a needle member connecting member located in the lumen of the housing and distal to the spacer.
10. The puncture catheter according to claim 9, wherein the spacer is made of a material with lower rigidity than the needle member connecting member.
11. The puncture catheter according to claim 9, wherein the needle member comprises a first cylindrical member connected to the puncture needle and a second cylindrical member connected to the puncture needle and positioned in the lumen of the first cylindrical member, and the needle member connecting member comprises a first needle member connecting portion to which the first cylindrical member is connected and a second needle member connecting portion to which the second cylindrical member is connected.
12. A puncture catheter comprising: a needle member having a medical puncture needle; and a connecting member having a lumen and connected to the proximal part of the needle member, wherein the connecting member has a helical member located in the lumen and proximal to the needle member.
13. The puncture catheter according to claim 12, further comprising a syringe whose distal end is inserted into the lumen of the connecting member, wherein when the syringe is inserted into the lumen of the connecting member, the distal end of the syringe abuts against the proximal end of the helical member.
14. The puncture catheter according to claim 13, wherein the length of the helical member in the insertion direction of the syringe, as measured when the syringe is inserted into the lumen of the connecting member, is shorter than the length of the helical member in the insertion direction of the syringe, as measured when the syringe is not inserted into the lumen of the connecting member.
15. The puncture catheter according to any one of claims 12 to 14, wherein the helical member has a section in which the diameter of the wire constituting the helical member increases toward the distal side.
16. The puncture catheter according to any one of claims 12 to 14, wherein the helical member has a section in which its inner diameter decreases toward the distal side.
17. The puncture catheter according to any one of claims 12 to 14, wherein the proximal end of the helical member is located at the proximal portion of the connecting member.
18. The puncture catheter according to any one of claims 12 to 14, wherein the connecting member has a housing having a lumen, and the helical member is disposed in the lumen of the housing.
19. The puncture catheter according to claim 18, wherein the connecting member is a needle member connecting member located in the lumen of the housing and distal to the helical member.
20. The puncture catheter according to claim 19, wherein the needle member comprises a first cylindrical member connected to the puncture needle and a second cylindrical member connected to the puncture needle and positioned in the lumen of the first cylindrical member, and the needle member connecting member comprises a first needle member connecting portion to which the first cylindrical member is connected and a second needle member connecting portion to which the second cylindrical member is connected.
21. A puncture catheter comprising: a needle member having a medical puncture needle; and a connecting member having a housing with a lumen and connected to the proximal part of the needle member, wherein the connecting member has a sliding member disposed in the lumen of the housing and movable relative to the housing in the longitudinal direction of the puncture catheter.
22. The puncture catheter according to claim 21, further comprising a syringe whose distal end is inserted into the lumen of the housing, wherein when the syringe is inserted into the lumen of the housing, the distal end of the syringe abuts against the proximal end of the slide member.
23. The puncture catheter according to claim 22, wherein the position of the slide member when the syringe is inserted into the lumen of the housing is distal to the position of the slide member when the syringe is not inserted into the lumen of the housing.
24. The puncture catheter according to any one of claims 21 to 23, wherein the proximal end of the sliding member is located at the proximal portion of the connecting member.
25. The puncture catheter according to any one of claims 21 to 23, wherein an elastic member is disposed in the lumen of the housing distal to the slide member.
26. The puncture catheter according to claim 25, wherein the distal end of the sliding member is capable of contacting the elastic member.
27. The puncture catheter according to claim 25, wherein the elastic member is a coil.
28. The puncture catheter according to any one of claims 21 to 23, wherein the needle member is connected to the slide member.
29. The puncture catheter according to claim 28, wherein the needle member comprises a first cylindrical member connected to the puncture needle and a second cylindrical member connected to the puncture needle and positioned in the lumen of the first cylindrical member, and the first cylindrical member and the second cylindrical member are connected to the slide member.
30. The puncture catheter according to any one of claims 21 to 23, wherein the connecting member is located in the lumen of the housing distal to the slide member and has a needle member connecting member to which the needle member is connected.
31. The puncture catheter according to claim 30, wherein the needle member comprises a first cylindrical member connected to the puncture needle and a second cylindrical member connected to the puncture needle and positioned in the lumen of the first cylindrical member, and the first cylindrical member and the second cylindrical member are connected to the needle member connecting member.
32. The puncture catheter according to any one of claims 21 to 23, wherein the sliding member has a lumen.
33. The puncture catheter according to claim 32, wherein the sliding member has a section in which its inner diameter decreases toward the distal end.
34. The puncture catheter according to any one of claims 21 to 23, wherein the connecting member has an engaging portion into which the sliding member can engage.
35. The puncture catheter according to claim 34, wherein the connecting member has an engaging member disposed in the lumen of the housing and having the engaging portion, and the engaging member is immovable in the longitudinal direction of the puncture catheter relative to the housing.
36. The puncture catheter according to claim 35, wherein the engaging member has a lumen.