Handle, and catheter system with handle

Abstract

Provided is a handle (6) having a lumen (60) into which a tube (4) connected to a puncture needle (3) is inserted, wherein: the handle (6) has an abutment member (61) having a portion abutting the outer surface of the tube (4); in a cross section passing through the central axis of the tube (4) and along the longitudinal direction of the tube (4), the outer surface of the tube (4) has a plurality of abutment portions abutting the abutment member (61) and non-abutment portions present between the abutment portions and not in contact with the abutment member (61); and the puncture needle (3) and the abutment member (61) are electrically connected by the abutment portions. Also provided is a catheter system comprising said handle (6).

Description

Handle and catheter system with handle

[0001] The present invention relates to a handle and a catheter system including the handle.

[0002] Treatments such as direct administration of a medicinal solution such as a myocardial regenerative cell preparation to cardiomyocytes that are losing function due to myocardial infarction or the like are being performed to regenerate cardiomyocytes. When administering a medicinal solution directly to an internal organ, a catheter with a needle must be inserted into a body cavity and the needle must be inserted into the organ. When inserting a needle into an organ, it may be necessary to transmit torque while passing electricity through the needle in order to determine the needle's penetration depth. For example, the following configurations have been developed for transmitting torque while passing electricity through the needle.

[0003] Patent Document 1 describes a drug delivery catheter for injecting small amounts of a therapeutic agent into the heart wall, which includes a catheter tube suitable for percutaneous insertion into the heart, having a distal end suitable for insertion into the heart and a proximal end housed in a housing, and a puncture needle suitable for puncturing the heart wall and disposed at the distal tip of the first lumen. The catheter is described as having a conductive helical coil mechanically secured to a pin by a crimp, and rotation of the pin or crimp relative to the catheter body causes rotation of the coil, which in turn rotates the puncture needle.

[0004] Special Publication No. 2003-529409

[0005] However, there is still room for improvement in the configuration for transmitting torque while passing electricity through the needle described in Patent Document 1.

[0006] The present invention has been made in consideration of the above circumstances, and its purpose is to provide a new handle that can easily move and rotate a tube placed in the lumen of the handle while supplying electricity to the puncture needle, and a catheter system equipped with such a handle.

[0007] Handles according to embodiments of the present invention that can solve the above problems are as follows: [1] A handle having an inner cavity into which a tube is inserted, the tube being connected to the proximal end of a medical puncture needle having a longitudinal direction and having an inner cavity extending in the longitudinal direction, wherein, when the tube is inserted into the inner cavity of the handle, the handle has an abutment member having a portion abutting against the outer surface of the tube, and in a cross section passing through the central axis of the tube and along the longitudinal direction of the tube, the outer surface of the tube has a plurality of abutment portions abutting against the abutment member and non-abutment portions that are present between the abutment portions and do not abut against the abutment member, and the puncture needle and the abutment member are electrically connected via the abutment portions.

[0008] The presence of non-contact portions between multiple contact portions facilitates reducing the contact area between the outer surface of the tube and the contact member. This facilitates reducing the frictional resistance between the outer surface of the tube and the contact member. This facilitates movement of the tube in the longitudinal direction of the puncture needle and rotation of the tube in the circumferential direction of the puncture needle within the handle. Furthermore, the electrical connection between the puncture needle and the contact member via the contact portions allows electricity to be supplied to the puncture needle. Therefore, the handle facilitates movement and rotation of the tube placed in the lumen of the handle while supplying electricity to the puncture needle.

[0009] A handle according to an embodiment of the present invention is preferably any one of the following [2] to [7]. [2] The handle according to [1], in which, in a cross section passing through the central axis of the tube and along the longitudinal direction of the tube, the length of the abutting portion in the longitudinal direction of the puncture needle is shorter than the length of the non-abutting portion in the longitudinal direction of the puncture needle. [3] The handle according to [1] or [2], in which the abutting member is a coil in which wire is wound helically. [4] The handle according to [3], in which the pitch of the coil is larger than the wire diameter of the wire of the coil. [5] The handle according to [1] or [2], in which the abutting member is a protruding member provided to protrude radially inward from the tube. [6] The handle according to [5], in which a plurality of the protruding members are provided, and each protruding member is spaced apart from the other protruding members. [7] The handle according to any one of [1] to [6], in which the abutting member is made of a conductive material.

[0010] The present invention also includes the following catheter systems. [8] A catheter system comprising the handle described in any one of [1] to [7], the puncture needle, the tube to which the puncture needle is connected, and a sheath whose proximal end is connected to the handle and which has a lumen into which the puncture needle and the tube are inserted. [9] The catheter system described in [8], in which the puncture needle and the tube are made of a conductive material.

[10] The catheter system described in [8] or [9], in which the puncture needle comprises a tubular member having a lumen extending in the longitudinal direction of the puncture needle and a spiral member in which a wire is spirally wound around the tubular member.

[11] The catheter system described in any one of [8] to

[10] , in which the tube includes a first tube having a plurality of grooves formed therein.

[12] The catheter system described in

[11] , in which the tube includes a second tube connected to the proximal end of the first tube, and in which the abutment member abuts against the outer surface of the second tube.

[13] A catheter system according to

[11] or

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

[0011] The handle according to the embodiment of the present invention can easily move and rotate the tube disposed inside the handle while supplying electricity to the puncture needle, and a catheter system equipped with this handle also has the same effect.

[0012] FIG. 1 is a side view (partial cross-sectional view) showing an example of a catheter system according to an embodiment of the present invention. FIG. 2 is a cross-sectional view (partial side view) enlarging a portion of the catheter system shown in FIG. 1. FIG. 3 is a side view (partial cross-sectional view) showing a modified example of a catheter system according to an embodiment of the present invention. FIG. 4 is a cross-sectional end view taken along line IV-IV shown in FIG. 3. FIG. 5 is a cross-sectional end view showing a modified example of the catheter system shown in FIG. 4. FIG. 6 is a cross-sectional view of the puncture needle and tube of the catheter system shown in FIG. 1. FIG. 7 is a cross-sectional view showing a modified example of the puncture needle and tube shown in FIG. 6.

[0013] The present invention will be described in detail below with reference to the drawings. However, the present invention is not limited to the illustrated examples, and appropriate modifications can be made within the scope of the above and below-described purpose, and all such modifications are within the technical scope of the present invention. In each drawing, hatching, symbols, etc. may be omitted for convenience. In such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various parts in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0014] One embodiment of the handle of the present invention is a handle having an inner cavity into which a tube is inserted, the inner cavity of which extends in the longitudinal direction of the puncture needle and is connected to the proximal end of a medical puncture needle having a longitudinal direction. When the tube is inserted into the inner cavity of the handle, the handle has an abutment member having a portion that abuts against the outer surface of the tube. In a cross section passing through the central axis of the tube and along the longitudinal direction of the tube, the outer surface of the tube has a plurality of abutment portions that abut against the abutment members and non-abutment portions that are located between the abutment portions and do not abut against the abutment members, and the puncture needle and the abutment member are electrically connected via the abutment portions.

[0015] The overall configuration of a handle and a catheter system equipped with the handle according to an embodiment of the present invention will be described with reference to Figures 1 to 7. Figures 1 and 3 show a catheter system 100 having a puncture needle 3, a tube 4, a sheath 5, and a handle 6. In these drawings, the longitudinal direction of the puncture needle 3 is indicated by x, the radial direction of the puncture needle 3 by y, and the circumferential direction of the puncture needle 3 by c. The radial direction y is perpendicular to the longitudinal direction x. The longitudinal direction x of the puncture needle 3 can also be referred to as the extension direction of the puncture needle 3. For ease of understanding, these drawings show an embodiment in which the longitudinal direction x of the puncture needle 3, the longitudinal direction of the tubular member 10, and the longitudinal direction of the tube 4 coincide; the radial direction y of the puncture needle 3, the radial direction of the tubular member 10, and the radial direction of the tube 4 coincide; and the circumferential direction c of the puncture needle 3, the circumferential direction of the tubular member 10, and the circumferential direction of the tube 4 coincide; however, the present invention is not limited to this embodiment.

[0016] In this specification, the proximal side refers to the direction toward the user's hand in the longitudinal direction x of the puncture needle 3, and the distal side refers to the opposite side of the proximal side, i.e., the direction toward the treatment target. Furthermore, when each component is divided into two equal halves in the longitudinal direction x of the puncture needle 3, the distal portion of each component is referred to as the distal section, and the proximal portion of each component is referred to as the proximal section. The distal end of each component is the end located most distally of each component. The proximal end of each component is the end located most proximal of each component. The end of each component refers to the portion including the end of each component and its periphery. In other words, the distal end of each component refers to the portion including the distal end of each component and its periphery, and the proximal end of each component refers to the portion including the proximal end of each component and its periphery.

[0017] FIG. 1 is a side view (partial cross-sectional view) showing an example of a catheter system according to an embodiment of the present invention. More specifically, the cross-section shown in FIG. 1 is a cross-section passing through the central axis of the tube and along the longitudinal direction of the tube. FIG. 2 is an enlarged cross-sectional view (partial side view) of a portion of the catheter system shown in FIG. 1. More specifically, a cross-sectional view (partial side view) of a portion where a handle is provided is shown. FIG. 3 is a side view (partial cross-sectional view) showing a modified example of a catheter system according to an embodiment of the present invention. More specifically, the cross-section shown in FIG. 3 is a cross-sectional view passing through the central axis of the tube and along the longitudinal direction of the tube. FIG. 4 is a cross-sectional end view taken along line IV-IV shown in FIG. 3. FIG. 5 is a cross-sectional end view showing a modified example of the catheter system shown in FIG. 4. FIG. 6 is a cross-sectional view of the puncture needle and tube of the catheter system shown in FIG. 1. FIG. 7 is a cross-sectional view showing a modified example of the puncture needle and tube shown in FIG. 6. The sheath and handle are omitted from FIGS. 6 and 7.

[0018] First, the handle 6 according to the embodiment of the present invention will be described.

[0019] 1 and 2, the handle 6 has an inner cavity 60. The tube 4 is inserted into the inner cavity 60 of the handle 6.

[0020] The puncture needle 3 is for medical use and is inserted into target tissue. As shown in Figure 1, the puncture needle 3 has a longitudinal direction x.

[0021] The tube 4 has an inner cavity extending in the longitudinal direction x of the puncture needle 3. The tube 4 is connected to the proximal end of the puncture needle 3.

[0022] 1 to 3, when the tube 4 is inserted into the lumen 60 of the handle 6, the handle 6 has an abutting member 61 having a portion in contact with the outer surface of the tube 4. In a cross section passing through the central axis of the tube 4 and along the longitudinal direction of the tube 4, the outer surface of the tube 4 has a plurality of abutting portions 611 in contact with the abutting member 61, and non-abutting portions 612 that are present between the abutting portions 611 and do not abut with the abutting member 61. The puncture needle 3 and the abutting member 61 are electrically connected via the abutting portions 611.

[0023] The presence of the non-contact portions 612 between the multiple contact portions 611 makes it easier to reduce the area of ​​contact between the outer surface of the tube 4 and the contact member 61. This makes it easier to reduce the frictional resistance that occurs between the outer surface of the tube 4 and the contact member 61. This makes it easier to move the tube 4 in the longitudinal direction x of the puncture needle 3 and rotate the tube 4 in the circumferential direction c of the puncture needle 3 within the handle 6. Furthermore, since the puncture needle 3 and the contact member 61 are electrically connected via the contact portions 611, electricity can be supplied to the puncture needle 3. Therefore, the handle 6 makes it easier to move and rotate the tube 4 placed in the lumen 60 of the handle 6 while supplying electricity to the puncture needle 3.

[0024] The handle 6 is a member that has a portion that is gripped by the user.

[0025] The material of which the handle 6 is made is not particularly limited, but examples thereof include polyolefin resins such as polypropylene (PP) and polyethylene (PE), polyester resins such as polyethylene terephthalate (PET), polycarbonate resin, ABS resin, and polyurethane resin.

[0026] As shown in FIGS. 1 to 5 , the handle 6 may have a gripping member 600 that is gripped by a user. The gripping member 600 preferably has a shape that is easy for a user to grip. The gripping member 600 may have a shape having an inner cavity, more specifically, a hollow cylindrical shape, a hollow truncated conical shape, a hollow polygonal prism shape, a hollow truncated polygonal pyramid shape, or a combination thereof. The gripping member 600 may have a configuration having an inner surface 601 facing the inner cavity of the gripping member 600 and an outer surface facing the exterior of the gripping member 600.

[0027] As shown in FIGS. 1 to 5, the handle 6 has an abutment member 61 having a portion that abuts against the outer surface of the tube 4 .

[0028] The abutment member 61 may be a coil 62 in which a wire 63 is wound in a spiral shape. By winding the wire 63, the wire 63 has an inner surface located on the inside and an outer surface located on the outside. The lumen formed on the inner surface side of the wire 63 is the lumen of the coil 62. The coil 62 may be configured to have an inner surface facing the lumen of the coil 62 and an outer surface facing the outside. In the longitudinal direction x of the puncture needle 3, the coil 62 has a distal end and a proximal end.

[0029] 1 and 2, when the abutment member 61 is a coil 62, the handle 6 is preferably configured by a gripping member 600 and the coil 62 disposed in the inner cavity of the gripping member 600. In this case, the inner cavity 60 of the handle 6 is formed by the gripping member 600 and the coil 62.

[0030] The outer surface of the coil 62 and the inner surface 601 of the gripping member 600 may be in contact with each other. The outer surface of the coil 62 and the inner surface 601 of the gripping member 600 may be fixed to each other. The outer surface of the coil 62 and the inner surface 601 of the gripping member 600 may be fixed indirectly via another member, or may be fixed directly without using another member. It is preferable that the coil 62 does not move in the longitudinal direction x of the puncture needle 3 relative to the gripping member 600.

[0031] Direct fixation of the coil 62 and the gripping member 600 means that the coil 62 and the gripping member 600 are fixed to each other without any other member in between. For example, fixing the coil 62 and the gripping member 600 to each other using an adhesive or fixing the coil 62 and the gripping member 600 to each other by welding falls under the category of direct fixation.

[0032] The indirect fixation of the coil 62 and the gripping member 600 refers to the fixation of the coil 62 and the gripping member 600 via another member. For example, the fixation of the coil 62 and the gripping member 600 via a connecting member that connects the coil 62 and the gripping member 600 corresponds to the indirect fixation.

[0033] When the handle 6 is composed of a gripping member 600 and a coil 62, it is preferable that the tube 4 be inserted into the lumen of the coil 62. The inner surface of the coil 62 and the outer surface of the tube 4 are in contact with each other, but are preferably not fixed to each other. It is preferable that the tube 4 moves relative to the coil 62 in the longitudinal direction x of the puncture needle 3 and in the circumferential direction c of the puncture needle 3.

[0034] 2, the pitch P of the coil 62 is preferably larger than the wire diameter of the wire material 63 of the coil 62. With the above configuration, it is easy to reduce the area of ​​contact between the outer surface of the tube 4 and the abutting member 61. This makes it easy to reduce the frictional resistance that occurs between the outer surface of the tube 4 and the abutting member 61. This makes it easy to move the tube 4 in the longitudinal direction x of the puncture needle 3 and rotate the tube 4 in the circumferential direction c of the puncture needle 3 within the handle 6.

[0035] The abutting member 61 may be a protruding member 64 provided to protrude radially inward of the tube 4. When the abutting member 61 is a protruding member 64, as shown in Figures 3 to 5, the handle 6 is preferably configured by a gripping member 600 and a protruding member 64 fixed to an inner surface 601 of the gripping member 600. In this case, the inner cavity 60 of the handle 6 is formed by the gripping member 600 and the protruding member 64.

[0036] In a cross section passing through the central axis of the tube 4 and along the longitudinal direction of the tube 4, the cross-sectional shape of the protruding member 64 may be semicircular, triangular, polygonal, or a combination thereof.

[0037] As shown in Figure 3, it is preferable that a plurality of protruding members 64 are provided, and that one protruding member 64 is spaced apart from the other protruding members 64. With this configuration, it is possible to easily reduce the area of ​​contact between the outer surface of the tube 4 and the abutting member 61. This makes it possible to easily reduce the frictional resistance that occurs between the outer surface of the tube 4 and the abutting member 61. This makes it easier to move the tube 4 in the longitudinal direction x of the puncture needle 3 and rotate the tube 4 in the circumferential direction c of the puncture needle 3 within the handle 6.

[0038] 2 and 3 , in a cross section passing through the central axis of the tube 4 and along the longitudinal direction of the tube 4, the length of the abutting portion 611 in the longitudinal direction x of the puncture needle 3 is preferably shorter than the length of the non-abutting portion 612 in the longitudinal direction x of the puncture needle 3. When there are multiple abutting portions 611 in a cross section passing through the central axis of the tube 4 and along the longitudinal direction of the tube 4, the lengths of the respective abutting portions 611 in the longitudinal direction x of the puncture needle 3 are summed to determine the length of the abutting portion 611 in the longitudinal direction x of the puncture needle 3. When there are multiple non-abutting portions 612 in a cross section passing through the central axis of the tube 4 and along the longitudinal direction of the tube 4, the lengths of the respective non-abutting portions 612 in the longitudinal direction x of the puncture needle 3 are summed to determine the length of the non-abutting portion 612 in the longitudinal direction x of the puncture needle 3. This configuration makes it easier to reduce the area of ​​contact between the outer surface of the tube 4 and the abutting member 61. This makes it easier to reduce the frictional resistance that occurs between the outer surface of the tube 4 and the abutment member 61. This makes it easier to move the tube 4 in the longitudinal direction x of the puncture needle 3 and rotate the tube 4 in the circumferential direction c of the puncture needle 3 within the handle 6.

[0039] The abutting member 61 is preferably made of a conductive material. The abutting member 61 may be made entirely of a conductive material, or only a portion of the abutting member 61 may be made of a conductive material. If only a portion of the abutting member 61 is made of a conductive material, it is preferable that the portion that abuts against the outer surface of the tube 4 is made of a conductive material. This makes it easier to electrically connect the puncture needle 3 and the abutting member 61 via the tube 4.

[0040] The contact member 61 is preferably connected to a power supply device 7 via a conductor 71. This allows electricity to be supplied to the puncture needle 3 via the contact member 61 and the tube 4.

[0041] Next, a catheter system according to an embodiment of the present invention will be described.

[0042] As shown in FIGS. 1 to 3, the catheter system 100 has a handle 6 having any of the above-described features.

[0043] As shown in Figures 1, 3, 6, and 7, the puncture needle 3 included in the catheter system 100 preferably includes a tubular member 10 having a lumen 11 extending in the longitudinal direction x of the puncture needle 3, and a spiral member 20 in which a wire rod 21 is spirally wound around the tubular member 10. The puncture needle 3 includes the spiral member 20 disposed around the tubular member 10, which allows the puncture needle 3 to be easily threaded into the target tissue by rotating the puncture needle 3 around the tubular member 10. This makes it easier to insert the puncture needle 3 into the target tissue. Furthermore, the wire rod 21 constituting the spiral member 20 bites into the tissue, making it difficult for the puncture needle 3 to come out of the tissue. Furthermore, the puncture depth can be easily adjusted by adjusting the rotation of the puncture needle 3.

[0044] As shown in FIGS. 1, 3, 6 and 7, the catheter system 100 has a puncture needle 3.

[0045] The puncture needle 3 is used when administering a liquid such as a cell preparation or a drug solution to a target tissue. Specifically, the puncture needle 3 can be used when directly administering the liquid to an internal organ, such as the heart, kidney, or liver. For example, the puncture needle 3 can be used when directly administering an iPS cell suspension to the liver or kidney, or when directly administering a cardiac regenerative cell preparation to the heart, or more specifically, the myocardium.

[0046] The puncture needle 3 is preferably one that is inserted into an internal organ of the body. The internal organ refers to an organ located inside the body, particularly in the abdominal or thoracic region, and is also called an internal organ.

[0047] The puncture needle 3 can be made of, for example, metal or resin. The puncture needle 3 may be made entirely of metal, or entirely of resin. The puncture needle 3 may be partially made of metal and other portions made of resin. The cylindrical member 10 and the spiral member 20 may be made of the same material, or may be made of different materials.

[0048] The puncture needle 3 is preferably made of only metal. Examples of metals that can be used to make the puncture needle 3 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni—Ti alloy, Co—Cr alloy, and combinations thereof.

[0049] Examples of resins that can be used to form the puncture needle 3 include polyether ether ketone (PEEK) and polycarbonate (PC). By forming the puncture needle 3 using only resin, without using any metal, the puncture needle 3 can be used by patients who are allergic to metals.

[0050] The length of the puncture needle 3 in the longitudinal direction x of the puncture needle 3 can be 2 mm or more, 3 mm or more, 4 mm or more, etc. The length of the puncture needle 3 in the longitudinal direction x of the puncture needle 3 can be 50 mm or less, 30 mm or less, 10 mm or less, etc. The length of the puncture needle 3 in the longitudinal direction x of the puncture needle 3 refers to the longest length of the puncture needle 3 in the longitudinal direction x. When used as a puncture needle for puncturing myocardium, the length of the puncture needle 3 in the longitudinal direction x of the puncture needle 3 is preferably 5 mm.

[0051] The length of the puncture needle 3 in the radial direction y of the puncture needle 3 can be 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, etc. The length of the puncture needle 3 in the radial direction y of the puncture needle 3 can be 10 mm or less, 5 mm or less, 1 mm or less, etc. The length of the puncture needle 3 in the radial direction y of the puncture needle 3 refers to the longest length of the puncture needle 3 in the radial direction y. When used as a puncture needle for puncturing myocardium, the length of the puncture needle 3 in the radial direction y of the puncture needle 3 is preferably 0.45 mm.

[0052] 1, 3, 6, and 7, the tubular member 10 is a tubular member having an inner lumen 11 extending in the longitudinal direction x of the puncture needle 3. A liquid such as a cell preparation or a drug solution can be delivered to the target tissue via this inner lumen 11.

[0053] The tubular member 10 can have an inner surface 12 facing the lumen 11 and an outer surface 13 facing the outside. In the longitudinal direction x of the puncture needle 3, the tubular member 10 has a distal end 10d and a proximal end 10p. It is preferable that the distal end 10d of the tubular member 10 is closed and the proximal end 10p is open.

[0054] 1, the tubular member 10 preferably has a tapered section 15 whose outer diameter decreases toward the distal side, and a straight tube section 16 located proximal to the tapered section 15. In particular, it is preferable that the tapered section 15 is provided in a portion including the distal end 10d of the tubular member 10. This makes it easier to puncture the distal end of the tubular member 10 into the target tissue. In addition, this reduces wobble of the rotation axis when the puncture needle 3 is rotated in the circumferential direction c of the puncture needle 3, which tends to improve stability when the puncture needle 3 is inserted.

[0055] 1, 3, 6, and 7, it is preferable that a hole 14 is formed in the tubular member 10, which connects the inner cavity 11 of the tubular member 10 with the outside of the puncture needle 3. Liquids such as cell preparations and drug solutions carried through the inner cavity 11 are carried to the target tissue through this hole 14.

[0056] It is preferable that the hole 14 be capable of discharging liquid from the lumen 11 of the tubular member 10 radially outward of the tubular member 10. For this reason, it is preferable that the hole 14 be located proximal to the distal end 10d of the tubular member 10 and distal to the proximal end 10p of the tubular member 10.

[0057] Only one hole 14 may be formed in the tubular member 10, or multiple holes 14 may be formed. When only one hole 14 is formed in the tubular member 10, it becomes easier to administer a liquid such as a cell preparation or a drug solution in a pinpoint manner. When multiple holes 14 are formed in the tubular member 10, it becomes easier to administer a liquid such as a cell preparation or a drug solution over a wide area.

[0058] The outer shape of the hole 14 when observed from a direction perpendicular to the longitudinal direction x of the puncture needle 3 can be a polygonal shape such as a triangle, a rectangle, or a pentagon, a circle, an ellipse, or a combination of these. Note that polygons include polygons with clear corner vertices and straight sides, as well as rounded polygons with rounded corners and polygons with at least some curved sides.

[0059] As shown in FIGS. 1, 3, 6 and 7, the puncture needle 3 has a spiral member 20 in which a wire 21 is wound spirally around a cylindrical member 10.

[0060] The helical member 20 is formed by helically winding a wire 21. By winding the wire 21, the wire 21 has an inner surface located on the inside and an outer surface located on the outside. The lumen formed on the inner surface side of the wire 21 is the lumen of the helical member 20. The tubular member 10 is disposed in the lumen of the helical member 20. The helical member 20 can be configured to have an inner surface 22 facing the lumen of the helical member 20 and an outer surface 23 facing the outside. In the longitudinal direction x of the puncture needle 3, the helical member 20 has a distal end 20d and a proximal end.

[0061] The puncture needle 3 may be provided with only one spiral member 20 or with a plurality of spiral members 20 .

[0062] The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 can be a polygonal shape such as a triangle, a rectangle, or a pentagon, a circle, an ellipse, or a combination of these. In a cross section perpendicular to the longitudinal direction x of the puncture needle 3, the cross-sectional shape of the wire 21 is preferably a polygonal shape, and more preferably a rectangle. The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 may be the same from the distal end 21d to the proximal end of the wire 21. When the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 is the same from the distal end 21d to the proximal end of the wire 21, the sizes of the cross-sectional shapes may be the same (congruent) or different (similar) depending on the position in the longitudinal direction x of the puncture needle 3.

[0063] The cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 may vary depending on the position in the longitudinal direction x of the puncture needle 3. For example, the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the midpoint of the puncture needle 3 in the longitudinal direction x may be rectangular, and the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the distal end of the wire 21 may be elliptical. Furthermore, the cross-sectional shape of the wire 21 in a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the midpoint of the puncture needle 3 in the longitudinal direction x may be rectangular with two long sides that are arc-shaped.

[0064] As shown in Figures 6 and 7, the wire 21 preferably has a solid structure. The entire wire 21 may have a solid structure, or only a portion of the wire 21 may have a solid structure. In particular, it is more preferable that the entire distal end of the wire 21 has a solid structure. A solid structure makes it easier to reduce the diameter of the wire 21. Although not shown, a mode in which the wire 21 has a hollow structure is also acceptable. For example, the wire 21 may have an inner cavity extending along the central axis of the wire 21.

[0065] The wire 21 may be a solid wire or a stranded wire.

[0066] The distal end 20d of the spiral member 20 is preferably located proximal to the distal end 10d of the tubular member 10. The distal end 20d of the spiral member 20 may be located distal to the proximal end of the tapered portion 15 of the tubular member 10, but is more preferably located proximal to the proximal end of the tapered portion 15 of the tubular member 10. The wire rod 21 may be disposed only radially outward from the straight tube portion 16 of the tubular member 10, and the wire rod 21 may not be disposed radially outward from the tapered portion 15 of the tubular member 10. With the above configuration, the distal end of the tubular member 10 can abut against the target tissue before the distal end of the spiral member 20. This makes it easier to rotate the puncture needle 3 around the tubular member 10 as an axis when rotating the puncture needle 3 in the circumferential direction c of the puncture needle 3, thereby reducing wobble of the rotation axis and improving stability when puncturing the puncture needle 3.

[0067] A portion of the tubular member 10 and a portion of the spiral member 20 may be fixed. More specifically, it is preferable that the proximal portion of the spiral member 20 be fixed to the proximal portion of the tubular member 10, and it is more preferable that the proximal end portion of the spiral member 20 be fixed to the proximal portion of the tubular member 10. This prevents the position of the spiral member 20 relative to the tubular member 10 from changing, making it easier to stably screw the puncture needle 3 into tissue. The tubular member 10 and the spiral member 20 may be indirectly fixed via another member, but it is preferable that a portion of the tubular member 10 and a portion of the spiral member 20 are directly fixed without via another member.

[0068] Direct fixation of the cylindrical member 10 and the spiral member 20 refers to the cylindrical member 10 and the spiral member 20 being fixed to each other without any other member in between. For example, fixing of the cylindrical member 10 and the spiral member 20 with an adhesive or fixing of the cylindrical member 10 and the spiral member 20 by welding falls under the category of direct fixation.

[0069] The indirect fixation of the cylindrical member 10 and the spiral member 20 refers to the fact that the cylindrical member 10 and the spiral member 20 are fixed via another member. For example, the fixation of the cylindrical member 10 and the spiral member 20 via a connecting member that connects the outer surface 13 of the cylindrical member 10 and the inner surface 22 of the spiral member 20 corresponds to the indirect fixation.

[0070] The proximal end of the helical member 20 refers to a portion of the helical member 20 that includes the proximal end and its surrounding area. The range of the proximal end of the helical member 20 may be, for example, the range described below. The range of the proximal end of the helical member 20 may be a range from the proximal end of the helical member 20 to a point one-third of the way distal to the proximal end of the helical member 20 when the helical member 20 is divided into three equal parts in the longitudinal direction x of the puncture needle 3. The range of the proximal end of the helical member 20 may be a range from the proximal end of the helical member 20 to a point one-quarter of the way distal to the proximal end of the helical member 20 when the helical member 20 is divided into four equal parts in the longitudinal direction x of the puncture needle 3. The range of the proximal end of the spiral member 20 may be from the proximal end of the spiral member 20 to a point 1 / 5 of the way distal to the proximal end of the spiral member 20 when the spiral member 20 is divided into five equal parts in the longitudinal direction x of the puncture needle 3.

[0071] The inner diameter of the spiral member 20 may be four times or less, or may be three times or less, but is preferably two times or less, the outer diameter of the tubular member 10. This configuration tends to reduce the gap between the tubular member 10 and the spiral member 20, making it easier to screw the puncture needle 3 into the target tissue by rotating the puncture needle 3 around the tubular member 10 as an axis. The inner diameter of the spiral member 20 is preferably larger than the outer diameter of the tubular member 10, and can be 1.1 times or more, 1.2 times or more, 1.3 times or more, the outer diameter of the tubular member 10, etc.

[0072] In a cross section perpendicular to the longitudinal direction x of the puncture needle 3 and passing through the midpoint of the puncture needle 3 in the longitudinal direction x, the length of the wire rod 21 in the radial direction of the tubular member 10 is preferably shorter than the length of the wire rod 21 in the circumferential direction of the tubular member 10. The longer the length of the wire rod 21 in the radial direction of the tubular member 10, the easier it is to adjust the puncture depth; however, this may make it more difficult to insert the puncture needle 3 into the tissue, resulting in a longer puncture time. By adopting the above configuration, the length of the wire rod 21 in the radial direction of the tubular member 10 can be made relatively short, making it easier to adjust the puncture depth without making it too difficult to insert the puncture needle 3 into the tissue. The length of the wire rod 21 in the radial direction of the tubular member 10 refers to the longest length of the wire rod 21 in the radial direction of the tubular member 10. The length of the wire rod 21 in the circumferential direction of the tubular member 10 refers to the longest length of the wire rod 21 in the circumferential direction of the tubular member 10.

[0073] 1, the wire 21 preferably has a tapered shape extending from the distal end 21d of the wire 21 to a position proximally away from the distal end 21d of the wire 21 by a length equal to half the pitch of the spiral member 20. By having a tapered shape extending to the above position, the wire 21 can easily penetrate the target tissue, making it easier to screw the puncture needle 3 into the target tissue. The tapered shape preferably becomes narrower toward the distal end 21d of the wire 21.

[0074] 1, 3, 6, and 7, the catheter system 100 has a tube 4 to which the puncture needle 3 is connected. The tube 4 is preferably connected to the proximal end of the puncture needle 3 and has an inner lumen extending in the longitudinal direction x of the puncture needle 3. The proximal end of the puncture needle 3 and the distal end of the tube 4 are preferably connected.

[0075] The tube 4 can be made of, for example, any of the materials exemplified as materials that can be used to make the puncture needle 3 .

[0076] The tube 4 may be made up of only one cylindrical member, or may be made up of a plurality of cylindrical members.

[0077] As shown in Figures 1, 3, 6, and 7, the tube 4 preferably includes a first tube 41 having a plurality of grooves 410 formed therein. By forming a plurality of grooves 410 in the first tube 41, flexibility can be imparted to the first tube 41. Furthermore, by connecting the tube 4 including the first tube 41 having the grooves 410 formed therein to the puncture needle 3, torque can be easily transmitted to the puncture needle 3. This improves the flexibility and operability of the catheter system 100.

[0078] 6 and 7 , the first tube 41 can be configured to have a lumen 401 extending in the longitudinal direction x of the puncture needle 3, an inner surface 402 facing the lumen 401, and an outer surface 403 facing the outside. In the longitudinal direction x of the puncture needle 3, the first tube 41 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the first tube 41 are open.

[0079] The first tube 41 may have a hollow cylindrical shape, a hollow polygonal prism shape, or the like.

[0080] The length of the first tube 41 in the longitudinal direction x of the puncture needle 3 can be 100 mm or more, 130 mm or more, 160 mm or more, etc. The length of the first tube 41 in the longitudinal direction x of the puncture needle 3 can be 300 mm or less, 270 mm or less, 240 mm or less, etc. The length of the first tube 41 in the longitudinal direction x of the puncture needle 3 refers to the longest length of the first tube 41 in the longitudinal direction x of the puncture needle 3. When used as a catheter system for puncturing the myocardium, the length of the first tube 41 in the longitudinal direction x of the puncture needle 3 is preferably 200 mm.

[0081] The length of the first tube 41 in the radial direction y of the puncture needle 3 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the first tube 41 in the radial direction y of the puncture needle 3 can be 20 mm or less, 15 mm or less, 10 mm or less, etc. The length of the first tube 41 in the radial direction y of the puncture needle 3 refers to the longest length of the first tube 41 in the radial direction y of the puncture needle 3. When used as a catheter system for puncturing the myocardium, the length of the first tube 41 in the radial direction y of the puncture needle 3 is preferably 0.9 mm.

[0082] 6 and 7, the lumen 11 of the tubular member 10 is preferably in communication with the lumen 401 of the first tube 41. This allows liquids such as cell preparations and medicinal solutions to be transported to the puncture needle 3 via the lumen 401 of the first tube 41.

[0083] The first tube 41 can be made of, for example, any of the materials exemplified as materials that can be used to make the puncture needle 3, but it is preferable that the first tube 41 be made of metal.

[0084] The grooves 410 formed in the first tube 41 may be through grooves as shown in Fig. 7 or bottomed grooves as shown in Fig. 6. Furthermore, both through grooves and bottomed grooves may be formed in the first tube 41. By combining through grooves and bottomed grooves or selecting either one of them for the grooves 410 formed in the first tube 41, it becomes easier to obtain the first tube 41 with the desired flexibility and rigidity.

[0085] 7 , a first resin layer 404 made of resin is preferably provided on the outer surface of the first tube 41. This makes it possible to transport liquids such as cell preparations and medicinal solutions to the puncture needle 3 via the lumen 401 of the first tube 41, regardless of whether the groove 410 formed in the first tube 41 is a through groove or a bottomed groove. Note that when the groove 410 is a through groove, it is more preferable that the first resin layer 404 is provided on the outer surface 403 of the first tube 41.

[0086] The first resin layer 404 may be provided so as to cover the entire outer surface 403 of the first tube 41, or may be provided so as to cover only a portion of the outer surface 403 of the first tube 41. As shown in Fig. 3 , the first resin layer 404 may also be provided on the groove 410.

[0087] The first resin layer 404 can be made of a synthetic resin such as a polyolefin resin (e.g., polyethylene or polypropylene), a polyamide resin (e.g., nylon), a polyester resin (e.g., PET), an aromatic polyether ketone resin (e.g., PEEK), a polyether polyamide resin, a polyurethane resin, a polyimide resin, or a fluororesin (e.g., PTFE, PFA, ETFE).

[0088] As shown in FIG. 1 , when observed from a direction perpendicular to the longitudinal direction x of the puncture needle 3, the extension direction of the groove 410 and the longitudinal direction x of the puncture needle 3 preferably intersect at an angle α. The angles α at which the extension direction of each groove 410 intersects with the longitudinal direction x of the puncture needle 3 may all be the same angle or different angles. The angle α is preferably 70° or greater, more preferably 73° or greater, and even more preferably 75° or greater. The angle α is preferably 85° or less, more preferably 83° or less, and even more preferably 80° or less. Setting the angle α within the above range makes it easier to transmit torque to the puncture needle 3.

[0089] The length of one groove 410 in the extension direction of the groove 410 is preferably shorter than the outer circumferential length of the first tube 41. The length of one groove 410 in the extension direction of the groove 410 refers to the longest length of the lengths of the groove 410 in the extension direction of the groove 410.

[0090] 1 , the plurality of grooves 410 include a first groove 411 and a second groove 412 located at a different position from the first groove 411, and when observed from a direction perpendicular to the longitudinal direction x of the puncture needle 3, it is preferable that the second groove 412 is located in the extension direction of the first groove 411. This makes it easier to transmit torque to the puncture needle 3.

[0091] 1, the maximum length between the first groove 411 and the second groove 412 in the extension direction of the first groove 411 is preferably shorter than the maximum length of the first groove 411 in the extension direction of the first groove 411. This allows the distance between the first groove 411 and the second groove 412 to be relatively short, making it easier to impart flexibility to the first tube 41.

[0092] 1, the plurality of grooves 410 includes a third groove 413 located adjacent to the first groove 411 in the longitudinal direction x of the puncture needle 3, and the maximum length between the first groove 411 and the third groove 413 in the longitudinal direction x of the puncture needle 3 is preferably shorter than the pitch length of the spiral member 20. This allows the distance between the first groove 411 and the third groove 413 to be relatively short, making it easier to impart flexibility to the first tube 41.

[0093] It is preferable that the distal end of the first tube 41 is connected to the puncture needle 3. The first tube 41 and the puncture needle 3 may be connected via a reducing-diameter member 30. The reducing-diameter member 30 is a member whose outer diameter decreases toward the distal side. More specifically, as shown in Figures 1, 3, 6, and 7, it is preferable that the proximal end of the tubular member 10 and the distal end of the first tube 41 are connected by the reducing-diameter member 30.

[0094] The reducing diameter member 30 preferably has a lumen 31 that penetrates the puncture needle 3 in the longitudinal direction x. The reducing diameter member 30 can be configured to have an inner surface facing the lumen 31 and an outer surface facing the outside. In the longitudinal direction x of the puncture needle 3, the reducing diameter member 30 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the reducing diameter member 30 are open. It is preferable that the lumen 31 of the reducing diameter member 30 communicates with the lumen 11 of the tubular member 10 and the lumen 401 of the first tube 41.

[0095] The reducing member 30 can be made of, for example, any of the materials exemplified as materials that can be used to make the puncture needle 3, but it is preferable that the reducing member 30 be made of metal. The material that makes up the first tube 41 and the material that makes up the reducing member 30 may be the same or different.

[0096] The shape of the diameter reducing member 30 may be, for example, a hollow polygonal truncated pyramid or a hollow truncated cone.

[0097] As shown in Figures 1, 3, 6 and 7, the tube 4 preferably includes a second tube 42 connected to the proximal end of the first tube 41, and the abutment member 61 abuts against the outer surface of the second tube 42.

[0098] The second tube 42 can be configured to have an inner cavity extending in the longitudinal direction x of the puncture needle 3, an inner surface facing the inner cavity, and an outer surface facing the outside. In the longitudinal direction x of the puncture needle 3, the second tube 42 has a distal end and a proximal end. It is preferable that both the distal end and the proximal end of the second tube 42 are open.

[0099] The second tube 42 may have a shape such as a hollow cylinder or a hollow polygonal column.

[0100] The length of the second tube 42 in the longitudinal direction x of the puncture needle 3 can be 1000 mm or more, 1200 mm or more, 1400 mm or more, etc. The length of the second tube 42 in the longitudinal direction x of the puncture needle 3 can be 2000 mm or less, 1800 mm or less, 1600 mm or less, etc. The length of the second tube 42 in the longitudinal direction x of the puncture needle 3 refers to the longest length of the second tube 42 in the longitudinal direction x of the puncture needle 3. When used as a catheter system for puncturing the myocardium, the length of the second tube 42 in the longitudinal direction x of the puncture needle 3 is preferably 1300 mm.

[0101] The length of the second tube 42 in the radial direction y of the puncture needle 3 can be 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. The length of the puncture needle 3 in the radial direction y of the puncture needle 3 can be 20 mm or less, 15 mm or less, 10 mm or less, etc. The length of the second tube 42 in the radial direction y of the puncture needle 3 refers to the longest length of the second tube 42 in the radial direction y of the puncture needle 3. When used as a catheter system for puncturing the myocardium, the length of the second tube 42 in the radial direction y of the puncture needle 3 is preferably 0.9 mm.

[0102] It is preferable that the distal end of the second tube 42 is connected to the proximal end of the first tube 41. It is also preferable that the lumen of the second tube 42 is in communication with the lumen 401 of the first tube 41. This makes it possible to transport liquids such as cell preparations and medicinal solutions to the puncture needle 3 via the lumen 401 of the first tube 41 and the lumen of the second tube 42.

[0103] The second tube 42 can be made of, for example, any of the materials exemplified as materials that can be used to make the puncture needle 3, but it is preferable that the second tube 42 be made of metal. The material that makes up the first tube 41 and the material that makes up the second tube 42 may be the same or different.

[0104] 1 and 3 , the catheter system 100 preferably includes a sheath 5 having a proximal end connected to a handle 6 and an inner lumen into which the puncture needle 3 and the tube 4 are inserted. The puncture needle 3 and the tube 4 are preferably movable in the inner lumen of the sheath 5 in the longitudinal direction x of the puncture needle 3.

[0105] The sheath 5 is preferably flexible because it is inserted into the body, allowing the sheath 5 to be deformed to conform to the shape of the body cavity. In addition, the sheath 5 is preferably elastic so as to maintain its shape.

[0106] Examples of the sheath 5 include a hollow body formed by arranging one or more wires in a predetermined pattern; a hollow body coated with a resin on at least one of the inner and outer surfaces; a resin tube; or a combination of these, such as a combination of these connected in the longitudinal direction. Examples of hollow bodies in which wires are arranged in a predetermined pattern include a tubular body having a mesh structure formed by simply crossing or weaving wires, and a coil formed by winding wires. The wires may be one or more solid wires or one or more twisted wires. The resin tube can be manufactured, for example, by extrusion molding. When the sheath 5 is a resin tube, the sheath 5 can be composed of a single layer or multiple layers. A portion of the sheath 5 in the longitudinal or circumferential direction may be composed of a single layer, and the other portion may be composed of multiple layers.

[0107] The sheath 5 can be made of, for example, a synthetic resin such as polyolefin resin (e.g., polyethylene or polypropylene), polyamide resin (e.g., nylon), polyester resin (e.g., PET), aromatic polyether ketone resin (e.g., PEEK), polyether polyamide resin, polyurethane resin, polyimide resin, or fluororesin (e.g., PTFE, PFA, or ETFE), or a metal such as stainless steel, carbon steel, or nickel-titanium alloy. These may be used alone or in combination of two or more.

[0108] 1, the puncture needle 3 is preferably delivered to the internal organ to be treated while being placed in the lumen of the sheath 5. After delivery, it is preferable to move the position of the puncture needle 3 distally relative to the sheath 5, and then project the puncture needle 3 from the distal end of the sheath 5 to puncture the organ.

[0109] The puncture needle 3 and the tube 4 are preferably made of a conductive material. This allows electricity to be supplied to the puncture needle 3 via the tube 4. The counter electrode used when passing electricity may be one placed on the patient's body surface, or one placed on the outer surface of the sheath 5. The electrode placed on the patient's body surface may be, for example, a plate-shaped, sheet-shaped, or pad-shaped electrode. The electrode placed on the outer surface of the sheath 5 is preferably annular, cylindrical, or ring-shaped.

[0110] This application claims the benefit of priority based on Japanese Patent Application No. 2023-145185, filed on September 7, 2023. The entire contents of the specification of Japanese Patent Application No. 2023-145185, filed on September 7, 2023, are incorporated herein by reference.

[0111] 10: Cylindrical member 10d: Distal end of cylindrical member 10p: Proximal end of cylindrical member 11: Lumen of cylindrical member 12: Inner surface of cylindrical member 13: Outer surface of cylindrical member 14: Hole 15: Tapered portion 16: Straight tube portion 20: Helical member 20d: Distal end of helical member 21: Wire 21d: Distal end of wire 22: Inner surface of helical member 23: Outer surface of helical member 3: Puncture needle 30: Reducing diameter member 31: Lumen of reducing diameter member 4: Tube 41: First tube 401: Lumen of first tube 402: Inner surface of first tube 403: Outer surface of first tube 404: First resin layer 410: Groove 411: First groove 412: Second groove 413: Third groove 42: Second tube 5: Sheath 6: Handle 60: Inner cavity of handle 600: Grip member 601: Inner surface of grip member 61: Abutment member 611: Abutment portion 612: Non-abutment portion 62: Coil P: Coil pitch 63: Wire 64: Protruding member 7: Power supply unit 71: Conductor 100: Catheter system x: Longitudinal direction of puncture needle y: Radial direction of puncture needle c: Circumferential direction of puncture needle

Claims

1. A handle having an inner cavity into which a tube is inserted, the tube having an inner cavity extending in the longitudinal direction and connected to the proximal end of a medical puncture needle having a longitudinal direction, wherein, when the tube is inserted into the inner cavity of the handle, the handle has an abutment member having a portion abutting the outer surface of the tube, and in a cross section passing through the central axis of the tube and along the longitudinal direction of the tube, the outer surface of the tube has a plurality of abutment portions abutting the abutment member and non-abutment portions which are present between the abutment portions and do not abut the abutment member, and the puncture needle and the abutment member are electrically connected via the abutment portions.

2. A handle as described in claim 1, wherein in a cross section passing through the central axis of the tube and along the longitudinal direction of the tube, the length of the abutting portion in the longitudinal direction of the puncture needle is shorter than the length of the non-abutting portion in the longitudinal direction of the puncture needle.

3. The handle according to claim 1, wherein the abutment member is a coil in which wire is wound in a spiral shape.

4. A handle as claimed in claim 3, wherein the pitch of said coil is greater than the wire diameter of said coil wire.

5. A handle as set forth in claim 1, wherein said abutment member is a protruding member provided so as to protrude radially inward from said tube.

6. A handle as claimed in claim 5, wherein a plurality of said protruding members are provided, and each protruding member is spaced apart from the other protruding members.

7. The handle according to claim 1, wherein said abutment member is made of a conductive material.

8. A catheter system comprising: a handle according to any one of claims 1 to 7; the puncture needle; the tube to which the puncture needle is connected; and a sheath having a proximal end connected to the handle and having an inner cavity into which the puncture needle and the tube are inserted.

9. The catheter system according to claim 8, wherein said puncture needle and said tube are made of a conductive material.

10. The catheter system according to claim 8, wherein the puncture needle comprises a tubular member having an inner lumen extending in the longitudinal direction of the puncture needle, and a spiral member in which a wire is wound spirally around the tubular member.

11. The catheter system of claim 8, wherein said tubes include a first tube having a plurality of grooves formed therein.

12. The catheter system according to claim 11, wherein the tube includes a second tube connected to a proximal end of the first tube, and the abutment member abuts against an outer surface of the second tube.

13. The catheter system according to claim 12, wherein a first resin layer made of resin is provided on the outer surface of the first tube.

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