Medical device

Abstract

The purpose of the present invention is to provide a medical device capable of delivering or suctioning a liquid while forming a hollow shaft from a coil. A medical device (1) is provided with: a hollow shaft (11) which is formed from a coil (11c) in which a wire material (w1) is wound around the long axis, and which has an inner space (p) on the inside in the radial direction of the coil (11c) in the long axis direction; a spiral protrusion (21) provided on the outer peripheral surface of the hollow shaft (11); and a lumen structure (31) which is attached to the hollow shaft (11) and which is provided so as to constitute a liquid-tight lumen (L1).

Description

Technical Field

[0001] This disclosure relates to a medical device. Background Technology

[0002] As medical devices, there are known examples such as dilators used to expand orifices formed in the body, and catheters used to treat lesions in body cavities.

[0003] In these medical devices, a technique of forming a hollow shaft from coils is known (see, for example, Patent Document 1).

[0004] Existing technical documents Patent documents Patent Document 1: Japanese Patent Application Publication No. 2007-98120 Summary of the Invention The problem that the invention aims to solve When doctors use the aforementioned medical devices to perform surgery, they may deliver contrast agents or medications into body cavities, or aspirate excess bodily fluids such as bile. Because the hollow shaft formed by the coils allows fluid to pass through the gaps between the coils, the doctor must first pull the medical device out of the body before re-inserting the liquid-tight catheter to the site of treatment for fluid delivery or aspiration.

[0005] This disclosure is based on the above circumstances, and provides a medical device that has a hollow shaft formed by a coil and is capable of delivering or aspirating liquid.

[0006] Methods for solving problems (1) A medical device comprising: a hollow shaft formed of a coil of wire wound around a long axis, having an inner space inside the coil in the radial direction along the long axis; a helical protrusion disposed on the outer peripheral surface of the hollow shaft; and a lumen structure mounted on the hollow shaft and disposed in a manner that constitutes a liquid-tight lumen.

[0007] (2) The medical device according to (1) above, wherein the lumen structure is a tube disposed in the inner space and extending along the long axis.

[0008] (3) The medical device according to (2) above, wherein the front end of the hollow shaft can rotate freely about the long axis relative to the tube body.

[0009] (4) The medical device according to (2) or (3) above, wherein the tube body is connected to the hollow shaft in a non-removable manner.

[0010] (5) The medical device according to (2) or (3) above, wherein the tube body and the hollow shaft are connected in a detachable manner.

[0011] (6) The medical device according to (1) above, wherein the lumen structure is a coating applied to the hollow shaft.

[0012] In this specification, unless otherwise specified, "major axis" means the central axis along the length of the hollow axis (e.g., Figure 1 , Figure 5 The term "anterior end" refers to the direction along the long axis (long axis direction) in which the medical device moves toward the treatment site (distal end). "Posterior end" refers to the direction along the long axis (long axis direction) opposite to the aforementioned anterior end (proximal end). "Anterior end" refers to the end of the anterior end of any component or part, and "posterior end" refers to the end of the posterior end of any component or part. "Radial direction" refers to the direction perpendicular to the long axis. Attached Figure Description

[0013] Figure 1 This is a schematic side view showing the first embodiment.

[0014] Figure 2A It was decomposed Figure 1 A schematic side view of the medical device, showing a structure in which a front tip, a hollow shaft, and a spiral protrusion are formed as one unit.

[0015] Figure 2B It was decomposed Figure 1 A schematic side view of the medical device, showing the structure in which the tube body and the handle are formed as one piece.

[0016] Figure 3 It is shown in magnification Figure 1 A schematic cross-sectional view of the front end.

[0017] Figure 4A This is a variation of the first embodiment, and is an enlarged schematic cross-sectional view showing the front end.

[0018] Figure 4B This is a variation of the first embodiment, and is an enlarged schematic cross-sectional view showing the front end.

[0019] Figure 4C This is a variation of the first embodiment, and is an enlarged schematic cross-sectional view showing the front end.

[0020] Figure 5 This is a schematic side view showing the second embodiment.

[0021] Figure 6 It is shown in magnification Figure 5 A schematic cross-sectional view of the front end.

[0022] Figure 7A This is a variation of the second embodiment, and is an enlarged schematic cross-sectional view showing the front end.

[0023] Figure 7B This is a variation of the second embodiment, and is an enlarged schematic cross-sectional view showing the front end.

[0024] Figure 7C This is a variation of the second embodiment, and is an enlarged schematic cross-sectional view showing the front end. Detailed Implementation

[0025] Hereinafter, embodiments of the present disclosure will be described with reference to the accompanying drawings. The present disclosure is not limited to the embodiments shown in the drawings. The dimensions of the parts shown in the drawings are for ease of understanding and do not necessarily correspond to actual dimensions.

[0026] In the accompanying diagrams, the left side shows the distal end (distal side) inserted deeper into the body, while the right side shows the proximal end (proximal side, near the hand) operated by the surgeon or other operator.

[0027] [First Implementation Method] Figures 1-3 This is a schematic diagram illustrating the first embodiment. Medical device 1 is a dilator. (As shown) Figure 1 , Figure 2A , Figure 2B As shown, the medical device 1 is roughly composed of a hollow shaft 11, a spiral protrusion 21, a lumen structure 31, a holding member 41, and a front end tip 51.

[0028] The hollow shaft 11 is formed by a coil of wire wound around a long axis, and has an inner space inside the coil in the radial direction along the long axis.

[0029] The hollow shaft 11 has a tapered portion 111, a large-diameter portion 112, and a main body portion 113. The tapered portion 111 is a tapered section that tapers towards the front end. The large-diameter portion 112 is a section whose front end is located at the base end of the tapered portion 111 and extends towards the base end in the direction of the major axis, with a substantially constant outer diameter. The main body portion 113 is a section whose front end is located at the base end of the large-diameter portion 112 and extends towards the base end in the direction of the major axis.

[0030] The tapered portion 111, the large-diameter portion 112, and the main body portion 113 are each formed by appropriately adjusting the shape (diameter of the first coil 11c) of the outermost periphery of the coil constituting the hollow shaft 11 (hereinafter also referred to as "first coil 11c") along the long axis direction. The first coil 11c is formed by spirally winding the wire w1 so that the adjacent wires w1 along the long axis direction of the hollow shaft 11 are close to each other.

[0031] The first coil 11c can be either a single-strand coil formed by winding a single strand of wire, or a multi-strand coil formed by winding two or more wires in multiple strands. Examples of wires include single wires (a single wire) and stranded wires (a bundle of wires formed by twisting two or more single wires together beforehand).

[0032] Since the first coil 11c is to be inserted into the body cavity, it is preferable to have antithrombotic properties, flexibility, and biocompatibility. Examples of materials that can be used as the wire w1 constituting the first coil 11c include resins such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluoropolymer resin; and metals such as stainless steel (e.g., SUS304) and superelastic alloys (e.g., nickel-titanium alloy).

[0033] Thus, since the hollow shaft 11 is formed by a first coil 11c made of wire w1 wound around a long axis, the flexibility of the hollow shaft 11 and the torque transmission capability of the first coil 11c can be improved. Torque transmission capability is the ability to transmit the rotational force applied to the base end of the hollow shaft 11 (the holding member 41 described later in this embodiment) to the front end of the hollow shaft 11.

[0034] The spiral protrusion 21 is a component provided on the outer peripheral surface of the hollow shaft and having a gap between adjacent portions along the long axis of the hollow shaft. The spiral protrusion 21 may be composed of a coil (hereinafter also referred to as "second coil 21c"). The second coil 21c may be configured, for example, by winding wire w2 around the outer peripheral surface of the hollow shaft 11 (in this embodiment, the outer peripheral surface of the tapered portion 111 and the large-diameter portion 112), protruding outward from the outer peripheral surface of the hollow shaft 11 in the radial direction of the hollow shaft 11, and by spacing adjacent wires w2 apart from each other in the long axis direction, thereby having a gap s.

[0035] Since the second coil 21c is to be inserted into the body cavity, it is preferable to have antithrombotic properties, flexibility, and biocompatibility. For example, the same material as the material exemplified for the wire w2 constituting the second coil 21c can be used.

[0036] The first coil 11c and the second coil 21c can be joined by means of, for example, brazing, welding, fixing with adhesive, or fusion welding of the ends of the two.

[0037] Thus, since the helical protrusion 21 is provided on the outer peripheral surface of the hollow shaft 11 and there is a gap s between adjacent portions along the long axis of the hollow shaft 11, the medical device 1 can be advanced by rotational operation through the thread action generated by the helical protrusion 21. If the helical protrusion 21 does not engage with the inner peripheral surface of the body cavity, it will not hinder the advancement brought about by the pushing operation.

[0038] The lumen structure 31 is mounted on a hollow shaft, forming a liquid-tight lumen inside the hollow shaft in the radial direction. In this embodiment, the lumen structure 31 is a liquid-tight tube 311 disposed within the inner space p of the first coil 11c and extending along its long axis. The tube 311 has an inner cavity 311h with an opening 311a at its front end. The inner cavity 311h remains liquid-tight to prevent liquid from leaking out of or flowing into the tube 311 from the outside. Thus, the medical device 1 possesses high liquid tightness with a simple structure.

[0039] The outer circumferential surface of tube 311 can abut against the inner circumferential surface of the first coil 11c, or it can be separated. For example... Figure 3 As shown, in this embodiment, the outer peripheral surface of the tube body 311 abuts against the inner peripheral surface of the front end of the first coil 11c, and the front end of the tube body 311 is configured to pass through the front end tip 51 described later and protrude from the front end of the front end tip 51.

[0040] The tube body 311 and the hollow shaft 11 can be connected in a non-removable manner. For example, the tube body 311 and the first coil 11c can be fixedly connected to the holding member 41, thereby connecting the tube body 311 and the hollow shaft 11 via the holding member 41. Thus, the tube body 311 and the hollow shaft 11 can always be used as a single unit.

[0041] The tube body 311 and the hollow shaft 11 can be connected in a detachable manner. There are no special limitations on the mechanism used for connection and disconnection. For example, a connection and disconnection mechanism (not shown) can be used to connect the holding member with the tube body fixedly connected to the first coil 11c. Thus, the tube body 311 can be inserted into the hollow shaft 11 or separated as needed, and the delivery of contrast agents or the aspiration of bodily fluids can be performed as appropriate.

[0042] As for the material constituting the tube body 311, since the tube body 311 is to be inserted into a body cavity, it is preferably characterized by antithrombotic properties, flexibility, and biocompatibility. The material constituting the tube body 311 is preferably flexible so as to conform to the curvature of the body cavity. Examples of materials forming the tube body 311 include, for example, polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, fluoropolymer resin, polyacrylic acid, polyimide resin, and polyamide-imide resin.

[0043] The gripping member 41 is a component used by the surgeon to push or rotate the medical device 1 into the body. In this embodiment, the gripping member 41 has an inner cavity 41h with an opening 41a at its base end and is fixedly connected to the base end of the tube body 311.

[0044] The inner lumen 311h of the tube body 311 is connected to the inner lumen 41h of the holding member 41, and the inner lumen 311h and the inner lumen 41h form the lumen L1. For example, during surgery, a guidewire is inserted into the lumen L1, or fluids such as contrast agents injected into the body cavity or body fluids aspirated from the body cavity are allowed to flow through the lumen L1.

[0045] The base of the tip 51 is fixedly connected to the front end of the hollow shaft 11. The tip 51 is a generally cylindrical hollow component extending from the front end of the hollow shaft 11 towards the front end side. For example, the tip 51 may have a surface flatter than the outer peripheral surface (the uneven surface formed by the wire w1) of the first coil 11c, and be formed into a hollow shape so that it can be inserted into the tube 311. The tip 51 may be formed, for example, by using a solder such as silver solder or gold solder to flatten the surface at the front end of the first coil 11c. This improves the insertion capability of the hollow shaft 11 into the pre-drilled hole, thereby enabling smooth surgical procedures.

[0046] The front end of the hollow shaft 11 can be configured to rotate freely about its major axis relative to the tube body 311. The inner circumferential surface of the front end of the first coil 11c is not fixedly connected (joined) to the outer circumferential surface of the tube body 311, but is configured such that the first coil 11c can rotate freely about the tube body 311. This allows high torque transmission to be maintained at the front end of the medical device 1. In this embodiment, the inner circumferential surface of the tip 51 is also not fixedly connected to the outer circumferential surface of the tube body 311. Therefore, the first coil 11c and the tip 51 are integrally formed and can rotate freely about the tube body 311.

[0047] An example of how medical device 1, exemplified as a medical device, is used will be described.

[0048] First, the doctor uses a needle (not shown) to puncture and create a hole in the target body tissue. Next, the doctor inserts a guide wire (not shown) into the lumen of the needle and then pulls the needle out of the body.

[0049] Next, the doctor inserts the base of the guidewire into the inner cavity 311h through the opening 311a of the tube 311, and then pushes the medical device 1 into the body cavity along the guidewire, inserting the tip 51 into the hole. Then, the doctor advances the medical device 1 while rotating the hollow shaft 11 by operating the holding member 41, thereby dilating the hole. At this time, through the spiral action of the spiral protrusion 21 (second coil 21c) generated by the rotation of the hollow shaft 11, the conical portion 111 advances towards the front end while passing through the hole, thus dilating the hole through the conical portion 111.

[0050] Next, the doctor delivers contrast agents or other liquids, or aspirates bodily fluids, through the lumen L1. Specifically, the doctor uses a connecting member (not shown) such as a Luer lock to connect a syringe (e.g., a contrast agent injection device, a liquid aspiration device, etc.) to the opening 41a of the holding member 41, and delivers or aspirates liquids through the lumen L1. At this time, since the tube body 311 is configured such that the inner lumen 311h constitutes a liquid-tight lumen L1, liquid delivery and aspiration can be performed without leakage of liquids within the lumen L1 to the outside.

[0051] After the liquid is delivered or aspirated, the doctor rotates the hollow shaft 11 in the opposite direction by operating the handle 41, and at the same time pulls the medical device 1 backward to remove it from the body.

[0052] As described above, since the medical device 1 has the above-described structure, it can exhibit excellent torque transmission performance and has the function of delivering liquids such as contrast agents or aspirating liquids such as body fluids through the lumen L1 formed by the tube body 311 in a liquid-tight manner.

[0053] Unlike the above embodiments, for example, a known loading and unloading mechanism can be used to detachably connect the tube body 311 and the hollow shaft 11 so that the tube body and the hollow shaft can be loaded and unloaded.

[0054] Unlike the embodiments described above, the front end of the tube can be configured not to protrude from the front tip. For example, as... Figure 4A and Figure 4B As shown, the front ends of tubes 311A ​​and 311B can be configured to abut only against the front end pins 51A and 51B, without needing to be fixed to the front end pins 51A and 51B. For example... Figure 4C As shown, the front end of the tube body 311C can be positioned away from the base end of the front end tip 51C. That is, the front end of the tube body 311C can be located at the midpoint of the first coil 11c in the long axis direction.

[0055] [Second Implementation] Figure 5 , Figure 6 This is a schematic diagram illustrating the second embodiment. Medical device 2 is an expander. (As shown...) Figure 5As shown, the medical device 2 is generally composed of a hollow shaft 11, a spiral protrusion 21, a lumen structure 32, a holding member 41, and a front end tip 51. The difference between the medical device 2 of this embodiment and the first embodiment lies in the structure of the lumen structure 32. The structures of the hollow shaft 11, the spiral protrusion 21, the holding member 41, and the front end tip 51 are the same as in the first embodiment; therefore, the same reference numerals are used for the same parts, and detailed descriptions are omitted. The method of using the medical device 2 is the same as in the first embodiment; therefore, detailed descriptions are omitted.

[0056] The tubular structure 32 is mounted on the hollow shaft 11 and is configured to form a liquid-tight tubular cavity. In this embodiment, the tubular structure 32 is a coating 321 applied to the hollow shaft 11.

[0057] The coating 321 is formed to cover at least a portion of the hollow shaft 11, such that liquid cannot flow in or out between adjacent wires w1 of at least the first coil 11c. In this embodiment, the inner cavity 321h formed on the radially inner side of the coating 321 constitutes a liquid-tight cavity L2. For example, as Figure 6 As shown, the part with coating 321 covers the entire part of the first coil 11c, the spiral protrusion 21, and the front end tip 51.

[0058] From the viewpoint of ensuring torque transmission, the material and thickness of the coating 321 are preferably determined in a manner that allows for unimpeded relative movement between adjacent wires w1 of the first coil 11c. Since the coating 321 is to be inserted into a body cavity, its material preferably has antithrombotic properties, flexibility, and biocompatibility.

[0059] Materials constituting the coating 321 may include, for example, polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, fluororesin, polyacrylic acid, polyimide resin, polyamide-imide resin, and other resin materials.

[0060] As described above, since the medical device 2 has the above-described structure, it can exhibit excellent torque transmission during operation and provide the function of delivering liquids such as contrast agents or aspirating liquids such as body fluids through the lumen L2 formed by the coating 321 in a liquid-tight manner.

[0061] In medical device 2, since the lumen structure 32 is composed of a coating 321, by reducing the thickness of the coating 321 while maintaining liquid tightness, a wide inner cavity 321h can be ensured in the inner space p. Therefore, medical device 2 has the function of more smoothly delivering or aspirating liquids.

[0062] The coated portion is not limited to the portions described in the above embodiments. Examples of coated portions include portions that cover only the entire first coil 11c and the second coil 21c (see [reference]). Figure 7A ), only covering the entire portion of the first coil 11c (see Figure 7B ), and the portions between adjacent wires w1 covering the first coil 11c (see Figure 7C ).

[0063] This disclosure is not limited to the structure of the above embodiments, but means that all equivalents and modifications within the claims are included based on the claims. A portion of the structure of the above embodiments may be deleted and replaced with other structures, or other structures may be added to the structure of the above embodiments.

[0064] For example, unlike the embodiments described above, the medical device may also be a device with a substantially constant outer diameter along its long axis (e.g., a catheter).

[0065] Unlike the embodiments described above, a medical device may also be provided that has both a tube body and a coating. Examples of such a medical device include those in which the front end of the tube body is positioned away from the base of the tip, and the portion of the first coil located at least between the base of the tip and the front end of the tube body is coated with a coating. In other words, the front end of the tube body may be located midway along the long axis of the first coil.

[0066] Explanation of reference numerals in the attached figures 1, 2 Medical devices (expanders) 11 Hollow Shaft 11c First coil 21 spiral convex part 21c Second Coil 31, 32 Tubular structures 311, 311A, 311B, 311C pipe body 311h Inner cavity 321 coating 321h Inner cavity 41 Holding components 51. Tip of the front end w1 cable w2 cable s gap p inner space L1, L2 lumen

Claims

1. A medical device, the medical device comprising: A hollow shaft, wherein the hollow shaft is formed by a coil of wire wound around a long axis, and has an inner space inside the coil in the radial direction along the long axis; A spiral-shaped protrusion is disposed on the outer peripheral surface of the hollow shaft; as well as A tubular structure is mounted on the hollow shaft and configured to form a liquid-tight tubular cavity.

2. The medical device according to claim 1, wherein, The tubular structure is a tube disposed in the inner space and extending along the long axis.

3. The medical device according to claim 2, wherein, The front end of the hollow shaft can rotate freely about its long axis relative to the tube body.

4. The medical device according to claim 2 or 3, wherein, The tube body is connected to the hollow shaft in a manner that cannot be removed.

5. The medical device according to claim 2 or 3, wherein, The tube body is connected to the hollow shaft in a detachable manner.

6. The medical device according to claim 1, wherein, The tubular structure is a coating applied to the hollow shaft.

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