Biological substance aspiration catheter

Abstract

This biological substance aspiration catheter 1 includes: a catheter body part 10 having an internal lumen 11; and a hollow tip part 20 provided at a tip portion of the catheter body part 10. The hollow tip part 20 includes: a tip-end opening 21 which communicates with the internal lumen 11; a tapered part 22 which is reduced in diameter toward the tip end; and a side port 23 which is provided in the tapered part 22 and communicates with the internal lumen 11. The side port 23 includes: a starting end 24 which is positioned nearer the rear end than the tip part of the tapered part 22 and the tip-end opening 21; and a terminal end 25 which is positioned on the rear end part side of the tapered part 22 or the hollow tip part 20. The side port 23 extends in the axis direction of the hollow tip part 20.

Description

Biomaterial Aspiration Catheter

[0001] The present invention relates to a biological material aspiration catheter for aspirating biological materials such as blood and body fluids.

[0002] Various medical suction devices have been known for aspirating biological materials (e.g., blood, body fluids, secretions, thrombi, sputum, etc.) from living bodies (e.g., oral cavity, nasal cavity, airway, etc.). For example, Patent Document 1 (Utility Model Registration No. 3142466) discloses a thrombus aspiration catheter device for inserting a thin tube called a catheter into a thrombus lodged in a limb such as a leg or arm, reaching the treatment site, and aspirating the thrombus itself. The thrombus aspiration catheter device of Patent Document 1 includes a thrombus aspiration catheter (1) including a tubular body having an aspiration lumen (8) extending from its base end to its tip, an aspiration syringe (6) for generating negative pressure, and a catheter connecting member having an internal lumen for connecting the internal spaces of the thrombus aspiration catheter (1) and the aspiration syringe (6).

[0003] Furthermore, Patent Document 2 (JP 2013-202115 A) discloses a thrombus aspiration catheter with a novel structure that can easily aspirate and remove thrombi adhering to the inner surface of a blood vessel over the entire circumference thereof, in which the opening of an aspiration lumen 16 formed in a tip portion 20 is an inclined opening portion 30 that is inclined with respect to the central axis, while an intermediate portion 22 is provided between a main body portion 18 on the base end side and the tip portion 20 and has a material hardness that is lower than that of the main body portion 18 and the tip portion 20, and a first curved portion 40 is formed in the main body portion 18, with the inclined opening portion 30 opening inward in the bending direction of the first curved portion 40. Furthermore, Patent Document 3 (WO 2022 / 246544) discloses a system in which the distal tip of a catheter is protected by a protective cover and the catheter is directly introduced through a blood vessel opening without an external sheath, and discloses various modes for sliding and inverting an umbrella portion 42 of the sheath on an aspiration catheter (AC) in the distal direction against the blood vessel wall (see FIGS. 3E to 3I).

[0004] Utility Model Registration No. 3142466 JP 2013-202115 Publication WO2022-246544 (US2024-238565A1, EP4355406A1)

[0005] In relatively large-diameter blood vessels (e.g., pulmonary arteries), occlusion of the blood vessel by a thrombus can lead to serious conditions (e.g., hypoxemia). To address this issue, it is conceivable to use an aspiration catheter with a large opening, such as that disclosed in Patent Document 2. However, when a large thrombus is aspirated using such an aspiration catheter, there is a risk that the thrombus will become stuck in the lumen. The umbrella portion of the sheath disclosed in Patent Document 3 is designed to allow the umbrella portion to be inverted, but does not directly contribute to the aspiration of the thrombus.

[0006] Therefore, an object of the present invention is to provide a biological fluid suction catheter for aspirating biological materials such as blood and bodily fluids, which can effectively aspirate biological materials (blood) containing clots (thrombi) even if the biological material (blood) being aspirated contains relatively large clots (thrombi).

[0007] The above object is achieved by the following: A biological material aspiration catheter for aspirating a biological material, the biological material aspiration catheter comprising: a catheter main body having an internal lumen; and a hollow tip section provided at the distal end of the catheter main body; the hollow tip section comprising a distal opening communicating with the internal lumen, a tapered section whose diameter decreases towards the distal end, and a side opening provided in the tapered section and communicating with the internal lumen; the side opening having a starting end located at the distal end of the tapered section and closer to the rear end than the distal opening, and a terminal end located at the rear end of the tapered section or the hollow tip section, and being an elongated side opening extending in the axial direction of the hollow tip section.

[0008] FIG. 1 is a front view showing an embodiment of a biological material aspiration catheter of the present invention. FIG. 2 is an enlarged explanatory longitudinal sectional view of the biological material aspiration catheter shown in FIG. 1. FIG. 3 is an enlarged plan view of the biological material aspiration catheter shown in FIG. 1. FIG. 4 is an enlarged plan view showing another embodiment of a biological material aspiration catheter of the present invention. FIG. 5 is an enlarged plan view showing another embodiment of a biological material aspiration catheter of the present invention. FIG. 6 is an enlarged partial front view showing the structure of the distal end portion and hollow tip of a catheter main body showing another embodiment of a biological material aspiration catheter of the present invention. FIG. 7 is an enlarged partial front view showing the structure of the distal end portion and hollow tip of a catheter main body showing another embodiment of a biological material aspiration catheter of the present invention. FIG. 8 is an enlarged partial front view showing the structure of the distal end portion and hollow tip of a catheter main body showing another embodiment of a biological material aspiration catheter of the present invention. FIG. 9 is an enlarged partial front view showing the structure of the distal end portion and hollow tip of a catheter main body showing another embodiment of a biological material aspiration catheter of the present invention. FIG. 10 is a front view showing an embodiment of a trap that can be included in a suction means that can be used with the biological material aspiration catheter of the present invention. FIG. 11 is a front view showing another embodiment of a biological material aspiration catheter of the present invention. Fig. 12 is an enlarged longitudinal sectional explanatory view of the proximal end of the biological material aspiration catheter shown in Fig. 11. Fig. 13 is an enlarged partial front view showing the structure of the catheter main body, the distal end of the tubular body, and the hollow tip, showing another embodiment of the biological material aspiration catheter of the present invention. Fig. 14 is a front view of the proximal end of the biological material aspiration catheter shown in Fig. 3.

[0009] The biological material aspiration catheter of the present invention will be described using an embodiment shown in the drawings. As shown in FIGS. 1 to 3 , the biological material aspiration catheter 1 of the present invention comprises a catheter main body 10 having an internal lumen 11 and a hollow tip section 20 provided at the distal end of the catheter main body 10. The hollow tip section 20 comprises a distal opening 21 communicating with the internal lumen 11, a tapered section 22 whose diameter decreases toward the distal end, and a side opening 23 provided in the tapered section 22 and communicating with the internal lumen 11. The side opening 23 has a starting end 24 located at the distal end of the tapered section 22 and proximal to the distal opening 21, and a terminal end 25 located at the proximal end of the tapered section 22 or the hollow tip section 20, and is an elongated side opening 23 extending in the axial direction of the hollow tip section 20. Furthermore, in the biological material aspiration catheter 1 of this embodiment, at least the hollow tip section 20 and the distal end of the catheter main body 10 are insertable into a blood vessel. The biological material suction catheter of the present invention is effective as a blood suction catheter, particularly as a blood suction catheter that may contain thrombus.

[0010] The catheter main body 10 of this embodiment is a flexible tubular member. Since the catheter main body 10 (at least the distal end) is inserted into a living body (blood vessel) (contacting the inner wall of the blood vessel), it is desirable to form the catheter main body 10 from a soft material.

[0011] The catheter main body 10 can be made from flexible materials such as polyolefins such as polypropylene and polyethylene, and olefin-based elastomers (e.g., polyethylene elastomer, polypropylene elastomer), polyesters such as polyethylene terephthalate, soft polyvinyl chloride, polyurethane and urethane-based elastomers, polyamide and amide-based elastomers, polyester and polyester elastomers, polytetrafluoroethylene and fluororesin elastomers, ethylene-vinyl acetate copolymer, synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, and natural rubbers such as latex rubber.

[0012] Furthermore, the outer surfaces of the catheter main body 10 (particularly the portion inserted into the living body (blood vessel)) and the hollow tip 20 may be made slidable. Slidability can be imparted, for example, by coating with a slidable substance or by treating with a lubricating agent. Examples of slidable substances include coating or fixing a hydrophilic polymer such as dimethylacrylamide-glycidyl methacrylate copolymer.

[0013] Although the present embodiment (FIGS. 1 and 2) shows the catheter main body 10 (catheter main body) as a single tubular member, the catheter main body 10 (catheter main body) may be configured by combining multiple members. Furthermore, the material and characteristics (flexibility, etc.) of the catheter main body 10 may be changed depending on the region. The outer diameter of the catheter main body 10 is preferably 1 to 10 mm, and more preferably 2 to 9 mm.

[0014] 1 and 2, the internal lumen 11 of the catheter main body 10 penetrates the catheter main body 10 from the base end to the tip end. The internal lumen 11 functions as a lumen for retrieving clots (thrombi) that are aspirated from the hollow tip portion 20 (described later) to guide the clots (thrombi) to the suction means, and also functions as a lumen for inserting the tubular body 40 (described later). The internal lumen 11 can also be used as a guidewire lumen for inserting a guidewire into the catheter main body 10. The internal diameter of the internal lumen 11 is preferably 1 to 9 mm, and more preferably 2 to 8 mm.

[0015] A hollow tip section 20 is provided at the distal end of the catheter main body 10. The axial length of the hollow tip section 20 is preferably 1 to 50 mm, more preferably 1 to 20 mm. Specifically, as shown in FIGS. 1 and 2 , the hollow tip section 20 is connected (coupled) to the distal end of the catheter main body 10 via a tubular connecting member 12. A configuration equivalent to such a connecting member 12 may be integrally provided with the catheter main body 10 or the hollow tip section 20. The connecting member 12 may be formed from an X-ray contrast material or a resin containing an X-ray contrast material. This allows the connecting member 12 to function as a marker, making it possible to determine the position of the distal end of the biological material aspiration catheter 1 under X-ray imaging. Examples of such X-ray contrast materials include gold, platinum, platinum-iridium alloy, silver, stainless steel, platinum, or alloys thereof, as well as powders of X-ray opaque materials such as barium sulfate, bismuth oxide, and tungsten. In addition, a structure equivalent to such a marker that is visible under X-ray imaging may be provided separately on the distal end portion of the catheter main body 10 or on the hollow tip portion 20.

[0016] The hollow tip portion 20 has a distal opening 21 that communicates with the internal lumen 11. In this embodiment, the distal opening 21 is a substantially circular opening (hole) as shown in FIG. 3, and its inner diameter (diameter) D1 is 1 to 9 mm (opening area (S2) is approximately 0.78 to 63.62 mm). ２ The opening area (S2) is preferably in the range of 2 to 8 mm (the opening area (S2) is approximately 3.14 to 50.27 mm ２ (range).

[0017] The hollow tip portion 20 has a tapered section 22 that tapers toward the tip. In this embodiment, as shown in FIGS. 1 and 2 , the distal end portion of the hollow tip portion 20 is tapered, and a straight section 26 is provided at the proximal end portion. The hollow tip portion 20 may also have a tapered section 22 almost entirely. The tapered section 22 is preferably provided all the way to the tip (tip opening 21). This allows the biological material aspiration catheter 1 to easily enter a living body (blood vessel). In this embodiment, the tapered section 22 tapers linearly toward the tip, but it may also taper while curving inward or outward.

[0018] The hollow tip section 20 is preferably flexible or elastic. Furthermore, since the hollow tip section 20 enters a living body (blood vessel) (contacting the inner wall of the blood vessel), it is desirable to form it from a soft material. The materials exemplified for the catheter main body 10 described above can be suitably used as materials for forming the hollow tip section 20. In particular, it is preferable to use flexible or elastic rubbers such as synthetic resin elastomers, such as olefin elastomers (e.g., polyethylene elastomer, polypropylene elastomer), polyamide elastomers, styrene elastomers (e.g., styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), polyurethane, urethane elastomers, and fluororesin elastomers; synthetic rubbers, such as urethane rubber, silicone rubber, and butadiene rubber; and natural rubbers, such as latex rubber. Alternatively, in order to break down coagulated biological materials (thrombi) into small pieces, the hollow tip portion 20 may be formed from materials such as fluororesins such as hard PTFE and ETFE, polyimide, polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefins (e.g., ultra-high molecular weight polyethylene, polypropylene), polyamide, polyimide, modified polyethylene ether polyamide imide, polyether imide, polystyrene sulfide, and liquid crystal polymers.

[0019] The hollow tip section 20 may also be formed from the same or a compatible thermoplastic material as the catheter main body 10. This facilitates thermal bonding of the two. The catheter main body 10 and hollow tip section 20 may also be bonded by adhesive or other means.

[0020] The hollow tip section 20 has a distal opening 21 and a side opening 23 provided in the tapered section 22 and communicating with the internal lumen of the catheter main body 10. The side opening 23 is elongated and extends in the axial direction of the hollow tip section 20, with a starting end 24 located at the distal end of the tapered section 22 and proximal to the distal opening 21, and a terminal end 25 located at the proximal end of the tapered section 22 or the hollow tip section 20. This allows clots (thrombi) aspirated (pulled axially) by the biological material aspiration catheter 1 to be aspirated through the distal opening 21 and broken down (pulverized) in the side opening 23 for aspirating. In this embodiment, as shown in FIGS. 1 and 2 , the side opening 23 extends axially with the same width. The axial length of the side opening 23 (the length along the tapered section 22) is preferably 0.5 to 49.5 mm, more preferably 0.5 to 19.5 mm.

[0021] In this embodiment, the entire side port 23 is provided in the tapered portion 22. In other words, the terminal end 25 of the side port 23 is located closer to the distal end than the proximal end of the tapered portion 22. This allows the clot (thrombus) aspirated (pulled axially) by the biological material aspiration catheter 1 to pass through the side port 23 from the starting end 24 to the terminal end 25 along the tapered portion 22, making it possible to more effectively break down (break down) the clot (thrombus) at the side port 23 and aspirate it. Note that the side port may have a portion provided in the tapered portion.

[0022] As shown in FIG. 2 , the width W1 of the widest part of the side opening 23 is preferably smaller than the inner diameter D1 of the distal opening 21. This prevents relatively large clots (thrombi) from being aspirated directly through the side opening 23, and prevents the biological material aspiration catheter 1 (inner lumen 11) from being clogged with such clots (thrombi). This also allows for more effective destruction of clots (thrombi) at the side opening 23, as described above. More preferably, the width W1 of the widest part of the side opening 23 is 0.01 to 0.1 times the inner diameter D1 of the distal opening 21, and more preferably 0.05 to 0.1 times. The width W1 of the widest part of the side opening 23 is preferably 0.05 to 0.9 mm, and more preferably 0.2 to 0.4 mm.

[0023] Furthermore, the opening area (S1) of the side port 23 is preferably smaller than the area (opening area: S2) of the distal opening 21. This allows the clot (thrombus) to be aspirated through the side port 23 while the destruction of the clot (thrombus) at the side port 23 proceeds as described above. More preferably, the opening area (S1) of the side port 23 is 0.03 to 0.7 times, and more preferably 0.03 to 0.15 times, the area (opening area: S2) of the distal opening 21. Note that the opening area (S1) of the side port 23 and the opening area (S2) of the distal opening 21 referred to here are the opening areas in a natural state where no external force is applied (a state in which the hollow tip portion 20 is not deformed by the tubular body 40, etc., described below).

[0024] It is preferable to provide a plurality of side ports 23. This allows the coagulated material (thrombus) aspirated (pulled axially) by the biological material aspirating catheter 1 to be broken down (fragmented) and aspirated at the plurality of side ports 23. In this embodiment, as shown in Figure 3, two side ports 23, 23 are provided in the hollow tip portion 20. It is preferable to provide 1 to 16 side ports 23, and it is particularly preferable to provide 4 to 8 side ports 23.

[0025] More preferably, a plurality of side ports 23 are provided, and the side ports 23 are arranged at equal angles relative to the central axis of the hollow tip portion 20. For example, as shown in FIG. 3, when two side ports 23 are provided, the side ports 23 are preferably arranged at 180-degree intervals. Furthermore, as shown in FIG. 4, when three side ports 23 are provided, the side ports 23 are preferably arranged at 120-degree intervals. Furthermore, as shown in FIG. 5, when four side ports 23 are provided, the side ports 23 are preferably arranged at 90-degree intervals. The side ports need only be arranged at approximately equal angles relative to the central axis of the hollow tip portion 20, and variations within 20 degrees are acceptable, with variations within 10 degrees being preferred.

[0026] The shape of the side port is not limited to the above. As shown in Fig. 6, the side port 23a may have a shape that widens toward the center in the axial direction. In other words, the side port 23a may have a shape that narrows toward both axial ends. This allows the clot (thrombus) aspirated (attracted toward the axial direction) by the biological material aspirating catheter 1 to be broken down (broken into small pieces) at the side port 23a (particularly at both narrowed axial ends) and then aspirated from the side port 23a (particularly at the widened central portion in the axial direction).

[0027] In this embodiment as well, the width W2 of the widest portion (axial center portion) of the side opening 23a is preferably smaller than the inner diameter D1 of the distal opening 21. The width W2 of the widest portion of the side opening 23a is preferably 0.1 to 0.5 times, and more preferably 0.2 to 0.3 times, the inner diameter D1 of the distal opening 21. The width W2 of the widest portion of the side opening 23a is preferably 0.2 to 2 mm, and more preferably 0.4 to 1 mm.

[0028] 7, the side opening 23b may have a wider end 25 than the starting end 24. This allows clots (thrombi) aspirated (pulled axially) by the biological material aspiration catheter 1 to be broken down (fragmented) at the side opening 23b (particularly at the starting end 24 and its vicinity) and then aspirated through the side opening 23b (particularly at the ending end 25 and its vicinity). In this embodiment, too, the width W3 of the widest portion (the axial rear end) of the side opening 23b is preferably smaller than the inner diameter D1 of the distal opening 21. The width W3 of the widest portion of the side opening 23b is preferably 0.1 to 0.5 times, and more preferably 0.2 to 0.3 times, the inner diameter D1 of the distal opening 21. The width W3 of the widest portion of the side opening 23b is preferably 0.1 to 2 mm, and more preferably 0.2 to 1 mm.

[0029] 8 and 9, the start ends 24 of the side openings 23c, 23d may include a tip bulge 27 extending in the tip direction, and the end ends 25 of the side openings 23c, 23d may include a rear bulge 28 extending in the rear direction. This makes it possible to aspirate the clot (thrombus) while breaking it down (breaking it down) at the tip bulge 27 and the rear bulge 28, even if the central portions of the side openings 23c, 23d (the portions sandwiched between the tip bulge 27 and the rear bulge 28) become blocked by the clot (thrombus).

[0030] 8 and 9, by making the outer edges of the leading bulge 27 and the rear bulge 28 smooth (edgeless, in this case, substantially circular), it is possible to prevent stress from concentrating at the ends (leading and rear ends) of the side openings 23c, 23d, and to prevent damage to the hollow tip portion 20 originating from the ends (starting end 24 and ending end 25) of the side openings 23c, 23d. Although it is preferable to provide both a leading bulge and a rear bulge, it is also possible to provide only one of them.

[0031] 8 extends in the axial direction with the same width, and is provided with a leading bulge 27 at the starting end 24 and a trailing bulge 28 at the ending end 25. In this embodiment, as shown in FIG. 8, it is preferable that the widthwise dimensions of the leading bulge 27 and the trailing bulge 28 are larger than the widthwise dimensions of the portion of the side opening 23c other than the leading bulge 27 and the trailing bulge 28.

[0032] 9 has a shape that widens toward the center in the axial direction, and is provided with a leading bulge 27 at the starting end 24 and a trailing bulge 28 at the terminal end 25. In this embodiment, as shown in FIG. 9, the widthwise dimensions of the leading bulge 27 and the trailing bulge 28 are preferably smaller than the widthwise dimension of the widest portion of the side opening 23d.

[0033] Also, in the embodiment shown in Figures 8 and 9, the width of the widest portion (axial center portion) of the side openings 23c, 23d is preferably smaller than the inner diameter D1 of the distal opening 21. Here, the width of the widest portion of the side opening 23c is preferably 0.01 to 0.1 times the inner diameter D1 of the distal opening 21, more preferably 0.05 to 0.1 times. The width of the widest portion of the side opening 23c is preferably 0.05 to 0.9 mm, more preferably 0.2 to 0.4 mm. The width of the widest portion of the side opening 23d is preferably 0.1 to 0.5 times the inner diameter D1 of the distal opening 21, more preferably 0.2 to 0.3 times. The width of the widest portion of the side opening 23d is preferably 0.2 to 2 mm, more preferably 0.4 to 1 mm.

[0034] Although not shown, the side openings 23 (including 23a, 23b, 23c, and 23d) may be provided substantially perpendicular to the hollow tip portion 20 (tapered portion 22). In other words, the inner peripheral surface of the side openings 23 may be substantially perpendicular to the outer peripheral surface of the tapered portion 22. The side openings 23 (including 23a, 23b, 23c, and 23d) may be provided at a desired angle to the hollow tip portion 20 (tapered portion 22). In other words, the inner peripheral surface of the side openings 23 may form an acute angle or an obtuse angle with the outer peripheral surface of the tapered portion 22.

[0035] 1 and 2, the rear end of the catheter main body 10 serves as a suction means connection part 13. In this embodiment, the suction means connection part 13 has a tapered shape that increases in diameter. The suction means connection part 13 may also be a hollow hub fixed to the rear end of the catheter main body 10.

[0036] The biological material aspiration catheter 1 is used in combination with a device that generates negative pressure, for example, a suction tool such as a suction syringe. The biological material aspiration catheter 1 and the suction tool may be connected not directly but via various structures, for example, an extension tube, a stopcock, a connector, etc. Here, the suction tool includes a suction tool capable of generating negative pressure for aspirating a biological material and various structures interposed between the biological material aspiration catheter 1 and the suction tool, and the rear end of the catheter main body 10 serves as a suction tool connector 13 that can be connected to such a suction tool (the tip of the suction tool).

[0037] The suction means may include a trap 50 capable of containing the biological material (blood and thrombus) aspirated by the biological material aspirating catheter 1. As shown in FIG. 10 , the trap 50 includes a container 51, a distal connection portion 52, and a proximal connection portion 53. The distal connection portion 52 and the proximal connection portion 53 are each tubular portions that communicate between the inside and outside of the container 51. The distal connection portion 52 and the proximal connection portion 53 are not in direct communication with each other (in other words, they communicate via the space within the container 51). Therefore, the biological material (blood) and clots (thrombus) introduced into the container 51 from the distal connection portion 52 fall by gravity and are contained in the container 51, but do not flow into the proximal connection portion 53. In this embodiment, a filter 54 is attached to the bottom of the distal connection portion 52, which can separate the aspirated liquid biological material (blood) and clots (thrombus).

[0038] The biological material aspiration catheter of the present invention may be a biological material aspiration catheter 1a as shown in Figures 11 and 12. In the biological material aspiration catheter 1a of this embodiment, detailed description of the same or corresponding components as those of the biological material aspiration catheter 1 described above will be omitted.

[0039] The hollow tip portion 20 of the biological material aspiration catheter 1a is flexible or elastic, and the biological material aspiration catheter 1a is equipped with a tubular body 40 that can be inserted into the inner lumen 11 and whose tip can abut against the inner surface of the portion where the side opening 23 of the hollow tip portion 20 is formed. The hollow tip portion 20 is deformed by pressure from the tip of the tubular body 40, and can push and expand the side opening 23.

[0040] As shown in Figures 11 and 12, the tubular body 40 has a lumen 41 that runs from the base end to the tip. The outer shape (outer diameter) of the tip of the tubular body 40 is larger than the inner shape of the portion of the hollow tip section 20 where the side port 23 is formed. As a result, as shown in Figure 11, the tip of the tubular body 40 inserted into the internal lumen 11 of the catheter main body 10 can abut against the inner surface of the portion of the hollow tip section 20 where the side port 23 is formed. Further, by advancing the tubular body 40, the tip of the tubular body 40 can press against and deform the hollow tip section 20, thereby expanding the side port 23. Note that by expanding the side port 23 with the tubular body 40 in this manner (deforming the hollow tip section 20), the opening area of ​​the side port 23 may be made larger than the opening area of ​​the tip opening 21.

[0041] The tubular body 40 preferably has pushability that enables it to push and expand the hollow tip portion 20. The tubular body 40 preferably has a certain degree of hardness and flexibility. The tubular body 40 is also preferably harder than the hollow tip portion 20. This makes it possible to more reliably press and deform the hollow tip portion 20, thereby expanding the side opening 23. Such a tubular body 40 may be made of a semi-rigid resin tube, or a soft or flexible resin tube provided with a reinforcing member.

[0042] Materials that can be used to form semi-rigid resin tubes include fluororesins such as PTFE and ETFE, polyimide, polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefins (e.g., ultra-high molecular weight polyethylene, polypropylene), polyamide, polyimide, modified polyethylene ether polyamide imide, polyetherimide, polystyrene sulfide, liquid crystal polymers, etc. Furthermore, in soft or flexible resin tubes provided with a reinforcing member, examples of soft or flexible resins that can be used include synthetic resin elastomers such as polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefins (e.g., polyethylene, polypropylene), polyamide, olefin-based elastomers (e.g., polyethylene elastomer, polypropylene elastomer), polyamide elastomers, styrene-based elastomers (e.g., styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), polyurethane, urethane-based elastomers, and fluororesin-based elastomers.

[0043] The reinforcing body is preferably provided on the inner surface, outer surface, or inner wall of the soft or flexible resin pipe. The reinforcing body can be formed, for example, by arranging multiple hard wires substantially parallel to the axial direction of the tubular body 40, or by winding the hard wires around the tubular body. The hard wires may be wound around the tubular body by coil winding or braiding. Metal wires are suitable as the hard wires forming the reinforcing body, and examples include stainless steel wires, amorphous alloy wires, platinum, gold, tungsten, tantalum, iridium, and the like; wires made of relatively high-rigidity polymeric materials such as polyimide, ultra-high molecular weight polyethylene, and fluororesin; and appropriate combinations of these.

[0044] In this embodiment, the rear end of the tubular body 40 serves as the suction means connection portion 43. Specifically, in this embodiment, as shown in Fig. 12, the rear end of the catheter main body 10 is connected to the hub 60, and the suction means (the tip of the suction means) as described above is connected to the rear end of the tubular body 40 protruding from the base end of the hub 60. In this embodiment, biological materials (blood) and clots (thrombi) are aspirated through the lumen 41 of the tubular body 40. Although not shown, a hole for suction (for example, for aspirating biological materials (blood and clots (thrombi)) that have been aspirated through the side port 23 and have entered between the outer surface of the tubular body 40 and the inner surface of the catheter main body 10 into the lumen 41 of the tubular body 40) may be provided in the central portion of the tubular body 40.

[0045] As shown in Figure 12, the hub 60 of this embodiment comprises a tubular hub body 61. The hub body 61 has a lumen 62 that runs from the base end to the tip. The rear end of the catheter body 10 is connected (coupled) to the tip of the hub body 61. The lumen 62 of the hub body 61 communicates with the internal lumen 11 of the catheter body 10. A tubular body 40 is inserted through the lumen 62 of the hub body 61 and the internal lumen 11 of the catheter body 10, and the rear end of the tubular body 40 that protrudes from the base end of the hub 60 (hub body 61) forms a suction means connection part 43.

[0046] The hub 60 of this embodiment includes a tubular branch portion 63 that branches off from a hub main body portion 61. A lumen (branch lumen) 64 of the branch portion 63 communicates with a lumen 62 of the hub main body portion 61. When not in use, the branch portion 63 (lumen 64) may be closed with a cap or the like. Note that a hub connected to a biological material suction catheter may not include such a branch portion.

[0047] 12, the hub 60 is equipped with an inner tube locking mechanism that allows or restricts the movement (forward or backward) of the tubular body 40 inserted through the hub main body 61. In this embodiment, the locking mechanism is composed of a valve body 65 that clamps the base end of the tubular body 40 in a liquid-tight manner when compressed and restricts the movement of the tubular body 40, an operating member 66 that compresses the valve body 65, and the hub main body 61. The provision of this locking mechanism allows the tubular body 40 to be fixed in an appropriate position.

[0048] The valve element 65 is installed in a valve element accommodating recess provided at the base end of the hub main body 61, and a tubular body insertion passage is formed inside the valve element 65. Even when the valve element 65 is not compressed, it maintains a liquid-tight state between itself and the tubular body 40 while allowing the tubular body 40 to move. The internal shape of the valve element 65 in this embodiment (in other words, the shape of the tubular body insertion passage) is formed in the shape of two approximately spherical shapes partially overlapping in the axial direction, with both ends and the center having a reduced diameter.

[0049] An elastic material is used as the constituent material of the valve body 65. Examples of elastic materials include rubbers such as synthetic rubbers, such as urethane rubber, silicone rubber, and butadiene rubber, and natural rubbers, such as latex rubber, and synthetic resin elastomers, such as olefin elastomers (e.g., polyethylene elastomers and polypropylene elastomers), polyamide elastomers, styrene elastomers (e.g., styrene-butadiene-styrene copolymers, styrene-isoprene-styrene copolymers, and styrene-ethylenebutylene-styrene copolymers), polyurethanes, urethane elastomers, and fluororesin elastomers.

[0050] The operating member 66 has a cylindrical valve disc pressing portion 67 in the center that protrudes toward the tip, and a threaded portion (female threaded portion) 69 that is formed to encase the valve disc pressing portion 67 and can be threadedly engaged with a threaded portion (male threaded portion) 68 formed on the outer surface of the rear end of the hub main body 61. A tubular body insertion passage is formed inside the valve disc pressing portion 67. The tip side portion of the valve disc pressing portion 67 enters the valve disc storage recess, as shown in Figure 12, so that the valve disc 65 can be compressed by moving the operating member 66 toward the tip.

[0051] In the locking mechanism of this embodiment, when the operating member 66 is rotated to advance the threading so as to move toward the tip of the hub 60, the tip of the valve body pressing portion 67 presses the rear end of the valve body 65. Further rotation of the operating member 66 advances the threading, compressing the valve body 65 in the axial direction. As the compression of the valve body 65 progresses, the valve body 65 tightly adheres to the tubular body 40, thereby gripping and fixing the tubular body 40. This allows the tubular body 40 to be fixed in an appropriate position. In particular, in this embodiment, the tip of the tubular body 40 presses and deforms the hollow tip portion 20, thereby maintaining the side opening 23 in an appropriately expanded state. The locking mechanism can be released by rotating the hub in the reverse direction. While it is preferable for the hub to include the locking mechanism described above, it is not necessary for the hub to include such a locking mechanism.

[0052] A hard or semi-hard material is used as the constituent material of the hub main body 61 and the operating member 66. Examples of hard or semi-hard materials that can be used include synthetic resins such as polyamide, polycarbonate, polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, or other polyolefins), styrene-based resins (for example, polystyrene, MS resin (methacrylate-styrene copolymer), MBS resin (methacrylate-butylene-styrene copolymer)), and polyester, and metals such as stainless steel, aluminum, and aluminum alloys.

[0053] 13, the tubular body 40a may have an axially extending recess 42 at its distal end. By arranging such a recess 42 at the portion of the hollow tip portion 20 where the side opening 23 is formed, the distal end of the tubular body 40a can push open the side opening 23 while preventing the tubular body 40a from blocking the side opening 23. A plurality of such recesses 42 may be provided at the distal end of the tubular body 40a at intervals in the circumferential direction.

[0054] 14 , in order to grasp the positions of the recess 42 and the side port 23 (to position the recess 42 at the formation portion of the side port 23), the tubular body 40a is preferably provided with a recess marker 45 on the outer surface of the portion (rear end) that protrudes from the hub 60 during use, at a position axially rearward of the recess 42, and the hub 60 is preferably provided with a side port marker 71 on its outer surface, at a position axially rearward of the side port 23. Note that such a side port marker may also be provided on the catheter main body 10.

[0055] Furthermore, the biological material aspiration catheter of the present invention may be used to aspirate biological materials (e.g., various secretions, sputum, etc.) from a living body (e.g., the oral cavity, nasal cavity, respiratory tract, etc.) in addition to thrombi in blood vessels or blood containing thrombi, as described above.

[0056] The biological material aspiration catheter of the present invention comprises a catheter main body having an internal lumen and a hollow tip section provided at the distal end of the catheter main body, the hollow tip section having a distal opening communicating with the internal lumen, a tapered section whose diameter decreases toward the distal end, and a side port provided in the tapered section and communicating with the internal lumen, the side port having a starting end located at the distal end of the tapered section and rearward of the distal opening, and a terminal end located at the rear end of the tapered section or the hollow tip section, and is an elongated side port extending in the axial direction of the hollow tip section. This allows for effective aspiration of biological material (blood) containing clots (thrombi), even when the biological material (blood) to be aspirated contains relatively large clots (thrombi).

[0057] The biological material aspiration catheter of the present invention may be embodied as follows: (1) A biological material aspiration catheter for aspirating a biological material, the biological material aspiration catheter comprising: a catheter main body having an internal lumen; and a hollow tip section provided at the distal end of the catheter main body, the hollow tip section comprising a distal opening communicating with the internal lumen, a tapered section whose diameter decreases toward the distal end, and a side opening provided in the tapered section and communicating with the internal lumen, the side opening having a starting end located at the distal end of the tapered section and closer to the rear end than the distal opening, and a terminal end located at the rear end of the tapered section or the hollow tip section, and being an elongated side opening extending in the axial direction of the hollow tip section.

[0058] This biological material aspiration catheter comprises a catheter main body having an internal lumen and a hollow tip section provided at the distal end of the catheter main body, the hollow tip section having a distal opening communicating with the internal lumen, a tapered section whose diameter decreases toward the distal end, and a side port provided in the tapered section and communicating with the internal lumen, the side port having a starting end located at the distal end of the tapered section and rearward of the distal opening, and a terminal end located toward the rear end of the tapered section or the hollow tip section, and is an elongated side port extending in the axial direction of the hollow tip section. This allows for effective aspiration of biological material (blood) containing clots (thrombi), even when the biological material (blood) to be aspirated contains relatively large clots (thrombi).

[0059] The biological material aspiration catheter may also be embodied as follows. (2) In the biological material aspiration catheter described in (1) above, the width of the widest part of the side port is preferably smaller than the inner diameter of the tip opening. (3) In the biological material aspiration catheter described in (1) or (2) above, the opening area of ​​the side port is preferably smaller than the area of ​​the tip opening. (4) In the biological material aspiration catheter described in any of (1) to (3) above, it is preferable that a plurality of side ports are provided. (5) In the biological material aspiration catheter described in any of (1) to (3) above, it is preferable that a plurality of side ports are provided and are arranged at equal angles with respect to the central axis of the hollow tip section. (6) In the biological material aspiration catheter described in any of (1) to (5) above, it is preferable that the hollow tip section is flexible or elastic. (7) In the biological material aspiration catheter described in any of (1) to (6) above, it is preferable that the side ports extend in the axial direction with the same width. (8) In the biological material aspiration catheter described in any one of (1) to (6) above, it is preferable that the side port has a shape that widens toward the center in the axial direction. (9) In the biological material aspiration catheter described in any one of (1) to (6) above, it is preferable that the end of the side port is wider than the start end. (10) In the biological material aspiration catheter described in any one of (1) to (9) above, it is preferable that the start end of the side port has a distal bulge extending toward the distal end, and the end of the side port has a proximal bulge extending toward the proximal end. (11) In the biological material aspiration catheter described in any one of (1) to (10) above, it is preferable that the proximal end of the catheter main body serves as a suction means connection portion. (12) In the biological material aspiration catheter described in any one of (1) to (11) above, it is preferable that at least the hollow tip portion and the distal end of the catheter main body are insertable into a blood vessel.(13) In the biological material aspiration catheter described in any one of (1) to (12) above, it is preferable that the hollow tip portion is flexible or elastic, the biological material aspiration catheter has a tubular body that can be inserted into the internal lumen and whose tip can abut against the inner surface of the part where the side opening is formed in the hollow tip portion, and the hollow tip portion is deformed by pressure from the tip of the tubular body to expand the side opening. (14) In the biological material aspiration catheter described in (13) above, it is preferable that the rear end of the tubular body serves as a part for connecting to a suction means.

Claims

1. A biological material aspiration catheter for aspirating biological materials, comprising: a catheter main body having an internal lumen; and a hollow tip section provided at the distal end of the catheter main body; the hollow tip section having a distal opening communicating with the internal lumen, a tapered section whose diameter decreases towards the distal end, and a side opening provided in the tapered section and communicating with the internal lumen; the side opening having a starting end located at the distal end of the tapered section and closer to the rear end than the distal opening, and a terminal end located at the rear end of the tapered section or the hollow tip section, and being an elongated side opening extending in the axial direction of the hollow tip section.

2. A biological material aspiration catheter according to claim 1, wherein the width of the widest part of said side opening is smaller than the inner diameter of said tip opening.

3. A biological material aspiration catheter according to claim 1 or 2, wherein the opening area of ​​the side port is smaller than the opening area of ​​the tip end.

4. A biological material suction catheter according to claim 1 or 2, wherein a plurality of said side ports are provided.

5. A biological material aspiration catheter according to claim 1 or 2, wherein a plurality of said side ports are provided and are arranged at equal angles to the central axis of said hollow tip portion.

6. A biological material aspiration catheter according to claim 1 or 2, wherein the hollow tip portion is flexible or elastic.

7. A biological material aspiration catheter according to claim 1 or 2, wherein the side ports extend in the axial direction with the same width.

8. A biological material aspiration catheter according to claim 1 or 2, wherein the side port has a shape that widens toward the center in the axial direction.

9. A biological material aspiration catheter according to claim 1 or 2, wherein the end of the side port is wider than the beginning.

10. A biological material suction catheter as described in claim 1 or 2, wherein the starting end of the side port has a distal bulge extending in the distal direction, and the ending end of the side port has a proximal bulge extending in the proximal direction.

11. A biological material aspiration catheter according to claim 1 or 2, wherein the rear end of the catheter body is a connecting portion for connecting to the aspiration means.

12. The biological material suction catheter according to claim 1 or 2, wherein at least the hollow tip portion and the distal end of the catheter body are insertable into a blood vessel.

13. A biological material suction catheter as described in claim 1 or 2, wherein the hollow tip portion is flexible or elastic, the biological material suction catheter comprises a tubular body that can be inserted into the internal lumen and whose tip can abut against the inner surface of the hollow tip portion where the side opening is formed, and the hollow tip portion is deformed by pressure from the tip of the tubular body, thereby being able to expand the side opening.

14. A biological material aspiration catheter according to claim 13, wherein the rear end of the tubular body is a connecting portion for connecting to the aspiration means.

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