Lancing Device

Abstract

This puncturing device (1) has a resin tube (10) having a distal end and a proximal end and extending in the longitudinal direction, a metal tube (20) disposed in the inner cavity of the resin tube (10), a metal core material (30) joined to the distal end of the metal tube (20), and a metal chip (40) joined to the distal end of the metal core material (30). The puncturing device (1) has a liquid flow path between the internal surface of the resin tube (10) and the outer surface of the metal core material (30). The flow path communicates with the inner cavity of the metal tube (20). The resin tube (10) has, on a side surface thereof, an opening (11) allowing the flow path to communicate with the outside of the resin tube (10).

Description

[Technical Field]

[0001] The present invention relates to a puncture device for puncturing biological tissue such as the atrial septum. [Background technology]

[0002] Catheters with electrodes are used in the examination and treatment of arrhythmias such as atrial fibrillation (AF) and atrioventricular reentrant tachycardia (AVRT). During examinations, surgeons insert the electrode catheter into the cardiac chamber and measure intracardiac potentials to identify the abnormal area of ​​the heart causing the arrhythmia. During treatment, surgeons perform ablation surgery, in which they pass energy, including high-frequency current, from the catheter's electrodes to the myocardium causing the arrhythmia, causing necrosis of the source of the arrhythmia and electrically isolating it from the heart. Furthermore, if atrial fibrillation occurs naturally during these examinations or treatments, or if atrial fibrillation is induced to identify the abnormal area of ​​the heart, surgeons defibrillate the heart by applying electrical stimulation from the catheter's electrodes.

[0003] When performing ablation surgery, a catheter is delivered from the right atrium to the left atrium using a Brockenbrough needle (septal puncture needle), which punctures the fossa ovalis in the atrial septum from the right atrium, opening a path for catheter insertion. This is called the Brockenbrough technique.

[0004] In the Brockenbrough technique, the tip of a septal needle is pressed against the fossa ovalis while the position of the device and fossa ovalis is confirmed using intracardiac echocardiography and X-rays, and electricity is passed through the needle to cauterize and penetrate the fossa ovalis. With the fossa ovalis penetrated by the needle, saline or a contrast agent or other liquid is injected from the tip of the needle, and intracardiac echocardiography and X-rays are used to confirm that the liquid has flowed into the left atrium, and the presence or absence of a perforation of the fossa ovalis is checked.

[0005] Septal puncture needles used in the Brockenbrough procedure include a medical device (see, for example, U.S. Patent No. 5,999,239) that includes a metallic elongated member having a proximal end and a distal end, the elongated member defining a lumen extending substantially between the proximal end and the distal end, and at least one opening from the lumen; and an imaging marker associated with the elongated member at a marker location and configured to substantially unimpede fluid flow through the lumen in use, the imaging marker having an outer diameter of the device at the marker location substantially equal to an outer diameter of the device adjacent the marker location. There is an energy delivery device (see, for example, Patent Document 2) that includes an elongated member defining a fluid-permeable lumen and a support spine extending proximally from the distal end of a medical device within a distal portion of the lumen, the proximal end of the support spine being positioned within the distal portion of the lumen; an elongated member defining a fluid-permeable lumen; a distal surface of the elongated member defining an opening communicating with the lumen; the distal surface including at least one electrically exposed conductive portion and at least one electrically insulating portion, the distal surface configured to avoid emboli generation during energy delivery via the electrically exposed conductive portion (see, for example, Patent Document 3). [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Special Publication No. 2015-518752 [Patent Document 2] Special Publication No. 2016-509942 [Patent Document 3] Special Publication No. 2016-513520 Summary of the Invention [Problem to be solved by the invention]

[0007] To make it easier to check whether the fossa ovalis has been perforated, it may be necessary to increase the flow rate of a liquid, such as physiological saline, flowing from the tip of a puncture needle. To increase the flow rate of the liquid from the puncture needle, the number of openings that serve as liquid outlets or the size of the openings can be increased. However, with puncture needles such as those described in Patent Documents 1 to 3, increasing the number or size of the openings reduces the strength of the portion where the openings are formed. Therefore, when the tip of the puncture needle is pressed against the fossa ovalis, the tip may bend, making it difficult to perforate the fossa ovalis.

[0008] Furthermore, the puncture needles described in Patent Documents 1 to 3 are difficult to manufacture because they require many manufacturing steps and it is difficult to perform processes such as forming an opening at the tip. Therefore, there is room for improvement in the manufacture of puncture needles.

[0009] The present invention has been made in consideration of the above circumstances, and its purpose is to provide a puncture device that can increase the strength of the tip of the puncture device even if the openings are made larger or the number of openings is increased to increase the flow rate of liquid released by the puncture device, and that is easy to manufacture. [Means for solving the problem]

[0010] The puncture device that can solve the above problem comprises a resin tube having a distal end and a proximal end and extending in the longitudinal direction, a metal tube arranged in the inner cavity of the resin tube, a metal core material joined to the distal end of the metal tube, and a metal tip joined to the distal end of the metal core material, and is characterized in that it has a liquid flow path between the inner surface of the resin tube and the outer surface of the metal core material, the flow path being connected to the inner cavity of the metal tube, and the resin tube having an opening on its side that connects the flow path to the outside of the resin tube.

[0011] In the pricking device of the present invention, it is preferable that a part of the outer surface of the metal core material contacts the inner surface of the resin tube along the longitudinal direction in the section where the flow path exists.

[0012] In the pricking device of the present invention, the cross-sectional area of ​​the metal core material is preferably larger than the cross-sectional area of ​​the flow channel in a cross section perpendicular to the longitudinal direction.

[0013] In the pricking device of the present invention, the metal core preferably has a recess extending in the longitudinal direction.

[0014] In the pricking device of the present invention, the metal core preferably has a plurality of recesses.

[0015] In the puncture device of the present invention, the metal core material is preferably in planar contact with the inner surface of the metal tube.

[0016] In the pricking device of the present invention, it is preferable that the metal core material be in planar contact with the inner surface of the metal tube at a plurality of locations in a cross section perpendicular to the longitudinal direction.

[0017] In the puncture device of the present invention, it is preferable that the metal core material be in planar contact with the inner surface of the resin tube at a plurality of locations in a cross section perpendicular to the longitudinal direction.

[0018] In the puncture device of the present invention, it is preferable that the metal core material has an outer surface that contacts the inner surface of the resin tube distal to the distal end of the metal tube.

[0019] In the puncture device of the present invention, the proximal end of the metal core is preferably located more proximal than the distal end of the metal tube, and the distal end of the metal core is preferably located more proximal than the distal end of the resin tube.

[0020] In the puncture device of the present invention, the distance from the distal end of the metal tube to the proximal end of the metal core material is preferably shorter than the distance from the distal end of the metal tube to the distal end of the metal core material.

[0021] In the puncture device of the present invention, the distal end of the metal tip is preferably located distal to the distal end of the resin tube.

[0022] In the puncture device of the present invention, the metal tip preferably has an inner cavity, and a radiopaque marker is preferably disposed in the inner cavity of the metal tip.

[0023] In the puncture device of the present invention, the opening is preferably located distal to the distal end of the metal tube. [Effects of the Invention]

[0024] According to the puncture device of the present invention, a liquid flow path is formed between the inner surface of the resin tube and the outer surface of the metal core, the flow path is connected to the lumen of the metal tube, and the resin tube has an opening on its side that connects the flow path to the outside of the resin tube, so that the strength of the distal end of the puncture device can be maintained even if the openings are enlarged or increased in number to increase the flow rate of the liquid released by the puncture device.In addition, the presence of a resin tube, a metal tube, a metal core, and a metal tip makes the puncture device easy to manufacture. [Brief explanation of the drawings]

[0025] [Figure 1] 1 shows a plan view of a lancing device according to an embodiment of the present invention. [Figure 2] 2 illustrates a plan view of the distal end of the lancing device shown in FIG. 1. [Figure 3] 3 shows a longitudinal cross-sectional view of the pricking device shown in FIG. 2. [Figure 4] 4 shows a cross-sectional view of the pricking device shown in FIG. 2 taken along line IV-IV. [Figure 5] 3 shows a VV cross-sectional view of the lancing device shown in FIG. 2. DETAILED DESCRIPTION OF THE INVENTION

[0026] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, hatching and component symbols may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from actual dimensions, as priority is given to helping understand the features of the present invention.

[0027] Fig. 1 is a plan view of a puncturing device 1 according to an embodiment of the present invention, Fig. 2 is a plan view of the distal end of the puncturing device 1, Fig. 3 is a cross-sectional view along the longitudinal direction of the puncturing device 1, and Fig. 4 and Fig. 5 are cross-sectional views perpendicular to the longitudinal direction of the puncturing device 1. The longitudinal direction of the puncturing device 1 can also be rephrased as the direction from the front to the rear of the puncturing device 1.

[0028] The puncture device 1 of the present invention comprises a resin tube 10 having a distal end and a proximal end and extending in the longitudinal direction, a metal tube 20 arranged in the inner cavity of the resin tube 10, a metal core material 30 joined to the distal end of the metal tube 20, and a metal tip 40 joined to the distal end of the metal core material 30, and has a liquid flow path 50 between the inner surface of the resin tube 10 and the outer surface of the metal core material 30, the flow path 50 communicating with the inner cavity of the metal tube 20, and the resin tube 10 has an opening 11 on its side that connects the flow path 50 to the outside of the resin tube 10.

[0029] The puncture device 1 is used, for example, to puncture the fossa ovalis, which is the septal part of the atrium, and open an insertion path for delivering a catheter used in ablation surgery or the like from the right atrium to the left atrium.

[0030] In the present invention, the proximal side refers to the side closer to the user in the extending direction of the puncture device 1, and the distal side refers to the side opposite the proximal side, i.e., the side to be treated. The extending direction of the puncture device 1 is also referred to as the longitudinal direction. In addition, in Figures 1 to 3, the lower side of the figure is the proximal side, and the upper side of the figure is the distal side.

[0031] 1 and 2, the puncture device 1 has a shaft 2 including a resin tube 10, a metal tube 20, a metal core material 30, and a metal tip 40, and may have a handle 3 at the proximal end of the shaft 2. The handle 3 preferably has a syringe port 4 for feeding a liquid such as saline or a contrast agent into a flow channel 50 through the shaft 2. By having the handle 3 have the syringe port 4, it becomes possible to feed a liquid into the flow channel 50 by connecting a syringe or the like to the syringe port 4, and this makes it easier to inject a liquid into the body from the tip of the puncture device 1 to check for perforation of the fossa ovalis.

[0032] The handle 3 preferably has a connector 6 for supplying electricity to the shaft 2 via a cable 5. Since the handle 3 has the cable 5 and the connector 6, by connecting the connector 6 to a power source for supplying high-frequency current, the metal tube 20, the metal core material 30, and the metal tip 40 of the shaft 2 can be electrically connected, and electricity can be supplied from the metal tip 40 to the counter electrode plate, facilitating perforation of the fossa ovalis.

[0033] It is preferable that the shaft 2 has a bent portion 12 at its distal end, where the shaft 2 is bent. By having the bent portion 12 at the distal end of the shaft 2, it becomes easier to insert the puncture device 1 into the heart. The angle of bending of the shaft 2 at the bent portion 12 can be adjusted to suit the shape and condition of the body lumen and the heart. The bent portion 12 may be located proximal to the proximal end of the metal core material 30. The bent portion 12 may also be provided in the portion where the metal core material 30 is located. By providing the bent portion 12 in the distal portion of the shaft 2, the operability of the puncture device 1 can be improved.

[0034] The resin tube 10 before being assembled into the puncture device 1 may have multiple lumens, but preferably has one. By having the resin tube 10 have one lumen, the area of ​​the lumen of the resin tube 10 in a cross section perpendicular to the longitudinal direction can be increased while the outer diameter of the resin tube 10 is reduced. This makes it easier to place the metal tube 20 in the lumen of the resin tube 10, and facilitates the manufacture of the puncture device 1.

[0035] As shown in FIGS. 2 and 3 , the resin tube 10 has a distal end and a proximal end and extends longitudinally. The material constituting the resin tube 10 is preferably an insulating material, such as polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyetherketone resins such as PEEK, polyetherpolyamide resins, polyurethane resins, polyimide resins, fluorine-based resins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride resins. The resin tube 10 may be composed of one type of synthetic resin or may contain multiple types of synthetic resins. The insulating material constituting the resin tube 10 allows the metal tube 20 and the metal core material 30 to be insulated by the resin tube 10 when electricity is applied to the metal tip 40. In particular, the material constituting the resin tube 10 preferably contains a fluorine-based resin, and more preferably contains PTFE. By including a fluorine-based resin in the material that constitutes the resin tube 10, the slipperiness of the outer surface of the resin tube 10 can be increased, resulting in a puncture device 1 that is easy to insert.

[0036] The longitudinal length of the resin tube 10 can be selected to be an appropriate length for treatment, and can be, for example, 500 mm or more and 1200 mm or less.

[0037] The outer diameter of the resin tube 10 is preferably 0.3 mm or more, more preferably 0.5 mm or more, and even more preferably 0.6 mm or more. By setting the lower limit of the outer diameter of the resin tube 10 within the above range, the rigidity of the resin tube 10 is increased, resulting in a puncture device 1 that is easy to insert into a blood vessel. Furthermore, the outer diameter of the resin tube 10 is preferably 2 mm or less, more preferably 1.8 mm or less, and even more preferably 1.5 mm or less. By setting the upper limit of the outer diameter of the resin tube 10 within the above range, the outer diameter of the puncture device 1 can be reduced. Therefore, the minimal invasiveness of the puncture device 1 can be improved.

[0038] The thickness of the resin tube 10 is preferably 50 μm or more, more preferably 100 μm or more, and even more preferably 150 μm or more. By setting the lower limit of the thickness of the resin tube 10 within the above range, the resin tube 10 can insulate the metal tube 20. This prevents cauterization of unintended locations inside the body when electricity is applied to the metal tip 40. Furthermore, the thickness of the resin tube 10 is preferably 350 μm or less, more preferably 300 μm or less, and even more preferably 250 μm or less. Setting the upper limit of the thickness of the resin tube 10 within the above range prevents the outer diameter of the resin tube 10 from becoming too large, making the puncture device 1 minimally invasive.

[0039] 2, 3, and 5, the metal tube 20 is disposed in the lumen of the resin tube 10. In other words, the resin tube 10 is disposed outside the metal tube 20. The metal tube 20 may have multiple lumens, but preferably has one. By having one lumen in the metal tube 20, the cross-sectional area of ​​the lumen in the direction perpendicular to the longitudinal direction can be increased, and the flow rate of the liquid sent to the flow channel 50 can be increased.

[0040] Examples of materials that can be used to form the metal tube 20 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material that can be used to form the metal tube 20 is preferably stainless steel. Using stainless steel as the material for the metal tube 20 increases the rigidity of the metal tube 20, thereby improving the pushability of the puncture device 1.

[0041] The longitudinal length of the metal tube 20 can be selected to be an appropriate length for treatment, and can be, for example, 500 mm or more and 1200 mm or less.

[0042] The outer diameter of the metal tube 20 is preferably 0.5 mm or more, more preferably 0.7 mm or more, and even more preferably 1 mm or more. By setting the lower limit of the outer diameter of the metal tube 20 within the above range, the rigidity of the metal tube 20 is increased, and the pushability of the puncture device 1 can be improved. Furthermore, the outer diameter of the metal tube 20 is preferably 2 mm or less, more preferably 1.8 mm or less, and even more preferably 1.5 mm or less. By setting the upper limit of the outer diameter of the metal tube 20 within the above range, it is easy to ensure a sufficient cross-sectional area of ​​the lumen in a cross section perpendicular to the longitudinal direction of the metal tube 20, and a sufficient amount of liquid can be sent to the flow path 50.

[0043] The thickness of the metal tube 20 is preferably 100 μm or more, more preferably 150 μm or more, and even more preferably 200 μm or more. By setting the lower limit of the thickness of the metal tube 20 within the above range, the rigidity of the metal tube 20 is increased. Therefore, when the puncture device 1 is inserted into a curved body lumen and the metal tube 20 becomes curved, the metal tube 20 can be prevented from bending and the inner lumen of the metal tube 20 from collapsing. Furthermore, the thickness of the metal tube 20 is preferably 350 μm or less, more preferably 300 μm or less, and even more preferably 250 μm or less. By setting the upper limit of the thickness of the metal tube 20 within the above range, the outer diameter of the metal tube 20 can be prevented from becoming excessively large. As a result, the diameter of the puncture device 1 can be reduced.

[0044] As shown in FIG. 3 , the metal core 30 is joined to the distal end of the metal tube 20. Examples of methods for joining the metal core 30 to the distal end of the metal tube 20 include welding, brazing (e.g., soldering), bonding, crimping, etc., press-fitting the metal core 30 into the metal tube 20, fitting the metal tube 20 and the metal core 30 together, and connecting the metal tube 20 and the metal core 30 via a separate part. Among these, methods for joining the metal core 30 to the distal end of the metal tube 20 are preferably fixing by welding, brazing, bonding, etc., and more preferably welding. Fixing the distal end of the metal tube 20 to the metal core 30 increases the bonding strength between the metal tube 20 and the metal core 30. Therefore, even if the puncture device 1 is bent, the metal core 30 is less likely to come off the metal tube 20.

[0045] As shown in Figures 3 and 5, the metal core 30 is preferably solid. When the metal core 30 is solid, the rigidity of the distal end of the puncture device 1 where the metal core 30 is present increases. This improves the pushability of the puncture device 1 and also makes it easier to perforate the fossa ovalis. Examples of the cross-sectional shape of the metal core 30 perpendicular to the longitudinal direction include a circle, an ellipse, a polygon, a cross, an H-shape, a U-shape, and a mountain shape.

[0046] Examples of materials that constitute the metal core material 30 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material that constitutes the metal core material 30 is preferably stainless steel. Using stainless steel as the material that constitutes the metal core material 30 makes it possible to increase the rigidity of the metal core material 30. This also increases the rigidity of the distal end of the puncture device 1, making it easier to perforate the fossa ovalis.

[0047] The outer diameter of the proximal end of the metal core material 30 is preferably smaller than the inner diameter of the distal end of the metal tube 20. By making the outer diameter of the proximal end of the metal core material 30 smaller than the inner diameter of the distal end of the metal tube 20, the proximal end of the metal core material 30 can be inserted into the distal end of the metal tube 20, and the bonding strength between the metal tube 20 and the metal core material 30 can be increased.

[0048] As shown in FIGS. 2 and 3 , the metal tip 40 is joined to the distal end of the metal core material 30. Methods for joining the metal tip 40 to the distal end of the metal core material 30 include, for example, welding, brazing (e.g., soldering), bonding, caulking, etc., press-fitting the metal core material 30 into the metal tip 40, fitting the metal core material 30 and the metal tip 40 together, and connecting the metal core material 30 and the metal tip 40 via a separate component. Among these, methods for joining the metal tip 40 to the distal end of the metal core material 30 are preferably fixation by welding, brazing, bonding, etc., and more preferably welding. Fixing the distal end of the metal core material 30 to the metal tip 40 allows the metal tip 40 to be firmly joined to the metal core material 30. Therefore, the metal tip 40 is less likely to fall off the metal core material 30 when pressed against the fossa ovalis, for example, when puncturing the fossa ovalis, resulting in a puncture device 1 with high durability.

[0049] Examples of materials that constitute the metal tip 40 include metals such as stainless steel, carbon steel, and nickel-titanium alloy. The material that constitutes the metal tip 40 is preferably the same as the material that constitutes the metal core material 30. By using the same material that constitutes the metal tip 40 as the material that constitutes the metal core material 30, it becomes easier to bond the metal core material 30 and the metal tip 40 together. This also has the effect of increasing the bonding strength between the metal core material 30 and the metal tip 40.

[0050] 2 and 3, the distal end of the metal tip 40 preferably has a curved surface shape. By making the distal end of the metal tip 40 curved, it is possible to make it less likely for the metal tip 40 to damage a body lumen such as a blood vessel when it comes into contact with the body lumen, and to make it less likely for damage or perforation to occur at an unintended location.

[0051] As described above, the metal tube 20 and metal core material 30 of the shaft 2, and the metal core material 30 and metal tip 40 are joined together, respectively, so that the three components of the metal tube 20, metal core material 30, and metal tip 40 are electrically connected and can pass electricity.

[0052] As shown in Fig. 4, the puncture device 1 has a liquid flow path 50 between the inner surface of the resin tube 10 and the outer surface of the metal core material 30, and the flow path 50 communicates with the inner cavity of the metal tube 20. As shown in Fig. 2, the resin tube 10 has an opening 11 on its side that communicates the flow path 50 with the outside of the resin tube 10. In other words, a liquid such as saline or a contrast agent that is fed into the inner cavity of the metal tube 20 flows into the flow path 50 and is released through the opening 11.

[0053] The puncture device 1 has a flow path 50 between the inner surface of the resin tube 10 and the outer surface of the metal core 30, which is in communication with the lumen of the metal tube 20. This allows the strength of the distal end of the puncture device 1 to be maintained even though the puncture device 1 is configured to discharge liquid fed into the lumen of the metal tube 20 through the opening 11. Even if the openings 11 are enlarged or the number of openings 11 is increased to increase the flow rate of liquid discharged by the puncture device 1, the strength of the distal end of the puncture device 1 can be maintained. Therefore, even if the puncture device 1 is pressed against the fossa ovalis when puncturing the fossa ovalis, bending of the distal end of the puncture device 1 can be prevented. Furthermore, in manufacturing the puncture device 1, the openings 11 are formed in the resin tube 10 after the metal core 30 is placed in the lumen of the resin tube 10, thereby allowing the flow path 50 in communication with the lumen of the metal tube 20 to be communicated with the outside of the resin tube 10. Therefore, unlike conventional puncture devices, there is no need to perform the difficult process of drilling a hole in the side of the metal tube 20 to release the liquid that has been pumped into the inner cavity of the metal tube 20 to the outside, making it easier to manufacture the puncture device 1.

[0054] Because the opening 11 is provided in the resin tube 10 in the flow path 50 portion, the portion of the resin tube 10 without the opening is in contact with the metal core 30. Because there is a portion where the resin tube 10 and the metal core 30 are in contact in this manner, the strength of the puncture device 1 can be maintained. The resin tube 10 may have flexibility inherent to the resin material, and the cross-sectional shape perpendicular to the longitudinal direction of the resin tube 10 before it is assembled into the puncture device 1 may differ from the cross-sectional shape perpendicular to the longitudinal direction of the resin tube 10 after it is assembled into the puncture device 1 and has the metal core 30 disposed in its lumen.

[0055] 4, it is preferable that there are a plurality of flow channels 50. When the puncture device 1 has a plurality of flow channels 50, a large amount of liquid can be discharged from the puncture device 1. As a result, it becomes easier to confirm the presence or absence of a perforation of the fossa ovalis using intracardiac echocardiography or X-ray irradiation.

[0056] The number of openings 11 is preferably the same as or greater than the number of flow channels 50. By having the number of openings 11 equal to or greater than the number of flow channels 50, the amount of liquid in the flow channels 50 that is released through the openings 11 can be increased. This makes it easier to check whether or not the fossa ovalis has been perforated. There may be multiple openings 11 on the outer periphery at the same position from the distal end of the resin tube 10, or multiple openings 11 at different positions from the distal end of the resin tube 10.

[0057] 2, the shape of opening 11 as viewed from a plane perpendicular to the depth direction of opening 11 may be, for example, circular, elliptical, polygonal, etc. Among these, it is preferable that opening 11 has a circular shape as viewed from a plane perpendicular to the depth direction of opening 11. By having opening 11 have a circular shape, when liquid is released from flow channel 50 through opening 11, pressure is less likely to concentrate at a specific point on the edge of opening 11, and damage such as tearing of part of opening 11 can be prevented.

[0058] The maximum length of opening 11 in a plane perpendicular to the depth direction of opening 11 is preferably 65% ​​or more, more preferably 70% or more, and even more preferably 75% or more of the outer diameter of resin tube 10. By setting the lower limit of the ratio of the maximum length of opening 11 to the outer diameter of resin tube 10 within the above range, a sufficient amount of liquid can be released from opening 11, making it easier to confirm the presence or absence of perforation of the fossa ovalis using intracardiac echo or X-ray irradiation. Furthermore, the upper limit of the ratio of the maximum length of opening 11 to the outer diameter of resin tube 10 is not particularly limited, and the maximum length of opening 11 in a plane perpendicular to the depth direction of opening 11 can be set to 93% or less, 90% or less, or 88% or less of the outer diameter of resin tube 10, for example.

[0059] The resin tube 10 may be a single tube extending from the distal end to the proximal end, and as shown in Figures 2 and 3, the resin tube 10 may have a distal resin tube 10d and a proximal resin tube 10p, with the metal core 30 disposed in the lumen of the distal resin tube 10d and the metal tube 20 disposed in the lumen of the proximal resin tube 10p. By having the distal resin tube 10d and the proximal resin tube 10p, the distal resin tube 10d can be made to have a size and material suitable for the metal core 30, and the proximal resin tube 10p can be made to have a size and material suitable for the metal tube 20. This facilitates the process of disposing the metal tube 20 and the metal core 30 in the lumen of the resin tube 10.

[0060] 3, when the resin tube 10 has a distal resin tube 10d and a proximal resin tube 10p, the proximal end of the distal resin tube 10d is preferably located closer to the proximal side than the distal end of the proximal resin tube 10p. By having the proximal end of the distal resin tube 10d located closer to the proximal side than the distal end of the proximal resin tube 10p, the proximal end of the distal resin tube 10d and the distal end of the proximal resin tube 10p overlap. Therefore, when the puncture device 1 is inserted into a lumen in the body, blood or the like can be prevented from entering the lumen of the resin tube 10 through a gap between the distal resin tube 10d and the proximal resin tube 10p.

[0061] The length of the overlapping portion between the proximal end of the distal-side resin tube 10d and the distal end of the proximal-side resin tube 10p can be selected taking into consideration the effect on the outer diameter of the resin tube 10 and the joining strength. Methods for joining the proximal end of the distal-side resin tube 10d and the distal end of the proximal-side resin tube 10p include, for example, heating, gluing, drawing, etc. the proximal end of the distal-side resin tube 10d and the distal end of the proximal-side resin tube 10p.

[0062] Furthermore, the proximal end of the distal-side resin tube 10d is preferably disposed in the lumen of the proximal-side resin tube 10p. By disposing the proximal end of the distal-side resin tube 10d in the lumen of the proximal-side resin tube 10p, the distal end of the proximal-side resin tube 10p can be brought into close contact with the outer surface of the distal-side resin tube 10d, as shown in Fig. 3. This makes it difficult for the liquid in the flow path 50 to leak out from between the distal-side resin tube 10d and the proximal-side resin tube 10p when the liquid is fed into the lumen of the metal tube 20 and passing through the flow path 50.

[0063] Furthermore, it is preferable that the proximal end of the distal-side resin tube 10d is joined without any gap to the distal end of the proximal-side resin tube 10p. By joining the proximal end of the distal-side resin tube 10d without any gap to the proximal-side resin tube 10p, when electricity is applied to the metal tip 40 via the metal tube 20, it is possible to prevent current traveling through metal members such as the metal tube 20, the metal core material 30, and the metal tip 40 from leaking out through the gap between the distal-side resin tube 10d and the proximal-side resin tube 10p.

[0064] 2, the outer diameter of the resin tube 10 at the portion where the distal end of the metal tube 20 is located is preferably larger than the outer diameter of the resin tube 10 at the portion where the distal end of the metal core material 30 is located. By making the outer diameter of the resin tube 10 at the portion where the distal end of the metal tube 20 is located larger than the outer diameter of the resin tube 10 at the portion where the distal end of the metal core material 30 is located, it is possible to form a small diameter portion on the distal side and a large diameter portion proximal to the small diameter portion at the distal end of the puncture device 1. Therefore, for example, when a dilator is used to insert the puncture device 1 into a lumen in the body, by configuring the small diameter portion to be exposed from the dilator, it is possible to easily control the length of the puncture device 1 exposed from the dilator.

[0065] 4, in a cross section perpendicular to the longitudinal direction, the cross-sectional area of ​​the metal core material 30 is preferably larger than the cross-sectional area of ​​the flow channel 50. When the cross-sectional area of ​​the metal core material 30 is larger than the cross-sectional area of ​​the flow channel 50, the rigidity of the portion of the distal end of the puncture device 1 where the metal core material 30 is located is increased. This makes it possible to improve the insertability of the puncture device 1.

[0066] In a cross section perpendicular to the longitudinal direction, the cross-sectional area of ​​the metal core material 30 is preferably 1.1 times or more, more preferably 1.3 times or more, and even more preferably 1.5 times or more, the cross-sectional area of ​​the flow channel 50. By setting the lower limit of the ratio of the cross-sectional area of ​​the metal core material 30 to the cross-sectional area of ​​the flow channel 50 within the above range, the rigidity of the distal end of the puncture device 1 in which the metal core material 30 is disposed can be sufficiently increased. Furthermore, the cross-sectional area of ​​the metal core material 30 is preferably 5 times or less, more preferably 4 times or less, and even more preferably 3 times or less the cross-sectional area of ​​the flow channel 50. By setting the upper limit of the ratio of the cross-sectional area of ​​the metal core material 30 to the cross-sectional area of ​​the flow channel 50 within the above range, the outer diameter of the distal end of the puncture device 1 can be prevented from becoming too large while ensuring the cross-sectional area of ​​the flow channel 50.

[0067] In the section where the flow path 50 exists, it is preferable that a part of the outer surface of the metal core material 30 contacts along the longitudinal direction with the inner surface of the resin tube 10. The part where the outer surface of the metal core material 30 and the inner surface of the resin tube 10 do not contact becomes the flow path 50, and the contacting part becomes the part that maintains the strength of the distal end of the puncture device 1.

[0068] 2, 4, and 5, the metal core 30 preferably has a recess 31 extending in the longitudinal direction. The metal core 30 only needs to have a portion that becomes the flow path 50 in relation to the resin tube 10. In particular, when the metal core 30 has the recess 31 extending in the longitudinal direction, the flow path 50 is easily formed between the inner surface of the resin tube 10 and the outer surface of the metal core 30, and a sufficient cross-sectional area of ​​the flow path 50 can be ensured. This makes it possible to ensure a sufficient amount of liquid is released from the opening 11.

[0069] In a cross section perpendicular to the longitudinal direction, the maximum distance between the recess 31 and the inner surface of the resin tube 10 is preferably 20% or more, more preferably 25% or more, and even more preferably 30% or more of the maximum length of the metal core 30. By setting the lower limit of the ratio of the maximum distance between the recess 31 and the inner surface of the resin tube 10 to the maximum length of the metal core 30 within the above range, the cross-sectional area of ​​the flow path 50 in a cross section perpendicular to the longitudinal direction can be ensured, and a sufficient amount of liquid can pass through the flow path 50. Furthermore, in a cross section perpendicular to the longitudinal direction, the maximum distance between the recess 31 and the inner surface of the resin tube 10 is preferably 70% or less, more preferably 60% or less, and even more preferably 50% or less of the maximum length of the metal core 30. By setting the upper limit of the ratio of the maximum distance between the recess 31 and the inner surface of the resin tube 10 to the maximum length of the metal core 30 within the above range, the strength of the metal core 30 can be maintained, and the rigidity of the distal end of the puncture device 1 where the metal core 30 is present can be ensured.

[0070] 4 and 5, the metal core material 30 preferably has a plurality of recesses 31. When the metal core material 30 has a plurality of recesses 31, the cross-sectional area of ​​the flow path 50 in a cross section perpendicular to the longitudinal direction can be increased, and the amount of liquid released from the opening 11 can be increased.

[0071] Although not shown, it is preferable that the metal core 30 has a first recess and a second recess, and the resin tube 10 has a first opening that connects the first flow path formed by the first recess to the outside of the resin tube 10, and a second opening that connects the second flow path formed by the second recess to the outside of the resin tube 10. Since the metal core 30 has the first recess and the second recess, and the resin tube 10 has the first opening and the second opening, each recess 31 forms a different flow path, making it possible to release liquid in different directions from each of the multiple openings 11. This makes it possible to increase the amount of liquid released and release liquid in multiple directions, making it easier to check for the presence or absence of a perforation of the fossa ovalis using intracardiac echocardiography or X-ray irradiation.

[0072] 3 and 5, the metal core material 30 is preferably in planar contact with the inner surface of the metal tube 20. By having the metal core material 30 in planar contact with the inner surface of the metal tube 20, the area of ​​contact between the metal tube 20 and the metal core material 30 can be increased. This makes it possible to increase the bonding strength between the metal tube 20 and the metal core material 30, and makes it difficult for the metal core material 30 to come off the metal tube 20 even when the puncture device 1 is inserted into a curved lumen in the body. The length of time that the metal core material 30 is in planar contact with the inner surface of the metal tube 20 in a cross section perpendicular to the longitudinal direction can be selected taking into consideration the bonding strength between the metal tube 20 and the metal core material 30 and the flow rate of the flow channel 50.

[0073] In a cross section perpendicular to the longitudinal direction, the length of the metal core 30 in planar contact with the inner surface of the metal tube 20 is preferably 10% or more, more preferably 20% or more, and even more preferably 30% or more of the length of the outer surface of the metal core 30. By setting the lower limit of the ratio of the length of the metal core 30 in planar contact with the inner surface of the metal tube 20 to the length of the outer surface of the metal core 30 within the above range, the length of the contact portion between the metal tube 20 and the metal core 30 in a cross section perpendicular to the longitudinal direction can be sufficiently secured, thereby improving the bonding strength between the metal tube 20 and the metal core 30. By specifying the contact area between the metal core 30 and the metal tube 20, it is possible to stabilize the resistance value of the current passing through metal components such as the metal tube 20, the metal core 30, and the metal tip 40. Furthermore, by increasing the contact area between the metal core 30 and the metal tube 20, the resistance value of the pricking device 1 can be reduced. Furthermore, in a cross section perpendicular to the longitudinal direction, the length over which the metal core material 30 is in planar contact with the inner surface of the metal tube 20 is preferably 70% or less, more preferably 60% or less, and even more preferably 50% or less of the length of the outer surface of the metal core material 30. By setting the upper limit of the ratio of the length over which the metal core material 30 is in planar contact with the inner surface of the metal tube 20 to the length of the outer surface of the metal core material 30 within the above range, a gap is formed between the inner surface of the metal tube 20 and the outer surface of the metal core material 30, and liquid in the lumen of the metal tube 20 can flow into the flow path 50 through this gap.

[0074] 5, in a cross section perpendicular to the longitudinal direction, the metal core material 30 is preferably in planar contact with the inner surface of the metal tube 20 at multiple locations. Since the metal core material 30 is in planar contact with the inner surface of the metal tube 20 at multiple locations, a configuration is achieved in which multiple gaps are formed between the inner surface of the metal tube 20 and the outer surface of the metal core material 30 in a cross section perpendicular to the longitudinal direction at the portion where the metal core material 30 is disposed in the lumen of the metal tube 20. In other words, the lumen of the metal tube 20 and the flow path 50 communicate with each other via these multiple gaps, making it possible to increase the amount of liquid sent to the flow path 50.

[0075] 4, in a cross section perpendicular to the longitudinal direction, the metal core material 30 is preferably in planar contact at multiple locations with the inner surface of the resin tube 10. When the metal core material 30 is in planar contact at multiple locations with the inner surface of the resin tube 10, multiple flow paths 50 are present, and the amount of liquid that the pricking device 1 releases from the opening 11 can be increased.

[0076] In a cross section perpendicular to the longitudinal direction, the length of the metal core 30 in face-to-face contact with the inner surface of the resin tube 10 is preferably 10% or more, more preferably 20% or more, and even more preferably 30% or more of the length of the outer surface of the metal core 30. By setting the lower limit of the ratio of the length of the metal core 30 in face-to-face contact with the inner surface of the resin tube 10 to the length of the outer surface of the metal core 30 within the above range, the length of the contact portion between the resin tube 10 and the metal core 30 in the cross section perpendicular to the longitudinal direction can be made sufficient. As a result, liquid sent into the flow path 50 is prevented from flowing between the resin tube 10 and the metal core 30 in portions other than the flow path 50, and the amount of liquid released from the opening 11 can be ensured. Furthermore, in a cross section perpendicular to the longitudinal direction, the length of the metal core 30 in face-to-face contact with the inner surface of the resin tube 10 is preferably 70% or less, more preferably 60% or less, and even more preferably 50% or less of the length of the outer surface of the metal core 30. By setting the upper limit of the ratio between the length of the metal core material 30 that is in planar contact with the inner surface of the resin tube 10 and the length of the outer surface of the metal core material 30 within the above range, the cross-sectional area of ​​the flow path 50 in a cross section perpendicular to the longitudinal direction can be increased, making it possible to increase the amount of liquid released from the opening 11.

[0077] 3, the metal core material 30 preferably has an outer surface that contacts the inner surface of the resin tube 10 distal to the distal end of the metal tube 20. Since the metal core material 30 has an outer surface that contacts the inner surface of the resin tube 10 distal to the distal end of the metal tube 20, a portion where the inner surface of the resin tube 10 and the outer surface of the metal core material 30 are in close contact with each other can be formed distal to the distal end of the metal tube 20. Therefore, the rigidity of the distal end of the puncture device 1 can be ensured while the liquid in the flow channel 50 is less likely to flow into areas other than the flow channel 50, and the liquid can be efficiently released from the opening 11.

[0078] 3, the proximal end of the metal core material 30 is preferably located closer to the proximal side than the distal end of the metal tube 20, and the distal end of the metal core material 30 is preferably located closer to the proximal side than the distal end of the resin tube 10. By having the proximal end of the metal core material 30 located closer to the proximal side than the distal end of the metal tube 20, the contact area between the inner surface of the metal tube 20 and the outer surface of the metal core material 30 can be increased, and the bonding strength between the metal tube 20 and the metal core material 30 can be increased. Furthermore, by having the distal end of the metal core material 30 located closer to the proximal side than the distal end of the resin tube 10, the metal core material 30 can be entirely covered with the resin tube 10 in the longitudinal direction, and the liquid sent into the flow channel 50 can be guided to the opening 11 and efficiently released from the opening 11.

[0079] 3, the distance D1 from the distal end of the metal tube 20 to the proximal end of the metal core material 30 is preferably smaller than the distance D2 from the distal end of the metal tube 20 to the distal end of the metal core material 30. By making the distance D1 smaller than the distance D2, it is possible to increase the rigidity of the puncture device 1 in the portion from the distal end of the metal tube 20 to the distal end of the metal core material 30, while preventing the rigidity of the puncture device 1 from becoming excessively high in the portion from the distal end of the metal tube 20 to the proximal end of the metal core material 30, where the metal core material 30 is disposed in the lumen of the metal tube 20. Therefore, when the puncture device 1 is inserted into a curved lumen in the body, the distal end of the puncture device 1 can bend along the lumen in the body, thereby improving the minimally invasive nature of the puncture device 1.

[0080] The distance D1 from the distal end of the metal tube 20 to the proximal end of the metal core material 30 and the distance D2 from the distal end of the metal tube 20 to the distal end of the metal core material 30 can be set appropriately, taking into consideration the balance between strength and the flow rate of the flow path 50. If the distance D2 is long, the bonding strength on the distal side of the puncture device 1 can be increased. On the other hand, if the distance D2 is long, the portion restricting the flow rate of the flow path 50 on the distal side of the puncture device 1 becomes long, which may make it difficult for the liquid to flow. Furthermore, if the distance D2 is long, the contact area between the metal tube 20 and the metal core material 30 becomes large, so it should also be considered that the electrical resistance value may vary.

[0081] As shown in FIG. 3, the distal end of the metal tip 40 is preferably located distal to the distal end of the resin tube 10. By having the distal end of the metal tip 40 located distal to the distal end of the resin tube 10, the distal end of the metal tip 40 is exposed from the resin tube 10. This exposed portion of the metal tip 40 functions as an electrode for cauterizing tissue. Furthermore, by having the proximal end of the metal tip 40 covered by the resin tube 10, the edge-shaped portion of the joint between the metal tip 40 and the metal core material 30 is less likely to be exposed, and this edge-shaped portion can be prevented from hitting and damaging cardiac tissue.

[0082] 3, the metal tip 40 has an inner cavity, and it is preferable that a radiopaque marker 60 is disposed in the inner cavity of the metal tip 40. By disposing the radiopaque marker 60 in the inner cavity of the metal tip 40, the contrast of the metal tip 40 against X-rays can be improved. Therefore, by using X-rays when using the puncture device 1, it becomes possible to easily confirm the position of the metal tip 40 inside the body.

[0083] The material constituting the radiopaque marker 60 can be, for example, a radiopaque substance such as lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, palladium, or cobalt-chromium alloy. Among these, a platinum-iridium alloy is preferable as the radiopaque substance. By using a platinum-iridium alloy as the material constituting the radiopaque marker 60, the contrast of X-rays can be improved, making it easier to confirm the position of the metal tip 40.

[0084] The shape of the radiopaque marker 60 may be a cylinder, a polygonal cylinder, a cylinder with a slit in a C-shaped cross section, a coil shape formed by winding a wire, a columnar shape, a polygonal prism shape, etc. The radiopaque marker 60 may be disposed in a location other than the lumen of the metal tip 40. Furthermore, the number of radiopaque markers 60 may be one or more.

[0085] 2, the opening 11 is preferably located distal to the distal end of the metal tube 20. By locating the opening 11 distal to the distal end of the metal tube 20, the opening 11 is located in a portion where the metal core material 30 is present. Therefore, the rigidity of the distal end of the pricking device 1 where the opening 11 is located can be maintained, and liquid can be released from the distal end of the pricking device 1 through the opening 11.

[0086] The opening 11 is preferably located closer to the proximal side than the proximal end of the metal tip 40. By locating the opening 11 closer to the proximal side than the proximal end of the metal tip 40, the metal tip 40 is not exposed from the opening 11, and the area of ​​the flow channel 50 exposed from the opening 11 can be increased. As a result, it is possible to increase the amount of liquid released from the opening 11. In addition, it is possible to eliminate shapes that obstruct the series of flow channels 50 from the opening 11, which has the effect of stabilizing the release of liquid from the opening 11.

[0087] As described above, the puncture device of the present invention includes a resin tube having a distal end and a proximal end and extending in the longitudinal direction, a metal tube disposed in the lumen of the resin tube, a metal core material joined to the distal end of the metal tube, and a metal tip joined to the distal end of the metal core material, and a liquid flow path is formed between the inner surface of the resin tube and the outer surface of the metal core material, the flow path being in communication with the lumen of the metal tube, and the resin tube having an opening on its side that connects the flow path to the outside of the resin tube. This configuration of the puncture device of the present invention allows for increased strength of the distal end of the puncture device regardless of the number or size of the openings, and also makes the puncture device easier to manufacture.

[0088] This application claims the benefit of priority to Japanese Patent Application No. 2020-188783, filed on November 12, 2020. The entire contents of the specification of Japanese Patent Application No. 2020-188783, filed on November 12, 2020, are incorporated herein by reference. [Explanation of symbols]

[0089] 1: Lancing device 2: Shaft 3: Handle 4: Syringe port 5: Cable 6: Connector 10: Resin tube 10d: Distal resin tube 10p: Proximal resin tube 11: Opening 12: Bend 20: Metal tube 30: Metal core material 31: Recess 40: Metal chip 50: Flow path 60: Radiopaque marker D1: Distance from the distal end of the metal tube to the proximal end of the metal core D2: Distance from the distal end of the metal tube to the distal end of the metal core

Claims

1. a resin tube extending in a longitudinal direction and having a distal end and a proximal end; a metal tube disposed in the lumen of the resin tube; a metal core joined to the distal end of the metal tube; a metal tip joined to the distal end of the metal core; a liquid flow path is provided between the inner surface of the resin tube and the outer surface of the metal core; the flow path communicates with the lumen of the metal tube; the resin tube has an opening on a side surface thereof that connects the flow path with the outside of the resin tube; A puncture device in which, in a section where the flow path exists, a part of the outer surface of the metal core material is in contact with the inner surface of the resin tube along the longitudinal direction.

2. a resin tube extending in a longitudinal direction and having a distal end and a proximal end; a metal tube disposed in the lumen of the resin tube; a metal core joined to the distal end of the metal tube; a metal tip joined to the distal end of the metal core; a liquid flow path is provided between the inner surface of the resin tube and the outer surface of the metal core; the flow path communicates with the lumen of the metal tube; the resin tube has an opening on a side surface thereof that connects the flow path with the outside of the resin tube; A puncture device, wherein the metal core material has an outer surface that contacts the inner surface of the resin tube distal to the distal end of the metal tube.

3. The pricking device according to claim 1 or 2, wherein a cross-sectional area of ​​the metal core material in a cross section perpendicular to the longitudinal direction is larger than a cross-sectional area of ​​the flow channel.

4. The pricking device according to any one of claims 1 to 3, wherein the metal core has a recess extending in the longitudinal direction.

5. The pricking device according to claim 4 , wherein the metal core has a plurality of the recesses.

6. The pricking device according to any one of claims 1 to 5, wherein the metal core material is in surface contact with the inner surface of the metal tube.

7. The puncture device according to claim 6 , wherein the metal core material is in planar contact with the inner surface of the metal tube at a plurality of locations in a cross section perpendicular to the longitudinal direction.

8. The puncture device according to any one of claims 1 to 7, wherein in a cross section perpendicular to the longitudinal direction, the metal core material is in planar contact with the inner surface of the resin tube at a plurality of locations.

9. The puncture device according to claim 1 , wherein the metal core member has an outer surface that contacts the inner surface of the resin tube on the distal side of the distal end of the metal tube.

10. a proximal end of the metal core material is located proximal to a distal end of the metal tube; The puncture device according to any one of claims 1 to 9, wherein the distal end of the metal core material is located proximal to the distal end of the resin tube.

11. A puncture device according to any one of claims 1 to 10, wherein the distance from the distal end of the metal tube to the proximal end of the metal core material is smaller than the distance from the distal end of the metal tube to the distal end of the metal core material.

12. The puncture device according to any one of claims 1 to 11, wherein the distal end of the metal tip is located distal to the distal end of the resin tube.

13. the metal tip has an internal cavity; The puncture device according to any one of claims 1 to 12, wherein an X-ray opaque marker is disposed in the inner cavity of the metal tip.

14. The puncture device according to any one of claims 1 to 13, wherein the opening is located distal to the distal end of the metal tube.

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