Lancing devices and treatment methods

Abstract

The present invention provides a puncture device and treatment method that can reduce the possibility of unintended tissue damage, as well as the possibility of unintended injection of fluid into tissue or accidental drainage of fluid from tissue. [Solution] The puncture device 10 comprises a long, metal tubular body 50, a needle portion 100 provided at the tip of the tubular body 50, and a hub portion 30 provided at the base end of the tubular body 50 to which a syringe can be connected. The tubular body 50 has a lumen 51 extending from the base end to the tip, a flexible portion 52 provided at the tip on the base end side of the needle portion 100, an X-ray opaque first marker portion 54 provided between the flexible portion 52 and the tip of the needle portion 100, and an X-ray opaque second marker portion 55 provided on the base end side of the flexible portion 52. The flexible portion 52 has a slit-shaped through-hole 56 that penetrates the side wall of the tubular body 50 and communicates the lumen 51 with the outside, and has lower bending rigidity than the portion adjacent to the flexible portion 52 and the needle portion 100.

Description

Technical Field

[0001] The present invention relates to a puncture instrument and a treatment method for puncturing a target site in a living body to supply a drug or drain body fluid.

Background Art

[0002] In recent years, treatments have been performed, such as performing arrhythmia ablation through the pericardial cavity located between two pericardial membranes that constitute the pericardium covering the myocardial tissue, draining body fluid from the pericardial cavity, or supplying a drug. For such treatments, for example, Patent Document 1 discloses a method and a device for approaching the pericardial cavity transvaginally.

Prior Art Document

Patent Document

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] When inserting a puncture instrument into the pericardial cavity transvaginally, the puncture site is identified and punctured using ultrasonic waves or X-rays. However, if the puncture is excessive, there is a possibility of puncturing and damaging the pericardium beyond the pericardial cavity.

[0005] In addition, after puncture, it is necessary to confirm that the needle tip (administration hole) is in the pericardial cavity and administer a liquid such as a drug solution into the pericardial cavity, but it is difficult to identify the position of the needle tip using ultrasonic waves or X-rays, and there is a possibility of administering the liquid into the heart or myocardium.

[0006] The present invention has been made to solve the above-described problems, and an object thereof is to provide a puncture instrument and a treatment method that can reduce the possibility of unintentional tissue damage and can reduce the possibility of accidental injection of a liquid into an unintended tissue or accidental drainage of a liquid from a tissue.

Means for Solving the Problems

[0007] The above objective is achieved by the invention described in (1) below. (1) The puncture device according to the present invention comprises a long, metal tubular body, a needle portion provided at the tip of the tubular body, and a hub portion provided at the base end of the tubular body to which a syringe can be connected, wherein the tubular body has a lumen extending from the base end to the tip, a flexible portion provided at the tip on the base end side of the needle portion, an X-ray opaque first marker portion provided between the flexible portion and the tip of the needle portion, and an X-ray opaque second marker portion provided on the base end side of the flexible portion, wherein the flexible portion has a slit-shaped through-hole that penetrates the side wall of the tubular body and communicates the lumen with the outside, and has lower bending rigidity than the portion adjacent to the flexible portion and the needle portion. [Effects of the Invention]

[0008] The lancet described in (1) above has a flexible portion in its tubular body, allowing for the activation / deactivation of the needle function depending on the protrusion length from the delivery device into which the lancet is inserted, thereby reducing the possibility of unintended tissue damage. Furthermore, the lancet has radiopaque markers at both the tip and proximal end of the flexible portion, making it possible to confirm under radiographic contrast that the needle portion and the flexible portion have reached the target position. Therefore, the lancet can reliably position the fluid-releasing portion, or the portion located tipping to the flexible portion, at the target position, reducing the possibility of unintended injection of fluid into tissue or accidental discharge of fluid from tissue.

[0009] (2) In the puncture device described in (1) above, the flexible portion may have a first transition portion in which the bending rigidity decreases from the tip towards the base of the flexible portion, and a second transition portion in which the bending rigidity decreases from the base towards the tip of the flexible portion. As a result, the bending rigidity of the flexible portion decreases from both sides in the axial direction toward the center, so that the bending of the flexible portion changes smoothly in the axial direction, and damage to the tubular portion due to stress concentration can be suppressed.

[0010] (3) In the lancet described in (2) above, the pattern of through holes in the first transition section may become sparser toward the tip of the flexible section, and the pattern of through holes in the second transition section may become sparser toward the base end of the flexible section. This allows the bending rigidity of the flexible section of the lancet to be easily and freely adjusted by the pattern of through holes.

[0011] (4) The puncture device described in (2) or (3) above may have a first reinforcing tube covering at least the tip of the first transition portion and a second reinforcing tube covering at least the base end of the second transition portion. This distributes the stress generated between the flexible portion and the portion adjacent to the flexible portion when the puncture device is operated, thereby suppressing excessive bending or damage of the tubular portion.

[0012] (5) In the puncture device described in any one of (1) to (4) above, the axial length of the flexible portion may be 20 mm or more and 50 mm or less. This allows the puncture device to reduce the length required to be inserted into the pericardial cavity while reliably reducing the possibility of damaging the pericardium or surrounding tissue with the needle portion when the flexible portion is exposed.

[0013] (6) In the puncture device described in any one of (1) to (5) above, the axial length of the flexible portion is 20 mm or more and 45 mm or less, and the minimum bending radius at which the flexible portion bends naturally due to gravity when the portion on the proximal end side of the tubular body is positioned vertically above the flexible portion with the tip side facing upward may be less than 17 mm. This makes the flexible portion of the puncture device more flexible and reliably reduces the possibility of damaging the pericardium or surrounding tissues with the needle.

[0014] (7) In the lancing device described in any one of (1) to (6) above, the outer diameter of the tubular body is 0.50 mm or less, the inner diameter of the tubular body is 0.25 mm or more, and the wall thickness of the tubular body is 0.025 mm or more. This allows the lancing device to reduce the possibility of bleeding from the punctured tissue by having an outer diameter of 0.50 mm or less of the tubular body, while allowing fluid to be administered through the lumen of the tubular body by having an inner diameter of 0.25 mm or more of the tubular body. Furthermore, the wall thickness of the body is 0.025 mm or more, which allows the needle portion to maintain its strength as a needle tube. When the puncture hole formed during puncture is formed from a blood vessel into the pericardial cavity, having an outer diameter of 0.50 mm or less of the tubular body reduces the possibility of cardiac tamponade occurring due to blood flowing into the pericardial cavity through the puncture hole.

[0015] (8) In the lancing device described in any one of (1) to (7) above, the needle tip angle of the needle portion may be 15° or more and 75° or less. This allows the lancing device to provide the needle portion with good lancing function.

[0016] (9) The treatment method according to the present invention involves preparing a puncture device comprising a long, metal tubular body, a needle portion provided at the tip of the tubular body, and a hub portion provided at the proximal end of the tubular body to which a syringe can be connected; inserting the tubular body transvascularly into the cardiac chamber; advancing the tubular body under X-ray contrast to puncture the cardiac wall with the needle portion from the cardiac chamber toward the pericardial cavity; inserting the first marker portion provided at the tip of the tubular body into the pericardial cavity; advancing the tubular body further to penetrate the side wall of the tubular body on the proximal end side of the first marker portion; The method is characterized by inserting a flexible portion having a slit-shaped through-hole that connects the lumen of the tubular portion to the outside into the pericardial cavity, stopping the advance of the tubular portion when the flexible portion is curved within the pericardial cavity and a second marker portion provided on the tubular portion on the proximal end side of the flexible portion is positioned adjacent to the heart wall, and administering or discharging fluid from a syringe connected to the hub portion into the pericardial cavity or from the pericardial cavity through the lumen extending from the proximal end to the tip of the tubular portion and the through-hole of the flexible portion.

[0017] Since the treatment method according to (9) above uses a tubular body having a flexible part, it is possible to switch between activation / inactivation of the needle function depending on the protruding length from the delivery tool into which the puncture instrument is inserted, and it is possible to reduce the possibility of damage to tissues such as the pericardium unintentionally. Further, since the treatment method uses a tubular body having radiopaque marker portions on both the tip side and the base end side of the flexible part, it is possible to confirm that the needle part has reached the target position and that the flexible part administration part has reached under X-ray imaging. Therefore, the treatment method can surely place the site for discharging the liquid located at the flexible part or on the tip side of the flexible part at the target position, and can reduce the possibility of accidental injection of the liquid into unintended tissues or accidental discharge of the liquid from the tissues.

Brief Description of the Drawings

[0018] [Figure 1] It is a plan view showing a medical system including a puncture instrument according to an embodiment. [Figure 2] It is a cross-sectional view showing a puncture instrument according to an embodiment. [Figure 3] It is a cross-sectional view showing the base end portion of a puncture instrument according to an embodiment. [Figure 4] It is a plan view showing the tip portion of a puncture instrument, where (A) shows this embodiment and (B) shows a modified example. [Figure 5] It is a plan view showing another modified example of the tip portion of a puncture instrument. [Figure 6] It is a plan view showing a modified example of the base end portion of a puncture instrument. [Figure 7] It is a schematic view showing a cross-section of a living body and a medical system in a plane. [Figure 8] It is a cross-sectional view taken along the line A-A of FIG. 7. [Figure 9] It is a cross-sectional view for explaining an example of use of a puncture instrument according to an embodiment, where (A) shows a state where the blood vessel wall is tenting by a catheter, and (B) shows a cross-sectional view showing a state where a puncture instrument is inserted into the catheter. [Figure 10]It is a cross-sectional view for explaining a usage example of the puncture instrument according to the embodiment, where (A) shows a state in which the blood vessel wall is punctured by the puncture instrument, and (B) shows a state in which the flexible part has reached the pericardial cavity. [Figure 11] It is a flowchart showing a treatment method. [Figure 12] It is a schematic cross-sectional view showing an outer diameter evaluation test device. [Figure 13] It is a graph showing the pressure reduction rate with respect to the outer diameter of the needle part in the outer diameter evaluation test. [Figure 14] It is a side view showing a bending radius measurement test and a puncture performance evaluation test.

Mode for Carrying Out the Invention

[0019] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensions in the drawings may, for the convenience of explanation, be exaggerated and different from the actual dimensions. Also, in this specification and the drawings, components having substantially the same function are denoted by the same reference numerals, and redundant description is omitted. In this specification, the side inserted into the lumen of the instrument is referred to as the "tip side", and the side for operation is referred to as the "base end side".

[0020] The puncture instrument 10 according to an embodiment of the present invention is a medical instrument for approaching the pericardial cavity 305 (target position) between two pericardia 303 that form a pericardium covering the myocardium 304 via a blood vessel, as shown in FIGS. 7 to 8. The puncture instrument 10 punctures the myocardium 304 from the cardiac cavity 306 and approaches the pericardial cavity 305. The puncture instrument 10 is used together with a catheter 200 that is a delivery tool for delivering the puncture instrument 10 to the target position, and a sheath 210 into which the catheter 200 can be inserted.

[0021] As shown in FIGS. 1, 7 to 8, the sheath 210 is used to hold the catheter 200 near the target position of the blood vessel or heart where puncture is to be performed. The sheath 210 is a known one, but may be a dedicated one with a bent tip or the like.

[0022] The catheter 200 is used to guide the puncture device 10 to the vicinity of the target location in the blood vessel or heart where the puncture is to be performed. The catheter 200 is a known type, but may be a specialized type.

[0023] As shown in Figures 1 to 3, the puncture device 10 includes a long puncture shaft 20, a hub portion 30 provided at the proximal end of the puncture needle to which a syringe can be connected, and an operating portion 40 to which the hub of the catheter 200 can be connected.

[0024] The puncture shaft 20 has a long, metal tubular section 50, a needle section 100 provided at the tip of the tubular section 50, a first reinforcing tube 70 and a second reinforcing tube 80 covering a portion of the tip of the tubular section 50, and a support tube 90 covering the base end of the tubular section 50.

[0025] The tube portion 50 has a lumen 51 extending from the base end to the tip, a flexible portion 52 provided on the base end side of the needle portion 100 at the tip, a base portion 53 located on the base end side of the flexible portion 52, a first marker portion 54 provided between the flexible portion 52 and the tip of the needle portion 100, and a second marker portion 55 provided on the base end side of the flexible portion 52.

[0026] As shown in Figures 2, 4(A), the flexible portion 52 has lower bending rigidity than the portion of the tubular portion 50 adjacent to the flexible portion 52 and the needle portion 100. The flexible portion 52 has a lumen 51 that extends from the tubular portion 50 and has a plurality of slit-shaped through holes 56 that penetrate the side wall of the tubular portion 50 and communicate the lumen 51 with the outside. The through holes 56 are formed, for example, by laser cutting a single metal tubular body that forms the tubular portion 50 and the needle portion 100. In this embodiment, the flexible portion 52 has a plurality of through holes 56 arranged along the axial direction of the tubular portion 50 and has a ring-shaped unit structure 57 between axially adjacent through holes 56. Each through hole 56 is formed in a 360-degree range along the circumferential direction of the tubular portion 50 and separates the unit structure 57 on the tip side from the unit structure 57 on the base side of the through hole 56 of the tubular portion 50. The through-hole 56 is formed in a meandering manner, and the unit structure 57 at the tip end and the unit structure 57 at the base end are formed in a meandering manner so that they interlock with each other on either side of the through-hole 56. That is, one unit structure 57 that contacts the other unit structure 57 on either side of the through-hole 56 has a plurality of protrusions 60 projecting toward the other unit structure 57, and each protrusion 60 spreads out in the circumferential direction of the tubular portion 50 at its top end. The other unit structure 57 has a plurality of recesses 61 with shapes corresponding to each of the protrusions 60. The plurality of protrusions 60 and the plurality of recesses 61 are evenly arranged in the circumferential direction. The unit structures 57 that interlock on either side of the through-hole 56 are mechanically separated, but they are designed to interlock and not separate. It is preferable that the bending rigidity of the flexible portion 52 is non-anisotropic and equal in any direction of bending.

[0027] The flexible portion 52 has a first transition portion 62 in which the bending rigidity decreases from the tip to the base end of the flexible portion 52, a second transition portion 63 in which the bending rigidity decreases from the base end to the tip end of the flexible portion 52, and a central portion 64 between the first transition portion 62 and the second transition portion 63 in which the bending rigidity is lowest.

[0028] The pitch P (distance between two axially adjacent through holes 56) of the through holes 56 located in the first transition section 62 gradually decreases toward the base end where the central section 64 is located. The pitch P of the through holes 56 located in the second transition section 63 gradually decreases toward the tip end where the central section 64 is located. In other words, the pattern of the multiple through holes 56 located in the flexible section 52 is densely arranged in the central section 64 and gradually becomes sparser toward both ends in the axial direction from the central section 64. The bending rigidity of the flexible section 52 is low in the central section 64 where the pattern of the multiple through holes 56 is densely arranged, and high at both ends where the pattern is sparsely arranged.

[0029] The form of the through-holes 56 is not limited to this. For example, each of the multiple through-holes 56 arranged in the axial direction of the pipe body 50 may be part of a single spirally connected slit. That is, the circumferential end of each through-hole 56 communicates with the circumferential end of another axially adjacent through-hole 56, so that the multiple through-holes 56 form a single spirally connected slit. In this case, the circumferential end of each unit structure 57 is connected with the circumferential end of another axially adjacent unit structure 57, so that the multiple unit structures 57 form a single spirally connected structure.

[0030] Furthermore, as shown in Figure 4(B), each through-hole 56 may be formed in a straight, slit-like shape with an angle of less than 360 degrees, without meandering.

[0031] As shown in Figures 1, 2, and 4, the first marker portion 54 is an X-ray contrast-enhanced member provided between the flexible portion 52 and the tip of the needle portion 100. The second marker portion 55 is an X-ray contrast-enhanced member provided on the proximal end side of the flexible portion 52. The first marker portion 54 and the second marker portion 55 are arranged, for example, as a ring-shaped member extending 360 degrees or a strip-shaped member with less than 360 degrees on the outer circumferential surface of the tubular portion 50 or the needle portion 100. For example, the first marker portion 54 and the second marker portion 55 are formed with a width of 1 mm in the axial direction, but the dimensions of the first marker portion 54 and the second marker portion 55 are not limited. Alternatively, the first marker portion 54 and the second marker portion 55 may be constructed by forming part or all of the tubular portion 50 or the needle portion 100 from an X-ray contrast-enhanced material. The X-ray contrast-enhanced component may be formed from an X-ray contrast-enhanced metal such as platinum, gold, barium sulfate, or bismuth oxide, or from a resin containing at least one of these.

[0032] The materials and shapes of the first marker portion 54 and the second marker portion 55 may or may not be the same.

[0033] The needle portion 100 is formed, for example, by cutting the tip of the tubular portion 50 at an angle. The needle portion 100 has a sealing member 101 positioned inside so as to close the lumen 51, which extends from the tubular portion 50, at the tip side of the flexible portion 52. The needle portion 100 does not necessarily have to have the sealing member 101. In this case, the lumen 51 opens at the needle portion 100. The material of the sealing member 101 is not particularly limited and may be metal or resin.

[0034] The puncture performance of the needle portion 100 improves as the needle tip becomes sharper. However, as the needle tip becomes sharper, the length of the needle tip increases, and the possibility of unintended tissue damage also increases. Therefore, it is preferable to set the needle tip angle θ, which is the angle of the tip of the needle portion 100, to an angle that reduces the possibility of unintended tissue damage while maintaining puncture performance.

[0035] The shape of the needle portion 100 is not particularly limited as long as it can puncture living tissue, and may be, for example, conical, knife-shaped, or shovel-shaped. The cross-sectional shape of the needle portion 100 does not have to be circular. The needle portion 100 may also be an electrode or the like that can emit energy such as electromagnetic waves or heat to the extent that it can perforate tissue. In this case, the needle portion 100 does not have to be sharp.

[0036] The first reinforcing tube 70 is a tubular member that covers the tip of the flexible part 52, sandwiching the tip of the flexible part 52 and covering it from the tip end to the base end. The first reinforcing tube 70 distributes the stress generated at the tip of the flexible part 52, which is the starting point (or ending point) of processing, when the puncture device 10 is used, thereby reducing the possibility of the tubular part 50 bending. The first reinforcing tube 70 may or may not cover the first marker part 54.

[0037] The second reinforcing tube 80 is a tubular member that covers the base end of the flexible part 52, sandwiching the base end of the flexible part 52 and covering it from the tip end to the base end. The second reinforcing tube 80 distributes the stress generated at the base end portion, which is the processing end point (or processing start point) of the flexible part 52, when the puncture device 10 is used, thereby reducing the possibility of the tubular body portion 50 bending. The second reinforcing tube 80 may or may not cover the second marker portion 55.

[0038] The material of the first reinforcing tube 70 and the second reinforcing tube 80 is not particularly limited, but resins such as polyimide can be preferably used.

[0039] As shown in Figures 2 and 3, the support tube 90 is a tubular member that covers and tightly seals the base end of the tube portion 50. The support tube 90 prevents the puncture device 10 from bending when it is inserted into the catheter 200. The material of the support tube 90 is not particularly limited, but metals such as stainless steel or resins such as polyimide can be suitably used.

[0040] The tip of the lancing device 10 may have a protective tube 21 that covers the flexible part 52, the first marker part 54, the second marker part 55, the first reinforcing tube 70, and the second reinforcing tube 80 together, as shown in the modified example in Figure 5. The protective tube 21 prevents the first marker part 54, the second marker part 55, the first reinforcing tube 70, and the second reinforcing tube 80 from falling off, thereby suppressing the retention of foreign matter in the body during the procedure. When the lancing device 10 has a protective tube 21, the drug solution cannot be released from the through hole 56 of the flexible part 52, so for example, the needle part 100 does not have a sealing member 101. This allows the drug solution to be released to the outside from the tip opening of the needle part 100. Alternatively, the lancing device 10 may have a protective tube 21 and a sealing member 101, and a hole may be formed in the side wall of the needle part 100 that is on the tip side of the protective tube 21 and on the proximal side of the sealing member 101, penetrating from the lumen 51 to the outer surface. Alternatively, the lancet 10 may include a protective tube 21 and a sealing member 101, wherein a hole is formed in the protective tube 21 that penetrates from the inner surface to the outer surface, and this hole communicates with the through hole 56.

[0041] As shown in Figures 1-3, the hub portion 30 is a part to which a syringe or the like can be connected for supplying a drug solution. The lumen of the hub portion 30 is in communication with the lumen 51 of the tubular portion 50.

[0042] The constituent material of the tubular body 50 is preferably somewhat hard, and suitable metals such as stainless steel, tantalum, titanium, platinum, gold, tungsten, cobalt-chromium, and nickel-titanium can be used.

[0043] The operating unit 40 has a first operating unit 41 to which the hub unit 30 is fixed, and a second operating unit 42 to which the hub of the catheter 200 can be connected.

[0044] The first operating section 41 has an outer cylinder 43 that houses the second operating section 42 so as to be movable in the axial direction. The outer cylinder 43 has an internal threaded portion 44 formed on its inner circumferential surface.

[0045] The second operating section 42 includes an inner cylinder 45 positioned inside the outer cylinder 43, and a connector 46 fixed to the tip of the inner cylinder 45 and capable of connecting the hub of the catheter 200. The connector 46 has a female thread that can be screwed onto a male thread formed on the outer circumferential surface of the hub of the catheter 200. The inner cylinder 45 has a male threaded portion 47 formed on its outer circumferential surface, which the female threaded portion 44 of the outer cylinder 43 screws onto. In addition, a scale 48 arranged axially is formed on the outer circumferential surface of the inner cylinder 45. The scale 48 can be compared with the position of the tip of the outer cylinder 43. The operator can connect the hub of the catheter 200 to the connector 46 and rotate the first operating section 41 relative to the second operating section 42, thereby rotating the female threaded portion 44 of the outer cylinder 43 that screws onto the male threaded portion 47 of the inner cylinder 45, and moving the first operating section 41 axially relative to the second operating section 42. This allows the puncture shaft 20 connected to the first operating unit 41 to be rotated and moved axially relative to the catheter 200 connected to the second operating unit 42. As the first operating unit 41 moves axially relative to the second operating unit 42, the operator can accurately recognize the amount of protrusion of the needle portion 100 from the tip of the catheter 200 by visually determining the position of the scale 48 which coincides with the position of the tip of the outer cylinder 43.

[0046] The configuration of the operating section 40 is not limited. For example, as shown in the modified example in Figure 6, the operating section 40 has a first operating section 110 to which the hub section 30 is fixed, and a second operating section 120 to which the hub of the catheter 200 can be connected. The first operating section 110 has a guide rail 111 that holds the second operating section 120 so as to be movable in the axial direction, a rack 112 having a plurality of teeth arranged in the axial direction, and a mark 113 displayed on the outer surface.

[0047] The second operating section 120 includes a sliding section 121 that can slide axially along the guide rail 111 of the second operating section 120, a rotating operating section 122 which is a worm gear rotatably positioned on the sliding section 121 and meshes with a rack 112, and a connector 123 fixed to the tip of the sliding section 121 to which the hub of the catheter 200 can be connected. In addition, a scale 124 arranged in the axial direction is formed on the outer surface of the sliding section 121. The scale 124 can be compared with the position of the mark 113 on the first operating section 110. The operator can move the first operating section 110 axially relative to the second operating section 120 by connecting the hub of the catheter 200 to the connector 123 and rotating the rotating operating section 122 with their fingers, thereby moving the rack 112 that meshes with the rotating operating section 122. At this time, the puncture shaft 20 does not rotate. As the first operating unit 110 moves axially relative to the second operating unit 120, the operator can visually determine the position of the scale 124 that coincides with the position of the marker 113, thereby accurately recognizing the amount of protrusion of the needle portion 100 from the tip of the catheter 200.

[0048] Next, an example of using the puncture device 10 according to the embodiment will be explained with reference to the flowchart shown in Figure 11.

[0049] As shown in Figures 7, 8, and 9(A), the surgeon inserts the sheath 210 percutaneously into a blood vessel (step S1), and guides the tip of the sheath 210 to reach a cardiac chamber 306 (e.g., the right atrium 301) or a blood vessel (e.g., the superior vena cava 302), for example, through the inferior vena cava 300. Next, the surgeon inserts the catheter 200 into the lumen of the sheath 210, and guides the tip of the catheter 200 to protrude from the tip of the sheath 210 and reach a predetermined position (step S2). At this time, the surgeon positions the tip of the catheter 200 at a puncture site X within the cardiac chamber 306 or blood vessel, from which the puncture instrument 10 can access the pericardial cavity 305 located between the two pericardium 303 that constitute the pericardial sac. Preferably, the puncture site X is a position where the pericardial cavity 305, which is the target of the approach, is wide and easy to access with the puncture instrument 10. For example, the target pericardial cavity 305 is preferably located between the superior vena cava 302 and the right atrial appendage 307. In this case, the puncture site X is located in the superior vena cava 302. However, the target pericardial cavity 305 of the approach is not particularly limited. Therefore, the puncture site X may be located in the heart rather than in a blood vessel.

[0050] Next, as shown in Figure 9(A), the surgeon tents the heart wall toward the pericardial cavity 305 at the puncture site X by pressing the tip of the catheter 200 (step S3). As a result, the heart wall is locally compressed while generating a repulsive force (tenting state).

[0051] Next, the operator connects a syringe to the hub portion 30 of the puncture device 10 and primes the puncture device 10 with the drug solution in the syringe. Next, as shown in Figure 9(B), the operator inserts the puncture device 10 into the lumen of the catheter 200 (step S4). While confirming the position of the first marker portion 54 using an X-ray image, the operator manipulates the puncture device 10 to move it toward the tip while tenting the inner wall of the blood vessel or the inner wall of the heart with the catheter 200. Then, as shown in Figure 10(A), the operator punctures the inner wall of the blood vessel or the inner wall of the heart with the needle portion 100 until the first marker portion 54 reaches the inner wall of the pericardial cavity 305 using an X-ray image (step S5). By confirming that the first marker portion 54 has reached the inner wall of the pericardial cavity 305, the operator can easily recognize that the needle portion 100 beyond the tip of the first marker portion 54 has reached the inner wall of the pericardial cavity 305. At this point, the second marker portion 55 has not yet reached the pericardial cavity 305. The operator may determine the amount of protrusion of the needle portion 100 from the catheter 200 using the scales 48 and 124 on the control unit 40. After the needle portion 100 reaches the pericardial cavity 305, the operator releases the tenting by the catheter 200 (step S6).

[0052] Next, the operator confirms the position of the second marker portion 55 using an X-ray image and manipulates the puncture instrument 10 to move it toward the tip. This causes the flexible portion 52 to protrude from the catheter 200, pass through the inner wall of the punctured blood vessel or the inner wall of the heart, and reach the pericardial cavity 305 (step S7). The operator can easily recognize that the flexible portion 52 has reached the pericardial cavity 305 by confirming that the second marker portion 55 has reached the pericardial cavity 305 using an X-ray image. The flexible portion 52, having protruded from the catheter 200, loses its support from the catheter 200 and becomes easily bendable. That is, until the flexible portion 52 is exposed to the outside of the catheter 200, the force pushing on the needle portion 100 is transmitted to the needle tip, but once the flexible portion 52 is exposed from the catheter 200, the flexible portion 52 cannot withstand the pushing force and bends, and the pushing force is not transmitted to the needle tip of the needle portion 100. As a result, the needle portion 100 loses its puncture ability, and accidental punctures can be suppressed. This prevents the needle portion 100 from advancing too far and penetrating the outer pericardium 303, allowing for safe and easy access to the pericardial cavity 305.

[0053] Next, the operator manipulates the syringe to push out the drug solution inside (step S8). The drug solution passes through the lumen 51 of the lancing device 10 and is released to the outside through the slit-shaped through-hole 56 of the flexible part 52 located in the pericardial cavity 305. If the lumen 51 is open at the tip of the needle portion 100, the needle portion 100, which is located further forward than the easily deformable flexible part 52, may move in a wobbly manner due to the force exerted by the drug solution passing through it. Furthermore, if the lumen 51 is open at the tip of the needle portion 100, the exit of the lumen 51 is easily blocked by the tip of the needle portion 100 coming into contact with biological tissue. However, since the needle portion 100 is sealed by the sealing member 101 and the drug is released in the flexible part 52, the movement of the needle portion 100 due to the fluid force of the drug solution can be suppressed, thereby improving safety. Furthermore, since the lumen 51 communicates with the outside through the through-hole 56 of the flexible part 52 rather than at the tip of the needle part 100, it is possible to prevent the exit of the lumen 51 from being blocked. Note that the needle part 100 may also be open at its tip without having a sealing member 101.

[0054] After administering the drug, the operator operates the control unit 40 to move the puncture shaft 20 proximal to the catheter 200. This causes the flexible portion 52 and needle portion 100, which protrude from the catheter 200 toward the tip, to be housed in the catheter 200. Next, the operator removes the puncture device 10 from the catheter 200. Alternatively, the operator may remove the puncture device 10 together with the catheter 200 from the sheath 210.

[0055] <Evaluation test of needle outer diameter using animal experiments> The total axial length of the puncture shaft 20 is 1000 mm, the outer diameter of the needle portion 100 is 0.41 mm, the axial length of the flexible portion 52 is 20 mm, the pitch P of the through holes 56 is 0.15 mm, and the number of cycles (the number of unit structures 57 of the flexible portion 52) is 134. An animal experiment was conducted using the puncture device 10. In the test, pigs were used as animals, and puncture was performed based on the method shown in FIG. 11. In the test, the tester inserted the puncture device 10 from the lower limb vein and punctured from the back of the right auricle 307 of the superior vena cava 302. After the tester performed the puncture, the heart was opened and observed.

[0056] As a result, a puncture hole was observed in the superior vena cava 302, but no blood was found to be mixed in the pericardial fluid of the pericardium.

[0057] <In Vitro needle outer diameter evaluation test> As shown in FIG. 12, a silicone sheet with a thickness of 0.5 mm was used as the puncture target, and tests were performed with a plurality of specimens having needle portions 100 with different outer diameters. The specimens used in the test had a simple structure without a flexible portion. The test device 400 could increase the pressure using an FT expander as a pressurizing means, maintain the pressure by bringing the O-ring 402 into contact with the silicone sheet 401, and measure the pressure with a pressure gauge. In the test, after the pressure was increased to 200 mmHg, the needle portion 100 was vertically punctured into the silicone sheet 401 and then pulled out, and the pressure reduction rate (%) when the pressure measured by the pressure gauge reached a steady state was calculated.

[0058] As a result, as shown in FIG. 13, there was a slight difference between the result of an outer diameter of 0.5 mm and the result of an outer diameter of 0.4 mm, which was equivalent to the outer diameter of 0.41 mm with no liquid leakage in the needle outer diameter evaluation test by the above animal experiment, but there was no significant difference. Therefore, if the outer diameter of the needle portion 100 is 0.5 mm or less, the average value of the pressure reduction rate is 50% or more, and it is considered that the possibility of bleeding when the needle portion 100 punctures the pericardial cavity 305 can be sufficiently reduced.

[0059] <Flexure radius measurement test and puncture performance evaluation test> Multiple specimens were created, each having a needle portion 100, a flexible portion 52, and a base portion 53, with variations in the pitch P and cycle number (number of unit structures 57) of the flexible portion 52. Each specimen was then subjected to a bending radius measurement test and a puncture performance evaluation test.

[0060] In the bending radius measurement test, as shown in Figure 14, the base 53 was positioned vertically so that the tip of each specimen faced upward, and the bending radius R at which the flexible part 52 bent naturally under no load, with only gravity acting on it, was measured. The radius of curvature R was measured at the position where the radius of curvature R of the flexible part 52 was smallest. Note that the smaller the radius of curvature R and the longer the axial length of the flexible part 52, the higher the flexibility of the flexible part 52.

[0061] In the puncture performance evaluation test, while holding the base 53 of each specimen, the needle portion 100 was moved toward a 0.5 mm thick silicone sheet 501 positioned perpendicular to the needle portion 100, and it was measured whether the needle portion 100 could puncture the silicone sheet 501.

[0062] Three of the samples had pitches P of 0.15 mm, 0.30 mm, and 0.45 mm, and a common cycle count of 100. Three of the samples also had a common pitch P of 0.3 mm, with cycle counts of 25, 50, and 100. One of the samples had a pitch P of 0.15 mm and a cycle count of 134. The axial length of the flexible portion 52 in each sample is the value obtained by multiplying the pitch P by the cycle count.

[0063] Table 1 shows the results of the flexion radius measurement test and the puncture evaluation test.

[0064] [Table 1]

[0065] As shown in Table 1, the results from a sample with 100 cycles and a sample with a pitch P of 0.3 mm confirmed that the bending radius R is affected by the pitch P, while the number of cycles has almost no effect.

[0066] Furthermore, the results of the puncture performance evaluation test confirmed that it is preferable for the axial length of the flexible portion 52 to be 20 mm or more in order to disable the puncture function of the needle portion 100. While the flexible portion 52 becomes more flexible with longer axial lengths, if it is too long, insertion into the limited space of the pericardial cavity 305 and drug administration become difficult. Therefore, it was determined that a maximum length of approximately 50 mm is preferable. Accordingly, it was determined that the axial length of the flexible portion 52 is preferably between 20 mm and 50 mm, and more preferably between 20 mm and 45 mm. This reliably reduces the possibility of the needle portion 100 puncturing and damaging the pericardium 303 or surrounding tissues while the flexible portion 52 protrudes from the catheter 200 and is exposed to the outside, while also reducing the required length of insertion of the puncture shaft 20 into the pericardial cavity 305.

[0067] Furthermore, based on the results of three samples that showed no puncture force in the puncture performance evaluation test, it was determined that the axial length of the flexible portion 52 should be between 20 mm and 45 mm, and the bending radius should be less than 17 mm. This makes the flexible portion 52 more flexible, and more reliably reduces the possibility of puncturing and damaging the pericardium 303 or surrounding tissues with the needle portion 100.

[0068] <Evaluation test of needle inner diameter> A test was conducted to evaluate the inner diameter of the needle portion 100 using four samples, each consisting of a cylindrical tube without a needle tip or flexible part, with an axial length of 1000 mm and inner diameters of 0.10 mm, 0.17 mm, 0.25 mm, and 0.35 mm.

[0069] The test involved administering 20 ml of medication by manually pumping a 5 ml syringe four times. The results are shown in Table 2.

[0070] [Table 2]

[0071] As a result, with a needle with an inner diameter of 0.1 mm, the injection resistance was too high and administration was not possible. The same was true for a needle with an inner diameter of 0.17 mm. With a needle with an inner diameter of 0.25 mm, the injection resistance was slightly high but administration was possible, and with a needle with an inner diameter of 0.35 mm, the injection resistance was not high and administration was possible. Therefore, it was determined that a needle inner diameter of 0.25 mm or more is preferable. However, when administering only a small amount of drug solution, the needle inner diameter may be less than 0.25 mm. For example, when administering only a small amount of drug solution using a syringe with a capacity of 1 ml, administration is possible even with a needle inner diameter of 0.1 mm.

[0072] <Needle tip angle evaluation test> A test was conducted to evaluate the needle tip angle θ using six samples, each consisting of a circular tube equipped with a needle portion 100 but without a flexible portion, with an axial length of 1000 mm and needle tip angles θ of 15 degrees, 30 degrees, 50 degrees, 60 degrees, 75 degrees, and 85 degrees.

[0073] In the needle tip angle evaluation test, simulating actual use, each specimen was inserted into catheter 200 with its tip bent at a 90-degree angle. A 0.5 mm thick silicone sheet was then placed in contact with the tip of catheter 200, and the specimen alone was moved towards the tip to attempt puncture of the silicone sheet. The results are shown in Table 3. [Table 3]

[0074] As shown in Table 3, the puncture performance of the needle portion 100 improved as the needle tip angle θ became smaller and sharper. However, with the smallest needle tip angle θ of 15 degrees, the needle tip of the needle portion 100 caught on the inner wall of the catheter 200, hindering its passage. Even with a needle tip angle θ of 15 degrees, the needle could pass through the catheter 200 if the tip of the catheter 200 was bent at approximately 30 degrees.

[0075] It was confirmed that the needle portion 100 can puncture the silicone sheet if the needle tip angle θ is between 15 and 75 degrees. However, it was confirmed that if the tip is acute, the needle tip may rub against the inner wall of the catheter 200 as it passes through the catheter 200, potentially damaging the catheter 200. Also, if the needle tip is too obtuse, puncture may not be possible if the correct puncture angle (insertion angle) cannot be secured inside the body. Based on the above, it was determined that a needle tip angle θ of 30 degrees or more and 60 degrees or less is preferable.

[0076] As described above, the lancing device 10 according to this embodiment comprises a long, metal tubular body 50, a needle portion 100 provided at the tip of the tubular body 50, and a hub portion 30 provided at the base end of the tubular body 50 to which a syringe can be connected. The tubular body 50 has a lumen 51 extending from the base end to the tip, a flexible portion 52 provided at the tip on the base end side of the needle portion 100, an X-ray opaque first marker portion 54 provided between the flexible portion 52 and the tip of the needle portion 100, and an X-ray opaque second marker portion 55 provided on the base end side of the flexible portion 52. The flexible portion 52 has a slit-shaped through-hole 56 that penetrates the side wall of the tubular body 50 and communicates the lumen 51 with the outside, and has lower bending rigidity than the portion adjacent to the flexible portion 52 and the needle portion 100. As a result, the puncture device 10 has a flexible portion 52 on its tubular body 50, allowing for the activation / deactivation of the needle function depending on the protrusion length from the catheter 200 (delivery device) into which the puncture device 10 is inserted, thereby reducing the possibility of unintended tissue damage such as the pericardium 303. Furthermore, since the puncture device 10 has radiopaque marker portions on both the tip and proximal ends of the flexible portion 52, it is possible to confirm under radiographic contrast that the needle portion 100 and the flexible portion 52 have reached the target position. Therefore, the puncture device 10 can reliably position the drug release portion located on the tip of the flexible portion 52 or further forward than the flexible portion 52 at the target position, reducing the possibility of accidental injection of drug into unintended tissue.

[0077] Furthermore, the flexible portion 52 has a first transition portion 62 in which the bending rigidity decreases from the tip towards the base end of the flexible portion 52, and a second transition portion 63 in which the bending rigidity decreases from the base end towards the tip end of the flexible portion 52. As a result, the bending rigidity of the flexible portion 52 decreases from both sides in the axial direction toward the center, so that the bending of the flexible portion 52 changes smoothly in the axial direction, and damage to the pipe portion 50 due to stress concentration can be suppressed.

[0078] Furthermore, in the first transition section 62, the pattern of through holes 56 becomes sparser towards the tip of the flexible section 52, and in the second transition section 63, the pattern of through holes 56 becomes sparser towards the base end of the flexible section 52. As a result, the bending rigidity of the flexible section 52 of the puncture device 10 can be easily and freely adjusted by the pattern of the through holes 56.

[0079] Furthermore, the lancing device 10 includes a first reinforcing tube 70 that covers at least the tip of the first transition portion 62, and a second reinforcing tube 80 that covers at least the base end of the second transition portion 63. This distributes the stress generated between the flexible portion 52 and the portion adjacent to the flexible portion 52 during operation of the lancing device 10, thereby suppressing excessive bending or damage to the tubular portion 50.

[0080] Furthermore, the axial length of the flexible portion 52 is between 20 mm and 50 mm. This allows the puncture device 10 to reduce the length required for insertion into the pericardial cavity 305 while reliably reducing the possibility of damaging the pericardium 303 or surrounding tissues with the needle portion 100 when the flexible portion 52 is exposed.

[0081] Furthermore, the axial length of the flexible portion 52 is between 20 mm and 45 mm, and the minimum bending radius R at which the flexible portion 52 bends naturally due to gravity when the proximal end of the tubular portion 50 is positioned vertically above the flexible portion 52 so that the tip of the tubular portion 50 faces upward is less than 17 mm. As a result, the puncture device 10 has a more flexible flexible portion 52, which reliably reduces the possibility of damaging the pericardium 303 or surrounding tissues with the needle portion 100.

[0082] Furthermore, the outer diameter of the tubular body 50 is 0.50 mm or less, the inner diameter of the tubular body 50 is 0.25 mm or more, and the wall thickness of the tubular body 50 is 0.025 mm or more. As a result, the puncture device 10 reduces the possibility of bleeding from the punctured tissue by having an outer diameter of 0.50 mm or less of the tubular body 50, while allowing the administration of drug solution through the lumen 51 of the tubular body 50 by having an inner diameter of 0.25 mm or more. In addition, the wall thickness of the tubular body 50 is 0.025 mm or more, which allows the needle portion 100 used for puncture to maintain its strength as a needle tube. When the puncture hole formed during puncture is formed from a blood vessel into the pericardial cavity 305, the outer diameter of the tubular body 50 is 0.50 mm or less, which reduces the possibility of cardiac tamponade occurring due to blood flowing into the pericardial cavity 305 through the puncture hole.

[0083] Furthermore, the needle tip angle θ of the needle portion 100 is between 15° and 75°. This allows the lancet device 10 to have good puncture functionality in the needle portion 100.

[0084] Furthermore, the treatment method in this embodiment involves preparing a puncture device 10 comprising a long, metal tube portion 50, a needle portion 100 provided at the tip of the tube portion 50, and a hub portion 30 provided at the proximal end of the tube portion 50 to which a syringe can be connected. The tube portion 50 is inserted transvascularly into the cardiac chamber 306, and under X-ray contrast, the tube portion 50 is advanced to puncture the cardiac wall with the needle portion 100 from within the cardiac chamber 306 toward the pericardial chamber 305. At the same time, the first marker portion 54 provided at the tip of the tube portion 50 is inserted into the pericardial chamber 305, and the tube portion 50 is advanced further toward the proximal end of the tube portion beyond the first marker portion 54. A flexible portion 52 having a slit-shaped through-hole 56 that penetrates the side wall of the portion 50 and connects the lumen 51 of the tubular portion 50 to the outside is inserted into the pericardial cavity 305. When the flexible portion 52 is curved within the pericardial cavity 305 and the second marker portion 55 provided on the tubular portion 50 proximal to the flexible portion 52 is positioned adjacent to the heart wall, the advancement of the tubular portion 50 is stopped, and a drug solution is administered into the pericardial cavity 305 or drained from the pericardial cavity 305 from a syringe connected to the hub portion 30 through the lumen 51 extending from the proximal end to the tip of the tubular portion 50 and the through-hole 56 of the flexible portion 52. As a result, because the treatment method uses a tubular portion 50 with a flexible portion 52, it is possible to switch between enabling and disabling the needle function depending on the protrusion length from the catheter 200 (delivery device) into which the puncture device 10 is inserted, thereby reducing the possibility of unintended damage to tissues such as the pericardium 303. Furthermore, since the treatment method uses a tubular portion 50 having radiopaque marker portions at both the tip and proximal ends of the flexible portion 52, it is possible to confirm under X-ray contrast that the needle portion 100 and the administration portion of the flexible portion 52 have reached the target position. Therefore, the treatment method can reliably position the drug-releasing site located at the tip of the flexible portion 52 or the flexible portion 52 at the target position, reducing the possibility of accidental injection of the drug into unintended tissue.

[0085] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention. For example, the use of the lancing device 10 is not limited to the administration of drug solutions. For example, the lancing device 10 may be used to administer liquids other than drug solutions (e.g., physiological saline solution) or to drain fluids (e.g., body fluids, etc.) from the pericardial cavity 305. [Explanation of symbols]

[0086] 10 Puncture device 20 puncture shafts 30 Hub section 50 Tube section 51 lumens 52 Flexible parts 53 Base 54 First Marker Section 55 Second Marker Section 56 Through hole 57 Unit Structure 62. First Transition Section 63 Second Transition Section 70 First reinforcing tube 80 Second reinforcing tube 90 Support tube 100 needle section 101 Sealing member 200 catheters (delivery devices) 305 Pericardial cavity 306 Heart chamber X puncture position θ Needle tip angle

Claims

1. It comprises a long, metal tubular section, a needle section provided at the tip of the tubular section, and a hub section provided at the base end of the tubular section to which a syringe can be connected. The tube portion has a lumen extending from the base end to the tip, a flexible portion provided at the tip on the base end side of the needle portion, an X-ray opaque first marker portion provided between the flexible portion and the tip of the needle portion, and an X-ray opaque second marker portion provided on the base end side of the flexible portion. The puncture device is characterized in that the flexible portion has a slit-shaped through-hole that penetrates the side wall of the tubular portion and connects the lumen to the outside, and has lower bending rigidity than the portion adjacent to the flexible portion and the needle portion.

2. The puncture device according to claim 1, characterized in that the flexible portion has a first transition portion in which the bending rigidity decreases from the tip to the base end of the flexible portion, and a second transition portion in which the bending rigidity decreases from the base end to the tip end of the flexible portion.

3. In the first transition section, the pattern of the through holes becomes sparser toward the tip of the flexible section. The puncture device according to claim 2, characterized in that the pattern of through holes in the second transition portion becomes sparser toward the base end of the flexible portion.

4. The puncture device according to claim 2 or 3, characterized by having a first reinforcing tube covering at least the tip of the first transition portion and a second reinforcing tube covering at least the base end of the second transition portion.

5. The puncture device according to claim 1 or 2, characterized in that the axial length of the flexible portion is 20 mm or more and 50 mm or less.

6. The axial length of the flexible part is 20 mm or more and 45 mm or less. The puncture device according to claim 5, characterized in that when the portion on the proximal end side of the flexible portion is positioned vertically above the flexible portion so that the tip side of the tubular portion faces upward, the bending radius at which the flexible portion bends naturally due to gravity is less than 17 mm.

7. The puncture device according to claim 1 or 2, characterized in that the outer diameter of the tubular body is 0.50 mm or less, the inner diameter of the tubular body is 0.25 mm or more, and the wall thickness of the tubular body is 0.025 mm or more.

8. The puncture device according to claim 1 or 2, characterized in that the needle tip angle of the needle portion is 15° or more and 75° or less.

9. A puncture device is prepared, comprising a long, metal tubular section, a needle section provided at the tip of the tubular section, and a hub section provided at the base end of the tubular section to which a syringe can be connected. The aforementioned tubular portion is inserted transvascularly into the heart chamber, Under X-ray contrast, the tube is advanced, and the needle portion is used to puncture the heart wall from the heart chamber toward the pericardial cavity, while the first marker portion provided at the tip of the tube is inserted into the pericardial cavity. The tubular portion is further advanced, and a flexible portion having a slit-shaped through-hole that penetrates the side wall of the tubular portion and connects the lumen of the tubular portion to the outside is inserted into the pericardial cavity, on the proximal end side of the first marker portion. With the flexible portion curved within the pericardial cavity, and the second marker portion provided on the tubular portion proximal to the flexible portion positioned adjacent to the heart wall, the forward movement of the tubular portion is stopped. A treatment method comprising administering fluid into the pericardial cavity or draining fluid from the pericardial cavity, from a syringe connected to the hub portion, through a lumen extending from the base end to the tip of the tubular portion and the through-hole of the flexible portion.

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