JP2024050301A - Device for puncturing blood vessel walls - Google Patents

Abstract

[Problem] When inserting a puncture needle into a blood vessel wall, the puncture needle is held more stably than in the prior art. [Solution] The blood vessel wall puncture device includes an expandable/contractable section that can expand and contract in the radial direction of the blood vessel, and a tube that houses the puncture needle so that it can freely protrude and retract from the tip of the tube, and is directly or indirectly engaged with the expandable/contractable section. [Selected Figure] Figure 1B

Description

The present invention relates to a device for puncturing a blood vessel wall.

Patent document 1 describes an invention in which a needle is inserted into the blood vessel wall in conjunction with the expansion and contraction of a balloon attached to a catheter.

Patent document 2 describes an invention in which a blood vessel wall puncture member is delivered from a catheter body to puncture a blood vessel, and a delivery catheter is advanced through the lumen of the blood vessel wall puncture member toward an extravascular target site.

Patent document 3 describes an invention in which a balloon is inflated to press the penetrating means against the blood vessel wall, causing the penetrating means to penetrate the blood vessel wall.

U.S. Pat. No. 6,302,870 JP 2004-528062 A U.S. Pat. No. 5,681,281

When inserting the needle into the blood vessel wall, it is necessary to hold the needle steadily.

If the needle is not held stably during insertion, it may deviate from the intended needle path or fail to accurately puncture the target.

In addition, there is a need to better prevent blood from leaking out of the blood vessel from the insertion site after the puncture needle has been inserted.

There is also a need to insert the puncture needle without stopping the blood flow in the blood vessel.

The first objective of the present invention is to enable the puncture needle to be held more stably than in conventional techniques when inserting the puncture needle into the blood vessel wall.

The second objective of the present invention is to be able to better prevent blood from leaking out of the blood vessel from the insertion site after the puncture needle is inserted into the blood vessel wall compared to conventional techniques.

The third objective of the present invention is to make it possible to insert a puncture needle into a blood vessel wall without stopping the flow of blood within the blood vessel, as compared to conventional techniques.

The first aspect is a device for puncturing a blood vessel wall, comprising an expansion/contraction section capable of expanding and contracting in the radial direction of the blood vessel, and a tube for accommodating a puncture needle so that the puncture needle can be freely inserted and removed from the tip of the tube, the tube being directly or indirectly engaged with the expansion/contraction section.

The second aspect is a blood vessel wall puncture device in which a hemostatic member is provided at the contact site of the expansion/contraction section that contacts the blood vessel wall in response to the expansion of the diameter of the expansion/contraction section.

The third aspect is a blood vessel wall puncture device according to the first aspect, in which the expansion/contraction section is formed with a communication hole for communicating blood in the direction of flow within the blood vessel.

The fourth aspect is a blood vessel wall puncture device in which a gap is formed between the expansion/contraction section and the blood vessel wall in the first aspect to allow blood to communicate in the direction of flow within the blood vessel.

The fifth aspect is a device for puncturing a blood vessel wall, in which the expansion/contraction section is a flexible mesh structure that can expand and contract radially in response to its axial contraction and expansion, respectively.

The sixth aspect is a blood vessel wall puncture device in the fifth aspect, which is provided with an operating unit that causes the expansion/contraction unit to contract and expand in the axial direction.

The seventh aspect is a blood vessel wall puncture device according to the fifth aspect, in which the expansion/contraction section has communication holes formed as meshes of the network structure to allow blood to communicate in the direction of flow within the blood vessel.

The eighth aspect is a blood vessel wall puncture device according to the seventh aspect, in which the mesh density at the contact site of the expansion/contraction section is greater than the mesh density at the other site of the expansion/contraction section.

The ninth aspect is a device for puncturing a blood vessel wall, comprising an expansion/contraction section capable of expanding and contracting in the radial direction of the blood vessel, a tube for housing a puncture needle so that the puncture needle can be freely inserted and withdrawn from the tip of the tube, the tube being directly or indirectly engaged with the expansion/contraction section, and a hemostatic member provided at a contact site of the expansion/contraction section that contacts the blood vessel wall in response to the expansion.

The tenth aspect is a blood vessel wall puncture device that includes an expansion/contraction section that can expand and contract in the radial direction of the blood vessel, a puncture needle that engages directly or indirectly with the expansion/contraction section, and a hemostatic member provided at a contact site of the expansion/contraction section that contacts the blood vessel wall in response to the expansion.

The eleventh aspect is a blood vessel wall puncture device according to the ninth aspect, in which at least a portion of the enlarged diameter portion where the hemostatic member is provided is radiopaque.

The twelfth aspect is a blood vessel wall puncture device according to the tenth aspect, in which at least a portion of the enlarged diameter portion where the hemostatic member is provided is radiopaque.

The thirteenth aspect is a blood vessel wall puncture device according to the ninth aspect, in which the expansion/contraction section includes a mesh structure, and communication holes for communicating blood in the flow direction within the blood vessel are formed as meshes of the mesh structure, and the density of the mesh at the contact site of the expansion/contraction section is greater than the density of the mesh at sites of the expansion/contraction section other than the contact site.

The fourteenth aspect is a blood vessel wall puncture device according to the tenth aspect, in which the expansion/contraction section includes a mesh structure, and communication holes for communicating blood in the flow direction within the blood vessel are formed as meshes of the mesh structure, and the density of the mesh at the contact site of the expansion/contraction section is greater than the density of the mesh at sites of the expansion/contraction section other than the contact site.

The fifteenth aspect is any one of the first to fourteenth aspects, in which at least a portion of the puncture needle or the tube is a device for puncturing a blood vessel wall that is radiopaque.

According to the first to fifteenth aspects, the puncture needle can be held more stably when inserted into the blood vessel wall compared to conventional techniques.

According to the second and ninth to fourteenth aspects, when inserting a puncture needle into a blood vessel wall, leakage of blood from the insertion site to the outside of the blood vessel after the puncture needle is inserted can be better suppressed compared to conventional techniques.

According to the third to eighth aspects and the thirteenth and fourteenth aspects, when inserting the puncture needle into the blood vessel wall, it is possible to insert the puncture needle without stopping the blood flow within the blood vessel, as compared to conventional techniques.

FIG. 1A is a diagram showing the overall configuration of a blood vessel wall puncture device. FIG. 1B is a diagram showing the overall configuration of a vascular wall puncture device. FIG. 2A is a partially enlarged view of FIG. 1A. FIG. 2B is a partially enlarged view of FIG. 1B. FIG. 3 is an enlarged view of the tube and the puncture needle. FIG. 4 is a flow chart showing the procedure of the process of the vascular wall puncture method. FIG. 5 is a view corresponding to FIG. 1B and illustrates an embodiment in which the mesh density of the contact portion of the mesh structure that contacts the blood vessel wall is greater than the mesh density of the tapered portion 127. FIG. 6 is a view corresponding to FIG. 1B, showing an embodiment in which the portion where the puncture needle engages with the expansion/contraction portion coincides with the contact portion where the puncture needle contacts the blood vessel wall. FIG. 7A is a view corresponding to FIG. 1B, showing an embodiment in which the expansion/contraction section comprises a self-expanding stent. FIG. 7B is a view corresponding to FIG. 1B, showing an embodiment in which the expansion section comprises a self-expanding stent. FIG. 8A is a view corresponding to FIG. 1B, showing an embodiment in which the expansion/contraction section is configured to be expanded/contracted by a balloon. FIG. 8B is a cross-sectional view of FIG. 8A. FIG. 8C is a perspective view of the balloon shown in FIG. 8A. FIG. 8D is a cross-sectional view showing another embodiment in which the expansion/contraction portion is configured to be expanded and contracted by a balloon. FIG. 9 is a diagram illustrating a method of fixing a tube to the balloon shown in FIG. 8A.

The following describes an embodiment of a device for puncturing a blood vessel wall.

Figures 1A and 1B show the overall configuration of the blood vessel wall puncture device.

The blood vessel wall puncture device 100 of this embodiment is broadly composed of a catheter 110, an expansion/contraction section 120, a puncture needle 130, a tube 140, and an operation section 150. Note that the blood vessel wall puncture device of the present invention only needs to include at least one of the puncture needle 130 and the tube 140, and does not necessarily need to include both the puncture needle 130 and the tube 140. In addition, the blood vessel wall puncture device of the present invention does not necessarily need to include the operation section 150.

(catheter)

The catheter 110 is formed in a size and shape that allows it to be inserted into the blood vessel 10. The catheter 110 is formed from a material, such as a synthetic resin, that is flexible enough to move along the curved blood vessel 10. The catheter 110 has an outer diameter that allows it to be inserted into the blood vessel 10, and is formed in a circular cross-sectional shape with an inner diameter that allows the operation wire 151 and tube 140 of the operation unit 150 to be inserted.

The base end 114 of the catheter 110 can be operated to push, pull, and rotate the catheter 110.

(Zoom section)

The expansion/contraction section 120 has its rear end 122 fixed to the tip 112 of the catheter 110 so that its longitudinal central axis is coaxial with the longitudinal central axis 110C of the catheter 110. The expansion/contraction section 120 is configured to be capable of expanding and contracting in the radial direction 10A of the blood vessel 10, i.e., in a direction perpendicular to the axial direction. The expansion/contraction section 120 has multiple holes 120M formed therein to allow blood to flow in the flow direction 10B within the blood vessel 10. The expansion/contraction section 120 is cylindrical, and the holes 120M communicate with each other via its internal space. This allows blood to pass through the expansion/contraction section 120 when it is expanded.

The catheter 110 and the expansion/contraction portion 120 of the present invention do not necessarily have to be fixed as in this embodiment. For example, as described later in Figures 7A and 7B, the catheter 110 may have a lumen into which the expansion/contraction portion 120 can be inserted, and the expansion/contraction portion 120 may be expanded by pushing the expansion/contraction portion 120 out of the lumen of the catheter 110 placed in the blood vessel 10. In the embodiment shown in Figure 7A, it is desirable to insert a composite in which the expansion/contraction portion 120 and the tube 140 are engaged with each other outside the patient's body into the lumen of the catheter 110.

1A and 1B, the expansion/contraction section 120 includes a flexible mesh structure 121 that can expand and contract in the radial direction 110A in response to contraction and expansion in the axial direction 110B of the catheter 110. In this embodiment, holes 120M for communicating blood with the flow direction 10B in the blood vessel 10 are formed as meshes of the mesh structure 121. The entire expansion/contraction section 120 in this embodiment is composed of the mesh structure 121. However, the holes 120M for passing blood may be provided in at least a part or all of the tapered portion 127 that is angled with respect to the flow direction 10B of the blood in the blood vessel 10 (i.e., the axial direction 110B of the catheter 110). In other words, at least a part or all of the part of the expansion/contraction section 120 that is inclined with respect to the flow direction 10B of the blood in the blood vessel 10 (i.e., the axial direction 110B) may be composed of the mesh structure 121.

The material for the mesh structure 121 can be, for example, a shape memory alloy such as a nickel-titanium alloy or a superelastic alloy.

Figures 2A and 2B show enlarged views of the adjacent portion 126' adjacent to the vascular wall 11 and the abutment portion 126 abutting against the vascular wall 11 of the expansion/contraction portion 120 shown in Figures 1A and 1B, respectively.

As shown in Figures 1B and 2B, the contact portion 126 of the surface 120S of the expansion/contraction portion 120 or the mesh structure 121 that contacts the vascular wall 11 is the portion that forms the largest diameter of the expansion/contraction portion 120 or the mesh structure 121 when expanded. As shown in Figure 1B, the length of the contact portion 126 along the axial direction 110B is defined as the effective length L. The expansion/contraction portion 120 or the mesh structure 121 has tapered portions 127 that decrease in diameter toward the tip portion 123 and the rear end portion 122, sandwiching the contact portion 126 that contacts the vascular wall 11.

As shown in FIG. 2B, a hemostatic member 125 is provided at the contact portion 126 of the surface 120S of the expansion/contraction portion 120 or the mesh structure 121, which contacts the vascular wall 11 in response to at least the expansion. As in the embodiment, the hemostatic member 125 may be provided across the tapered portion 127. For example, a resin layer having hemostatic properties, such as PTFE (polytetrafluoroethylene) or polyurethane, is supported as the hemostatic member 125 at the contact portion 126 of the surface 120S of the mesh structure 121, which contacts the vascular wall 11. Also, a film having a resin layer having hemostatic properties on its outer surface may be wrapped around the outside of the contact portion 126 of the mesh structure 121.

The expansion force for expanding the expansion/contraction section 120 is desirably set from the viewpoint of being able to withstand the reaction force from the blood vessel wall 11 when the puncture needle 130 is inserted (particularly the reaction force of a vector perpendicular to the blood vessel wall 11) and to provide sufficient expansion force to provide stability for the insertion operation. For example, the expansion force at at least one point of the expansion/contraction section 120 with a diameter of 5 to 15 mm can be set in the range of 1 kPa to 3000 kPa. The lower limit of the expansion force can be specifically set to 1.5 kPa, 2 kPa, 3 kPa, or 5 kPa. The upper limit of the expansion force can be specifically set to 2800 kPa, 2500 kPa, 2000 kPa, or 1500 kPa.

The frictional force between the expansion/contraction section 120 and the blood vessel wall 11 is desirably set from the viewpoint of providing a frictional force sufficient to withstand the reaction force from the blood vessel wall 11 when the puncture needle 130 is inserted (particularly the reaction force of a vector parallel to the blood vessel wall 11) and to provide stability to the insertion operation. The frictional force can be set in the range of 0.1 N to 10 N for the artificial blood vessel model "Eve" (manufactured by Finebio Co., Ltd.). The lower limit of the frictional force can be set specifically to 0.2 N, 0.3 N, 0.5 N, or 1 N. The upper limit of the frictional force can be set specifically to 9 N, 8 N, 6 N, or 5 N.

From the viewpoint of safely providing sufficient expansion force to provide stability during insertion, the effective length L of the expansion/contraction portion 120 or the mesh structure 121 can be set to 1 mm or more, preferably 3 mm or more, or 5 mm or more. When the portion corresponding to the effective length L of the expansion/contraction portion 120 or the mesh structure 121 also serves as the hemostatic member 125, it is desirable to set the effective length L from the viewpoint of ease of hemostasis (e.g., ease of the procedure of covering the insertion site (puncture hole) 13 of the blood vessel wall 11 with the hemostatic member 125). The effective length L of the expansion/contraction portion 120 or the mesh structure 121 can be preferably set to 8 mm or more, or 10 mm or more. On the other hand, considering that an excessive effective length L of the expansion/contraction portion 120 or the mesh structure 121 may reduce the operability of the blood vessel wall puncture device 100, the effective length L of the expansion/contraction portion 120 or the mesh structure 121 can be set to 50 mm or less, preferably 30 mm or less, or 20 mm or less.

The contact area 126 where the expansion/contraction section 120 contacts the vascular wall 11 contributes to expansion force and hemostasis, while the tapered area 127 contributes to the ease of blood flow. For this reason, it is desirable that the contact area 126 of the expansion/contraction section 120 where the expansion/contraction section 120 contacts the vascular wall 11 has a larger thickness of the struts 120T that form the network structure 121 and/or a larger density of the mesh (holes, mesh) 120M of the network structure 121 than the tapered area 127.

Specifically, the ratio of the strut thickness and mesh density of the contact portion 126 to the strut thickness and mesh density of the tapered portion 127 can be set independently to 1.1 times or more, preferably 1.5 times or more, or 2.0 times or more for the strut thickness and mesh density when not expanded. The upper limit of the ratio of the strut thickness and mesh density of the contact portion 126 to the strut thickness and mesh density of the tapered portion 127 is not particularly limited, but can be set to 5.0 times, 4.0 times, or 3.0 times from the viewpoint of mass production.

Figure 5 corresponds to Figure 1B. Figure 5 illustrates an embodiment of the blood vessel wall puncture device 100 in which the mesh (holes, mesh 120M) density of the contact portion 126 of the mesh structure 121 that contacts the blood vessel wall 11 is set to be greater than the mesh (holes, mesh 120M') density of the tapered portion 127.

However, without being limited to this embodiment, the strut thickness and/or mesh density of the contact portion 126 that contacts the vascular wall 11 may be made equal to the strut thickness and/or mesh density of the tapered portion 127. In this case, in order to ensure sufficient hemostasis regardless of the strut thickness and mesh density of the tapered portion 127, it is desirable to wrap a film having a resin layer with hemostatic function on its outer surface around the outside of the contact portion 126 of the mesh structure 121.

In order to suppress positional deviation during the expansion and contraction process of the hemostasis site or puncture site within the blood vessel 10, it is desirable for the shortening ratio of the expansion and contraction section 120 to be low. The shortening ratio is defined as the maximum value/shortest value of the overall length of the expansion and contraction section 120. The shortening ratio of the expansion and contraction section 120 can be set to 1 to 5 times, preferably 1 to 1.5 times. The shortening ratio of the expansion and contraction section 120 can be adjusted by the taper angle φ of the tapered section 127, mesh density, etc. Figure 5 shows the taper angle φ of the tapered section 127. The taper angle φ of the tapered section 127 can be set in the range of 5 to 80°. In addition, the mesh density of the tapered section 127 can be set in the range of 2 pieces/cm^2 to 15 pieces/cm^2.

At least a portion of the expansion/contraction section 120 where the hemostatic member 125 is provided may be X-ray opaque. This allows the hemostatic member 125 in the blood vessel 10 to be easily seen on an X-ray fluoroscopic image. This allows the operation of covering the insertion site (puncture hole) 13 of the puncture needle 130 with the hemostatic member 125 to be easily performed.

The radiopaque material may be coated around the entire circumference of the struts 120T of the expansion/contraction section 120, or it may be coated around only a portion of the circumference of the struts 120T. In either case, the portion of the struts 120T coated with the radiopaque material can be made radiotransparent.

The portion of the expansion/contraction section 120 that is X-ray opaque may have a certain length (e.g., 1 mm or more) or may be dot-shaped (e.g., less than 1 mm).

In addition, the membrane wrapped around the outside of the contact portion 126 of the mesh structure 121, i.e., the membrane having a resin layer with hemostatic properties on its outer surface, may contain an X-ray impermeable material.

The maximum diameter of the contact area 126 that contacts the vascular wall 11 can be set appropriately so that an appropriate expansion force is applied to the vascular wall 11 depending on the region of the blood vessel 10 in which the vascular wall puncture device 100 is used. The maximum diameter of the contact area 126 that contacts the vascular wall 11 can be set to 3 mm to 15 mm when used in the brain region, and can be set to 3 mm to 20 mm when used in the abdominal region.

The expansion/contraction section 120 of this embodiment passively expands and contracts by contraction and extension in the axial direction 110B by the operation section 150 described later. However, without being limited to this, the expansion/contraction section 120 may be configured as a self-expanding stent and expanded and contracted by self-expandability, as exemplified in Figures 7A and 7B. In cases where the expansion/contraction section 120 is configured as a self-expanding stent, the operation section 150 is not necessarily required.

Also, as illustrated in Figures 8A, 8B, 8C, and 8D, the expansion/contraction section 120 may be configured using a balloon 129 instead of a mesh structure 121. The expansion/contraction section 120 can be expanded and contracted in diameter in response to the introduction and discharge of fluid into and from the internal space of the balloon 129.

(puncture needle)

Figures 2A and 2B show enlarged views of the tip 131 of the puncture needle 130 shown in Figures 1A and 1B, respectively.

The puncture needle 130 is made of a material and has a shape that allows it to be inserted into and removed from the blood vessel wall 11. The puncture needle 130 is also made of an elastically deformable material, such as stainless steel or a nickel-titanium alloy.

Depending on the medical purpose, the puncture needle 130 can eject any material from its tip, place a member at its tip, or provide a member at its tip that can protrude. For example, gel-like substances or cells (stem cells, T cells, IPS cells, etc.) can be ejected from the tip of the puncture needle 130, and optical fibers that irradiate visible light, X-rays, radiation, etc., fibers for heating, cooling, or electricity, sensors that detect pH, temperature, etc., stents, stent grafts, guide wires, coils, catheters for draining bodily fluids (cerebrospinal fluid, ascites, etc.), etc. can be placed at the tip of the puncture needle 130 or provided so as to protrude from the tip of the puncture needle 130.

For example, as shown in FIG. 3, the puncture needle 130 is configured in a ring shape containing a drug injection path 133 for drug injection purposes. The puncture needle 130 has a puncture needle tip 131 formed in a shape having a bevel surface 132.

The base end 134 of the puncture needle 130 is connected to a handle 135 in a manner that allows the puncture needle 130 to be pushed, pulled, and rotated. The drug injection path 133 of the puncture needle 130 is connected to a syringe 136 for drug injection.

The outer diameter of the puncture needle 130 can be set to 2.11 mm to 0.1 mm, preferably 0.51 mm to 0.31 mm, taking into consideration the balance between elastic deformation, insertion performance, and ease of engagement with the mesh structure 121.

As shown in FIG. 2B, the engagement point 128 where the puncture needle 130 engages with the expansion/contraction section 120 can be set within 10 mm along the axial direction 110B from the abutment site 126 where the puncture needle 130 abuts against the vascular wall 11. This allows the puncture point 13 of the vascular wall 11 where the puncture needle 130 is inserted to be located at the position where the hemostatic member 125 abuts or in a position nearby. Therefore, after the puncture needle 130 is removed, the hemostatic member 125 can be easily and quickly positioned at the puncture point 13 of the vascular wall 11.

The engagement point 128 where the puncture needle 130 engages with the expansion/contraction section 120 may be either a position corresponding to the abutment site 126 that abuts against the vascular wall 11 or a distal or proximal side of the abutment site 126. When the engagement point 128 is aligned with a position corresponding to the abutment site 126 that abuts against the vascular wall 11, it is desirable from the viewpoint of preventing blood leakage when the puncture needle 130 is inserted. However, compared to when the engagement point 128 is positioned distal or proximal to the abutment site 126, there is a risk that a void (a hole through which the puncture needle 130 penetrated) in the hemostatic member 125 will remain after insertion. Therefore, there is a risk that blood will leak from this void in the hemostatic member 125. For this reason, it is desirable to move the hemostatic member 125 slightly after insertion to shift the void from the puncture site 13, or to remove the tube 140 and the puncture needle 130 to eliminate the void in the hemostatic member 125.

Figure 6 corresponds to Figure 1B. Figure 6 shows an embodiment in which the engagement point 128 where the puncture needle 130 engages with the expansion/contraction portion 120 coincides with the abutment portion 126 where the puncture needle 130 abuts against the blood vessel wall 11.

At least a portion of the puncture needle 130 (preferably within a range of about 100 mm from the tip of the puncture needle 130) may be X-ray opaque. This allows the puncture site 13 of the vascular wall 11 to be visually confirmed on an X-ray fluoroscopic image. This simplifies the operation of covering the puncture site 13 with the hemostatic member 125.

(Tube)

Returning to Figures 1A and 1B, the tube 140 is arranged along the catheter 110. The tube 140 is inserted into the insertion passage 111 in the catheter 110. The tube 140 houses the puncture needle 130 so that it can freely protrude and retract from the tube tip 141.

The tube 140 is made of a flexible material, such as synthetic resin, so that it can change position along the curved blood vessel 10 together with the catheter 110. The tube 140 has an outer diameter that allows it to be inserted into the insertion passage 111, and is formed into a circular cross-sectional shape with an inner diameter that allows the puncture needle 130 to be inserted.

The tube tip 142 of the tube 140 is attached to the expansion/contraction section 120 so that it can be moved in a direction 10A1 toward the blood vessel wall 11 as the expansion/contraction section 120 expands, and in a direction 10A2 away from the blood vessel wall 11 as the expansion/contraction section 120 contracts.

The tube 140 may be directly or indirectly engaged with the expansion/contraction section 120. Here, "directly" means that the tube 140 is engaged with the expansion section 120 so as to be able to protrude from the surface 120S of the expansion/contraction section 120. Also, "indirectly" means that the tube 140 is not capable of protruding from the surface 120S of the expansion/contraction section 120, but is engaged with the expansion/contraction section 120 so as to be able to protrude from the gap between the expansion/contraction section 120 and the catheter 110, or that the tube 140 is engaged with the expansion/contraction section 120 so as to be able to protrude from the gap between the expansion/contraction section 120 and the telescopic operation member 153.

In an embodiment in which the vascular wall puncture device 100 does not include a tube 140, the puncture needle 130 can be directly or indirectly engaged with the expansion/contraction section 120 in a similar manner. This allows the puncture needle 130 to move in a direction 10A1 approaching the vascular wall 11 as the expansion/contraction section 120 expands, and in a direction 10A2 away from the vascular wall 11 as the expansion/contraction section 120 contracts.

Figure 7B shows an embodiment in which the tube 140 is indirectly engaged with the expansion/contraction portion 120.

The blood vessel wall puncture device 100 shown in FIG. 7B has a lumen into which the expansion/contraction portion 120 can be inserted into the catheter 110, and the expansion/contraction portion 120 is expanded in diameter by pushing the expansion/contraction portion 120 out of the lumen of the catheter 110 placed in the blood vessel 10. The tube 140 moves toward the blood vessel wall 11 through the gap between the expansion/contraction portion 120 and the catheter 110 while engaging with the surface 120S of the expansion/contraction portion 120.

The method of engagement of the tube 140 with the expansion/contraction section 120 is preferably by fastening. However, the method of engagement is not limited to fastening, and the tube 140 may simply be engaged so that it is difficult for it to come off the mesh 120M of the network structure 121.

As shown in FIG. 2B, the engagement point 128 where the tube 140 engages with the expansion/contraction section 120 can be set within 10 mm along the axial direction 110B from the contact site 126 where the tube 140 contacts the blood vessel wall 11. This allows the insertion point 13 of the blood vessel wall 11 where the puncture needle 130 is inserted to be positioned at or near the position where the hemostatic member 125 contacts.

The engagement point 128 where the tube 140 engages with the expansion/contraction section 120 may be a position corresponding to the abutment site 126 that abuts against the vascular wall 11, or may be either distal or proximal to the abutment site 126. If the engagement point 128 is aligned with a position corresponding to the abutment site 126 that abuts against the vascular wall 11, this is desirable from the viewpoint of preventing blood leakage when the puncture needle 130 is inserted. However, compared to when the engagement point 128 is located distal or proximal to the abutment site 126, there is a risk that a void (a hole through which the tube 140 penetrated) in the hemostatic member 125 may remain after insertion.

In addition, from the viewpoint of making it easier to design the puncture angle θ small, it is desirable to position the engagement point 128 on the distal side of the abutment site 126. On the other hand, when a balloon 129 is used in the expansion/contraction section 120 as shown in Figures 8A, 8B, 8C, and 8D, it is desirable to position the engagement point 128 on the proximal side of the abutment site 126 from the viewpoint of preventing the tube 140 from interfering with the balloon 129.

The outer diameter of the tube 140 can be set to a range of 1.2 mm to 0.2 mm, preferably 0.6 mm to 0.3 mm, in consideration of the balance between elastic deformation and ease of engagement with the mesh structure 121.

At least a portion of the tube 140 (preferably within about 100 mm from the tip of the puncture needle 140) may be X-ray opaque. This allows the vicinity of the puncture site 13 in the blood vessel wall 11 to be easily visualized on an X-ray fluoroscopic image. This simplifies the operation of covering the puncture site 13 with the hemostatic member 125.

The puncture angle θ illustrated in FIG. 2B is preferably close to 90°, since it is easier to prevent the insertion site 13 from shifting. The puncture angle θ may be set to 80° or less, from the viewpoints of design freedom and operability during delivery and retrieval. When the tip of the puncture needle 130 is to penetrate the blood vessel wall 11, the puncture angle θ can be set to 5° or more, preferably 15° or more. When the tip of the puncture needle 130 is to puncture into the blood vessel wall 11, the puncture angle θ can be set in the range of 0.5 to 10°, preferably in the range of 3 to 8°.

In this way, the tube 140 is directly or indirectly engaged with the expansion/contraction section 120, so that the puncture needle 130 can be inserted into the blood vessel wall 11 while the tube tip 142, which is the base of the puncture needle 130, is stably held.

Figures 7A and 7B are views corresponding to Figure 1B. Figures 7A and 7B show an embodiment in which the expansion/contraction section 120 includes a self-expanding stent.

A pusher wire 160 is fixed to the rear end 122 of the expansion/contraction section 120. The expansion/contraction section 120 is inserted into the catheter 110 in a reduced diameter state. The pusher wire 160 is inserted into the catheter 110 together with the expansion/contraction section 120, and its rear end is operably connected to a handle (not shown) outside the catheter 110. The expansion/contraction section 120 can be moved forward and backward relative to the catheter 110 by using this handle to push the pusher wire 160 forward and backward relative to the catheter 110.

When the catheter 110 is positioned at the target site in the blood vessel 10, the expansion/contraction section 120 is moved forward so as to be released outward from the tip 112 of the catheter 110, and the tube 140 is moved forward so as to be released outward from the tip 112 of the catheter 110. This causes the expansion/contraction section 120 to expand in diameter due to its self-expanding properties, and the tube 140 moves toward the blood vessel wall 11 while engaging with the surface 120S of the expansion/contraction section 120. As a result, the expansion/contraction section 120 abuts against the target site of the blood vessel wall 11, and the tube tip 141 of the tube 140 abuts against the target site of the blood vessel wall 11.

In the embodiment shown in FIG. 7A, it is preferable to insert the composite in a state where the tube 140 is directly engaged with the expansion/contraction portion 120 outside the patient's body into the lumen of the catheter 110. The tube 140 is inserted through the mesh 120M of the tapered portion 127 of the expansion/contraction portion 120 toward the inside 120V of the expansion/contraction portion 120, and further inserted through the mesh 120M of the abutment portion 126 of the expansion/contraction portion 120 toward the outside. The tube 140 is inserted into the same lumen as the lumen into which the pusher wire 160 is inserted. Note that in an embodiment in which the vascular wall puncture device 100 does not include the tube 140, it is preferable to insert the composite in a state where the puncture needle 130 is directly engaged with the expansion/contraction portion 120 outside the patient's body into the lumen of the catheter 110 in a similar manner.

Figure 8A is a view corresponding to Figure 1B and shows an embodiment in which the expansion/contraction section 120 is configured to be expanded and contracted by a balloon 129.

Figure 8B shows a cross-sectional view of Figure 8A.

Figure 8C shows a perspective view of the balloon 129 shown in Figure 8A.

Figure 8D is a cross-sectional view corresponding to Figure 8B, showing another embodiment in which the expansion/contraction section 120 is configured to be expanded and contracted by a balloon 129.

As shown in Figures 8A, 8B, and 8C, balloons 129, for example three balloons 129A, 129B, and 129C, are arranged at the tip 112 of the catheter 110 via a fluid introduction/extraction tube 129T. The fluid introduction/extraction tube 129T is inserted into the catheter 110. The balloons 129A, 129B, and 129C are arranged so that their longitudinal direction coincides with the axial direction 110B of the catheter 110. The balloons 129A, 129B, and 129C can be non-compliant balloons. Note that a non-compliant balloon is a high-pressure resistant balloon whose balloon diameter does not increase even if the pressure is increased above a certain inflation pressure.

The tube 140 is inserted through the central gap 129D between the balloons 129A, 129B, and 129C and the gap 129E between the balloons 129A and 129B at the top of the figure. The tube 140 is disposed in the central gap 129D between the balloons 129A, 129B, and 129C and the gap 129E between the balloons 129A and 129B at the top of the figure so that the tube tip 141 faces the blood vessel wall 11 at the top of the figure. It is preferable that the tube tip 141 of the tube 140 is bent upward in advance or that the tube 140 has a structure that allows it to be bent upward.

The tube 140 is engaged with the balloon 129.

When using a balloon 129 in the expansion/contraction section 120, it is desirable to locate the engagement point 128 where the tube 140 engages with the expansion/contraction section 120 in a position where the tube 140 does not interfere with the balloon 129.

Figure 9 illustrates a method of engaging tube 140 with balloons 129A, 129B, and 129C shown in Figure 8A. Tube 140 is connected to balloon 129C at the bottom of the figure by connecting member 129F. Tube 140 is slidably inserted into insertion hole 129G of connecting member 129F. That is, tube 140 is slidable in axial direction 110B at engagement point 128, and can be moved in axial direction 110B in response to the expansion and contraction of balloons 129A, 129B, and 129C.

The balloon 129 can expand and contract in diameter by introducing and discharging a fluid, such as a contrast agent, into and from its internal space via a fluid introduction/discharge tube 129T.

In the embodiment shown in Figures 8A, 8B, and 8C, as shown in Figure 8B, for example, multiple (e.g., three) balloons 129A, 129B, and 129C are arranged at equal intervals in the circumferential direction within the cross section of the blood vessel 10, and each balloon 129A, 129B, and 129C expands and contracts in diameter within the cross section of the blood vessel 10. When the balloons 129A, 129B, and 129C expand in diameter, a gap 120M is formed between the balloons 129A, 129B, and 129C and the blood vessel wall 11. Therefore, when the expansion/contraction section 120 expands in diameter, blood can be communicated in the flow direction 10B within the blood vessel 10 through the gap 120M.

8A, 8B, and 8C, the vascular wall puncture device 100 may be configured not to include the tube 140. In this embodiment, the puncture needle 130 is engaged with the balloons 129A, 129B, and 129C.

Figure 8D shows another embodiment in which the expansion/contraction section 120 is formed from a single balloon 129H. The balloon 129H is formed in an arc shape with a notch 129I in cross section. As in the embodiment shown in Figures 8A, 8B, and 8C, the tube 140 is engaged with the balloon 129H, for example, via a connecting member 129F. Note that the puncture needle 130 may be engaged with the balloon 129H.

The balloon 129H expands and contracts within the cross section of the blood vessel 10. When the balloon 129H expands, a gap 120M of a shape and size corresponding to the shape and size of the notch 129I is formed between the balloon 129H and the blood vessel wall 11. Therefore, when the expansion/contraction section 120 expands, blood can be communicated in the flow direction 10B within the blood vessel 10 through the gap 120M.

(Operation section)

Returning to Figures 1A and 1B, the operation unit 150 causes the expansion/contraction unit 120 to contract and extend in the axial direction 110B of the catheter 110.

Figure 1A shows an expanded state in which the expansion/contraction section 120 is expanded in the axial direction 110B of the catheter 110. Figure 1B shows a contracted state in which the expansion/contraction section 120 is contracted in the axial direction 110B of the catheter 110.

The operating unit 150 includes an operating wire 151, an extension/retraction operating member 153, and a handle 155.

The telescopic operation member 153 is composed of a cylindrical member with an open rear end, and is positioned at the tip side of the expansion/contraction section 120.

The operation wire 151 is arranged in the extension/contraction operation member 153, the expansion/contraction section 120, and the catheter 110 so as to be coaxial with the longitudinal center axis of the extension/contraction operation member 153, the longitudinal center axis of the expansion/contraction section 120, and the longitudinal center axis 110C of the catheter 110. The operation wire 151 is inserted through the insertion passage 111 in the catheter 110.

The tip 123 of the expansion/contraction section 120 is fixed to the rear end 153B of the expansion/contraction operating member 153.

The operation wire 151 is fixed to the tip 153A of the telescopic operation member 153 in such a manner that the wire tip 152 penetrates and protrudes forward. The base end 154 of the operation wire 151 is connected to a handle 155 in such a manner that the operation wire 151 can be pushed and pulled. The wire tip 152 may be curved so as to function as a guide wire.

When it is desired to change the shape of the expansion/contraction section 120 from the extended state shown in FIG. 1A to the contracted state shown in FIG. 1B, the handle 155 is pulled in the direction 155A. This operation moves the operation wire 151 together with the expansion/contraction operation member 153 in the axial rearward direction 110B1 relative to the catheter 110. As a result, the expansion/contraction section 120 contracts in the axial rearward direction 110B1, and expands in diameter in the radial expansion direction 10A1 in response to the contraction.

As a result, the tube tip 142 is moved from the state shown in FIG. 2A to the state shown in FIG. 2B in the direction 10A1 approaching the blood vessel wall 11, and the tube tip 142 is clamped between the blood vessel wall 11 and the expansion/contraction section 120.

When the expansion/contraction section 120 contracts axially rearward 110B1, the mesh density of the contact area 126 of the expansion/contraction section 120 that contacts the blood vessel wall 11, i.e., the holes 120M, increases (regardless of whether or not it is operated by the operating section 150). In this state, the hemostatic member 125 provided at the contact area 126 contacts the blood vessel wall 11 at high density. This increases the hemostatic ability. When the expansion section 120 is expanded to its maximum diameter, the mesh density of the contact area 126 that contacts the blood vessel wall 11, i.e., the density of the holes 120M, can be set to 3/cm or more, preferably 10/cm or more.

When it is desired to change the shape of the expansion/contraction section 120 from the contracted state shown in FIG. 1B to the extended state shown in FIG. 1A, the handle 155 is operated in the pushing direction 155B. This operation moves the operation wire 151 together with the extension/contraction operation member 153 in the axial forward direction 110B2 relative to the catheter 110. As a result, the expansion/contraction section 120 is extended in the axial forward direction 110B2, and contracts in the diameter reduction direction 10A2 in response to the extension.

As a result, the tube tip 142 is moved in the direction 10A2 away from the blood vessel wall 11 from the state shown in FIG. 2B to the state shown in FIG. 2A.

(Method of puncturing blood vessel wall and administering medicine)

Figure 4 is a flowchart showing the processing steps of the vascular wall puncture method and drug administration method of the embodiment.

The vascular wall puncture method and drug administration method of the embodiment can be performed, for example, by a surgeon or a surgical machine based on an X-ray image. A CT device or the like may irradiate X-rays on a patient on a bed, perform CT (Computed Tomography), and obtain CT fluoroscopic images of each cross section inside the patient's body. The obtained CT fluoroscopic images are displayed on the display screen of a monitor device, and the vascular wall puncture device 100 is operated while viewing the CT fluoroscopic images displayed on the display screen. This is one example, and the method of obtaining images is arbitrary. An ultrasound image may be obtained, and the vascular wall puncture device 100 may be operated based on the ultrasound image displayed on the display screen.

(inserting catheter)

The catheter 110 of the vascular wall puncture device 100 is inserted into the blood vessel 10. For example, a sheath tube (not shown) can be inserted into the blood vessel 10 at an insertion position through the patient's skin, and the catheter 110 of the vascular wall puncture device 100 can be inserted into the blood vessel 10 through the sheath tube (step S1).

(Move the catheter to the desired location)

The vascular wall puncture device 100 is moved to the target position in the blood vessel 10. This operation can be performed in the usual manner, for example, by operating the catheter 110 in the direction 115A to push the base end 114 along a leading guide wire (not shown), the vascular wall puncture device 100 can be advanced to the target position within the blood vessel 10.

At this stage, it is desirable that the puncture needle 130 is not protruding from the tube 140. This makes it possible to prevent the puncture needle 130 from damaging the blood vessel wall 11 while the blood vessel wall puncture device 100 is moving. The puncture needle 130 may be inserted into the tube 140 before the catheter 110 is positioned at the target position, typically before the catheter 110 is inserted into the blood vessel 10, or after the catheter 110 is positioned at the target position.

In addition, when the operating section 150 is fixed to the catheter 110 as in the embodiment shown in Figures 1A and 1B, the wire tip 152 protrudes forward of the telescopic operating member 153, so that the wire tip 152 can also function as a guide wire that corresponds to the curvature of the blood vessel 10. In this case, the vascular wall puncture device 100 can be advanced to the target position while corresponding to the curvature of the blood vessel 10.

When the blood vessel wall puncture device 100 is moved along the blood vessel 10, the expansion/contraction section 120 is contracted in diameter, leaving a gap between it and the blood vessel wall 11. Blood can pass along this gap. This allows the blood vessel wall puncture device 100 to advance along the blood vessel 10 to the target position without impeding the flow of blood within the blood vessel 10.

When using a vascular wall puncture device 100 in which the catheter 110 and expansion/contraction portion 120 are not fixed, as shown in Figures 7A and 7B, after the catheter 110 is placed at the target position in the blood vessel 10, the expansion/contraction portion 120 is inserted into the lumen of the catheter 110 in a reduced diameter state and advanced, and then pushed out from the opening of the lumen (typically the distal end), thereby placing the expansion/contraction portion 120 at the target position.

It is desirable to insert the composite in which the expansion/contraction portion 120 and the tube 140 are engaged outside the body into the lumen of the catheter 110. This allows the tube 140 to be engaged with the expansion/contraction portion 120 at the intended engagement point at the target position. In an embodiment in which the vascular wall puncture device 100 does not include the tube 140, it is desirable to insert the composite in which the expansion/contraction portion 120 and the puncture needle 130 are engaged outside the body in a similar manner into the lumen of the catheter 110 (step S2).

(Expand the expansion section)

Returning to Figures 1A, 1B, 2A, and 2B, when the catheter 110 reaches the target position in the blood vessel 10, the expansion/contraction section 120 is expanded in the radial direction 10A of the blood vessel 10, and the tube tip 142 is moved in a direction 10A1 approaching the blood vessel wall 11.

In the state shown in Figures 1A and 2A, the handle 155 is pulled in the direction 155A. This operation moves the operation wire 151 together with the extension/retraction operation member 153 in the axial rearward direction 110B1 relative to the catheter 110. This causes the expansion/contraction section 120 to contract in the axial rearward direction 110B1, and expands in diameter in the radial expansion direction 110A1 in response to the contraction.

As a result, as shown in Figures 1B and 2B, the tube tip 142 is moved in a direction 10A1 approaching the vascular wall 11, and the tube tip 142 is clamped between the vascular wall 11 and the expansion/contraction section 120. Note that the catheter 110 may be rotated by performing an operation to rotate the base end 114 of the catheter 110, and adjusted so that it is positioned at a circumferential target portion of the vascular wall 11.

When using a blood vessel wall puncture device 100 in which the expansion/contraction section 120 has self-expanding properties as illustrated in Figures 7A and 7B, the expansion/contraction section 120 is released from the lumen of the catheter 110, causing the expansion/contraction section 120 to actively expand in diameter and come into contact with the blood vessel wall 11. When using a blood vessel wall puncture device 100 in which the expansion/contraction section 120 is configured with a balloon 129 as illustrated in Figures 8A, 8B, 8C, and 8D, introducing a fluid (typically a contrast agent) into the internal space of the expansion/contraction section 120 causes the expansion/contraction section 120 to expand in diameter and come into contact with the blood vessel wall 11.

When the expansion/contraction section 120 is expanded and in contact with the blood vessel wall 11, the hemostatic member 125 contacts the blood vessel wall 11 at high density. This makes it easier to increase the hemostatic ability. On the other hand, even when the expansion/contraction section 120 is in an expanded state, blood passes through the inside and outside of the holes 120M, which serve as the mesh of the network structure 121. This allows subsequent operations to be performed without impeding the flow of blood within the blood vessel 10 (step S3).

(inserting the needle)

1B and 2B, the puncture needle tip 131 of the puncture needle 130 is caused to protrude from the tube tip 141 and inserted into the blood vessel wall 11 toward the target site 12P outside the blood vessel wall 11. The handle 135 is operated in a pushing direction 135A to cause the puncture needle tip 131 of the puncture needle 130 to protrude from the tube tip 141. At this time, the handle 135 may be operated in a rotating direction to rotate the puncture needle tip 131 of the puncture needle 130. The operation of causing the puncture needle tip 131 of the puncture needle 130 to protrude from the tube tip 141 may be performed after the operation of expanding the diameter of the expansion/contraction portion 120 is completed, or may be performed simultaneously with the operation of expanding the diameter of the expansion/contraction portion 120.

As shown in FIG. 2B, the puncture needle 130 can be inserted into the blood vessel wall 11 while the tube tip 142, which is the base of the puncture needle 130, is stably held. This allows the tip of the puncture needle to be accurately positioned at the target site 12P outside the blood vessel wall 11. In this state, the syringe 136 is operated to inject the drug into the target site 12P outside the blood vessel wall 11 (step S4).

(Remove the needle)

When the drug injection is completed, the puncture needle tip 131 of the puncture needle 130 is inserted into the tube tip 141 and stored in the tube 140. The handle 135 is pulled in the direction 135B to store the puncture needle tip 131 of the puncture needle 130 in the tube 140 (step S5).

(Move the hemostatic device to the puncture hole)

The puncture hole 13 of the puncture needle 130 remains in the blood vessel wall 11 after the needle is removed, and blood may leak out. In the embodiment shown in Figures 1A and 1B, the puncture needle 130 may be engaged at a location of the expansion/contraction section 120 where the hemostatic member 125 is not provided. Therefore, when the needle is removed, the hemostatic member 125 may not cover the puncture hole 13. Therefore, in order to cover the puncture hole 13 more completely, it is desirable to move the hemostatic member 125 to the puncture hole 13 after the needle is removed.

In addition, from the viewpoint of protecting the blood vessel 10 from friction with the hemostatic member 125, the expansion/contraction section 120 may be reduced in diameter when moving to the puncture hole 13, and then expanded again after the movement. However, when the puncture needle 130 is engaged with the expansion/contraction section 120 near the hemostatic member 125 as in the embodiment shown in Figures 1A and 1B, the blood vessel 10 can be protected from friction with the hemostatic member 125 without reducing the diameter of the expansion/contraction section 120. This simplifies the operation of moving to the puncture hole 13 (step S6).

(Hemostasis using hemostatic devices)

The hemostatic member 125 is moved to the puncture hole 13, and the hemostatic member 125 is brought into contact with the puncture hole 13. Therefore, even if bleeding occurs when the puncture needle 130 is inserted, the hemostatic member 125 stops the bleeding (step S7).

(reducing the diameter of the expansion/contraction section)

The expansion/contraction section 120 is contracted in the radial direction 10A of the blood vessel 10, and the tube tip 142 is moved in a direction 10A2 away from the blood vessel wall 11.

Operate the handle 155 in the pushing direction 155B. This operation moves the operating wire 151, together with the extension/retraction operating member 153, axially forward 110B2 relative to the catheter 110. This causes the expansion/contraction section 120 to extend axially forward 110B2 and contract in diameter in the diameter contraction direction 110A2 in response to the extension.

As a result, as shown in Figures 1A and 2A, the tube tip 142 is moved in a direction 10A2 away from the blood vessel wall 11.

The operation of reducing the diameter of the expansion/contraction section 120 may be performed after the operation of storing the puncture needle tip 131 of the puncture needle 130 in the tube 140 has been completed, or may be performed simultaneously with the operation of storing the puncture needle tip 131 of the puncture needle 130 in the tube 140.

When using a blood vessel wall puncture device 100 in which the expansion/contraction section 120 has self-expanding properties as illustrated in Figures 7A and 7B, the expansion/contraction section 120 is retracted into the lumen of the catheter 110, causing the expansion/contraction section 120 to contract in diameter. When using a blood vessel wall puncture device 100 in which the expansion/contraction section 120 is composed of a balloon 129 as illustrated in Figures 8A, 8B, 8C, and 8D, the expansion/contraction section 120 is contracted in diameter by discharging fluid (typically contrast medium) from the internal space of the expansion/contraction section 120 (step S8).

(Move the catheter to the insertion position)

Returning to Figures 1A and 2A, the blood vessel wall puncture device 100 is moved to the insertion position with the puncture needle 130 submerged in the tube tip 142. By operating the base end 114 of the catheter 110 in the pulling direction 115B, the blood vessel wall puncture device 100 can be retracted along the blood vessel 10 to the insertion position.

Because the puncture needle 130 is submerged within the tube 140, it is possible to avoid the puncture needle 130 damaging the blood vessel wall 11 while the blood vessel wall puncture device 100 is moving.

When using the blood vessel wall puncture device 100 in which the catheter 110 and the expansion/contraction part 120 are not fixed as shown in Figs. 7A and 7B, the expansion/contraction part 120 is accommodated in the lumen of the catheter 110 in a reduced diameter state and retreated to the insertion position, and the expansion/contraction part 120 and the tube 140 are removed from the lumen. The removal may be performed in a one-step manner in which the composite in which the expansion/contraction part 120 and the tube 140 are engaged is removed, or in a two-step manner in which the expansion/contraction part 120 is removed after the tube 140 is removed. Note that even in an embodiment in which the blood vessel wall puncture device 100 does not include the tube 140, the removal may be performed in a one-step manner in which the composite in which the expansion/contraction part 120 and the puncture needle 130 are engaged is removed, or in a two-step manner in which the expansion/contraction part 120 is removed after the puncture needle 130 is removed (step S9).

(Remove the catheter)

The catheter 110 is then removed from the patient's body (step S10).

(Image capture method)

Next, we will explain the imaging method using the blood vessel wall puncture device 100 of the embodiment.

In the state shown in FIG. 1A, that is, at the stage where it is assumed that the vascular wall puncture device 100 has been completely moved to the target site, the X-ray opaque parts of the expansion/contraction portion 120 (particularly the hemostatic member 125), the tube 140 and/or the puncture needle 130 are imaged. This makes it possible to visually confirm the positional relationship between the expansion/contraction portion 120 (particularly the hemostatic member 125), the tube 140 and/or the puncture needle 130 and the target site 12P.

Next, in the state shown in FIG. 1B, that is, at the stage where it is assumed that the expansion section 120 has been expanded and the tip of the tube 140 (or the puncture needle 130) has been positioned near the blood vessel wall 11, the X-ray opaque parts of the expansion section 120 (particularly the hemostatic member 125), the tube 140 and/or the puncture needle 130 are imaged. This makes it possible to visually confirm or grasp with high accuracy the positional relationship between the site punctured by the puncture needle 130, the hemostatic site 125, and the target site 12P.

Next, after the needle is removed and after the hemostasis member 125 is moved to the puncture hole 13, an image of the X-ray opaque portion of the hemostasis member 125 is taken. This allows the positional relationship between the hemostasis member 125 and the puncture hole 13 to be visually confirmed, and the hemostasis status to be visually confirmed and understood with high accuracy.

In addition, at each of the above imaging stages, it is desirable to inject a contrast agent into the blood vessel 10 to visually confirm the state of the blood vessel course and blood leakage (hemostasis).

According to the imaging method using the blood vessel wall puncture device 100 of the embodiment, accurate operation can be performed with a small number of CT fluoroscopy images while checking the positional relationship between the X-ray opaque portion of the blood vessel wall puncture device 100, the target site 12P, and the puncture hole 13. This allows the CT fluoroscopy time to be reduced, and the patient's radiation exposure to be reduced.

100 Blood vessel wall puncture device 110 Catheter 120 Expanding/contracting portion 130 Puncture needle 140 Tube 142 Tube tip 11 Blood vessel wall

Claims (15)

An expansion/contraction section capable of expanding and contracting in the radial direction of a blood vessel;
a tube for accommodating a puncture needle so as to be freely projected and retracted from a tip of the tube, the tube being directly or indirectly engaged with the expansion/contraction section;
A device for puncturing a blood vessel wall comprising: a hemostatic member is provided at a contact portion of the expansion/contraction portion that contacts a blood vessel wall in response to the expansion;
The blood vessel wall puncture device according to claim 1. The expansion/contraction section is formed with a communication hole for communicating blood in the direction of blood flow within the blood vessel.
The blood vessel wall puncture device according to claim 1. A gap is formed between the expansion/contraction portion and the blood vessel wall to allow blood to flow in the direction of blood flow within the blood vessel.
The blood vessel wall puncture device according to claim 1. The expansion/contraction section includes a flexible mesh structure that can expand and contract in the radial direction in response to contraction and expansion in the axial direction,
The blood vessel wall puncture device according to claim 1. an operation unit that causes the expansion/contraction unit to perform a contraction operation and an extension operation in the axial direction;
The blood vessel wall puncture device according to claim 5 . In the expansion/contraction section, communication holes for communicating blood in the flow direction within the blood vessel are formed as meshes of the network structure.
The blood vessel wall puncture device according to claim 5. the mesh density at the contact portion of the expansion/contraction portion is greater than the mesh density at a portion of the expansion/contraction portion other than the contact portion;
The blood vessel wall puncture device according to claim 7. An expansion/contraction section capable of expanding and contracting in the radial direction of a blood vessel;
a tube for accommodating a puncture needle so as to be freely projected and retracted from a tip of the tube, the tube being directly or indirectly engaged with the expansion/contraction section;
a hemostatic member provided at a contact portion of the expansion/contraction portion that contacts a blood vessel wall in response to the expansion;
A device for puncturing a blood vessel wall comprising: An expansion/contraction section capable of expanding and contracting in the radial direction of a blood vessel;
A puncture needle that is directly or indirectly engaged with the expansion/contraction portion;
a hemostatic member provided at a contact portion of the expansion/contraction portion that contacts a blood vessel wall in response to the expansion;
A device for puncturing a blood vessel wall comprising: The blood vessel wall puncture device according to claim 9, wherein at least a portion of the enlarged diameter portion where the hemostatic member is provided is X-ray impermeable. The blood vessel wall puncture device according to claim 10, wherein at least a portion of the enlarged diameter portion where the hemostatic member is provided is X-ray impermeable. The expansion/contraction section includes a mesh structure,
the network structure has a network of communicating holes for communicating blood in the direction of blood flow within the blood vessel;
a mesh density at the contact portion of the expansion/contraction portion is greater than a mesh density at a portion of the expansion/contraction portion other than the contact portion;
The blood vessel wall puncture device according to claim 9. The expansion/contraction section includes a mesh structure,
the network structure has a network of communicating holes for communicating blood in the direction of blood flow within the blood vessel;
the mesh density at the contact portion of the expansion/contraction portion is greater than the mesh density at a portion of the expansion/contraction portion other than the contact portion;
The blood vessel wall puncture device according to claim 10. The blood vessel wall puncture device according to any one of claims 1 to 14, wherein at least a portion of the puncture needle or the tube is X-ray opaque.