Medical tubular body transport device

Abstract

The present application provides a medical tubular body delivery device which can reliably release a medical tubular body without lowering the operability even when a proximal side is pulled by a pulling member in a state where the vicinity of the medical tubular body is bent. The medical tubular body delivery device is a device for delivering a medical tubular body into a body, and includes an outer tube in which the medical tubular body is disposed in an inner lumen, a pulling member connected to the outer tube and extending to a proximal side, an inner tube disposed in the inner lumen of the outer tube, and a cylindrical low-rigidity member disposed at a proximal end of the outer tube and having a rigidity lower than that of the outer tube.

Description

Technical Field

[0001] This invention relates to a medical tubular body transport device. Background Technology

[0002] In recent years, minimally invasive treatment techniques have been developed for transporting and placing medical tubular bodies into lesions within the body. Examples of medical tubular bodies include stents, stent grafts, occluders, infusion catheters, and artificial valves. Stents are generally used to treat various diseases caused by narrowing or occlusion of blood vessels or other biological lumens. In this technique, a transport device is used to transport the medical tubular body through the body's lumen and place it into the lesion. The transport device has an outer tube. While the medical tubular body is held within the lumen of this outer tube, it is transported through the body's lumen to the lesion. After transport, a traction member connected to the outer tube and extending proximally is pulled towards the proximal side, releasing the medical tubular body from the lumen of the outer tube and placing it into the lesion. Furthermore, in this specification, the surgeon's side of the medical tubular body transport device is designated as the proximal end, and the opposite side, i.e., the side closer to the lesion, is designated as the distal end.

[0003] Figure 1 This illustrates an example of an implementation of a conventional medical tubular body delivery device. Figure 1 This is a cross-sectional view of a medical tubular transport device, showing the distal side of the medical tubular transport device. Figure 1 The illustrated medical tubular body transport device includes: an outer tube 12 for housing a medical tubular body 11 within its lumen; a traction tube 14, located closer to the medical tubular body 11 than the medical tubular body 11, and forming part of the outer tube 12; and an inner tube 13, disposed within the lumen of the outer tube 12. The distal end of the inner tube 13 extends into the lumen of the distal contact 16. The proximal end of the inner tube 13 extends to the proximal end of the medical tubular body transport device (at the surgeon's hand), enabling the surgeon's hand-side manipulations to be transmitted via the inner tube 13 to the distal end of the medical tubular body transport device. A traction member 15 is connected to the traction tube 14, which is part of the outer tube 12, and extends proximally along the inner tube 13. By pulling the traction component 15 to the proximal side, the traction tube 14 and the outer tube 12 are pulled to the proximal side, and the medical tubular body 11 is pushed out from the inner lumen of the outer tube 12 into the inner lumen, released and placed in the lesion in the body.

[0004] For example, such medical tubular transport devices are disclosed in Patent Documents 1 to 3. Specifically, Patent Document 1 describes a telescopic catheter, characterized in that the telescopic catheter has an elongated tubular sheath made of a relatively soft material and a tension element for transmitting tensile force to the sheath and longitudinally introducing the sheath, the tension element having an end disposed within the relatively soft material, at least the thickness of the end being substantially thinner than its length.

[0005] Patent Document 2 describes a support device transfer system comprising: a support device; an outer sheath that covers the support device in a compact transfer configuration in the radial direction and is retractable to allow the support device to expand radially and move to an unfolded configuration; and a stretching member that stretches the outer sheath proximally and retracts it, wherein a portion of the outer sheath is radially thermally thermally contracted on the support member having the aforementioned heat-shrinkability in order to radially capture the distal portion of the stretching member between the outer sheath and a support member having the aforementioned heat-shrinkability.

[0006] Patent Document 3 describes a support device delivery system comprising: a support device; and an outer sheath that covers the support device in a compact delivery configuration in the radial direction of the support device and is retractable relative to the support device to allow the support device to expand radially to achieve an unfolded structure. The outer sheath includes a first layer and a reinforcing layer that are stacked on top of each other. A portion of a stretching member is mounted on the outer sheath by radially capturing the portion between the first layer and the reinforcing layer of the outer sheath.

[0007] Patent Document 1: Japanese Patent Publication No. 2012-510329

[0008] Patent Document 2: Japanese Patent Publication No. 2013-512705

[0009] Patent Document 3: Japanese Patent Publication No. 2013-512706

[0010] Such a medical tubular delivery device is inserted into a lumen within the body; however, due to the complex tortuosity of the lumen, the medical tubular delivery device also bends along with the tortuosity of the lumen. Therefore, as... Figure 1 As shown, when the traction component 15 is pulled towards the proximal side while the proximal end of the traction tube 14 is bent, the traction component 15... Figure 1 As shown by the dashed line 15, the line is straightened in the direction of being pulled. As a result, stress is concentrated at the closest position 15b in the connection between the traction component 15 and the traction tube 14, and the traction component 15 may sometimes detach from the traction tube 14. Summary of the Invention

[0011] The present invention was made in view of the above-mentioned situation, and its object is to provide a medical tubular body transport device that, even when the traction member is pulled to the proximal side while the medical tubular body is bent in the vicinity, the traction member will not detach from the outer tube, and the medical tubular body can be reliably released.

[0012] This invention includes the following inventions.

[0013] [1] A medical tubular body transport device is a device for transporting a medical tubular body into the body, characterized in that it comprises: an outer tubular body for the medical tubular body to be disposed in the inner cavity; a traction member connected to the outer tubular body and extending proximally; an inner tubular body disposed in the inner cavity of the outer tubular body; and a cylindrical low-rigidity member disposed at the proximal end of the outer tubular body and having a lower rigidity than the outer tubular body.

[0014] [2] According to the medical tubular transport device described in [1], when the pressing load on the outer tubular body is set as a and the pressing load on the cylindrical low-rigidity component is set as b, the ratio of load b to load a (b / a) is 20% to 85%.

[0015] [3] According to the medical tubular transport device described in [1] or [2], the aforementioned low-rigidity cylindrical component covers the proximal end of the aforementioned outer tubular body.

[0016] [4] According to the medical tubular transport device described in [3], the proximal end of the tubular low-rigidity component is closer to the side than the proximal end of the outer tube.

[0017] [5] According to the medical tubular transport device described in [1] or [2], the distal end of the aforementioned low-rigidity cylindrical component abuts against the proximal end of the aforementioned outer tube.

[0018] [6] According to the medical tubular transport device described in [5], the distal end of the aforementioned low-rigidity cylindrical component and the proximal end of the aforementioned outer tube are not compatible.

[0019] [7] The medical tubular transport device described in [5] or [6] has a cylindrical component that covers the proximal end of the outer tubular body and at least a portion of the traction component.

[0020] [8] According to the medical tubular transport device described in [7], the rigidity of the tubular component is lower than that of the outer tubular body.

[0021] [9] According to the medical tubular transport device described in [8], the rigidity of the tubular component is higher than that of the tubular low-rigidity component.

[0022]

[10] According to any one of [7] to [9], when the pressing load on the outer tube is set as a and the pressing load on the cylindrical component is set as c, the ratio of load c to load a (c / a) is 35% to 90%.

[0023]

[11] In any of the medical tubular transport devices described in [7] to

[10] , the proximal end of the tubular low-rigidity component is closer to the side than the proximal end of the tubular component.

[0024]

[12] According to any one of [1] to

[11] , the traction component is connected to the outer surface of the outer tube.

[0025]

[13] The medical tubular transport device described in any of [1] to

[12] is also connected to the traction component and the cylindrical low-rigidity component.

[0026]

[14] According to the medical tubular transport device described in

[13] , the traction component is connected to the outer surface of the tubular low-rigidity component.

[0027]

[15] The medical tubular transport device described in any of [1] to

[14] has an inner tubular body through which a guide wire is inserted.

[0028]

[16] The medical tubular transport device according to any one of [1] to

[15] has a protective tube in which at least the proximal end of the outer tube, the inner tube and the traction member are disposed in the inner cavity.

[0029]

[17] The medical tubular body transport device described in any of [1] to

[16] is a self-expanding stent.

[0030] The medical tubular transport device of the present invention has a cylindrical low-rigidity member with lower rigidity than the outer tubular body disposed at its proximal end. Therefore, when a traction member connected to the outer tubular body is pulled towards the proximal side while the outer tubular body, in which the medical tubular body is disposed within the lumen, is bent near the proximal end, the cylindrical low-rigidity member deforms significantly prior to the outer tubular body. The stress applied between the outer tubular body and the traction member is dispersed in the contact area between the traction member and the cylindrical low-rigidity member, thus preventing the traction member from easily detaching from the outer tubular body. Furthermore, because a cylindrical low-rigidity member with lower rigidity than the outer tubular body is disposed at its proximal end, the following ability of the outer tubular body relative to the bent inner tubular body is improved, preventing an increase in frictional resistance between the outer and inner tubular bodies. As a result, the outer tubular body can be easily pulled towards the proximal side. Attached Figure Description

[0031] Figure 1 This is a cross-sectional view illustrating an example of a distal-side implementation of a conventional medical tubular body delivery device.

[0032] Figure 2 This is a cross-sectional view showing a first embodiment of the medical tubular body transport device according to the present invention.

[0033] Figure 3 It's enlarged. Figure 2 The diagram shows the area near the connection point between the outer tube and the traction component.

[0034] Figure 4 This is a cross-sectional view showing a second embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the area near the connection position between the outer tube and the traction component.

[0035] Figure 5 This is a cross-sectional view showing a third embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the area near the connection position between the outer tube and the traction component.

[0036] Figure 6 This is a cross-sectional view showing the fourth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the area near the connection position between the outer tube and the traction component.

[0037] Figure 7 This is a cross-sectional view showing the fifth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the area near the connection position between the outer tube and the traction component.

[0038] Figure 8This is a cross-sectional view showing the sixth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the area near the connection position between the outer tube and the traction component.

[0039] Figure 9 This is a schematic diagram showing a device for measuring the indentation load. Detailed Implementation

[0040] The medical tubular body transport device of the present invention is a device for transporting a medical tubular body into the body, characterized by comprising: an outer tubular body for which the medical tubular body is disposed in the inner cavity; a traction member connected to the outer tubular body and extending proximally; an inner tubular body disposed in the inner cavity of the outer tubular body; and a cylindrical low-rigidity member disposed at the proximal end of the outer tubular body, and having a lower rigidity than the outer tubular body.

[0041] Because a cylindrical low-rigidity member with lower rigidity than the outer tube body is disposed at the proximal end of the outer tube body, when the traction member connected to the outer tube body is pulled towards the proximal side while the proximal end of the outer tube body is bent, the cylindrical low-rigidity member deforms significantly before the outer tube body. The stress applied between the outer tube body and the traction member is dispersed in the contact area between the traction member and the cylindrical low-rigidity member, thus making it less likely for the traction member to detach from the outer tube body. Furthermore, by disposing of a cylindrical low-rigidity member with lower rigidity than the outer tube body at the proximal end of the outer tube body, even if the inner tube body disposed within the inner cavity of the outer tube body buckles, the following behavior of the outer tube body relative to the inner tube body can be improved. That is, the cylindrical low-rigidity member deforms more easily than the outer tube body relative to stress; therefore, when stress is applied and the inner tube body buckles, the cylindrical low-rigidity member deforms first than the outer tube body, easily following the buckling of the inner tube body. Furthermore, since the traction component contacts the cylindrical low-rigidity component, the tensile stress applied to the connection between the traction component and the outer tube is dispersed. Therefore, even when the traction component is pulled proximally, the proximal end of the outer tube does not easily contact the inner tube. As a result, even when the traction component is pulled proximally, the frictional resistance generated between the outer and inner tubes does not increase, thus allowing the outer tube to be easily pulled proximally. Therefore, the operability of the medical tubular body transport device is not reduced, and the medical tubular body can be reliably released from the medical tubular body transport device.

[0042] Preferably, when the pressing load on the outer tube is set as 'a' and the pressing load on the cylindrical low-rigidity component is set as 'b', the ratio of load b to load a (b / a) satisfies 20% to 85%. By setting the ratio of load b to load a (b / a) to 20% or more, the cylindrical low-rigidity component will not be damaged even when the traction component is stretched towards the proximal side, and it deforms in the direction in which the traction component is stretched, thus preventing the traction component from breaking off. The ratio of b / a is more preferably 30% or more, and even more preferably 40% or more. On the other hand, by setting the ratio of load b to load a (b / a) to 85% or less, the cylindrical low-rigidity component deforms in the direction in which the traction component is stretched, thus mitigating the stress applied to the nearest position in the connection between the outer tube and the traction component, and preventing the traction component from breaking off from the outer tube. The ratio of b / a is more preferably 75% or less, and even more preferably 50% or less. The specific method for measuring the ratio of load b to load a (b / a) will be described later.

[0043] Hereinafter, an example embodiment of the medical tubular body transport device according to the present invention will be specifically described with reference to the accompanying drawings. The present invention is not limited to the illustrated examples and may be implemented with modifications that conform to the above and following spirit, all of which are included within the technical scope of the present invention. Furthermore, in the various drawings, for ease of explanation, there are instances where component reference numerals are omitted; in such cases, reference numerals and other figures are provided. Additionally, the various dimensions in the drawings are intended to aid in understanding the features of the present invention, and therefore may differ from actual dimensions.

[0044] A cylindrical low-rigidity component is disposed at the proximal end of the outer tube. For example, the distal end of the cylindrical low-rigidity component may cover the proximal end of the outer tube, and the distal end of the cylindrical low-rigidity component may also abut (or be in a state of contact) with the proximal end of the outer tube.

[0045] First, an embodiment in which the distal end of the cylindrical low-rigidity component covers the proximal end of the outer tube body will be described.

[0046] Figure 2 This is a cross-sectional view showing a first embodiment of the medical tubular body transport device according to the present invention. Furthermore, in Figure 2 Only the distal side of the medical tubular body delivery device is shown. Additionally, Figure 3 It is shown in magnification Figure 2 A cross-sectional view showing the area near the connection point between the outer tube 24 and the traction component 25. Figure 3 In the middle, relative to the attached figure, the left side is the distal side of the medical tubular transport device, and the right side is the proximal side of the medical tubular transport device.

[0047] In a first embodiment of the medical tubular body transport device according to the present invention, it includes: an outer tube 24 for housing a medical tubular body 21 within its cavity; a traction member 25 connected to the outer tube 24 and extending proximally; an inner tube 23 disposed within the cavity of the outer tube 24; and a cylindrical low-rigidity member 27 disposed at the proximity end of the outer tube 24, having a lower rigidity than the outer tube 24.

[0048] The inner lumen of the inner tube 23 is through which a guide wire (not shown) is inserted. The distal end of the inner tube 23 reaches the lumen of the distal contact 26. On the other hand, the proximal end of the inner tube 23 extends to the proximal side (operator's hand side) of the medical tubular transport device, enabling the operator's hand operation to be transmitted to the distal side of the medical tubular transport device via the inner tube 23.

[0049] The traction component 25 extends along the inner tube 23 to the proximal side. By pulling the traction component 25 to the proximal side, the outer tube 24 is pulled to the proximal side, pushing the medical tubular body 21 from the inner lumen of the outer tube 24 into the inner lumen of the body, thus releasing it.

[0050] exist Figure 2 , Figure 3 In the illustrated medical tubular transport device, the distal end of the cylindrical low-rigidity component 27 covers the proximal end of the outer tube 24 and the distal end of the traction component 25. The proximal end 27a of the cylindrical low-rigidity component 27 is positioned closer to the position side than the proximal end 24a of the outer tube 24. By positioning the proximal end 27a of the cylindrical low-rigidity component 27 closer to the position side than the proximal end 24a of the outer tube 24, such as... Figure 2 As shown, when the traction member 25 is pulled towards the proximal side while bent near the proximal end of the outer tube 24, the cylindrical low-rigidity member 27 deforms significantly more than the outer tube 24. The cylindrical low-rigidity member 27 acts as a buffer material, making it difficult for the traction member 25 to straighten. As a result, stress is less likely to concentrate at the closest position in the connection between the traction member 25 and the outer tube 24, thus preventing the traction member 25 from detaching from the outer tube 24.

[0051] The ratio (L2 / L1) of the distance L2 between the proximal end 24a of the outer tube 24 and the proximal end 27a of the cylindrical low-rigidity member 27 to the axial length L1 of the cylindrical low-rigidity member 27 is preferably 0.1 to 0.7. By making the ratio (L2 / L1) 0.1 or more, the stress-relieving effect of the cylindrical low-rigidity member 27 can be effectively utilized. The ratio (L2 / L1) is more preferably 0.3 or more, and even more preferably 0.4 or more. On the other hand, by making the ratio (L2 / L1) 0.7 or less, the cylindrical low-rigidity member 27 is less likely to detach from the outer tube 24. The ratio (L2 / L1) is more preferably 0.6 or less, and even more preferably 0.5 or less.

[0052] The distance L2 between the proximal end 24a of the outer tube 24 and the proximal end 27a of the cylindrical low-rigidity component 27, i.e. the length L2 of the axial extension of the cylindrical low-rigidity component 27 beyond the proximal end 24a of the outer tube 24, is preferably 3 to 30 mm, more preferably 25 mm or less, and even more preferably 20 mm or less.

[0053] exist Figure 2 , Figure 3 In the embodiment shown, when calculating the ratio of load b to load a (b / a), as follows: Figure 3 As shown, the indentation load 'a' for the outer tube 24 is measured at the position of arrow a, and the indentation load 'b' for the cylindrical low-rigidity component 27 is measured at the position of arrow b. That is, the indentation load 'a' for the outer tube 24 is measured at the position not covered by the cylindrical low-rigidity component 27, and the indentation load 'b' for the cylindrical low-rigidity component 27 is measured at the position not covered by the outer tube 24.

[0054] The distal portion of the traction component 25 is connected to the proximal portion of the outer tube 24, for example, as shown in the diagram. Figure 2 As shown, the distal portion of the traction component 25 can be brought into contact with the proximal portion of the outer tube 24 and connected using an adhesive or the like. Alternatively, the distal portion of the traction component 25 can be embedded into the proximal portion of the outer tube 24 and connected.

[0055] The distal end of the traction member 25 can have any shape. To improve the connection strength with the outer tube 24, it can be cylindrical or flat. In the case of a cylindrical shape, the outer diameter can change from the distal end to the proximal end; for example, the cross-sectional shape can change from a perfect circle to an ellipse. In the case of a flat shape, the thickness and width can change from the distal end to the proximal end. Furthermore, the connection strength with the outer tube 24 can be improved by surface treatment of the outer surface of the distal end of the traction member 25. For example, a surface treatment that roughens it to a pear-skin texture can be used. Alternatively, the distal end of the traction member 25 can be wound and fixed to the proximal portion of the outer tube 24, or it can be deformed into a meandering shape before fixing.

[0056] The distal end of the traction component 25 can also be located further distally than the distal end of the cylindrical low-rigidity component 27, but preferably as follows: Figure 3 As shown, the distal end of the traction component 25 is closer to the position side than the distal end of the cylindrical low-rigidity component 27.

[0057] Next, a second embodiment of the medical tubular body transport device according to the present invention will be described. Figure 4This is a cross-sectional view showing a second embodiment of the medical tubular body transport device according to the present invention, enlarged to show the vicinity of the connection position between the outer tube 24 and the traction member 25. Repeated descriptions are avoided by using the same reference numerals for the same parts as in other figures (the same applies hereinafter). Figure 4 In the middle, relative to the attached figure, the left side is the distal side of the medical tubular transport device, and the right side is the proximal side of the medical tubular transport device.

[0058] exist Figure 4 In the second embodiment shown, relative to Figure 3 In the first embodiment shown, the traction member 25 is positioned inside the outer tube 24. Therefore, the traction member 25 is positioned close to the axial position of the medical tubular transport device, making it easier to pull the outer tube 24 proximally. Furthermore, from the viewpoint of preventing the traction member 25 from easily detaching from the outer tube 24, it is preferable for the traction member 25 to be positioned as such, rather than inside the outer tube 24. Figure 3 It is positioned on the outside of the outer tube 24 as shown.

[0059] Next, a third embodiment of the medical tubular body transport device according to the present invention will be described. Figure 5 This is a cross-sectional view showing a third embodiment of the medical tubular body transport device according to the present invention, with an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. Figure 5 In the middle, relative to the attached figure, the left side is the distal side of the medical tubular transport device, and the right side is the proximal side of the medical tubular transport device.

[0060] exist Figure 5 In the third embodiment shown, relative to Figure 3 In the first embodiment shown, the traction member 25 is disposed outside the outer tube 24 and the cylindrical low-rigidity member 27. This improves production efficiency. Furthermore, from the viewpoint of making the traction member 25 less likely to detach from the outer tube 24, the distal end of the traction member 25 is preferably disposed outside the outer tube 24 and the cylindrical low-rigidity member 27, rather than being disposed elsewhere. Figure 3 It is arranged as shown between the outer tube 24 and the cylindrical low-rigidity component 27.

[0061] Next, an embodiment in which the distal end of the cylindrical low-rigidity component 27 abuts against the proximal end of the outer tube 24 will be described. Figure 6 This is a cross-sectional view showing a fourth embodiment of the medical tubular body transport device according to the present invention, with an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. Figure 6 In the middle, relative to the attached figure, the left side is the distal side of the medical tubular transport device, and the right side is the proximal side of the medical tubular transport device.

[0062] exist Figure 6 In the fourth embodiment shown, the proximal end of the outer tube 24 abuts against the distal end of the cylindrical low-rigidity member 27. Therefore, even when the traction member 25 is pulled towards the proximal side while bent near the proximal end of the outer tube 24, the cylindrical low-rigidity member 27 deforms significantly ahead of the outer tube 24, following the traction member 25, thus preventing the traction member 25 from becoming too straight. Consequently, stress is less likely to concentrate at the connection point between the traction member 25 and the outer tube 24, thus preventing the traction member 25 from detaching from the outer tube 24.

[0063] When the distal end of the cylindrical low-rigidity component 27 abuts against the proximal end of the outer tube 24, the length of the cylindrical low-rigidity component 27 in the longitudinal direction is preferably 3 to 25 mm, more preferably 4 mm or more, more preferably 20 mm or less, and even more preferably 15 mm or less.

[0064] Next, a fifth embodiment of the medical tubular body transport device according to the present invention will be described. Figure 7 This is a cross-sectional view showing a fifth embodiment of the medical tubular body transport device according to the present invention, with an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. Figure 7 In the middle, relative to the attached figure, the left side is the distal side of the medical tubular transport device, and the right side is the proximal side of the medical tubular transport device.

[0065] exist Figure 7 In the fifth embodiment shown, relative to Figure 6 In the fourth embodiment shown, the traction member 25 is disposed inside the outer tube 24 and the cylindrical low-rigidity member 27. By disposing the traction member 25 inside the outer tube 24 and the cylindrical low-rigidity member 27, the traction member 25 is positioned close to the axis of the medical tubular transport device, thus facilitating the stretching of the outer tube 24 towards the proximal side. Furthermore, from the viewpoint of preventing the traction member 25 from easily detaching from the outer tube 24, it is preferable for the traction member 25 to be disposed inside the outer tube 24 and the cylindrical low-rigidity member 27 as follows: Figure 3 As shown, it is arranged on the outside of the outer tube 24 and the cylindrical low-rigidity component 27.

[0066] When the distal end of the cylindrical low-rigidity component 27 abuts against the proximal end of the outer tube 24, it is preferable that the abutment portion of the cylindrical low-rigidity component 27 and the outer tube 24 is non-molten. This prevents stress concentration at the abutment portion.

[0067] exist Figure 6 , Figure 7 In the embodiment shown, when calculating the ratio of load b to load a (b / a), as follows: Figure 6 , Figure 7 As shown, the indentation load a for the outer tube 24 is measured at the position of arrow a, and the indentation load b for the cylindrical low-rigidity component 27 is measured at the position of arrow b.

[0068] Next, a sixth embodiment of the medical tubular body transport device according to the present invention will be described. Figure 8 This is a cross-sectional view showing a sixth embodiment of the medical tubular body transport device according to the present invention, with an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. Figure 8 In the middle, relative to the attached figure, the left side is the distal side of the medical tubular transport device, and the right side is the proximal side of the medical tubular transport device.

[0069] exist Figure 8 In the sixth embodiment shown, relative to Figure 6 The fourth embodiment shown includes a cylindrical member 28 that covers the proximal end of the outer tube 24 and at least a portion of the traction member 25. This prevents the traction member 25 from easily detaching from the outer tube 24.

[0070] The proximal end 27a of the cylindrical low-rigidity component 27 can also be located more distally than the proximal end 28a of the cylindrical component 28, but preferably as follows: Figure 8 As shown, the proximal end 27a of the cylindrical low-rigidity member 27 is closer to the position side than the proximal end 28a of the cylindrical member 28. By configuring the cylindrical member 28 such that the proximal end 28a of the cylindrical member 28 is further to the position side than the proximal end 27a of the cylindrical low-rigidity member 27, the traction member 25 is sandwiched between the cylindrical member 28 and the cylindrical low-rigidity member 27. Therefore, regardless of whether the traction member 25 is stretched in the axially outward or inward direction relative to the medical tubular transport device, the traction member 25 is less likely to detach from the outer tube 24. In addition, with this structure, when the outer tube 24 is moved proximal by traction of the traction member 25, the frictional resistance generated between the proximal end of the cylindrical low-rigidity member 27 and the inner tube 23 can be reduced, and the operating load when unfolding the medical tubular body can be suppressed.

[0071] The distal end of the traction member 25 can also be located further distally than the distal end of the cylindrical member 28, but from the viewpoint of making the traction member 25 less likely to detach from the outer tube 24, it is preferable to... Figure 8 As shown, the distal end of the traction component 25 is closer to the side than the distal end of the cylindrical component 28.

[0072] Preferably, the rigidity of the cylindrical component 28 is lower than that of the outer tube 24. Therefore, when the traction component 25 is pulled proximally while the outer tube 24 is bent near its proximal end, the cylindrical component 28 deforms significantly more than the outer tube 24, following the traction component 25, thus preventing the traction component 25 from straightening out. As a result, stress is less likely to concentrate at the proximal end of the connection between the traction component 25 and the outer tube 24, thus preventing the traction component 25 from detaching from the outer tube 24. Furthermore, with this structure, when the outer tube 24 is moved proximally by pulling the traction component 25, the frictional resistance generated between the proximal end of the low-rigidity cylindrical component 27 and the inner tube 23 can be reduced, suppressing the operational load when unfolding the medical tubular body.

[0073] Furthermore, the rigidity of the cylindrical member 28 can be the same as that of the low-rigidity cylindrical member 27, but preferably the rigidity of the cylindrical member 28 is higher than that of the low-rigidity cylindrical member 27. That is, preferably the rigidity of the cylindrical member 28 is lower than that of the outer tube 24 and higher than that of the low-rigidity cylindrical member 27. With such a structure, the rigidity from the proximal portion of the outer tube 24 to the proximal end 27a of the low-rigidity cylindrical member 27 can be continuously reduced. Even if the traction member 25 is pulled radially outward from the outer tube 24, the cylindrical member 28 or the low-rigidity cylindrical member 27 will buckle preferentially, which can further suppress the occurrence of breakage from the outer tube 24.

[0074] When the pressing load on the outer tube is set as 'a' and the pressing load on the cylindrical member 28 is set as 'c', the ratio of load c to load a (c / a) is preferably 35% to 90%. By making the ratio of load c to load a (c / a) 35% or more, the cylindrical member 28 will not be damaged when the traction member 25 is stretched towards the proximal side, and will deform in the stretching direction of the traction member 25. Therefore, the tensile stress is dispersed, and the traction member 25 is less likely to break off from the outer tube 24. The ratio c / a is more preferably 40% or more, and even more preferably 70% or more. On the other hand, by making the ratio of load c to load a (c / a) 90% or less, the cylindrical member 28 easily deforms in the stretching direction of the traction member 25. Therefore, stress concentration at the proximal end of the connection between the outer tube 24 and the traction member 25 can be prevented, and the traction member 25 is less likely to break off from the outer tube 24. The ratio c / a is more preferably 88% or less. The specific method for determining the ratio of load c to load a (c / a) will be described later.

[0075] exist Figure 8 In the sixth embodiment shown, when calculating the ratio of load c to load a (c / a), as follows: Figure 8As shown, the indentation load 'a' for the outer tube 24 is measured at the position of arrow a, and the indentation load 'c' for the cylindrical component 28 is measured at the position of arrow c. That is, the indentation load 'a' for the outer tube 24 is measured at the position not covered by the cylindrical component 28, and the indentation load 'c' for the cylindrical component 28 is measured at the position covering the outer tube 24.

[0076] Preferably, the cylindrical component 28 is bonded to the cylindrical low-rigidity component 27. As a result, the traction component 25 disposed between the cylindrical component 28 and the cylindrical low-rigidity component 27 is less likely to detach from the outer tube 24.

[0077] The cylindrical component 28 and the cylindrical low-rigidity component 27 can be bonded by adhesive or by thermoforming, preferably by thermoforming.

[0078] The cylindrical component 28 and the outer tube 24 can be fused together, but are preferably immiscible. By being immiscible, the cylindrical component 28 and the outer tube 24 are independently movable, and therefore can easily deform to follow the complex movements of the medical tubular transport device.

[0079] The distal end of the traction component 25 is preferably bonded to both the cylindrical component 28 and the outer tube 24, for example, by adhesive bonding or by thermoforming, preferably by thermoforming. In the case of thermoforming, the connection strength of the traction component 25 can be further improved by applying an adhesive resin such as polyethylene to the inner surface of the cylindrical component 28.

[0080] In the medical tubular body transport device according to the present invention, it is preferable that the traction member 25 is connected not only to the outer tube 24 but also to the cylindrical low-rigidity member 27. This prevents the traction member 25 from easily detaching from the outer tube 24. Furthermore, when the traction member 25 is pulled proximally during the deployment of the medical tubular body, causing the outer tube 24 to move proximally, the tension of the traction member 25 can be transmitted to the outer tube 24 via the cylindrical low-rigidity member 27. Therefore, the traction tension can be transmitted to the outer tube 24 more effectively even in a bent shape, resulting in the suppression of the load during stent deployment.

[0081] The traction component 25 and the cylindrical low-rigidity component 27 can be bonded, for example, by adhesive bonding or by hot-press bonding based on the partial melting of the cylindrical low-rigidity component 27, preferably by hot-press bonding.

[0082] In the medical tubular body transport device according to the present invention, when the traction member 25 is connected to the cylindrical low-rigidity member 27, it is preferable that the traction member 25 is connected to the outer surface of the cylindrical low-rigidity member 27. By connecting the traction member 25 to the outer surface of the cylindrical low-rigidity member 27, it is easier to manufacture.

[0083] In the medical tubular body transport device according to the present invention, it is preferable to have a protective tube body in which at least the proximal end of the outer tube body 24, the inner tube body 23, and the traction member 25 are disposed within the cavity. By covering with the protective tube body, at least the proximal end of the outer tube body 24, the inner tube body 23, and the traction member 25 can be concentrated, thereby improving the operability of the medical tubular body transport device.

[0084] Materials used to form the outer tube 24 and the inner tube 23 include, for example, polyethylene, fluoropolymers [e.g., polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), etc.], polyamide, polyamide elastomer, polyimide, polyurethane, polyester, silicone, polyether ether ketone (PEEK), and other resin materials.

[0085] The outer tube 24 can be a single-layer structure or a multi-layer structure, preferably a multi-layer structure. By adopting a multi-layer structure, it is easy to make the rigidity of the outer tube 24 higher than that of the cylindrical low-rigidity component 27. As an example of a multi-layer structure, a two-layer structure in which the inner layer is polyimide and the outer layer is polyamide elastomer can be exemplified.

[0086] The material used to construct the cylindrical low-rigidity component 27 is not particularly limited, as long as the rigidity of the cylindrical low-rigidity component 27 is lower than that of the outer tube 24. The aforementioned resin material can be used. Among them, polyamide elastomer is preferred.

[0087] The cylindrical low-rigidity component 27 can be a single-layer structure or a multi-layer structure, preferably a multi-layer structure. By adopting a multi-layer structure, the sliding properties of the inner side of the cylindrical low-rigidity component 27 can be improved, making it easier to slide. As the material constituting the outer layer of the cylindrical low-rigidity component 27, the aforementioned resin material can be used. As the material constituting the inner layer of the cylindrical low-rigidity component 27, examples include polyethylene, fluoropolymers [e.g., polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), etc.]. As an example of a multi-layer structure, a bilayer structure in which the inner layer is polyethylene and the outer layer is polyamide elastomer can be exemplified.

[0088] The material used to construct the cylindrical component 28 is not particularly limited, as long as the rigidity of the cylindrical component 28 is the same as or higher than that of the cylindrical low-rigidity component 27. The aforementioned resin material can be used. Among them, a polyamide-based elastomer is preferred.

[0089] The traction component 25 can be made of the aforementioned resin material, but metal is preferred. Examples of metals include titanium, stainless steel, and nickel-titanium alloys.

[0090] As a medical tubular body 21, for example, stents, stent grafts, obstructions, injection catheters, artificial valves, etc., can be used. Among these, stents are preferred. Examples of stents include coil-shaped stents formed from a single wire of metal or polymer material, stents processed by laser cutting of a metal tube, stents formed by laser cutting of metal sheets, rolling them into a cylindrical shape, and laser welding them, stents obtained by laser welding and assembling wire-shaped components, or stents made by weaving multiple wire-shaped metals. Stents are classified into balloon-expandable stents, which expand by a balloon fitted with the stent, and self-expanding stents, which expand by removing external components that inhibit stent expansion. In this invention, self-expanding stents are preferred.

[0091] This application is based on and enjoys the priority interest in Japanese Patent Application No. 2020-158618, filed on September 23, 2020. The entire contents of the description of the aforementioned Japanese Patent Application No. 2020-158618 are incorporated herein by reference.

[0092] Example

[0093] The rigidity of a medical tubular delivery device should be evaluated using the following steps.

[0094] In this invention, the rigidity of a medical tubular transport device is evaluated based on the indentation load when a wedge-shaped indenter is pressed into the device. The measuring apparatus uses a small benchtop testing machine, the "EZ-SX," manufactured by Shimadzu Corporation. Figure 9 This is a schematic diagram of a device used to measure the indentation load. Figure 9 In the diagram, relative to the attached figure, the left side represents the distal end of the medical tubular transport device, and the right side represents the proximal end of the medical tubular transport device.

[0095] like Figure 9 As shown, the medical tubular transport device 32 is mounted on the platform 31 with its distal end further distal than the distal end B of the platform 31. A portion of the medical tubular transport device 32 is clamped and fixed to the platform 31. The distance from position A where the medical tubular transport device 32 is fixed to the distal end B of the platform 31 is 30 mm. The indenter 33 is positioned at position C, 13 mm distal to the distal end B of the platform 31. The indenter 33 is pressed vertically downward relative to the medical tubular transport device 32, and the load at this point (indentation load) is measured. A wedge-shaped indenter is used, the indentation speed is 1.0 mm / s, the indentation distance is 1.2 mm, and the load at the moment of indentation to 1.0 mm is measured.

[0096] Production Figure 8The rigidity of the medical tubular transport device 32 shown is specifically evaluated. For the medical tubular transport device 32, the inner layer of the outer tubular body 24 is made of polyimide, and the outer layer is made of polyamide elastomer (Pebax 7233 manufactured by Arkema). The inner layer of the cylindrical low-rigidity component 27 is made of high-density polyethylene, and the outer layer is made of polyamide elastomer (Pebax 7233 manufactured by Arkema). The cylindrical component 28 is made of polyamide elastomer (Pebax 7233 manufactured by Arkema). The traction component 25 is made of stainless steel (SUS304).

[0097] Figure 8 The indentation load a at position a (i.e., the indentation load a for the outer tube) is 0.15 N, the indentation load b at position b (i.e., the indentation load b for the cylindrical low-rigidity component) is 0.062 N, and the indentation load c at position c (i.e., the indentation load c for the cylindrical component) is 0.13 N. Therefore, the ratio of load b to load a (b / a) is 0.062 / 0.15 × 100 = 41.3%, and the ratio of load c to load a (c / a) is 0.13 / 0.15 × 100 = 86.7%.

[0098] Explanation of reference numerals in the attached figures

[0099] 11, 21...Medical tubular body; 12, 24...Outer tubular body; 13, 23...Inner tubular body; 14...Traction tubular body; 15, 25...Traction component; 16, 26...End contact; 27...Cylindrical low-rigidity component; 28...Cylindrical component; 31...Platform; 32...Medical tubular body transport device; 33...Indenter.

Claims

1. A medical tubular body delivery device, characterized in that, have: The outer tube is for the medical tubular body to be placed within the inner cavity; A traction component is connected to the outer tube and extends toward the proximal side; Inner tube, disposed within the cavity of the outer tube; and A cylindrical, low-rigidity component is disposed near the proximal end of the outer tube, and its rigidity is lower than that of the outer tube. The cylindrical low-rigidity component covers the proximal end of the outer tube. The proximal end of the cylindrical low-rigidity component is closer to the position side than the proximal end of the outer tube. The proximal end of the cylindrical low-rigidity component is not opposite to the outer tube.

2. A medical tubular body delivery device, characterized in that, a device for delivering a medical tubular body into the body, wherein... have: The outer tube is for the medical tubular body to be placed within the inner cavity; A traction component is connected to the outer tube and extends toward the proximal side; Inner tube, disposed within the cavity of the outer tube; and A cylindrical, low-rigidity component is disposed near the proximal end of the outer tube, and its rigidity is lower than that of the outer tube. The distal end of the cylindrical low-rigidity component abuts against the proximal end of the outer tube in the longitudinal direction.

3. The medical tubular body delivery device according to claim 1 or 2, wherein, When the pressing load on the outer tube is set as a and the pressing load on the cylindrical low-rigidity component is set as b, the ratio of load b to load a (b / a) is 20% to 85%.

4. The medical tubular body transport device according to claim 2, wherein, The distal end of the cylindrical low-rigidity component does not fit into the proximal end of the outer tube.

5. The medical tubular body delivery device according to claim 2 or 4, wherein, A cylindrical component having a proximal end of the outer tube and at least a portion of the traction component.

6. The medical tubular body transport device according to claim 5, wherein, The rigidity of the cylindrical component is lower than that of the outer tube.

7. The medical tubular body transport device according to claim 6, wherein, The rigidity of the cylindrical component is higher than that of the low-rigidity cylindrical component.

8. The medical tubular body delivery device according to claim 5, wherein, When the pressing load on the outer tube is set as a and the pressing load on the cylindrical component is set as c, the ratio of load c to load a (c / a) is 35% to 90%.

9. The medical tubular body transport device according to claim 5, wherein, The proximal end of the cylindrical low-rigidity component is closer to the position side than the proximal end of the cylindrical component.

10. The medical tubular body delivery device according to claim 1 or 2, wherein, The traction component is connected to the outer surface of the outer tube.

11. The medical tubular body delivery device according to claim 1 or 2, wherein, The traction component is also connected to the cylindrical low-rigidity component.

12. The medical tubular body transport device according to claim 11, wherein, The traction component is connected to the outer surface of the cylindrical low-rigidity component.

13. The medical tubular body delivery device according to claim 1 or 2, wherein, The inner tube is for the guide wire to be inserted into the inner cavity.

14. The medical tubular body delivery device according to claim 1 or 2, wherein, A protective tube having at least a proximal end of the outer tube, the inner tube, and the traction component disposed within the inner cavity.

15. The medical tubular body delivery device according to claim 1 or 2, wherein, The medical tubular body is a self-expanding stent.

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