Patent Application
20210196931
The present invention relates to a delivery device for a medical tubular body.
In recent years, a minimum invasive therapy in which a medical tubular body is delivered to a lesion site in the body has been developed. In the therapy, a delivery device is used that delivers a medical tubular body through body lumens and places it at a lesion site. The delivery device has an outer tube that holds the medical tubular body therein, and delivers the medical tubular body to a lesion site through body lumens, keeping the medical tubular body to be held in the outer tube. After delivering the medical tubular body, the medical tubular body can be released from the inside of the outer tube to be placed on the lesion site.
The medical tubular body includes, for example, a stent, a stent graft, an obturator, an infusion catheter, and a prosthesis valve. Of these, the stent is generally a medical tubular body used for treating various diseases caused by stenosis or occlusion of blood vessels or other body lumens.
It is required for a delivery device delivering the above medical tubular body to have good trackability and handleability, which means that handling of an operator is easy to be transferred to a distal side, such that the delivery device can be smoothly passed through body lumens, and should be unlikely to be deformed, kinked, or broken. A delivery device for a medical tubular body is, for example, disclosed in Patent Document 1. The Patent Document 1 discloses a stent delivery catheter including an outer shaft and an inner shaft; and the outer shaft having dual lumens, the inner shaft having a guide tube for a guidewire and a pusher wire in parallel, wherein the guide tube for a guidewire and the pusher wire are separately and slidably extended in the dual lumens of the outer shaft, and the pusher wire is connected to a midway in the longitudinal direction of the guide tube for a guidewire.
Patent Document 1: JP 5664040 B2
An example of an embodiment of a conventional delivery device for a medical tubular body is shown in
As shown in
The present invention has been achieved focusing on the circumstances described above, and the purpose thereof is to offer a delivery device for a medical tubular body that is less likely to kink without decreasing handleability.
The present invention includes the following inventions.
[1] A delivery device for a medical tubular body, comprising: an outer tube in which the medical tubular body is to be disposed; an inner rod disposed in the outer tube; and a guidewire insertion member disposed proximal to the medical tubular body, the guidewire insertion member having a penetration passage in which a guidewire is to be passed through; the inner rod partially fixed to the guidewire insertion member; and the guidewire insertion member having a cross-sectional area in a cross-section perpendicular to an axis direction satisfying the following formula (1).
cross-sectional area Sa>cross-sectional area Sb (1)
in the formula (1), the cross-sectional area Sa is a cross-sectional area of the guidewire insertion member at a center position in the axis direction between a distal-most position of the guidewire insertion member and a proximal-most position of a fixing region where the guidewire insertion member and the inner rod are fixed to each other, and in the formula (1), the cross-sectional area Sb is a cross-sectional area of the guidewire insertion member at a proximal-most position of the fixing region.
[2] The delivery device for a medical tubular body according to [1], wherein given that axis line (a) is an axis line through a gravity center of the penetration passage, axis line (b) is an axis line through a gravity center of the guidewire insertion member in a cross-section perpendicular to the axis direction at a center position in the axis direction between a distal-most position of the guidewire insertion member and a proximal-most position of the fixing region of the guidewire insertion member, and axis line (c) is an axis line through a gravity center of the inner rod, distance (a-c) between the axis line (a) and the axis line (c) is longer than distance (a-b) between the axis line (a) and the axis line (b).
[3] The delivery device for a medical tubular body according to [1] or [2], wherein a proximal end part of the guidewire insertion member has a taper shape.
[4] The delivery device for a medical tubular body according to any one of [1] to [3], further comprising a protection member disposed outside the inner rod at a proximal side to the fixing region
[5] The delivery device for a medical tubular body according to [4], wherein a distance between a distal-most position of the protection member and a proximal-most position of the guidewire insertion member is 30 mm or less.
[6] The delivery device for a medical tubular body according to any one of [1] to [5], wherein the delivery device is of a rapid exchange type where the outer tube has a guidewire port, and the guidewire port is disposed distal to a proximal end of the outer tube.
[7] The delivery device for a medical tubular body according to any one of [1] to [6], further comprising a guidewire tube disposed in the penetration passage, wherein the guidewire is to be passed through in the guidewire tube; and the guidewire tube extends from a side that is proximal to a proximal opening of the penetration passage to a side that is distal to a distal opening of the penetration passage.
[8] The delivery device for a medical tubular body according to any one of [1] to [6], further comprising an inner tube disposed in the outer tube, wherein the guidewire is to be passed through in the inner tube; and a distal end of the inner tube and a proximal opening of the penetration passage are fixed to each other.
[9] The delivery device for a medical tubular body according to any one of [1] to [6], and [8], further comprising a guidewire tube disposed in the outer tube, wherein the guidewire is to be passed through in the guidewire tube; and a proximal end of the guidewire tube and a distal opening of the penetration passage are fixed to each other.
[10] The delivery device for a medical tubular body according to [6], further comprising an internal tube disposed in the outer tube, wherein the guidewire is to be passed through in the internal tube; and a proximal end of the internal tube is fixed to the guidewire port.
[11] The delivery device for a medical tubular body according to [10], wherein a part of the internal tube is disposed in the penetration passage.
[12] The delivery device for a medical tubular body according to [10] or [11], further comprising a guidewire tube disposed in the penetration passage, wherein the guidewire is to be passed through in the guidewire tube.
[13] The delivery device for a medical tubular body according to [10] or [11], further comprising a guidewire tube disposed in the outer tube, wherein the guidewire is to be passed through in the guidewire tube; and a proximal end of the guidewire tube and a distal opening of the penetration passage are fixed to each other.
[14] The delivery device for a medical tubular body according to [12], wherein a part of the internal tube is disposed in the guidewire tube.
[15] The delivery device for a medical tubular body according to [12] or [14], wherein a proximal end of the guidewire tube is located proximal to a proximal opening of the penetration passage.
[16] The delivery device for a medical tubular body according to any one of [12], [14], and [15], wherein a proximal end part of the guidewire tube has a taper shape.
[17] The delivery device for a medical tubular body according to any one of [1] to [16], wherein the guidewire insertion member is colored.
[18] The delivery device for a medical tubular body according to any one of [1] to [17], wherein the medical tubular body is a self-expanding stent.
According to the present invention, a delivery device for a medical tubular body can be offered that is less likely to kink without decreasing handleability even though it is excessively bent, because a guidewire insertion member is formed such that a cross-sectional area of the guidewire insertion member in a cross-section perpendicular to an axis direction satisfies a certain relationship.
A delivery device for a medical tubular body according to the present invention has an outer tube in which the medical tubular body is disposed, an inner rod disposed in the outer tube, and a guidewire insertion member disposed proximal to the medical tubular body; and the guidewire insertion member has a penetration passage in which a guidewire is to be passed through, the inner rod is partially fixed to the guidewire insertion member, and a cross-sectional area of the guidewire insertion member in a cross-section perpendicular to an axis direction satisfies the following formula (1).
cross-sectional area Sa>cross-sectional area Sb (1)
In the formula (1), the cross-sectional area Sa is a cross-sectional area of the guidewire insertion member at a center position in an axis direction between a distal-most position of the guidewire insertion member and a proximal-most position of a fixing region where the guidewire insertion member and the inner rod is fixed, and in the formula (1), the cross-sectional area Sb is a cross-sectional area of the guidewire insertion member at a proximal-most position of the fixing region.
Since forming the guidewire insertion member such that the cross-sectional area of the guidewire insertion member in a cross-section perpendicular to the axis direction satisfies the relationship shown in the above formula (1) makes a cross-sectional area of the guidewire insertion member at a proximal side smaller, it becomes easier for stress to keep from locally concentrating when the delivery device for a medical tubular body is passed through tortuous body lumens. In other words, the stiffness in the axis direction of the delivery device for a medical tubular body gradually changes, which makes it unlikely for the delivery device for a medical tubular body to kink. In addition, since the guidewire insertion member has smaller cross-section area at the proximal-most position of a fixing region to the inner rod, stress imposed on the guidewire insertion member from the medical tubular body when the medical tubular body is released can be concentrated on the inner rod. Accordingly, it becomes easier for unnecessary force not to be generated when the outer tube is pulled to the proximal side to release the medical tubular body, which can reduce risks including breaking of the outer tube or delivery of the medical tubular body to incorrect position off the expected position, and as a result, safer treatment is available.
Hereinafter, an example of an embodiments of a delivery device for a medical tubular body according to the present invention will be described in reference to figures, however, the present invention is not limited by the figures, and can be altered in design within a scope in compliance with the intent described above and below, and all the changes are to be encompassed within a technical scope of the present invention.
The delivery device for a medical tubular body has an outer tube 22 in which a medical tubular body 21 is disposed, an inner rod 23 disposed in the outer tube 22, and a guidewire insertion member 24 located proximal to the medical tubular body 21.
The guidewire insertion member 24 has a penetration passage 25 in which a guidewire is to be passed through, and the inner rod 23 is partially fixed to the guidewire insertion member 24. Any method for fixing the inner rod 23 to the guidewire insertion member 24 is available, and for example, it includes a method in which the inner rod 23 is press fitted into the guidewire insertion member 24 to be fixed (being pinched), or a method in which the inner rod 23 is inserted into a lumen that is preliminarily formed in the guidewire insertion member 24 and the inner rod 23 and the lumen are fixed together with an adhesive or the like.
The guidewire insertion member 24 has a cross-section area in a cross section perpendicular to an axis direction of the guidewire insertion member 24 satisfying the following formula (1).
cross-sectional area Sa>cross-sectional area Sb (1)
In the above formula (1), the cross-sectional area Sa is a cross-sectional area of the guidewire insertion member 24 at a center position 24d in an axis direction between a distal-most position 24a of the guidewire insertion member 24 and a proximal-most position 24c of a fixing region 24b where the guidewire insertion member 24 and the inner rod 23 are fixed to each other. The cross-sectional area Sa is an area calculated on the basis of an outline of the guidewire insertion member 24 at the center position 24d, which should be calculated including an area of the penetration passage 25.
In the above the formula (1), the cross-sectional area Sb is a cross-sectional area of the guidewire insertion member 24 at a proximal-most position 24c of the fixing region 24b of the guidewire insertion member 24. The cross-sectional area Sb is an area calculated on the basis of an outline of the guidewire insertion member 24 at the proximal-most position 24c.
Since forming the guidewire insertion member such that the cross-sectional area in a cross-section perpendicular to the axis direction of the guidewire insertion member satisfies the relationship shown in the above formula (1) makes a cross-sectional area of the guidewire insertion member at a proximal side smaller, it becomes easier for stress to keep from locally concentrating when the delivery device for a medical tubular body is passed through tortuous body lumens. In other words, the stiffness in the axis direction of the delivery device for a medical tubular body gradually changes, which makes it unlikely for the delivery device for a medical tubular body to kink. In addition, since the guidewire insertion member has smaller cross-sectional area at the proximal-most position of the fixing region to the inner rod, stress imposed on the guidewire insertion member from the medical tubular body when the medical tubular body is released can be concentrated on the inner rod. Accordingly, it becomes easier for unnecessary force not to be generated when the outer tube is pulled to the proximal side to release the medical tubular body, which can reduce risks including breaking of the outer tube or delivery of the medical tubular body to incorrect position off the expected position, and as a result, safer treatment is available.
In the outer tube 22, a guidewire tube 26 in which the guidewire is passed through is disposed, and a proximal end of the guidewire tube 26 just should be, for example shown in
The present invention is not limited to the configuration where the proximal end of the guidewire tube 26 is fixed to the distal opening 25b of the penetration passage 25, and as described later, may include the configuration where the guidewire tube 26 is disposed in the penetration passage 25, and the guidewire tube 26 extends from a side that is proximal to a proximal opening of the penetration passage 25 to a side that is distal to the distal opening 25b of the penetration passage 25.
In addition, at a distal end of the guidewire insertion member 24, a pusher that makes it easier for the medical tubular body 21 to be pushed out may be disposed.
The guidewire insertion member 24 is preferably configured such that, as shown in
Any shape of the proximal end part of the guidewire insertion member 24 is available, as long as the cross-sectional area Sb of the guidewire insertion member 24 at the proximal-most position 24c of the fixing region 24b satisfies the relationship of the above formula (1), and the shapes are exemplified by a taper shape, a concavo-convex shape, a stepwise shape, and a wave shape. Of these, the taper shape is more preferable.
The guidewire insertion member 24 is preferably colored. Colored guidewire insertion member 24 makes it easier for it to be visually observed endoscopically, which makes it easier for the guidewire insertion member 24 to be located. The colored guidewire insertion member 24 is sometimes referred to as a visual marker. Any color is available for the guidewire insertion member 24 that is easy to be visually observed endoscopically, and for example, comparatively contrasting color to gastrointestinal mucous membrane or blood is preferable, and especially preferably yellow.
The inner rod 23, as shown in
Distance x between distal-most position 27a of the protection member 27 and a proximal-most position 24e of the guidewire insertion member 24 is preferably 30 mm or less. The distance x of 30 mm or less makes the stiffness of the delivery device for a medical tubular body in the longitudinal direction continuous, which improves resistance against bending of the device, and the device is less likely to kink. The distance x is preferably as short as possible. The distance x is more preferably 20 mm or less, even more preferably 10 mm or less, and especially preferably 5 mm or less. Thanks to the distance of 5 mm or less, the protection member 27 can improve pushability of the inner rod 23, and the protection member 27 can integrally support stress imposed from the guidewire insertion member along with the inner rod 23 when the medical tubular body is released.
Any shape of a distal end part of the protection member 27 is available, and for example as shown in
The complementary shape of the protection member 27 means that the protection member 27 has plane contact with the guidewire insertion member 24 when the distal end part of the protection member 27 and the proximal end part of the guidewire insertion member 24 are contact with each other. The complementary shape can reduce uncovered area of the inner rod 23, which can improve pushability of the inner rod 23 with the protection member 27, and the protection member 27 can integrally support stress imposed from the guidewire insertion member along with the inner rod 23 when the medical tubular body is released. Moreover, the complementary shape increases contact area of the protection member 27 with the guidewire insertion member 24, which can improve efficiency of stress transfer. The distal end part of the protection member 27 preferably has a taper shape, and the guidewire insertion member 24 also preferably has a taper shape.
Constituent materials of the protection member 27 are exemplified by resin materials including polyethylene, fluorine resin (such as PTFE, PFA and the like), polyamide, polyamide-based elastomer, polyurethane, polyester, silicone, and polyetheretherketone (PEEK).
The delivery device for a medical tubular body is preferably of rapid exchange type where the outer tube 22 has a guidewire port, and the guidewire port is preferably disposed distal to a proximal end of the outer tube 22.
The delivery device for a medical tubular body may be configured, as shown in
Methods for fixing the distal end of the inner tube 41 and the proximal opening 25a of the penetration passage 25 to each other are exemplified by a method including preparing the guidewire insertion member 24 and the inner tube 41, and fixing them together by thermal fusion bonding or adhesive bonding.
While the rapid exchange type is shown as an embodiment of the delivery device for a medical tubular body in
The delivery device for a medical tubular body shown in
The delivery device for a medical tubular body has the configuration, as shown in
While the rapid exchange type is shown as an embodiment of the delivery device for a medical tubular body in
The delivery device for a medical tubular body has the configuration, as shown in
As shown in
Methods for fixing the internal tube 51 are exemplified by a method where the filler 30 is formed by thickening a part of the outer tube 22 to fill a gap with the proximal end part of the internal tube 51, a method where the filler 30 composed of resin and the like is disposed between the proximal end part of the internal tube 51 and the outer tube 22 and they are fixed together with adhesive, or a method where the proximal end part of the internal tube 51 and the outer tube 22 is adhesive bonded with the filler 30 that is used as an adhesive. Alternatively, an inner wall of the outer tube 22 and an outer wall of the internal tube 51 may be pressed to each other to be fixed without the filler 30, for example, by thermal fusion bonding or pressure bonding.
The embodiment of the delivery device for a medical tubular body shown in
A part of the internal tube 51 may be disposed in the penetration passage 25 as shown in
The delivery device for a medical tubular body shown in the
The internal tube 51 may be extended to the distal side of the penetration passage 25 through the penetration passage 25, and disposed in the guidewire tube 26 fixed to the distal opening 25b of the penetration passage 25. Such a configuration can prevent the guidewire from tangling with the inner rod 23 and the like, which may cause the inner rod 23 impossible to be operated, or can prevent the guidewire from precluding the release of the medical tubular body when the medical tubular body is pushed out and released by pulling the outer tube 22 to the proximal side, because the guidewire is necessarily disposed inside the internal tube 51, the penetration passage 25, or the guidewire tube 26.
The delivery device for a medical tubular body may have the configuration, as shown in
A part of the internal tube 51 may be disposed in the guidewire tube 26 as shown in
The proximal end of the guidewire tube 26 may be located on the side that is proximal to the proximal opening 25a of the penetration passage 25, as shown in
The shape of the proximal end part of the guidewire tube 26 is exemplified by a taper shape, a concavo-convex shape, a stepwise shape, and a wave shape, and of these, the taper shape is more preferable.
Another example of embodiments of the delivery device for a medical tubular body according to the present invention is shown in
The delivery device for a medical tubular body shown in
In the configuration, the guidewire tube 26 in which the guidewire is to be passed through is disposed in the penetration passage 25, the distal side of the guidewire tube 26 extends to the tip 28, the proximal side of the guidewire tube 26 extends to the position of the proximal opening 25a of the penetration passage 25. The shape of the proximal end part of the guidewire tube 26 corresponds to the shape of the proximal end part of the guidewire insertion member 24. The shape of the proximal end part of the guidewire tube 26 corresponding to the shape of the proximal end part of the guidewire insertion member 24 makes it easier for the internal tube 51 to be inserted into the guidewire tube 26. Note that corresponding shape means that the proximal opening of the guidewire tube 26 and the proximal opening of the guidewire insertion member 24 are in the same plane when seeing the proximal opening of the guidewire tube 26 from the proximal side in the longitudinal direction. In another words, the proximal end face of the guidewire insertion member 24 and the proximal end face of the guidewire tube 26 are in the same plane.
To make the shape of the proximal end part of the guidewire tube 26 and the shape of the proximal end part of the guidewire insertion member 24 corresponding to each other, for example, the guidewire insertion member 24 and the guidewire tube 26 may be cut off together in the condition where the guidewire tube 26 is inserted in the guidewire insertion member 24.
In the configuration shown in
In the
As shown in
The locking part 29 may be disposed at any position as long as the locking part 29 can prevent the medical tubular body 21 from going backward, and for example, it is disposed at a position proximal to the center position of a longitudinal length of the medical tubular body 21.
Alternatively, without the locking part 29, the proximal end of the medical tubular body 21 may be supported by the distal end of the guidewire insertion member 24.
The medical tubular body includes, for example, a stent, a stent graft, an obturator, an infusion catheter, and a prosthesis valve.
Of these, a stent is preferable. The stent can be exemplified by a stent having a coiled shape formed with one wire made of metal or polymer material, a stent obtained by cutting with a laser from a metal tube, a stent obtained by assembling linear materials by laser welding, or a stent obtained by weaving more than one metal wire. The stent is classified into a balloon-expandable stent having a stent that expands with a mounted balloon, and a self-expanding stent that expands by itself by removing an restrainer of expansion of the stent. In the present invention, the self-expanding stent is preferably used.
The present application claims priority based on Japanese Patent Application No. 2018-157665 filed on Aug. 24, 2018. All the contents described in Japanese Patent Application No. 2018-157665 filed on Aug. 24, 2018 are incorporated herein by reference.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2018-157665 | Aug 2018 | JP | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/JP2019/017306 | 4/23/2019 | WO | 00 |
