The present invention relates to an indwelling device and a cylindrical treatment tool.
Conventionally, there are several known cylindrical treatment tools such as a stent graft used for treatment of aneurysm or the like generated in a blood vessel wall, and indwelling devices for delivering and indwelling a cylindrical treatment tool to an affected part (see Patent Documents 1-3). Generally, these types of indwelling devices are made to indwell a cylindrical treatment tool on an affected area by delivering the cylindrical treatment tool in a radially contracted state to the affected area and expanding radially the cylindrical treatment tool in the affected area.
For example, one of the conventional indwelling devices is made to be capable of indwelling a so-called later-opening-head cylindrical treatment tool. Specifically, this indwelling device has a head chip capable of housing an arm part disposed on an open end of the main part of the cylindrical treatment tool, so as to deliver the cylindrical treatment tool to an affected area, with the arm part left housed in the head chip, and to expand the main part at the affected area, followed by releasing the arm part from the head chip to allow it to come into contact with a blood vessel wall (see Patent Document 1).
The conventional indwelling device mentioned above has two shafts as a mechanism that releases the arm part housed in the head chip: a shaft connected to the head chip that houses the arm part, and a shaft that holds the arm part relatively movable relative to the head chip. Since these two shafts have a dual structure in which one shaft is inserted into the hollow part of the other shaft, a sheath that houses the cylindrical treatment tool is likely to have an increased diameter. However, in view of reducing invasiveness on a patient's body or the like, it is desirable that the sheath have a reduced diameter.
The present invention has been made in view of the above-described circumstances, and an object thereof is to provide a reduced diameter of a sheath that houses a cylindrical treatment tool, thus achieving to reduce invasiveness on the patient's body.
The indwelling device according to the present invention is
an indwelling device that causes a cylindrical treatment tool, which is radially expandable, to indwell a living body lumen, the indwelling device comprising:
a sheath in a tubular shape that is capable of housing the cylindrical treatment tool, and
a shaft member in an elongated shape configured to move back and forth inside the sheath along an axial direction of the sheath,
wherein the shaft member
has a first controlling part and a second controlling part that engage with a first engaging part and a second engaging part of the cylindrical treatment tool, respectively, to control radial movement of an opening end of the cylindrical treatment tool,
and wherein the shaft member is displaced relative to the cylindrical treatment tool in the axial direction to allow a first engagement between the first controlling part and the first engaging part and a second engagement between the second controlling part and the second engaging part to be released independently of each other.
Furthermore, the cylindrical treatment tool according to the present invention is
a cylindrical treatment tool that is caused to indwell a living body lumen using an indwelling device, the cylindrical treatment tool comprising:
a main part in a tubular shape configured to radially expand, and
a first engaging part and a second engaging part each protruding in a direction away from one opening end of the main part in an axial direction of the main part by a predetermined protrusion length and configured to engage with the indwelling device;
wherein the first engaging part and the second engaging part
each engage with the indwelling device to allow control of radial movement of the one opening end, and each independently make engagement with the indwelling device releasable.
According to the present invention, it is possible to provide a reduced diameter of a sheath that houses the cylindrical treatment tool, and to achieve to reduce invasiveness on a patient's body.
So far, the present invention has been briefly described. Furthermore, the details of the present invention will be further clarified by reading through the embodiments for performing the invention described below (hereinafter referred to as “embodiment”) with reference to the accompanying drawings.
[Cylindrical Treatment Tool and Indwelling Device]
In the present embodiment, a stent graft 10 is used as a cylindrical treatment tool to be indwelled inside a blood vessel by the indwelling device 1. Hereinafter, structures of the indwelling device 1 and the stent graft 10 according to the present embodiment will be described with reference to
As shown in
The sheath 20 has a sheath body part 21, and a hub 22 disposed at the end of the base end side of the sheath body part 21. The hub 22 has a nut (illustration omitted) or the like that fixes the shaft 30 to the sheath 20 or releases the fixing.
The sheath body part 21 is formed of a flexible material. Examples of the flexible material include biocompatible synthetic resin (elastomer) selected from fluorine resin, polyamide resin, polyethylene resin, polyvinyl chloride resin, and the like; a resin compound in which such resins are mixed with other materials; a multilayer structure made of such synthetic resins; and a composite of such synthetic resins and metal wire.
The shaft 30 is a shaft member including a tubular shaft body part 31 and a tubular smaller-diameter shaft part 32, which is coaxially continuous with the tip side of the shaft body part 31 as well as has a diameter smaller than that of the shaft body part 31. Inside the shaft 30, a hollow part 33 is continuously formed over the entire area in the axial direction (longitudinal direction). As shown in
The smaller-diameter shaft part 32 has a function of holding the stent graft 10 being contracted. Specifically, as shown in
On the hollow tube 35 and the end of the tip side of the smaller-diameter shaft part 32 projected from the hollow tube 35 to the tip side, the head chip 36 is disposed, which covers the outer circumferences of these as well as elongates taperedly further toward the tip side. The guide wire 40 is exposed from the tip opening of the head chip 36.
Examples of the materials composing the fixture 34 and the hollow tube 35 include various materials that have appropriate hardness and flexibility, such as resins (plastic, elastomer, and the like) and metals. Examples of the materials composing the head chip 36 include various materials with appropriate hardness and flexibility, such as synthetic resin (elastomer) composed of polyamide resin, polyurethane resin, polyvinyl chloride resin, and the like.
The smaller-diameter shaft part 32 has, for example, a diameter smaller than that of the shaft body part 31 by at least the thickness of the stent graft 10. In other words, when the shaft 30 is inserted inside the sheath 20, a space for holding the stent graft 10 is defined between the outer surface of the smaller-diameter shaft part 32 and the inner surface of the sheath body part 21. In this space, the stent graft 10 in a contracted state is held as described later. Here, the maximum diameter of the head chip 36 is, for example, substantially equal to the outer diameter of the sheath body part 21.
As shown in
More specifically, as shown in
The skeleton part 12 is configured to, for example, have a self-expanding wire mesh texture with a thin metal wire folded up and down in zigzags as well as formed into a tubular shape, and can be deformed from a contracted state, with contracting itself radially inward, to an expanded state, with expanding itself radially outward to define the cylindrical flow path. Examples of the materials composing the skeleton part 12 include known metals or metal alloys represented by stainless steel, Ni—Ti alloy, titanium alloy, and the like.
The film part 13 is fixed to the skeleton part 12 so as to cover the skeleton part 12 along the skeleton part 12 and defines the above-mentioned cylindrical flow path. Examples of the materials for the film part 13 include fluorine resin such as PTFE (polytetrafluoroethylene) and polyester resin such as polyethylene terephthalate.
One open end 11a of the main part 11 includes a connecting portion 14, which protrudes in a direction away from the open end 11a in the axial direction of the main part 11, and a blood vessel wall fixing portion 15, which protrudes in a direction away from the open end 11a in the axial direction and by a protrusion length longer than that of the connecting portion 14. At the protruding end part of the blood vessel wall fixing portion 15, for example, a fixing pin 16 for fixing the blood vessel wall fixing portion 15 to a blood vessel wall is disposed so as to protrude radially outward.
In the example shown in
Here, the open end 11a preferably includes two or more of the connecting portions 14 and two or more of the blood vessel wall fixing portions 15, but the numbers of the connecting portions 14 and the blood vessel wall fixing portions 15 are an example and is not limited thereto, and can be arbitrarily changed as appropriate.
As shown in
Each of the columnar parts 34b has, for example, a substantially rectangular parallelepiped shape that is slightly curved along the circumferential direction, and the surface on the axial center side of the smaller-diameter shaft part 32 is formed into a substantially flat surface. In addition, each of the plurality of the connecting portions 14 of the stent graft 10 is hooked on the corresponding columnar part 34b of the fixture 34 from the outside, thereby being held in a contracted state while being biased radially outward with self-expanding force. Moreover, the width along the circumferential direction of the tip of the columnar part 34b (a direction orthogonal to the axial direction and the radial direction) is smaller than, for example, the interval between the two ends on the base end side of the connecting portion 14, which forms the “V” shape in a contracted state, more specifically, the interval between the middle parts of the two arms opening to the base end side of the connecting portion 14.
The hollow tube 35 is arranged so as to be separated from the fixture 34 by a predetermined interval L.
The hollow tube 35 is configured to have a bottomed cylinder shape having a cylindrical part 35a and an end wall part 35b, which closes the opening on the tip side of the cylindrical part 35a. Furthermore, the smaller-diameter shaft part 32, which is inserted into the cylindrical part 35a having the opening on the base end side, is coaxially fixed to the end wall part 35b. The plurality of the blood vessel wall fixing portions 15 of the stent graft 10 has their protruding ends inserted into the hollow part of the hollow tube 35 by a predetermined length, thereby being held in a contracted state while being biased radially outward with self-expanding force.
Here, the depth from the base end side opening of the hollow part of the cylindrical part 35a to the tip-side bottom surface is, for example, larger than the length derived by summing the length of a part receiving insertion of the blood vessel wall fixing portion 15 and the axial length of the columnar part 34b. That is, as described later, the depth of the hollow part is set to an extent such that the tip of the blood vessel wall fixing portion 15 would not come into contact with the tip-side bottom surface of the hollow part of the cylindrical part 35a, even if the shaft 30 is moved to the base end side in order to release the catch of the connecting portion 14 on the columnar part 34b (see
Accordingly, the shaft 30 is displaced relative to the stent graft 10 from the state as shown in
In addition, when the shaft 30 is displaced toward the base end side relative to the stent graft 10 in this way, the blood vessel wall fixing portion 15 will be displaced inside the hollow part with maintaining a state of being inserted into the hollow part of the hollow tube 35. Specifically, at this time, the hollow tube 35 is relatively displaced toward the base end side relative to the blood vessel wall fixing portion 15. Thus, when the shaft 30 is displaced toward the base end side relative to the stent graft 10 in order to bring the connecting portion 14 into an expanded state, the blood vessel wall fixing portion 15 is securely maintained in a contracted state, without being accidentally brought into an expanded state, thus allowing the connecting portion 14 and the blood vessel wall fixing portion 15 to expand surely at different timings.
Furthermore, after the connecting portion 14 is in the expanded state, the shaft 30 is displaced toward the tip side relative to the stent graft 10, thereby also causing the hollow tube 35 to become displaced in the same direction. Then, once the amount of displacement of the shaft 30 toward the tip relative to the stent graft 10 is larger than the length of a part, in the blood vessel wall fixing portion 15, inserted into the hollow part of the hollow tube 35 in the state of
In this way, by moving the shaft 30, which has the fixture 34 and the hollow tube 35, toward the base end side and the tip side, each of the engagements of the connecting portion 14 and the blood vessel wall fixing portion 15 of the stent graft 10 with the fixture 34 and the hollow tube 35 can be released separately.
[Indwelling Procedure of the Cylindrical Treatment Tool]
Next, the procedure in indwelling the stent graft 10 on an affected area inside a blood vessel using the indwelling device 1 will be described with reference to
First, a guide wire 40, which is arranged inside the blood vessel 50 so as to pass through the affected area, is inserted through the shaft 30 from the tip side end of the indwelling device 1. In this state, the stent graft 10 is maintained in a contracted state by being covered with the sheath 20 (see
Then, as shown in
Then, as shown in
Then, the shaft 30 is displaced toward the base end side by a predetermined distance relative to the stent graft 10, which is fixed to the inner wall surface of the blood vessel 50 (see
As a result, as shown in
After that, as shown in
[Action and Effect]
As described above, with the indwelling device 1 for the stent graft 10 according to the embodiment of the present invention, the single shaft 30, which has the fixture 34 and the hollow tube 35, can release separately each control of radial outward movements of the connecting portion 14 and the blood vessel wall fixing portion 15, and can provide the sheath 20 with a smaller outer diameter compared to one that multiply includes a plurality of shaft members, thereby enabling to reduce invasiveness to a patient's body. For example, it will be possible to provide easier passage through the blood vessel 50, such as the aorta and iliac artery, and also to reduce frequency of complications such as blood vessel damage. Furthermore, this allows the catheter to be directly (percutaneously) inserted into the blood vessel 50 to deliver or indwell the stent graft 10, thus enabling to reduce invasiveness to the patient's body more preferably.
In addition, since use of a single shaft 30 allows a space between the shaft 30 and the sheath 20 to be relatively wide, the sheath 20 having a relatively large outer diameter can be eliminated in housing of the stent graft 10, even in the case of, for example, the stent graft 10 having a relatively large outer diameter even in a contracted state, such as the stent graft 10 having a relatively large outer diameter or expansion force in an expanded state. That is, use of a single shaft 30 enables to employ the sheath 20 having a diameter smaller than that of the conventional ones, while enabling also to house the stent graft 10 having a relatively large outer diameter in a contracted state, even with use of the sheath 20 having an outer diameter similar to that of the conventional ones.
[Other Aspects]
It should be noted that the present invention is not limited to each of the embodiments described above, and can employ various modified examples within the scope of the present invention. For example, the material, shape, size, number, arrangement site, and the like of each element in the embodiments mentioned above are arbitrary and not limited as long as the present invention can be achieved.
In addition, the above-described embodiment has been illustrated with an alternate arrangement of the connecting portions 14 and the blood vessel wall fixing portions 15 in the circumferential direction at the open end 11a of the stent graft 10. However, this embodiment is an example, to which the present invention is not limited, and the arrangement of the connecting portion 14 and the blood vessel wall fixing portion 15 can be arbitrarily changed as appropriate. In other words, when relatively high fixing strength to the blood vessel wall is intended, it is preferable to dispose a relatively large amount of the blood vessel wall fixing portion 15 compared to the connecting portion 14. In contrast, when there is no need to increase fixing strength to the blood vessel wall from the blood vessel wall fixing portion 15, such as in the case where expanding force of the stent graft 10 is enough to allow fixation to the blood vessel wall, there may be no longer any need to dispose a number of the blood vessel wall fixing portion 15.
Moreover, the above-described embodiment has been illustrated with a portion having the fixing pin 16 as the blood vessel wall fixing portion 15. However, this embodiment is an example, to which the present invention in not limited, and it can be arbitrarily changed as appropriate whether the fixing pin 16 is equipped. In other words, when there is no need to increase fixing strength to the blood vessel wall from the blood vessel wall fixing portion 15, such as in the case where expanding force of the stent graft 10 is enough to allow fixation to the blood vessel wall, there is not always need to dispose the fixing pin 16 on the blood vessel wall fixing portion 15.
Additionally, in the above-described embodiment, as shown in
Furthermore, the above-described embodiment has been made as the shaft 30 is displaced toward the base end side relative to the stent graft 10, thereby releasing the engagement between the connecting portion 14 and the fixture 34, and is displaced toward the tip side, thereby releasing the engagement between the blood vessel wall fixing portion 15 and the hollow tube 35. However, this embodiment is an example, to which the invention is not limited. Any change can be arbitrarily made as appropriate, as long as a configuration is made in which the shaft 30 is axially displaced relative to the stent graft 10, thereby allowing the engagement between the connecting portion 14 and the fixture 34 and the engagement between the blood vessel wall fixing portion 15 and the hollow tube 35 to be released independently of each other. For example, a fixture is made that includes a plurality of columnar parts with different axial lengths in which the connecting portion 14 is engaged with the shorter columnar part and the blood vessel wall fixing portion 15 is engaged with the longer columnar part. Then, the shaft 30 may be displaced toward the base end side relative to the stent graft 10, thereby, first, releasing the engagement between the fixture and the connecting portion 14, and may be further displaced toward the base end side, thereby releasing the engagement between the fixture and the blood vessel wall fixing portion 15. In this case, there is no longer any need to equip the hollow tube 35, and the configuration of the indwelling device can be made simpler.
In addition, the above-described embodiment has been illustrated with the stent graft 10 to be indwelled and used inside the blood vessel 50. However, this is an example, to which the present invention is not limited, and for example, any tool may be used that is indwelled in a living body lumen other than a blood vessel (e.g., a gastrointestinal tract). Moreover, the cylindrical treatment tool according to the present invention may have a configuration in which the skeleton part 12 is not covered with the film part 13 (bare stent).
The content of disclosures in the specification, drawings, and abstract included in Japanese Patent Application No. 2018-051632 filed on Mar. 19, 2018 is incorporated into the present application in their entirety.
Number | Date | Country | Kind |
---|---|---|---|
JP2018-051632 | Mar 2018 | JP | national |
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/JP2019/011058 | 3/18/2019 | WO |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2019/181821 | 9/26/2019 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
20040220585 | Nikolchev | Nov 2004 | A1 |
20070250151 | Pereira | Oct 2007 | A1 |
20080039927 | Barr | Feb 2008 | A1 |
20080114442 | Mitchell et al. | May 2008 | A1 |
20080262590 | Murray | Oct 2008 | A1 |
20140236278 | Argentine et al. | Aug 2014 | A1 |
20170079819 | Pung et al. | Mar 2017 | A1 |
Number | Date | Country |
---|---|---|
2001-526574 | Dec 2001 | JP |
2008-119481 | May 2008 | JP |
2009-534157 | Sep 2009 | JP |
4928449 | May 2012 | JP |
5408866 | Feb 2014 | JP |
6261619 | Jan 2018 | JP |
WO 9853761 | Dec 1998 | WO |
WO 2017049312 | Mar 2017 | WO |
WO-2017195125 | Nov 2017 | WO |
WO 2019181821 | Sep 2019 | WO |
Entry |
---|
International Search Report and the Written Opinion dated Jun. 11, 2019 From the International Searching Authority Re. Application No. PCT/JP2019/011058 and its Translation of Search Report Into English. (11 Pages). |
Number | Date | Country | |
---|---|---|---|
20200405520 A1 | Dec 2020 | US |