Embolic material
阅读说明:本技术 栓塞材料 (Embolic material ) 是由 生野恵理 伊藤祐贵 阪川洋一 于 2019-03-19 设计创作,主要内容包括:本发明提供栓塞材料(10),其通过向与分支血管(94)相连的大动脉瘤(92)内介由导管(100)进行填充而阻止血液从分支血管(94)向大动脉瘤(92)内的流入,栓塞材料(10)具备:长条状填充体(12),其形成为比导管(100)的内径细;和赋形部(14),其设置于所述填充体(12)的一部分、并从导管(100)出来后形成比分支血管(94)的宽度大的结构物。(The invention provides an embolic material (10) that prevents the inflow of blood from a branch blood vessel (94) into a large aneurysm (92) connected to the branch blood vessel (94) by filling the large aneurysm (92) with the material via a catheter (100), the embolic material (10) comprising: an elongated filler (12) formed to be thinner than the inner diameter of the catheter (100); and a shaped part (14) which is provided in a part of the filler (12) and which forms a structure having a width larger than that of the branch vessel (94) after coming out of the catheter (100).)
1. An embolization material which prevents the inflow of blood from a branch blood vessel (94) into an aneurysm (92) connected to the branch blood vessel (94) or the outflow of blood from the aneurysm (92) into the branch blood vessel (94) by filling the aneurysm (92) into the aneurysm (92) via a catheter (100),
The plug material is provided with:
an elongated filler (12) formed to be thinner than the inner diameter of the catheter (100); and
a shaped section (14) formed by bending or curving at least a part of the filler (12) after exiting the catheter (100),
the shaped section (14) expands to a width larger than the inner diameter of the branch vessel (94) in a bent or curved state.
2. The embolic material of claim 1, wherein the filler body (12) is formed of a hydrogel that swells upon contact with blood.
3. The embolic material according to claim 1 or 2, wherein the shaped portion (14) comprises a shape memory member wound in a coil shape around an outer circumferential portion of the filler (12).
4. The embolization material of claim 1 or 2, wherein the shaped portion (14B) comprises a shape memory member embedded within the filler (12).
5. The embolization material of any one of claims 1 to 4, wherein the shaped portion (14) is formed at both ends of the filling body (12).
6. The embolic material according to any of claims 1 to 4, wherein the shaped portion (14) is formed throughout the entire area of the filling body (12).
7. The embolization material of claim 5, wherein the shaped portion (14) is shaped in the following manner: the extension in the width direction of the filler (12) is made to extend to a range larger than the inner diameter of the branch vessel (94) by bending the filler (12).
8. The embolic material of claim 5, wherein the shaped portion is shaped in a circular or polygonal ring shape having a diameter larger than an inner diameter of a branch vessel (94).
9. The embolization material according to claim 5, wherein the shaped portion (54) is shaped into an umbrella shape having a diameter larger than the inner diameter of the branch vessel (94) by unwinding the distal end of the branched filling body (52) to the proximal end side of the filling body (52).
10. The embolic material of claim 5, wherein the shaped portion (64) is shaped in the following manner: the end of the branched filling body (61) is formed in a spherical shape having a diameter larger than the inner diameter of the branched blood vessel (94).
11. The embolization material of claim 1, wherein the shaped portion (14) forms a structure having a diameter of 3mm or more.
12. The embolic material of claim 1, wherein the filler body (12) has a diameter in a state prior to swelling that is less than an inner diameter of the branch vessel (94), and a portion of the filler body (12) outside the shaped portion enters the branch vessel (94) for occlusion.
13. The embolization material of claim 12, wherein a straight section that is not shaped is provided at a distal end of the filling body (12).
Technical Field
The present invention relates to embolic materials for treating tumors formed in blood vessels.
Background
In the treatment of aortic aneurysms, methods of setting artificial blood vessels by an open abdominal or thoracic surgery have been conventionally employed, and since invasive treatment is carried out and the burden on patients is large, in recent years, the treatment has shifted to stent graft treatment, which is an endovascular treatment.
The stent graft therapy is a therapy in which a catheter is inserted from the femoral artery of a patient and an artificial blood vessel with a spring (stent graft) is placed in the affected part to prevent blood from flowing into the aortic aneurysm.
However, some complications are known to arise in stent graft therapy. As one example, there is a Type II endoleak (Type2 endoleaks). Type II endoleaks are complications in which blood flow that has flowed anterogradely from a branch vessel located in a large aneurysm portion to a terminal blood vessel is retrograde into the aneurysm from the terminal blood vessel side by the provision of stent graft, and remains within the aneurysm. If it is left for a long period of time, the large aneurysm may be enlarged by the reverse blood flow. Such type II endoleaks occur in the long term in about 20% to 30% of patients who have undergone stent graft therapy.
As a method for treating type II endoleaks, a method of blocking the initial part of a branch vessel branching from a large aneurysm with an embolic coil has been proposed. In addition, a method for filling a large aneurysm with a liquid embolic material is proposed in "A Novel and Simple Technique for organizing the Type2Endoleaks Through Direct Sac Access From the remote step-gradient Landing zone", G.Coppeita., European Journal of Vascular and Endovasular Surgery, Volume 47Issue 4p.394-401, April/2014. JP-A-2002-539853 and JP-A-2004-537353 disclose methods for filling a gel-like plug material.
Disclosure of Invention
However, there are sometimes many branch vessels that connect to the aortic aneurysm. In addition, sometimes the branch vessels are thin or intricate, and thus it is difficult to access all the branch vessels, and it is difficult to occlude all the branch vessels with an embolic coil. The current situation is as follows: although a treatment for blocking a main branch blood vessel connected to a large aneurysm is performed, there is a problem that inflow of blood from an incompletely treated branch blood vessel cannot be prevented, and a recurrence rate is high.
The treatment method using a liquid embolic material is a treatment method of occluding all blood vessels connected to an aortic aneurysm by injecting a liquid embolic material that coagulates when in contact with blood into the aortic aneurysm.
However, there are problems as follows: when a liquid embolic material is injected into an aortic aneurysm, the liquid embolic material before solidification flows out to the distal portion of a branch blood vessel, and distal embolization of the blood vessel occurs at a site distant from the aortic aneurysm, thereby generating a new complication.
Therefore, as a method for blocking all blood vessels connected to the aortic aneurysm without accessing all the branch blood vessels, it is considered that a long embolizing material which can be filled via a catheter is filled into the aortic aneurysm, and the embolizing material which can be filled via the catheter may be thinner than a part of the branch blood vessels connected to the aortic aneurysm, and in this case, the embolizing material may flow out to the distal end of the branch blood vessels and embolize the blood vessels distally at a site distant from the aortic aneurysm, similarly to the liquid embolizing material.
The purpose of the present invention is to provide an embolic material that can prevent complications caused by the outflow of the entire embolic material from a branch blood vessel connected to an aortic aneurysm, and can prevent the inflow of blood into the aortic aneurysm.
In order to achieve the above object, an embolization material according to an aspect of the present invention is an embolization material that prevents inflow of blood from a branch vessel into a large aneurysm or outflow of blood from the large aneurysm into the branch vessel by filling the large aneurysm connected to the branch vessel via a catheter, the embolization material including: an elongated filler body formed to be thinner than an inner diameter of the conduit; and a shaped portion formed by bending or curving at least a part of the filler after exiting from the catheter, wherein the shaped portion expands to a width larger than the inner diameter of the branch vessel in the bent or curved state.
When a branch vessel is inserted into a tumor or when the branch vessel is inserted into the tumor by reverse sealing, the thickness of the catheter is sometimes restricted due to the difficulty, and a thin embolization material may be injected through a catheter that is smaller than the inner diameter of the branch vessel. Even in such a case, since the embolization material is provided with the shaped portion having a width larger than that of the branch vessel in a part thereof, the embolization material as a whole does not enter the branch vessel by mistake and block an undesired position. This prevents the backflow of blood into the tumor without causing new complications. In addition, even when an embolizing material having a diameter smaller than the inner diameter of the branch vessel is used, the effect of directly embolizing the branch vessel by allowing a portion other than the shaped portion to enter the branch vessel can be expected.
In the above embolic material, the filler may be formed of a hydrogel that swells when contacted with blood. Here, the hydrogel is a polymer material that swells by contact with moisture or a solvent and increases in volume. The hydrogel also includes a stimuli-responsive gel starting material that increases in volume in response to stimuli of pH, temperature, moisture, ionic strength, and the like. Such an embolic material does not adhere to the distal end of the catheter like a liquid embolic material, and thus the treatment using the catheter becomes easy. In addition, since the filler swells after installation, the amount of the plugging material to be installed may be small. Further, since the inside of the hemangioma is gradually filled by swelling without filling the whole inside of the hemangioma immediately after installation, the pressure does not increase rapidly, and the safety is also excellent.
In the above-mentioned plug material, the shaped portion may include a shape memory member wound in a coil shape around an outer peripheral portion of the filler. The shape memory member is a member that deforms into a predetermined shape according to temperature, solvent (moisture), pH, ionic strength, or the like. By shaping such a shape memory member into a predetermined shape in advance, the distal end of the filler discharged from the catheter can be deformed to form a structure larger than the branch vessel. As a result, the embolic material can be prevented from flowing into the branch blood vessel.
In the plug material, the shaped portion may include a shape memory member embedded in the filler. With this shape memory member, a structure larger than the inner diameter of the branch vessel can be formed at the distal end portion of the filler. This prevents the embolic material from flowing into the branch blood vessel.
In the above plug material, the shaped portion may be shaped by polymerization in a mold having the shape of the structure. The crosslinked structure of the molecules constituting the filler reflects the shape in the mold at the time of synthesis, and therefore the filler shows a shape shaped in advance when swollen after installation. This prevents the embolic material from flowing into the branch blood vessel.
In the above plug material, the shaped portion may be formed of an elastic member or a shape memory member connected to a distal end of the filler. This prevents the embolic material from flowing into the branch blood vessel.
In the above plug material, the shaped portions may be formed at both ends of the filler. The shaped portion may be formed over the entire region of the filler. With these configurations, inflow of embolic material into the branch vessel can also be prevented. In addition, by shaping the tip, the risk of the tip of the embolic material penetrating into the tumor portion and penetrating the tumor can be reduced.
In the above-mentioned plug material, the shaped portion may be shaped as follows: the extension is extended in the width direction of the filling body to a range larger than the inner diameter of the branch vessel by bending the filling body. This prevents the embolic material from flowing into the branch blood vessel.
In the embolic material, the shaped portion may be shaped into a circular or polygonal ring shape having a diameter larger than the inner diameter of the branch vessel. The shaped portion may be shaped into an umbrella shape having a diameter larger than the inner diameter of the branch vessel by unwinding the distal end of the branched filling body to the proximal end side of the filling body. Further, the shaped portion may be shaped as follows: the distal end of the branched filling body is formed in a spherical shape having a diameter larger than the inner diameter of the branched blood vessel. These shaped portions also prevent the embolic material from entering the branch vessel.
The embolization material is used for treating a large aneurysm, and the shaped portion may be configured to form a structure having a diameter of 3mm or more. Thus, the width of the structure of the shaped portion becomes larger than the inner diameter of a branch blood vessel connected to the aortic aneurysm, for example, a subintimal artery having a thickness of about 3mm and a lumbar artery having a thickness of about 2mm, and therefore, the entry of embolic material into the branch blood vessel can be prevented. Such embolic materials are suitable for the treatment of type II endoleaks.
Among the above-mentioned plug materials, may be: the filler has a diameter smaller than the inner diameter of the branch vessel in a state before swelling, and a part of the filler other than the shaped portion enters the branch vessel to be occluded. This also allows the following effects to be expected: not only the embolizing material itself fills the interior of the aneurysm, but also a portion other than the shaped portion enters the branch vessel to embolize the branch vessel directly.
In the above plug material, a linear portion that is not shaped may be provided at a distal end portion of the filler. With such an embolization material, the straight portion easily enters the branch vessel, and the straight portion entering the branch vessel can be expected to have an effect of occluding the branch vessel.
The embolization material according to the present invention can prevent complications from occurring due to the embolization material flowing out of the entire branch blood vessel connected to the aortic aneurysm, and can prevent the blood from flowing into the aortic aneurysm.
Drawings
Fig. 1 is a perspective view of a plugging material according to embodiment 1 of the present invention.
Fig. 2 is a schematic view showing an example of use of the embolic material of fig. 1 in an aortic aneurysm.
FIG. 3 is a schematic view showing an example of the action of the plugging material of FIG. 1.
Fig. 4 is a perspective view of a plugging material according to embodiment 2 of the present invention.
FIG. 5A is a plan view of the plugging material according to embodiment 3, FIG. 5B is a sectional view taken along line VB-VB in FIG. 5A, and FIG. 5C is a sectional view taken along line VC-VC in FIG. 5A.
Fig. 6 is a perspective view of the plugging material according to embodiment 4.
Fig. 7 is a plan view showing a part of a mold used for manufacturing the plug material of fig. 6, fig. 7B is a plan view showing a state where a raw material of the plug material is poured into the mold of fig. 7A, and fig. 7C is a plan view of the plug material molded in the mold of fig. 7A.
Fig. 8 is a perspective view of a distal end portion of a plugging material according to embodiment 5 of the present invention.
Fig. 9 is a perspective view of a distal end portion of a plugging material according to embodiment 6 of the present invention.
Fig. 10 is a side view of a distal end portion of the plugging material according to embodiment 7.
Fig. 11A is a perspective view showing a 1 st configuration example of the shaped portion of fig. 10, fig. 11B is a perspective view showing a 2 nd configuration example of the shaped portion of fig. 10, fig. 11C is a perspective view showing a 3 rd configuration example of the shaped portion of fig. 10, and fig. 11D is a perspective view showing a 4 th configuration example of the shaped portion of fig. 10.
Fig. 12A is a perspective view showing a 5 th configuration example of the shaped portion of fig. 10, and fig. 12B is a perspective view showing a 6 th configuration example of the shaped portion of fig. 10.
FIG. 13 is a side view showing a configuration example of the shaped portion 7 in FIG. 10.
Fig. 14 is a perspective view of an shaped portion of an embolic material according to embodiment 8 of the present invention, and fig. 14B is a perspective view showing a modification of the shaped portion of fig. 14A.
Fig. 15 is a perspective view of a shaped portion of an embolization material according to embodiment 9 of the present invention.
Fig. 16 is a perspective view of a shaped portion of an embolization material according to
Fig. 17 is a perspective view of a plugging material according to embodiment 11 of the present invention.
Fig. 18 is a perspective view of a shaped portion of an embolization material according to
Detailed Description
Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings.
(embodiment 1)
As shown in fig. 1, the
The
The
Examples of the monomer or polymer (a) include ethylenically unsaturated monomers (e.g., acrylic monomers or amine monomers, N' -methylenebisacrylamide, N-vinylpyrrolidone, 2-hydroxyethyl methacrylate, and N-isopropylacrylamide), monomers containing polyhydric alcohols or polyethylene glycols, and derivatives thereof. In addition, a hydrogel formed of a polysaccharide-based polymer may be used.
By using the above composition, the
Therefore, in the
In the present embodiment, the shaped
The shaped
As the shape memory member constituting the
The shaped
The
As shown in fig. 2, the vicinity of a normal blood vessel 94A located above and below the large aneurysm 92 is occluded by a stent graft 98 disposed inside a blood vessel 96. The large aneurysm 92 is connected to a plurality of branch vessels 94 heading to the terminal portion of, for example, the leg, the intestine, the spinal cord, or the like.
After the stent graft 98 is placed, a method of securing the access to the aortic aneurysm 92 by forming a gap between the stent graft 98 and the blood vessel 96 and inserting the
A
The
Further, the inventors of the present application conducted experiments, and as a result, it was found that a portion other than the shaped
As described above, the
Since the
Further, since the filling
In addition, by shaping the tip, the risk of the leading end of the
(embodiment 2)
As shown in fig. 4, the plugging material 10A according to the present embodiment is formed in a coil shape over the entire region of the
The
The width W and the total length L of the coiled structure formed by the shaped
The embolic material 10A of the present embodiment is inserted into the catheter 100 (see fig. 2) in a state where the
(embodiment 3)
As shown in fig. 5A, the
As shown in fig. 5C, a
The shape of the shaped
The
When the
In the
(embodiment 4)
As shown in fig. 6, the plug material 10C according to the present embodiment includes a shaped
The plug material 10C of the present embodiment is produced by the steps shown in fig. 7A to 7C. First, as shown in fig. 7A, a
Next, as shown in fig. 7B, the raw material of the hydrogel constituting the
Then, as shown in fig. 7C, the
The plug material 10C is supplied in a state of being stretched linearly after drying. When the embolization material 10C is placed in the aortic aneurysm 92 through the
As described above, the plug material 10C of the present embodiment can also provide the same effects as those of the
(embodiment 5)
As shown in fig. 8, the
The
The coiled
As described above, the
(embodiment 6)
As shown in fig. 9, the plugging
The
The
(7 th embodiment)
In the present embodiment, various modifications of the shaped
As shown in fig. 10, in the
The shaped portion 34 of the
The shaped portion 34C according to the 3 rd configuration example shown in fig. 11C is shaped like a rectangular ring. The shaped portion 34D according to the 4 th configuration example shown in fig. 11D is shaped like a rectangular vortex. The width W in the longitudinal direction of the shaped portions 34C and 34D is formed to be larger than the inner diameter D of the branch blood vessel 94 connected to the aortic aneurysm 92.
The shaped
The shaped
The same effects as those of the
(embodiment 8)
As shown in fig. 14A, the plug material 40A according to the present embodiment has a shaped portion 44A shaped into a rectangular coil shape at the distal end portion of the filling
As shown in fig. 14B, the plug material 40B according to the modification of the present embodiment has a shaped portion 44B formed by winding the end portion of the filling
(embodiment 9)
As shown in fig. 15, the embolization material 50 according to the present embodiment includes a filler 52 formed by twisting a plurality of filaments 51 made of hydrogel. The diameter (thickness) of the filler 52 may be, for example, about 1 mm. A
When the embolic material 50 is placed in the aortic aneurysm 92 through the
The shaped portion 54 may be formed by winding the
The plug material 50 of the present embodiment can also provide the same effects as those of the
(embodiment 10)
As shown in fig. 16, the embolization material 60 according to the present embodiment includes bundling portions 62a and 62b for bundling a plurality of filaments 61 made of hydrogel as a shaping portion 64. The filaments 61 are bundled by the proximal bundling part 62a and the distal bundling part 62b, and the portion between them can be expanded radially outward.
A core 20 shaped in a C-shape so as to spread outward in the radial direction is inserted into each filament 61. The
When the embolization material 60 is placed in the aortic aneurysm 92 through the
The plug material 60 of the present embodiment can also provide the same effects as those of the
(embodiment 11)
As shown in fig. 17, the plug material 70 according to the present embodiment has a shaped portion 74 provided in a part of a filler 72, and an end portion thereof is a straight portion 73 which is not shaped. In the illustrated filler 72, an example in which 2 shaped portions 74 are formed is shown, but the present embodiment is not limited thereto, and the number of shaped portions 74 may be 1. The amount of the shaped portion 74 of the filler 72 may be 3 or more. Further, the shaped portion 74 may be provided at one end portion and the straight portion 73 may be formed at the other end portion.
The diameter of the filler 72 is preferably smaller than the inner diameter D of the branch vessel 94. This facilitates entry of the linear portion 73 into the branch blood vessel 94. The shape of the shaped portion 74 of the plug material 70 is not limited to the coil shape, and various shapes such as those shown in fig. 5A to 16 may be employed. The linear portion 73 at the distal end of the filling body 72 thus configured easily enters the branch blood vessel 94. Further, the linear portion 73 of the filler 72 swells 2 to 4 times in diameter in the branch blood vessel 94, and thus an effect of directly embolizing the branch blood vessel 94 by the linear portion 73 can be expected.
(embodiment 12)
As shown in fig. 18, in the
For the
Next, in the hollow pipe (pipe) -shaped template, a pipe of a portion corresponding to the shaping
Then, the tube wound around the template is heated to polymerize the solution therein, thereby forming a hydrogel and forming the
The
The plug material shaped by polymerizing hydrogel in a mold or a tube tends to be softer than the plug material shaped by shape memory alloy or the like. When the end of the shaped portion is erroneously inserted into the branch vessel, the embolic material may be sucked into the branch vessel from the distal end side at a stroke, and the entire embolic material may be erroneously inserted into the branch vessel.
In contrast, with the
While the above description has been made by taking an embodiment suitable for the present invention, it is needless to say that the present invention is not limited to the above embodiment, and various changes can be made within a range not departing from the gist of the present invention.
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