WO2013121725A1

WO2013121725A1 - Therapy device and therapy set

Info

Publication number: WO2013121725A1
Application number: PCT/JP2013/000543
Authority: WO
Inventors: 克彦清水; 善明若山; 崇彦川原
Original assignee: テルモ株式会社
Priority date: 2012-02-14
Filing date: 2013-01-31
Publication date: 2013-08-22

Abstract

This therapy device (9) has a stimulus-imparting member (7) for imparting a stimulus to an affected area (2) on the outside of a cerebral blood vessel (3), wherein the stimulus-imparting member (7) is capable of delivery to the vicinity of the affected area (2) from the interior of the cerebral blood vessel (3) via the cerebral blood vessel (3).

Description

Treatment device and treatment set

The present invention relates to a treatment device and a treatment set, and more particularly, to a treatment device and a treatment set for treating cranial nerve diseases such as epilepsy, Parkinson's disease, and trigeminal neuralgia.

Cranial nerve diseases include epilepsy, Parkinson's disease, trigeminal neuralgia, etc., and there are many patients for each, and treatment is required.

"Epileptic" is a disease that causes irregular muscle spasms, loss of consciousness, loss of consciousness, and the like due to abnormal electrical signals from lesions (cells that generate abnormal electrical signals).
Treatment of such “epilepsy” is centered on treatment by drug administration, but the effect of treatment by drug administration may not be obtained. In such a case, craniotomy is performed and the lesion is surgically removed. Etc. are done.

“Parkinson's disease” is a disease in which dopamine produced in the midbrain is reduced, resulting in abnormal neurotransmission and inability to smoothly exercise the body.
As for the treatment of such “Parkinson's disease”, treatment by drug administration is the center, but the effect of treatment by drug administration may not be obtained, in which case, the head is opened and an electrode is implanted in the lesion, Giving electrical stimulation.

The treatment of “trigeminal neuralgia” is centered on treatment by drug administration, but there may be cases where the effect of treatment by drug administration cannot be obtained.In that case, the nerve that causes trigeminal neuralgia is opened. Cutting with a high-frequency probe using surgery or heat is performed.

In this way, for cranial nerve diseases such as epilepsy, Parkinson's disease, trigeminal neuralgia, etc., if the therapeutic effect of drug administration cannot be obtained, a highly invasive treatment such as craniotomy may be performed. There is a need for a less invasive treatment other than administration.

Conventionally, as a treatment device that can realize a less invasive renal disease treatment, for example, using a catheter, an electrode is sent into a blood vessel and placed outside the blood vessel through an intravascular-extravascular approach, There is a therapeutic device that induces neuromodulation by applying a pulsed electric field outside a blood vessel (see, for example, Patent Document 1).

However, a treatment device that can realize treatment of a cranial nerve disease with a low degree of invasiveness has not been developed yet, and its development is strongly desired.

Special table 2009-521993

This invention makes it a subject to solve the said various problems in the past and to achieve the following objectives. That is, an object of the present invention is to provide a treatment device and a treatment set that can realize a treatment for a cranial nerve disease with a low degree of invasiveness.

As a result of intensive studies to achieve the above object, the present inventors have provided a stimulus applying member for applying a stimulus to a lesioned part outside the cerebral blood vessel from the inside of the cerebral blood vessel to the vicinity of the lesioned part through the cerebral blood vessel. As a result of the delivery, it has been found that treatment of cranial nerve diseases with a low degree of invasiveness can be realized, and the present invention has been completed.

The present invention is based on the above findings by the present inventors, and means for solving the above problems are as follows. That is, the treatment device of the present invention is a treatment device having a stimulus imparting member that imparts a stimulus to a lesioned part outside the cerebral blood vessel, and the stimulus imparting member passes from the inside of the cerebral blood vessel through the cerebral blood vessel. It can be delivered to the vicinity of the lesion.
Delivering a stimulus applying member for applying a stimulus to a lesioned part outside the cerebral blood vessel from the inside of the cerebral blood vessel to the vicinity of the lesioned part via the cerebral blood vessel, it is possible to realize a treatment for a cranial nerve disease having a low invasiveness. it can.

It is preferable that the treatment device of the present invention further includes a fixing member that fixes the stimulus applying member to the cerebral blood vessel.
When the fixing member for fixing the stimulus applying member to the cerebral blood vessel is further provided, the stimulus applying member can be placed in the vicinity of the lesioned part.

In the treatment device of the present invention, the fixing member includes an inner metal fiber layer composed of a plurality of metal netting strands, an outer metal fiber layer surrounding the inner metal fiber layer and composed of a plurality of metal braided strands, and the inner surface. It is preferable to have fixing means for binding and fixing the terminal end and the base end of the metal braided strand forming each of the metal fiber layer and the outer metal fiber layer.
When the fixing member has an inner metal fiber layer, an outer metal fiber layer, and a fixing means, the opening in the cerebral blood vessel can be closed when the fixing member is in the expanded preset configuration.

In the treatment device of the present invention, it is preferable that the stimulation is at least one of mechanical stimulation, electrical stimulation, and thermal stimulation.

In the treatment device of the present invention, it is preferable that the stimulus applying member for applying the mechanical stimulus is a spiral body or a needle.
When the stimulus applying member that applies the mechanical stimulus is a spiral body or a needle, the mechanical stimulus can be efficiently applied to the lesioned part.

In the treatment device of the present invention, it is preferable that the fixing member and a needle as the stimulus applying member are connected via the fixing means.
When the fixing member and the needle as the stimulus applying member are connected via the fixing means, the cerebral blood vessel can be punctured with a needle placed in the vicinity of the lesion.

The treatment device of the present invention is characterized in that the stimulus applying member is delivered by a delivery device.
When the stimulus applying member is delivered by a delivery device, the stimulus applying member can be delivered efficiently.

In the treatment device of the present invention, the delivery device is preferably a catheter.
When the delivery device is a catheter, the stimulus applying member can be delivered more efficiently.

The treatment set of the present invention includes the treatment device of the present invention and a delivery device that delivers the stimulus applying member from the inside of the cerebral blood vessel to the vicinity of the lesioned part through the cerebral blood vessel.
Delivering a stimulus applying member for applying a stimulus to a lesioned part outside the cerebral blood vessel from the inside of the cerebral blood vessel to the vicinity of the lesioned part via the cerebral blood vessel, it is possible to realize a treatment for a cranial nerve disease having a low invasiveness. it can.

According to the present invention, it is possible to provide a treatment device and a treatment set that can solve the conventional problems, achieve the object, and realize treatment of a cranial nerve disease with a low degree of invasiveness.

FIG. 1 is an explanatory diagram illustrating an example of a method of using a treatment device according to the first embodiment of the present invention (part 1). Drawing 2 is an explanatory view showing an example of a usage method of a treatment device concerning a 1st embodiment of the present invention (the 2). FIG. 3 is an explanatory diagram showing an example of a method of using the treatment device according to the first embodiment of the present invention (part 3). FIG. 4 is an explanatory diagram showing an example of a method for using the treatment device according to the first embodiment of the present invention (part 4). FIG. 5 is a perspective view showing an example of a covered stent (stent graft) used when the treatment device according to the first embodiment of the present invention is used. FIG. 6 is an enlarged front view showing an example of a fixing member in the treatment device according to the first embodiment of the present invention. FIG. 7 is an enlarged side view showing an example of a fixing member (when contracted) in the treatment device according to the first embodiment of the present invention. FIG. 8 is an enlarged side view showing an example of a fixing member (when expanded) in the treatment device according to the first embodiment of the present invention. FIG. 9 is an enlarged side view showing another example of the treatment device (during contraction) according to the first embodiment of the present invention. FIG. 10 is an enlarged side view showing another example of the treatment device (during expansion) according to the first embodiment of the present invention. FIG. 11 is an explanatory diagram illustrating an example of another method for fixing a stimulus imparting member in the treatment device according to the first embodiment of the present invention (part 1). FIG. 12 is an explanatory diagram illustrating an example of a method for fixing another stimulus applying member in the treatment device according to the first embodiment of the present invention (part 2). FIG. 13 is an explanatory diagram illustrating an example of a method for fixing another stimulus applying member in the treatment device according to the first embodiment of the present invention (part 3). FIG. 14 is an explanatory diagram of an example of another method for fixing a stimulus imparting member in the treatment device according to the first embodiment of the present invention (part 4). FIG. 15 is an explanatory diagram illustrating an example of a treatment device detachment system (before detachment) according to the first embodiment of the present invention. FIG. 16 is an enlarged side view showing an example of the treatment device detachment system (after detachment) according to the first embodiment of the present invention. FIG. 17 is an explanatory diagram illustrating another example of the delivery device that delivers the treatment device according to the first embodiment of the present invention. FIG. 18 is an explanatory diagram showing an example of a method of using a treatment device according to the second embodiment of the present invention (part 1). FIG. 19 is an explanatory diagram illustrating an example of a method of using a treatment device according to the second embodiment of the present invention (part 2). FIG. 20 is an explanatory diagram showing an example of a method of using a treatment device according to the third embodiment of the present invention (part 1). FIG. 21 is an explanatory diagram illustrating an example of a method of using a treatment device according to the third embodiment of the present invention (part 2). FIG. 22 is an explanatory diagram illustrating an example of a method for using the treatment device according to the third embodiment of the present invention (part 3).

(Therapeutic device)
The treatment device of the present invention includes at least a stimulus imparting member, and further includes a fixing member and other members as necessary.

<Stimulus imparting member>
The stimulus applying member is a member that gives a stimulus to a lesioned part outside the cerebral blood vessel, and as long as it is a member that can be delivered from the inside of the cerebral blood vessel to the vicinity of the lesioned part through the cerebral blood vessel, in particular. There is no restriction | limiting, According to the objective, it can select suitably, For example, a helical body, a needle | hook, a ring, an electrode, a heating source, a cooling source, etc. are mentioned.

<< Cerebrovascular >>
The cerebral blood vessel is not particularly limited as long as it is a blood vessel existing in the brain (cerebrum, diencephalon, cerebellum, brain stem (midbrain, pons, medulla oblongata)), and can be appropriately selected according to the purpose.

<< lesion site >>
The lesion is not particularly limited as long as it is a cell that generates an abnormal electrical signal or a nerve that transmits the signal, and can be appropriately selected according to the purpose, such as epilepsy, Parkinson's disease, trigeminal neuralgia, The affected cells of cranial nerve diseases such as
The term “in the vicinity of a lesion” means a position outside the cerebral blood vessel where a stimulus can be given to the lesion. Normally, when the distance from the lesion is within 10 mm, the lesion is stimulated. Can be granted.

<< Stimulus >>
There is no restriction | limiting in particular as said irritation | stimulation, According to the objective, it can select suitably, For example, mechanical irritation | stimulation, electrical irritation | stimulation, thermal irritation | stimulation, etc. are mentioned.

-Mechanical stimulation-
There is no restriction | limiting in particular as said mechanical stimulus, According to the objective, it can select suitably, For example, the physical stimulus provided with a helical body, a needle | hook, etc. are mentioned.

-Electrical stimulation-
There is no restriction | limiting in particular as said electrical stimulus, According to the objective, it can select suitably, For example, the electrical stimulus provided by an electrode etc. is mentioned.

The electric power in the electrical stimulation is not particularly limited and may be appropriately selected depending on the purpose, but is preferably 1W to 60W, more preferably 10W to 40W, and particularly preferably 20W to 30W.
When the electric power is less than 1 W, nerve tissue may not be stimulated, and when it exceeds 60 W, damage to normal cells may occur. On the other hand, when the electric power is within the preferable range, it is advantageous in terms of controlling the stimulation range, and when the electric power is within the more preferable range or the particularly preferable range, it is further advantageous.

-Thermal stimulation-
There is no restriction | limiting in particular as said thermal stimulus, According to the objective, it can select suitably, For example, the heating stimulus provided by a heating source, the cooling stimulus provided by a cooling source, etc. are mentioned.

-Heating stimulus-
The heating temperature to which the heating stimulus is applied is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 50 ° C to 100 ° C, more preferably 60 ° C to 80 ° C, and more preferably 65 ° C to 75 ° C. ° C is particularly preferred.
If the heating temperature is less than 50 ° C, the cells may not be cauterized. If the heating temperature exceeds 100 ° C, normal cells may be damaged. On the other hand, when the heating temperature is within the preferable range, it is advantageous in terms of controlling the stimulation range, and when the heating temperature is within the more preferable range or within the particularly preferable range, it is further advantageous.

--Cooling stimulus--
The cooling temperature to which the cooling stimulus is applied is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 0 ° C to 30 ° C, more preferably 5 ° C to 25 ° C, and more preferably 15 ° C to 20 ° C. ° C is particularly preferred.
If the cooling temperature is less than 0 ° C, water may solidify, and if it exceeds 30 ° C, normal cells may be damaged. On the other hand, the cooling temperature within the preferred range is advantageous in terms of controlling the stimulation range, and is more advantageous within the more preferred range or the particularly preferred range.

<< Delivery >>
The delivery is not particularly limited as long as it is delivery from the inside of the cerebral blood vessel to the vicinity of the lesioned part via the cerebral blood vessel, and can be appropriately selected according to the purpose. For example, using a delivery device Done.

-Delivery device-
There is no restriction | limiting in particular as long as it is a device which delivers a stimulus imparting member as said delivery device, According to the objective, it can select suitably, For example, a catheter, a cannula, etc. are mentioned.

--catheter--
The catheter is not particularly limited and may be appropriately selected depending on the intended purpose. Examples thereof include a cerebrovascular catheter having an outer diameter of 1.7 French to 6 French.
There is no restriction | limiting in particular as said cerebrovascular catheter, According to the objective, it can select suitably, For example, a guiding catheter, a microcatheter, etc. are mentioned.

--- Cannula--
The cannula is not particularly limited and may be appropriately selected depending on the intended purpose. Examples thereof include a cannula having an outer diameter of 0.25 mm to 1.7 mm.

<< Spiral body >>
The spiral body is not particularly limited as long as it has a spiral shape, and can be appropriately selected according to the purpose. Examples thereof include a coil and a spring.

-Structure of spiral body-
There is no restriction | limiting in particular as a structure of the said helical body, According to the objective, it can select suitably, Either a single layer structure or a multilayer structure may be sufficient.
In addition, the spiral body is appropriately folded by a delivery device (for example, a catheter or a cannula) so as to be accommodated in the delivery device when delivered from the inside of the brain blood vessel to the vicinity of the lesioned portion via the brain blood vessel. A possible structure is preferred.

-Shape and size of spiral body-
In the following, characteristic values (wire diameter, spiral radius, pitch width, number of turns) for specifying the shape and size of the spiral body are shown, and these values are the spirals in the folded state in the delivery device. It is not the characteristic value of the rod-shaped body, but the characteristic value of the spiral-shaped body when mechanical stimulation is applied (during expansion).

The wire diameter of the spiral body is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 50 μm to 900 μm, more preferably 100 μm to 500 μm, and particularly preferably 200 μm to 400 μm.
When the wire diameter is less than 50 μm, imaging may not be performed under X-rays, and when it exceeds 900 μm, delivery to the cerebral blood vessels may not be possible. On the other hand, when the wire diameter is within the preferred range, it is advantageous in terms of controlling the stimulation range, and when the wire diameter is within the more preferred range or the particularly preferred range, it is further advantageous.

The spiral radius of the spiral body is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 0.5 mm to 50 mm, more preferably 1 mm to 30 mm, and particularly preferably 2 mm to 10 mm.
If the spiral radius is less than 0.5 mm, the cells may not be stimulated, and if it exceeds 50 mm, normal tissue may be damaged. On the other hand, when the spiral radius is within the preferable range, it is advantageous in terms of controlling the stimulation range, and it is further advantageous when the spiral radius is within the more preferable range or the particularly preferable range.

The length of the spiral of the spiral body is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 1 mm to 50 mm, more preferably 5 mm to 40 mm, and particularly preferably 10 mm to 30 mm.
When the length is less than 1 mm, the cells may not be stimulated, and when it exceeds 50 mm, the normal tissue may be damaged. On the other hand, when the length is within the preferred range, it is advantageous in terms of controlling the stimulation range, and when the length is within the more preferred range or the particularly preferred range, it is further advantageous.

-Material of spiral body-
The material of the spiral body is not particularly limited and may be appropriately selected depending on the purpose. For example, metals such as Ni—Ti, SUS, Pt, Au, and the like; polylactic acid, nylon, fluorine, Examples thereof include urethane-based polymers, inorganic materials, and the like.

<< Needle >>
-Needle structure-
There is no restriction | limiting in particular as a structure of the said needle | hook, According to the objective, it can select suitably, Either a single layer structure or a multilayer structure may be sufficient.
In addition, the needle can be appropriately folded so that the needle fits in the delivery device when delivered from the inside of the brain blood vessel to the vicinity of the lesioned portion via the brain blood vessel by the delivery device (eg, catheter, cannula). A structure is preferred.

-Needle shape and size-
The characteristic values (maximum diameter, total length, taper length) for specifying the shape and size of the needle are shown below. These values are the characteristics of the spiral body in the folded state in the delivery device. It is not the value but the characteristic value of the needle when applying mechanical stimulation (during expansion).

The maximum diameter of the needle is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 0.5 mm to 50 mm, more preferably 1 mm to 30 mm, and particularly preferably 2 mm to 10 mm.
When the maximum diameter is less than 0.5 mm, cells may not be stimulated, and when it exceeds 50 mm, normal tissue may be damaged. On the other hand, when the spiral radius is within the preferable range, it is advantageous in terms of controlling the stimulation range, and it is further advantageous when the spiral radius is within the more preferable range or the particularly preferable range.

The total length of the needle is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 0.5 mm to 50 mm, more preferably 1 mm to 30 mm, and particularly preferably 2 mm to 10 mm.
If the total length is less than 0.5 mm, the cells may not be stimulated, and if it exceeds 50 mm, normal tissue may be damaged. On the other hand, when the total length is within the preferable range, it is advantageous in terms of controlling the stimulation range, and it is further advantageous when the total length is within the more preferable range or the particularly preferable range.

-Needle material-
The material of the needle is not particularly limited and may be appropriately selected depending on the purpose. For example, metals such as Ni—Ti, SUS, Pt, Au, etc .; polylactic acid, nylon, fluorine, urethane And the like; inorganic materials; and the like.

<< Ring >>
-Ring structure-
There is no restriction | limiting in particular as a structure of the said ring, According to the objective, it can select suitably, Either a single layer structure or a multilayer structure may be sufficient.
In addition, the ring can be appropriately folded so that the ring fits in the delivery device when delivered from the inside of the brain blood vessel to the vicinity of the lesioned part via the brain blood vessel by the delivery device (eg, catheter, cannula). A structure is preferred.

-Ring shape and size-
The characteristic values (wire diameter, total length, maximum ring diameter, minimum ring diameter) for specifying the shape and size of the ring are shown below, and these values are the spiral in the folded state in the delivery device. It is not the characteristic value of the body, but the characteristic value of the ring when mechanical stimulation is applied (during expansion).

The ring wire diameter is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 50 μm to 900 μm, more preferably 100 μm to 500 μm, and particularly preferably 200 μm to 400 μm.
When the wire diameter is less than 50 μm, imaging may not be performed under X-rays, and when it exceeds 900 μm, delivery to the cerebral blood vessels may not be possible. On the other hand, when the wire diameter is within the preferred range, it is advantageous in terms of controlling the stimulation range, and when the wire diameter is within the more preferred range or the particularly preferred range, it is further advantageous.

The maximum ring diameter of the ring is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 1 mm to 50 mm, more preferably 5 mm to 40 mm, and particularly preferably 10 mm to 30 mm.
If the maximum ring diameter is less than 1 mm, it may be impossible to surround the cerebral blood vessel, and if it exceeds 50 mm, normal cells may be damaged. On the other hand, when the maximum ring diameter is within the preferable range, it is advantageous in terms of controlling the stimulation range, and when the maximum ring diameter is within the more preferable range or the particularly preferable range, it is further advantageous.

-Material of the ring-
The material of the ring is not particularly limited and can be appropriately selected depending on the purpose. For example, metals such as Ni—Ti, SUS, Pt, Au, etc .; polylactic acid, nylon, fluorine, urethane And the like; inorganic materials; and the like.

<< Electrode >>
There is no restriction | limiting in particular as said electrode, According to the objective, it can select suitably.

-Electrode structure-
There is no restriction | limiting in particular as a structure of the said electrode, According to the objective, it can select suitably, Either a single layer structure or a multilayer structure may be sufficient.
In addition, the electrode can be appropriately folded so as to be accommodated in the delivery device when delivered from the inside of the cerebral blood vessel to the vicinity of the lesioned part via the cerebral blood vessel by a delivery device (for example, a catheter, cannula). A structure is preferred.

-Electrode shape-
There is no restriction | limiting in particular as a shape of the said electrode, According to the objective, it can select suitably, For example, plate shape, spiral shape, needle shape, etc. are mentioned.

-Surface area (size) of electrode-
The surface area of the electrode is not particularly limited and may be appropriately selected depending on the intended ^purpose, but is preferably 1 mm 2 ~ 7000 mm ^{^2,} more preferably 15 mm 2 ~ 3700 mm ^{^2,} particularly preferably 60mm ² ~ 900mm 2.
If the surface area is less than 1 mm ² , the tissue may not be stimulated, and if it exceeds 7,000 mm ² , normal cells may be damaged. On the other hand, when the surface area is within the preferable range, it is advantageous in terms of the stimulation control range, and when the surface area is within the more preferable range or the particularly preferable range, it is further advantageous.

-Material of the electrode-
There is no restriction | limiting in particular as a material of the said electrode, According to the objective, it can select suitably, For example, common electrode materials, such as platinum, etc. are mentioned.

<< Heating source >>
There is no restriction | limiting in particular as said heat source, According to the objective, it can select suitably, For example, an electrode, a hot balloon, etc. are mentioned.

-Heat source structure-
There is no restriction | limiting in particular as a structure of the said heat source, According to the objective, it can select suitably, Either a single layer structure or a multilayer structure may be sufficient.
In addition, the heating source can be appropriately folded so as to be accommodated in the delivery device when delivered from the inside of the brain blood vessel to the vicinity of the lesioned part via the brain blood vessel by the delivery device (for example, catheter, cannula). It is preferable that it is a simple structure.

-Shape of heating source-
There is no restriction | limiting in particular as a shape of the said heat source, According to the objective, it can select suitably, For example, plate shape, spiral shape, needle shape, etc. are mentioned.

-Surface area (size) of heating source-
The surface area of the heating source is not particularly limited and may be appropriately selected depending on the intended ^purpose, but is preferably 1 mm 2 ~ 7000 mm ^{^2,} more preferably 15 mm 2 ~ 3700 mm ^{^2,} particularly preferably 60 mm 2 ~ 900 mm ² .
If the surface area is less than 1 mm ² , the tissue may not be stimulated, and if it exceeds 7,000 mm ² , normal cells may be damaged. On the other hand, when the surface area is within the preferable range, it is advantageous in terms of the stimulation control range, and when the surface area is within the more preferable range or the particularly preferable range, it is further advantageous.

-Material of heating source-
There is no restriction | limiting in particular as a material of the said heat source, According to the objective, it can select suitably, For example, common polymer materials, such as conventional electrode materials, such as platinum, nylon, etc. are mentioned.

<< Cooling source >>
There is no restriction | limiting in particular as said cooling source, According to the objective, it can select suitably, For example, a Peltier device etc. are mentioned.

-Cooling source structure-
There is no restriction | limiting in particular as a structure of the said cooling source, According to the objective, it can select suitably, Either a single layer structure or a multilayer structure may be sufficient.
In addition, the cooling source is accommodated in the delivery device when delivered from the inside of the cerebral blood vessel to the vicinity of the lesioned part via the cerebral blood vessel by the delivery device (for example, catheter, cannula) A foldable structure is preferable as appropriate.

-Cooling source shape-
There is no restriction | limiting in particular as a shape of the said cooling source, According to the objective, it can select suitably, For example, plate shape, spiral shape, needle shape, etc. are mentioned.

-Surface area (size) of cooling source-
The surface area of the cooling source is not particularly limited and may be appropriately selected depending on the intended ^purpose, but is preferably 1 mm 2 ~ 7000 mm ^{^2,} more preferably 15 mm 2 ~ 3700 mm ^{^2,} particularly preferably 60 mm 2 ~ 900 mm ² .
If the surface area is less than 1 mm ² , the tissue may not be stimulated, and if it exceeds 7,000 mm ² , normal cells may be damaged. On the other hand, when the surface area is within the preferable range, it is advantageous in terms of the stimulation control range, and when the surface area is within the more preferable range or the particularly preferable range, it is further advantageous.

-Material of cooling source-
There is no restriction | limiting in particular as a material of the said cooling source, According to the objective, it can select suitably, For example, aluminum etc. are mentioned.

<Fixing member>
The fixing member is not particularly limited as long as it is a member that fixes the stimulus imparting member to the cerebral blood vessel, and can be appropriately selected according to the purpose. For example, a blood vessel as shown in JP-A-2009-213900 Examples thereof include a fixing member configured to sandwich a wall.

The fixing member fixes the stimulus applying member to the cerebral blood vessel, so that the stimulus applying member can be placed in the vicinity of the lesioned part. Thereby, for example, the stimulus applying member continuously swings due to the pulsation of the cerebral blood vessel to which the stimulus applying member is fixed, and mechanical stimulation can be continuously applied to the lesioned part.

<Other members>
There is no restriction | limiting in particular as said other member, According to the objective, it can select suitably.

Hereinafter, embodiments of the treatment device of the present invention will be described with reference to the drawings.

<First Embodiment>
The first embodiment will be described below.
1 to 4 are explanatory views showing an example of a method of using the treatment device according to the first embodiment of the present invention.

First, (i) a sheath is inserted into a blood vessel, and (ii) a treatment guide wire (not shown) and a microcatheter are brought through the sheath to a cerebral blood vessel near the lesion. (Iii) Next, as shown in FIG. 1, a covered stent (stent graft) 4 is delivered inside the cerebral blood vessel 3 in the vicinity of the lesion 2 that generates the abnormal electrical signal 1 along the treatment guide wire. , Detain. After the covered stent (stent graft) 4 is placed, the treatment guide wire is pulled out, and the microcatheter is not pulled out and is maintained.

Here, the covered stent (stent graft) 4 includes, for example, as shown in FIG. 5, a stent body 4a and a cylindrical cover 4b covering the side surface of the stent body 4a. The cylindrical cover 4b is made of a highly elastic elastomer material having a shape restoring property, and is configured so that blood does not leak even when puncturing from the inside of the cerebral blood vessel 3.

(Iv) Next, as shown in FIG. 2, the tip 5a of the microcatheter 5 is bent in the direction of the lesion 2 and fixed. (V) Push in a delivery device A (for example, MyClass microcoil delivery system manufactured by Johnson & Johnson Co., Ltd.) provided with a treatment device 9 having a needle-like stimulus imparting member 7 and a fixing member 8 at the tip. As a result, the treatment device 9 is pushed through the lumen of the microcatheter 5 and passes through the tip 5 a of the microcatheter 5. Thereby, the needle-like stimulus imparting member 7 in the treatment device 9 penetrates the vascular wall 3 a by piercing the cylindrical cover 4 b of the covered stent 4 and the vascular wall 3 a of the cerebral blood vessel 3. Thereafter, as shown in FIG. 3, at least a part of the needle-like stimulus imparting member 7 is positioned in the vicinity of the lesioned part 2, and one member 8 a of the two members of the fixing member 8 is outside the cerebral blood vessel 3. The treatment device 9 is disposed such that the other member 8b of the fixing member 8 is located inside the cerebral blood vessel 3, the treatment device 9 is disconnected from the delivery device A by an electric current, and the treatment device 9 is placed. Pull out delivery device A. (Vi) Thereafter, the microcatheter 5 is pulled out. Here, as described above, the cylindrical cover 4b of the covered stent 4 is made of a highly elastic elastomer material having a shape restoring property. Therefore, the needle-like stimulus applying member 7 from the inside of the cerebral blood vessel 3 is used. No blood leaks even if the cerebral blood vessel 3 is punctured.

Next, as shown in FIG. 4, one member 8 a of the fixing member 8 and the other member 8 b of the fixing member 8 are expanded so as to sandwich the blood vessel wall 3 a of the cerebral blood vessel 3, and the stimulus applying member 7 is fixed to the cerebral blood vessel 3.

As described above, the fixing member 8 fixes the stimulus applying member 7 to the cerebral blood vessel 3 so that the stimulus applying member 7 can be placed in the vicinity of the lesioned part 2. Thereby, the stimulus applying member 7 is continuously swung by the pulsation of the cerebral blood vessel 3, and the mechanical stimulus can be continuously applied to the lesioned part 2.

Here, examples of the fixing member 8 include a fixing member configured to sandwich the blood vessel wall 3a as shown in FIGS. 6 to 8 (see Japanese Patent Application Laid-Open No. 2009-213900).

FIG. 6 is an enlarged front view showing an example of a fixing member in the treatment device of the present invention.
In FIG. 6, the fixing member 8 includes inner metal fiber layers 22 and 24 made of a plurality of metal mesh strands, and an outer metal fiber layer 20 made of a plurality of metal braid strands surrounding the inner metal fiber layer.

FIG. 7 is an enlarged side view showing an example of a fixing member (when contracted) in the treatment device of the present invention.
In FIG. 7, the fixing member 8 includes two disks such as a member 8 a and a member 8 b aligned in the axial direction, and fixing means (clamps) 26 are formed at both ends of the fixing member 8 in the axial direction. ing. The ends and base ends of the metal braided strands forming the inner metal fiber layers 22 and 24 and the outer metal fiber layer 20 are bound and fixed to each other by a clamp 26. The clamp 26 has a screw hole 28 (see FIG. 8 to be described later). The screw hole 28 is configured to receive and engage a screw end provided on the stimulation applying member and the delivery device.
Here, the fixing member 8 has a preset shape deformed to a small cross-sectional dimension and can be delivered by a delivery device.
FIG. 9 shows a case where a needle-like stimulus applying member 60 as a stimulus applying member is fixed to the clamp 26.

FIG. 8 is an enlarged side view showing an example of a fixing member (when expanded) in the treatment device of the present invention.
In FIG. 8, the fixing member 8 has an expanded preset shape so that the blood vessel wall can be sandwiched between the

members

8a and 8b connected to each other via a short cylindrical portion 16 and the opening of the blood vessel can be closed. It is configured.
FIG. 10 shows a case where a needle-like stimulus imparting member 60 as a stimulus imparting member is fixed to the clamp 26.
When the fixing member 8 having the above configuration is connected to the needle-like stimulus applying member 60 via the clamp 26 (FIGS. 9 and 10), the cerebral blood vessel can be punctured with a needle placed near the lesioned part. At the same time, the opening in the cerebral blood vessel 3 can be closed when in the expanded preset configuration.

In the first embodiment described above, the needle-like stimulus imparting member 60 that imparts mechanical stimulus is used as the stimulus imparting member 7 in the treatment device 9, but the present invention is not limited to this, and needle-like stimulus imparting is not limited thereto. In place of the member 60, a spiral body (FIGS. 18 and 19 to be described later) and a ring for applying mechanical stimulation; an electrode for applying electrical stimulation; a heat source and a cooling source for applying thermal stimulation; it can.

In the first embodiment described above, the stimulus applying member 7 is fixed to the blood vessel wall 3a of the cerebral blood vessel 3 by the fixing member 8. However, the present invention is not limited to this. For example, (i) FIG. Thus, the needle-like stimulus applying member 60 may be fixed to the cerebral blood vessel 3 by penetrating the cerebral blood vessel 3, and (ii) as shown in FIG. By forming a ring along the outer peripheral surface of the blood vessel wall 3a of the blood vessel 3, the range of motion of the ring-like stimulus applying member 70 may be limited to the vicinity of the cerebral blood vessel 3. (iii) As shown in FIG. In addition, the spiral stimulus applying member 80 may be fixed to the cerebral blood vessel 3 by being bonded to the blood vessel wall 3a of the cerebral blood vessel 3. (iv) As shown in FIG. The

portions

90a, 90b, 90c are embedded in the blood vessel wall 3a. By being written, stimulating member 90 may be fixed to the cerebrovascular 3.

In the first embodiment described above, the microcatheter 5 is used as a delivery device for delivering the stimulus applying member 7, but the present invention is not limited to this, and other delivery devices such as a guiding catheter and a cannula are used. It may be used.

In the first embodiment described above, the treatment device 9 is moved using the delivery device, and the treatment device 9 is disconnected from the delivery device by electric current. However, the present invention is not limited to this. For example, FIG. In the instant detachment system as shown in 15 and 16, the detachment ring 42 is moved from the holding ring 41 to the treatment device 9 side and separated by pulling out the release wire 40 in the lumen of the delivery pusher portion 30. A thing may be used.

In the first embodiment described above, the covered stent 4 is indwelled using the microcatheter 5 and further the treatment device 9 is indwelled. However, the present invention is not limited to this, and the guiding catheter is not limited thereto. May be used. In that case, the covered stent 4 and the treatment device 9 may be placed only with the guiding catheter, or the microcatheter 5 may be fed through the lumen of the guiding catheter GC as shown in FIG. By feeding the microcatheter 5 through the lumen of the guiding catheter GC, the guide wire with needle or the needle-like stimulus applying member 7 is assisted to puncture the cylindrical cover 4b and the blood vessel wall 3a, or the stimulus applying member. 7 can assist the passage of the spiral body 7 through the cylindrical cover 4b and the blood vessel wall 3a.
Moreover, when delivering the covered stent (stent graft) 4 to the lesioned part 2, the microcatheter 5 and the guiding catheter GC may not be used.

In the first embodiment described above, the needle-like stimulus imparting member 7 is punctured into the cylindrical cover 4b of the covered stent 4 and the blood vessel wall 3a of the cerebral blood vessel 3. However, the present invention is not limited to this. You may puncture the cylindrical cover 4b and the blood vessel wall 3a with the front-end | tip 5a of the microcatheter 5, or the front-end | tip of a guiding catheter.

<Second Embodiment>
The second embodiment will be described below with a focus on differences from the first embodiment. In addition, the same code | symbol is attached | subjected to the site | part which has the same function and structure as 1st Embodiment.
18 to 19 are explanatory views showing an example of a method of using the treatment device according to the second embodiment of the present invention.

In the second embodiment, after (i) to (iii) in the first embodiment, (iv) the tip 5a of the microcatheter 5 is bent in the direction of the lesion 2 and fixed. (V) A guide wire with a needle is advanced through the lumen of the microcatheter 5 to pass the tip 5a of the microcatheter 5. Thereby, the guide wire with a needle is pierced into the cylindrical cover 4b of the covered stent 4 and the blood vessel wall 3a of the cerebral blood vessel 3 to penetrate the blood vessel wall 3a. Thereafter, the tip 5a of the microcatheter 5 is advanced to the outside of the cerebral blood vessel 3 along the guide wire with needle, and the guide wire with needle is pulled out. (Vi) Thereafter, as shown in FIG. 18, a delivery device A (for example, Johnson & Johnson Co., Ltd.) provided with a treatment device 9 having a spiral body as the stimulus imparting member 7 and a fixing member 8 at its tip. By pushing the MyClass microcoil delivery system), the treatment device 9 is pushed through the lumen of the microcatheter 5 to pass through the tip 5a of the microcatheter 5, and at least a part of the stimulus applying member 7 is the lesioned part 2 The therapeutic device is such that one of the two members 8a of the fixing member 8 is located outside the cerebral blood vessel 3 and the other member 8b of the fixing member 8 is located inside the cerebral blood vessel 3. 9, the treatment device 9 is disconnected from the delivery device A by an electric current, and the treatment device 9 is left in place, and the delivery device Pull out the A. (Vii) Thereafter, the microcatheter 5 is pulled out. Next, as shown in FIG. 19, the stimulus applying member is expanded so that one member 8 a of the fixing member 8 and the other member 8 b of the fixing member 8 sandwich the blood vessel wall 3 a of the cerebral blood vessel 3. 7 is fixed to the blood vessel wall 3a. Here, as described above, the cylindrical cover 4b of the covered stent 4 is made of a highly elastic elastomer material having a shape restoring property. No blood leaks even if the microcatheter 5 is inserted to the outside of the cerebral blood vessel 3 by puncturing 3.
In the second embodiment, the guide wire with needle is inserted into the cylindrical cover 4b of the covered stent 4 and the blood vessel wall 3a of the cerebral blood vessel 3, and after passing through the blood vessel wall 3a, the microcatheter 5 is guided with the needle. The guide wire with needle is pulled out along the wire to the outside of the cerebral blood vessel 3, but the guide wire with needle is not limited to this, and the cylindrical cover 4 b of the covered stent 4 and the cerebral blood vessel 3 are not limited thereto. After piercing the blood vessel wall 3a and penetrating the blood vessel wall 3a to form a microscopic hole as a passage, without pulling the microcatheter 5 outside the brain blood vessel 3, the guide wire with needle is pulled out, The treatment device 9 may be allowed to pass through a minute hole formed in the tubular cover 4b and the blood vessel wall 3a of the cerebral blood vessel 3 as a passage.

<Third Embodiment>
The third embodiment will be described below with a focus on differences from the first embodiment. In addition, the same code | symbol is attached | subjected to the site | part which has the same function and structure as 1st Embodiment.

20 to 22 are explanatory diagrams showing an example of a method of using the treatment device according to the third embodiment of the present invention.

As shown in FIGS. 20 to 22, a covered stent including a stimulus applying member 7 having a metal portion composed of at least one needle 100 inside a cerebral blood vessel 3 in the vicinity of a lesioned part 2 that generates an abnormal electrical signal 1. The main body of the stent in the covered stent (stent graft) 4 protruding in the extending direction from the inside of the sheath 10 by pulling the sheath 10 or pushing out the covered stent (stent graft) 4 when arranging the (stent graft) 4 4a and the needle 100 are self-expanding, and the needle 100 penetrates the blood vessel.
Here, the sheath 10 is not particularly limited as long as it is tubular, and examples thereof include a guiding catheter, a microcatheter, and a tube having a diameter larger than that of the catheter.

In this way, the stimulus applying member 7 composed of at least one needle 100 is protruded from the stent main body 4a, and the needle 100 penetrates the tubular cover 4b and the blood vessel wall 3a of the cerebral blood vessel 3, thereby causing the lesion 2 Is given mechanical stimulation.

Here, since the stimulus applying member composed of the plurality of needles 100 in the treatment device 9 is connected to the stent body 4 a placed in the cerebral blood vessel 3, it is fixed to the cerebral blood vessel 3.

As described above, the plurality of needles 100 are fixed to the cerebral blood vessel 3 so that a covered stent (stent graft) including the plurality of needles 100 can be placed in the vicinity of the lesioned part 2.
Thereby, the plurality of needles 100 are continuously swung by the pulsation of the cerebral blood vessel 3, and mechanical stimulation can be continuously applied to the lesioned part 2.

In the third embodiment, a plurality of needles 100 for applying mechanical stimulation are used as the stimulus applying member 7 in the treatment device 9, but the present invention is not limited to this. It is also possible to use a spiral body and a ring for applying an electrical stimulus; an electrode for applying an electrical stimulus; a heat source and a cooling source for applying a thermal stimulus;

The treatment device of the present invention can be suitably used for the treatment of cranial nerve diseases (particularly epilepsy, Parkinson's disease, trigeminal neuralgia).

1 abnormal electrical signal 2 lesion 3 brain blood vessel 3a blood vessel wall 4 covered stent (stent graft)

4a Stent body

4b Tubular cover 5 Microcatheter 5a Microcatheter tip 7 Stimulation member 8 Fixing member 8a Member 8b Member 9 Treatment device 16 Cylindrical portion 20 Outer metal fiber layer 22 Inner metal fiber layer 24 Inner metal fiber layer 26 Clamp 28 Screw-in hole 30 Delivery pusher section 40 Release wire 41 Retaining ring 42 Detach ring 60 Needle-like stimulus applying member 70 Ring-like stimulus applying member 80 Spiral stimulus applying member 90 Stimulation applying member

90a Fixing part

90b Fixing part

90c Fixing part 100 Needle A Delivery Device GC guiding catheter

Claims

A treatment device having a stimulus imparting member that imparts a stimulus to a lesioned part outside the cerebral blood vessel,
The treatment device, wherein the stimulus imparting member can be delivered from the inside of the cerebral blood vessel to the vicinity of the lesioned part through the cerebral blood vessel.
The treatment device according to claim 1, further comprising a fixing member for fixing the stimulus applying member to the cerebral blood vessel.
The fixing member includes an inner metal fiber layer made of a plurality of metal mesh strands, an outer metal fiber layer surrounding the inner metal fiber layer and made of a plurality of metal braided strands, the inner metal fiber layer, and the outer metal. The treatment device according to claim 1 or 2, further comprising fixing means for binding and fixing the end and the base end of the metal braided strand forming each of the fiber layers.
The treatment device according to claim 1, wherein the stimulus is a mechanical stimulus.
The treatment device according to claim 1, wherein the stimulus is an electrical stimulus.
The treatment device according to claim 1, wherein the stimulus is a thermal stimulus.
The treatment device according to claim 4, wherein the stimulus applying member for applying the mechanical stimulus is a spiral body.
The treatment device according to claim 4, wherein the stimulus applying member for applying the mechanical stimulus is a needle.
The treatment device according to claim 3, wherein the fixing member and a needle as the stimulus applying member are connected via the fixing means.
The treatment device according to claim 1, wherein the stimulus applying member is delivered by a delivery device.
The treatment device according to claim 10, wherein the delivery device is a catheter.
A treatment set comprising: the treatment device according to claim 1; and a delivery device for delivering the stimulus applying member from the inside of the cerebral blood vessel to the vicinity of the lesioned part through the cerebral blood vessel.