WO2013121725A1 - Therapy device and therapy set - Google Patents

Therapy device and therapy set

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Publication number
WO2013121725A1
WO2013121725A1 PCT/JP2013/000543 JP2013000543W WO2013121725A1 WO 2013121725 A1 WO2013121725 A1 WO 2013121725A1 JP 2013000543 W JP2013000543 W JP 2013000543W WO 2013121725 A1 WO2013121725 A1 WO 2013121725A1
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WO
Grant status
Application
Patent type
Prior art keywords
member
device
treatment
cerebrovascular
stimulating
Prior art date
Application number
PCT/JP2013/000543
Other languages
French (fr)
Japanese (ja)
Inventor
克彦 清水
善明 若山
崇彦 川原
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551Spinal or peripheral nerve electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • A61B2017/12054Details concerning the detachment of the occluding device from the introduction device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36064Epilepsy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067Movement disorders, e.g. tremor or Parkinson disease

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 the treatment set

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

As brain diseases, epilepsy, Parkinson's disease, trigeminal neuralgia, etc., include, for each, there are a number of patients, in need of treatment.

The term "epilepsy", the abnormality electrical signal from lesions (cell for generating an abnormal electrical signals), irregular twitching of muscles, loss of consciousness, consciousness impairment, a disease that causes such.
The treatment of such "epilepsy", is a central treatment with drug delivery, there is a case that the effects of the drug therapy administered is not obtained, in that case, surgical removal that the lesion was craniotomy such as has been carried out.

The "Parkinson's disease", in order to dopamine produced in the midbrain is decreased, abnormal neurotransmission occurs, a disease can not be smooth movement of the body.
The treatment of such "Parkinson's disease", is a central treatment with drug delivery, there is a case that the effects of the drug therapy administered is not obtained, in which case the craniotomy and implanted electrodes to lesion, It has been made, such as to provide electrical stimulation.

The treatment of "trigeminal neuralgia" is a central treatment with drug delivery, there is a case that the effects of the drug therapy administered is not obtained, in which case, by craniotomy, the nerve responsible for trigeminal neuralgia It is being carried out, such as cutting with a high frequency probe using a surgical or heat.

Thus, epilepsy, Parkinson's disease, since the relative trigeminal neuralgia, cranial nerve diseases such as, when the effect of treatment with drug administration can not be obtained, sometimes high therapeutic invasive degree that craniotomy is made, medicine less invasive than dose treatment is sought.

Conventionally, as a therapeutic device that can realize low renal diseases of invasive, for example, using a catheter, a blood vessel by feeding electrode into the vessel - through the extravascular approach path disposed outside the vessel, the pulsed electric field by applying extravascularly have therapeutic device to induce neuromodulation (e.g., see Patent Document 1).

However, for the treatment device which can realize low brain disease treatment of invasive, not been developed, at present its development is strongly desired.

JP-T 2009-521993 JP

The present invention is to solve the various problems in the art, and achieving the following object. That is, the present invention aims to provide a treatment device and treatment set can be realized with low brain disease treatment of invasive.

The present inventors have found that the result of object has been accomplished, and the stimulus imparting member for imparting a stimulus to the lesion in the external cerebrovascular, near the lesion from the interior of cerebrovascular via cerebrovascular by delivering, it found that it is possible to realize a lower cranial nerve diseases of invasive, thereby completing the present invention.

The present invention is based on the findings by the present inventors, as a means for solving the problems are as follows. That is, the treatment device of the present invention is a treatment device having a stimulating member for applying a stimulus to the lesion in the external cerebrovascular, said stimulating member, from the interior of the cerebrovascular via the cerebrovascular characterized in that that may be delivered to the vicinity of the lesion.
The stimulating member for applying a stimulus to the lesion in the external of the cerebrovascular and delivered to the lesion near the interior of the cerebrovascular via the cerebrovascular, is possible to realize a low invasive brain disease treatment it can.

Treatment device of the present invention preferably further has a fixing member for fixing the stimulating member to the cerebrovascular.
If further comprising a fixing member for fixing the stimulating member to the cerebrovascular may retain the stimulating member proximate the lesion.

Treatment device of the present invention, the fixing member, and the inner metal fiber layer comprising a plurality of metal braided strands and outer metal fabric layers which surround the inner metal fabric layers consisting of a plurality of metal braided strands, the inner it is preferred to have a fixing means for fixing by tying together the distal and proximal metal braided strands forming each of the metal fiber layer outer metal fiber layer.
The fixing member, and the inner metal fabric layers, and an outer metal fiber layer and having a fixing means, when in the expanded preset configuration, it is possible to close the opening in the brain blood vessels.

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

Treatment device of the present invention, it is preferable stimulating member for applying the mechanical stimulation is spiral member or needle.
When stimulating member for applying the mechanical stimuli is a spiral member or a needle, it is possible to efficiently impart mechanical stimulation to the lesion.

This treatment device of the invention is that the needle as the stimulating member and the fixing member through the fixing means are connected are preferred.
When the needle and is connected as the stimulating member and the fixing member via the fixing means, it is possible to perform puncturing of the brain vessels needle placement near the lesion.

Treatment device of the present invention is characterized in that said stimulating member is delivered by the delivery device.
When the stimulus imparting member is delivered by the delivery device can deliver the stimulating member efficiently.

Treatment device of the present invention, it is preferable that the delivery device is a catheter.
When the delivery device is a catheter, it is possible to deliver the stimulating member more efficiently.

Treatment set of the present invention is characterized by having a treatment device of the present invention, a delivery device for delivering the stimulating member proximate the lesion from the interior of the cerebral blood vessel through the brain blood vessels.
The stimulating member for applying a stimulus to the lesion in the external of the cerebrovascular and delivered to the lesion near the interior of the cerebrovascular via the cerebrovascular, is possible to realize a low invasive brain disease treatment it can.

According to the present invention, to solve the various problems in the art, the can achieve the purpose, it is possible to provide a treatment device and treatment set can be realized with low brain disease treatment of invasive.

Figure 1 is an explanatory diagram showing an example of use of the treatment device according to the first embodiment of the present invention (Part 1). Figure 2 is an explanatory diagram showing an example of use of the treatment device according to the first embodiment of the present invention (Part 2). Figure 3 is an explanatory diagram showing an example of use of the treatment device according to the first embodiment of the present invention (Part 3). Figure 4 is an explanatory diagram showing an example of use of the treatment device according to the first embodiment of the present invention (Part 4). Figure 5 is a perspective view showing an example of a covered stent (stent graft) used when using the treatment device according to a first embodiment of the present invention. Figure 6 is an enlarged front view showing one example of a fixing member in the treatment device according to the first embodiment of the present invention. Figure 7 is an enlarged side view showing an example of a fixing member in the treatment device according to the first embodiment of the present invention (during contraction). Figure 8 is an enlarged side view showing an example of a fixing member in the treatment device according to the first embodiment of the present invention (when expanded). Figure 9 is an enlarged side view showing another example of a treatment device according to the first embodiment of the present invention (during contraction). Figure 10 is an enlarged side view showing another example of a treatment device according to the first embodiment of the present invention (when expanded). Figure 11 is an explanatory diagram showing an example of a fixing method other stimulating member in the treatment device according to the first embodiment of the present invention (Part 1). Figure 12 is an explanatory diagram showing an example of a fixing method other stimulating member in the treatment device according to the first embodiment of the present invention (Part 2). Figure 13 is an explanatory diagram showing an example of a fixing method other stimulating member in the treatment device according to the first embodiment of the present invention (Part 3). Figure 14 is an explanatory diagram showing an example of a fixing method other stimulating member in the treatment device according to the first embodiment of the present invention (Part 4). Figure 15 is an explanatory diagram showing an example of a first detachment system treatment device according to an embodiment of the present invention (before leaving). Figure 16 is an enlarged side view showing an example of a detach system treatment device according to the first embodiment of the present invention (after withdrawal). Figure 17 is an explanatory diagram showing another example of a delivery device for delivering a therapeutic device according to a first embodiment of the present invention. Figure 18 is an explanatory diagram showing an example of use of the treatment device according to a second embodiment of the present invention (Part 1). Figure 19 is an explanatory diagram showing an example of use of the treatment device according to a second embodiment of the present invention (Part 2). Figure 20 is an explanatory diagram showing an example of use of the treatment device according to a third embodiment of the present invention (Part 1). Figure 21 is an explanatory diagram showing an example of use of the treatment device according to a third embodiment of the present invention (Part 2). Figure 22 is an explanatory diagram showing an example of use of the treatment device according to a third embodiment of the present invention (Part 3).

(Treatment device)
Treatment device of the present invention, at least, will have a stimulating member, optionally further comprising a fixing member, the other members.

<Stimulating member>
As the stimulating member, a member for applying a stimulus to the lesion in the external cerebrovascular, as long as the member that can be delivered to the vicinity of the lesion from the interior of the cerebral blood vessel through the cerebral vessels, in particular limit is not, it can be appropriately selected depending on the purpose, for example, spiral body, a needle, a ring, electrodes, heat source, the cooling source, and the like.

<< cerebrovascular >>
As the cerebral blood vessels, brain long as the blood vessels present in the (cerebral, diencephalon, cerebellum, brain stem (mesencephalon, bridge, medulla)) is not particularly limited and may be appropriately selected depending on the purpose.

<< lesion >>
As the lesion, as long as the nerve that transduce cell and the signal for generating an abnormal electrical signals is not particularly limited and may be appropriately selected depending on the intended purpose, e.g., epilepsy, Parkinson's disease, trigeminal neuralgia, diseased cells brain diseases such as, and the like.
Note that the "lesion near", an external cerebrovascular means the position capable of imparting a stimulus to the lesion, usually, when the distance from the lesion is within 10 mm, the stimulus to the lesion it can be imparted.

<< stimulus >>
As the stimulus is not particularly limited and may be appropriately selected depending on the purpose, for example, mechanical stimulation, electrical stimulation, thermal stimulation, and the like.

- mechanical stimulation -
Examples of the mechanical stimulation is not particularly limited and may be appropriately selected depending on the purpose, for example, spiral body, physical stimulus imparted by a needle or the like, and the like.

- Electrical stimulation -
As the electrical stimulus is not particularly limited and may be appropriately selected depending on the intended purpose, e.g., electrical stimulus applied by an electrode or the like, and the like.

As power in the electrical stimulation is not particularly limited and may be appropriately selected depending on the intended purpose, preferably 1W ~ 60 W, and more preferably from 10W ~ 40W, 20W ~ 30W is particularly preferred.
It said power is less than 1W, may be unable to stimulate neural tissue, exceeds 60 W, there is any damage to normal cells. Meanwhile, the power falls within the preferred range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

- Thermal stimulation -
Wherein as a thermal stimulus is not particularly limited and may be appropriately selected depending on the intended purpose, e.g., heating stimulus applied by the heating source, cooling stimulus imparted by a cooling source, and the like.

- heating stimulation -
The heating temperature of the heating stimulus is applied is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 50 ° C. ~ 100 ° C., more preferably from 60 ℃ ~ 80 ℃, 65 ℃ ~ 75 ℃ is particularly preferred.
Wherein the heating temperature is less than 50 ° C., may not ablate the cells exceeds 100 ° C., there is any damage to normal cells. Meanwhile, the heating temperature falls within the preferred range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

- cooling stimulus -
The cooling temperature of the cooling stimulus is applied is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 0 ° C. ~ 30 ° C., more preferably from 5 ℃ ~ 25 ℃, 15 ℃ ~ 20 ℃ is particularly preferred.
The cooling temperature is less than 0 ° C., sometimes water is solidified, when it exceeds 30 ° C., there is any damage to normal cells. Meanwhile, the cooling temperature falls within the preferred range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

<< delivery >>
As the delivery as long as it is delivered from the interior of the cerebral blood vessel through the brain blood vessels into the lesion vicinity is not particularly limited and may be appropriately selected depending on the purpose, for example, using a delivery device It is performed Te.

- delivery device -
As the delivery device, as long as a device to deliver a stimulating member is not particularly limited and may be appropriately selected depending on the intended purpose, e.g., a catheter, such as cannulas and the like.

--catheter--
As the catheter is not particularly limited and may be appropriately selected depending on the purpose, for example, such as cerebral vascular catheter having an outer diameter of 1.7 French 1-6 French.
As the cerebrovascular catheter is not particularly limited and may be appropriately selected depending on the purpose, for example, guiding catheters, micro-catheters, and the like.

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

<< spiral-shaped body >>
As the spiral body, as long as a spiral shape is not particularly limited and may be appropriately selected depending on the purpose, for example, a coil, spring, and the like.

- structure of the spiral-shaped body -
The structure of the helical member is not particularly limited and may be appropriately selected depending on the purpose, a single-layer structure may be either a multi-layer structure.
Furthermore, the helical member, the delivery device (e.g., a catheter, cannula) by, when delivered to the vicinity of the lesion from the interior of cerebrovascular via cerebrovascular, to fit within the delivery device, as appropriate, the folding preferably a possible structure.

- a spiral body shape and size -
The following characteristic values ​​for identifying the shape and size of the spiral body (wire diameter, helical radius, pitch, number of turns) show, these values ​​are spiral folded state in the delivery device rather than the characteristic value of Jo, and is a characteristic value of the spiral body in conferring mechanical stimulus (when expanded).

As the wire diameter of the helical member is not particularly limited and may be appropriately selected depending on the intended purpose, preferably 50 [mu] m ~ 900 .mu.m, more preferably from 100 [mu] m ~ 500 [mu] m, particularly preferably 200 [mu] m ~ 400 [mu] m.
The wire diameter is less than 50 [mu] m, may not be the contrast under X-ray, exceeds 900 .mu.m, it may not be delivered to the brain blood vessels. Meanwhile, the wire diameter is within the above preferable range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

The helix radius of the spiral member is not particularly limited and may be appropriately selected depending on the intended purpose, preferably 0.5 mm ~ 50 mm, more preferably from 1 mm ~ 30 mm, particularly preferably 2 mm ~ 10 mm.
The helical radius is less than 0.5 mm, it may not be stimulating the cells exceeds 50 mm, it may damage the normal tissues. Meanwhile, the spiral radius falls within the preferred range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

The length in 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 ~ 50 mm, more preferably 5 mm ~ 40 mm, particularly preferably 10 mm ~ 30 mm.
It said length is less than 1 mm, may be unable to stimulate cell, exceeds 50 mm, it may damage the normal tissues. Meanwhile, the length falls within the preferred range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

- Material of the spiral-shaped body -
Examples of the material of the spiral member is not particularly limited and may be appropriately selected depending on the purpose, for example, Ni-Ti, SUS, Pt, metal such as Au; polylactic acid, nylon, fluorine, polymer urethane, and the like; inorganic material; and the like.

<< needle >>
- of the needle structure -
The structure of the needle is not particularly limited and may be appropriately selected depending on the purpose, a single-layer structure may be either a multi-layer structure.
Further, the needle, the delivery device (e.g., a catheter, cannula) by, when delivered to the vicinity of the lesion from the interior of cerebrovascular via cerebrovascular, to fit within the delivery device, as appropriate, foldable it is preferably a structure.

- needle shape and size -
The following characteristic values ​​for identifying the shape and size of the needle (maximum diameter, total length, taper length) show, these values ​​are characteristic of the spiral body of a folded state in the delivery device not the value is a characteristic value of the needles in conferring mechanical stimulus (when expanded).

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 ~ 50 mm, more preferably from 1 mm ~ 30 mm, particularly preferably 2 mm ~ 10 mm.
The maximum diameter is less than 0.5 mm, it may not be stimulating the cells exceeds 50 mm, it may damage the normal tissues. Meanwhile, the spiral radius falls within the preferred range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

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 ~ 50 mm, more preferably from 1 mm ~ 30 mm, particularly preferably 2 mm ~ 10 mm.
The total length is less than 0.5 mm, it may not be stimulating the cells exceeds 50 mm, it may damage the normal tissues. Meanwhile, the total length falls within the preferred range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

- of needle Material -
The material of the needle is not particularly limited and may be appropriately selected depending on the purpose, for example, Ni-Ti, SUS, Pt, metal such as Au; polylactic acid, nylon, fluorine, urethane polymers and the like; inorganic material; and the like.

<< ring >>
- the structure of the ring -
The structure of the ring is not particularly limited and may be appropriately selected depending on the purpose, a single-layer structure may be either a multi-layer structure.
Further, the ring, the delivery device (e.g., a catheter, cannula) by, when delivered to the vicinity of the lesion from the interior of cerebrovascular via cerebrovascular, to fit within the delivery device, as appropriate, foldable it is preferably a structure.

- Ring shapes and sizes -
The following characteristic values ​​for identifying the shape and size of the ring (wire diameter, total length, the maximum ring diameter, the minimum ring diameter) show, these values ​​are spiral folded state in the delivery device rather than the characteristic value of Jo, and is a characteristic value of the ring in conferring mechanical stimulus (when expanded).

The wire diameter of the ring is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 50 [mu] m ~ 900 .mu.m, more preferably from 100 [mu] m ~ 500 [mu] m, particularly preferably 200 [mu] m ~ 400 [mu] m.
The wire diameter is less than 50 [mu] m, may not be the contrast under X-ray, exceeds 900 .mu.m, it may not be delivered to the brain blood vessels. Meanwhile, the wire diameter is within the above preferable range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

The maximum ring size of the ring is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 1 mm ~ 50 mm, more preferably 5 mm ~ 40 mm, particularly preferably 10 mm ~ 30 mm.
It said maximum ring diameter is less than 1 mm, may not be possible to surround the cerebrovascular, exceeds 50 mm, it may damage the normal cells. Meanwhile, the maximum ring diameter is within the above preferable range, it is advantageous in terms of control of the stimulus range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

- ring of material -
The material of the ring is not particularly limited and may be appropriately selected depending on the purpose, for example, Ni-Ti, SUS, Pt, metal such as Au; polylactic acid, nylon, fluorine, urethane polymers and the like; inorganic material; and the like.

<< electrode >>
As the electrode is not particularly limited and may be appropriately selected depending on the purpose.

- of the electrode structure -
The structure of the electrode is not particularly limited and may be appropriately selected depending on the purpose, a single-layer structure may be either a multi-layer structure.
Also, the electrode, the delivery device (e.g., a catheter, cannula) by, when delivered to the vicinity of the lesion from the interior of cerebrovascular via cerebrovascular, to fit within the delivery device, as appropriate, foldable it is preferably a structure.

- the electrode shape -
The shape of the electrode is not particularly limited and may be appropriately selected depending on the purpose, for example, plate-like, helical, needle, and the like.

- surface area of ​​the electrode (size) -
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.
The surface area is less than 1 mm 2, may not be able to stimulate tissue, it exceeds 7,000 mm 2, which may damage the normal cells. Meanwhile, the surface area falls within the preferred range, it is advantageous in terms of stimulus control range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

- of electrode material -
The material of the electrode is not particularly limited and may be appropriately selected depending on the purpose, for example, conventional electrode materials such as platinum, and the like.

<< heating source >>
Examples of the heating source is not particularly limited and may be appropriately selected depending on the purpose, for example, electrodes, hot balloon, and the like.

- structure of the heating source -
The structure of the heating source is not particularly limited and may be appropriately selected depending on the purpose, a single-layer structure may be either a multi-layer structure.
Further, the heating source, the delivery device (e.g., a catheter, cannula) by, when delivered to the vicinity of the lesion from the interior of cerebrovascular via cerebrovascular, to fit within the delivery device, as appropriate, foldable it is preferably a structure.

- of the heating source shape -
The shape of the heating source is not particularly limited and may be appropriately selected depending on the purpose, for example, plate-like, helical, needle, and the like.

- surface area of ​​the heating source (size) -
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 .
The surface area is less than 1 mm 2, may not be able to stimulate tissue, it exceeds 7,000 mm 2, which may damage the normal cells. Meanwhile, the surface area falls within the preferred range, it is advantageous in terms of stimulus control range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

- Material of the heating source -
The material of the heating source is not particularly limited and may be appropriately selected depending on the purpose, for example, conventional electrode materials such as platinum, conventional polymer materials such as nylon, and the like.

<< cooling source >>
As the cooling source is not particularly limited and may be appropriately selected depending on the purpose, for example, a Peltier device, and the like.

- of cooling source structure -
The structure of the cooling source is not particularly limited and may be appropriately selected depending on the purpose, a single-layer structure may be either a multi-layer structure.
In addition, the cooling source, the delivery device (e.g., a catheter, cannula) by the time (when expanded) to be delivered to the vicinity of the lesion from the interior of cerebrovascular via cerebrovascular, to fit within the delivery device, appropriately, it is preferred that the foldable structures.

- of cooling source shape -
The shape of the cooling source is not particularly limited and may be appropriately selected depending on the purpose, for example, plate-like, helical, needle, and the like.

- surface area of ​​the cooling source (size) -
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 .
The surface area is less than 1 mm 2, may not be able to stimulate tissue, it exceeds 7,000 mm 2, which may damage the normal cells. Meanwhile, the surface area falls within the preferred range, it is advantageous in terms of stimulus control range, the more preferable range, or, if it is within the particularly preferable range, it is more advantageous.

- Material of the cooling source -
The material of the cooling source is not particularly limited and may be appropriately selected depending on the purpose, for example, aluminum, and the like.

<Fixed member>
As the fixing member, so long as the stimulating member is a member for fixing the cerebrovascular is not particularly limited and may be appropriately selected depending on the purpose, for example, a blood vessel, such as shown in JP-A-2009-213900 configured fixed member so as to sandwich the wall, and the like.

By the fixing member for fixing the stimulating member to the cerebrovascular, said stimulating member can be placed in the vicinity of the lesion. Thus, for example, by pulsation of cerebrovascular said stimulating member is fixed, it can be said stimulating member is continuously swung, imparting continuous mechanical stimulation to the lesion.

<Other members>
The other members are not particularly limited, it can be appropriately selected depending on the purpose.

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

<First embodiment>
Hereinafter, a description will be given of a first embodiment.
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) inserting a sheath into the blood vessel, (ii) through the sheath, bring the therapeutic guidewire (not shown) and the microcatheter until cerebrovascular nearby lesions. (Iii) Next, along the therapeutic guidewire, as shown in FIG. 1, inside of cerebrovascular 3 in the vicinity of the lesion 2 for generating an abnormal electrical signals 1, to deliver the covered stent (stent graft) 4 , to detention. After placement of the covered stent (stent graft) 4, a therapeutic guidewire withdrawal, microcatheter keep maintained without withdrawn.

Here, covered stent (stent graft) 4 includes, for example, as shown in FIG. 5, the stent body 4a, and a cylindrical cover 4b for covering the side surface of the stent body 4a. The cylindrical cover 4b, and high elasticity of the elastomer material is used having a shape restoring property, even if the puncture from the inside of cerebrovascular 3 is configured so as blood does not leak.

(Iv) Next, as shown in FIG. 2, by bending the tip 5a of the microcatheter 5 in lesions two directions, and fixed. Pushed (v) needle-like stimulating member 7 and having a fixing member 8 treatment device 9 is delivery device A provided at a distal end (e.g., Johnson & Johnson My class microcoil delivery systems, Ltd.) it allows pushing forward the treatment device 9 through the lumen of the microcatheter 5, passing the tip 5a of the microcatheter 5. Thus, needle-like stimulating member 7 in the treatment device 9, pierce the cylindrical cover 4b and the vessel wall 3a of cerebrovascular 3 of the covered stent 4, through the vessel wall 3a. Thereafter, as shown in FIG. 3, at least a portion of the needle-like stimulating member 7 is positioned in the vicinity of the lesion 2, one of the members 8a of the two members to the outside of cerebrovascular third fixed member 8 position and the other member 8b of the fixing member 8 is disposed a treatment device 9 to be positioned inside the cerebrovascular 3, is cut by the current therapeutic device 9 from the delivery device a indwelling treatment device 9, withdrawing the delivery device a. (Vi) then pulled out microcatheter 5. Here, as described above, the cylindrical cover 4b of the covered stent 4, the high elasticity of the elastomeric material having a shape recovery property is used, a needle-like stimulating member from the interior of cerebrovascular 3 7 the does not leak blood even if the puncture in brain blood vessel 3.

Next, as shown in FIG. 4, and one member 8a of the fixing member 8, so that the other member 8b of the fixing member 8 to sandwich the vessel wall 3a of cerebrovascular 3, dilates, stimulating member 7 are fixed to the brain blood vessel 3.

As described above, by fixing member 8 for fixing the stimulating member 7 in cerebrovascular 3, the stimulating member 7 can be placed in the vicinity of the lesion 2. Accordingly, the pulsation of cerebrovascular 3 can stimulating member 7 is continuously swung, imparting continuous mechanical stimulation to the lesion 2.

Here, the fixing member 8, for example, a fixing member configured to sandwich the vessel wall 3a as shown in FIGS. 6-8 (see JP 2009-213900), and the like.

Figure 6 is an enlarged front view showing one example of a fixing member in the treatment device of the present invention.
6, the fixing member 8 has an inner metal fabric layers 22 and 24 composed of a plurality of metal braided strands and an outer metal fiber layer 20 composed of a plurality of metal braided strands surrounds the inner metal fabric layers.

Figure 7 is an enlarged side view showing an example of a fixing member in the treatment device of the present invention (during contraction).
7, the fixing member 8, two disk like members 8a and member 8b are aligned in the axial direction, at both ends in the axial direction of the fixing member 8, the fixing means (clamp) 26 is formed ing. Is fixedly bundled together by the inner metal fabric layers 22, 24 and the outer metal fiber layer 20 metal braided strands of distal and proximal clamp 26 to form a respective said. Clamp 26 has a threaded bore 28 (see FIG. 8 to be described later), the threaded hole 28 accepts a threaded end provided on the stimulating member and the delivery device are configured to be engaged.
Here, the fixing member 8 has a preset shape deformed to a small cross-sectional dimensions, so that can be delivered by the delivery device.
Further, a case where needle-like stimulating member 60 as stimulating member is fixed to the clamp 26 in Fig.

Figure 8 is an enlarged side view showing an example of a fixing member in the treatment device of the present invention (when expanded).
8, the fixing member 8 has an extended preset shape, you can pinch the vessel wall members 8a and member 8b which are connected to each other via a short cylindrical portion 16 and a closable opening in the vessel It is configured.
Further, a case where needle-like stimulating member 60 as stimulating member is fixed to the clamp 26 in Figure 10.
Can be fixed member 8 having the above configuration performs puncture into the brain vessels needle placement when connected to a needle-like stimulating member 60 (FIGS. 9 and 10), in the vicinity of the lesion via a clamp 26 with, when in the expanded preset configuration, it is possible to close the opening in cerebrovascular 3.

In the first embodiment described above, as a stimulus imparting member 7 in the treatment device 9, but with a needle-like stimulating member 60 to impart mechanical stimuli, the present invention is not limited thereto, applying needle stimulation instead of member 60, (FIGS. 18 and 19 described later) and the ring spiral body to impart mechanical stimulus; heat source and the cooling source to apply heat stimulation; electrodes for applying electrical stimulation also be used as it can.

In the first embodiment described above, but stimulating member 7 is fixed to the vessel wall 3a of cerebrovascular 3 by the fixing member 8 it is not limited thereto, for example, shown in (i) Figure 11 as such, needle-like stimulating member 60, by penetrating the cerebrovascular 3 may be fixed to cerebrovascular 3, as shown in (ii) 12, a ring-shaped stimulating member 70, brain by forming a ring along the outer circumferential surface of the vessel wall 3a of the vessel 3 may be restricted range of motion of the ring-shaped stimulating member 70 is in the vicinity of cerebrovascular 3, as shown in (iii) 13 to, by helical stimulating member 80 is adhered to the vessel wall 3a of cerebrovascular 3 may be fixed to cerebrovascular 3, as shown in (iv) 14, fixed in stimulating member 90 site 90a, 90b, 90c is buried in the blood vessel wall 3a By Murrell, stimulating member 90 may be fixed to the cerebrovascular 3.

In the first embodiment described above, as a delivery device for delivering the stimulating member 7, but using a microcatheter 5, it is not limited thereto, a guiding catheter, other delivery devices of the cannula or the like it may be used.

In the first embodiment described above, by moving the treatment device 9 using a delivery device, but is disconnected by cutting the current treatment device 9 from the delivery device, the present invention is not limited thereto, for example, FIG. in the instant detach system as shown in 15 and 16, by pulling the release wire 40 in the lumen of the delivery pusher portion 30, which is configured to decouple by moving the detached ring 42 from the retaining ring 41 to the treatment device 9 side it may be used things.

In the first embodiment described above, by using a micro-catheter 5, indwelling covered stent 4, further is performed until that placing a treatment device 9 is not limited thereto, a guiding catheter it may be used. In that case, the guiding catheter only, may be carried out placement of a covered stent 4 and treatment device 9, as shown in FIG. 17, may be fed to the micro-catheter 5 through the lumen of the guiding catheter GC. By feeding the microcatheter 5 through the lumen of the guiding catheter GC, or assist in the needle with guide wire or needle-like stimulating member 7 is punctured into the tubular cover 4b and the vessel wall 3a, stimulating member spiral member as 7 or can assist in passing the cylindrical cover 4b and the vessel wall 3a.
Further, the covered stent (stent graft) 4 when to deliver to the lesion 2, may not be used microcatheter 5 and the guiding catheter GC.

In the first embodiment described above, the needle-like stimulating member 7, although puncture cylindrical cover 4b and the vessel wall 3a of cerebrovascular 3 of the covered stent 4 is not limited thereto, the tip 5a and the tip of the guiding catheter of the microcatheter 5 may puncture the cylindrical cover 4b and the vessel wall 3a.

<Second Embodiment>
Hereinafter, the second embodiment will be described focusing on different points from the first embodiment. Incidentally, parts having the same function and configuration as the first embodiment are denoted by the same reference numerals.
18 to 19 are explanatory views showing an example of the use of the treatment device according to a second embodiment of the present invention.

In the second embodiment, the above after (i) ~ (iii) in the first embodiment, by bending the tip 5a of (iv) microcatheter 5 in lesions two directions, and fixed. (V) a needle with a guidewire advancing through the lumen of the microcatheter 5, passing the tip 5a of the microcatheter 5. Thus, the needle with guide wire, pierce the cylindrical cover 4b and the vessel wall 3a of cerebrovascular 3 of the covered stent 4, passing the blood vessel wall 3a. Then, along the front end 5a of the microcatheter 5 with needle guide wire is advanced to the outside of cerebrovascular 3, pulled out with needle guide wire. (Vi) Subsequently, as shown in FIG. 18, delivery device treatment device 9 is provided at the tip with a spiral member as stimulating member 7 and the fixing member 8 A (e.g., Johnson & Johnson, Inc. by pushing the manufacturing My class microcoil delivery systems), and pushed a treatment device 9 through the lumen of the microcatheter 5, passed through a tip 5a of the microcatheter 5, at least a portion lesion stimulating member 7 2 treatment device as located near, one of the members 8a of the two members of the fixing member 8 is positioned outside of cerebrovascular 3, the other member 8b of the fixing member 8 is located inside of cerebrovascular 3 9 disposed, it is cut by the current therapeutic device 9 from the delivery device a indwelling treatment device 9, the delivery device Pull out the A. (Vii) Then, pull out the micro-catheter 5. Next, as shown in FIG. 19, and one member 8a of the fixing member 8, so that the other member 8b of the fixing member 8 to hold the vessel wall 3a of cerebrovascular 3, stimulating dilates member 7 are fixed to the vessel wall 3a. Here, as described above, the cylindrical cover 4b of the covered stent 4, the high elasticity of the elastomeric material having a shape recovery property is used, with needle guide wire cerebrovascular from the interior of cerebrovascular 3 3 is punctured into, it does not leak blood even if advancing the microcatheter 5 to the outside of cerebrovascular 3.
In the second embodiment, a needle with guide wire, pierce the cylindrical cover 4b and the vessel wall 3a of cerebrovascular 3 of the covered stent 4, after passing through the vessel wall 3a, a microcatheter 5 with needle guide along the wire is advanced to the outside of cerebrovascular 3, although withdrawn needle with guide wire is not limited thereto, the needle with guide wire, cylindrical cover 4b and cerebrovascular 3 of covered stent 4 pierce the vessel wall 3a, by penetrating the vascular wall 3a, after the formation of the minute pores of the passages, without entering the microcatheter 5 to the outside of cerebrovascular 3, pull out the needle with guide wire, the cylindrical cover 4b and microvoids formed in the vessel wall 3a of cerebrovascular 3 as a passage may be passed through a treatment device 9.

<Third Embodiment>
Hereinafter, the third embodiment will be described focusing on different points from the first embodiment. Incidentally, parts having the same function and configuration as the first embodiment are denoted by the same reference numerals.

20 to 22 are explanatory views showing an example of the use of the treatment device according to a third embodiment of the present invention.

20-as shown in Figure 22, inside the vicinity of cerebrovascular 3 of lesions 2 for generating an abnormal electrical signals 1, covered stent comprising a stimulating member 7 having a metal portion consisting of a needle 100 of at least one when arranging the (graft) 4, or draw sheath 10, or by extruding the covered stent (stent graft) 4, the stent main body in covered stent (stent graft) 4 protruding from the sheath 10 within the extending direction thereof 4a and needle 100 to self-expand, the needle 100 penetrates the vessel.
Here, the sheath 10, as far as it is tubular, is not particularly limited, for example, guiding catheters, micro-catheters, tubes, and the like also is larger in diameter than the catheter.

In this manner, the stimulus imparting member 7 consisting of a needle 100 of at least one to protrude from the stent body 4a, the needle 100, through the cylindrical cover 4b and the vessel wall 3a of cerebrovascular 3, lesions 2 to impart mechanical stimulus to.

Here, stimulating member comprising a plurality of needles 100 in the treatment device 9, because it is connected to the stent body 4a which is placed in the cerebral blood vessel 3, it is fixed to the cerebrovascular 3.

As described above, by a plurality of needles 100 is fixed to the cerebrovascular 3, covered stent comprising a plurality of needles 100 (stent graft) can be placed in the vicinity of the lesion 2.
Accordingly, the pulsation of cerebrovascular 3, a plurality of needles 100 is continuously oscillating, it is possible to impart continuous mechanical stimulation to the lesion 2.

In the third embodiment, as a stimulus imparting member 7 in the treatment device 9, but using a plurality of needles 100 to impart mechanical stimuli, the present invention is not limited thereto, instead of the needle 100, mechanical heat source and cooling source to apply heat stimulation; spiral body and ring imparts stimulus; electrical stimulation electrodes for imparting the like can be used.

Treatment device of the present invention, brain diseases (in particular, epilepsy, Parkinson's disease, trigeminal neuralgia) is suitably used in the treatment of.

1 abnormality electrical signal 2 lesions 3 cerebrovascular 3a vascular wall 4 covered stent (stent graft)
4a stent body 4b tubular cover 5 microcatheter 5a microcatheter tip 7 stimulating member 8 fixing member 8a member 8b member 9 treatment device 16 cylindrical portion 20 outer metal fiber layer 22 inner metal fabric layers 24 inside the metal fiber layer 26 Clamp 28 screwing holes 30 delivery pusher unit 40 releases the wire 41 retaining ring 42 detaching ring 60 needle stimulating member 70 the ring-like stimulating member 80 spirally stimulating member 90 stimulating member 90a fixed portion 90b fixed portion 90c fixed sites 100 needles A delivery device GC guiding catheter

Claims (12)

  1. A therapeutic device having a stimulating member for applying a stimulus to the lesion in the external cerebrovascular,
    Treatment device wherein stimulating member, characterized in that from the inside of the cerebrovascular via the cerebrovascular may be delivered to the vicinity of the lesion.
  2. Treatment device according to claim 1, further comprising a fixing member for fixing the stimulating member to the cerebrovascular.
  3. The fixing member, and the inner metal fabric layers formed of a plurality of metal braided strands and an outer metal fiber layer comprising a plurality of metal braided strands surrounds the inner metal fabric layers, the outer metal and the inner metal fabric layers treatment device according to claim 1 or 2, characterized in that it has a fixing means for fixing by tying the distal and proximal metal braided strands forming each of the fiber layers to each other.
  4. Treatment device according to claim 1, wherein the stimulus is a mechanical stimulus.
  5. Treatment device according to claim 1, wherein the stimulus is an electrical stimulus.
  6. Treatment device according to claim 1, wherein the stimulus is a thermal stimulus.
  7. Treatment device according to claim 4, wherein the stimulating element for imparting the mechanical stimulus is spiral body.
  8. Treatment device according to claim 4, wherein the stimulating element for imparting the mechanical stimulus is needle.
  9. Treatment device according to claim 3, characterized in that the needle as the stimulating member and the fixing member through the fixing means are connected.
  10. Treatment device according to claim 1, wherein said stimulating member, characterized in that it is delivered by the delivery device.
  11. Treatment device of claim 10, wherein the delivery device is a catheter.
  12. And treatment device of claim 1, treatment set characterized by having a delivery device for delivering the stimulating member to the lesion near the interior of the cerebrovascular through the brain blood vessels.
PCT/JP2013/000543 2012-02-14 2013-01-31 Therapy device and therapy set WO2013121725A1 (en)

Priority Applications (2)

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JP2012-029915 2012-02-14

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11514269A (en) * 1995-10-13 1999-12-07 トランスバスキュラー インコーポレイテッド Method and apparatus for implementing and / or other transvascular approach for forming a bypass artery occlusion
JP2006141993A (en) * 2004-10-19 2006-06-08 Tohoku Univ Cooling apparatus for internal organs
JP2007521125A (en) * 2004-02-05 2007-08-02 チルドレンズ・メディカル・センター・コーポレイションChildren’s Medical Center Corporation Transcatheter delivery of the replacement heart valve
JP2009142667A (en) * 2001-07-06 2009-07-02 Syntach Ag Anti-arrhythmia devices and methods of use
JP2009213900A (en) * 2004-03-19 2009-09-24 Aga Medical Corp Medical device for occluding vascular defect

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11514269A (en) * 1995-10-13 1999-12-07 トランスバスキュラー インコーポレイテッド Method and apparatus for implementing and / or other transvascular approach for forming a bypass artery occlusion
JP2009142667A (en) * 2001-07-06 2009-07-02 Syntach Ag Anti-arrhythmia devices and methods of use
JP2007521125A (en) * 2004-02-05 2007-08-02 チルドレンズ・メディカル・センター・コーポレイションChildren’s Medical Center Corporation Transcatheter delivery of the replacement heart valve
JP2009213900A (en) * 2004-03-19 2009-09-24 Aga Medical Corp Medical device for occluding vascular defect
JP2006141993A (en) * 2004-10-19 2006-06-08 Tohoku Univ Cooling apparatus for internal organs

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