WO2011030820A1 - 塞栓コイル - Google Patents
塞栓コイル Download PDFInfo
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- WO2011030820A1 WO2011030820A1 PCT/JP2010/065513 JP2010065513W WO2011030820A1 WO 2011030820 A1 WO2011030820 A1 WO 2011030820A1 JP 2010065513 W JP2010065513 W JP 2010065513W WO 2011030820 A1 WO2011030820 A1 WO 2011030820A1
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- coil
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- shape
- different points
- embolic coil
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
- A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12154—Coils or wires having stretch limiting means
Definitions
- the present invention relates to an embolic coil used for endovascular treatment. More specifically, the present invention relates to an embolization coil used for cerebral aneurysm and blood vessel embolization.
- an intravascular treatment method using a catheter or the like is known as a less invasive treatment method for an intravascular lesion such as an aneurysm.
- an embolic coil used for the purpose of being placed at an application site such as a blood vessel or an aneurysm is required to have various characteristics described below.
- the embolic coil body has a function to prevent expansion beyond its yield point. thing.
- the flexibility of the end of the embolic coil is made higher than the central region so that it can be bent quickly when engaging the blood vessel wall.
- the surface of the stretch preventing member is prevented from breaking (for example, preventing breakage when it is wound to a small diameter), and the embolization coil is delivered (moving the embolization coil in the catheter, position after collection There was still room for consideration in terms of operability such as correction and relocation.
- the inventors of the present invention are embolic coils in which an extension preventing wire and a coil partially or wholly wound by pitch are fixed at least at two different points.
- the embolic coil is characterized in that the stretch preventing wire has a portion provided with a shape that can be expanded and contracted in a portion disposed between the two different points.
- “fixed at least at two different points” means not only when the coil and the extension preventing wire are directly fixed, but also indirectly fixed via, for example, the tip of the pusher or the tip of the coil. If it is, it shall be counted as the fixed point.
- “Two points different from each other” means two points separated in the axial direction when the coil is linear.
- the coil since the coil has a pitch winding portion, it is possible to prevent breakage of the extension preventing wire, and further, by providing a stretchable shape to the extension preventing wire, it is possible to deliver due to pitch winding. It becomes possible to reduce the deterioration of.
- the “pitch winding coil” means that the windings of adjacent wires forming the coil are not in close contact with each other, and there is a gap between the windings, and the size of the gap is the wire of the wire. It means a coil having a portion that is 5% or more of the width.
- adherence winding part was provided.
- the coil since the coil has both a pitch winding part and a close winding part, it is possible to obtain better delivery performance than a coil that is entirely wound by pitch (sufficient expansion prevention) It is easy to achieve both the effect of preventing breakage of the wire and the delivery property).
- the “closely wound coil” means that the windings of adjacent wires forming the coil are in close contact with each other, or there is a gap between the windings, and the size of the gap is the wire width of the wire. Means a coil having a portion smaller than 5%.
- the natural length of the portion of the coil arranged between the two different points (here, the axial length when the coil is placed in a straight groove without applying a force in the axial direction is naturally Provided an embolic coil that is longer than the natural length of the portion of the anti-stretching wire disposed between the two different points.
- the natural length of the coil of the specific portion and the natural length of the extension preventing wire have a specific relationship, it is possible to further reduce the fatigue fracture caused by stress concentration of the extension preventing wire.
- the embolization coil is provided in which the portion of the stretch preventing wire provided with the stretchable shape is stretched in the axial direction of the coil and is disposed between the two different points.
- the extension preventing wire in the coil in a stretched state, it is possible to further reduce fatigue fracture due to stress concentration of the extension preventing wire.
- the embolic coil is provided in which the shape of the stretchable wire provided with the stretchable shape is a periodic shape.
- the shape of the portion to which the stretchable wire can be stretched is a periodic shape, it is possible to improve the delivery performance of the embolic coil more effectively and reliably.
- the embolic coil is provided in which the pitch winding portion in the coil is partially arranged on the hand side of the coil.
- the limit length of the portion disposed between the two different points of the extension preventing line is set to the natural length (100%) of the portion disposed between the two different points of the coil.
- the embolic coil was 130% or less.
- the length of the pitch winding portion of the portion disposed between the two different points of the coil is 5 to 40 of the natural length of the portion disposed between the two different points of the coil. % Provided an embolic coil.
- an embolic coil in which the stretchable shape of the stretch preventing wire is formed by twisting two or more strands.
- the present invention it is possible to provide an excellent embolic coil in which the extension preventing wire is not easily broken. Moreover, according to this invention, the embolic coil which reduced the deterioration of delivery property can be provided.
- FIG. 1 In a conventional embolization coil, when a coil is pitch-wound, it is a mimetic diagram which shows that a slack arises in an extension prevention line and a kink-like symptom arises in a coil. It is the schematic diagram which illustrated the stress which has arisen in the coil by the extension
- the present invention is an embolic coil in which a stretch prevention wire and a coil partially or wholly wound by pitch are fixed at least at two different points, and the extension prevention wire has two different points.
- the present invention relates to an embolic coil characterized by having a portion provided with an expandable / contractable shape in a portion disposed between the two.
- FIG. 1 is a cross-sectional view showing an example of a constituent member of an embolic coil of the present invention with respect to a coil and an extension preventing wire.
- the coil 1 has a primary shape in which a wire 1a is wound, a pitch winding portion 4 is disposed on the proximal side 5 of the coil 1, and a close winding portion 3 is disposed on the tip side thereof.
- the proximal side of the coil refers to the side of the coil that is disposed on the operator side during treatment.
- the stretch preventing wire 2 is provided with a periodic waveform shape over its entire length as a stretchable shape.
- the natural length 6 of the coil 1 is longer than the natural length 7 of the extension preventing wire 2. Therefore, for example, when two end portions of the coil 1 and the extension preventing wire 2 are selected as two different points, and both are fixed directly or indirectly at the both end portions of the coil 1, the two different ones of the coil 1 are selected.
- the natural length 6 of the portion arranged between the points is longer than the natural length 7 of the portion arranged between two different points of the extension preventing line 2.
- the coil 1 includes a pitch winding portion
- the stretch preventing wire 2 includes a portion to which a stretchable shape is given.
- the coil and the extension preventing wire need only be fixed at two points separated in the axial direction when the coil is linear, as described in the description of FIG. 1 above. It is not always necessary to fix the coil and the extension preventing wire at both ends. That is, two arbitrary points in the axial direction of the coil are selected, two arbitrary points in the axial direction of the extension preventing line are selected, and both are fixed at the two corresponding axial points. .
- the portion arranged between the two points for example, if the relationship between the natural length of the coil and the natural length of the extension preventing wire is in the specific relationship described above, the effects of the present invention are more suitably exhibited. can do. Therefore, the configuration of the coil and the extension preventing wire other than the portion arranged between the two points can be appropriately determined within a range that does not hinder the effect of the present invention.
- part or all of the coil is pitch-wound, so that it is possible to reduce the risk that the stretch prevention wire breaks even when the coil is wound to a small diameter.
- part or all of the coil is formed by pitch winding, in the conventional embolization coil using the extension preventing wire not provided with the expandable shape, for example, in order to move the embolization coil in the catheter
- the embolic coil 20 is bent in the catheter 8
- the extension preventing wire 22 is slackened in the coil 21.
- FIG. 3 illustrates each stress generated in the coil by the extension preventing wire in the state of the embolic coil shown in FIG.
- a force 9 in the coil axial direction in FIG. 3, the length direction of the catheter 8
- an extension preventing wire not shown
- a force vector 10 in FIG. 3, the length direction of the catheter 8 and the radial force
- the stretchable wire is provided with a stretchable shape, so that when the coil having a pitch winding is compressed, the stretchable shape inside the coil is each part. It is possible to obtain the effect of dispersing the force that is bent each time and presses against the inner wall surface (outer wall) such as a catheter surrounding the outer surface of the coil, and the deterioration of the delivery property can be eliminated.
- the stretchable shape as used herein refers to, for example, a wave shape or a spiral shape, when a force is applied in the axial direction of the embolic coil, it is difficult to transmit the force in the axial direction, and the radial direction (in the axial direction). It means that the structure is easy to transmit force by dispersing in the vertical direction.
- the coil used in the present invention is partially or entirely pitch-wound, so that it is possible to compress the coil before the stretch prevention wire is stretched, and avoid the risk of the stretch prevention wire breaking. it can.
- the embolic coil has a secondary shape of the coil (generally, the embolic coil has a primary coil shape forming the coil and a secondary coil shape macroscopically forming the coil itself as a wire. When inserting into an aneurysm having a smaller diameter, the extension preventing wire is easily arranged along the aneurysm wall side inside the coil.
- the pitch winding portion can be formed by stretching.
- the pitch interval of the pitch winding portion is 5% or more, more preferably 20% or more, with respect to the outer diameter of the wire forming the coil, and the effect of preventing the breakage of the extension preventing wire more stably. Is obtained.
- the pitch interval does not exceed 40% with respect to the outer diameter of the wire.
- the “pitch interval” means a distance between adjacent wires in the pitch winding portion of the coil.
- the distance between the said wire materials may be uniform over the whole pitch winding part, and may be changed suitably.
- the coil used in the present invention may be pitch-wound as a whole, but for the purpose of preventing unnecessary compression during delivery and lowering the delivery property, it has both a pitch winding portion and a close winding portion. It is preferable to form.
- the embolization coil having a secondary shape when the embolization coil having a large secondary diameter is wound with a small diameter, the coil proximal side where the extension prevention wire is insufficient (here, the coil proximal side is used in the treatment, It is preferable that a part of the coil (referred to the side disposed on the operator side) be pitch-wound.
- the ratio of the pitch winding portion of the coil to the portion arranged between the two different points is relative to the natural length of the portion arranged between the two different points of the coil. It is preferably 5 to 40%. In this way, by disposing a pitch winding portion of a necessary degree only on a part of the coil, it becomes possible to further reduce the deterioration of the delivery property while maintaining the effect of preventing the extension prevention wire from breaking.
- the coil used in the present invention is preferably formed by winding a wire material to form a coil shape having a lumen and forming a primary coil, and further forming a secondary coil shape using the primary coil itself as a wire material.
- the secondary coil shape may be various two-dimensional shapes or three-dimensional shapes such as a spiral shape.
- the three-dimensional shape is preferable because it easily occupies a certain space without being aggregated when it is placed in a blood vessel.
- the coil used in the present invention can be produced from various biocompatible materials such as metal wires and resins, but metal wires that are particularly stable and easily maintain a three-dimensional shape are preferred (especially metal wires do not spiral).
- a metal coil wound in a shape is preferable).
- the metal wire material having biocompatibility include platinum, tungsten, titanium, gold, iridium, palladium, tantalum and alloys thereof, stainless steel, and the like. Among these, it is preferable to consist of platinum or a platinum alloy. It should be noted that the head disposed at the tip of the coil can be similarly produced from the above metals and resins.
- the stretch preventing wire used in the present invention is given a shape that can be stretched. As a result, it was possible to eliminate the deterioration of the delivery property caused by the pitch winding (the coil having the pitch winding was compressed by providing a stretchable shape to the extension preventing wire arranged inside the coil. At this time, an effect of dispersing the force of pressing the coil against the outer wall by loosening the extension preventing wire is obtained, and it is possible to eliminate the deterioration of the delivery property).
- the stretchable shape may be given to the entire extension preventing line, or may be given to the whole or a part of the portion arranged between the two different points.
- the shape that can be stretched and imparted to the stretch prevention wire there is no particular limitation on the shape that can be stretched and imparted to the stretch prevention wire, and if it can be changed into a shape such as a properly stretched state or a contracted state in the coil, it is a periodic shape. Alternatively, it may be a random shape that is not periodic. From the viewpoint of more effectively and reliably improving the delivery of the embolic coil, a periodic shape is preferable, and examples thereof include a periodic shape such as a wave shape and a helical shape.
- the wave shape or the spiral shape may include a two-dimensional shape or a three-dimensional shape.
- one wave shape may be one cycle, or a plurality of wave shapes may be one cycle.
- the width (amplitude) of each wave shape included in one cycle and the wavelength may be different. Furthermore, the shape of each period does not need to be completely matched, and some deformation may be allowed.
- the degree of “stretchable” is not particularly limited, but when the natural length of the portion arranged between the two different points of the stretch prevention line is 100%, the length is 105% or more. It is preferable to be able to extend to a length of 110% or more, more preferably to a length of 110% or more, and even more preferable to be able to extend to a length of 120% or more.
- the maximum width of the extendable shape is not particularly limited, and the effect of the present invention can be obtained by the maximum width regardless of whether the shape is a periodic shape or a random shape that is not periodic.
- the width (maximum width) of the stretchable shape given to the extension preventing wire is within the coil (primary coil).
- the inner diameter is preferably equal to or smaller than the inner diameter of the cavity.
- the extension preventing wire 32 formed of a stranded wire 36 formed by twisting strands is a two-dimensional shape that is a periodic shape as an extendable shape. Wave shape is given.
- the given periodic shape width (maximum width) corresponds to a portion indicated by reference numeral 11. In the extension preventing wire 32 shown in FIG. 4, for example, a series of portions indicated by a twisted wire valley 33, a mountain 34, and a valley 35 form one cycle.
- the width of the periodic shape is equal to or smaller than the inner diameter of the primary coil, it becomes possible to improve the delivery property of the embolic coil more effectively and reliably.
- the length of one cycle of the periodic shape is preferably 100 ⁇ m or more and 10 mm or less, and more preferably 200 ⁇ m or more and 500 ⁇ m or less. If the length of one cycle is larger than 10 mm, the number of places where the stress is dispersed decreases, so that the delivery property tends to be lowered. If the length is smaller than 100 ⁇ m, the wire is bent at a steep angle, so that the strength of the wire is increased. It tends to decrease.
- the portion of the stretch prevention wire that is provided with a stretchable shape does not necessarily have to be formed by one wire, and one strand is reciprocated between two different points a plurality of times (that is, It is also possible to fix to a coil or the like.
- the stretch prevention wire used in the present invention can be formed as a stranded wire by twisting two or more strands. Further, when two or more strands are twisted, the strands are preferably twisted so that the twist interval is 2 to 100 times the strand diameter. Even within that range, it is possible to reduce the risk of unraveling two or more strands when processing a stretch-preventing wire into a shape that can be expanded and contracted, especially by twisting tightly. it can.
- FIG. 5 is the figure which expanded and showed the example which twisted two so that a twist space
- the natural length of the portion disposed between the two different points of the coil is equal to the portion of the portion disposed between the two different points of the extension preventing line. It is preferably longer than the natural length.
- the natural length of the portion of the coil disposed between the two different points is particularly arranged between the two different points of the extension preventing line.
- the natural length of the portion is 100%, it is preferably longer than 100% and 130% or less.
- the coil and the extension preventing wire may have such a length relationship for each full length, or such a length only for a portion arranged between two specific points.
- the relationship may be as follows.
- the specific portion of the extension preventing wire is disposed between the two different points in a state where the specific portion of the extension preventing wire extends in the axial direction of the coil.
- the method of fixing the coil and the extension preventing wire so as to be in such an arrangement.
- the limit length of the portion to which the stretchable shape of the extension preventing wire is given is the natural length (100%) of the portion arranged between the two different points of the coil,
- the stretch prevention wire is preferably 130% or less in order to prevent coil plastic deformation.
- the “limit length” means the length when the portion of the extension preventing line is cut when the portion arranged between the two different points of the extension preventing line is extended in the axial direction. It is.
- the extension preventing wire used in the present invention can be made from various materials having biocompatibility such as a metal wire and a resin wire, like the above-described coil, but the three-dimensional shape is particularly stably maintained. Easy metal wires are preferred.
- the metal wire material having biocompatibility include platinum, tungsten, titanium, gold, iridium, palladium, tantalum and alloys thereof, stainless steel, and the like. Among these, it is preferable to consist of platinum or a platinum alloy.
- the coil 1 constituting the embolic coil 40 of this example has the same structure as the coil shown in FIG. 1 (the same reference numerals are used for the same components, and the description of the same parts is omitted).
- a substantially hemispherical head 1b is arranged to avoid catching in the catheter and damage to the blood vessel wall, and toward the coil proximal side 5 in the lumen of the coil 1 of the head 1b.
- a protruding first loop 1c is provided.
- the extension preventing wire 42 includes a second loop 41b made of one strand 41a at the tip, and the portion other than the second loop 41b is formed of a stranded wire formed by twisting the strand 41a.
- a wave-like periodic shape having an amplitude 11 is given over the entire length.
- the first loop 1c and the second loop 41b are inserted into and fixed to the coil 1 and the extension preventing wire 42 at their tip portions.
- On the proximal side 5 of the coil both are directly fixed by welding or an adhesive, or indirectly fixed via a connecting member 45.
- a conventionally known connection member 45 may be used.
- FIG. 6B shows the extension preventing line 42 before fixing, and reference numeral 7 denotes its natural length.
- FIG. 6A shows a cross-section of the embolic coil 40 after assembly, but the extension preventing wire 42 in FIG. 6A is arranged in a state of extending in the axial direction of the coil.
- Such an embolic coil can be suitably used for endovascular treatment, for example, cerebral aneurysm or vascular embolization.
- Example 1 Using a metal coil with a coil inner diameter of 150 ⁇ m and a natural length of 200 mm, formed of a platinum-tungsten alloy wire (wire outer diameter of 45 ⁇ m), a pitch winding portion with an interval of 30% of the wire outer diameter at one end 30 mm on the hand side of the coil The remainder was a tightly wound part. The ratio of the pitch winding portion is 15%.
- a wire material stranded wire having a natural length of 195 mm having a wave shape with an amplitude of 100 ⁇ m formed of a platinum-tungsten alloy wire material was used.
- FIG. 6 shows a cross-sectional view of the embolic coil used in Example 1 and the extension preventing wire before being fixed to the coil.
- Example 2 A metal coil having a natural length of 200 mm and formed of a platinum-tungsten alloy wire (wire outer diameter: 45 ⁇ m) and having a coil inner diameter of 150 ⁇ m and a tight winding over the entire length was used.
- an embolic coil having a spiral secondary shape with a diameter of 16 mm was prepared by placing a linear extension preventing wire having a natural length of 200 mm between two ends of the coil, which was formed of a platinum-tungsten alloy wire. The limit length of the portion disposed between the two points of the extension preventing line is 100% with respect to the natural length of the portion.
- the sample is arranged so that the distal end of the sample is located within the catheter about 10 cm proximal from the distal opening of a general microcatheter, and the portion about 10 cm from the distal end of the sample from that position is the microcatheter
- the catheter After moving the sample until it comes out from the distal end opening of the tube (a part of the proximal end side of the sample exists inside the catheter), the catheter about 10 cm proximal from the distal end opening of the microcatheter
- the sample is moved so that the end on the tip side of the sample is located inside. This series of operations was repeated 5 times as one reciprocation.
- the “average value” means an average value of the maximum values when the maximum value during the one reciprocal operation is measured and repeated five times.
- Coil Coil 2. Stretch prevention line Closely wound part 4. 4. Pitch winding part 5. Coil hand side 6. Natural length of coil before fixing 7. Natural length of stretch prevention wire before fixing 8. Catheter 10. Coil axial force Force vector 11. Width of the periodic shape of the stretch prevention line Stretch prevention wire twist interval
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Abstract
Description
ここで、「少なくとも互いに異なる2点で固定」とは、コイルと伸張防止線とが直接固定されている場合のほかに、例えばプッシャーの先端部やコイル先端部等を介して間接的に固定されている場合もその固定の点として数えるものとする。また、「互いに異なる2点」とは、コイルが直線状である際にその軸方向の離れた2点を意味する。
これによれば、コイルがピッチ巻き部位を有していることで、伸張防止線の破断を防止でき、更に、伸張防止線に伸縮可能な形状を付与することで、ピッチ巻きに起因するデリバリ性の悪化を低減することが可能となる。
ここで「ピッチ巻きコイル」とは、コイルを形成する隣り合った線材の巻き同士が密着しておらず、巻き間に隙間を有しており、かつ、該隙間の大きさが、線材の線幅の5%以上である部分を有するコイルを意味する。
ここで「密着巻きコイル」とは、コイルを形成する隣り合った線材の巻き同士が密着しているか、巻き間に隙間を有しており、かつ、該隙間の大きさが、線材の線幅の5%より小さい部分を有するコイルを意味する。
本発明で使用するコイルは、一部又は全部がピッチ巻きになっており、これにより伸張防止線が突っ張る前にコイルを圧縮することが可能で、伸張防止線が破断するリスクを回避することができる。例えば、塞栓コイルをそのコイルの2次形状(一般に、塞栓コイルは、コイルを形成している1次コイル形状と、そのコイル自体が線材となって巨視的に形成する2次コイル形状を有している。)より小さい径の動脈瘤に挿入する場合、伸張防止線がコイル内部で動脈瘤壁側に沿うように配置されやすい。その為、動脈瘤に塞栓コイルの先端側から挿入し、最終的にコイル手元側を挿入する際に、伸張防止線の長さが不足し、突っ張って破断する可能性がある。しかし、この構造によればコイルのピッチ巻き部分が縮むことで伸張防止線の不足を補い、破断を防ぐことができる。
このような配置となるようにコイルと伸張防止線を固定する方法としては、特に限定はなく、例えば、コイルを圧縮した状態で伸張防止線を固定する方法や、伸張防止線を延伸した状態で固定する方法などが挙げられる。また、塞栓コイルの状態で、伸張防止線が伸張した状態を維持できるように、伸張防止線の伸縮性とコイルの伸縮性の強度を適宜調整すると良い。
コイル1と伸張防止線42は、その先端部分において、第1ループ1cと第2ループ41bとが相互に挿通されて固定されている。またコイルの手元側5では、両者は溶接もしくは接着剤により直接固定、または接続部材45を介して間接的に固定されている。接続部材45は従来公知のものを用いればよい。
また、図6(b)は固定前の伸張防止線42を示しており、符号7はその自然長である。図6(a)は、組立て後の塞栓コイル40の断面を示しているが、図6(a)中の伸張防止線42は、コイルの軸方向に伸張した状態で配置されている。
このような塞栓コイルは、血管内治療、例えば、脳動脈瘤や血管の塞栓などに好適に用いることができる。
て説明する。
白金-タングステン合金線材(線材外径45μm)により形成された、コイル内径150μm、自然長200mmの金属コイルを用い、該コイルの手元側の一端30mmに間隔が線材外径の30%のピッチ巻き部分を設け、残りは密着巻き部分とした。ピッチ巻き部分の割合は15%となる。また、伸縮可能な伸張防止線として、白金-タングステン合金線材により形成された、振幅100μmの波形状を有する自然長195mmの線材(撚り線)を利用した。また、伸張防止線の下記の2点の間に配置されている部分の限界長さは、その部分の自然長に対して115%であった。伸張防止線を200mmに延伸させた状態でコイルの両端部2点の間に配置し、直径16mmのらせん状2次形状を有する塞栓コイルを作製した。本実施例1にて使用した塞栓コイル及びコイルに固定する前の伸張防止線の断面図を図6に示した。
白金-タングステン合金線材(線材外径45μm)により形成された、コイル内径150μm、自然長200mmの金属コイルを用い、該コイルの手元側の一端30mmに間隔が線材外径の30%のピッチ巻き部分を設け、残りは密着巻き部分とした。ピッチ巻き部分の割合は15%となる。また、白金-タングステン合金線材により形成された、自然長200mmの直線状の伸張防止線をコイル端部2点の間に配置し、直径16mmのらせん状2次形状を有する塞栓コイルを作製した。尚、伸張防止線の上記の2点の間に配置されている部分の限界長さは、その部分の自然長に対して100%となる。
白金―タングステン合金線材(線材外径45μm)により形成された、コイル内径150μm、全長にわたり密着巻きを形成する、自然長200mmの金属コイルを用いた。また、白金-タングステン合金線材により形成された、自然長200mmの直線状の伸張防止線をコイル端部2点の間に配置し、直径16mmのらせん状2次形状を有する塞栓コイルを作製した。尚、伸張防止線の上記の2点の間に配置されている部分の限界長さは、その部分の自然長に対して100%となる。
尚、「カテーテル内で5回往復させた」とは、具体的には以下の通りである。一般的なマイクロカテーテルの先端開口部から約10cm基端側のカテーテル内部にサンプルの先端側端部が位置するようにサンプルを配し、その位置からサンプルの先端部から約10cmの部分がマイクロカテーテルの先端開口部から外部に出た状態になるまでサンプルを移動させた後(サンプルの基端側の一部はカテーテル内部に存在する)、マイクロカテーテルの先端開口部から約10cm基端側のカテーテル内部にサンプルの先端側端部が位置するようにサンプルを移動させる。この一連の操作を一往復として、5回繰り返した。
また、「平均値」とは、前記の一往復の操作の間の最大値を測定し、5回繰り返した時の各最大値の平均値を意味する。
2.伸張防止線
3.密着巻き部分
4.ピッチ巻き部分
5.コイル手元側
6.固定前のコイル自然長
7.固定前の伸張防止線自然長
8.カテーテル
9.コイル軸方向の力
10.力のベクトル
11.伸張防止線の周期的な形状の幅
12.伸張防止線の撚り間隔
Claims (13)
- 伸張防止線と一部又は全部がピッチ巻きになったコイルとが、少なくとも互いに異なる2点で固定されている塞栓コイルであって、前記伸張防止線が、その前記互いに異なる2点の間に配置されている部分に、伸縮可能な形状が付与されている部分を有することを特徴とする塞栓コイル。
- 前記コイルがピッチ巻き部分と密着巻き部分の両方を有している請求項1に記載の塞栓コイル。
- 前記コイルの前記互いに異なる2点の間に配置されている部分の自然長が、前記伸張防止線の前記互いに異なる2点の間に配置されている部分の自然長より長い請求項1又は2に記載の塞栓コイル。
- 前記伸張防止線の前記伸縮可能な形状が付与されている部分が、コイルの軸方向に伸張した状態で、前記互いに異なる2点の間に配置されている請求項1~3のいずれか一項に記載の塞栓コイル。
- 前記伸張防止線の前記伸縮可能な形状が付与されている部分の形状が、周期的な形状である請求項1~4のいずれか一項に記載の塞栓コイル。
- 前記コイルと前記伸張防止線とを固定する前の状態において、前記伸張防止線の伸縮可能な形状の最大幅が、前記コイルの内径以下である請求項1~5のいずれか一項に記載の塞栓コイル。
- 前記コイルにおけるピッチ巻き部分が、前記コイルの手元側に部分的に配置されている請求項1~6のいずれか一項に記載の塞栓コイル。
- 前記コイルの前記互いに異なる2点の間に配置されている部分の自然長が、前記伸張防止線の前記互いに異なる2点の間に配置されている部分の自然長を100%とした時に、100%より長く、130%以下である請求項3に記載の塞栓コイル。
- 前記伸張防止線の前記互いに異なる2点の間に配置されている部分の限界長さが、前記コイルの前記互いに異なる2点の間に配置されている部分の自然長(100%)に対して、130%以下である請求項1~8のいずれか一項に記載の塞栓コイル。
- 前記コイルの前記互いに異なる2点の間に配置されている部分のピッチ巻き部分の長さが、前記コイルの前記互いに異なる2点の間に配置されている部分の自然長の5~40%である請求項1~9のいずれか一項に記載の塞栓コイル。
- 前記伸張防止線の伸縮可能な形状が付与されている部分が、2本以上の素線が撚られて形成されている請求項1~10のいずれか一項に記載の塞栓コイル。
- 前記伸張防止線の伸縮可能な形状が付与されている部分が、金属製ワイヤにより形成されている請求項1~11のいずれか一項に記載の塞栓コイル。
- 前記金属製ワイヤが白金または白金合金よりなる請求項12に記載の塞栓コイル。
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Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2668915A1 (en) * | 2012-06-01 | 2013-12-04 | Acandis GmbH & Co. KG | System for delivering a stretch resistant vaso-occlusive device and a method of producing same |
US8801747B2 (en) | 2007-03-13 | 2014-08-12 | Covidien Lp | Implant, a mandrel, and a method of forming an implant |
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US9687245B2 (en) | 2012-03-23 | 2017-06-27 | Covidien Lp | Occlusive devices and methods of use |
US9713475B2 (en) | 2014-04-18 | 2017-07-25 | Covidien Lp | Embolic medical devices |
WO2019026363A1 (ja) * | 2017-07-31 | 2019-02-07 | 株式会社カネカ | 生体内留置具および生体内留置具送達システム |
US11504131B2 (en) | 2017-07-31 | 2022-11-22 | Kaneka Corporation | In-vivo indwelling instrument, in-vivo indwelling instrument delivering system and method for producing in-vivo indwelling instrument |
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH08336600A (ja) | 1995-06-06 | 1996-12-24 | Target Therapeutics Inc | 可変剛直コイル |
JPH09108229A (ja) | 1995-06-30 | 1997-04-28 | Target Therapeutics Inc | 伸張抵抗性血管閉塞コイル |
JP2001517484A (ja) * | 1997-09-24 | 2001-10-09 | コンセプタス インコーポレイテッド | 避妊用頚部横断式卵管閉塞装置および方法 |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE10155191A1 (de) * | 2001-11-12 | 2003-05-22 | Dendron Gmbh | Medizinisches Implantat |
EP1582152B1 (en) | 2003-01-10 | 2011-04-06 | Kaneka Corporation | Embolus forming in-vivo indwelling implant |
JP2004261234A (ja) * | 2003-02-20 | 2004-09-24 | Kaneka Medix Corp | 塞栓形成用体内留置具 |
US7651513B2 (en) * | 2003-04-03 | 2010-01-26 | Boston Scientific Scimed, Inc. | Flexible embolic device delivery system |
US7645292B2 (en) * | 2003-10-27 | 2010-01-12 | Boston Scientific Scimed, Inc. | Vaso-occlusive devices with in-situ stiffening elements |
US20050090856A1 (en) * | 2003-10-27 | 2005-04-28 | Scimed Life Systems, Inc. | Vasco-occlusive devices with bioactive elements |
US7608089B2 (en) * | 2004-12-22 | 2009-10-27 | Boston Scientific Scimed, Inc. | Vaso-occlusive device having pivotable coupling |
US20070225738A1 (en) * | 2006-03-24 | 2007-09-27 | Cook Incorporated | Aneurysm coil and method of assembly |
AU2007260653B2 (en) * | 2006-06-15 | 2013-01-24 | Microvention, Inc. | Embolization device constructed from expansible polymer |
US8034073B2 (en) * | 2006-08-18 | 2011-10-11 | Codman & Shurtleff, Inc. | Stretch resistant embolic coil |
DE102007038446A1 (de) * | 2007-08-14 | 2009-02-19 | pfm Produkte für die Medizin AG | Embolisiereinrichtung |
CA2739603A1 (en) * | 2008-10-13 | 2010-04-22 | Stryker Corporation | Vaso-occlusive coil delivery system |
-
2010
- 2010-09-09 WO PCT/JP2010/065513 patent/WO2011030820A1/ja active Application Filing
- 2010-09-09 CN CN201080039829.2A patent/CN102481154B/zh active Active
- 2010-09-09 KR KR1020127008953A patent/KR101686273B1/ko active IP Right Grant
- 2010-09-09 US US13/394,806 patent/US9474532B2/en active Active
- 2010-09-09 JP JP2011530869A patent/JPWO2011030820A1/ja active Pending
- 2010-09-09 EP EP10815415.4A patent/EP2476380B1/en active Active
-
2015
- 2015-04-09 JP JP2015080043A patent/JP6011672B2/ja active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH08336600A (ja) | 1995-06-06 | 1996-12-24 | Target Therapeutics Inc | 可変剛直コイル |
JPH09108229A (ja) | 1995-06-30 | 1997-04-28 | Target Therapeutics Inc | 伸張抵抗性血管閉塞コイル |
JP2001517484A (ja) * | 1997-09-24 | 2001-10-09 | コンセプタス インコーポレイテッド | 避妊用頚部横断式卵管閉塞装置および方法 |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9050095B2 (en) | 2004-09-22 | 2015-06-09 | Covidien Lp | Medical implant |
US8801747B2 (en) | 2007-03-13 | 2014-08-12 | Covidien Lp | Implant, a mandrel, and a method of forming an implant |
US9011480B2 (en) | 2012-01-20 | 2015-04-21 | Covidien Lp | Aneurysm treatment coils |
US10893868B2 (en) | 2012-01-20 | 2021-01-19 | Covidien Lp | Aneurysm treatment coils |
US9687245B2 (en) | 2012-03-23 | 2017-06-27 | Covidien Lp | Occlusive devices and methods of use |
EP2668915A1 (en) * | 2012-06-01 | 2013-12-04 | Acandis GmbH & Co. KG | System for delivering a stretch resistant vaso-occlusive device and a method of producing same |
US9713475B2 (en) | 2014-04-18 | 2017-07-25 | Covidien Lp | Embolic medical devices |
WO2019026363A1 (ja) * | 2017-07-31 | 2019-02-07 | 株式会社カネカ | 生体内留置具および生体内留置具送達システム |
JPWO2019026363A1 (ja) * | 2017-07-31 | 2020-05-28 | 株式会社カネカ | 生体内留置具および生体内留置具送達システム |
JP7097365B2 (ja) | 2017-07-31 | 2022-07-07 | 株式会社カネカ | 生体内留置具および生体内留置具送達システム |
US11504131B2 (en) | 2017-07-31 | 2022-11-22 | Kaneka Corporation | In-vivo indwelling instrument, in-vivo indwelling instrument delivering system and method for producing in-vivo indwelling instrument |
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EP2476380A4 (en) | 2016-12-28 |
JP6011672B2 (ja) | 2016-10-19 |
US20120172921A1 (en) | 2012-07-05 |
KR101686273B1 (ko) | 2016-12-13 |
JPWO2011030820A1 (ja) | 2013-02-07 |
KR20120068022A (ko) | 2012-06-26 |
CN102481154B (zh) | 2015-04-01 |
US9474532B2 (en) | 2016-10-25 |
CN102481154A (zh) | 2012-05-30 |
EP2476380A1 (en) | 2012-07-18 |
EP2476380B1 (en) | 2018-08-22 |
JP2015128677A (ja) | 2015-07-16 |
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