JP2016182299A - In-vivo indwelling member and manufacturing method therefor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an in-vivo indwelling member that has thinness similar to the conventional one at the time of being guided by using a transportation catheter and is capable of expanding the member's volume greater than that before transportation after the member has been inserted into a swelling such as an aneurysm, and provide a manufacturing method capable of simply manufacturing the in-vivo indwelling member.SOLUTION: An in-vivo indwelling member includes: a cylindrical first coil formed by a first wire wound with intervals; a cylindrical second coil formed by a second wire wound along gaps of the first wire spaced at the intervals; and an expansion member that has a part provided on the cylindrical outer surface side of the first coil and provided on the cylindrical inner surface side of the second coil and extends along the second coil's longer axis.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an in-vivo indwelling member and a method for manufacturing the same, for example, an in-vivo indwelling member using a multi-strand coil and a method for manufacturing the same.

  Examples of a method for treating an aneurysm that has occurred in a blood vessel include a method of inserting an in-vivo indwelling member such as an embolic material into the aneurysm. By such a treatment method, it is possible to form a thrombus around the in-vivo indwelling member in the aneurysm and prevent its rupture. As such an in-vivo indwelling member, for example, a primary coil that extends in a linear shape obtained by winding a metal wire such as platinum in a coil shape, and a spiral or other three-dimensional complex A secondary coil shaped into a secondary shape is used. Then, the in-vivo indwelling member is inserted into the lumen of the delivery catheter of the in-vivo indwelling member in the state of the primary coil, transported to the target site, and restored to the state of the secondary coil when discharged from the catheter. To do.

  Aneurysms such as the aforementioned aneurysms are often formed in the walls of thin blood vessels. In order to guide the delivery catheter to the aneurysm formed on the wall of this thin blood vessel, it is necessary to make the outer diameter of the catheter smaller than the inner diameter of the blood vessel. Therefore, it is necessary to make the primary coil of the in-vivo indwelling member discharged from the catheter sufficiently thin so that it can pass through the catheter lumen.

  However, when trying to embolize an aneurysm or the like using a thin primary coil, it is difficult to secure a sufficient volume for embolization with one in-vivo indwelling member. The member needs to be inserted into the aneurysm. Even with an average size of the aneurysm, it is necessary to insert and indwell about 10 to 30 in-vivo indwelling members into one aneurysm, depending on the case. Due to the time, both doctors and patients are burdened.

  As a countermeasure against this problem, it is conceivable to secure the volume with one in-vivo indwelling member. As such a measure, for example, it is conceivable to increase the length of the primary coil constituting the in-vivo indwelling member. However, in this method, when trying to push out the primary coil inserted into the catheter in a linear state, the primary coil cannot meander and advance in the catheter, or it becomes extremely difficult. Therefore, prolonged surgery is unavoidable.

  As another method for securing the volume with one in-vivo indwelling member, it is also conceivable to increase the volume of the in-vivo indwelling member after discharging from the catheter. That is, in the delivery catheter, the primary coil is maintained in a shape thinner than the lumen of the catheter, and the primary coil is deformed into a thick shape when discharged from the catheter. According to this method, since the in-vivo indwelling member thicker than that at the time of conveyance can be indwelled in the aneurysm, an effect of reducing the number of in-vivo indwelling members used for the treatment can be expected.

  For example, Patent Document 1 shows an example of an in-vivo indwelling member in which an intermediate element that swells in an aqueous environment is arranged on the outer surface of an inner element and fixed with the outer element. In this example, it is shown that when the intermediate element touches blood in the aneurysm, the intermediate element expands to the extent that it protrudes from the external element.

  Further, Patent Document 2 is a device for expanding a tubular organ for expanding a circular organ of a human body such as a blood vessel or an esophagus. However, the expanded diameter is memorized so that it can be inserted into the tubular organ. The example of the tubular organ expansion member which consists of one coil (multi-strand coil) which made the diameter-reduced shape-memory alloy several line | wire coil is shown.

JP 2005-537830 A Utility Model No. 2514515

  However, in the invention described in Patent Document 1, an intermediate element that is a cylindrical expandable polymer is provided on the outer surface of the closely wound coil-shaped inner element, and a coil-shaped outer element having a pitch is provided outside the intermediate element. Provided. Since it has such a multilayer structure, there is a limit to making the in-vivo indwelling member thinner.

  Moreover, in the invention described in Patent Document 2, when the diameter of the multi-strand coil is increased, the length of the multi-strand coil is reduced. Therefore, a sufficient volume expansion effect cannot be obtained.

  The present invention has been made to solve the above problems. And, the purpose is that when guiding with a delivery catheter, it has the same thinness as before, and after being inserted into an aneurysm or other aneurysm, the volume can be expanded from before the delivery. An object of the present invention is to provide an indwelling member and to provide a production method capable of easily producing such an in vivo indwelling member.

  The inventor has conducted intensive studies and found that the predetermined first coil, the second coil provided so as to have a specific positional relationship with the first coil, and the first and second coils have a specific positional relationship. The in-vivo indwelling member including the expansion member provided as described above has found that the above-described problems can be solved, and has completed the present invention.

  A first aspect of the present invention is a first coil wound along a gap between a cylindrical first coil formed by a first wire wound at an interval and the first wire separated by the interval. A cylindrical second coil formed of two wires, a portion installed on the cylindrical outer surface side of the first coil and a portion installed on the cylindrical inner surface side of the second coil, It is related with the indwelling member containing the expansion | swelling member extended along a major axis direction.

  In the present invention, it is preferable that the second wire has lower rigidity than the first wire. In this case, the second wire is preferably thinner than the first wire.

  In the present invention, it is preferable that the second coil has a portion whose inner maximum width is equal to or larger than the inner maximum width of the first coil.

  In this invention, it is preferable that the said expansion | swelling member is installed so that between the adjacent 1st wire and 2nd wire may pass alternately.

  In this invention, it is preferable that the said expansion | swelling member is installed so that the full length of the said 2nd coil may be covered.

  In the present invention, when the expansion member is expanded, at least a part of the second coil is pushed out by the expansion member toward the outside of the first coil, It is preferable that the amount of deviation between the axial position of the first coil and the axial position of the second coil is large.

  In the present invention, the expansion member preferably includes a swellable material. Moreover, it is preferable that the said expansion | swelling member has a linear structure.

  In the present invention, it is preferable that the secondary coil is provided to the primary coil that is configured by using the first coil, the second coil, and the expansion member and is provided with a linear primary shape. . In this case, it is more preferable that the secondary shape is given in advance only to the first coil.

  2nd of this invention is a manufacturing method of the in-vivo indwelling member containing a 1st wire, a 2nd wire, and an expansion member, Comprising: A 1st wire is wound at intervals and a cylindrical 1st coil is formed. A first coil forming step, an expansion member disposing step of disposing the expansion member on at least a part of the outer surface in the axial direction of the cylindrical first coil formed in the first coil forming step, and the expansion member A second coil forming step of forming a cylindrical second coil by winding the second wire along the gap of the first wire separated from the outside by the interval. It relates to a manufacturing method.

  In this invention, it is preferable to further include the secondary shape provision process which provides a secondary shape with respect to the said 1st coil obtained at the said 1st coil formation process, and heats it. In this case, it is more preferable to further include a linear form maintaining step of making the first coil provided with the secondary shape obtained in the secondary shape applying step linear.

  According to the present invention, when guiding with a delivery catheter, the body has the same thinness as before, and after being inserted into an aneurysm such as an aneurysm, the volume can be expanded from before the delivery. An indwelling member can be provided simply. In addition, the present invention can be expected to reduce the number of in-vivo indwelling members used and shorten the operation time, and as a result, reduce the burden on doctors and patients.

It is the front view which showed typically a part of 1st Embodiment of the in-vivo indwelling member which concerns on this invention. It is the top view which showed typically a part of 1st Embodiment of the in-vivo indwelling member which concerns on this invention. It is AA sectional drawing of FIG. It is BB sectional drawing of FIG. It is the perspective view which showed typically embodiment of the 1st wire or 2nd wire used for the in-vivo indwelling member which concerns on this invention. It is the perspective view which showed typically embodiment of the expansion | swelling member used for the in-vivo indwelling member which concerns on this invention. It is the front view which showed typically a part of 2nd Embodiment of the in-vivo indwelling member which concerns on this invention. It is the top view which showed typically a part of 2nd Embodiment of the in-vivo indwelling member which concerns on this invention. It is CC sectional drawing of FIG. It is DD sectional drawing of FIG. It is the front view which showed typically the state when the expansion member of the in-vivo indwelling member which concerns on 1st Embodiment expanded. It is the top view which showed typically the state when the expansion member of the in-vivo indwelling member which concerns on 1st Embodiment expanded. It is EE sectional drawing of FIG. It is the perspective view which showed typically the embodiment of the mandrel which can be used by this invention. It is explanatory drawing for demonstrating the 1st coil formation process in embodiment of the manufacturing method which concerns on this invention. It is explanatory drawing for demonstrating the expansion member arrangement | positioning process in embodiment of the manufacturing method which concerns on this invention. It is explanatory drawing for demonstrating the 2nd coil formation process in embodiment of the manufacturing method which concerns on this invention. It is explanatory drawing for demonstrating the secondary shape provision process in embodiment of the manufacturing method which concerns on this invention. It is explanatory drawing for demonstrating the linear form maintenance process in embodiment of the manufacturing method which concerns on this invention. It is the perspective view which showed typically 3rd Embodiment of the in-vivo indwelling member which concerns on this invention. It is the perspective view which showed typically 4th Embodiment of the in-vivo indwelling member which concerns on this invention. It is explanatory drawing for demonstrating the usage method of the in-vivo indwelling member which concerns on this invention. It is explanatory drawing for demonstrating the usage method of the in-vivo indwelling member which concerns on this invention.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, although a member code | symbol may be abbreviate | omitted for convenience, in such a case, it shall refer to another drawing. Moreover, the dimension of the various members in drawing may be adjusted so that it may be easy to see for convenience.

  The in-vivo indwelling member according to the present invention is wound along a gap between a cylindrical first coil formed by a first wire wound at an interval and the first wire separated at the interval. A cylindrical second coil formed by the formed second wire, a portion installed on the cylindrical outer surface side of the first coil and a portion installed on the cylindrical inner surface side of the second coil, And an expansion member extending along the major axis direction of the two coils.

As described above, in the present invention, a single coil (hereinafter sometimes referred to as a “multiple coil”) is formed of a plurality of wires by winding the second wire along the gap between the first wires. Form. The expansion member extends along the major axis direction of the second coil, and has a portion installed on the cylindrical outer surface side of the first coil and installed on the cylindrical inner surface side of the second coil.
With these configurations, the in-vivo indwelling member configured using the multi-strand coil can be thinned to such an extent that it can be easily inserted into the lumen of the delivery catheter. Since the second coil is pushed out by the expansion member relative to the outside of one coil, the volume of the second coil is relatively increased without shortening the length. The volume of the in-vivo indwelling member configured using the can be greatly increased before being inserted into the delivery catheter.

  FIG. 1 is a front view schematically showing a part of a first embodiment of an in-vivo indwelling member according to the present invention, FIG. 2 is a plan view thereof, and FIG. FIG. 4 is a cross-sectional view taken along line A, and FIG. 4 is a cross-sectional view taken along line BB in FIG.

The in-vivo indwelling member 1 shown in FIGS. 1 to 4 includes a first coil 13, a second coil 15, and an expansion member 16. The first coil 13 is formed by the first wire 11 wound at an interval 12. The first coil 13 has a cylindrical structure. The second coil 15 is formed by the second wire 14 that is wound along the gap of the first wire 11 that is separated by the interval 12. The second coil 15 also has a cylindrical structure. The expansion member 16 is installed on the cylindrical outer surface side of the first coil 13 and has a portion installed on the cylindrical inner surface side of the second coil 15.
In the present invention, for convenience, wires and coils are distinguished and referred to by serial numbers, but any of them may be referred to as first or second.

The first coil 13 and the second coil 15 are formed by the first wire 11 and the second wire 14, respectively.
The 1st wire 11 and the 2nd wire 14 which can be used in this invention will not be specifically limited if it is a continuous thing which has both ends. As a structure of such a wire, a single wire, a double wire, or a combination of a single wire and a double wire can be adopted. Examples of the double wire include a stranded wire obtained by twisting a plurality of wires, and a plurality of parallel wires. As a combination of a single wire and a double wire, for example, a single wire and a double wire may be arbitrarily continuous in the length direction of the strands to form a series. Thus, in this invention, the wire which continued between both ends is called a series of wires, and the thing which mutually connected several wire rods in the vicinity of each edge part is included.

The cross-sectional shape of each wire constituting the single wire or the double wire is not particularly limited, and various shapes such as a circle, an ellipse, and a square can be selected.
Further, when the cross-sectional shape of the single wire is circular, the diameter (wire diameter) can be arbitrarily selected, for example, from about φ0.010 mm to 0.200 mm, although it depends on the size of the knob. Of these, 0.030 mm or more and 0.100 mm or less is preferable from the viewpoint of strength and hardness when the in-vivo indwelling member is used. Similarly, when the cross-sectional shape of the single wire is not circular, the maximum width can be arbitrarily selected from about 0.010 mm to 0.200 mm, preferably 0.030 mm to 0.100 mm. In the case of a double wire, the size of the cross section may be selected according to the single wire as a whole of the double wire, or each wire constituting the double wire may be of the same level as in the case of a single wire.

  The material of the first wire 11 and the second wire 14 is not particularly limited, and an inorganic material or an organic material can be used. As the intangible material, a metal or the like can be used. For example, platinum (platinum), tungsten, gold, tantalum, iridium, titanium, stainless steel, nickel, titanium, and two or more kinds of metals selected from these metals An alloy containing As the alloy, for example, an alloy of tungsten and platinum, an alloy of iridium and platinum, and an alloy of nickel and titanium are preferable. These metals are radiopaque materials. As the organic material, a biocompatible resin or the like can be used. However, when radiopaque is used, a resin composition in which materials having such characteristics are mixed can be used.

  In the present invention, the first wire and the second wire may have the same configuration or different configurations. However, as will be described later, when the in-vivo indwelling member is provided with a secondary shape with respect to a linear primary coil, the in-vivo indwelling member From the viewpoint of easiness of volume expansion, etc., the second wire preferably has lower rigidity than the first wire. The rigidity of the wire can be adjusted as appropriate depending on the material, thickness, structure, etc. of the wire, but it is preferable to adjust the rigidity of the wire. That is, the second wire is preferably thinner than the first wire.

  FIG. 5 shows an example of an embodiment of a first wire and a second wire that can be used in the present invention. The wire 10 shown in FIG. 5 is a single wire having both ends at one end and the other end and continuous between the both ends. The cross section of the single wire is circular, and the radius between both ends is substantially constant. In the following description, a case where the single wire 10 having the structure shown in FIG. 5 is used as the first wire 11 and the second wire 14 will be described unless otherwise specified. However, the wires having various structures described above are used. Can be adopted.

  As the first coil 13, various coil-like and cylindrical structures obtained by winding the first wire 11 with an interval 12 can be adopted. The direction in which the first wire 11 is wound is not particularly limited, and may be clockwise or counterclockwise. Further, the interval 12 when the first wire is wound is not particularly limited as long as the second wire 14 and the two expansion members 16 can be arranged between the first wires 11 separated by the interval 12. The interval 12 may be arbitrarily changed along the length direction of the first coil 13 or may be constant. In particular, when the second coil 15 is provided in a part of the first coil 13, it is only necessary to have a part having the interval 12, and the other part may be densely wound, or may be appropriately spaced. Pitch winding may be used. In addition, the shape in plan view from the direction orthogonal to the axial direction of the coiled structure of the first coil may be a shape such as a circle, an ellipse, an egg shape, or a polygon. The width (diameter) of the coiled structure may be constant in the major axis direction of the first coil 13 or may be arbitrarily changed. In addition, the maximum width (outer diameter) of the coil-shaped structural portion can be determined as appropriate according to the indwelling site and application, but the inner diameter of the catheter generally used to transport the in-vivo indwelling member to an aneurysm or the like From the viewpoint of adapting to the cavity diameter, when the shape in plan view is circular, it is preferably 0.100 mm or more and 0.500 mm or less. The length of the coil-shaped structural part can be appropriately determined according to the indwelling site and the application, but is preferably 10 mm or more and 1000 mm or less from the viewpoint of stably extruding the in-vivo indwelling member with the pusher member for extrusion. In the first embodiment shown in FIG. 1, the planar view shape is circular, and the diameter thereof is constant in the major axis direction of the first coil 13.

The second coil 15 can employ various coiled and cylindrical structures obtained by winding the second wire 14 along the gap between the first wires 11 separated by the interval 12. From the viewpoint of arranging the second wire 15 in the gap of the first wire 11 in which the second wire 14 is separated by the interval 12 of the first coil 13, the coil-like structure of the second coil 15 has an interval 12. It is preferable to have a structure corresponding to the gap between the first wires 11 separated from each other, and it is more preferable to have a structure similar to the coiled structure of the first coil 13. Therefore, the winding direction of the second coil 15 is the same as that of the first coil 13, and the central axis 19 in the major axis direction of the second coil 15 is substantially coaxial with the central axis 18 of the first coil 13. . In the first embodiment shown in FIG. 1, the second coil 15 has a structure similar to the coiled structure of the first coil 13.
As the shape in plan view from the direction orthogonal to the major axis direction of the coil-like structure of the second coil, a shape such as a circle, an ellipse, an egg shape, or a polygon can be adopted. In the first embodiment shown in FIG. The width (diameter) of the coiled structure may be constant in the major axis direction of the second coil or may be arbitrarily changed. In the first embodiment shown in FIG. Further, the size of the maximum width (outer diameter) of the coil-shaped structural part can be appropriately determined according to the indwelling site and application, but is generally used to transport the in-vivo indwelling member to an aneurysm or the like. From the viewpoint of adapting to the lumen diameter of the catheter, when the shape in plan view is circular, it is preferably 0.100 mm or more and 0.500 mm or less. However, it is preferable that the second coil has a portion whose inner maximum width is equal to or larger than the inner maximum width of the first coil. Thereby, an expansion member can be stably installed in a predetermined position.
The length of the coil-shaped structural portion of the second coil 15 can be appropriately determined according to the indwelling site and application, taking into account the length of the first coil. In the example shown in FIG. 1, the length of the coil-shaped structural portion of the second coil 15 is the same as that of the first coil 13, but with respect to the gap of the first wire 11 formed in the first coil 13. Thus, a plurality of second coils 15 can be installed so as to be arranged in series. In the case of such a structure, by changing the arrangement of the expansion member 16 for each second coil 15, the position where each second coil is pushed with respect to the circumferential direction of the first coil 13 can be changed, The type of the second wire can be changed.

  The expansion member that can be used in the present invention is not particularly limited as long as it can be in an expanded state in the aneurysm, and various types of mechanisms for expanding the expansion member can be employed. For example, (i) a shape memory alloy that memorizes the inflated state is used to restore the inflated shape near body temperature, (ii) a fluid supplied from a catheter is poured into the inside of the inflatable member to inflate the inflatable member, (Iii) What is comprised with the member containing the material expanded by body fluids, such as blood, etc. are mentioned. Among these, from the viewpoint of ease of production, certainty and the like, those of (iii) are preferable, and examples of the material that expands by such body fluid include swelling materials such as a water-absorbing polymer (hydrogel). Can be mentioned. Examples of such a water-absorbing polymer include polyethylene glycol and polyvinyl alcohol.

  Hereinafter, an example in which a water-absorbing polymer is used as the material of the member constituting the expansion member will be described unless otherwise specified. However, the various swelling mechanisms described above can be employed.

The expansion member used in the present invention has a portion that is installed on the cylindrical outer surface side of the first coil and that is installed on the cylindrical inner surface side of the second coil, and extends along the major axis direction of the second coil. The structure is not particularly limited as long as it expands. However, when the expansion member is expanded, at least a part of the second coil is easily pushed toward the outside of the first coil by the expansion member. From a viewpoint etc., what has a linear structure is preferable. Examples of the linear structure include a straight line shape, a curved line shape, and a wavy line shape, and among these, a linear structure is preferable.
The length of the expansion member is not particularly limited, and can be appropriately determined according to the length or arrangement of the expansion member. For example, it may be a length that can be installed so as to cover the entire length of the second coil in the long axis direction, or may be a length that can be set so as to cover a part of the total length of the second coil in the long axis direction. However, from the viewpoint of increasing the effect of expanding the volume of the in-vivo indwelling member and from the viewpoint of ease of manufacture, the inflatable member has a length that allows installation so that one expansion member extends over the entire length of the second coil. preferable.
The number of installed expansion members can be appropriately determined according to the structure of the second coil and the expansion member, the length and arrangement of the expansion member, and the like. For example, in the case where the expansion member has a linear structure, when one having a length that can be installed over the entire length of the second coil is used, one is preferable, and the total length of the second coil in the long axis direction is preferable. In the case of a length that can be installed so as to cover a part of them, one or two or more can be used, and when two or more are used, the second coil is not overlapped in the cylindrical circumferential direction. It is preferable to use a number that can be installed in the longitudinal direction of two coils. When two or more are used in this way, the expansion members may be arranged in a line along the long axis direction of the second coil, or at least one expansion member may be displaced in the circumferential direction. You may arrange in.
The cross-sectional shape of the expansion member is not particularly limited, and various shapes such as a circle, an ellipse, an arc shape, and a square (a polygon such as a square and a rectangle) can be selected. When the cross-sectional shape is circular, the diameter can be arbitrarily selected from, for example, φ0.010 mm or more and 0.200 mm or less, although it depends on the diameters of the first wire 11 and the second wire 14. Similarly, when the cross-sectional shape is not circular, the maximum width can be arbitrarily selected from about 0.010 mm to 0.200 mm. The cross-sectional shape of the expansion member may be constant along the length direction or may be arbitrarily changed. However, from the viewpoint of expanding the expansion member to the same extent along the major axis direction of the second coil and expanding the volume more effectively or from the viewpoint of ease of extrusion manufacturing of the expansion member, in the length direction. It is preferably constant along.

FIG. 6 shows an example of an embodiment of an expansion member that can be used in the present invention. The expansion member 16 shown in FIG. 6 is a single wire that has both ends at one end and the other end and extends in a straight line continuous between the both ends. The cross-sectional shape of the single wire is elliptical, and the major axis and minor axis are substantially constant between both ends. As shown in FIG. 13, when the cross-sectional shape is elliptical, the gap between the first wire 11 and the second wire 14 can be occupied as much as possible by the expansion member during expansion.
In the following description, unless otherwise specified, the case where a member having a linear structure as shown in FIG. 6 is used as the expansion member 16 will be described. However, the expansion member having various structures described above may be employed. Is possible.

In the present invention, the expansion member extends along the long axis direction of the second coil, and is installed on the cylindrical outer surface side of the first coil and the portion installed on the cylindrical inner surface side of the second coil. Have. The arrangement of the expansion member with respect to the first and second coils may satisfy such a condition, but from the viewpoint of easiness of expanding the volume of the in-vivo indwelling member and the ease of manufacture, the adjacent first wires It is preferable that they are installed so as to pass alternately between the second wire and the second wire.
1-4 show an example of an embodiment in which an expansion member is installed as such. In the first embodiment shown in FIGS. 1 to 4, the single-wire expansion member 16 that extends linearly shown in FIG. 6 includes the cylindrical outer surface side of the first coil 13 in the first wire 11 and the first wire 11 in the second wire 14. It passes along the cylindrical inner surface side of the two coils 15 in order and in parallel along the axis of the long axis direction of the second coil so as to pass between the adjacent first wire 11 and second wire 14. It is growing.

Next, a second embodiment of the in-vivo indwelling member according to the present invention will be described. The second embodiment is the same as the first embodiment except that the second wire is thinner than the first wire in the first embodiment. Hereinafter, it will be briefly described with reference to the drawings.
7 is a front view schematically showing a second embodiment of the in-vivo indwelling member according to the present invention, FIG. 8 is a plan view thereof, and FIG. 9 is a sectional view taken along the line CC in FIG. FIG. 10 is a sectional view taken along the line DD of FIG. 7 to 10, the same components as those in the first embodiment are denoted by the same reference numerals.

  The in-vivo indwelling member 2 shown in FIGS. 7 to 10 includes a first coil 13, a second coil 15 a, and an expansion member 16. The first coil 13 is formed by the first wire 11 wound at an interval 12. The first coil 13 has a cylindrical structure. The second coil 15 a is formed by the second wire 14 a that is wound along the gap between the first wires 11 that are separated by the interval 12. The second coil 15a also has a cylindrical structure. The expansion member 16 is installed on the cylindrical outer surface side of the first coil 13 and has a portion installed on the cylindrical inner surface side of the second coil 15.

  As shown in FIGS. 7 to 10, the second coil 15 a is thinner than the first wire 11 so that the rigidity is lower than that of the first wire 11 constituting the first coil 13. Further, the shape of the first coil 13 in a plan view from the direction orthogonal to the axial direction of the coiled structure is circular, whereas the second coil 15a has an egg shape. Further, the maximum width inside the second coil 15a (the egg-shaped maximum width portion) is larger than that of the first coil 13 (see FIG. 10). On the other hand, the second coil 15 a has a structure similar to the coiled structure of the first coil 13. The length of the second coil 15 a in the major axis direction is the same as that of the first coil 13. Moreover, the single-wire expansion member 16 extending linearly shown in FIG. 6 includes a cylindrical outer surface side of the first coil 13 in the first wire 11, and a cylindrical inner surface side of the second coil 15 in the second wire 14. , And in parallel with each other along the long axis of the second coil so as to pass between the adjacent first wire 11 and second wire 14.

  Next, the operation of the in-vivo indwelling member according to the present invention will be described with reference to FIGS. 1 to 4 and FIGS. 11 to 13 by taking the case of the first embodiment as an example.

FIG. 11 is a front view schematically showing a state when the expansion member 16 of the in-vivo indwelling member 1 according to the first embodiment is expanded, FIG. 12 is a plan view thereof, and FIG. It is EE sectional drawing of.
1-4, when the indwelling member 1 comes into contact with a body fluid such as blood, the expansion member 16 swells. Before the diameter expansion, as shown in FIG. 4, the first shaft 11 and the second wire 14 constituting the first coil 13 and the second coil 15 in which the central axes 18 and 19 are substantially coaxial are sewn. Thus, the expansion member 16 installed in a wavy line shape is deformed into a linear shape while expanding the diameter. As a result, the expansion member 16 cannot stay in the gap between the first wire 11 and the second wire 14 as shown in FIG. 11, and the second coil 15 is pushed out of the first coil 13. That is, the relative positions of the first coil 13 and the second coil 15 change as the central axis 18 of the first coil 13 and the central axis 19 of the second coil 15 are shifted so as to have a predetermined distance. At this time, from the viewpoint of increasing the volume of the in-vivo indwelling member 1, the position of the center axis 18 (axis) of the first coil 13 and the center axis of the second coil 15 are located after the expansion member 16 before expansion. It is preferable that the amount of deviation from the 19 (axis) position is large.

As shown in FIGS. 1 to 4 and FIGS. 11 to 13, even when the expansion member 16 expands, the first coil 13 and the second coil 15 are expanded only by changing the relative positional relationship between them. There is virtually no change in shape before and after. Therefore, when the expansion member 16 expands, the volume increases from before the expansion by the amount by which the second coil 15 is pushed out of the first coil 13 by the expansion member 16.
The details are as follows. As shown in FIGS. 3 and 13, before the expansion member 16 is expanded, the first coil 13 and the second coil 15 are approximately one annular shape in plan view from a direction parallel to the central axes 18 and 19 ( 3), after the expansion, the annular shape becomes an approximately 8-shaped shape (FIG. 13) that is overlapped so that the center point is shifted (FIG. 13). Has increased. On the other hand, as shown in FIGS. 1 and 11, the first coil 13 and the second coil 15 have no change in the coiled structure (the inner and outer diameters, the gap between the wires) before and after the expansion of the expansion member 16. Thus, although the total length of the in-vivo indwelling member 1 does not change before and after the expansion of the expansion member 16, the in-vivo indwelling member is increased because the area surrounded by the outer shape in plan view parallel to the long axis direction is increased. The volume of 1 will increase.

The structure of the in-vivo indwelling member according to the present invention can be appropriately determined according to the application. For example, as shown in FIGS. 1 and 7, it may have a linear structure, or after forming a primary coil with a linear primary shape, a secondary shape is given to the primary coil. Alternatively, other structures may be used. Among these, for example, when used for an application in which the entire aneurysm is arranged so as to be substantially along the wall surface, a structure in which a secondary shape is given to the primary coil is preferable from the viewpoint of stably arranging the aneurysm. . Examples of such a secondary shape include a spiral shape and a complicated three-dimensional shape other than the spiral shape.
As a spiral shape, for example, like the in-vivo indwelling member 3 according to the third embodiment shown in FIG. 20, the outer diameter of the primary coil 5 formed linearly shown in FIG. In this way, there are those having a shape wound clockwise a predetermined number of times. The winding direction, the interval when winding the primary coil, the number of turns, and the outer diameter can be selected as appropriate. Further, the winding direction, the interval, and the outer diameter may be the same over the entire length of the secondary shape or may be changed.
Further, as a complicated three-dimensional shape other than a spiral shape, for example, a plurality of curved loops such as an arc, a circle, and a spiral are continuously formed as in the in-vivo indwelling member 4 according to the fourth embodiment shown in FIG. It is comprised and what has a three-dimensional structure where all the curved loops do not exist on the same plane is mentioned. In the in-vivo indwelling member 4 shown in FIG. 21, the details of the primary coil 6 (the first and second coils and the expansion member) are omitted. The overall shape of the in-vivo indwelling member 4 shown in FIG. 21 is generally a cube or a rectangular parallelepiped, but a spherical shape, an elliptical spherical shape, an egg shape, a polyhedral shape, a polygonal column shape, a cylindrical shape, a polygonal pyramid shape, a conical shape, a random shape. Various structures such as shapes and combinations of these shapes can be employed. In addition, the secondary shape of the in-vivo indwelling member of this invention is not restricted to these, Various secondary shapes can be employ | adopted.
The size of the secondary shape may be appropriately determined according to the size of the aneurysm or the like of the aneurysm in the living body and the use. For example, when the secondary shape is used so that the whole is arranged along the wall surface inside the aneurysm. Is preferably 1 mm or more and 30 mm or less, and more preferably 3 mm or more and 15 mm or less from the viewpoint of stably disposing in the aneurysm.

  The in-vivo indwelling member according to the present invention may be provided with, for example, a hemispherical tip at one end thereof, an extension preventing member may be provided in the lumen of the multi-strip coil, or at the other end. An extrusion pusher member for extruding from the delivery catheter may be joined via the detachment element portion.

Next, an embodiment of a method for producing an in-vivo indwelling member according to the present invention will be described.
The in-vivo indwelling member manufacturing method according to the present invention is a in-vivo indwelling member manufacturing method including the first wire, the second wire, and the inflating member as described above, and the first wire is wound at intervals. The expansion member is arranged on at least a part of the outer surface in the axial direction of the first cylindrical coil formed in the first coil forming step and the first coil forming step of rotating to form the first cylindrical coil. And a second coil formation for forming a cylindrical second coil by winding the second wire along the gap between the first wires spaced apart from the outside of the expansion member by the interval. And a process.
By having such a configuration, the in-vivo indwelling member according to the present invention can be easily manufactured.

  About the embodiment of the manufacturing method of the in-vivo indwelling member according to the present invention, the in-vivo indwelling member 1 having the linear structure shown in FIG. 1 and the in-vivo provided with the secondary shape as shown in FIG. 20 or FIG. Although the case of the indwelling members 3 and 4 is demonstrated as an example, it is not necessarily limited to these.

A method for manufacturing the in-vivo indwelling member 1 shown in FIG. 1 will be described with reference to FIGS.
First, in the first coil forming step, the first wire 11 is wound at an interval 12a to form a cylindrical first coil 13. Although the formation method of the 1st coil 13 at this time is not specifically limited, It is preferable to wind the 1st wire 11 around a mandrel.
FIG. 14 is a perspective view schematically showing an embodiment of a mandrel that can be used in the present invention. The mandrel 30 shown in FIG. 14 is not particularly limited as long as the first wire 11 can be wound with a gap 12a along the long axis direction. Examples of such a mandrel 30 include, but are not limited to, a hollow linear body and a solid linear body. A circular shape, an elliptical shape, a polygonal shape, or the like can be adopted as the outer shape of the cross section of the mandrel 30 in the direction orthogonal to the major axis direction. When the outer shape of the cross section is circular, the diameter (wire diameter) can be arbitrarily selected, for example, from about φ0.100 mm to 0.450 mm. Similarly, when the outer shape of the cross section of the mandrel 30 is not circular, the maximum width can be arbitrarily selected from about 0.100 mm to 0.450 mm.
FIG. 15 is a front view schematically showing a state when the first wire 11 is wound with an interval 12 a along the long axis direction of the mandrel 30. As shown in FIG. 15, the cylindrical first coil 13 is formed by winding the first wire 11 along the mandrel 30. In the example shown in FIG. 15, the first coil 13 is formed in a cylindrical shape.
In this step, although not shown, the mandrel 30 may be fixed by pulling both ends using a fixing jig or the like. Further, when the first wire 11 is wound around the mandrel 30, the start end 21 portion of the first wire 11 may be fixed to the mandrel 30 or the fixing jig described above. In this case, the fixing method is tape attachment, fastening with screws, binding by winding the first wire 11 around the mandrel 30, binding by winding a winding string around the mandrel 30, and slits provided on the mandrel. However, the present invention is not limited to these.
As a method of winding the first wire 11 around the mandrel 30, it may be wound by moving the first wire 11 in the circumferential direction of the mandrel 30, or the mandrel 30 is rotated about the central axis in the major axis direction as a rotation axis. The first wire 11 to which the start end 21 portion is fixed may be wound along the long axis direction of the mandrel 30 while being wound, or another method may be used. As a method for rotating the mandrel 30, there is a method in which a rotating device that rotates around the central axis is provided at both ends of the mandrel 30, and both ends of the mandrel 30 are rotated at the same speed. Can be mentioned.
The distance 12a of the first wire when the first wire 11 is wound around the mandrel 30 may match the desired distance 12 of the first coil 13, but if coil springback occurs after the winding is completed, Considering this, it is preferable that the distance is larger than 12.

  As described above, after the first wire 11 is wound around the mandrel 30 for a required length, the remaining portion 23 of the first wire 11 is removed, and a portion that becomes the cylindrical first coil 13 is formed.

Next, in the expansion member arranging step, the expansion member 16 is arranged on at least a part of the outer surface in the axial direction of the cylindrical first coil 13 formed in the first coil forming step. The arrangement of the expansion member 16 with respect to the outer surface of the first coil 13 is not particularly limited, and may be parallel to the major axis direction of the first coil 13 or may be twisted with the major axis direction in the tangential direction of the outer surface. Alternatively, other arrangements may be used. However, from the viewpoint of effectively expanding the volume of the in-vivo indwelling member, the viewpoint of ease of manufacture, and the like, the linear expansion member 16 is disposed so as to be parallel to the long axis direction of the first coil 13. Is preferred.
FIG. 16 schematically shows a state when the linear expansion member 16 is disposed on the cylindrical outer surface in parallel with the long axis direction of the first coil 13 along the long axis direction of the first coil 13. It is the shown front view. Although not shown, both ends of the expansion member 16 may be fixed to the mandrel 30. There is no particular limitation on the fixing method at that time, attachment using a tape, fastening using a screw, binding by winding an expansion member around a mandrel, binding by winding a winding string around the mandrel 30, and provision on the mandrel 30 However, the present invention is not limited to these.
Further, since the expansion member 16 is linear, particularly linear, the expansion member 16 need only be disposed and fixed on the outer surface of the first coil 13. Therefore, unlike Patent Document 1, it is not necessary to cover the entire outer surface of the first coil 13 in order to obtain a multilayer structure, and the process can be simplified.

Next, in the second coil forming step, the second wire 14 is wound along the gap 17 of the first wire 11 separated from the outside of the expansion member 16 at the interval 12a, so that the cylindrical second coil 15 is wound. Form.
Also in this step, although not shown, the mandrel 30 may be fixed with both ends pulled by using a fixing jig or the like. Further, when the second wire 14 is wound around the mandrel 30, the start end 24 portion of the second wire 14 may be fixed to the mandrel 30 or the fixing jig described above. At this time, the fixing method is tape sticking, screw fastening, bundling the second wire 14 around the mandrel 30, bundling the winding string around the mandrel 30, and slits provided on the mandrel. However, the present invention is not limited to these.
The method of winding the second wire 14 is not particularly limited, and the second wire 14 may be wound by moving it in the circumferential direction of the mandrel 30, or the mandrel 30 may be rotated about the central axis in the major axis direction. The second wire 14 to which the start end 24 portion is fixed may be wound along the long axis direction of the mandrel 30 while being rotated, or another method may be used.
FIG. 17 shows the gap between the first wire 11 in which the second wire 14 is arranged with its starting end 24 portion being close to the starting end 21 portion of the first wire 11 and spaced from the outside of the expansion member 16 by a distance 12a. FIG. 17 is a front view schematically showing a state when wound along 17. As shown in FIG. 17, the cylindrical second coil 15 is formed by winding the second wire 14 along the mandrel 30. In the example shown in FIG. 17, since the mandrel 30 has a circular cross section, the second coil 15 is seen in a plan view from a direction orthogonal to the major axis direction by winding the second wire 14 from the outside of the expansion member 16. Is formed into an egg-shaped cylinder.

As described above, after winding the second wire 14 for a required length, the end 22 of the first wire 11 constituting the first coil 13 and the end 25 of the second wire constituting the second coil 15 are close to each other. Thus, the remaining portion 26 of the second wire 14 is removed, and a portion to be the cylindrical second coil 15 is formed.
Thereafter, the mandrel 30 is removed to obtain the linear indwelling member 1 in which the first coil 13, the second coil 15, and the expansion member 16 are integrated.

  In the present invention, other embodiments than the embodiments shown in FIGS. 15 to 17 can be adopted. For example, as shown in FIG. 15, for a part of the first coil, a part of the first wire 11 is wound with an interval 12a and the other part is closely attached and wound to open the interval 12a. The first coil forming step is formed so as to form a first coil in which a portion wound around and a portion wound in close contact with each other are formed, and the second wire 14 is formed in a part of the gap 17 of the first coil. Examples of the second coil forming step include winding the second wire 14 around a portion other than the gap 17 of the first wire 11. Further, as an example of winding the second wire 14 around a portion other than the gap 17 of the first wire 11, a configuration in which the second coil extends to at least one end side of the first coil 13, etc. It is done.

  Next, the manufacturing method of the in-vivo indwelling members 3 and 4 to which the secondary shape as shown to FIG. 20 and FIG. 21 was provided is demonstrated, referring FIGS.

  Also in this case, as described above, first, in the first coil forming step, the first wire 11 is wound at an interval 12a to form the cylindrical first coil 13. The details of this step are as described above.

  Next, a secondary shape imparting step of imparting a secondary shape to the first coil 13 obtained in the first coil forming step and heating it is performed. At this time, if necessary, the fixing jigs attached to both ends of the mandrel 30 are removed, and then the mandrel 30 is removed to obtain the first coil 13 that is linear and formed in a cylindrical shape. Thereafter, a secondary shape as shown in FIGS. 20 and 21 is applied to the first coil 13. FIG. 18 is a perspective view showing a state when a spiral secondary shape is imparted to the first coil 13.

The spiral secondary shape as shown in FIG. 18 can be obtained by, for example, winding the first coil 13 in close contact with a linear mandrel and then fixing it by heating. The secondary shape having a three-dimensional and complicated shape as shown in FIG. 21 is, for example, a secondary shape together with the first coil 13 after the first coil 13 is arranged in the secondary shape mold in the first shape state. The shape mold is deformed to the second shape, and the secondary coil shown in FIG. 21 is heated using a secondary mold that can deform the first coil 13, or a plurality of cylindrical rod shapes are connected in combination. After the first coil 13 is wound around the secondary shape mandrel and heated, the first coil 13 detached from the secondary shape mandrel can be placed in the mold and heated again. .
The heating condition at this time can be appropriately determined according to the material constituting the first wire 11 and is, for example, 15 minutes or more at a temperature of 400 ° C. or higher.
Further, the mandrel may be heated while being inserted into the lumen of the first coil 13.

The secondary shape is not limited to the shape shown in FIGS. 20 and 21 and may be another shape. Such a secondary shape is obtained by, for example, winding and fixing the first coil 13 around a mandrel for a secondary shape formed so as to correspond to a desired secondary shape, or in a deformable die or mold. It can give to the 1st coil 13 by arrange | positioning 1 coil 13 and heating it.
The shape of the secondary shape mandrel may be set as appropriate according to the desired secondary shape. For example, a spherical shape, an elliptical spherical shape, an egg shape, a polyhedral shape, a polygonal column shape, a cylindrical shape, a polygonal pyramid shape, A conical shape, the shape which combined these, etc. are mentioned. In order to make it easy to wind the first coil 13, a groove or a protrusion may be provided on the secondary shape mandrel.
The internal shape of the mold may be set as appropriate according to the desired secondary shape. For example, a spherical shape, an elliptical spherical shape, an egg shape, a polyhedral shape, a polygonal column shape, a cylindrical shape, a polygonal pyramid shape, a conical shape, The shape etc. which combined these are mentioned. Moreover, you may use the hollow pipe arrange | positioned like the secondary shape to give as a casting_mold | template.
If the physical properties of the expansion member do not change even when the above-described heating is performed, the secondary shape is formed on the primary coil (including the first and second coils and the expansion member) by the method described above. It may be given.

  As heating conditions at this time, a secondary shape is more reliably imparted to the first coil 13 and the primary coil (including the first and second coils and the expansion member, and the expansion member does not change its physical properties by heating). From the viewpoint, the heating may be performed twice or more. For example, the first coil 13 may be heated while being wound around the secondary shape mandrel, and then the first coil 13 removed from the secondary shape mandrel may be placed in the mold and heated again.

  Next, it is preferable to perform a linear form maintaining step of making the first coil 13 provided with the secondary shape obtained in the secondary shape applying step linear. In this step, for example, if necessary, a linear mandrel can be inserted into the lumen of the first coil 13 over its entire length to temporarily return to the linear form. As the mandrel to be inserted, the mandrel 30 used in the primary shape imparting step may be used, or a different mandrel may be used as long as it can be inserted into the lumen of the first coil. Thereafter, in this step, although not shown, the both ends of the mandrel 30 may be fixed using a fixing jig or the like. In addition, when the secondary shape was given to the 1st coil 13 with the mandrel 30 inserted, the secondary shape was given by fixing the both ends of the mandrel 30 using a fixing jig or the like. The first coil can be temporarily returned to the linear form.

The in-vivo indwelling members 3 and 4 to which the secondary shape is given are obtained by performing the expansion member arranging step and the second coil forming step described above, in which the linear form maintaining step is performed.
In the present invention, it is preferable that the secondary shape is previously given only to the first coil. Thereby, the in-vivo indwelling member provided with the secondary shape can be easily manufactured.

The in-vivo indwelling members 3 and 4 obtained as described above use the restoring force to restore the secondary shape to which the first coil 13 is given, and the second coil 15 to which the secondary shape is not given. Is deformed into a shape corresponding to the secondary shape given to the first shape, so that the in-vivo indwelling members 3 and 4 as a whole are given a secondary shape. In addition, when the secondary shape is given to a part of the first coil, the part of the second coil wound along the gap 17 of the part has a shape corresponding to the secondary shape of the first coil. Deform.
Therefore, as described above, from the viewpoint of easily deforming the second coil into a shape corresponding to the secondary shape applied to the first coil, from the viewpoint of ease of volume expansion of the in-vivo indwelling member, etc., the second wire Is preferably less rigid than the first wire, and more preferably thinner than the first wire. For example, as shown in FIG. 7, the first coil 13 formed by the first wire 11, the second coil 15 a formed by the second wire 14 a thinner than the first wire 11, and the primary coil configured by the expansion member 16. 6, it is preferable that the secondary shape is given to the entire in-vivo indwelling member by giving the secondary shape only to the first coil 13 in advance.

A method of using the in-vivo indwelling member according to the present invention will be briefly described.
FIG. 22 is an explanatory view schematically showing a state when the in-vivo indwelling member 41 is inserted into the aneurysm 42 generated in the mother blood vessel 43, and FIG. 23 is an in-vivo indwelling member in the aneurysm 42. It is explanatory drawing which showed typically the state by which 41 is detained. The in-vivo indwelling member 41 in FIGS. 22 and 23 is composed of a multi-strand coil using the first coil 13, the second coil 15a and the expansion member 16 as shown in FIG. It is described as. The in-vivo indwelling member 41 is provided with a complicated three-dimensional secondary shape.
As described above, in order to insert the in-vivo indwelling member 41 into the aneurysm 42, first, the in-vivo indwelling member 41 is arranged in a state of being stretched substantially linearly in the lumen of the delivery catheter 44, and is used for delivery. The distal end of the catheter 44 is inserted into the aneurysm 42. At this time, the push-in pusher member 45 and the in-vivo indwelling member 41 whose proximal end portion is fixed to the distal end portion thereof via a detachable element portion (not shown) are disposed in the lumen of the delivery catheter 41. Inserted. At this time, the in-vivo indwelling member 41 has the same degree of thinness as a conventional in-vivo indwelling member that does not increase in volume, and thus can be inserted into the lumen of the catheter.
When the pusher pusher member 45 is moved to the distal end side of the delivery catheter 44 and the proximal end portion is gradually pushed out from the distal end opening portion of the delivery catheter 44 sequentially from the distal end portion of the in-vivo indwelling member 41, an aneurysm is obtained. The secondary shape is restored inside 42 (see FIG. 22). Thereafter, the pusher member 45 for extrusion is cut off at the detachment element portion, and the in-vivo indwelling member 41 is placed inside the aneurysm 42 (see FIG. 23).
When the in-vivo indwelling member 41 is discharged from the catheter opening, the expansion member 16 expands when it comes into contact with blood (see FIG. 23). At this time, for example, as in FIG. 11, the second coil 15a is moved outward from the first coil 14 so that the central axis 18 of the first coil 13 and the central axis 19a of the second coil 15a are shifted from the same axis. By being pushed out, the volume of the in-vivo indwelling member 41 is expanded from before the conveyance. Therefore, one in-vivo indwelling member 41 can occupy a larger volume in the aneurysm 42 than in the prior art while having the same length as in the prior art. Accordingly, it is possible to expect a reduction in the number of in-vivo indwelling members used and a reduction in operation time, and as a result, it can be expected to reduce the burden on doctors and patients.

1, 2, 3, 4, 41 In-vivo indwelling member 5, 6 Primary coil 10 Wire 11 First wire 12, 12a Interval 13 First coil 14, 14a Second wire 15, 15a Second coil 16 Expansion member 17 Gap 18, 19, 19a Central shaft 21, 24 Start end 22, 25 End 23, 26 Remaining 30 Mandrel 42 Aneurysm 43 Mother blood vessel 44 Delivery catheter 45 Pusher member for extrusion

Claims (14)

A cylindrical first coil formed by a first wire wound at an interval;
A cylindrical second coil formed by a second wire wound along the gap of the first wire separated by the interval;
An expansion member installed on the cylindrical outer surface side of the first coil and having a portion installed on the cylindrical inner surface side of the second coil, and extending along the major axis direction of the second coil;
In vivo indwelling member.   The in-vivo indwelling member according to claim 1, wherein the second wire has lower rigidity than the first wire.   The in-vivo indwelling member according to claim 2, wherein the second wire is thinner than the first wire.   The in-vivo indwelling member according to any one of claims 1 to 3, wherein the second coil has a portion whose inner maximum width is equal to or larger than the inner maximum width of the first coil.   The in-vivo indwelling member according to any one of claims 1 to 4, wherein the expansion member is installed so as to alternately pass between adjacent first wires and second wires.   The in-vivo indwelling member according to any one of claims 1 to 5, wherein the expansion member is installed so as to extend over the entire length of the second coil. When the expansion member is expanded, at least a part of the second coil is pushed toward the outside of the first coil by the expansion member,
The in-vivo indwelling according to any one of claims 1 to 6, wherein a displacement amount between the axial position of the first coil and the axial position of the second coil is larger after the expansion member than before expansion. Element.   The in-vivo indwelling member according to claim 1, wherein the expansion member includes a swellable material.   The in-vivo indwelling member according to any one of claims 1 to 8, wherein the expansion member has a linear structure.   The secondary coil is provided to the primary coil that is configured by using the first coil, the second coil, and the expansion member and is provided with a linear primary shape. The in-vivo indwelling member according to Item 1.   The in-vivo indwelling member according to claim 10, wherein the secondary shape is previously given only to the first coil. A method for producing an in-vivo indwelling member including a first wire, a second wire, and an expansion member,
A first coil forming step of winding a first wire at intervals to form a cylindrical first coil;
An expansion member disposing step of disposing the expansion member on at least a part of the outer surface in the axial direction of the cylindrical first coil formed in the first coil forming step;
A second coil forming step of winding a second wire to form a cylindrical second coil along the gap of the first wire separated from the outside of the expansion member by the interval;
The manufacturing method of the in-vivo indwelling member containing this.   The manufacturing method of the in-vivo indwelling member of Claim 12 which further includes the secondary shape provision process which provides a secondary shape with respect to the said 1st coil obtained at the said 1st coil formation process, and heats it. The manufacturing method of the in-vivo indwelling member of Claim 13 which further includes the linear form maintenance process which makes the 1st coil to which the secondary shape obtained by the said secondary shape provision process was provided linear.

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