JP2001046510A - Treatment instrument for lesion part in body cavity - Google Patents

Abstract

PROBLEM TO BE SOLVED: To facilitate expansion work of an indwelling instrument in body cavity after inserting the indwelling instrument to a desired position and to enable the indwelling instrument to be accurately and securely indwelt by composing the treatment instrument of the indwelling instrument in body cavity which has an outer diameter-maintaining function to arbitrarily expand the outer diameter and an expanding tool to expand the indwelling instrument. SOLUTION: This treatment instrument is equipped with a tube structure, whose outer diameter is deformable to a first outer diameter and a second outer diameter larger than the first one, and an indwelling instrument 2 with an outer diameter maintaining function to maintain the outer diameter of the structure at an arbitrary outer diameter from the first one to the second one. The outer diameter of the indwelling instrument 2 is made expandable by an outer diameter expanding tool. The tube structure is mainly constituted of a plural number of spirally wound struts 27 (27a, 27b). The outer diameter maintaining function 23 is constituted of an extensible guide tubes 31 (31a to 31C), rods to deform the outer diameter of the structure by contracting the guide tube 31 by traction, etc. The rods are made to be drawn through traction wires 41 (41a-41C).

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an intracorporeal lesion used for improving lesions such as aneurysms and stenosis formed in a living body such as blood vessels, bile ducts, trachea, esophagus, urethra and other organs. The present invention relates to a device for treatment of a part.

[0002]

2. Description of the Related Art The aorta is more susceptible to aneurysms than peripheral arteries. The aneurysm gradually expands, and eventually the aneurysm wall of the blood vessel cannot burst against the blood pressure and ruptures. When ruptured, it is an extremely malignant disease with a very high mortality of 75-80% in the abdomen and more than 70% in the chest. Conventionally, in the treatment of this aneurysm, a method of removing a lesion site and embedding a prosthesis (artificial blood vessel) or wrapping the periphery of the lesion portion with a graft has been performed. However, these methods require a surgical laparotomy, resulting in a large invasion of the patient, a large amount of bleeding, and a long hospital stay. Therefore, there is a problem that it cannot be applied to elderly patients without physical strength or elderly people with chronic diseases. In order to solve these problems, there has been proposed a method for percutaneously placing an indwelling object (stent graft) to treat an aneurysm, stenosis or occlusion in a lumen.

[0003]

However, in the currently used main in-vivo indwelling devices, after inserting the in-vivo indwelling object to the target indwelling site, the operation of expanding the in-lumen indwelling object at the target site is performed. However, it is difficult to place it accurately and reliably, and furthermore, the blood vessel diameter varies depending on the patient, and the diameter cannot be arbitrarily expanded to match the blood vessel diameter at the living body insertion site. An object of the present invention is to easily insert an intraluminal indwelling object at a target site after inserting the intraluminal indwelling object to the target indwelling site, and accurately and surely indwell the intraluminal indwelling object. Further, the present invention provides a device for treating a lesion in a body cavity, in which the size of the diameter expansion can be selected so as to be adapted to the diameter of the blood vessel at the living body insertion site.

[0004]

The above object is achieved by providing a tubular structure which is deformable to a first outer diameter and a second outer diameter larger than the first outer diameter. An intraluminal indwelling object having an outer diameter maintaining function of maintaining an outer diameter of a body at an arbitrary outer diameter from the first outer diameter to the second outer diameter, and an outer diameter of the inluminal indwelling object A device for treating a lesion in a body cavity, the device having an outer diameter extending tool for expanding the outer diameter, wherein the outer diameter maintaining function extends in the longitudinal direction of the structure and is expandable and contractable fixed to the structure. A guide tube, a rod for contracting the guide tube by traction to change the outer diameter of the structure, and a compressed state maintaining member for maintaining the compressed state of the guide tube in cooperation with the rod. The rod is formed on a side surface and has a plurality of locking portions arranged in a longitudinal direction. The maintenance member includes an engagement portion that engages with the locking portion of the rod and can maintain the engagement state, and the outer diameter expansion tool is a rod towing that is detachably anchored to the rod. For treating a lesion in a body cavity, which is provided with the pulling wire of the present invention.

Preferably, a plurality of the outer diameter maintaining functions are provided, and a plurality of the outer diameter extending tools are provided so as to correspond to the respective outer diameter maintaining functions. Further, the locking portion of the rod may be a plurality of teeth formed on a side surface of the rod, and the engaging portion of the compressed state maintaining member may be a locking claw engaging with the tooth. preferable. Further, the compressed state maintaining member includes a rod insertion passage and a locking claw provided in the rod insertion passage, and the rod has a plurality of teeth linearly arranged in a longitudinal direction from a lower portion of the rod. It is preferable to provide a unit. The engagement between the locking portion of the rod and the engaging portion of the compressed state maintaining member allows the rod to advance in the compression direction of the guide tube, and inhibits the advance of the rod in the extension direction of the guide tube. It is preferable that Further, it is preferable that the extension device includes a wire storage tube that stores the pulling wire such that a rear end of the wire protrudes. Further, it is preferable that the instrument for treating a lesion in a body cavity includes positioning support means for placing the indwelling object in a target placement site. Further, the positioning support means includes an intraluminal indwelling object holding wire for anchoring to the structure, and an intraluminal indwelling object pushing tube body that is housed so that the rear end of the wire projects. Preferably, it is provided. And it is preferable that the wire for holding an in-lumen object is loop-shaped and can be cut. Further, it is preferable that the instrument for treating a lesion in a body cavity includes a sheath housing the indwelling object inside a distal end portion.

[0006]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a device for treating a lesion in a body cavity according to the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings. FIG. 1 is a perspective view of the device for treating a lesion in a body cavity of the present invention. 2 to 4 are partial cross-sectional side views for explaining the mechanism and operation of the outer diameter maintaining function and the outer diameter expanding device of the device for treating a lesion in a body cavity of the present invention.

An instrument 1 for treating a lesion in a body cavity according to the present invention has a tubular structure that can be deformed into a first outer diameter, a second outer diameter larger than the first outer diameter, and an outer part of the structure. An intraluminal indwelling object 2 having an outer diameter maintaining function of maintaining the diameter at an arbitrary outer diameter from the first outer diameter to the second outer diameter; And an outer diameter expansion tool 24 of The outer diameter maintaining function 23 is provided for extending and contracting the guide tube 31 extending in the longitudinal direction of the structure and fixed to the structure, and for changing the outer diameter of the structure by contracting the guide tube 31 by traction. The rod 32 and the guide tube 3 in cooperation with the rod 32
1 and a compressed state maintaining member 65 for maintaining the compressed state. The rod 32 is formed on the side surface,
A plurality of locking portions 62 are provided in the longitudinal direction, and the compressed state maintaining member 65 includes an engaging portion 66 that can be engaged with the locking portion 62 of the rod 32 and can maintain the engaged state. The outer diameter expander 24 includes a pulling wire 41 for rod retraction that is detachably moored to the rod 32.

The device 1 for treating a lesion in a body cavity includes an intraluminal indwelling object 2 having an outer diameter maintaining function 23, and an outer diameter expansion tool 24 for expanding the outer diameter of the inluminal indwelling object 2. . The in-lumen indwelling object 2 of the embodiment shown in FIG. 1 is to be inserted and indwelled (implanted) in an aneurysm formation site in the aorta, and has a tubular structure (three-dimensional structure). Body). The structure is formed in a tube shape as shown in FIG. The structure may have a main tube and two branch tubes branched from the main tube.

The structure is mainly composed of a plurality of struts (linear bodies) 27 spirally wound. The structure of this embodiment has a plurality of struts 2 spirally wound in the same direction (winding substantially parallel).
7a and a plurality of struts 27b wound in the opposite direction to the plurality of struts 27a. Therefore, a number of intersections where the struts 27a and the struts 27b intersect are formed in the structure. The struts 27 (27a, 27b) form the skeleton of the structure. In addition, the shape and form of the strut 27
The shape is not limited to a spiral shape, and may be, for example, a ring shape (in particular, a shape in which a plurality of rings are connected) or a net shape. The outer diameter of the structure changes due to the action of an external force. That is, a natural state (a state in which no external force is applied)
In this case, the outer diameter is the first outer diameter (hereinafter, this state is referred to as a “reduced state”).
The outer diameter of the structure can be expanded between the first outer diameter and the second outer diameter (hereinafter, this state is referred to as “expanded state”). In this case, the first outer diameter is such that the intraluminal indwelling object 2 can move in the aorta, and the second outer diameter is that the intraluminal indwelling object 2 can sufficiently adhere to the inner wall of the aorta. Of the degree.

The in-lumen indwelling object 2 has outer diameter maintaining functions 23a, 23b and 23c for maintaining the outer diameter of the structure at an arbitrary outer diameter from the first outer diameter to the second outer diameter. ing. The outer diameter maintaining function includes a plurality of extendable guide tubes 31 extending along the longitudinal direction of the structure and fixed to the structure.
a, 31b, 31c, and guide tubes 31a, 3
In order to shrink the outer diameter of the structure by contracting 1b and 31c, rods 32 housed in respective guide tubes are used.
a, 32b, 32c and rods 32a, 32b, 32c
Compressed state maintaining members 65a, 65b, 6 for maintaining the compressed state of the guide tubes 31a, 31b, 31c in cooperation with
5c. In this embodiment, the guide tube is
Three tubes are arranged at substantially equal intervals and in parallel along the circumferential direction of the tube. The number of guide tubes is not limited to this, but is preferably about 1 to 12.

Strut 27 and outer diameter maintaining function 23
Examples of the constituent materials of a, 23b, and 23c include stainless steel, a Ni—Ti alloy, a Cu—Zn alloy, and Ni—A
alloys, tungsten, tungsten alloys, titanium, titanium alloys, various metals such as tantalum, and relatively high-rigidity polymer materials such as polyamide, polyimide, ultra-high-molecular-weight polyethylene, polypropylene, and fluorine-based resin, or
Although what combined these suitably is mentioned, Among them, especially what uses stainless steel or stainless steel as a core material is preferable. The wire diameter of the strut 27 is
Although not particularly limited, it can be preferably about 0.03 to 2 mm. More preferably, 0.1 to 1 m
m.

Also, as shown in FIG.
The ends of the struts 27 are fixed to the upper end and the lower end of each of a, 31b, and 31c. Guide tube 31a,
The part that intersects the strut 27 in the middle of 31b and 31c is also fixed, and the intersection part between the struts 27 is also fixed. The fixing is performed by, for example, bonding with an adhesive, brazing such as soldering, welding, ligating, or the like. The fixing of the struts 27 to the intermediate portions of the guide tubes 31a, 31b, 31c and the fixing of the intersections between the struts 27 are preferably loosely fixed so that the intersection angle is variable. Thereby, expansion and contraction of the in-lumen indwelling object 2 can be performed more smoothly. In addition, the guide tubes 31a, 31b, 31c that constitute the outer diameter maintaining function are:
Together with the struts 27, they form part of the skeleton of the structure. In particular, the guide tubes 31a, 31b, 31c play the role of pillars extending in the longitudinal direction of the structure. This makes it possible to ensure necessary and sufficient strength and elasticity, particularly uniform strength and elasticity, without complicating the structure of the structure.

Further, a film (not shown) for covering the inner surface, outer surface or both surfaces of the structure may be provided. Thereby, since the in-lumen indwelling object 2 and the inner surface of the lumen are in close contact with each other, it is possible to prevent a positional deviation after the indwelling and an angular deviation from the axis of the blood vessel. It is preferable that the film expands and contracts with a change in the outer diameter of the structure, or expands from a folded state. Membrane, for example, woven fabric, knitted fabric, non-woven fabric, fibrous porous membrane such as paper, other non-fibrous porous membrane,
Any of a dense film such as a polymer sheet may be used.

When a fiber material is used as the membrane, for example, natural fibers such as cellulose fiber, cotton, linter, kapok, flax, cannabis, ramie, silk, wool, nylon (polyamide), fluororesin fiber, rayon , Cupra, acetate, vinyl resin fiber, acrylic, polyethylene terephthalate (polyester), polypropylene or other chemical fiber, or a combination of two or more of the above-mentioned natural and chemical fibers (blend, etc.) can be used. When a polymer sheet is used as the film,
Examples of the material include polyesters such as polyethylene, polypropylene, polyurethane, polyethylene terephthalate, and polybutylene terephthalate, polyvinyl chloride, polytetrafluoroethylene, natural rubber, isoprene rubber, silicone rubber, styrene-butadiene rubber, and latex rubber. Various thermoplastic elastomers such as rubber, polyamide, polyester, and polyurethane can be used. Further, the film may be a laminate of two or more layers made of the same or different materials.

The location of the membrane relative to the structure may be the whole or a part of the structure, but preferably covers the central portion in the longitudinal direction of the structure, more preferably the inner or outer surface of almost the entire structure. Is preferred. Thereby, when the structure is expanded, the lumen inner wall and the lumen
Therefore, the position of the placed intraluminal indwelling object (stent) 2 can be prevented.

Next, the structure of the outer diameter maintaining function 23 and the outer diameter expanding tool 24 will be described. The outer diameter maintaining function includes a plurality of extendable and contractible guide tubes 31a, 31b, 31c extending along the longitudinal direction of the structure and fixed to the structure.
And the rods 32a, 32b, 32c housed in the respective guide tubes in order to shrink the guide tubes 31a, 31b, 31c by traction to deform the outer diameter of the structure.
And compressed state maintaining members 65a, 65b, 65c for maintaining the compressed state of the guide tubes 31a, 31b, 31c in cooperation with the rods 32a, 32b, 32c. The maintaining means in the outer diameter maintaining function includes the rod 32a,
The engaging portions 62a, 62b, 62c of the 32b, 32c and the engaging portions 66a of the compressed state maintaining members 65a, 65b, 65c,
66b and 66c.

The locking portions 62a, 62b, 62c of the rods 32a, 32b, 32c and the compressed state maintaining member 65
The engagement of the a, 65b, 65c with the engaging portions 66a, 66b, 66c allows the rod to advance in the compression direction of the guide tubes 31a, 31b, 31c, and allows the rod to advance in the extension direction of the guide tubes. It has become a hindrance. Locking part 62
a, 62b and 62c are so-called tooth portions, and the engaging portions 6
6a, 66b, 66c are the tooth portions 62a, 62b, 62c
And a locking claw portion to be engaged with. The compressed state maintaining member 6
5a, 65b, 65c and guide tubes 31a, 31b, 31
c is preferably fixed by bonding with an adhesive, fusion, brazing, welding, or the like. The corresponding outer diameter expansion tools 24a, 24b, 24c are detachably connected (coupled) to the compressed state maintaining members 65a, 65b, 65c, respectively. Outer diameter expansion tools 24a, 24b, 24c
Is used to expand the reduced-diameter structure.

Since each outer diameter maintaining function and each outer diameter expanding tool have substantially the same configuration, respectively,
The outer diameter maintaining function and the outer diameter expanding tool connected thereto will be representatively described with reference to FIGS. The outer diameter maintaining function 23a is, as described above, a telescopic guide tube 31.
a, a rod 32a inserted into the guide tube 31a,
Plural tooth portions (locking portions) provided on the side surface of the rod 32a
62a, and a compressed state maintaining member 65a provided below the guide tube 31a and having a locking claw (engaging portion) 66a that engages with the tooth portion 62a inside.

The rod 32a has a hook 34a at the front end for engaging with the guide tube 31a, and a mooring portion 35a at the rear end for mooring with the pulling wire 41a.
The rod 32a is moored directly to the traction wire 41a at the mooring portion 35a, but is not limited thereto, and may be moored to the traction wire 41a via a ring member (not shown). The guide tube 31a is configured by a coil (coil spring) made of an elastic material. This guide tube 3
Although 1a is extended in its natural state, it can be contracted by the towing operation of the rod 32a.

As described above, the strut 27 is fixed to the guide tube 31a. As shown in FIG. 2, when the guide tube 31a is in the extended state, the strut 27 fixed to the guide tube 31a is also extended in the axial direction, and the structure is in a reduced diameter state. As shown in FIG. 3, when the guide tube 31a contracts due to the pulling of the rod 32a, the axial distance between the fixing points of the struts 27 with respect to the guide tube 31a is reduced, and the struts 27 are expanded in the radial direction. Expands the diameter. In addition, the contraction rate of the guide tube 31a may be the same over the entire length of the guide tube 31a, but the guide tube 31a may have portions having different contraction rates in the longitudinal direction. In this case, the position of the fixing point of the strut 27 with respect to the guide tube 31a and the distance between the fixing points are selected to partially increase the diameter expansion ratio (= second outer diameter / first outer diameter) of the structure. Can be changed to As a result, it is possible to arbitrarily set the shape of the structure in the expanded state,
It is possible to further improve the followability and adaptability to the indwelling site of the lumen, and the like. As a method of giving different shrinkage rates to the guide tubes, for example, a method of connecting a plurality of unit guide tubes having different mechanical properties (spring elasticity and the like) in the longitudinal direction to form one guide tube 31 or one guide tube For the tube, there is a method of changing the coil winding conditions (density (number of turns), coil outer diameter, etc.) to make the elastic modulus different.

The rod 32a is formed of an elongated flat or rod-like member, and has a hook (stopper) 34a at the upper end for engaging with the upper end of the guide tube 31a and a rear end of the rod 32a bent at the lower end. A plurality of teeth portions (locking portions) 62a formed at substantially equal intervals in the longitudinal direction and in substantially the same shape are formed on the side surface of the mooring portion 35a formed by excluding the tip portion. The mooring part 35a
It is preferably formed in the shape of a hook, and the upper end opening of the hook is preferably formed to be sufficiently wider than the outer diameter of the wire of the pulling wire 41a. Thus, the pulling wire 41a can be easily released from the rod 32a after the diameter expanding operation of the in-lumen indwelling object 2 (described later). In addition,
The mooring portion 35a is not limited to the one described above, and has a structure that does not come off from the pulling wire 41a during the expanding operation, and that the pulling wire 41a can be easily released after the expanding operation. Anything may be used.

The tooth portion (locking portion) 62a is shown in FIGS.
In the embodiment shown in FIG. 5, a plurality of rods are formed in an inverted triangular shape and are linearly arranged at equal intervals (equal pitch) in the longitudinal direction upward from the lower part of the rod. Further, the upper end of the inverted triangular tooth portion 62a is a flat portion 63a, and the side surface is an inclined portion 64b. The compressed state maintaining member 65a includes a rod insertion passage and a locking claw (engaging portion) 66a provided in the rod insertion passage. Locking claw 6
6a functions as a stopper. Locking claw 66a
Can easily bend downwards for downward forces,
It is formed in a shape that is unlikely to bend upward when an upward force is applied. The width of the rod insertion passage at the tip of the locking claw 66a is smaller than the thickness of the rod at the flat portion 63a. For this reason, the tip of the locking claw 66a is pressed against the flat portion 63a of the enlarged diameter portion 63a by the repulsive force of the compressed guide tube 31a, and the state is maintained.

When the rod 32a is pulled downward, the locking claw 66a is moved to one tooth (locking part) of the rod.
While being in contact with the inclined portion 64a of 62a, it is curved in a direction to enlarge the rod insertion passage, and the end of the inclined portion 64a passes through the locking claw 66a, and is restored to the original shape again. The tip of the locking claw 66a is pressed against the flat portion 63a of the tooth portion 62a that has passed over by the repulsive force of the compressed guide tube 31a, and the state is maintained. Also, even if the rod 32a is to be advanced upward, the tip of the locking claw 66a is engaged with the flat portion 63a of the tooth 62a, and the shape of the claw 66a is as described above. Since the rod 32a is made so as not to bend easily against an upward force, the rod 32a cannot be advanced upward. By arranging the teeth at any intervals, the degree of contraction of the guide tube can be adjusted arbitrarily.

The outer diameter maintaining function (in other words, the outer diameter maintaining mechanism) is provided if the outer diameter of the structure can be maintained at an arbitrary outer diameter from the first outer diameter to the second outer diameter. However, the present invention is not limited to the above. For example, as in the embodiment shown in FIG. 5, wedge-shaped teeth (locking portions) 68 are continuously arranged on the rod 70 on both sides or on both sides, and the compressed state maintaining member 71 corresponds to the teeth 68. 6, and a spherical tooth 74 is continuously arranged on a rod 76 as in the embodiment shown in FIG.
7 may be provided with a locking claw 78 corresponding to the spherical tooth 74. The outer diameter maintaining function shown in FIGS. 5 and 6 can achieve the same effect by the same operation as the outer diameter maintaining function shown in FIGS. In the above-described embodiment, the rod 32 is provided with the teeth 62, and the compressed state maintaining member 65 is provided with the locking claw 66. However, the present invention is not limited to this. ,
The compressed state maintaining member 65 may be provided with the teeth 62.

In the embodiment of the present invention, after the teeth and the engaging claw are engaged, the rod 32a can advance only downward and cannot advance upward. As long as it has a resultant force, it may be manufactured to have a structure that can move upward and downward. Further, the tooth portion 62a may be separate from or integrated with the rod 32a. In such a structure, a locking portion made of a male screw is formed at a lower portion of the rod 32a as an outer diameter maintaining function, and a female screw which is screwed with the male screw of the rod is provided below or near the lower end of the guide tube 31a. A nut (compressed state maintaining member) may be provided to maintain the compressed state of the guide tube by a screwing force between the rod and the nut. In this embodiment, the degree of contraction of the guide tube 31a can be adjusted in both directions of expansion and contraction by rotating the rod 32a left and right. That is, in this embodiment, the rod 32a can be advanced both upward and downward. In this case, in the case of this embodiment, the tip of the rod is
It is held rotatably.

The material of the coil forming the guide tube 31a,
As the material for forming the rod 32a and the material for forming the ring member, those described above as the material for forming the strut 27 can be suitably used. The outer diameter of the guide tube 31a is
It is not particularly limited, and although it depends on the outer diameter of the in-lumen indwelling object 2, it is usually preferably about 0.2 to 2.5 mm in consideration of the burden and strength of the patient when inserted into the body cavity, 0.4-1.
About 2 mm is more preferable. The cross-sectional shape of the coil of the guide tube 31a is not limited to a circle, but may be any shape such as an ellipse, a square (a flat shape), and the like. Also, the rod 32
The width or wire diameter of a (excluding the tooth portion) is not particularly limited, but is usually preferably about 0.05 to 1.5 mm, and more preferably about 0.1 to 0.8 mm. The wire diameter of the ring member is not particularly limited, but in the case of a separate ring member, a relatively thin one is preferable to obtain sufficient flexibility, and specifically, about 0.03 to 0.3 mm is preferable. , And about 0.08 to 0.15 mm.

The tooth portion (locking portion) 62a is preferably formed integrally with the rod 32a, but may be formed separately and fixed to the side surface of the rod. As a constituent material of the tooth portion when it is made of a separate member, in the case of a metal material, for example, iron or an iron-based alloy (such as stainless steel), copper or a copper-based alloy, aluminum or an aluminum alloy, titanium or a titanium alloy can be given. Can be Tooth part 62a
As a resin material constituting, for example, ultra-high molecular weight polyethylene, polypropylene, polyamide, polyimide,
Polystyrene, polycarbonate, polymethyl methacrylate, ABS resin, polyethylene terephthalate, polyester such as polybutylene terephthalate, polysulfone, polyether sulfone, polyphenylene sulfide, polyacetal, polyether ether ketone,
And polytetrafluoroethylene. When the rod is integrally formed with the rod 32a, it is preferable to use the same material as the constituent material of the strut 27.

As for the size of the tooth portion 62a, the guide tube 3
Preferably, the width is 0.05 to 1.5 mm, and the length is 0.5 to 1.5 mm.
It is preferable that the thickness is 5.0 mm and the thickness is 0.3 to 1.0 mm. Further, the pitch of the teeth is preferably 0.5 to 5.0, and the number of the teeth is preferably about 1 to 100. As a constituent material of the compressed state maintaining member 65a, the tooth portion 62a
It is preferably the same as described above. In addition, the locking claw portion 6
As the size of 6a, the width is 0.06 to 1.6 mm,
Length is 0.5-10.0mm, depth is 0.3-
It is preferably 2.0 mm. The locking claw 66
The external shape of a is preferably rounded. The rear end of the locking claw 66a is preferably tapered downward so that the tube 42a can be easily removed after the expansion operation.

The outer diameter expanding tool 24a is anchored to the rod 32a and pulls the pulling wire 41a for pulling the rod 32a, and a wire storage tube 42a for storing the pulling wire 41a so that the rear end of the wire 41a projects. It has. The distal end of the tube 42a is detachably connected (connected) to the rear end of the compressed state maintaining member 65a connected (connected) to the rear end of the guide tube 31a. The tube 42a has a moderate rigidity, that is, the rod 3
When the guide tube 31a is contracted by pulling the 2a, the guide tube 31a has a rigidity enough to prevent bending and the like and a moderate flexibility (flexibility) against the compressive force generated in the axial direction, For example, a resin tube or a close-wound coil made of the same coil material as the guide tube 31a is used.

The outer diameter of the pulling wire 41a is smaller than the inner diameter of the tube 42a, so that the pulling wire 41a can smoothly slide in the tube 42a. A hook 421a is provided at the upper end of the pulling wire 41a, and the hook 421a is moored to the mooring portion 35a of the rod 32a. Traction wire 4
The rear end of the tube 1a protrudes from the rear end opening of the tube 42a by a predetermined length.
22a are formed. The rod 32a can be pulled by operating the support portion 422a and pulling the pulling wire 41a downward. It is to be noted that the carrier 42
2a may be separate from or integral with the pulling wire 41a.

Specifically, the hook 421a and the mooring portion 35
When the pulling wire 41a is pulled downward in a state in which the rod 32a is moored, the rod 32a is pulled downward, and the teeth 62a provided near the lower portion of the rod 32a sequentially enter the inside of the compressed state maintaining member 65a. However, intermittent engagement of the tooth portion 62a and the claw portion 66a occurs. Thereby, the guide tube 31a
When the in-lumen indwelling object 2 expands in diameter and stops pulling the wire, the teeth and the claw engage, and the in-lumen indwelling object 2 is maintained in the expanded state. In addition, at a predetermined position on the lower end side of the pulling wire 41a, the movement amount (traction amount) of the pulling wire 41a is set.
It is preferable that a marker (not shown) is attached as a display means for indicating. It is preferable that the markers can be distinguished by different colors or shapes.
Markers can be used for various purposes. For example, as shown in FIG. 2, the tooth portion 62a is above the locking claw portion 66a and the two are not yet engaged, and as shown in FIG. It is possible to know whether or not it is in a state of being engaged with the pawl portion 66a. Further, a plurality of markers may be attached in accordance with the pitch of the tooth portions 62a so that it is possible to know which tooth portion 62a is engaged from the lower end. The markers are respectively provided at positions corresponding to these states, and the states can be confirmed by distinguishing the markers that appear and disappear from the lower end opening of the wire storage tube. In addition, as another example of the display means, the pulling wire 4
A scale corresponding to the amount of movement of the pulling wire 41a may be given to 1a or its pulling means (a take-up reel or the like). Although the description has been made using one outer diameter maintaining function (guide tube 31a, rod 32a) and expansion tool 24a, the other outer diameter maintaining function (guide tube 31b, rod 32b, guide tube 31c, rod 32c) and expansion are described. Tools 24b, 24
The same applies to c.

The outer diameter of the wire storage tube 42 is not particularly limited, and depends on the outer diameter of the in-lumen indwelling object 2. However, in consideration of the load and strength of the patient when inserting the wire into the body cavity, it is usually used. ,
0.2 to 2.5 mm is preferable, and 0.4 to 1.2 m
m is more preferable. As a material for forming the wire storage tube 42, a polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer,
Ethylene-vinyl acetate copolymer), polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide elastomer, thermoplastic resin such as polyurethane, silicone rubber, fluorine resin such as PFA, PTFE, fluorine elastomer, etc. And preferably the thermoplastic resin described above.

The material of the pulling wire 41 is made of a material having a certain degree of flexibility in order to facilitate the removal operation. As a constituent material of the pulling wire 41, for example, stainless steel, Ni-Ti alloy,
Various metals such as Cu-Zn alloy, Ni-Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, tantalum, and relatively high rigidity such as polyamide, polyimide, ultra-high molecular weight polyethylene, polypropylene, aramid, and fluororesin. Examples thereof include a polymer material and a material obtained by appropriately combining these. Among them, stainless steel is particularly preferable. The wire diameter of the pulling wire 41 is
Although not particularly limited, it is usually preferably about 0.1 to 1.5 mm, more preferably about 0.2 to 0.8 mm. With the outer diameter maintaining function and outer diameter expanding device having the above-mentioned structure, operability is excellent, and the outer diameter maintaining function and outer diameter expanding device function are fully exhibited, and the diameter is reduced. Can be. This contributes to reducing the burden on the patient during insertion into the lumen. In addition, the size of the expanded diameter of the indwelling object can be selected so as to be adapted to the diameter of the blood vessel at the living body insertion site, so that overexpansion is less likely to occur.

Next, the operation (action) of the outer diameter maintaining function and the outer diameter expanding tool will be described with reference to FIGS. As shown in FIG. 2, first, in a state where no external force is applied to the outer diameter maintaining function 23a, the guide tube 31a of the outer diameter maintaining function 23a is in an extended state, whereby the structure is in a reduced diameter state. ing. At this time, the tooth portion 62a of the rod 32a is housed in the guide tube 31a above the compressed state maintaining member 65a. Also, the rod 32a
The mooring portion 35a is moored to the pulling wire 41a by engaging the hook 421a, and the tension can be transmitted. Further, the mooring portion 35a is located below the claw portion (engaging portion, stopper) 66a inside the compressed state maintaining member 65a.

Next, as shown in FIG.
With the pulling wire 41a downward (solid arrow direction)
Then, the tooth portion 62a of the rod 32a enters the inside of the compressed state maintaining member 65a, and the tooth portion 62a
6a is repeatedly engaged and disengaged. As a result, the guide tube 31a gradually contracts, and the diameter of the structure gradually increases.
Then, by stopping the pulling of the pulling wire 41a, the expanded state is maintained. Further, since the tooth portion 62a is formed by alternately continuing the flat portion and the inclined portion, the outer diameter of the structure is changed from the first outer diameter to the second outer diameter in accordance with the amount of pulling of the pulling wire 41a. It can be expanded and maintained at any outer diameter up to the outer diameter. In addition, the degree of expansion of the above-mentioned structure can be determined by the operator by visually recognizing the position of the marker, or by attaching an X-ray contrast marker to the indwelling object 2 or the like and visually recognizing it under X-ray contrast. Can be grasped outside the body.

Next, as shown in FIG.
The user performs operations such as upward movement and rotation of the
a, and then remove the hook 421a from the
a is moved downward again to store the hook 421a in the wire storage tube 42a.
The tip of 2a is removed from the rear end of the locking claw 66a. Thereby, the outer diameter extension tool 24a is separated from the outer diameter maintaining function 23a. The above operation is performed by the outer diameter maintaining function 23.
The same applies to the outer diameter maintaining function and the outer diameter expansion tool other than the outer diameter expansion tool 24a and the outer diameter expansion tool 24a. The operator can easily and smoothly perform such an operation in a short time.

The in-lumen indwelling object 2 is
Positioning support means 25 for placing the object at the target placement site
It has. The positioning support means 25 includes a wire 102 for holding the in-lumen indwelling object for anchoring to the in-lumen in-well object 2.
And a tube body 101 for pushing an in-lumen indwelling object to be housed so that the rear end of the wire 102 protrudes. The positioning support means 25 is moored on the rear end side of the in-lumen indwelling object 2. The anchoring of the positioning support means 25 to the in-lumen indwelling object 2 is performed by struts 27 constituting
This is performed by passing the distal end of the wire 102 for holding the in-lumen indwelling object through the intersection between the a and the strut 27b.

The outer diameter of the tubular body 101 for extruding the indwelling object is not particularly limited, and depends on the outer diameter of the indwelling object 2. In consideration of this, usually, it is preferably about 0.2 to 5.0 mm,
It is more preferably about 4 to 3.0 mm. As a material for forming the tube body 101 for in-lumen indwelling object extrusion, various metals such as stainless steel, Ni-Ti alloy, Ti, Ti alloy, Cu-Zn alloy, Ni-Al alloy, W, W alloy, and tantalum, Polyolefin (eg, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc.), polyvinyl chloride, ethylene-
Thermoplastic resin such as vinyl acetate copolymer, polyamide elastomer, polyurethane, silicone rubber, PFA, P
Fluorine-based resins such as TFE and fluorine-based elastomers can be used, and the above-mentioned thermoplastic resins are preferred. The constituent material of the in-lumen indwelling object holding wire 102 is formed of a material having a certain degree of flexibility in order to facilitate the removal operation. As the constituent material of the wire 102, the material used in the above-described pulling wire 41 is used. Further, the wire diameter of the wire 102 is preferably substantially the same as the above-described pulling wire 41.

The placement of the intraluminal indwelling object 2 at the target site is performed by first guiding the rear end of the reduced-diameter indwelling object 2 to the target site using the positioning support means 25, In a state where the means 25 is fixed at the above-mentioned portion, the outer diameter expansion tool 24
This is performed by performing the above-described extension work using.
Then, first, after releasing the outer diameter extension tool 24 from the outer diameter maintaining function 23 as described above, a portion of the positioning support means 25 protruding from the rear end of the tube body 101 of the wire 102 for holding the in-lumen indwelling object. Is cut out and pulled until the cut end of the wire 102 passes through the intersection of the strut 27a and the strut 27b, thereby releasing the connection between the in-lumen indwelling object 2 and the positioning support means 25. As in the embodiment of the present invention, the outer diameter expansion tool 24 and the positioning support means 2
5 is anchored at the rear end side of the in-lumen indwelling object 2, the in-lumen indwelling object placed at the target indwelling site in the non-expanded state can be expanded without changing the rear end position, and the in-lumen indwelling The object can be accurately placed at the target placement site.

Next, another embodiment of the present invention, a device for treating a lesion in a body cavity in which a positioning support means 25 is moored to the distal end side of the in-lumen indwelling object 2 will be described. FIG. 7 is an external view of a device for treating a lesion in a body cavity according to another embodiment of the present invention. The configuration of the intracavitary lesion treatment device 10 of the present invention includes:
Except that the positioning and maintaining means 25 is anchored to the distal end side of the in-lumen indwelling object 2, there is no difference from the above-described device 1 for treating a lesion in a body cavity. Hereinafter, the differences will be mainly described.

The device 10 for treating a lesion in a body cavity includes an intraluminal indwelling object 2 having an outer diameter maintaining function 23, an expansion tool 24 connected (anchored) to a rear end side of the intraluminal indwelling object 2, Positioning support means 2 connected (anchored) to the rear end side of the in-lumen indwelling object 2
5 is provided. As the in-lumen indwelling object 2, the outer diameter expansion tool 24, and the positioning maintaining means 25, those described above are used. The positioning and maintaining means 25 includes the wire 10 for holding the in-lumen indwelling object for mooring to the in-lumen indwelling object 2 as described above.
2 and a tube body 101 for pushing an in-lumen indwelling object to be housed so that the rear end of the wire 102 protrudes. The positioning support means 25 is moored on the distal end side of the in-lumen indwelling object 2. The anchoring of the positioning support means 25 is performed by the strut 27a and the strut 2
7b is carried out when the distal end of the wire 102 for holding an in-lumen indwelling object penetrates the intersection with 7b.

As described above, the outer diameter expansion tool 24a includes the pulling wire 41a and the wire storage tube 42a that stores the pulling wire 41a so that the rear end protrudes. In the device 10 for treating a lesion in the body cavity, unlike the device 1 for treating a lesion in the body cavity, the pulling wire 41a is used for anchoring the rod 32a and fixing the rod 32a. The guide tube 31a is pushed through the locking claw 66a to contract the guide tube 31a. The connection between the distal end of the storage tube 42a and the rear end of the locking claw 66a is performed as described above. The tube 42a has an appropriate rigidity, that is, a rigidity enough to resist the compressive force generated in the axial direction when the guide tube 31a is contracted by pushing out the storage tube 42a and not causing bending or the like, and an appropriate flexibility. (Flexibility). For example, a tube made of a resin tube or a close-wound coil made of the same coil material as the guide tube 31a is used.

The rear end of the pulling wire 41a is connected to the tube 4
2a protrudes from the rear end opening by a predetermined length, and a traction operation portion is formed at the lower end thereof. The guide tube 31a can be contracted by supporting the towing operation unit and fixing the rod 32a and pushing the storage tube 42a upward. Specifically, in a state where the hook 421a and the mooring portion 35a are engaged with each other, the supporting portion 422a is supported to fix the pulling wire 41a, and the storage tube 42a is pushed upward. Proceeding upward, the tooth portion 62a provided near the lower portion of the rod 32a
Portion penetrates into the compressed state maintaining member 65a, and the teeth 6
2a and claw part 66a are locked. As a result, the guide tube 31a contracts, and the expanded state of the in-lumen indwelling object 2 is maintained. In addition, a marker is provided at a predetermined position on the lower end side of the pulling wire 41a as a display means for indicating the moving amount (towing amount) of the pulling wire 41a.

First, the distal end of the in-lumen indwelling object 2 in a reduced diameter state is guided to the target site by using the positioning support means 25, and the positioning and supporting means is placed. 25 with the outer diameter expansion tool 24
This is performed by performing the above-described extension work using.
As in this embodiment, when the outer diameter expander 24 is anchored at the rear end of the in-lumen indwelling object and the positioning and maintaining means 25 is anchored at the distal end side of the in-lumen indwelling object, the unexpanded state is applied to the target indwelling site. The placed intraluminal indwelling object can be expanded without changing the tip position, and the intraluminal indwelling object can be accurately indwelled at the target indwelling site.

Next, another embodiment of the present invention will be described. FIG.
FIG. 9 is an external view of a device for treating a lesion in a body cavity according to another embodiment of the present invention. FIG. 9 is an enlarged cross-sectional view of a base end portion of the device for treating a lesion in a body cavity in FIG. FIG. 4 is an enlarged cross-sectional view for explaining a proximal end portion of the device for treating a lesion in a body cavity. The device 100 for treating a lesion in a body cavity according to the present invention includes a tubular structure deformable to a first outer diameter, a second outer diameter larger than the first outer diameter, and an outer diameter of the structure. 2 from the outer diameter of 1
An in-lumen indwelling object 2 having an outer diameter maintaining function 23 for maintaining the outer diameter of the in-lumen indwelling object 2 at an arbitrary outer diameter up to an outer diameter of ing. And
The outer diameter maintaining function 23 of the in-lumen indwelling object 2 includes an extendable guide tube 31 extending in the longitudinal direction of the structure and fixed to the structure, and contracting the guide tube 31 by traction to form the structure. It has a rod 32 for changing the outer diameter, and an outer diameter maintaining function for maintaining the outer diameter of the structure at an arbitrary outer diameter.
Is provided with a pulling wire 41 for pulling. The extension tool 24 includes a wire storage tube 42 that stores the pulling wire 41 so that the rear end thereof protrudes.
Further, the intracavitary lesion treatment device 100 includes a sheath 51 in which the intraluminal indwelling object 2 is housed inside the distal end portion. Also,
The device 100 for treatment of a lesion in a body cavity includes a positioning support means 25 for placing the indwelling object 2 in a target placement site.

As the in-lumen indwelling object 2, the outer diameter expansion tool 24 and the positioning support means 25, those described above are used. At the rear end of the sheath 51, a connector 53 branched into four branches is fixed. The configuration of the outer diameter expander 24 is the same as that of the expander 24 of the device 1 for treating a lesion in a body cavity, and the wires 41a, 41b, 41c and the wire storage tubes 42a, 42b, 42c are formed in the sheath 51. After passing through the lumen, the rear end portion (supporting portions 422a, 422)
b, 422c) protrude from the rear end of the connector 53.

The sheath 51 has an in-lumen indwelling object 2 having a reduced diameter (a first outer diameter or a further reduced diameter) inside the distal end portion.
Can be stored. Further, the sheath 51 is a tubular body as shown in FIG. 8, and the front and rear ends are open. As a constituent material of the sheath 51, a polyolefin (for example, polyethylene, polypropylene, ethylene-
Propylene copolymer, ethylene-vinyl acetate copolymer), polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide elastomer, thermoplastic resin such as polyurethane, silicone rubber, PFA, PTFE, fluorine-based elastomer such as fluorine-based elastomer Resins and the like can be used, and the above-mentioned thermoplastic resins are preferable. Further, the material constituting the sheath 51 may contain a contrast agent. As the contrast agent to be contained, for example, barium sulfate, bismuth, tungsten and the like are suitable. Further, a marker (not shown) may be provided at the distal end of the sheath 51. The marker is preferably formed by a coil spring or a ring. As a material for forming the marker, a material having high X-ray contrast, for example, Pt, Pt alloy, W, W alloy,
It is preferable to use Au, an Au alloy, Ir, an Ir alloy, Ag, an Ag alloy, or the like.

The sheath 51 has an outer diameter of 0.7 to 21 mm, preferably 0.9 to 8.5 mm, and an inner diameter of 0.5 to 20 m, depending on the vascular site to be used.
m, preferably 0.7 to 8 mm, and a length of 50 to 14
It is 50 mm, preferably 100 to 950 mm. Further, the inner surface of the in-lumen indwelling object storage portion of the sheath 51 may be coated with a low-friction material to facilitate discharge of the in-lumen indwelling object 2. As the low friction material, silicone oil, fluorine resin (PTFE, ETFE, etc.) can be used.

The configuration and size of the positioning and supporting means 25 are the same as those of the supporting means 25 of the instrument 1 for treating a lesion in a body cavity. The rear end protrudes from the rear end of the connector 53 and the front end is the indwelling object 2. The tube body 101 for in-lumen indwelling object extrusion extending to the vicinity of the rear end, and housed in the tube body 101,
The distal end and the rear end protrude from the tube body 101, and the distal end is provided with a wire 102 for holding an in-lumen indwelling object that is connected to the in-lumen indwelling object 2. The protruding portion of the tube body 101 is slightly longer than the in-lumen indwelling object 2. The length of the protruding portion of the rear end of the wire 102 is slightly longer than the in-lumen indwelling object 2.

In this embodiment, the positioning support means 25 is for placing the intraluminal indwelling object 2 at a target site and discharging the intraluminal indwelling object 2 from the sheath 51. For this reason, the proximal end of the sheath 51 is fixed with one hand, and the rear end of the in-lumen indwelling object pushing tube body 101 of the positioning support means 25 is pushed with the other hand, whereby the in-lumen indwelling object 2 can be discharged from the distal end of the sheath 51. Thereafter, the in-lumen indwelling object 2 is guided to the target indwelling site using the positioning support means 25, and the above-described diameter expanding operation is performed using the outer diameter expansion tool 24 with the positioning support means 25 fixed. Thereby, the in-lumen indwelling object 2 can be indwelled at a target site. Thereafter, as described above, after the extension tool 24 and the outer diameter maintaining function 23 are released, the wire 102 of the positioning support means 25 is connected to the tube body 10.
1 is cut at a portion protruding from the rear end, and is pulled out until it passes through the intersection of the struts 27a and 27b of the structure, whereby the in-lumen indwelling object 2 and the positioning support means 25 are removed.
Break the connection with. Finally, the indwelling operation is completed by extracting the sheath 51.

[0051]

According to the present invention, there is provided an instrument for treating a lesion in a body cavity, wherein the tubular structure is deformable to a first outer diameter and a second outer diameter larger than the first outer diameter. An intraluminal indwelling object having an outer diameter maintaining function of maintaining an outer diameter of a body at an arbitrary outer diameter from the first outer diameter to the second outer diameter, and an outer diameter of the inluminal indwelling object A device for treating a lesion in a body cavity, the device having an outer diameter extending device for expanding the outer diameter, wherein the outer diameter maintaining function extends in the longitudinal direction of the structure and is expandable and contractable fixed to the structure. A guide tube, a rod for contracting the guide tube by traction to change the outer diameter of the structure, and a compressed state maintaining member for maintaining the compressed state of the guide tube in cooperation with the rod. And the rod is formed on a side surface and includes a plurality of locking portions arranged in a longitudinal direction. The retaining member includes an engaging portion that engages with the locking portion of the rod and can maintain the engaged state, and the outer diameter expansion tool is a tow wire for retraction of the rod that is detachably moored to the rod. It has. Therefore, the outer diameter of the in-lumen indwelling object can be maintained at an arbitrary outer diameter, and the in-lumen indwelling object can be indwelled while adjusting the outer diameter.

[Brief description of the drawings]

FIG. 1 is a perspective view of a device for treating a lesion in a body cavity of the present invention.

FIG. 2 is a partial cross-sectional side view for explaining the mechanism and operation of an outer diameter maintaining function and an outer diameter expanding device of the device for treating a lesion in a body cavity of the present invention.

FIG. 3 is a partial cross-sectional side view for explaining a mechanism and an operation of an outer diameter maintaining function and an outer diameter expanding tool of the device for treating a lesion in a body cavity of the present invention.

FIG. 4 is a partial cross-sectional side view for explaining a mechanism and an operation of an outer diameter maintaining function and an outer diameter expanding device of the instrument for treating a lesion in a body cavity of the present invention.

FIG. 5 is a view showing another embodiment of the outer diameter maintaining function used in the device for treating a lesion in a body cavity of the present invention.

FIG. 6 is a view showing another embodiment of the outer diameter maintaining function used in the device for treating a lesion in a body cavity of the present invention.

FIG. 7 is an external view of a device for treating a lesion in a body cavity according to another embodiment of the present invention.

FIG. 8 is an external view of a device for treating a lesion in a body cavity according to another embodiment of the present invention.

FIG. 9 is an enlarged cross-sectional view of a proximal end portion of the device for treating a lesion in a body cavity in FIG. 8;

FIG. 10 is an enlarged cross-sectional view for explaining a proximal end portion of the device for treating a lesion in a body cavity.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Instrument for treating lesion in body cavity 2 Indwelling object in lumen 10 Instrument for treating lesion in body cavity 31 Guide tube 32 Rod 41 Traction wire 42 Wire storage tube 62 Teeth 66 Locking claw 100 Instrument for treating lesion in body cavity

Claims (8)

[Claims] 1. A tubular structure that is deformable to a first outer diameter and a second outer diameter larger than the first outer diameter, and the outer diameter of the structure is changed from the first outer diameter to the first outer diameter. An in-lumen indwelling device having an outer diameter maintaining function of maintaining the outer diameter at an arbitrary outer diameter up to the second outer diameter, and an outer diameter expanding device for expanding the outer diameter of the in-lumen indwelling object are provided. An instrument for treating a lesion in a body cavity, wherein the outer diameter maintaining function is such that an extendable guide tube extending in the longitudinal direction of the structure and fixed to the structure is provided, and the guide tube is contracted by traction. And a compression state maintaining member for maintaining the compressed state of the guide tube in cooperation with the rod, wherein the rod is formed on a side surface. And a plurality of locking portions arranged in the longitudinal direction, wherein the maintenance member is provided with a locking portion of the rod. An intra-body cavity, comprising: an engaging portion that can be engaged and can maintain an engaged state, wherein the outer diameter expanding device includes a pulling wire for pulling a rod that is removably moored to the rod. Equipment for treating lesions. 2. The body cavity according to claim 1, wherein a plurality of the outer diameter maintaining functions are provided, and a plurality of the outer diameter expanding tools are provided so as to correspond to the respective outer diameter maintaining functions. Equipment for treating lesions. 3. The locking portion of the rod includes a plurality of teeth formed on a side surface of the rod, and the engaging portion of the compressed state maintaining member includes a locking claw that engages with the teeth. 3. The device for treating a lesion in a body cavity according to claim 1 or 2. 4. The compressed state maintaining member includes a rod insertion passage and a locking claw provided in the rod insertion passage, and the rod is linearly arranged in a longitudinal direction from a lower portion of the rod. The device for treating a lesion in a body cavity according to claim 3, comprising a plurality of teeth. 5. The engagement between the locking portion of the rod and the engaging portion of the compressed state maintaining member allows the rod to advance in the direction of compression of the guide tube, and allows the rod to move in the direction of extension of the guide tube. The device for treating a lesion in a body cavity according to any one of claims 1 to 4, which inhibits progress. 6. The treatment for a lesion in a body cavity according to claim 1, wherein the extension device includes a wire storage tube that stores the pulling wire such that a rear end of the wire protrudes. Appliances. 7. The body cavity according to any one of claims 1 to 6, wherein the body cavity treatment device includes positioning support means for placing the indwelling object at a target placement site. Equipment for treating lesions. 8. The in-lumen indwelling object holding wire for anchoring to the structure, and the in-lumen indwelling object pushing tube for accommodating the wire so that a rear end portion of the wire protrudes. The device for treating a lesion in a body cavity according to claim 7, comprising a body.