TREATMENT INSTRUMENT FOR ENDOSCOPE

A treatment instrument for an endoscope is equipped with a sheath; and a balloon which is provided at the sheath, the balloon being configured to be expandable to an unfolded inflated shape from a folded initial shape by supplying a fluid, the balloon having a first region and a second region provided at both end portions in a longitudinal direction, and an intermediate section provided between the first region and the second region. In the initial shape of the balloon, an amount of residual strain of the intermediate section is larger than the amount of residual strain of the first region and the amount of residual strain of the second region. When an internal pressure of the balloon has a first internal pressure value, the first region and the second region are unfolded to be faster than the intermediate section, thereby having a greater diameter than the intermediate section.

FIELD OF THE INVENTION

The present invention relates to a treatment instrument for an endoscope used when performing a dilation treatment on a stenosed part or an occluded part in a luminal organ of a living body.

DESCRIPTION OF RELATED ART

Conventionally, a procedure for performing a dilation treatment or the like of a stenosed part or an occluded part (hereinafter referred to as “stenosed part or the like”) of the digestive tract while using an endoscope is performed. In such a procedure, for example, a treatment instrument for an endoscope equipped with a balloon is used. Specifically, the endoscope and the treatment instrument for the endoscope are inserted into the luminal organ of the living body together, and the balloon is inflated while the balloon is inserted into the stenosed part or the like to dilate the stenosed part or the like. When the treatment instrument for an endoscope is disposed to dilate the stenosed part in the luminal organ of the living body in this manner, the balloon slides against the stenosed part or the like while the balloon is inflated, and the balloon may become detached from the part to be dilated. In this case, it is necessary for a surgeon to temporarily deflate the balloon and perform positioning of the balloon again, which makes the operation complicated.

Therefore, in order to prevent the balloon from slipping with respect to the stenosed part or the like in a state of being inflated, a treatment instrument for an endoscope using a balloon having a small-diameter portion between a distal end portion and a proximal end portion in a state of being inflated has been proposed (see, for example, PCT International Publication No. WO2010/042869, Japanese Unexamined Patent Application, First Publication No. 2010-4915, PCT International Publication No. WO00/057945).

SUMMARY OF THE INVENTION

A treatment instrument for an endoscope according to a first aspect of the present invention is equipped with a sheath; and a balloon which is provided at the sheath, the balloon being configured to be expandable to an unfolded inflated shape from a folded initial shape by supplying a fluid, the balloon having a first region and a second region provided at both end portions in a longitudinal direction, and an intermediate section provided between the first region and the second region. In the initial shape of the balloon, an amount of residual strain of the intermediate section is larger than the amount of residual strain of the first region and the amount of residual strain of the second region. When an internal pressure of the balloon has a first internal pressure value, the first region and the second region are unfolded faster than the intermediate section, thereby having a greater diameter than the intermediate section. When the internal pressure of the balloon has a second internal pressure value greater than the first internal pressure value, the first region, the second region, and the intermediate section are unfolded to have the inflated shape. When the internal pressure of the balloon is greater than a third internal pressure value greater than the second internal pressure value, a material forming the balloon stretches and expands to be greater than the diameter at the second internal pressure value.

According to a second aspect of the present invention, in the treatment instrument for an endoscope according to the first aspect, the balloon may be folded to have a plurality of wing sections protruding radially outward in the initial shape, and the wing sections may be folded by being wound around an axis of the balloon.

According to a third aspect of the present invention, in the treatment instrument for the endoscope according to the first aspect, the balloon may be configured such that an outer diameter increases up to the second internal pressure value, according to the inflation due to the progress of the unfolding rather than the expansion due to the stretching of the balloon material, and at an internal pressure greater than the third internal pressure value, the outer diameter increases, according to the expansion due to the stretching of the balloon material rather than the inflation due to the progress of the unfolding.

According to a fourth aspect of the present invention, in the treatment instrument for the endoscope according to any one of the first to third aspects, in the initial shape, the outer diameter of the intermediate section may be smaller than the outer diameters of the first region and the second region.

According to a fifth aspect of the present invention, the treatment instrument for the endoscope according to any one of the first to fourth aspects may further include markers provided at boundaries between the intermediate section, the first region, and the second region.

According to a fifth aspect of the present invention, in the treatment instrument for the endoscope according to the fourth aspect, the marker may be configured to be visible under an endoscope or X-ray fluoroscopy.

DETAILED DESCRIPTION OF THE INVENTION

An embodiment of the present invention will be described with reference toFIGS. 1 to 10.FIG. 1is a cross-sectional view illustrating a treatment instrument for the endoscope1according to this embodiment. The treatment instrument for the endoscope1is equipped with a sheath2, a balloon3, a connecting section4, a distal end tip5, and a stylet6.

The sheath2is a member which has a lumen21, is long in a direction of a longitudinal axis L, and has flexibility. A proximal end portion of the balloon3is tightly connected to the distal end portion of the sheath2. The connecting section4is provided at the proximal end portion of the sheath2. The connecting section4has a communication passage41, which allows communication from the distal end to the proximal end along the longitudinal axis L, formed therein. A lumen21of the sheath2communicates with the interior of the balloon3and a communication passage41of the connecting section4. Therefore, the balloon3can be inflated, by supplying fluid to the balloon3via the communication passage41and the lumen21, using a syringe or the like connected to the connecting section4or the like.

At the distal end portion of the sheath2, a marker22capable of being checked under X-ray fluoroscopy is provided.

The balloon3is a bag-like member made up of, for example, a transparent film (for example, PEBAX (registered trademark) manufactured by ARKEMA Co.) made of polyamide resin.

The balloon3is folded by forming folds such that a plurality of wing sections extending in the longitudinal direction are formed after forming the material into a substantially cylindrical shape. Hereinafter, a shape in which a diameter is reduced by this folding is referred to as an “initial shape” of the balloon3. Details of the initial shape will be described later.

When the fluid is injected, the balloon3is deployed while unfolding by the wing section spreading, and inflates to a substantially cylindrical shape. In this way, a shape after inflating substantially only by unfolding is hereinafter referred to as the “inflated shape” of the balloon3. By removing the fluid injected into the inflated balloon3, the balloon3can fold again and deflate in a dimension in a radial direction. When the internal pressure of the balloon3having the inflated shape becomes a predetermined value or more, the balloon3expands to increase in diameter, while the constituent film stretches. That is, the balloon3is a so-called semi-compliant balloon.

The distal end tip5is provided at the distal end of the treatment instrument for the endoscope1. The distal end tip5is a substantially conical member extending in the direction of the longitudinal axis L, and its distal end portion is formed in a spherical shape in order to prevent damage to tissue when inserted into a body cavity.

The distal end portion of the balloon3is tightly fixed to the proximal end portion of the distal end tip5.

The stylet6is a shaft member, is inserted through the inside of the balloon3, and extends along the longitudinal axis L from the distal end to the proximal end of the balloon3. The distal end portion of the stylet6is connected to the proximal end of the distal end tip5. The stylet6extends through the interior of the balloon3, the lumen21of the sheath2, and the communication passage41of the connecting section4and is fixed to the inner wall of the communication passage41of the connecting section4. The stylet6is made of, for example, stainless steel, a nickel-titanium alloy or the like.

FIG. 2illustrates the initial shape which is the shape of the balloon3before inflation. In the initial configuration, the balloon3has a first region31adjacent to the distal end tip5, a second region32adjacent to the sheath2, and an intermediate section33between the first region31and the second region32. An outer diameter D1of the first region31and the second region32located at both ends in the longitudinal direction (the same as an axial direction of the balloon3) of the balloon3is larger than an outer diameter D2of the intermediate section33.

A method of a folding process for forming the aforementioned initial shape will be described. The folding process of the balloon3is performed by combining the folding process illustrated inFIGS. 3 and 4and the winding process illustrated inFIGS. 5 and 6.

First, as illustrated inFIG. 3, a plurality of folding members100are brought into close contact with each other from the outer side of the balloon3in the radial direction. Then, part of the balloon3is sandwiched between the folding members100and bent. Thus, as illustrated inFIG. 4, a folding line35extending in the longitudinal direction of the balloon3is formed, and the balloon3has a plurality of wing sections36formed to protrude radially outward with the folding line35as a ridge line. The number of wing sections36to be formed can be appropriately set by changing the number of folding members100.

Next, as illustrated inFIG. 5, a plurality of diaphragm members101are brought into close contact with each other from the radially outer side of the balloon3having the wing section36formed thereon. By combining the plurality of the diaphragm members101, a columnar internal space can be formed at the center portion thereof, and by appropriately relatively moving the plurality of diaphragm members101, it is possible to change the dimension of the internal space in the radial direction.

When the plurality of diaphragm members101are relatively moved in the state of the balloon3being disposed in the internal space and the radial dimension of the internal space is gradually reduced, the diaphragm member101and the ridge line of the wing section36are first brought into contact with each other. Thereafter, due to friction between the diaphragm member101and the wing section36, the ridge line of the wing section36moves in the circumferential direction of the balloon3, and the protruding direction of the wing section36is inclined in the circumferential direction. Thereafter, as the radial dimension of the internal space is reduced, as illustrated inFIG. 6, the wing section36is wound around the axis of the balloon3about the stylet6to provide curling. At this time, a plurality of valley sections37are formed to protrude radially inward at a base side of the wing section36. The outer diameter of the curled balloon3is substantially the same as the inner diameter of the internal space formed by the diaphragm member101. Accordingly, a pair of diaphragm members101having sizes corresponding to the first region31, the second region32, and the intermediate section33are prepared, respectively, and the diaphragm member101disposed around the first region31and the second region32is relatively moved until the inner diameter of the internal space becomes D1, and the diaphragm member101disposed around the intermediate section33is relatively moved until the inner diameter of the internal space becomes D2. Accordingly, it is possible to form the balloon3having the initial shape illustrated inFIG. 2.

The above-described forming method of the initial shape is an example, and the method for forming the balloon according to the present embodiment is not limited thereto.

In the balloon3having this initial shape, the amount of residual strain differs between the first region31, the second region32and the intermediate section33, due to a difference in amount of deformation of the film caused by the folding process. In the present specification, the “amount of residual strain” means the total amount of residual strain within a predetermined unit length range in the axial direction of the balloon. When a certain region has a length equal to or longer than the unit length in the axial direction, the amount of residual strain per unit length calculated by averaging the amount of residual strain of each part is taken as the amount of residual strain in the region.

In the balloon3having the initial shape, the residual strain exclusively occurs in the portion of the folding line35, which is the top portion of the wing section36, and the valley section37bent so as to be convex toward the stylet6at the middle between two adjacent wing sections36. As the amount of deformation occurring in the film constituting the balloon3due to the folding process increases, the residual strain generated in the folding line35and the valley section37increases. Accordingly, the balloon3according to the present embodiment is configured so that the amount of residual strain is larger in the intermediate section33than in the first region31and the second region32.

In the aforementioned method for forming the initial shape, it is possible to adjust the amount of deformation of the balloon3, for example, by adjusting the movement distance of the diaphragm member101inward in the radial direction of the balloon at the time of the winding process. Therefore, in the balloon3according to the present embodiment, at the time of forming the initial shape, by setting the movement distance of the diaphragm member101disposed around the intermediate section33to be larger than the movement distance of the diaphragm member101disposed around the first region31and the second region32, the amount of deformation of the intermediate section33is set to be larger than the amounts of deformation of the first region31and the second region32. Therefore, the amount of residual strain in the intermediate section33can be set to be larger than the amount of residual strain in the first region31and the second region32.

The method for adjusting the amount of residual strain is not limited thereto, and for example, by setting the amount of driving force of the diaphragm member101at the time of winding process, or the amount of driving force or movement distance of the folding member100at the time of folding process, the amount of residual strain may be set to be larger at the intermediate section33than at the first region31and the second region32. Further, the amount of residual strain may be adjusted by performing a heat treatment on the balloon3at the time of winding process or the folding processing.

An operation at the time of use of the treatment instrument for the endoscope1configured as described above will be described.

The treatment instrument for the endoscope1is introduced into the body of the patient P via a channel provided in the insertion portion151of the endoscope150. As illustrated inFIG. 7, the user connects an inflator200to the connecting section4, and inserts the inflator into the insertion portion151from a forceps port152of the endoscope150. Thereafter, the endoscope150is inserted into the body of the patient P, and the distal end of the endoscope150is moved forward to a region in which the dilation procedure is performed, for example, to the vicinity of a predetermined part of the esophagus. Connection between the treatment instrument for the endoscope1and the inflator200or insertion of the treatment instrument for the endoscope1into the endoscope150may be performed after the endoscope150is inserted into the body of the patient P.

While observing a target site to be subjected to the dilation procedure with the endoscope150, the user causes the instrument for an endoscope1to protrude from the endoscope150and inserts the distal end tip5into the target site. The user further moves the treatment instrument for the endoscope1forward and holds the treatment instrument for the endoscope1so that the balloon3breaks through the target site, that is, the distal end portion and the proximal end portion of the balloon3are located on the distal side and the proximal side with respect to the target site, respectively.

The user actuates the inflator200to supply a fluid such as water or air to the balloon3. The balloon3inflates while the internal pressure is raised by the supplied fluid. Since the amount of residual strain of the intermediate section33is larger than that of the first region31and the second region32, a larger force is required such that the folding line35and the valley section37linearly stretch and the wing section36spreads.

FIG. 8is a graph illustrating a relationship between the internal pressure of the balloon3and the outer diameters of the first region31, the second region32, and the intermediate section33. In a state in which the internal pressure of the balloon3has reached a predetermined first internal pressure value P1due to the supply of the fluid, in the first region31and the second region32, unfolding has progressed faster than at the intermediate section33. On the other hand, since the progress of unfolding of the intermediate section33is slow, the diameter of the intermediate section33is smaller than that of the first region31and the second region32, and the balloon3overall has a dumbbell shape as illustrated inFIG. 9. Therefore, even if the balloon3slips due to mucus or the like on the surface of the luminal organ, the first region31and the second region32serve as an anchor to suppress the movement, and thereby a situation such as detachment of the balloon3from the target site St is suitably prevented.

InFIG. 9, the shape of the intermediate section33illustrates the same state as the initial shape, but this is an example, and it is obvious that the shape may be a state when the intermediate section starts to inflate.

When the internal pressure of the balloon3reaches the second internal pressure value P2, which is higher than the first internal pressure value, the folding is released at all of the first region31, the second region32, and the intermediate section33, and the balloon3is restored to almost a substantially cylindrical shape (inflated shape) before the folding process as illustrated inFIG. 10. At this time, the radial dimensions of the first region31, the second region32, and the intermediate section33are the same or substantially the same. Since the intermediate section33inflates to substantially the same diameter as the first region31and the second region32, the target site St can be sufficiently dilated.

At the second internal pressure value P2, the film itself forming the balloon3is hardly stretched. Here, since the balloon3is a semi-compliant type, by setting the internal pressure to be larger than a third internal pressure value P3which is higher than the second internal pressure value as necessary, the whole of the balloon3is further inflated, while stretching the material, and a larger dilation force can be applied to the target site St.

In more detail, since the material forming the balloon3itself hardly stretches until the internal pressure of the balloon3reaches the second internal pressure value P2, the balloon3inflates exclusively depending on the progress of unfolding, and the outer diameters of the first region31, the second region32, and the intermediate section33increase.

Since the folding is almost released after the internal pressure of the balloon3reaches the second internal pressure value P2, even if the internal pressure rises, almost no increase in the external diameter occurs. When the internal pressure of the balloon3rises further and becomes larger than the third internal pressure value P3, the film material forming the balloon3starts to stretch. However, since expansion due to the progress of unfolding hardly occurs, the outer diameters of the first region31, the second region32, and the intermediate section33increase exclusively depending on the stretching of the film material.

As described above, according to the treatment instrument for the endoscope1of the present embodiment, the amount of residual strain of the intermediate section33in the balloon3is set to be larger than the amount of residual strain of the first region31and the second region32disposed with the intermediate section33interposed therebetween. As a result, at the first internal pressure value P1, a dumbbell shape in which the first region31and the second region32have inflated to have an outer diameter larger than that of the intermediate section33is obtained, and it is possible to suitably prevent the balloon from being detached or displaced from the target site St during the treatment process on the target site St.

Further, at the second internal pressure value P2, the intermediate section33can be inflated to substantially the same diameter as the first region31and the second region32, and the target site St can be sufficiently dilated.

As a result, prevention of misalignment with respect to the target site and sufficient expansion of the target site are compatible, and it is possible to perform an appropriate expansion treatment at the target site such as a stenosed part.

In the present embodiment, the first internal pressure value and the second internal pressure value can be set to desired values, by appropriately setting the amounts of residual strain of the first region31, the second region32, and the intermediate section33. The second internal pressure value may be set on the basis of the pressure intended to act on the target site, and may be, for example, 3 atmospheres (atm). It is preferable to set the first internal pressure value to be sufficiently lower than the second internal pressure value, for example, 0.5 atm, so that the positional deviation prevention effect can be exhibited at an early stage.

Further, in the aforementioned example, the description has been given of a case where the outer diameter in the initial shape is set to be different between the first region31, the second region32, and the intermediate section to set amounts of residual strain of both regions different from each other. However, the method for setting different amounts of residual strain for both is not limited thereto. Several methods for generating different amounts of residual strain in the first region31, the second region32and the intermediate section33will be described below.

First, by changing an angle formed by the material of the balloon with the folding line35between the intermediate section and the other region, the amount of residual strain can be adjusted. That is, in the folding process, as an angle θ1illustrated inFIG. 11decreases, the amount of residual strain increases. The angle θ1can be changed, for example, by changing the shape of the surface in contact with the balloon3in the folding member100described above.

Further, when the radius of curvature of the top of the wing section increases, the amount of residual strain decreases. Therefore, by forming the folding line35at the intermediate section and increasing the radius of curvature of the top of the wing section to such an extent that no ridge line is formed which is clear in the other region, the amount of residual strain at the intermediate section can be relatively increased.

Also, by changing the number of wing sections in the intermediate section and the other region, the amount of residual strain can be adjusted. As the number of wing sections increases, since the number of folding lines35and valley sections37increases, the amount of residual strain increases.

In addition, when forming the initial shape, if the diameter is reduced without forming the wing sections, a large number of irregular folding lines folded to be weaker than the folding line35are formed. Thus, the amount of residual strain decreases.

Therefore, it is possible to relatively increase the amount of residual strain in the intermediate section, also by forming the wing section only in the intermediate section and not forming the wing section in the other regions.

Further, when forming the initial shape, if the wing section is pulled and wound while applying tension, the valley section is strongly bent and the amount of residual strain increases. Therefore, by applying a tension only to the intermediate section or by applying a larger tension to the intermediate section, the amount of residual strain at the intermediate section can be relatively increased.

Furthermore, when incorporating heat treatment at the time of forming the initial shape, the amount of residual strain can be changed, by switching between the presence or absence of heat treatment and the temperature conditions. In general, the amount of residual strain is higher when the heat treatment is performed, and the amount of residual strain is higher when the heat treatment is performed at a higher temperature. Therefore, by applying a heat treatment only to the intermediate section or by setting the temperature of the heat treatment at the intermediate section to be higher than at other regions, the amount of residual strain at the intermediate section can be relatively increased.

Further, when the material of the balloon3is partially modified, the amount of residual strain at the intermediate section can be set to be relatively large without changing the process at the time of forming the initial shape for each region. For example, by forming a balloon with a crosslinked polymer and accelerating crosslinking by irradiating only the intermediate section with an electron beam, the rigidity of the intermediate section is relatively enhanced. When a uniform initial shape forming process is performed on this balloon, since the degree of plastic deformation becomes strong at the intermediate section, the amount of residual strain increases.

Each of the above-described methods can be appropriately combined, respectively. Since the amounts of residual strain of each region change complicatedly in combination, for example, it is also possible to set the amount of residual strain of the intermediate section33to be relatively large, while setting the outer diameters of the first region31, the second region32, and the intermediate section33in the initial shape to be the same or substantially the same.

Although the embodiment of the present invention has been described in detail with reference to the drawings, the specific configuration is not limited to this embodiment, and changes in design and the like within the scope not departing from the gist of the present invention are also included.

Further, the constituent elements described in each of the embodiments and each of the modified examples described above can be configured by being appropriately combined.

For example, in the above-described embodiment, the example in which the stylet6is inserted into the balloon3has been described. However, a configuration in which a sheath having a guide wire lumen and a fluid supply lumen is inserted through the balloon instead of the stylet may be provided. In this case, the guide wire inserted into the guide wire lumen can be made to protrude to the distal end of the balloon, and can be used as a guide for breaking through a site in which a strong constriction occurs, an occlusion part or the like.

Further, as in the modified example illustrated inFIG. 12, a marker40that is visible under endoscope observation or under X-ray fluoroscopy may be provided at a boundary between the first region31, the second region32, and the intermediate section33.

With this configuration, the balloon can be disposed at a more appropriate position with respect to the target site, and the positional deviation prevention effect can be reliably exerted.

As long as the boundary between the intermediate section and another region can be recognized, the marker40may be provided in either the intermediate section or the other region.

Further, in the initial shape of the balloon, when the outer diameter difference between the intermediate section and another region is large, a step caused by the outer diameter difference can be used as a marker that can be visually recognized under endoscope observation.

Furthermore, at the time of shipping of the treatment instrument for the endoscope of the present invention, as illustrated in a modified example illustrated inFIG. 13, the balloon3may be covered with a cover70having an internal space corresponding to the initial shape. In this way, it is possible to suitably maintain the initial shape until usage and to suppress change in amount of residual strain or the like.

Further, in the above embodiment, an example in which the balloon is a semi-compliant type has been described. However, a so-called non-compliant type balloon in which, even if the internal pressure is equal to or higher than the second internal pressure value, the material forming the balloon does not substantially stretch, may be used.