Patent Application
20180153536
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.
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).
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.
An embodiment of the present invention will be described with reference to
The sheath 2 is a member which has a lumen 21, is long in a direction of a longitudinal axis L, and has flexibility. A proximal end portion of the balloon 3 is tightly connected to the distal end portion of the sheath 2. The connecting section 4 is provided at the proximal end portion of the sheath 2. The connecting section 4 has a communication passage 41, which allows communication from the distal end to the proximal end along the longitudinal axis L, formed therein. A lumen 21 of the sheath 2 communicates with the interior of the balloon 3 and a communication passage 41 of the connecting section 4. Therefore, the balloon 3 can be inflated, by supplying fluid to the balloon 3 via the communication passage 41 and the lumen 21, using a syringe or the like connected to the connecting section 4 or the like.
At the distal end portion of the sheath 2, a marker 22 capable of being checked under X-ray fluoroscopy is provided.
The balloon 3 is 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 balloon 3 is 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 balloon 3. Details of the initial shape will be described later.
When the fluid is injected, the balloon 3 is 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 balloon 3. By removing the fluid injected into the inflated balloon 3, the balloon 3 can fold again and deflate in a dimension in a radial direction. When the internal pressure of the balloon 3 having the inflated shape becomes a predetermined value or more, the balloon 3 expands to increase in diameter, while the constituent film stretches. That is, the balloon 3 is a so-called semi-compliant balloon.
The distal end tip 5 is provided at the distal end of the treatment instrument for the endoscope 1. The distal end tip 5 is 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 balloon 3 is tightly fixed to the proximal end portion of the distal end tip 5.
The stylet 6 is a shaft member, is inserted through the inside of the balloon 3, and extends along the longitudinal axis L from the distal end to the proximal end of the balloon 3. The distal end portion of the stylet 6 is connected to the proximal end of the distal end tip 5. The stylet 6 extends through the interior of the balloon 3, the lumen 21 of the sheath 2, and the communication passage 41 of the connecting section 4 and is fixed to the inner wall of the communication passage 41 of the connecting section 4. The stylet 6 is made of, for example, stainless steel, a nickel-titanium alloy or the like.
A method of a folding process for forming the aforementioned initial shape will be described. The folding process of the balloon 3 is performed by combining the folding process illustrated in
First, as illustrated in
Next, as illustrated in
When the plurality of diaphragm members 101 are relatively moved in the state of the balloon 3 being disposed in the internal space and the radial dimension of the internal space is gradually reduced, the diaphragm member 101 and the ridge line of the wing section 36 are first brought into contact with each other. Thereafter, due to friction between the diaphragm member 101 and the wing section 36, the ridge line of the wing section 36 moves in the circumferential direction of the balloon 3, and the protruding direction of the wing section 36 is inclined in the circumferential direction. Thereafter, as the radial dimension of the internal space is reduced, as illustrated in
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 balloon 3 having this initial shape, the amount of residual strain differs between the first region 31, the second region 32 and the intermediate section 33, 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 balloon 3 having the initial shape, the residual strain exclusively occurs in the portion of the folding line 35, which is the top portion of the wing section 36, and the valley section 37 bent so as to be convex toward the stylet 6 at the middle between two adjacent wing sections 36. As the amount of deformation occurring in the film constituting the balloon 3 due to the folding process increases, the residual strain generated in the folding line 35 and the valley section 37 increases. Accordingly, the balloon 3 according to the present embodiment is configured so that the amount of residual strain is larger in the intermediate section 33 than in the first region 31 and the second region 32.
In the aforementioned method for forming the initial shape, it is possible to adjust the amount of deformation of the balloon 3, for example, by adjusting the movement distance of the diaphragm member 101 inward in the radial direction of the balloon at the time of the winding process. Therefore, in the balloon 3 according to the present embodiment, at the time of forming the initial shape, by setting the movement distance of the diaphragm member 101 disposed around the intermediate section 33 to be larger than the movement distance of the diaphragm member 101 disposed around the first region 31 and the second region 32, the amount of deformation of the intermediate section 33 is set to be larger than the amounts of deformation of the first region 31 and the second region 32. Therefore, the amount of residual strain in the intermediate section 33 can be set to be larger than the amount of residual strain in the first region 31 and the second region 32.
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 member 101 at the time of winding process, or the amount of driving force or movement distance of the folding member 100 at the time of folding process, the amount of residual strain may be set to be larger at the intermediate section 33 than at the first region 31 and the second region 32. Further, the amount of residual strain may be adjusted by performing a heat treatment on the balloon 3 at the time of winding process or the folding processing.
An operation at the time of use of the treatment instrument for the endoscope 1 configured as described above will be described.
The treatment instrument for the endoscope 1 is introduced into the body of the patient P via a channel provided in the insertion portion 151 of the endoscope 150. As illustrated in
While observing a target site to be subjected to the dilation procedure with the endoscope 150, the user causes the instrument for an endoscope 1 to protrude from the endoscope 150 and inserts the distal end tip 5 into the target site. The user further moves the treatment instrument for the endoscope 1 forward and holds the treatment instrument for the endoscope 1 so that the balloon 3 breaks through the target site, that is, the distal end portion and the proximal end portion of the balloon 3 are located on the distal side and the proximal side with respect to the target site, respectively.
The user actuates the inflator 200 to supply a fluid such as water or air to the balloon 3. The balloon 3 inflates while the internal pressure is raised by the supplied fluid. Since the amount of residual strain of the intermediate section 33 is larger than that of the first region 31 and the second region 32, a larger force is required such that the folding line 35 and the valley section 37 linearly stretch and the wing section 36 spreads.
In
When the internal pressure of the balloon 3 reaches the second internal pressure value P2, which is higher than the first internal pressure value, the folding is released at all of the first region 31, the second region 32, and the intermediate section 33, and the balloon 3 is restored to almost a substantially cylindrical shape (inflated shape) before the folding process as illustrated in
At the second internal pressure value P2, the film itself forming the balloon 3 is hardly stretched. Here, since the balloon 3 is a semi-compliant type, by setting the internal pressure to be larger than a third internal pressure value P3 which is higher than the second internal pressure value as necessary, the whole of the balloon 3 is 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 balloon 3 itself hardly stretches until the internal pressure of the balloon 3 reaches the second internal pressure value P2, the balloon 3 inflates exclusively depending on the progress of unfolding, and the outer diameters of the first region 31, the second region 32, and the intermediate section 33 increase.
Since the folding is almost released after the internal pressure of the balloon 3 reaches 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 balloon 3 rises further and becomes larger than the third internal pressure value P3, the film material forming the balloon 3 starts to stretch. However, since expansion due to the progress of unfolding hardly occurs, the outer diameters of the first region 31, the second region 32, and the intermediate section 33 increase exclusively depending on the stretching of the film material.
As described above, according to the treatment instrument for the endoscope 1 of the present embodiment, the amount of residual strain of the intermediate section 33 in the balloon 3 is set to be larger than the amount of residual strain of the first region 31 and the second region 32 disposed with the intermediate section 33 interposed therebetween. As a result, at the first internal pressure value P1, a dumbbell shape in which the first region 31 and the second region 32 have inflated to have an outer diameter larger than that of the intermediate section 33 is 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 section 33 can be inflated to substantially the same diameter as the first region 31 and the second region 32, 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 region 31, the second region 32, and the intermediate section 33. 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 region 31, the second region 32, 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 region 31, the second region 32 and the intermediate section 33 will be described below.
First, by changing an angle formed by the material of the balloon with the folding line 35 between the intermediate section and the other region, the amount of residual strain can be adjusted. That is, in the folding process, as an angle θ1 illustrated in
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 line 35 at 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 lines 35 and valley sections 37 increases, 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 line 35 are 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 balloon 3 is 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 section 33 to be relatively large, while setting the outer diameters of the first region 31, the second region 32, and the intermediate section 33 in 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 stylet 6 is inserted into the balloon 3 has 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 in
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 marker 40 may 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 in
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2015-148480 | Jul 2015 | JP | national |
This application is a continuation application based on a PCT International Application No. PCT/JP2016/063985, filed on May 11, 2016, whose priority is claimed on Japanese Patent Application No. 2015-148480, filed Jul. 28, 2015. Both of the content of the PCT International Application and the Japanese Application are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/JP2016/063985 | May 2016 | US |
| Child | 15875707 | US |
