JP2022138961A - Medical appliance - Google Patents

Abstract

To provide a medical appliance of a structure having further excellent low invasive characteristics.SOLUTION: A medical appliance 100 includes: a body part; and a cylindrical balloon member 60 provided coaxially with the body part along an outer peripheral surface of the body part, which expands toward the outside of the body part when fluid is introduced. The balloon member 60 includes a fixed part 61 fixed onto the outer peripheral surface of the body part (cylindrical body 10) at each of both ends in an axial direction. An intermediate part between the fixed parts 61 in the balloon member 60 is an expansion part 62 that is not fixed onto the outer peripheral surface of the body part. Each of both ends of the expansion part 62 in the axial direction is a thin wall part 67 formed to be relatively thin. An intermediate part between both ends of the expansion part 62 in the axial direction is a thick wall part 66 formed to be relatively thick.SELECTED DRAWING: Figure 3

Description

The present invention relates to medical devices.

Some medical instruments are of a type that is used by being inserted into a living body lumen. Such a medical device is constructed by attaching an inflatable balloon member to a tubular or cylindrical main body, and by injecting a fluid such as a liquid into the balloon member, the balloon member can be expanded. can be inflated inside a biological lumen. By inflating the deflated (pre-inflated) balloon member at a desired position inside the body lumen, the balloon member can be fixed and retained at the desired position.

As such a medical device, for example, there is one described in Patent Document 1.
The medical device of Patent Document 1 (described as a medical leak test device in the same document) includes a main body and a balloon member that expands outward of the main body when a fluid is introduced. configured with.

Japanese Patent Publication No. 2009-519778

According to studies by the inventors of the present application, the structure of the medical device of Patent Document 1 has room for improvement in terms of minimal invasiveness.

SUMMARY OF THE INVENTION The present invention has been made in view of the above problems, and provides a medical device having a structure that is excellent in less invasiveness.

According to the present invention, a main body that is a tubular body or a cylindrical body;
a cylindrical balloon member provided along the outer peripheral surface of the main body coaxially with the main body and inflated outwardly of the main body by introduction of a fluid;
with
The balloon member has a fixing portion fixed to the outer peripheral surface of the body portion at each of both ends in the axial direction,
an intermediate portion between the fixed portions of the balloon member is an expansion portion that is not fixed to the outer peripheral surface of the body portion;
Each of both end portions of the expansion portion in the axial direction is a thin portion formed to be relatively thin,
A medical device is provided in which an intermediate portion between both ends of the inflatable portion in the axial direction is a thick-walled portion formed relatively thick.

ADVANTAGE OF THE INVENTION According to this invention, the medical instrument of the structure excellent in less invasiveness is realizable.

1 is an overall view of a medical instrument according to a first embodiment; FIG. 2(a) and 2(b) are views showing the distal end portion of the medical instrument according to the first embodiment, of which FIG. 2(a) is a side view and FIG. 2(b) is a tubular body. 3A and 3B are axial cross-sectional views of the respective balloon members prior to inflation; FIG. 3(a) and 3(b) are views showing the distal end portion of the medical instrument according to the first embodiment, of which FIG. 3(a) is a side view and FIG. 3(b) is a tubular body. 3A and 3B are cross-sectional views along the axial direction of the , respectively showing the balloon member inflated. 4(a) and 4(b) are views showing the medical instrument according to the first embodiment, of which FIG. 4(a) is a cross-sectional view taken along line AA in FIG. 2(a); FIG. 4(b) is a cross-sectional view taken along line BB in FIG. 2(b). 5(a) and 5(b) are views showing the distal end portion of the medical instrument according to the second embodiment, of which FIG. 5(a) is a side view and FIG. 5(b) is a tubular body. is a cross-sectional view along the axial direction of the. 6(a) and 6(b) are views showing the distal end portion of the medical device according to the third embodiment, of which FIG. 6(a) is a side view and FIG. 6(b) is a tubular body. is a cross-sectional view along the axial direction of the. FIG. 10 is a view showing the distal end portion of the medical instrument according to the fourth embodiment, and is a cross-sectional view along the axial direction of the tubular body;

An embodiment of the present invention will be described below with reference to FIGS. 1 to 4(b). In addition, in all the drawings, the same reference numerals are given to the same constituent elements, and the description thereof will be omitted as appropriate.
Although FIG. 1 shows the balloon member 60 inflated for the sake of convenience, the balloon member 60 is not actually inflated at normal times before use.

The embodiments described below are merely examples for facilitating understanding of the present invention, and do not limit the present invention. That is, the shape, size, arrangement, etc. of the members described below can be changed or improved without departing from the scope of the present invention, and the present invention includes equivalents thereof.
It should be noted that the various components of the medical device 100 of the present invention do not need to exist individually. that a plurality of constituent elements are formed as one member, that one constituent element is formed of a plurality of members, that a certain constituent element is part of another constituent element, or that a certain constituent element is one It is permissible for a part and a part of another component to overlap, and so on.
Moreover, hereinafter, the distal side of the medical device 100 is also referred to as the distal side, and the proximal side thereof is referred to as the proximal side. In addition, the distal end means a certain range including the distal end (most proximal end) and its periphery, and the proximal end means a certain range including the proximal end (most proximal end) and its periphery. shall mean
Further, hereinafter, the axial direction of the tubular body 10 may be simply referred to as the axial direction, and the radial direction of the tubular body 10 may be simply referred to as the radial direction.
Further, unless otherwise specified, the thickness and dimensions of each portion of the medical device 100 are those of the balloon member 60 when it is deflated (before being inflated).

As shown in any one of FIGS. 1 to 4B, the medical device 100 according to this embodiment includes a main body (in this embodiment, a tubular body 10) which is a tubular body or a cylindrical body, and a main body. and a tubular balloon member 60 provided along the outer peripheral surface of the body portion coaxially with the body portion and inflated toward the outside of the body portion by introduction of fluid.
The balloon member 60 has a fixed portion 61 fixed to the outer peripheral surface of the main body (tubular body 10) at each of both ends in the axial direction. The portion is an expansion portion 62 that is not fixed to the outer peripheral surface of the main body portion, and each of both end portions of the expansion portion 62 in the axial direction is a thin portion 67 that is formed to be relatively thin. A thick portion 66 is formed relatively thick at an intermediate portion between both ends of the expanded portion 62 in the axial direction.
It should be noted that the terms “relatively thin” and “relatively thick” here mean that the average thickness of the thin portion 67 is equal to the thickness of the thick portion 66. means that it is smaller than the average value of

As an example, the medical device 100 is used to supply a liquid such as a drug solution to a biological lumen.
By inflating the deflated (before inflated) balloon member 60 at a desired position inside the body lumen, the balloon member 60 can be fixed at the desired position. In this state, the inflated balloon member 60 presses the inner wall of the biological lumen and is fixed to the biological lumen.
Examples of biological lumens in which the medical device 100 is used include blood vessels, trachea, gastrointestinal tracts such as intestines, and the like.

According to the present embodiment, the balloon member 60 has thin-walled portions 67 formed to be relatively thin at both ends of the inflatable portion 62 in the axial direction. In the intermediate portion between them, there is a thick portion 66 formed relatively thick. That is, each of both ends (thin-walled portion 67) of the inflatable portion 62 tends to expand relatively outward, and an intermediate portion (thick-walled portion 66) between both ends of the inflatable portion 62 in the axial direction expands outward. It is relatively difficult to expand toward Therefore, in the inflated balloon member 60 , the expansion amount of the outwardly directed thick portion 66 is smaller than the expansion amount of the outwardly directed thin portion 67 . In other words, in the inflated balloon member 60 , the shape of the thick portion 66 is closer to a cylindrical shape coaxial with the tubular body 10 than the shape of the thin portion 67 .
As a result, a wider contact area can be ensured between the inner wall surface of the biological lumen and the outer peripheral surface of the inflated balloon member 60, as compared with the case where the balloon member 60 has a substantially uniform thickness.
As a result, the pressure (force per unit area) of the balloon member 60 against the biological lumen can be reduced, so that the medical device 100 can have a less invasive structure.
Furthermore, since the balloon member 60 can be more stably fixed to the inside of the living body lumen, the axial displacement of the balloon member 60 with respect to the living body lumen results in the outer peripheral surface of the balloon member 60 and the living body. It is possible to prevent the inner wall surface of the lumen from rubbing against each other.
Thus, according to the above configuration, it is possible to realize a medical device having a structure that is excellent in less invasiveness.

In the case of this embodiment, the main body is a tubular body 10, and the tubular body 10 is an elongated tubular member. have in
More specifically, as shown in FIGS. 3(a) and 3(b), the tubular body 10 has a first lumen 21 for feeding a liquid such as a drug solution into the biological lumen, It has a second lumen 22 for the balloon member 60 for supplying fluid to the balloon member 60 and a third lumen 23 for measuring the fluid pressure inside the biological lumen.
However, it is sufficient that the tubular body 10 has at least the second lumens 22, and the number of lumens that the tubular body 10 has may be, for example, three or more.
The first lumen 21 is formed over the entire length of the tubular body 10 . The distal end of first lumen 21 opens at the distal end of tubular body 10 to form first opening 13 . A proximal end of the first lumen 21 communicates with a liquid-sending branch tube 31 (see FIG. 1).
Although the cross-sectional shape of the first lumen 21 is not particularly limited, it is substantially elliptical in this embodiment. The diameter of the first lumen 21 may be uniform regardless of the position in the axial direction of the tubular body 10, or may vary depending on the position in the axial direction.
The second lumen 22 is formed from the proximal end of the tubular body 10 to the distal end 10a. The distal end of the second lumen 22 is arranged in the region where the balloon member 60 is formed, and the proximal end of the second lumen 22 communicates with a later-described horizontal hole 24 (see FIG. 1).
Although the cross-sectional shape of the second lumen 22 is not particularly limited, it is substantially elliptical in this embodiment. The diameter of the second lumen 22 may be uniform regardless of the axial position of the tubular body 10, or may vary depending on the axial position.
A third lumen 23 is formed from the proximal end to the distal end of the tubular body 10 . The distal end of third lumen 23 opens at the distal end of tubular body 10 to form second opening 14 . The proximal end of the third lumen 23 communicates with a pressure monitoring branch tube 33 (see FIG. 1).
Although the cross-sectional shape of the third lumen 23 is not particularly limited, it is substantially elliptical in this embodiment. The diameter of the third lumen 23 may be uniform regardless of the position in the axial direction of the tubular body 10, or may vary depending on the position in the axial direction.

The diameter (equivalent circle diameter) of the first lumen 21 is set larger than those of the second lumen 22 and the third lumen 23 . More specifically, as shown in FIGS. 4( a ) and 4 ( b ), the diameter of the first lumen 21 is, for example, 2/3 or more of the diameter of the tubular body 10 . Thereby, the liquid can be well circulated in the lumen of the first lumen 21 .
The diameter (equivalent circle diameter) of the second lumen 22 is set, for example, to be larger than the diameter of the third lumen 23 (equivalent circle diameter).
However, the size relationship of the diameter of each lumen is not limited to the above example, and can be appropriately set according to the use of each lumen.

Each lumen is arranged dispersedly within the cross section of the tubular body 10, for example.
More specifically, for example, the center of each lumen is radially eccentric with respect to the axial center of the tubular body 10 . More specifically, the first lumen 21 is arranged in the central portion in the radial direction, the second lumen 22 is arranged on one side of the first lumen 21 in the short axis direction, and the third lumen 23 is arranged on the other side. It is
However, the positional relationship of each lumen is not limited to the above example, and can be appropriately set according to the use of each lumen.

The first lumen 21 is used, for example, as a liquid feeding lumen for supplying a liquid such as a drug solution into a living body lumen. As described above, since the first lumen 21 is formed to have a relatively large diameter, the liquid can be well circulated in the lumen of the first lumen 21 .

The tubular body 10 is made of, for example, a resin material such as polyurethane or polyamide. By configuring the tubular body 10 from a resin material such as polyurethane or polyamide, the workability of the tubular body 10 is improved.

It is also preferable that, for example, a hydrophilic layer (not shown) is formed on the outer peripheral surface of the tubular body 10 . Thereby, the sliding resistance when the medical device 100 is inserted into the biological lumen can be reduced.
The hydrophilic layer may be formed over the entire length of the tubular body 10, or may be formed in a partial length region on the distal end side of the tubular body 10. As shown in FIG.
The material of the hydrophilic layer is not particularly limited, but examples thereof include hydrophilic resin materials such as maleic anhydride-based polymers such as polyvinyl alcohol (PVA), copolymers thereof, and polyvinylpyrrolidone.

Although the diameter of tubular body 10 is not particularly limited, it is preferably 2 mm or more and 5 mm or less. Moreover, the total length of the tubular body 10 is not particularly limited, but is preferably 500 mm or more and 1000 mm or less. Moreover, as shown in FIGS. 2(a) and 2(b), the outer diameter of the most distal end of the tubular body 10 may be slightly enlarged toward the distal side.
However, the diameter and overall length of the tubular body 10 can be appropriately set according to the application of the medical device 100 .

For example, an annular marker 11 is embedded near the distal end of the tubular body 10 . Note that the outer peripheral surface of the marker 11 may be exposed on the outer peripheral surface of the tubular body 10, for example.
The marker 11 is made of, for example, an X-ray opaque material such as platinum or tungsten. By using the position of the marker 11 as an index, the position of the distal end portion 10a of the tubular body 10 within the body lumen can be accurately recognized under X-ray (radiation) observation.

The balloon member 60 is composed of, for example, a single layer or two or more layers of resin sheets. In addition, when it is composed of a single-layer resin sheet, it is preferable that the whole is integrally formed into a cylindrical shape. When it is composed of two layers of resin sheets, it is preferable that the resin sheets formed separately are coaxially laminated and joined to each other so that the whole is integrated into a cylindrical shape. As shown in FIGS. 2(a) and 2(b), the balloon member 60 is formed in a tubular shape or the like, and surrounds the outer peripheral surface of the distal end portion 10a of the tubular body 10 in a circumferential manner. It is attached to the tubular body 10 in a liquid-tight manner. By introducing a fluid into the gap between the tubular body 10 and the tubular body 10 , the tubular body 10 expands outward.
In the present embodiment, as an example, a fixing portion (not shown) such as an adhesive is provided in the fixing portion 61 of the balloon member 60 so that the balloon member 60 is liquid-tightly and circumferentially fixed to the tubular body 10 . ing.
However, the method of attaching the balloon member 60 to the tubular body 10 is not particularly limited. 10 may be attached.

As described above, the intermediate portion between the fixed portions 61 in the balloon member 60 is the expandable portion 62 that is not fixed to the outer peripheral surface of the tubular body 10 .
In the case of this embodiment, the expanding portion 62 is arranged between the fixed portions 61 in the axial direction.
More specifically, in a state in which balloon member 60 is fixed to tubular body 10 , the entire one surface of balloon member 60 is arranged along the outer peripheral surface of tubular body 10 . Then, the balloon member 60 is inflated by injecting fluid into the gap between the one surface of the inflatable portion 62 and the outer peripheral surface of the tubular body 10 . Also, the one surface of each fixing portion 61 is fixed to the outer peripheral surface of the tubular body 10 .
Further, in the case of the present embodiment, as an example, the fixing portion 61 and the expansion portion 62 are continuous with each other (no other component is interposed). More specifically, the fixed portion 61 and the thin portion 67 are continuous with each other, and the thin portion 67 and the thick portion 66 are continuous with each other.

The balloon member 60 is an elastic member and is obtained by injection molding a soft resin material into a sheet. The soft resin material is not particularly limited, but soft resin materials such as polyamide, polyolefin, polyvinyl chloride, polyurethane, polyphenylene sulfide, fluororesin, and polyester, as well as rubber such as polyurethane elastomer, polyamide elastomer, silicone rubber, and latex rubber. material.

In the case of this embodiment, the tubular body 10 has a horizontal hole 24 that allows the second lumen 22 and the radially outer space of the tubular body 10 to communicate with each other.
A fluid (not shown) such as physiological saline injected into the second lumen 22 is discharged from the lateral hole 24 into the radially outer space of the tubular body 10 , that is, the inside of the balloon member 60 .
By arranging the lateral hole 24 at a position corresponding to the proximal side portion of the inflatable portion 62,
The lateral hole 24 is, for example, a side hole whose depth direction is perpendicular to the axial direction of the tubular body 10 . One end of the lateral hole 24 communicates with the inside of the balloon member 60 , and the other end of the lateral hole 24 communicates with the distal end of the second lumen 22 .

Moreover, the lateral hole 24 is preferably arranged at a position corresponding to, for example, the proximal side portion of the expansion portion 62 .
More specifically, for example, when using the medical device 100, the operation of injecting a liquid into the balloon member 60 to inflate it and then removing the liquid from the balloon member 60 is repeated one or more times (for example, a plurality of times). to replace the gas inside the balloon member 60 with liquid (hereinafter referred to as priming). According to the above-described configuration, even if air bubbles remain inside the inflated balloon member 60, the remaining air bubbles can be raised by simply tilting the medical device 100 so that the balloon member 60 is positioned upward. can be discharged smoothly from the inside of the Therefore, the priming can be performed quickly.

A fluid such as physiological saline is injected into the balloon member 60 through the second lumen 22 and the lateral hole 24 to inflate the balloon member 60 outward from the tubular body 10 (FIGS. 3A and 3B). See FIG. 3(b)). More specifically, as shown in FIGS. 2A and 2B, when the balloon member 60 is not inflated, the peripheral surface of the balloon member 60 extends along the outer peripheral surface of the tubular body 10, for example. are placed. In the inflated state of the balloon member 60, the inflatable portion 62 of the balloon member 60 inflates (expands) outward from the tubular body 10, as shown in FIG. 2(b).

Here, the thickness (T1 shown in FIGS. 2A and 2B) of the thick portion 66 is, for example, substantially constant. As a result, when the balloon member 60 is inflated, the internal pressure applied to the balloon member 60 acts perpendicularly and substantially uniformly on the entire thick portion 66 , so that the outer diameter of the thick portion 66 of the inflated balloon member 60 is substantially constant regardless of the position in the axial direction. That is, the central portion (thick portion 66) of the inflated balloon member 60 has a substantially cylindrical shape. Therefore, a wider contact area can be secured between the inner wall surface of the biological lumen and the outer peripheral surface of the inflated balloon member 60, so that the balloon member 60 can be better fixed to the biological lumen. .
In a state before the balloon member 60 is inflated. The outer diameter and inner diameter of the thick portion 66 are, for example, substantially constant regardless of the position in the axial direction.

Moreover, in the case of the present embodiment, the fixed portion 61 is preferably formed thinner than the thick portion 66 .
By doing so, the step at the boundary between the tubular body 10 and the balloon member 60 can be made smaller. The sliding resistance against the inner wall of the lumen can be reduced.
In the case of this embodiment, the thickness (T2 shown in FIGS. 2A and 2B) of the fixing portion 61 is, for example, substantially constant.
The thickness T1 of the thick portion 66 is preferably 1.5 times or more the thickness T2 of the fixed portion 61, for example. is more preferably twice or more.

Furthermore, it is more preferable that the thickness T2 of the fixing portion 61 is equal to or less than the thickness of the thin portion 67 .
By doing so, the step at the boundary between the tubular body 10 and the balloon member 60 can be further reduced, so that when the medical device 100 including the balloon member 60 moves in the lumen of a living body, it is possible to move the medical device 100 inside the living body. The sliding resistance against the inner wall of the lumen can be further reduced.
More specifically, the thickness of the fixed portion 61 is preferably smaller than the average value of the thickness of the thin portion 67 , and more preferably the thickness of the fixed portion 61 is equal to the minimum thickness of the thin portion 67 . It is equal to or less than the minimum thickness of the thin portion 67 .

Moreover, it is preferable that the thickness of the thin portion 67 gradually decreases toward the fixed portion 61 side, for example.
By doing so, when the balloon member 60 is inflated, it can be steeply inflated at the boundary between the fixed portion 61 and the thin portion 67 (rising is improved).
In this embodiment, as an example, the minimum thickness of the thin portion 67 (T3 shown in FIGS. 2A and 2B) is substantially equal to the thickness T2 of the fixed portion 61. FIG.
Further, the maximum thickness of the thin portion 67 (T4 shown in FIGS. 2A and 2B) is substantially equal to the thickness T1 of the thick portion 66. As shown in FIG.
Further, the outer diameter of the thin portion 67 gradually decreases toward the fixed portion 61 side, while the inner diameter of the thin portion 67 is substantially constant regardless of the position in the axial direction.
Further, in the state in which the balloon member 60 is inflated, the outer diameter of the balloon member 60 gradually decreases in the thin portion 67 toward the fixed portion 61 side.

In the case of this embodiment, the dimension of the expansion portion 62 in the axial direction is larger than the outer diameter of the tubular body 10 (main body portion).
As a result, the shape of the inflated balloon member 60 becomes elongated in the axial direction. Therefore, the contact area of the outer peripheral surface of the balloon member 60 with respect to the inner wall surface of the body lumen can be further ensured.
In the case of this embodiment, the dimension of the expansion portion 62 in the axial direction (L1 shown in FIGS. 2(a) and 2(b)) is the minimum value of the outer diameter of the tubular body 10 (FIGS. 2(a) and 2 It is larger than R1) shown in (b) and larger than the maximum value of the outer diameter of the tubular body 10 (R2 shown in FIGS. 3(a) and 3(b)). However, the dimension L1 of the expansion portion 62 should be at least larger than the minimum value R1 of the outer diameter of the tubular body 10 .

Furthermore, in the axial direction, the dimension of the thick portion 66 is preferably larger than, for example, the dimension of each of the thin portions 67. By doing so, in the inflated balloon member 60, the cylindrical portion ( The proportion occupied by the thick portion 66) is greater than the proportion occupied by the tapered portion (thin portion 67). In other words, as shown in FIGS. 3(a) and 3(b), the shape of the inflated balloon member 60 becomes closer to a substantially bale shape elongated in the axial direction. Therefore, the contact area between the inner wall surface of the body lumen and the outer peripheral surface of the balloon member 60 can be secured more favorably.
In the case of this embodiment, in the axial direction, the dimension L2 of the thick portion 66 (L2 shown in FIGS. 2A and 2B) is, for example, the dimension of each thin portion 67 (FIG. 2A). and L3) shown in FIG. Preferably.
In the case of the present embodiment, the dimensions L3 of the thin portions 67 are set equal to each other, but the dimensions L3 of the thin portions 67 may be set to different dimensions. In this case, the dimension L2 of the thick portion 66 should be at least greater than the dimension L2 of the thin portion 67, which is set to have a smaller dimension. Preferably, the dimension L2 of the thick portion 66 is, for example, greater than the dimension L3 of the thinner portion 67, which is set to the larger dimension. It is larger than the total value of the dimension L3 of each of the portions 67.

Here, each of the thick portion 66 and the thin portion 67 of the balloon member 60 can be formed by compression molding, for example.
More specifically, each of the thick portion 66 and the thin portion 67 can be formed by transferring the unevenness of the mold.
In this case, the soft resin material used for the balloon member 60 preferably has high fluidity, for example. By doing so, the elastic modulus of the balloon member 60 obtained by compression molding becomes substantially uniform. On the other hand, as described above, the outward expansion of the main body (tubular body 10) is relatively easy for both ends (thin-walled portions 67) of the inflatable portion 62, and the inflatable portion 62 in the axial direction is relatively easy to expand. The intermediate portion (thick portion 66) between the both ends becomes relatively difficult.
In addition to the above example, for example, by locally laminating a plurality of sheet materials in the balloon member 60, a relatively thick thick portion 66, a relatively thin thin portion 67, may be formed respectively. In this case, the thickness of the thick portion 66 is the sum of the thicknesses of the respective sheet materials forming the thick portion 66 . Similarly, the thickness of the thin portion 67 is the sum of the thicknesses of the sheet materials forming the thin portion 67 .

The average thickness of the thick portion 66 is preferably, for example, 1.5 times or more the average thickness of the thin portion 67, and more preferably the average thickness of the thick portion 66. The value is preferably, for example, twice or more the average value of the thickness of the thin portion 67 .
By doing so, the thin portion 67 is relatively easy to expand, while the thick portion 66 is relatively difficult to expand. Therefore, in the inflated balloon member 60 , the amount of change in the outer diameter of the thick portion 66 in the axial direction of the balloon member 60 is further suppressed compared to the thin portion 67 .

The average thickness of the thick portion 66 is, for example, preferably 0.5 mm or more and 1.5 mm or less, and more preferably 0.7 mm or more and 1 mm or less.
The average thickness of the thin portion 67 is, for example, preferably 0.1 mm or more and 0.5 mm or less, and more preferably 0.2 mm or more and 0.4 mm or less.

The dimension L1 of the expansion portion 62 is, for example, preferably 10 mm or more and 30 mm or less, more preferably 12 mm or more and 24 mm or less.
The dimension L2 of the thick portion 66 is, for example, preferably 6 mm or more and 24 mm or less, more preferably 10 mm or more and 18 mm or less.
The dimension L3 of each thin portion 67 is, for example, preferably 2 mm or more and 5 mm or less, more preferably 2 mm or more and 4 mm or less.

As shown in FIG. 1, the proximal end of tubular body 10 is connected to, for example, a generally cylindrical branch 30 . The branch portion 30 includes a main portion 30a and three branch portions 30b, 30c, and 30d branched in three directions from the distal end of the main portion 30a. Here, the three branching portions 30b to 30d are referred to as a first branching portion 30b, a second branching portion 30c, and a third branching portion 30d, respectively.
A liquid-sending branch pipe 31 is provided at the first branch portion 30b, a balloon branch pipe 32 is provided at the second branch portion 30c, and a pressure monitor branch pipe 33 is provided at the third branch portion 30d. is provided.

Each of the first branch portion 30b to the third branch portion 30d and the main portion 30a has a through hole (not shown) formed along its axial direction. Here, the through hole of the first branch portion 30b is the first through hole, the through hole of the second branch portion 30c is the second through hole, and the through hole of the third branch portion 30d is the third through hole. called. Moreover, the through-hole which main part 30a has is called the 4th through-hole.
The proximal end of the fourth through-hole is connected to the distal end of each of the first to second through-holes and communicates with each other. Also, the proximal end of the tubular body 10 is inserted into the fourth through hole.
A first lumen 21 is connected to the first through hole. A liquid-sending branch pipe 31 is connected to the first through-hole. Therefore, the first lumen 21 and the liquid-sending branch pipe 31 are communicated with each other via the first branch portion 30b. The proximal end of the liquid-feeding branch tube 31 is provided with a liquid-feeding connector 31a (see FIG. 1). A liquid-feeding syringe (not shown) is attached to the liquid-feeding connector 31a.
A second lumen 22 is connected to the second through hole. A balloon branch tube 32 is connected to the second through hole. Therefore, the second lumen 22 and the balloon branch tube 32 communicate with each other via the second branch portion 30c. A proximal end of the balloon branch tube 32 is provided with a balloon connector 32a (see FIG. 1). A balloon syringe (not shown) is attached to the balloon connector 32a.
A third lumen 23 is connected to the third through hole. A pressure monitoring branch pipe 33 is connected to the third through hole. Therefore, the third lumen 23 and the pressure monitor branch tube 33 are communicated with each other via the third branch portion 30d. A pressure monitor connector 33 a (see FIG. 1 ) is provided at the proximal end of the pressure monitor branch tube 33 . The pressure monitor connector 33a is connected to a pressure measuring device (not shown). A pressure monitor cap 33b is attached to the proximal end of the pressure monitor connector 33a.

In the case of this embodiment, by supplying the liquid from the liquid-feeding syringe to the liquid-feeding connector 31a, the liquid-feeding branch tube 31, the first through hole, the first lumen 21, and the first opening 13 The liquid can be injected into the interior of the biological lumen through the .
Further, as shown in FIG. 1, an opening/closing member 34 is attached to the outer peripheral surface of the liquid-feeding branch pipe 31 . By opening and closing the opening/closing member 34, it is possible to switch between supply and stop of the liquid.
In this embodiment, the opening/closing member 34 is, for example, a Robert clamp. However, the opening/closing member 34 is not particularly limited, and examples thereof include roller clamps, pinch clamps, and the like.
When the opening/closing member 34 is closed, the opening/closing member 34 clamps the liquid-feeding branch tube 31 to close the lumen (flow path) of the liquid-feeding branch tube 31, thereby stopping the liquid supply. .
When the opening/closing member 34 is operated to open, the lumen (channel) of the liquid feeding branch tube 31 is opened, and the liquid is supplied.

In the case of this embodiment, by supplying fluid such as physiological saline from the balloon syringe to the balloon connector 32a, the balloon branch tube 32, the second through hole, the second lumen 22, and the balloon hole The fluid is injected into the balloon member 60 through the portion 22a. As a result, the balloon member 60 changes from a deflated state (see FIGS. 2(a) and 2(b)) to an expanded state (see FIGS. 3(a) and 3(b)). The fluid preferably contains, for example, a contrast medium, so that it can be recognized that the balloon member 60 has been expanded to a desired diameter under X-ray (radiation) observation.

The balloon connector 32a has, for example, a one-way valve (not shown). The inflated state of the balloon member 60 is maintained by the one-way valve restricting the flow of liquid from the distal side to the proximal side.

In this embodiment, the medical device 100 is connected to the pressure measuring device through the third lumen 23, the pressure monitor branch tube 33, and the pressure monitor connector 33a.
A pressure measuring device is used to measure and monitor the pressure inside the coronary sinus in each of the inflated and deflated states of the balloon member 60 .
Although the pressure measuring device is not particularly limited, it may be a transducer or the like for detecting hydraulic pressure.

Note that the medical device 100 includes, for example, a fourth lumen (not shown), an operation line (not shown) inserted through the fourth lumen, and an operation section connected to the proximal end of the operation line. (not shown). In this case, the bending operation of the tubular body 10 can be performed by operating the operation portion.
The operating wire is, for example, a twisted wire configured by twisting a plurality of strands together. However, the operating wire may be composed of a single wire rod.
The operating wire is not particularly limited, but examples thereof include low carbon steel (piano wire), stainless steel (SUS), steel wire with corrosion-resistant coating, titanium or titanium alloy, or metal wire such as tungsten. .

[Second embodiment]
Next, 2nd Embodiment is described using Fig.5 (a) and FIG.5(b).
The medical device according to this embodiment differs from the medical device 100 according to the first embodiment in the points described below, and is different from the medical device 100 according to the first embodiment in other respects. configured similarly.

The thin portion 67 of the present embodiment has, for example, a first portion 67a positioned at the boundary with the fixed portion 61 and a second portion 67b positioned farther from the fixed portion 61 than the first portion 67a. ing.
The thickness of the second portion 67b gradually decreases toward the fixing portion 61 side, and the thickness of the first portion 67a is constant and less than or equal to the thickness of the second portion 67b.
As a result, when the balloon member 60 is inflated, the thin portion 67 rises more favorably. is further suppressed compared to That is, in the inflated balloon member 60 , the shape of the thick portion 66 is closer to the cylindrical shape (balloon shape) than the shape of the thin portion 67 .

In the case of this embodiment, as an example, the first portion 67a and the second portion 67b are connected to each other. More specifically, the fixed portion 61 and the first portion 67a are connected to each other, and the second portion 67b and the thick portion 66 are connected to each other.
Therefore, the thickness of the first portion 67a is the minimum thickness T3 of the thin portion 67, and the maximum thickness of the second portion 67b is the maximum thickness T4 of the thin portion 67. FIG. Therefore, the thickness of the first portion 67a is substantially equal to the thickness T2 of the fixed portion 61, and the maximum thickness of the second portion 67b is substantially equal to the thickness T1 of the thick portion 66. As shown in FIG. Also, the minimum value of the thickness of the second portion 67b is substantially the same as the thickness of the first portion 67a.
Also, the outer diameter and inner diameter of the first portion 67a are substantially constant regardless of the position in the axial direction. The outer diameter of the second portion 67b gradually decreases toward the fixed portion 61, while the inner diameter of the thin portion 67 is substantially constant regardless of the position in the axial direction.

[Third embodiment]
Next, 3rd Embodiment is described using Fig.6 (a) and FIG.6(b).
The medical device according to this embodiment differs from the medical device 100 according to the first and second embodiments in the points described below, and the other points are the same as those in the first and second embodiments. is configured in the same manner as the medical instrument 100 according to .

As in the second embodiment, the thin portion 67 of this embodiment includes a second portion 67b whose thickness gradually decreases toward the fixing portion 61 side, and a second portion 67b whose thickness is constant and whose thickness is constant. and a first portion 67a that is less than or equal to the thickness of 67b. However, in the case of the present embodiment, the thickness of the second portion 67b sharply decreases toward the fixed portion 61 side as compared with the second portion 67b of the second embodiment.
As a result, in the expanded balloon member 60 , the amount of change in the outer diameter of the thick portion 66 in the axial direction of the balloon member 60 is further suppressed compared to the thin portion 67 . That is, in the inflated balloon member 60 , the shape of the thick portion 66 is closer to the cylindrical shape than the shape of the thin portion 67 . In other words, the shape of the inflated balloon member 60 becomes a substantially bale shape elongated in the axial direction.
Note that the term "abruptly decreasing" as used herein means that the amount of thickness change is at least greater than the dimension in the axial direction of the area where the thickness is changing. In the case of this embodiment, it is preferable that the amount of change in thickness is, for example, twice or more the length dimension in the axial direction of the area where the thickness changes. By doing so, in the inflated balloon member 60, the amount of change in the outer diameter of the thick portion 66 in the axial direction can be suppressed more than the amount of change in the outer diameter of the thin portion 67 in the axial direction. .
In this embodiment, the dimension of the second portion 67b in the axial direction is preferably 1/5 or less of the dimension of the first portion 67a, and preferably 1/10 or less of the dimension of the first portion 67a. More preferred. By doing so, the average thickness of the thin portion 67 can be set to a smaller value than the average thickness of the thick portion 66 .

Further, in the case of this embodiment, in the balloon member 60 in the natural state, one surface is formed with a step (discontinuity) by the thick portion 66 and the thin portion 67 (the second portion 67b), and the other surface is discontinuous. surface is smoother than the one surface.
The surface of the balloon member 60 on which the step is formed by the thick portion 66 and the thin portion 67 (the one surface) is the inner surface. In other words, the surface on which the step is formed is arranged along the outer peripheral surface of the tubular body 10 .
As a result, in a state in which the inflated balloon member 60 is fixed to the biological lumen, the smooth surface of the balloon member 60 rather than the surface on which the step is formed faces the biological lumen. Since it hits the inner wall surface, it is less invasive.
In addition, in the case of the first embodiment and the second embodiment, the surface of the balloon member 60 in the natural state on which the step (unevenness) is formed by the thick portion 66 and the thin portion 67 is the inner surface. good too.

In the case of this embodiment, as shown in FIGS. 6A and 6B, the inner peripheral surface of the thick portion 66 is arranged along the outer peripheral surface of the tubular body 10, while the thin portion 67 The inner peripheral surface of is spaced apart from the outer peripheral surface of the tubular body 10 .
Also, the inclination angle of the inner peripheral surface of the second portion 67b with respect to the inner peripheral surface of the first portion 67a is, for example, a substantially right angle or an obtuse angle close to a right angle.

[Fourth Embodiment]
Next, a fourth embodiment will be described with reference to FIG.
The medical device according to this embodiment differs from the medical device 100 according to the first to third embodiments in the points described below, and in other respects, the medical device according to the first to third embodiments. It is configured similarly to the medical instrument 100 .

In this embodiment, as in the third embodiment, the surface of the balloon member 60 on which the step is formed by the thick portion 66 and the thin portion 67 (the one surface) is the outer peripheral surface of the tubular body 10. are placed along the However, in the case of this embodiment, on the outer peripheral surface of the tubular body 10, at least the portion corresponding to the thick portion 66 of the balloon member 60 has a relatively small diameter, and the concave portion 10c formed in a circular shape is formed. Configure. As shown in FIG. 7, before the balloon member 60 is inflated, at least the thick portion 66 is accommodated inside the recess 10c, and the outer peripheral surface of the thick portion 66 and the outer peripheral surface of the thin portion 67 are accommodated inside the recess 10c. are flush with each other. That is, before the balloon member 60 is inflated, the outer diameter of the balloon member 60 is substantially constant regardless of the position in the axial direction.
As a result, the sliding resistance when the medical device 100 is inserted into the body lumen can be reduced, so the medical device 100 can be realized with a structure that is superior in less invasiveness.
In addition, in the case of the first embodiment and the second embodiment as well, the recess 10c is formed in the outer peripheral surface of the tubular body 10, and at least the thick portion 66 is in the recess 10c in the state before the balloon member 60 is inflated. may be configured to be housed inside the

Further, for example, the thick portion 66 and the thin portion 67 may be accommodated inside the recess 10c before the balloon member 60 is inflated.
In the case of this embodiment, before the balloon member 60 is inflated, for example, the second portions 67b of the thick portion 66 and the thin portion 67 are housed inside the recess 10c.
More specifically, in the example shown in FIG. 7, the depth of formation of the recess 10c is approximately the same as the thickness T1 of the thick portion 66 minus the minimum thickness T3 of the thin portion 67, for example. is set to In the axial direction, the dimension of the recess 10c is set to be approximately equal to the sum of the dimension of the thick portion 66 and the dimension of the second portion 67b. Also, in the concave portion 10c, the formation depth of the portion corresponding to the second portion 67b sharply decreases toward the fixed portion 61 side, similarly to the second portion 67b. As a result, the outer peripheral surface of the thick portion 66 and the outer peripheral surface of the thin portion 67 are flush with each other before the balloon member 60 is inflated.

Although each embodiment has been described above with reference to the drawings, these are examples of the present invention, and various configurations other than those described above can be adopted.

For example, in the above description, an example in which the inner wall of the tubular body 10 defines a plurality of lumens has been described, but the present invention is not limited to this example, and a plurality of tubes are embedded inside the tubular body 10. , the inner walls of the plurality of tubes may each define a plurality of lumens.

Moreover, in the above description, an example in which the main body is the tubular body 10 has been described, but the main body may be a cylindrical tubular body (not shown). In this case, the balloon member 60 is provided along the outer peripheral surface of the tubular body, and is inflated outwardly of the tubular body by introducing a fluid between it and the tubular body. Then, the shape of the inflated balloon member 60 becomes, for example, a flat cylindrical shape whose dimension in the radial direction is larger than the dimension in the axial direction. Even in such a form, by providing the balloon member 60 with the thick portion 66 and the thin portion 67, the contact area between the inner wall surface of the biological lumen and the outer peripheral surface of the inflated balloon member 60 can be improved. can be secured.

Further, in the above description, an example in which the one surface of each fixing portion 61 is fixed to the outer peripheral surface of the tubular body 10 has been described. It may be. In this case, the fixing portion 61 on the distal end side is folded back toward the proximal end side, and the fixing portion 61 on the proximal end side is folded back toward the distal end side. The expanding portion 62 is arranged outside the fixing portion 61 in the radial direction.

This embodiment includes the following technical ideas.
(1) a main body that is a tubular body or a cylindrical body;
a cylindrical balloon member provided along the outer peripheral surface of the main body coaxially with the main body and inflated outwardly of the main body by introduction of a fluid;
with
The balloon member has a fixing portion fixed to the outer peripheral surface of the body portion at each of both ends in the axial direction,
an intermediate portion between the fixed portions of the balloon member is an expansion portion that is not fixed to the outer peripheral surface of the body portion;
Each of both end portions of the expansion portion in the axial direction is a thin portion formed to be relatively thin,
A medical device according to claim 1, wherein an intermediate portion between both end portions of the inflatable portion in the axial direction is a thick portion formed relatively thick.
(2) The medical device according to (1), wherein the fixing portion is thinner than the thick portion.
(3) The medical device according to (2), wherein the fixing portion has a thickness equal to or less than the thickness of the thin portion.
(4) The medical device according to any one of (1) to (3), wherein the thickness of the thin portion gradually decreases toward the fixed portion.
(5) the thin portion has a first portion located at the boundary with the fixed portion and a second portion located farther from the fixed portion than the first portion;
The thickness of the second portion gradually decreases toward the fixed portion,
The medical device according to (4), wherein the thickness of the first portion is constant and is equal to or less than the thickness of the second portion.
(6) The medical device according to any one of (1) to (5), wherein the dimension of the expansion portion in the axial direction is larger than the outer diameter of the body portion.
(7) The medical device according to any one of (1) to (6), wherein the dimension of the thick portion is greater than the dimension of each of the thin portions in the axial direction.
(8) The medical device according to any one of (1) to (7), wherein the expanding portion is arranged between the fixing portions in the axial direction.
(9) the main body is the tubular body;
The tubular body has a first lumen for supplying liquid, a second lumen for supplying the fluid to the balloon member, and a space radially outside the tubular body and the second lumen for mutual communication. a lateral hole, and
The medical device according to any one of (1) to (8), wherein the lateral hole is arranged at a position corresponding to a proximal side portion of the inflatable portion.

10 tubular body 10a distal end 10c recess 11 marker 13 first opening 14 second opening 21 first lumen 22 second lumen 23 third lumen 24 lateral hole 30 branch 30a main portion 30b first branch 30c Second branch portion 30d Third branch portion 31 Liquid sending branch tube 31a Liquid sending connector 32 Balloon branch tube 32a Balloon connector 33 Pressure monitor branch tube 33a Pressure monitor connector 33b Pressure monitor cap 34 Open/close member 60 Balloon member 61 Fixed portion 62 Expansion portion 66 Thick portion 67 Thin portion 67a First portion 67b Second portion 100 Medical device

Claims (9)

a main body that is a tubular body or a cylindrical body;
a cylindrical balloon member provided along the outer peripheral surface of the main body coaxially with the main body and inflated outwardly of the main body by introduction of a fluid;
with
The balloon member has a fixing portion fixed to the outer peripheral surface of the body portion at each of both ends in the axial direction,
an intermediate portion between the fixed portions of the balloon member is an expansion portion that is not fixed to the outer peripheral surface of the body portion;
Each of both end portions of the expansion portion in the axial direction is a thin portion formed to be relatively thin,
A medical device according to claim 1, wherein an intermediate portion between both end portions of the inflatable portion in the axial direction is a thick portion formed relatively thick. The medical instrument according to claim 1, wherein the fixing portion is thinner than the thick portion. 3. The medical device according to claim 2, wherein the fixing portion has a thickness equal to or less than the thickness of the thin portion. 4. The medical instrument according to any one of claims 1 to 3, wherein the thickness of the thin portion gradually decreases toward the fixed portion. The thin portion has a first portion positioned at a boundary with the fixed portion and a second portion positioned farther from the fixed portion than the first portion,
The thickness of the second portion gradually decreases toward the fixed portion,
5. The medical device according to claim 4, wherein the wall thickness of the first portion is constant and is equal to or less than the wall thickness of the second portion. 6. The medical device according to any one of claims 1 to 5, wherein the dimension of the expansion portion in the axial direction is larger than the outer diameter of the body portion. 7. The medical device of any one of claims 1-6, wherein the dimension of the thickened portion is greater than the dimension of each of the thinned portions in the axial direction. 8. The medical device according to any one of claims 1 to 7, wherein the expansion portion is arranged between the fixed portions in the axial direction. The main body is the tubular body,
The tubular body has a first lumen for supplying liquid, a second lumen for supplying the fluid to the balloon member, and a space radially outside the tubular body and the second lumen for mutual communication. a lateral hole, and
9. The medical device according to any one of claims 1 to 8, wherein the lateral hole is arranged at a position corresponding to a proximal side portion of the inflatable portion.

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