JP4101323B2 - Medical tube - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a medical tube having a variable bending motion tissue peeling function for insertion into a living body for examination or treatment. More specifically, the present invention relates to a medical tube having a tissue bending function of variable bending movement utilizing a partial extension difference of a balloon when a pressurized fluid is injected.
[0002]
[Prior art]
Surgery, which has been highly invasive in the past, is now gradually replaced by minimally invasive procedures. For example, minimally invasive treatment methods based on catheter technology and endoscopes such as PTCA, PTA, stents, atherectomy, embolization, and endoscopic surgery have shown remarkable spread.
[0003]
Especially in the field of catheter technology, various balloon catheters are used for the purpose of supplying medicinal solutions or infusions to specific sites in body cavities such as blood vessels, gastrointestinal tracts, fallopian tubes, and ureters, and expanding stenosis by expanding balloons. Has been developed. However, with the exception of some endoscopic operations, application examples that utilize catheters are intended for body cavities.
[0004]
[Problems to be solved by the invention]
Along with the expansion of the application field of catheters, a catheter approach method that is not limited to an approach using a living body lumen such as a blood vessel is desired.
In order to perform treatment by allowing the catheter to reach the target site from outside the living body lumen, unlike the case of the in-vivo approach, a cavity must first be formed in various tissues with low friction. This sometimes requires the tissue to be exfoliated extensively. After reaching the target site, various tools are applied using the multi-lumen of the catheter to perform diagnosis and treatment.
[0005]
As a method of exfoliating the tissue, it is conceivable that the distal end portion of the catheter is continuously deformed and moved after the catheter reaches the target site of the tissue to be exfoliated. Various structures have been proposed for the mechanism for bending the catheter tip, but they are all complicated and unavoidable to increase the diameter of the catheter, and have been developed from the viewpoint of an approach from outside the living body lumen. No multifunctional catheter has yet been found.
The present invention has been made to solve the above-described problems of the prior art, and the object of the present invention is to peel a living tissue with a variable bending motion from the viewpoint of an approach from outside the living body lumen. It is an object of the present invention to provide a medical tube structure that has a function and can be reduced in diameter with a simple structure.
[0006]
[Means for Solving the Problems]
As a result of various studies to achieve the above object, the present inventor provided at least two portions with small extensibility extending in a part in the axial direction in a portion of the cylindrical balloon less than half of the circumferential direction. The extensibility can be obtained by displacing the small extensibility portions in the axial direction of the cylindrical balloon and by locating them on the opposite side in the circumferential direction of the cylindrical balloon and changing the degree of crosslinking in the circumferential direction of the balloon. small portion was formed of, and by injecting the pressurized fluid into the balloon, inflated more largely side balloon extensibility large, the side small extensibility is not too inflated, smaller the balloon is a compliant Curved partly into an S shape, and the degree of curvature can be adjusted by the pressure of the pressurized fluid, and the tissue can be exfoliated with variable curvature by changing the pressure of the pressurized fluid in pulses. It found that ability is achieved, thereby completing the present invention.
[0007]
That is, the first aspect of the present invention is a shaft tube inserted into a living body, a cylindrical balloon fluidly joined to the outer periphery of the distal end portion of the shaft tube, and the shaft tube provided in the shaft tube. A first lumen that communicates with the balloon and at least one second lumen that is provided in the shaft tube and opens at a tip of the shaft tube; There are at least two parts with low extensibility extending in the axial direction in less than half of the circumferential direction, and these low extensibility parts are shifted in the axial direction of the cylindrical balloon. The medical tube is characterized in that it is located on the opposite side in the circumferential direction of the cylindrical balloon , and a portion having a low extensibility is formed by changing the degree of crosslinking in the circumferential direction of the balloon. .
[0008]
The second aspect of the present invention includes a shaft tube inserted into a living body, a cylindrical balloon in which one end of a cylindrical balloon is fluid-tightly joined to a distal end of the shaft tube, and a distal end portion. A long medical treatment or diagnostic tool directly or indirectly fluid-tightly joined to the other end of the cylindrical balloon is provided in the shaft tube and communicated with the balloon so that fluid can pass therethrough. And a first lumen containing the elongated medical procedure or diagnostic tool, and the cylindrical balloon extends to a part of its axial direction in a portion less than half of its circumferential direction There are at least two portions with low extensibility, and these low extensibility portions are offset in the axial direction of the cylindrical balloon and are positioned on the opposite side in the circumferential direction of the cylindrical balloon , Low extensibility by changing the degree of crosslinking in the circumferential direction of the balloon A medical tube, wherein the portion is formed.
[0009]
Furthermore, the third aspect of the present invention is the shaft tube inserted into the living body, the cylindrical balloon in which one end of the cylindrical balloon is fluid-tightly joined to the distal end of the shaft tube, and the distal end portion A long medical treatment or diagnostic tool directly or indirectly fluid-tightly joined to the other end of the cylindrical balloon is provided in the shaft tube and communicated with the balloon so that fluid can pass therethrough. And a first lumen housing the elongated medical procedure or diagnostic tool, and at least one second lumen provided in the shaft tube and opened to an outer periphery of a distal end portion of the shaft tube; The cylindrical balloon has at least two portions with low extensibility extending in a part in the axial direction in a portion less than half of the circumferential direction, and these portions with low extensibility Is offset in the axial direction of the cylindrical balloon and Located on the opposite side in the circumferential direction of the Jo balloon is a medical tube, wherein the small portion of該伸malleable by circumferentially varying the degree of crosslinking of the balloon is formed.
[0010]
DETAILED DESCRIPTION OF THE INVENTION
Below, the medical tube concerning this invention is demonstrated in detail based on the embodiment shown to drawing.
FIG. 1 is a perspective view showing an example of a cylindrical balloon used for the medical tube of the present invention, which is composed of a relatively low extensibility portion 1 and a relatively high extensibility portion 2. The small first portion 1A extends in a part of the cylindrical balloon in the circumferential direction and is approximately half the length in the axial direction, and the second portion 1B having low extensibility is a part in the circumferential direction of the cylindrical balloon in the axial direction. The first part 1A and the second part 1B exist on opposite sides in the circumferential direction of the cylindrical balloon and are shifted in the axial direction of the cylindrical balloon.
[0011]
Although FIG. 1 shows a cylindrical balloon having two portions having low extensibility, a cylindrical balloon having three or more portions having low extensibility can also be used. For example, when there are three locations, the first portion having low extensibility extends in the circumferential direction of a part of the cylindrical balloon with a length of about 1/3 of the axial direction, and the second portion having low extensibility has A part of the cylindrical balloon extends in the circumferential direction with a length of about 1/3 of the axial direction, and the third part having low extensibility is a part of the cylindrical balloon in the circumferential direction and about 1/3 of the axial direction. The first part and the second part are on opposite sides in the circumferential direction of the cylindrical balloon, and the first part and the third part are on the same side in the circumferential direction of the cylindrical balloon. They exist and may be configured so as to be shifted in the axial direction of the cylindrical balloon.
This difference in extensibility is caused by differences in mechanical properties such as stretch ratio, elastic modulus, rigidity, and hardness of materials constituting the balloon, and differences in physical properties such as film thickness.
[0012]
Examples of the material of the balloon used for the medical tube of the present invention include natural rubber, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, soft polyvinyl chloride, polyurethane, polyisoprene, polyamide, polyamide. Examples include elastomers, polyimides, polyimide elastomers, silicones, and the like. Preferably, a polymer material having flexibility such as natural rubber, polyethylene, soft polyvinyl chloride, and silicone is used. More preferred is low density polyethylene. These materials are radiation crosslinkable.
[0013]
The portions 1A and 1B having a low extensibility may be continuously changed in adjacent portions in the circumferential direction of the balloon, or may be changed in stages. 1B is preferably 30% or less of the entire circumference, more preferably 10% or less. Further, the portions 1A and 1B having low extensibility may be continuously extended over a part or the whole of the balloon in the axial direction or may be provided intermittently depending on a desired degree of curvature.
[0014]
A balloon having a difference in extensibility as described above can be obtained by, for example, molding by changing the film thickness of the balloon in the circumferential direction, or by molding using two kinds of resins having different physical property values. However, it is preferably obtained by performing a radiation crosslinking treatment so that the degree of crosslinking changes in the circumferential direction of the balloon.
The radiation cross-linking treatment is carried out by irradiating with high energy rays such as electron beams and γ rays (including X-rays, β rays, heavy charged particle rays, neutron rays in special cases), ultraviolet rays, etc. can do.
[0015]
An explanation will be given of a case where a balloon having a difference in extensibility is manufactured by carrying out an electron beam crosslinking treatment as a radiation crosslinking treatment. For example, a balloon is formed using low-density polyethylene, and an electron beam is formed in the circumferential direction of the balloon. The extensibility is changed by changing the amount of crosslinking. Preferably, the portion 2 having high extensibility of the balloon is irradiated so that the electron beam irradiation amount is 5 to 35 Mrad, and the portions 1A and 1B having low extensibility are irradiated with the electron beam irradiation portion 2 having high extensibility. Irradiate 3 to 10 Mrad more than More preferably, the portion 2 having high extensibility of the balloon is irradiated so that the electron beam irradiation amount is 20 to 25 Mrad, and the portions 1A and 1B having low extensibility are irradiated with the electron beam of the portion 2 having high extensibility. Irradiate 3-5 Mrad more than the dose.
[0016]
Figure 2 is a cross-sectional view of a portion of the medical tube of the first aspect of the present invention, FIG. 3 is a sectional view taken along line III-III in FIG. As shown in FIGS. 2 to 3, the medical tube according to the first aspect of the present invention includes a shaft tube 3 to be inserted into a living body, and a cylinder fluid-tightly joined to the outer periphery of the distal end portion of the shaft tube 3. Shaped balloon 4. A first lumen 5 communicating with the balloon 4 is provided in the shaft tube 3, and at least one second lumen 6 opened at the tip of the shaft tube 3 is provided. ing. In the present invention, the cylindrical balloon 4 has the special shape and characteristics described with reference to FIG.
[0017]
The shaft tube 3 has a high flexibility such as polyethylene, polyethylene terephthalate, soft polyvinyl chloride, polypropylene, polyurethane, polyamide, polyimide, polytetrafluoroethylene, silicone rubber, and ethylene-vinyl acetate copolymer. Consists of molecular materials.
Further, in order to improve the slidability with respect to the body cavity or the like when the medical tube is inserted, for example, a hydrophilic polymer (for example, maleic anhydride copolymer) or a fluorine-based polymer is provided on the outer surface of each of the shaft tube 3 and the balloon 4. A low friction material such as a resin (eg, polytetrafluoroethylene) may be coated.
[0018]
In the medical tube of the first aspect of the present invention, a tubular reinforcing material is embedded in the vicinity of the outer peripheral surface of the shaft tube 3 so as to surround each of the lumens 5 and 6 over a part or the entire length of the shaft tube 3. Is preferred. As a material of this reinforcing material, for example, a metal material such as stainless steel or a superelastic alloy, a resin material such as polyamide, polyethylene, polypropylene, polyester, polyimide, ABS resin, or a linear body made of carbon fiber or the like is used. In particular, those composed of a braid formed by crossing the linear bodies into a net shape are preferable. By installing such a reinforcing material, the torsional rigidity of the shaft tube 3 is increased, and the torque transmissibility in which the rotational force is transmitted to the distal end side during the rotation operation on the proximal end side is improved. Further, even if the shaft tube 3 is bent, particularly when it is bent at a steep angle, the lumens 5 and 6 are prevented from being blocked or narrowed accordingly.
[0019]
Further, in order to be able to confirm the position of the shaft tube 3 under X-ray fluoroscopy in a state where the shaft tube 3 is inserted into the living body, it is preferable to impart X-ray contrast properties to the shaft tube 3. As a method for this, for example, a method of blending a radiopaque material such as barium sulfate, bismuth oxide, tungsten or the like into the constituent material of the shaft tube 3, a marker made of such a radiopaque material is added to the shaft tube. And a method of embedding or attaching to the surface at a predetermined position.
[0020]
In the medical tube of the first aspect of the present invention, when the medical tube is used, the first lumen 5 communicating with the balloon is connected to the pressurized fluid source via the fluid pressure controller, and the pulse Pulse pressure is applied to the balloon using a pulsating pump for generating pressure. This pressurized fluid may be a gas or a liquid. The adjustment pressure range by the fluid pressure controller is preferably 0 to 15 atm, and the S-shaped bending angle changes arbitrarily according to this pressure. Further, since a pulse-like pressure having a minimum value pressure of 0 atm and a maximum value pressure of 1 to 5 atm is further added to this pressure, an S-shaped bending motion occurs. It is preferable that the balloon is not S-shaped when the pulsed pressure is a minimum pressure, and the balloon is S-shaped when the pulse pressure is a maximum value. balloon. The pulse frequency to be applied depends on the energy required for exfoliation of the living tissue, but is generally preferably 1 to 20 Hz. Adjustment of the fluid pressure controller may be manual or electric.
[0021]
In the medical tube of the first aspect of the present invention, at least one second lumen 6 opened at the tip of the shaft tube can be used as a channel for insertion of a guide wire, a medical procedure, a diagnostic tool or the like. . Examples of medical treatments or diagnostic tools that can be used include endoscopes, forceps, various treatment tools, cytodiagnosis brushes, injection needles, high frequency waves, ultrasonic waves, hydraulic shock waves, etc. (for stone crushing, laser irradiation) (For ablation, etc.), various sensors and their conductors.
[0022]
In addition, a fluid is injected into a living tissue or a tubular organ using a gap between the above-described medical treatment or diagnostic tool or the like and a lumen wall, or using a separate second lumen 6, or Can be aspirated. Specifically, a medical tube is inserted and used to administer a medical solution or the like into an indwelling living tissue or tubular organ, or when viewing the inside of a living tissue or tubular organ with an endoscope. It is also used as a flush channel for injecting a transparent liquid (for example, physiological saline, glucose solution) for extruding body fluids such as blood and bile that hinders blood flow.
[0023]
The medical tube shown in FIGS. 2 and 3 has one second lumen 6, but the medical tube of the present invention has two pieces as shown in FIG. 4 according to its use. The second lumen 6 may be provided, or more second lumens 6 may be provided. A shaft tube having such a large number of lumens and a method for producing the same are known in the prior art.
[0024]
FIG. 5 is a cross-sectional view of a portion of the medical tube of the second embodiment of the present invention. The medical tube of the second aspect of the present invention is a cylindrical balloon in which one end of a shaft tube 3 to be inserted into a living body and a cylindrical balloon 4 is fluid-tightly joined to the tip of the shaft tube 3. 4 and a long medical treatment or diagnostic tool 7 whose tip is joined directly or indirectly to the other end of the cylindrical balloon 4 in a fluid-tight manner. A first lumen 5 is provided in the shaft tube 3 so as to allow fluid to pass through the balloon, and the long medical treatment or diagnostic tool 7 is accommodated in the first lumen 5. ing. The cylindrical balloon 4 is a balloon having the special shape and characteristics described with reference to FIG.
[0025]
As this medical treatment or diagnostic tool, for example, an endoscope, forceps, various treatment tools, cytodiagnosis brush, high frequency, ultrasonic wave, hydraulic shock wave, etc. are emitted (for stone crushing, laser irradiation, ablation, etc.) Examples include probes, various sensors, and their lead wires.
As a joining method of the long medical treatment or diagnostic tool 7 and the cylindrical balloon 4 in the second aspect of the present invention, they may be joined directly, or another tube is interposed between them. It may be made to join indirectly, or other tubes may be straddled across both and joined indirectly.
[0026]
FIG. 5 shows an example in which an endoscope for observing a living tissue or a tubular organ is incorporated as a medical procedure or diagnostic tool 7. This endoscope includes a light transmission fiber bundle (light guide fiber bundle) 71, a light reception fiber bundle (image fiber bundle) 72, and a lens 73 attached to the tip of the light reception fiber bundle 72. Yes. The distal end portion of the light transmission fiber bundle 71 extends beyond the lens 73 to the distal end of the medical tube. The other end (tip) of the cylindrical balloon 4 is fluid-tightly joined to the light transmission fiber bundle 71 and the lens 73 by an adhesive 74.
[0027]
The medical tube according to the second aspect of the present invention does not have a lumen that opens at the tip of the shaft tube, so that fluid is injected into a biological tissue or tubular organ, or fluid is aspirated. I can't. However, when the medical tube is used, the first lumen 5 communicating with the balloon 4 is connected to the pressurized fluid source via the fluid pressure controller and connected to the pulsating pressure generating pulsation pump. As described in the medical tube shown in FIG. 2 and FIG. 3, the bending angle is arbitrarily changed corresponding to the adjustment pressure by the fluid pressure controller and the pulsating pressure generating pulsating pump, and the degree of the bending is the fluid. Since the pressure can be continuously changed according to the pressure and the pulse-like pressure, the direction in which the medical tube is pushed forward while peeling the living tissue can be accurately identified while confirming with an endoscope. Moreover, the structure is extremely simple, and a very thin medical tube can be obtained.
[0028]
6 and 7 are cross-sectional views of a part of the medical tube according to the third embodiment of the present invention. The medical tube according to the third aspect of the present invention includes a cylindrical tube in which a shaft tube 3 inserted into a living body and one end of a cylindrical balloon 4 are fluid-tightly joined to the tip of the shaft tube 3. 4 and a long medical treatment or diagnostic tool 7 whose tip is joined directly or indirectly to the other end of the cylindrical balloon 4 in a fluid-tight manner. In the shaft tube 3, there is provided a first lumen 5 communicating with the balloon 4 so as to allow fluid to pass therethrough. Further, at least one opening opened on the outer periphery of the distal end portion of the shaft tube 3. A second lumen 6 is provided. Further, the long medical treatment or diagnostic tool 7 is accommodated in the first lumen 5.
[0029]
The long medical treatment or diagnostic tool is the same as that described above for the medical tube of the second aspect of the present invention, and the long medical treatment or diagnostic tool 7 and the cylindrical balloon 4 are the same. The joining method is also the same as described above. 6 and 7 also show an example in which an endoscope for observing a living tissue or a tubular organ is incorporated as a medical treatment or diagnostic tool 7, and this endoscope is also the same as described above. .
[0030]
The medical tube according to the third aspect of the present invention has a lumen that opens to the outer periphery of the distal end portion of the shaft tube 3, so that fluid is injected into a living tissue or tubular organ, or fluid is sucked. In addition, when the medical tube is used, the first lumen 5 communicating with the balloon 4 is connected to the pressurized fluid source via the fluid pressure controller, and a pulsating pump for generating pulsed pressure is obtained. 2 and 3, as described in the medical tube shown in FIG. 2 and FIG. 3, the bending angle is arbitrarily changed corresponding to the adjustment pressure by the fluid pressure controller and the pulsed pressure generating pulsation pump, The degree of curvature can be continuously changed according to the fluid pressure, so it is possible to accurately identify the direction of pushing the medical tube with an endoscope while peeling biological tissue. Rukoto can. Moreover, the structure is extremely simple, and a very thin medical tube can be obtained.
[0031]
FIG. 8 shows that a first lumen 5 communicating with a balloon 4 of a medical tube is connected to a pressurized fluid source via a fluid pressure controller and connected to a pulsating pump for generating a pulsed pressure. A state in which the fluid is injected in a pulse shape and the balloon is bent toward the portion having a relatively low extensibility and bent into an S shape is shown. The degree of the curvature can be continuously changed according to the fluid pressure.
As mentioned above, although the medical tube of this invention was demonstrated based on embodiment of illustration, this invention is not limited to this.
[0032]
【The invention's effect】
As described above, the medical tube of the present invention does not require a complicated structure, can be reduced in diameter, and provides a medical tube structure having a function of exfoliating a living body tissue with variable bending motion. can do.
[Brief description of the drawings]
FIG. 1 is a perspective view of a cylindrical balloon used for a medical tube of the present invention.
FIG. 2 is a cross-sectional view of a portion of the medical tube of the first aspect of the present invention.
FIG. 3 is a cross-sectional view taken along line III-III in FIG.
FIG. 4 is a cross-sectional view showing another example of the medical tube according to the first aspect of the present invention.
FIG. 5 is a cross-sectional view of a portion of the medical tube of the second aspect of the present invention.
FIG. 6 is a cross-sectional view of a portion of the medical tube of the third aspect of the present invention.
FIG. 7 is a cross-sectional view showing another example of the medical tube according to the third aspect of the present invention.
FIG. 8 is a cross-sectional view showing a state where the balloon of the medical tube of the present invention is curved in an S shape.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Part with relatively small extensibility 2 Part with relatively large extensibility 3 Shaft tube 4 Cylindrical balloon 5 First lumen 6 Second lumen 7 Long medical treatment or diagnostic tool 71 Fiber bundle 72 for light transmission Receiving fiber bundle 73 Lens 74 Adhesive

Claims (6)

A shaft tube inserted into the living body;
A cylindrical balloon fluid-tightly joined to the outer periphery of the tip of the shaft tube;
A first lumen provided in the shaft tube and in communication with the balloon;
At least one second lumen provided in the shaft tube and opening at a tip of the shaft tube;
The cylindrical balloon has at least two portions with low extensibility extending in a part in the axial direction in a portion less than half of the circumferential direction, and these low extensibility portions are cylindrical balloons. Is located in the axial direction and is located on the opposite side in the circumferential direction of the cylindrical balloon ,
A medical tube characterized in that a portion having a low extensibility is formed by changing the degree of crosslinking in the circumferential direction of the balloon . A shaft tube inserted into the living body;
The cylindrical balloon in which one end of the cylindrical balloon is fluid-tightly joined to the tip of the shaft tube;
A long medical treatment or diagnostic instrument having a tip part joined directly or indirectly fluid-tightly to the other end of the cylindrical balloon;
A first lumen provided in the shaft tube, in fluid communication with the balloon and containing the elongated medical procedure or diagnostic tool;
The cylindrical balloon has at least two portions with low extensibility extending in a part in the axial direction in a portion less than half of the circumferential direction, and these low extensibility portions are cylindrical balloons. Is located in the axial direction and is located on the opposite side in the circumferential direction of the cylindrical balloon ,
A medical tube characterized in that a portion having a low extensibility is formed by changing the degree of crosslinking in the circumferential direction of the balloon . A shaft tube inserted into the living body;
The cylindrical balloon in which one end of the cylindrical balloon is fluid-tightly joined to the tip of the shaft tube;
A long medical treatment or diagnostic instrument having a tip part joined directly or indirectly fluid-tightly to the other end of the cylindrical balloon;
A first lumen provided in the shaft tube and in fluid communication with the balloon and containing the elongated medical procedure or diagnostic tool;
Having at least one second lumen provided in the shaft tube and open to an outer periphery of a tip portion of the shaft tube;
The cylindrical balloon has at least two portions with low extensibility extending in a part in the axial direction in a portion less than half of the circumferential direction, and these low extensibility portions are cylindrical balloons. Is located in the axial direction and is located on the opposite side in the circumferential direction of the cylindrical balloon ,
A medical tube characterized in that a portion having a low extensibility is formed by changing the degree of crosslinking in the circumferential direction of the balloon .   The medical tube according to any one of claims 1 to 3, wherein the portion having low extensibility is 30% or less of the entire circumference of the balloon.   The medical tube according to claim 4, wherein the portion having low extensibility is 10% or less of the entire circumference of the balloon.   The medical tube according to any one of claims 1 to 5, wherein the portion having low extensibility is formed by a radiation crosslinking treatment.

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