JP2008079783A - Treatment device in biological duct - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a treatment device in a biological duct capable of simply and safely delivering a therapeutic substance to wide areas of an affected area. <P>SOLUTION: This treatment device in a biological duct is provided with an inner tube having an inflatable/deflatable balloon in the outer circumferential face near the distal end, an outer tube positioned outside the inner tube and slidable between a cover position covering the balloon and an exposure position exposing the balloon, and an inflation/deflation means inflating/deflating the balloon. The treatment device is characterized in mounting the therapeutic substance on the outer face of the balloon, being inserted into the biological duct with the outer tube positioned on the cover position, sliding the outer tube from the cover position to the exposure position, inflating the balloon by the inflation/deflation means to administer the therapeutic substance to the affected part, after the administration, deflating the balloon by the inflation/deflation means and being pulled out from the biological duct. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a treatment apparatus in a living body duct that is inserted into a living body duct such as an esophagus and supplies a therapeutic substance such as a sheet or a medicine to an affected part.

EMR (endoscopic mucosal resection) and ESD (endoscopic submucosal dissection) are known as endoscopic treatment methods for diseases in living ducts such as the esophagus. In particular, ESD can treat a wide range of affected areas such as the entire circumference of the inner wall of the duct. On the other hand, if the treatment area becomes larger, the risk of complications such as adhesion, stenosis, and obstruction of the affected area increases. Measures to prevent it are necessary. As an effective means for preventing such complications, a technique has been proposed in which a mucosal epithelial cell sheet cultured and regenerated from the patient's own oral mucosa is transplanted into the affected area (for example, Non-Patent Document 1). Conventionally, endoscope forceps have been used as means for transporting a therapeutic substance such as a cell sheet to an affected area, but the shape and size of the therapeutic substance that can be handled by the forceps are limited. For example, it has been difficult to carry out a transplantation operation by carrying a large cell sheet that can be transplanted all around the inner wall of a biological duct with forceps. Therefore, a treatment tool that can easily and safely supply a therapeutic substance to a wide affected area is desired.
“Reconstruction of the esophagus by transendoscopically cultured oral mucosal epithelial cell sheet transplantation”, Tokyo Women's Medical University, Vol. 76, No. 4, p 179-183, April 2006

  An object of the present invention is to provide an in-vivo treatment device that can easily and safely deliver a therapeutic substance to a wide affected area.

  The present invention relates to an in-vessel treatment device that supplies a therapeutic substance to an affected part of an inner wall of a living body duct, an inner tube having a balloon that can be inflated and contracted on an outer peripheral surface near the distal end portion, and an outer tube located on the outer tube. And an outer tube slidable between a cover position covering the balloon and an exposed position exposing the balloon, and an inflating / deflating means for inflating / deflating the balloon. The outer tube is inserted from the cover position to the exposed position while being in the cover position, the balloon is inflated by the expansion / contraction means, and the therapeutic substance is administered to the affected area. It is characterized in that the balloon is deflated by the contraction means and pulled out from the biological duct.

  The inner tube and the outer tube are preferably made of a transparent or translucent material capable of observing the balloon and the affected area from the inside with an endoscope inserted into the inner tube. In this case, the inner tube is provided with an index indicating the position in the longitudinal direction or the circumferential direction, and the index can be observed by an endoscope inserted into the inner tube to align the affected part with the therapeutic substance. This is more preferable.

  The inner tube and the outer tube are preferably provided with a slide restricting portion that determines the moving ends of the cover position and the exposed position of the outer tube with respect to the inner tube. Furthermore, it is preferable to provide a detachable slide preventer that restricts the sliding of the outer tube from the cover position to the exposed position when inserted into the biological duct.

  In addition, air leakage that can be attached to and detached from the distal end of the inner tube opposite to the distal end in the insertion direction and through which the endoscope can be inserted, restricts the air flow between the inner tube and the outside air while the endoscope is inserted. It is preferable to provide a prevention valve.

  Although various substances can be selected as the therapeutic substance for use, the present invention is particularly suitable when the therapeutic substance supplied to the affected area is a cell sheet. Alternatively, the therapeutic substance may be a drug.

  According to the treatment apparatus for living body duct of the present invention as described above, a therapeutic substance can be supplied easily and safely to a wide affected area.

  Hereinafter, an embodiment of a treatment device in a living body duct of the present invention will be described with reference to the drawings. FIG. 1 shows an overall configuration of a treatment apparatus 10 in a living body duct. The treatment apparatus 10 in the body duct is inserted into the body duct with the end portion in the right hand direction of FIGS. 1 and 2 as a tip portion, and a grip operation unit 20 (see FIGS. 3 and 3) on the end side opposite to the tip portion. 4) is provided. In addition, in FIG.1 and FIG.2, FIG.7 thru | or 11 which show the whole structure of the treatment apparatus 10 in a biological duct, illustration of the detailed structure of the holding | grip operation part 20 is abbreviate | omitted.

  The in-vivo treatment device 10 includes an inner tube 11 and an outer tube (cover tube) 12. The inner tube 11 is a cylindrical body into which the endoscope 13 can be inserted, and a balloon 14 made of an elastic body that can be expanded and contracted is provided in the vicinity of the distal end portion thereof. The balloon 14 has a cylindrical shape surrounding the outer peripheral surface of the inner tube 11, and the front and rear end portions of the balloon 14 in the longitudinal direction of the inner tube 11 are fixed in a sealed state to the outer peripheral surface side of the inner tube 11 over the entire circumferential direction. The middle part of the balloon 14 is not fixed to the inner tube 11. An air supply pipe 15 is formed in the side wall of the inner tube 11. The air supply tube 15 extends along the longitudinal direction of the inner tube 11, one end thereof is opened on the outer peripheral surface of the inner tube 11 facing the balloon 14, and the other end is on the gripping operation unit 20 side described later. It is open. In this embodiment, the air supply tube 15 has a multi-lumen structure formed in the meat of the inner tube 11, but another thin tube is placed along the inner diameter side or the outer diameter side of the inner tube 11 to It is also possible to have a multi-tube structure. An inflation device 16 is connected to the opening on the gripping portion side of the air feeding tube 15, and air can be injected and sucked into the air feeding tube 15 by the inflation device 16. When air is injected into the air supply tube 15, the air flows into the space between the inner tube 11 and the balloon 14 and the balloon 14 is inflated, as shown in FIG. 2. Conversely, when the balloon 14 is inflated and sucked by the inflation device 16, the air between the inner tube 11 and the balloon 14 is sucked out and the balloon 14 is deflated as shown in FIG. The inflation device 16 includes a pressure gauge 17, and the inflation / deflation state of the balloon 14 can be known with reference to the pressure gauge 17. In this embodiment, the syringe-type inflation device 16 is used. However, it is also possible to use a different type of inflation device (for example, an integrated device having an air supply and suction function and a pressure gauge function). is there.

  The inner tube 11 is provided with spacers 18 and 19 before and after the balloon 14. Each of the spacers 18 and 19 is a cylindrical member that surrounds the inner tube 11, and the outer diameter size thereof is substantially equal, and the end of the spacer 18 positioned on the distal end side of the inner tube 11 is more than the other region of the spacer 18. A large-diameter flange-like slide restricting portion 18a is provided. The inner diameter size in the vicinity of the distal end portion of the outer tube 12 corresponds to the outer diameter size of the spacers 18 and 19, and the inner peripheral surface of the outer tube 12 is the length of the inner tube 11 with respect to the outer peripheral surfaces of the spacers 18 and 19. It is slidably supported in the direction. The sliding movement end of the outer tube 12 in the distal direction of the inner tube 11 is determined by the distal end portion of the outer tube 12 coming into contact with the slide restricting portion 18a (FIG. 1). When the outer tube 12 is at the moving end in the distal direction, the outer tube 12 covers the balloon 14 as shown in FIG. Hereinafter, the position of the outer tube 12 covering the balloon 14 is referred to as a cover position. When the balloon 14 is contracted, a sufficient radial clearance is secured between the inner peripheral surface of the outer tube 12 and the balloon 14, and the outer tube 12 is slid to the cover position with respect to the inner tube 11. In addition, the outer tube 12 and the balloon 14 do not interfere with each other.

  The end face of the inner tube 11 that projects forward from the spacer 18 is cut obliquely with respect to the longitudinal axis of the inner tube 11. The end surface of the inner tube 11 is processed into a rounded shape without corners so that the inside of the inner tube 11 is not damaged when inserted into the living body duct. Although not shown, the inner tube 11 is provided with a plurality of markings (indexes) indicating the longitudinal position and the circumferential position, and this marking is observed with the endoscope 13 inserted into the inner tube 11. be able to.

  3 and 4 show the detailed structure of the grip operation unit 20. In the grip operation unit 20, a holding unit 21 is provided at the end of the inner tube 11. A large-diameter flange-like slide restricting portion 21a is provided on the distal end side of the holding portion 21, and a valve mounting portion 21b is provided at the end opposite to the slide restricting portion 21a. An uneven portion (grip portion) 21c is formed between the slide restricting portion 21a and the valve mounting portion 21b to make it easier for the practitioner to grip. The holding portion 21 is provided with an air supply tube 21d connected to the above-described air supply tube 15 disposed in the inner tube 11, and a connector 21e is provided at an opening of the air supply tube 21d. The aforementioned inflation device 16 is connected to the connector 21e. An air leakage prevention valve 22 can be attached to and detached from the valve mounting portion 21b. The air leakage prevention valve 22 has an attachment ring portion 22a that is attached to and detached from the valve mounting portion 21b, and an elastic valve portion 22b that closes the inner diameter of the attachment ring portion 22a. FIG. 5 shows a single shape of the air leakage prevention valve 22, and as shown in the figure, the tip end portion of the mounting ring portion 22a can be engaged with and disengaged from the retaining groove 21f on the inner peripheral surface of the valve mounting portion 21b. A retaining flange 22c is provided. The elastic valve portion 22b is made of a material having airtightness and elasticity such as rubber, and a through hole 22d through which the endoscope 13 can be inserted is formed in the center portion thereof.

  A handle portion 25 is provided at the end of the outer tube 12 in the grip operation portion 20. The handle portion 25 includes a large-diameter flange-like slide restricting portion 25a having substantially the same diameter as the slide restricting portion 21a. Between the slide restricting portion 21a and the slide restricting portion 25a, a slide prevention tool 26 (FIG. 6) having a C-shaped cross section is detachable. In the state where the slide prevention tool 26 is attached as shown in FIG. 3, the slide restricting portion 25 a and the slide restricting portion 21 a are separated from each other, and the outer tube 12 in the pulling direction (left hand direction in FIG. 3) with respect to the inner tube 11. Movement is restricted. At this time, the outer tube 12 is in the above-described cover position, and the distal end portion of the outer tube 12 abuts on the slide restricting portion 18a on the distal end side of the treatment device 10 in the living body duct, and the distal end side of the inner tube 11 The movement of the outer tube 12 is also restricted. If the slide prevention tool 26 is removed here, the outer tube 12 can be slid with respect to the inner tube 11 until the slide restricting portion 25a comes into contact with the slide restricting portion 21a, as shown in FIG. When the outer tube 12 is slid to the contact position between the slide restricting portion 25a and the slide restricting portion 21a, as shown in FIG. 2, the tip of the outer tube 12 is retracted to the position of the spacer 19, and the balloon 14 is exposed. The Hereinafter, the position of the outer tube 12 that exposes the balloon 14 is referred to as an exposed position.

  As described above, the balloon 14 can be inflated and contracted, and is made of a transparent or translucent elastic material. As a specific material, latex, silicon rubber, or the like is preferable. The inner tube 11 and the outer tube 12 are transparent or translucent so that the affected part can be observed by the endoscope 13 inserted into the inner tube 11 in a positioning operation during an insertion operation described later and an expansion / contraction operation of the balloon 14. ing. The inner tube 11 and the outer tube 12 are also flexible so that they can be deformed according to their shapes when inserted into the biological duct. As a material satisfying such conditions, the inner tube 11 and the outer tube 12 are preferably made of silicon rubber or fluorine rubber. The spacers 18 and 19 near the tip of the inner tube 11 are preferably formed of a transparent resin such as PP (polypropylene), PE (polyethylene), PS (polystyrene), and PC (polycarbonate). Further, the vicinity of the distal end portion of the outer tube 12 is preferably formed of a transparent rigid member that is harder than its main body, and specifically, PP (polypropylene), PE (polyethylene), which are the same as the spacers 18 and 19, It is good to form with transparent resin, such as PS (polystyrene) and PC (polycarbonate). Thus, when the front-end | tip part of the outer tube 12 consists of a rigid member, the physical protection capability of the therapeutic substance (cell sheet) when carrying out the biological duct insertion of the treatment apparatus 10 in the biological duct is improved. In addition, in order to improve the slidability of the outer tube 12 with respect to the inner tube 11, a sliding contact surface between the inner tube 11 and the outer tube 12 (for example, outer peripheral surfaces of the spacers 18 and 19) may be coated. Good.

  A method of using the in-vivo treatment device 10 having the above structure will be described. First, as a preparation stage, the outer tube 12 is slid to the exposed position where the slide restricting portion 25a contacts the slide restricting portion 21a to expose the balloon 14, and the therapeutic substance 27 is mounted on the outer surface of the exposed balloon 14. The therapeutic substance 27 is appropriately selected depending on the purpose of use of the treatment device 10 in the body tract, such as a cell sheet for preventing complications after ESD treatment (a sheet in which oral mucosal epithelial cells are cultured) and a drug. The therapeutic substance 27 is mounted using the markings applied to the inner tube 11 as a guide. Subsequently, the outer tube 12 is slid to the cover position where it abuts against the slide restricting portion 18a to store the therapeutic substance 27, and the anti-slide tool 26 is mounted between the slide restricting portion 25a and the slide restricting portion 21a (FIG. 3). ). In this state, the outer tube 12 covers and protects the therapeutic substance 27, and the slide prevention tool 26 prevents the outer tube 12 from being accidentally slid in the protection release direction (exposed position direction).

  Subsequently, the insertion portion of the endoscope 13 is inserted into the through hole 22d, the air leakage prevention valve 22 is attached, and when the endoscope 13 is inserted into the in-vivo treatment device 10, the retaining groove 21f is inserted. The air leakage prevention valve 22 is fixed to the valve mounting portion 21b by engaging the retaining flange 22c. The procedure for inserting the endoscope 13 into the treatment apparatus 10 (through hole 22d) after the air leakage prevention valve 22 is fixed to the valve mounting portion 21b may be used. It is better to attach the air leakage prevention valve 22 first. FIG. 7 shows a state where the above preparation is completed. The therapeutic substance 27 is protected from physical damage and drying due to contact with the outside by the outer tube 12 covering the outside.

  When the above preparation is completed, the in-vivo treatment device 10 with the endoscope 13 inserted is inserted into the patient's in-vivo channel 30 (for example, the esophagus) while viewing the endoscopic image. At this time, if the biological duct 30 to be inserted is an organ crushed in a normal state such as the esophagus, air is supplied from an air supply port (not shown) at the distal end of the endoscope 13 as necessary. spread. The air leakage prevention valve 22 restricts the air flow between the inside of the inner tube 11 and the outside air by the elastic valve portion 22b in a state where the endoscope 13 is inserted into the through hole 22d, and the air leakage prevention valve 22 is fed to the distal end portion of the endoscope 13. When air is supplied from the air mouth, the air that has flowed back in the inner tube 11 is prevented from being ejected to the grip operation unit 20 side. When the tip of the device reaches the vicinity of the affected part 31 as shown in FIG. 8, both the therapeutic substance 27 (or the marking indicating the position of the therapeutic substance 27 described on the inner tube) and the affected part 31 are internally viewed. The positions of the in-vivo treatment device 10 and the endoscope 13 are adjusted so as to be reflected in the mirror image. More specifically, while viewing the endoscopic image, the position and orientation of the treatment apparatus 10 in the in-vivo channel are corrected so that the positions and directions of the therapeutic substance 27 and the affected part 31 match. At this time, the position of the endoscope 13 is adjusted as necessary so that both the therapeutic substance 27 and the affected part 31 can be observed at all times. Since the inner tube 11 and the outer tube 12 are made of a transparent or translucent material, the in-vivo treatment device 10 (therapeutic substance 27) can be positioned while directly observing with the endoscope. . When the therapeutic substance 27 to be administered cannot be directly observed with the endoscope 13, the therapeutic substance 27 and the affected part 31 are indirectly used with the marking (not shown) provided in the inner tube 11 as a mark. Align with. Since the inner tube 11 is transparent or semi-transparent, it is possible to observe the marking and the inside of the biological duct 30 (affected part 31) at the same time by seeing through the inner tube 11.

  When the position of the treatment device 10 in the body duct is determined, the inflation device 16 with the pressure gauge 17 is attached to the connector 21e. Then, with the slide prevention tool 26 removed and the concavo-convex portion 21c at the end of the inner tube 11 gripped, the handle tube 25 is held and the outer tube 12 is slid forward until the slide restricting portion 25a contacts the slide restricting portion 21a. Let At this time, only the outer tube 12 is moved without moving the inner tube 11 side so that the positional relationship between the therapeutic substance 27 and the affected part 31 is not shifted. The concavo-convex portion 21c formed on the holding portion 21 of the inner tube 11 functions as an anti-slip means that prevents the inner tube 11 from being unintentionally displaced when the outer tube 12 is slid. Further, since the balloon 14 and the therapeutic substance 27 are completely exposed when the slide restricting portion 25a is brought into contact with the slide restricting portion 21a, the exposure position can be easily and surely taken into consideration without considering a fine slide amount. The outer tube 12 can be slid up to. When the outer tube 12 is slid to the exposed position, the slide restricting portion 25a and the slide restricting portion 21a are fixed with the tape 32 as shown in FIG. 4 so that the outer tube 12 does not inadvertently return to the cover position on the distal end side of the inner tube 11. To.

  When the above procedure is completed, the exposed therapeutic substance 27 is in a state of facing the affected area 31 as shown in FIG. Subsequently, when the balloon 14 is inflated to a predetermined pressure using the inflation device 16, the therapeutic substance 27 is pressed against the affected part 31 as shown in FIG. After a predetermined time has elapsed so that the therapeutic substance 27 is reliably administered to the affected part 31 side, the air in the balloon 14 is sucked by the inflation device 16 to completely deflate the balloon 14. Then, the therapeutic substance 27 leaves the balloon 14 and remains on the affected part 31 side. The pressure when inflating the balloon 14 and the maintenance time of the inflated state are appropriately adjusted according to the type of the therapeutic substance 27 used. For example, in the case where the biological duct 30 is the esophagus and the therapeutic substance 27 is a cell sheet for preventing complications after ESD, it takes 10 to 30 minutes to engraft at the transplant site by the action of the adhesion protein produced by the cell sheet. The balloon 14 may be inflated as much as possible.

  After the balloon 14 is deflated, the in-vivo treatment device 10 is extracted from the in-vivo channel 30 as shown in FIG. At this time, both the holding portion 21 and the handle portion 25 are grasped so that the sliding of the outer tube 12 toward the distal end side of the inner tube 11 is performed, and the treatment device 10 in the body duct is pulled out together with the endoscope 13. . After the treatment device 10 in the body duct is pulled out, the affected part 31 is observed with an endoscope as necessary.

  As described above, by using the intravascular treatment device 10 of the present embodiment, it is possible to supply a therapeutic substance to an affected area extremely easily and safely compared to a conventional treatment instrument using forceps or the like. . In particular, by using the balloon 14 that expands and contracts around the circumference as a means for loading and transporting the therapeutic substance, it is possible to reliably perform a single operation even on a wide affected area that extends over the entire circumference of the biological duct. Can spread therapeutic substances. Further, when the therapeutic substance 27 is transferred (when the treatment device 10 in the body duct is inserted), the therapeutic substance 27 is protected from physical breakage and drying by the outer tube 12, and therefore, compared with the conventional transfer method. The therapeutic substance 27 is easy to handle. Furthermore, since the inner tube 11 and the outer tube 12 are made transparent or translucent so that the positioning operation at the time of insertion can be performed while directly observing with the endoscope 13, it is excellent in terms of workability and work accuracy.

It is sectional drawing which shows the whole structure of the treatment apparatus in a biological duct to which this invention is applied. It is sectional drawing which shows the state which slid the outer tube to the exposure position with the treatment apparatus in the biological duct of FIG. 1, and inflated the balloon. It is sectional drawing which shows the detailed structure of the holding part of the treatment apparatus in the biological duct of FIG. It is sectional drawing which shows the holding part of the state which removed the slide prevention tool from the state of FIG. 3, and slid the outer tube to the exposure position of the balloon. It is sectional drawing of an air leak prevention valve single-piece | unit. It is a perspective view of a slide prevention tool simple substance. It is sectional drawing which shows the state where the preparations for use of the treatment apparatus in a biological duct of embodiment were prepared. It is sectional drawing which shows the state which inserted the treatment device in a biological duct into the biological duct, and aligned the therapeutic substance and the affected part. It is sectional drawing which shows the state which slid the outer tube from the state of FIG. 8 to the exposure position, and exposed the therapeutic substance and the balloon. FIG. 10 is a cross-sectional view showing a state where a balloon is inflated from the state of FIG. 9 and a therapeutic substance is pressed against an affected area. It is sectional drawing which shows the state which transplantation of the therapeutic substance to an affected part is completed and withdraws the treatment device in a biological duct.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Treatment device 11 in biological duct Inner tube 12 Outer tube 13 Endoscope 14 Balloon 15 Air supply tube 16 Inflation device (expansion / contraction means)
17 Pressure gauge 18 19 Spacer 18a Slide restricting portion 20 Grasping operation portion 21 Holding portion 21a Slide restricting portion 22 Air leakage prevention valve 25 Handle portion 25a Slide restricting portion 26 Slide preventing device 27 therapeutic substance 30 biological duct 31 affected part

Claims (7)

In the in-vessel treatment device that supplies the therapeutic substance to the affected part of the inner wall of the in-vessel channel,
An inner tube having an inflatable balloon on the outer peripheral surface near the tip,
An outer tube located outside the inner tube and slidable into a cover position covering the balloon and an exposed position exposing the balloon;
Expansion and contraction means for expanding and contracting the balloon;
With
A therapeutic substance is mounted on the outer surface of the balloon, and the outer tube is inserted into the living body duct with the cover positioned at the cover position. The outer tube is slid from the cover position to the exposed position, and the balloon is moved by the expansion / contraction means. A treatment apparatus for treatment in a living body, which is inflated to administer a therapeutic substance to an affected area, and is deflated from a living body duct by deflating a balloon by means of inflation / deflation. The in-vivo treatment device according to claim 1, wherein the inner tube and the outer tube are made of a transparent or translucent material capable of observing the balloon and the affected part from the inside by an endoscope inserted into the inner tube. A treatment apparatus for living body ducts. The treatment apparatus according to claim 2, wherein the inner tube has an index indicating a longitudinal position and a circumferential position thereof, and the index can be observed by an endoscope inserted in the inner tube. A biological in-vessel treatment device. The treatment apparatus according to any one of claims 1 to 3, further comprising a slide restricting portion that determines a moving end of each of the cover position and the exposure position of the outer tube with respect to the inner tube. In-vivo treatment device. The treatment apparatus in a living body tract according to any one of claims 1 to 4, wherein the detachable slide preventer regulates sliding of the outer tube from the cover position to the exposed position when the device is inserted into the living body duct. A treatment apparatus for living body ducts, comprising: The biological intravascular treatment device according to any one of claims 1 to 5, wherein the endoscope is attachable to and detachable from a distal end opposite to the distal end portion in the insertion direction of the inner tube, and the endoscope can be inserted. An in-vivo treatment device comprising an air leakage prevention valve that restricts air flow between the inside of the inner tube and outside air in the inserted state. The in-vivo treatment device according to any one of claims 1 to 6, wherein the therapeutic substance is a cell sheet or a drug.

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