JP4864680B2 - Intravascular treatment device - Google Patents

Description

  The present invention relates to an in-vivo treatment device that is inserted into a in-vivo channel and used for transporting and administering a therapeutic substance.

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 large, the risk of complications such as inflammation, stenosis, and obstruction of the affected area also 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 (Non-patent Document 1). Conventionally, as a means for transporting a therapeutic substance such as a fragile cell sheet to an affected area, the cell sheet is placed on a paper, and this paper is held and clamped with forceps extracted from an endoscope to be transported and administered to the affected area. However, the shape and size of the therapeutic substance that can be handled by forceps is limited, and a very advanced endoscope operation technique is required. 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 is excellent in workability during transportation and administration of a therapeutic substance into a in-vivo channel and can be obtained at low cost.

A treatment apparatus in a living body tract of the present invention is sandwiched between an intermediate cylinder part , a cylindrical part composed of a pair of end parts attachable to both ends of the intermediate cylinder part, and the intermediate cylinder part and the pair of end parts. a balloon being in a collapsible supported on the outer peripheral surface of the cylindrical portion is provided with a deflating portion for inflating and deflating the balloon, from the balloon, respectively deflated pair of end portions that constitute the cylindrical portion Also has a large-diameter flange portion, and is inserted into the living body conduit with the balloon deflated, and inflated by the inflating and deflating means and pressed against the inner wall of the living body conduit, and is placed in the living body conduit. It is characterized by that.

Each of the pair of end portions constituting the cylindrical portion preferably has a through hole that allows the inside and the outside of the intermediate cylindrical portion to communicate with each other .

The expansion / contraction means preferably includes outflow prevention means that allows air to flow into the balloon and prevents outflow. For example, the deflating means, and an air flow hole that opens to the outer peripheral surface of the intermediate cylinder portion, and a detachably an air line to the air flow holes, in close contact with the outer peripheral surface of the intermediate tubular portion of the air flow hole The outflow prevention means can be constituted by the envelope tube which can be elastically deformed.

  Provided with a tubular guide member inserted into the biological duct prior to the treatment device body in the biological duct, and the insertion property is improved by inserting the biological treatment device body through the guide member. Can do.

Vivo conduit treatment device of the present invention, by keeping mounted a sheet-like therapeutic agent to the outer surface of the balloon during insertion into a living body duct, easily sheet therapeutic agent against the affected area Can be administered.

  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. The in-vivo treatment device 10 shown in FIG. 1 to FIG. 3 includes a cylindrical intermediate cylinder part 11, first and second end parts 12 and 13 attached to both ends of the intermediate cylinder part 11, Air supply for performing air supply and suction from the balloon 14 provided on the outer peripheral surface side of the intermediate cylinder portion 11 so as to be inflatable and inflatable, and an inflation device 30 (shown in FIGS. 1 and 2) to inflate and inflate the balloon 14. A tube (air supply tube) 15 and an annular check valve tube (outflow prevention means, outer tube) 16 that is attached to the outer peripheral surface of the intermediate cylinder portion 11 and prevents leakage of air in the balloon 14 are provided. The first end portion 12 and the second end portion 13 are formed with through-holes 12a and 13a in the axial direction for communicating the internal space of the intermediate tube portion 11 and the outside, respectively. As a whole, it has a hollow cylindrical shape. A pressure gauge capable of measuring the air pressure in the balloon 14 is provided in the middle of the inflation device 30 or the air supply tube 15. In the following, the left hand direction in the figure is the front end of the intravascular treatment device 10 and the right hand direction is the rear end.

  4 to 8 show a manufacturing process of the treatment device 10 in the body duct. As shown in FIG. 4, an air circulation hole 11 a penetrating the outer peripheral surface and the inner peripheral surface is formed in the vicinity of the rear end portion of the intermediate cylinder portion 11. A check valve tube 16 is placed on the outer peripheral surface of the intermediate cylinder portion 11 so as to cover the air circulation hole 11a (FIG. 5). The check valve tube 16 has airtightness and can be elastically deformed, and is in close contact with the outer peripheral surface of the intermediate cylindrical portion 11 to airtightly close the opening of the air circulation hole 11a.

  Subsequently, a cylindrical balloon 14 is put on the outer side of the intermediate cylinder portion 11. As shown in FIG. 6, the balloon 14 is longer than the intermediate cylinder 11 in the axial direction of the intermediate cylinder 11, and the positions are determined such that both ends of the balloon 14 protrude from both ends of the intermediate cylinder 11, respectively. It is done. As shown in FIG. 7, both end portions of the balloon 14 are folded back to the inner peripheral surface side of the intermediate cylinder portion 11, and an end surface portion 14 a that covers the end surface of the intermediate cylinder portion 11 and the inner peripheral surface of the intermediate cylinder portion 11. A folded portion 14b is formed.

  Subsequently, as shown in FIG. 8, the first end portion 12 and the second end portion 13 are attached to the front and rear end portions of the intermediate cylinder portion 11, respectively. The first end portion 12 and the second end portion 13 are respectively provided with large-diameter flange portions 12b and 13b and small-diameter insertion portions 12c and 13c. The outer diameter sizes of the insertion portions 12c and 13c are within the intermediate cylinder portion 11. The size is set to be inserted in the press-fitted state. When attaching the first end portion 12, the insertion portion 12c is inserted from the front end side of the intermediate cylinder portion 11, and the flange portion 12b covers the front end portion of the intermediate cylinder portion 11 (strictly speaking, the front end portion of the intermediate cylinder portion 11 is covered). Push in until it touches the end face 14a). When attaching the second end portion 13, the insertion portion 13 c is inserted from the rear end side of the intermediate tube portion 11, and the flange portion 13 b is inserted into the rear end portion of the intermediate tube portion 11 (strictly speaking, the rear end of the intermediate tube portion 11). Until it touches the end face part 14a) covering the part. Then, the front end part of the balloon 14 is clamped by the intermediate cylinder part 11 and the first end part 12, and the rear end part of the balloon 14 is clamped by the intermediate cylinder part 11 and the second end part 13, and the balloon 14 is held. . The sandwiched portions at the front and rear ends of the balloon 14 are kept airtight.

  As shown in FIG. 8, in the state in which the treatment device 10 in the body duct is completed, the intermediate portion of the balloon 14 (the portion in contact with the outer peripheral surface of the intermediate tube portion 11) is not fixed and can be elastically deformed. On the other hand, since the airtightness is maintained at the front and rear end portions (the sandwiched portion) of the balloon 14 as described above, air is supplied between the outer peripheral surface of the intermediate tube portion 11 and the balloon 14 as shown in FIG. The balloon 14 can be inflated. An air circulation hole 13 d is formed in the second end portion 13. One end of the air circulation hole 13d communicates with the air circulation hole 11a, and the other end is opened to the rear end face side of the second end portion 13 (flange portion 13b). When supplying air into the balloon 14, as shown in FIG. 1, the air supply tube 15 is inserted into the air circulation hole 13d from the rear end side opening, and through the opening of the air circulation hole 11a, The tip of the air supply tube 15 is protruded to the outer peripheral surface side. Normally, the opening of the air circulation hole 11a is hermetically closed by the check valve tube 16, but the air supply tube 15 is inserted until the tip of the air supply tube 15 exceeds the area where the check valve tube 16 is attached. Thus, air can be supplied into the balloon 14 (FIG. 2). At this time, the check valve tube 16 made of an elastic material is pushed up by the air supply tube 15 and a part thereof is elastically deformed. When air is supplied from the inflation device 30 through the inserted air supply tube 15, the balloon 14 is inflated as shown in FIG. When the air supply tube 15 is pulled out in this state, the check valve tube 16 airtightly blocks the air circulation hole 11a, so that the air in the balloon 14 does not flow out, and the balloon 14 is maintained in an inflated state. Conversely, when the air supply tube 15 is inserted into the air circulation holes 11a and 13d in an expanded state and the air in the balloon 14 is sucked by the inflation device 30, the balloon 14 can be contracted as shown in FIG. The outer diameter sizes of the flange portions 12b and 13b at the first end portion 12 and the second end portion 13 are set larger than the outer diameter size of the balloon 14 at the time of contraction (FIG. 1), and the flange portions 12b and 13b. The outer edge is rounded.

  The material constituting the intermediate cylinder part 11 and the first and second end parts 12 and 13 is preferably polypropylene (PP) or polyethylene (PE). As described above, the balloon 14 and the check valve tube 16 are made of an elastic material that can be expanded and contracted, and silicon rubber is preferable as a specific material.

The use procedure of the treatment apparatus 10 having the above-described structure will be described with reference to FIG. As a preparation stage, the therapeutic substance 17 (FIGS. 11 to 14) is mounted on the outer surface of the balloon. The therapeutic substance 17 to be loaded is a cell sheet for preventing complications after the treatment of mucosal dissection (ESD or EMR) of a biological duct (sheet in which oral mucosal epithelial cells are cultured), a sheet-like drug, etc. It is appropriately selected depending on the purpose of use. In addition, the air supply tube 15 is inserted into the air flow hole 13d and the air flow hole 11a in the treatment device 10 in the biological duct, and setting is performed so that the balloon 14 can be inflated by air supply from the inflation device 30. .

  When the preparation is completed, as shown in FIG. 9, a sheath (guide member) 18 is inserted into a biological duct 20 such as an esophagus to be treated. The sheath 18 is a flexible tube having an inner diameter size through which the main body treatment device 10 body can pass, and the end opposite to the illustrated end inserted into the living body duct 20 is outside the body. Has been issued. The sheath 18 is a guide member for inserting / removing the endoscope 19 and the in-vessel treatment device 10 with respect to the in-vivo channel 20, and the sheath 18 allows the in-vessel treatment device 10 and the endoscope 19 to be removed. Since the passage is secured, the insertion / removal work becomes easy, and the burden on the patient at the time of insertion / removal can be reduced.

  Subsequently, as shown in FIG. 10, an endoscope 19 is inserted into the living body duct 20 through the sheath 18, and treatment (ESD or EMR) for peeling the mucous membrane of the affected area 21 is performed. After the treatment is completed, the endoscope 19 is pulled out, and the treatment device 10 in the body duct is inserted into the body duct 20 through the sheath 18 as shown in FIG. At this time, the sheath 18 protects the therapeutic substance 17 from physical damage, and prevents the therapeutic substance 17 from adhering to places other than the affected part 21. In addition, since the outer diameter size of the flange portions 12b and 13b of the first end portion 12 and the second end portion 13 is sufficiently larger than the outer diameter size of the balloon portion 14 at the time of contraction, the treatment device 10 in the body duct is sheathed. The inner diameter of the flange portion 12b, 13b is in contact with the inner diameter portion when passing through the inner diameter of the flange 18, and the therapeutic substance 17 does not come into contact with the inner diameter portion of the sheath 18. 17 is protected. Further, since the outer edge portions of the flange portions 12b and 13b are rounded, the movement resistance when the flange portions 12b and 13b are in contact with the inner diameter portion of the sheath 18 is small, and the living body within the sheath 18 The in-pipe treatment device 10 can be moved smoothly. Then, the treatment apparatus 10 in the body duct is protruded from the distal end portion of the sheath 18 to reach the vicinity of the affected area 21 after the treatment, and while being observed from the rear by the endoscope 19 as shown in FIG. The insertion position of the intravascular treatment device 10 is determined so that 21 opposes.

  At the stage when the above procedure is completed, the therapeutic substance 17 is in a state of facing the affected area 21 after the treatment. As described above, in the state where the treatment device 10 in the biological duct is out of the sheath 18, the outer edge portions of the flange portions 12b and 13b are most likely to come into contact with the inner diameter portion of the biological duct 20, but the outer edge portion is rounded. Because of its shape, there is little risk of damaging living tissue. Subsequently, when the balloon 14 is inflated until air is supplied through the air supply tube 15 by the inflation device 30 until a predetermined pressure is reached, the therapeutic substance 17 is pressed against the affected area 21 as shown in FIG. The pressure for inflating the balloon 14 is set so that the treatment apparatus 10 in the in-vivo conduit alone remains in this press-contact position without requiring any other holding means (so as not to drop out in the in-vivo duct 20). The pressure of the balloon 14 is measured by a pressure gauge provided in the middle of the inflation device 30 or the air supply tube 15, and it is possible to easily determine that the pressure has reached a predetermined pressure. When it is confirmed that the balloon 14 is at a predetermined pressure via the pressure gauge, the air supply tube 15, the endoscope 19 and the sheath 18 are withdrawn from the biological duct 20 in this order (FIG. 14). ) The in-vivo treatment device 10 is placed in the in-vivo channel 20.

  The time for placing the in-vivo treatment device 10 in the in-vivo channel 20 is appropriately selected according to the intended medical effect. For example, in the case where the therapeutic substance 17 is a cell sheet for preventing complications after ESD, the treatment in the body duct is performed at least until it is deposited on the transplant site by the action of the adhesion protein produced by the cell sheet. The indwelling time of the device 10 is assumed. In general, since endoscopy is performed on the day after the ESD operation, the in-vivo treatment device 10 may be collected at that time. When collecting the treatment device 10 in the biological duct, after inserting the sheath 18 into the biological duct 20 in the same manner as the insertion, the air feeding tube 15 is inserted from the air circulation hole 13d to the air circulation hole 11a, The tip of the air supply tube 15 protrudes into the balloon 14. Then, the air in the balloon 14 is sucked by the inflation device 30 through the air supply tube 15 to contract the balloon 14. As a result, the pressure contact state between the balloon 14 and the biological conduit 20 is released, so that the treatment device 10 in the biological conduit is pulled out and collected through the sheath 18.

  As described above, the in-vivo treatment device 10 of the present embodiment can administer 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, even for a wide affected area that extends over the entire circumference of the biological duct, it can be uniformly performed by a single operation. Can spread therapeutic substances.

  In addition, since the treatment device 10 in the living body duct contracts the balloon 14 at the time of insertion into and removal from the living body duct and inflates the balloon 14 at the indwelling position in the living body duct, the inner diameter of the living body duct to be inserted The diameter size when the balloon 14 is deflated can be made relatively small with respect to the size. Therefore, it is easy to perform the insertion / removal operation with respect to the biological duct, and the pain given to the patient can be reduced. Furthermore, insertion property can be improved by using the sheath 18.

  Further, the treatment device 10 in the body duct has a simple structure in which the front and rear end portions of the balloon 14 are sandwiched and held between the intermediate cylinder portion 11 and the end portions 12 and 13, and can be manufactured at low cost.

  In addition, since the pressure contact force can be freely adjusted by changing the internal pressure of the balloon 14 in the treatment device 10 in the living body duct, it can be reliably placed in the body duct with the optimum pressure contact force. Moreover, it can be widely used for biological ducts having various inner diameters and shapes.

  Moreover, in the treatment device 10 in the biological tract, in a state where the treatment device 10 is indwelled in the biological tract, the balloon 14 is pressed against the affected part, so that foreign substances such as saliva and gastric juice can be used until the therapeutic substance is deposited. The therapeutic substance as well as the affected area can be protected.

  Further, since the treatment device 10 in the biological duct is a penetrating cylindrical body having through-holes 12a and 13a on the front and rear, the biological duct is closed by the treatment device 10 in the biological duct even when the treatment device 10 is placed in the biological duct. It will not come off. For example, when the biological duct is the esophagus, saliva and drink can pass through the treatment apparatus 10 in the biological duct, and the burden on the patient in the indwelling state of the device can be reduced.

  The in-vivo treatment device of the present invention is not limited to the illustrated embodiment, and can be in a different form without departing from the gist of the invention. For example, in the illustrated embodiment, the check valve tube 16 attached to the outer peripheral surface of the intermediate cylinder portion 11 is used as means for preventing air leakage from the inflated balloon 14, but instead of this, the inside of the air circulation hole 13d is used. It is possible to make modifications such as providing a valve member for controlling the air flow.

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 expanded the balloon of the treatment apparatus in the biological duct of FIG. It is sectional drawing which shows the state which pulled out the air supply tube in the balloon expansion state of FIG. It is sectional drawing of the intermediate | middle cylinder part which comprises the treatment device in a biological duct. It is sectional drawing of the state which covered the check valve tube in the intermediate | middle cylinder part. It is sectional drawing of the state which covered the balloon further on the intermediate cylinder part. It is sectional drawing which shows the state before turning the end part of the balloon covered on the intermediate | middle cylinder part, and attaching a 1st end part and a 2nd end part. It is sectional drawing which shows the treatment device in a biological duct of the completion state which attached the 1st end part and the 2nd end part to the intermediate | middle cylinder part. It is sectional drawing of the state which inserted the sheath for a guide into the biological duct prior to insertion of an endoscope and the treatment apparatus in a biological duct. It is sectional drawing which shows the state which inserts an endoscope in a biological duct through a sheath, and is performing the treatment. It is sectional drawing which shows the state which inserted the treatment device in the biological duct through the sheath to the vicinity of the affected part in a biological duct. It is sectional drawing which shows the state which is aligning the treatment apparatus in a biological duct with respect to an affected part, observing with an endoscope. It is sectional drawing which shows the state which inflated the balloon of the positioned treatment apparatus in a biological duct, and pressed the therapeutic substance against the affected part. It is sectional drawing which shows the state which expansion | swelling of the balloon was completed and the air supply tube was removed from the treatment apparatus in a biological duct.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Treatment device 11 in biological ducts Intermediate | middle cylinder part 12 1st edge part 13 2nd edge part 14 Balloon 15 Air supply tube (air supply pipe)
16 Check valve tube (outflow prevention means, outer tube)
17 therapeutic substance 18 sheath (guide member)
19 Endoscope 20 Biological duct 21 Affected part 30 Inflation device

Claims (6)

An intermediate tubular portion and the intermediate cylindrical portion cylindrical portion consisting of attachable pair of end portions at opposite ends of, on the outer peripheral surface of the cylindrical portion is sandwiched between the intermediate cylinder portion and a pair of end portions A balloon supported so as to be inflatable and inflatable, and an inflating / deflating means for inflating and inflating the balloon, each of the pair of end portions having a flange portion having a diameter larger than that of the balloon in a contracted state,
Intravascular treatment characterized in that the balloon is deflated and inserted into a biological duct, and the balloon is inflated by the expansion / contraction means and pressed against the inner wall of the biological duct to be placed in the biological duct. device. 2. The treatment apparatus according to claim 1 , wherein each of the pair of end portions has a through hole that allows the inside and the outside of the intermediate cylinder portion to communicate with each other. . The in-vessel treatment device according to claim 1 or 2 , wherein the expansion / contraction means includes outflow prevention means that allows inflow of air into the balloon and prevents outflow. . The treatment apparatus according to claim 3 , wherein the expansion / contraction means includes an air circulation hole that opens on an outer peripheral surface of the intermediate cylinder portion , and an air supply tube that can be inserted into and removed from the air circulation hole. The in-vessel treatment device, wherein the outflow prevention means has an elastically deformable envelope tube that is in close contact with the outer peripheral surface of the intermediate cylinder portion and closes the air circulation hole. The treatment apparatus in a living body duct according to any one of claims 1 to 4 , wherein the treatment apparatus body is inserted into the living body duct prior to the living body treatment device body, and insertion of the living body treatment device body is guided. A treatment apparatus for a living body, comprising a tubular guide member. 6. The treatment apparatus according to any one of claims 1 to 5 , wherein a sheet-like therapeutic substance is mounted on the outer surface of the balloon and is inserted into the biological duct. Road treatment device.

Images