JP2022176674A - Medical solution leakage prevention balloon catheter - Google Patents

Abstract

To prevent a medical solution sheet from being peeled off together with a balloon without blocking the blood flow during treatment, while ensuring excellent operability for spraying the medical solution.SOLUTION: A medical solution leakage prevention balloon catheter 1 comprises a catheter body 2 having a predetermined length, and a balloon 3 attached to the front end of the catheter body. The catheter body has a pair of U-shaped or C-shaped balloon mounting portions 12 on the front end side, and the proximal end portion of the balloon mounting portion is connected to a connecting member 7 to move forward and backward, so that the front end portion can be opened and closed in an opposed directions by moving forward and backward. The balloon comprises a U-shaped or C-shaped balloon body 14 like the balloon mounting portion, and a mounting tube 16 which is provided on the plane of the balloon body and can be accommodated to substantially cover the balloon mounting portion. An opening is formed in the proximal end of the mounting tube for receiving the balloon mounting portion inserted from the distal end thereof.SELECTED DRAWING: Figure 1

Description

The present invention relates to a balloon catheter for preventing drug leakage, and more particularly, when a drug solution such as glue is sprayed or applied to an anastomotic site (target site) such as a blood vessel, which is an affected area in a surgical operation, the drug solution leaks to a site other than the target site. The present invention relates to a technology capable of preventing

In the surgical treatment of ischemic heart disease, coronary artery bypass grafting (CABG) is performed in which a new blood flow path is created by anastomosing a graft vessel to an artery on the peripheral side of the stenosis. In this CABG operation, the anastomosis is covered by spraying a liquid bioadhesive (fibrin glue) for the purpose of preventing anastomotic failure. In this case, the bioglue is laminated to a certain thickness on the anastomotic site to increase the strength of the adhesive and prevent blood leakage. It may flow and spread naturally from the surface, and a sufficient thickness may not be obtained. Therefore, if the glue is sprayed for a long time to layer the glue, the force of the spray causes the glue to flow and spread to areas other than the target area, making it difficult to layer the glue successfully. there were.

In order to solve these problems, the applicant previously proposed a balloon catheter (Patent Document 1) in which a circular balloon is provided with a plurality of balloon support legs that can be collapsed. The balloon catheter comprises a catheter body having a predetermined length, an annular balloon attached to the front end of the catheter body, and an outer cylinder fitted around the outer periphery of the catheter body so as to be relatively slidable in the front-rear direction. a tube; and a plurality of balloon support legs each having a base end rotatably supported by a pivot mechanism on the front end of the outer cylindrical tube and a tip end attached to the balloon, the catheter body comprising: and the distal ends of the balloon support legs are attached to one side surface of the balloon at predetermined intervals in the circumferential direction. When the support leg is slid to one side, the part supported by the support legs separates from the catheter body and tilts at a predetermined angle to stand up, and when it is slid to the other side, it approaches the catheter body and falls down is configured to be

However, in the balloon catheter of Patent Document 1, since the grafted blood vessel is exposed, when the balloon is pressed against the grafted blood vessel, the blood vessel may be crushed as shown in FIG. 11, which may block blood flow. all right. In addition, when the drug solution is sprayed onto the heart wall, the catheter must be operated using the gap between the supporting legs. Furthermore, for the treatment, it is necessary to spray the drug solution into the ring-shaped balloon, layer it into a sheet, and then remove the balloon. There was also a problem that the was peeled off together.

JP 2018-57567 A

Therefore, the present invention can solve the above-mentioned conventional problems, does not block the blood flow during treatment, has good operability of spraying the medical solution, and the medical solution sheet can be peeled off together with the balloon. An object of the present invention is to provide a balloon catheter capable of preventing

In order to solve the above-mentioned problems, the invention according to claim 1 is a balloon catheter for preventing drug leakage, comprising a catheter body having a predetermined length, and a balloon attached to the front end of the catheter body. The catheter main body has a pair of U-shaped or C-shaped balloon mounting portions on the front end side, and the base ends of these balloon mounting portions are connected to a connecting member so that they can advance and retreat. In addition, the tip portion can be opened and closed in opposite directions by advancing and retreating, and the balloon includes a balloon main body formed in a U-shape or a C-shape similar to the balloon mounting portion, and a flat surface of the balloon main body. a mounting tube that is provided on the balloon mounting portion and can be accommodated so as to substantially cover the balloon mounting portion, and an opening that receives the balloon mounting portion by inserting the balloon mounting portion from the distal end side thereof on the proximal end side of the mounting tube. A part is formed.

According to the invention of claim 2, in claim 1, the mounting tube comprises a pair of tubes, each of which has a distal end substantially aligned with the distal end of the balloon body, and each proximal end of the balloon body. Each proximal end is formed with an opening into which the balloon mounting portion pair is inserted and received from the distal end side.

The invention according to claim 3 is based on claim 1 or 2, wherein the catheter body has an inner shaft and an outer shaft which are movably inserted into each other on the proximal end side, and both of these shafts and the balloon are attached. The connecting member that connects the pair of parts has a link mechanism, in which the pivot pin on one side facing in the axial direction is pivotally supported on the front end portion of the inner shaft, and the pivot pin on the other side It is pivotally supported at the proximal ends of the pair of balloon mounts.

According to a fourth aspect of the invention, in the third aspect, an operation member for moving the inner shaft with respect to the outer shaft is provided on the rear end side of the inner shaft and the outer shaft.

The invention according to claim 5 is the invention according to claim 4, wherein the balloon mounting part is in a closed state and releases the drug solution sheet when it is mounted on or removed from the mounting tube by movement of the inner shaft by the operation member. It is configured to be openable and closable so that it is in an open state when spraying the chemical solution and is in a normal state when the chemical solution is sprayed.

The present invention is as described above, and according to the first aspect of the invention, the catheter body has a pair of balloon mounting portions formed in a U-shape or a C-shape on the front end side, and Since the distal end portions of the balloon mounting portion can be opened and closed in opposite directions, there is no interruption of blood flow during treatment as in the conventional art. Moreover, the operability of spraying the chemical solution is also good. In addition, the medical solution sheet can be released by opening the balloon mounting portion, and there are excellent effects such as being able to reliably prevent the medical solution sheet from peeling off together with the balloon as in the past.

According to the second aspect of the invention, the pair of balloon mounting portions can be easily inserted into and housed in the pair of mounting tubes through the openings thereof.

According to the third aspect of the invention, since the connecting member has the link mechanism, the inner shaft can be smoothly moved with respect to the outer shaft.

According to the fourth aspect of the invention, the inner shaft can be easily moved by operating the operating member.

According to the fifth aspect of the present invention, the opening and closing are performed in the closed state when attaching to or removing from the attachment tube, the open state when releasing the chemical sheet, and the normal neutral state when spraying the chemical liquid. State operations can be performed more smoothly.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a front cross-sectional view showing a partly omitted balloon catheter for preventing drug leakage according to an embodiment of the present invention; Fig. 3 is a front cross-sectional view showing an enlarged balloon portion of the same; Fig. 3 is a cross-sectional plan view showing essential parts such as the balloon mounting portion of the same; Fig. 3 is an enlarged plan view showing a state in which the same balloon mounting portion is mounted on a balloon mounting tube; FIG. 10 is an operation explanatory view showing a state during chemical spraying; It is action explanatory drawing. It is action explanatory drawing. It is action explanatory drawing. FIG. 4 is a plan sectional view corresponding to FIG. 3 showing another embodiment; FIG. 4 is an enlarged plan cross-sectional view of a main part corresponding to FIG. 3 showing still another embodiment; It is drawing which shows a conventional example. It is drawing which shows a conventional example.

DESCRIPTION OF THE PREFERRED EMBODIMENTS A medical solution leakage prevention balloon catheter according to an embodiment of the present invention will be described below with reference to the drawings.

1 to 4, 1 is a balloon catheter. This balloon catheter 1 comprises a catheter body 2 having a predetermined length and a balloon 3 attached to the front end of this catheter body.

The catheter body 2 is made of a hard material such as metal or resin suitable for the living body, and includes an inner shaft 5, an outer shaft 6, and a pair of frame-shaped balloons attached to the front end sides of these shafts via a connecting member 7. It has parts 11 and 12 and. The inner shaft 5 is fitted on the outer shaft 6 so as to be axially movable. The balloon mounting portions 11 and 12 are formed in a bifurcated shape so that the attached overall shape is U-shaped or C-shaped in plan view, and are opposed to each other via a link mechanism described later as indicated by arrows in FIG. It can be opened and closed in the horizontal direction. The degree of opening of the balloon mounting portions 11 and 12 in FIG. 3 indicates the normal state when spraying the drug solution, the closed state when inserting or withdrawing from the body cavity described later, and the open state when releasing the sheet. Become.

The balloon 3 is entirely made of a soft material suitable for the living body such as silicone rubber, and includes a U-shaped or C-shaped balloon main body 14 having the same shape as the balloon mounting portions 11 and 12, and the balloon main body. and a pair of mounting tubes 15 and 16 which are provided so as to form a pair on the plane of (planar view surface) and can be accommodated so as to substantially cover the balloon mounting portions 11 and 12 . The distal ends of the mounting tubes 15 and 16 are positioned substantially coincident with the distal end of the balloon main body 14, and the proximal ends thereof extend close to the proximal end of the balloon main body 14, and the balloon mounting portions 11 and 12 are attached to the proximal ends. Openings 17 and 18 are formed for insertion and reception from the tip side. As is clear from FIG. 4, the balloon mounting portions 11 and 12 are covered with the mounting tubes 15 and 16 except for a portion on the proximal end side. In other words, only the proximal end portions of the balloon mounting portions 11 and 12 are visible in a plan view. A balloon main body 14 and mounting tubes 15 and 16 constituting the balloon 3 are integrally formed by adhesion or the like. When the balloon mounting portions 11 and 12 housed in the mounting tubes 15 and 16 are opened and closed, the integrated balloon main body 14 and the mounting tubes 15 and 16 are elastically changed so as to follow the movement. there is

As shown in detail in FIGS. 2 and 3, the connecting member 7 is composed of a four-bar link mechanism that is horizontally extendable in FIG. That is, connecting portions 21 and 22 are formed at the base ends of the balloon mounting portions 11 and 12 by bending them at a predetermined angle, and the base ends of these connecting portions are attached to the front end portion of the outer shaft 6 with a pivot pin 23 . . The ends of the connecting portions 21 and 22 are attached to one ends of the links 25 and 26 by pivot pins 27 and 28, respectively, and the other ends of the links 25 and 26 are attached to the front end of the inner shaft 5 by pivot pins 29. is attached with A locking projection 31 is provided on the front end of the inner shaft 5 near the pivot pin 29 and can be locked by being fitted into a locking recess 32 provided on the front end of the outer shaft 6 . Therefore, in order to bring the balloon mounting portions 11 and 12 from the normal state shown in FIG. make it In order to open it, it is moved in the opposite direction so that it engages with the other wall of the locking recess 32 . As a result, the connecting member 7 is laid down or undulated while the engaging projection 31 reciprocates in the engaging recess 32, thereby allowing the balloon mounting portions 11 and 12 to be opened and closed.

In FIG. 1, reference numeral 35 denotes an operation member for moving the inner shaft 5 relative to the outer shaft 6, which is accommodated in a recess 37 provided in an operation grip portion 36 attached to the proximal end of the outer shaft 6. there is That is, the rear ends of the inner shaft 5 and the outer shaft 6 protrude into the recess 37 of the operation grip part 36 , and the rear end of the outer shaft 6 is covered and the inner shaft 5 is threadedly engaged. A member 35 is arranged. The operation member 35 has an operation knob 38 screwed onto the inner shaft 5 , and the inner shaft 5 can be advanced or retracted with respect to the outer shaft 6 by rotating this operation knob. Reference numeral 39 denotes a recess which is concentrically formed over a predetermined length in the axial direction in communication with the recess 37 for receiving the base end side of the inner shaft 5 .

By rotating the operation knob 38 of the operation member 35, the balloon mounting portions 11 and 12 are opened and closed in conjunction with each other. That is, when the operation knob 38 is turned in one direction, the inner shaft 5 moves leftward in FIG. 3, for example. At this time, the connecting member 7 and the balloon mounting portions 11 and 12 connected to the inner shaft 5 by pivot pins are pushed in, and while the balloon mounting portions 11 and 12 are opened, the operation knob 38 is turned in the opposite direction, and the inner shaft 5 is opened. moves to the right, and the balloon mounting portions 11 and 12 are closed.

As shown in FIGS. 1 and 2, one end opening of an air supply tube 41 is attached to the balloon main body 14 of the balloon 3 so as to communicate with the inside of the balloon main body 14 . A two-way stopcock 42 is attached to the opening of the other end of the air supply tube 41 , and a gas supply source such as a syringe (not shown) is connected to this stopcock, so that air can be supplied to and degassed from the balloon body 14 . It is possible. Therefore, the balloon main body 14 is inflated by being supplied with gas from the air supply tube 41 and is contracted by being discharged. Then, in the expanded state, it is possible to adhere to the surface tissue of the heart so as to press it down, and spray it in this adhered state. As a medium for expanding and contracting the balloon main body 14, a fluid such as a liquid may be used instead of a gas.

The balloon catheter 1 configured as described above is shipped with the mounting tubes 15 and 16 for the balloon 3 mounted on the balloon mounting portions 11 and 12 of the catheter main body 2 .
<Explanation of action>

Next, the action of the balloon catheter 1 will be described.

As shown in FIG. 5, in coronary artery bypass surgery, when a drug solution is sprayed onto the anastomosis between a coronary artery near the heart and a graft vessel to prevent blood from leaking from the anastomosis, the balloon mounting portion of the balloon catheter 1 With 11 and 12 in the closed direction, or in a normal state, a small incision (not shown) made in the chest wall near the heart is inserted into the body cavity with the balloon 3 leading.

When the balloon 3 of the balloon catheter 1 inserted into the body cavity reaches a predetermined position and is in the closing direction, the balloon mounting portions 11 and 12 are opened to return to the normal state. Thereafter, gas is injected from a gas supply source such as a syringe (not shown) attached to the two-way cock 42 to inflate the balloon body 14 .

Next, the balloon 3 is pressed against the anastomosis, and the inside of the balloon 3 is sprayed with a chemical solution (fibrin glue). The sprayed drug solution is pooled and accumulated inside the balloon 3, laminated and fixed.

FIG. 6 shows a state in which the chemical solutions are layered and formed into a sheet at the completion of spraying. Since the medicinal solution sheet is fixed to the balloon as it is, the operating member 35 is operated to open the balloon mounting portions 11 and 12 as shown in FIG. This avoids sticking between the medical solution sheet and the balloon.

After confirming that the medical solution sheet has been fixed at the anastomosis, the balloon is removed from the area where the medical solution sheet is present as shown in FIGS. 8(A) and (B). After the gas in the balloon main body 14 is discharged and contracted, the balloon mounting portions 11 and 12 are closed, and the balloon catheter 1 is removed from the body through a small incision.

As described above, if the balloon catheter 1 is used, the balloon 3 can be inserted into the body cavity through a small incision and pressed against the affected anastomotic site to spray the drug solution, and the sprayed drug solution can be sprayed. can also be reliably prevented by the balloon 3 from leaking out. This leakage prevention effect is because even if the affected area is soft tissue such as an anastomosis and the heart is beating, the pulsation can be stabilized by pressing the balloon against the heart wall. It is possible. Furthermore, there is also a secondary effect of facilitating spraying by stabilizing the pulsation. Also, even in MICS surgery, the balloon 3 can be used by inserting it into the body cavity through a small incision, so that the operability is extremely good.

Until now, the diameter of the balloon could not be adjusted because the balloon was ring-shaped. Especially if the balloon is small relative to the heart, there is no big problem. With this structure, it is possible to change the size of the balloon 3 by adjusting the opening and closing conditions of the balloon mounting portions 11 and 12, and to match the size of the patient's heart. In addition, even on the side of the heart, which has a smaller area than the surface of the heart, the nebulization range can be adjusted by adjusting the opening/closing width of the device. In addition, when the target area is the lateral or posterior surface of the heart, the heart can be abducted by the balloon, so a nebulization space can be secured and the drug solution can be layered.

That is, conventionally, CABG, which is the purpose of use, is a procedure for anastomosing a graft vessel to a coronary artery buried in the heart. There was a fear that the balloon 3 would be crushed and block the blood flow, but by making the balloon 3 U-shaped or C-shaped, the graft vessel is not crushed.

In addition, when the drug solution is sprayed onto the heart wall, the catheter must be operated using the gap between the supporting legs. Since there are no supporting legs and it has a flat frame shape, interference between the catheter and the supporting legs has disappeared.

Furthermore, it is necessary to separate the balloon after the ring-shaped balloon is laminated by spraying the drug solution into a sheet. However, even if the medical solution sheet sticks to the balloon, it can be released from the balloon 3 by opening the balloon mounting portions 11 and 12 . Furthermore, it became possible to pressure-bond the drug solution sheet to the heart surface without wrinkles.

FIG. 9 shows another embodiment. In this embodiment, the proximal ends of the balloon mounting portions 51 and 52 of the catheter body are shorter than those shown in FIG. . The base ends of the balloon mounting portions 51 and 52 that face the pivot pin 53 in the radial direction are attached to one ends of the links 58 and 59 by pivot pins 61 and 62, respectively. The other ends of the links 58 and 59 are attached to a convex portion 65 provided at the front end of the inner shaft 55 with pivot pins 64 . The convex portion 65 of the inner shaft 55 corresponds to the locking convex portion of the above embodiment, and is engaged with the inner cavity of the outer shaft 56 so as to be axially movable.

By moving the inner shaft 55 back and forth with respect to the outer shaft 56, the balloon mounting portions 51 and 52 can be changed from the normal state shown in the drawing to the closing direction or the opening direction. Therefore, according to this embodiment, the link as shown in FIG. 3 does not largely protrude from the outer peripheral surface of the outer shaft. Therefore, it is possible to suppress the possible influence on the living body caused by the projection. Although not shown, this embodiment also includes an operating member similar to the operating member shown in FIG.

FIG. 10 shows yet another embodiment. In this embodiment, the link mechanism itself is the same as in FIG. The outer shaft consists of a large-diameter outer shaft 76a and a small-diameter outer shaft 76b which are connected to each other. The proximal end of the connecting portion of the balloon mounting portions 51 and 52 is attached by a pivot pin 53 to the front end portion of the large-diameter outer shaft 76a. A front-end opening of a small-diameter outer shaft 76b is inserted and connected to a rear-end opening of the large-diameter outer shaft 76a. A connecting member 78 connecting the other ends of the links 58 and 59 and the convex portion 77 of the inner shaft 75 is provided at the front end of the inner shaft 75, and the other ends of the links 58 and 59 pivot on the connecting member. It is attached with a support pin 79 .

With the above configuration, the same advantages as those of the embodiment of FIG. 9 can be expected, and in addition, the large-diameter outer shaft 76a and the small-diameter outer shaft 76b are used as the outer shafts, resulting in a small diameter that occupies most of the length. The outer diameter of the outer shaft 76b can be reduced. Moreover, the provision of the connecting member 78 simplifies the structure of the inner shaft 75 and reduces the manufacturing cost.

In each of the above-described embodiments, the balloon mounting portions 11 and 12 are illustrated as U-shaped or C-shaped when viewed from the top, but they are not limited to these illustrated examples, and may be slightly changed in shape. Also, the components such as the mounting tubes 15 and 16 and the connecting member 7 are examples, and other arbitrary members may be used as long as they have the same effect. Needless to say, the invention can be arbitrarily changed or modified in details such as design within the scope of the claims.

1 balloon catheter 2 catheter main body 3 balloon 5 inner shaft 6 outer shaft 7 connecting members 11, 12 balloon mounting portion 14 balloon main bodies 15, 16 mounting tubes 17, 18 openings 21, 22 connecting portions 23, 27, 28, 29 pivots Support pins 25, 26 Link 31 Engagement projection 32 Engagement recess 35 Operation member 36 Operation grip 37 Recess 38 Operation knob 39 Recess 41 Air supply tube 42 Two-way stopcock

Claims (5)

A balloon catheter for preventing drug leakage, comprising a catheter body having a predetermined length and a balloon attached to the front end of the catheter body,
The catheter main body has a pair of U-shaped or C-shaped balloon attachment portions on the front end side, and the proximal end portions of the balloon attachment portions are connected to a connecting member so that they can advance and retreat. In addition, the tip can be opened and closed in the opposite direction by advancing and retreating,
The balloon includes a balloon main body formed in a U-shape or a C-shape similar to the balloon mounting portion, and a mounting balloon which is provided on the plane of the balloon main body and can be accommodated so as to substantially cover the balloon mounting portion. A balloon catheter for preventing medicinal solution leakage, comprising: a tube, and an opening formed at the proximal end of the mounting tube for receiving the balloon mounting portion inserted from the distal end thereof. The mounting tubes are composed of a pair of tubes, each of which has a distal end substantially aligned with the distal end of the balloon body, and each proximal end extending to the vicinity of the proximal end of the balloon body, to which the balloon is attached. 2. The balloon catheter for preventing leakage of drug solution according to claim 1, wherein an opening is formed for receiving the pair of parts by inserting them from the distal end side thereof. The catheter body has an inner shaft and an outer shaft that are movably fitted to each other on the proximal end side, and the connecting member that connects both shafts and the balloon mounting portion pair has a link mechanism, A pivot pin on one side of the link mechanism that is axially opposed is pivotally supported on the front end portion of the inner shaft, and a pivot pin on the other side is pivotally supported on the proximal end portion of the pair of balloon mounting portions. 3. The balloon catheter for drug solution leakage prevention according to 1 or 2. 4. The balloon catheter for preventing drug leakage according to claim 3, wherein an operation member for moving the inner shaft with respect to the outer shaft is provided on the rear end side of the inner shaft and the outer shaft. By moving the inner shaft by the operating member, the balloon attachment portion is closed when attached to or removed from the attachment tube, opened when the chemical sheet is released, and normal when the chemical is sprayed. 5. The medical solution leakage prevention balloon catheter according to claim 4, which is configured to be openable and closable.

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