Balloon catheter to prevent leakage of drug solution

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

[Technical field]

[0001] This invention relates to a balloon catheter for preventing leakage of medicinal liquid, and more specifically to a technology that can prevent leakage of medicinal liquid such as glue to areas other than the target area when spraying or applying the medicinal liquid such as glue to the anastomosis (target area) of a blood vessel or other affected area during surgery. [Background technology]

[0002] In the surgical treatment of ischemic heart disease, coronary artery bypass graft (CABG) is performed to create a new blood flow path by anastomosing a graft blood vessel to an artery on the peripheral side of the stenosis. In this CABG surgery, in order to prevent anastomosis failure, a liquid bioadhesive (fibrin glue) is sprayed with a spray to cover the anastomosis. In this case, a certain thickness of bioadhesive is layered on the anastomosis to increase the strength of the adhesive and prevent blood leakage. However, due to the viscosity of the glue, the glue may flow naturally from the applied area between the time the liquid is applied and the time it hardens, making it difficult to obtain a sufficient thickness. Therefore, if the glue is sprayed for a long time to layer it, the force of the spray causes the glue to flow and spread to areas other than the intended area, making it difficult to layer the glue properly.

[0003] In order to solve these problems, the applicant previously proposed a balloon catheter (Patent Document 1) in which a plurality of collapsible balloon support legs are provided on an annular balloon. This balloon catheter comprises a catheter body of a predetermined length, an annular balloon attached to the front end of the catheter body, an outer tube fitted around the outer periphery of the catheter body so as to be relatively slidable in the front-rear direction, and a plurality of balloon support legs whose base ends are pivotally supported by a pivot mechanism on the front end of the outer tube and whose tip ends are attached to the balloon, the front end of the catheter body and the tip ends of the balloon support legs are attached to one side of the balloon at predetermined intervals in the circumferential direction, and the balloon is configured such that when the outer tube or the catheter body is slid to one side relative to the catheter body or the outer tube, the part supported by the support legs is inclined at a predetermined angle away from the catheter body and stands upright, and when the outer tube or the catheter body is slid to the other side, it approaches the catheter body and is collapsed.

[0004] However, in the balloon catheter of Patent Document 1, since the graft blood vessel is exposed, when the balloon is pressed against it, it was found that the blood vessel may be crushed as shown in Figure 11, and blood flow may be blocked. In addition, when spraying the drug solution on the heart wall, the catheter must be operated using the gap between the support legs, but the catheter and the support legs interfere with each other, making it difficult to spray the drug solution, and the operability was poor. Furthermore, the treatment requires spraying the drug solution inside the ring-shaped balloon, laminating it into a sheet, and then detaching the balloon, but when the drug solution sheet sticks to the balloon as shown in Figure 12, the drug solution sheet is peeled off along with the balloon, which is a problem. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2018-57567 A Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, an object of the present invention is to provide a balloon catheter which can solve the above-mentioned problems of the conventional art, which does not block blood flow during treatment, which has good operability for spraying the medicinal solution, and which can prevent the medicinal solution sheet from peeling off together with the balloon. [Means for solving the problem]

[0007] In order to solve the above-mentioned problems, the invention described in claim 1 provides a balloon catheter for preventing leakage of drug solutions, comprising a catheter body of a predetermined length and a balloon attached to the front end of the catheter body, the catheter body having a pair of balloon mounting parts formed in a U-shape or C-shape at the front end, the base ends of these balloon mounting parts are connected to a connecting member so as to be able to advance and retreat, and the tip ends can be opened and closed in opposing directions by advancing and retreating, the balloon has a balloon body formed in a U-shape or C-shape similar to the balloon mounting parts, and a mounting tube provided on the plane of the balloon body and capable of being accommodated so as to cover the balloon mounting parts, and an opening is formed on the base end side of the mounting tube to receive the balloon mounting parts by inserting them from the tip side.

[0008] The invention described in claim 2 is the same as claim 1, wherein the mounting tube is made up of a pair of tubes, each of whose tip ends is aligned with the tip end of the balloon body, and each of whose base ends extends to the base end of the balloon body, A pair An opening is formed for receiving the balloon mounting part by inserting it from its tip side.

[0009] The invention described in claim 3 is the same as claim 1 or 2, wherein the catheter body has an inner shaft and an outer shaft that are movably inserted into each other at the base end side, and these shafts and the A pair The connecting member for connecting the balloon mounting portion has a link mechanism, Direction of the longitudinal axis of the link mechanismThe pivot pin on one side of the pair of opposing sides is pivotally supported on the front end of the inner shaft, and the pivot pin on the other side is A pair It is pivotally supported at the proximal end of the balloon mounting portion.

[0010] The invention described in claim 4 is based on claim 3, and further includes an operating member provided on the rear end side of the inner shaft and the outer shaft for moving the inner shaft relative to the outer shaft.

[0011] The invention described in claim 5 is the same as claim 4, A pair The balloon mounting section is in a closed state when the balloon mounting section is mounted on or removed from the mounting tube by moving the inner shaft with the operating member. The liquid medicine is sprayed onto the affected area and then layered into a sheet. When releasing the liquid sheet, it is in the open state, and when spraying the liquid, it is in the closed state. A state between closed and open The housing is configured so as to be openable and closable. Effect of the Invention

[0012] This invention is as described above, and according to the invention described in claim 1, the catheter body has a pair of balloon mounting parts formed in a U-shape or C-shape at the front end side, and the tip parts of the balloon mounting parts can be opened and closed in opposite directions, so that blood flow is not blocked during treatment as in the past. Moreover, the operability of spraying the drug solution is also good. In addition, by opening the balloon mounting parts, the drug solution sheet can be released, and it is possible to reliably prevent the drug solution sheet from peeling off together with the balloon as in the past, and other excellent effects are obtained.

[0013] According to the invention described in claim 2, the pair of balloon mounting parts can be easily inserted into the pair of mounting tubes from the openings thereof and housed therein.

[0014] According to the invention recited in claim 3, since the connecting member has a link mechanism, the inner shaft can be moved smoothly relative to the outer shaft.

[0015] According to the invention as recited in claim 4, the inner shaft can be easily moved by operating the operating member.

[0016] According to the invention described in claim 5, the device is in a closed state when being attached to or removed from the attachment tube, The liquid medicine is sprayed onto the affected area and then layered into a sheet. When releasing the liquid sheet, it is in the open state, and when spraying the liquid, it is in the closed state. A state between closed and open In addition, the opening and closing operations can be performed more smoothly. [Brief description of the drawings]

[0017] [Figure 1] 1 is a front cross-sectional view showing, with some parts omitted, a balloon catheter for preventing leakage of a drug solution according to one embodiment of the present invention. FIG. [Diagram 2] FIG. 4 is an enlarged front cross-sectional view of the balloon portion of the embodiment. [Diagram 3] FIG. 2 is a cross-sectional plan view showing the main parts such as the balloon mounting part of the embodiment. [Figure 4] FIG. 2 is an enlarged plan view showing the state in which the balloon mounting portion of the above-mentioned embodiment is mounted on a balloon mounting tube. [Diagram 5] FIG. 4 is an explanatory diagram showing the state when a chemical solution is sprayed. [Figure 6] FIG. [Figure 7] FIG. [Figure 8] FIG. [Figure 9] FIG. 4 is a cross-sectional plan view corresponding to FIG. 3 and showing another embodiment. [Figure 10] FIG. 5 is an enlarged plan sectional view of a main portion corresponding to FIG. 3 and showing still another embodiment. [Figure 11] 1 is a diagram showing a conventional example. [Figure 12] 1 is a diagram showing a conventional example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Hereinafter, a balloon catheter for preventing leakage of a drug solution according to one embodiment of the present invention will be described with reference to the drawings.

[0019] In FIGS. 1 to 4, reference numeral 1 denotes a balloon catheter. This balloon catheter 1 includes a catheter body 2 having a predetermined length and a balloon 3 attached to the front end of the catheter body.

[0020] The catheter body 2 is made of a rigid material such as a metal or resin suitable for a living body, and has an inner shaft 5, an outer shaft 6, and a pair of frame-shaped balloon mounting portions 11 and 12 attached to the front end side of both shafts via a connecting member 7. The inner shaft 5 is inserted into the outer shaft 6 so as to be axially movable relative thereto. The balloon mounting portions 11 and 12 are formed in a bifurcated shape such that the overall attached form is U-shaped or C-shaped in plan view, and can be opened and closed in the horizontal direction facing each other via a link mechanism as shown by an arrow in FIG. 3. The opening degree of the balloon mounting portions 11 and 12 in FIG. 3 indicates the normal state when spraying a chemical solution, and becomes a closed state when inserting or removing the catheter into or from the body cavity described later, and becomes an open state when releasing the sheet.

[0021] The balloon 3 is entirely made of a flexible material suitable for living organisms, such as silicone rubber, and is composed of a balloon body 14 formed in a U-shape or C-shape similar to the balloon mounting parts 11, 12, and a pair of mounting tubes 15, 16 that are provided on the plane (surface in plan view) of the balloon body so as to be paired and can be accommodated so as to cover the balloon mounting parts 11, 12. The distal ends of the mounting tubes 15, 16 are positioned almost in line with the distal end of the balloon body 14, and the proximal ends extend close to the proximal end of the balloon body 14, and the proximal ends are formed with openings 17, 18 through which the balloon mounting parts 11, 12 are inserted from the distal end side and received. As is clear from FIG. 4, the balloon mounting parts 11, 12 are covered by the mounting tubes 15, 16 except for a part on the proximal end side. In other words, only the proximal end of the balloon mounting parts 11, 12 is visible in plan view. The balloon body 14 and the mounting tubes 15, 16 that constitute the balloon 3 are integrally formed by adhesion or the like. The integrated balloon body 14 and mounting tubes 15, 16 are adapted to undergo elastic change in response to the opening and closing movements of the balloon mounting sections 11, 12 housed in the mounting tubes 15, 16.

[0022] As shown in detail in Figs. 2 and 3, the connecting member 7 is a four-joint link mechanism that can expand and contract horizontally in Fig. 3. That is, the connecting parts 21 and 22 are formed at the base ends of the balloon mounting parts 11 and 12 by bending at a predetermined angle, and the base ends of these connecting parts are attached to the front end of the outer shaft 6 by a pivot pin 23. The respective tips of the connecting parts 21 and 22 are attached to one end of the links 25 and 26 by pivot pins 27 and 28, and the other ends of the links 25 and 26 are attached to the front end of the inner shaft 5 by a pivot pin 29. A locking protrusion 31 is provided at the front end of the inner shaft 5 near the pivot pin 29, and can be fitted into and locked in a locking recess 32 provided at the front end of the outer shaft 6. Therefore, in order to move the balloon mounting parts 11 and 12 from the normal state in Fig. 3 to a state in the closing direction, the inner shaft 5 is moved rightward relative to the outer shaft 6 so that it is locked to one wall of the locking recess 32. To open the balloon mounting parts 11, 12, the connecting member 7 is moved in the opposite direction so as to engage with the other wall of the engaging recess 32. As a result, the connecting member 7 falls or rises while the engaging protrusion 31 reciprocates within the engaging recess 32, allowing the balloon mounting parts 11, 12 to be opened or closed.

[0023] In Fig. 1, 35 is an operating member for moving the inner shaft 5 relative to the outer shaft 6, and is housed in a recess 37 provided in an operating grip part 36 attached to the base end side of the outer shaft 6. That is, the rear ends of the inner shaft 5 and the outer shaft 6 protrude into the recess 37 of the operating grip part 36, and the operating member 35 is arranged to cover the rear end of the outer shaft 6 and to be screwed into the inner shaft 5. The operating member 35 has an operating knob 38 screwed into the inner shaft 5, and by turning this operating knob, it is possible to advance and retract the inner shaft 5 relative to the outer shaft 6. 39 is a recess formed concentrically in the axial direction over a predetermined length in communication with the recess 37 to receive the base end side of the inner shaft 5.

[0024] With the above-described configuration, by rotating the operation knob 38 of the operating member 35, the balloon mounting parts 11, 12 open and close in tandem. That is, when the operation knob 38 is turned in one direction, the inner shaft 5 moves, for example, to the left in Figure 3. At this time, the connecting member 7 connected to the inner shaft 5 by a pivot pin and the balloon mounting parts 11, 12 are pushed in, opening the balloon mounting parts 11, 12. On the other hand, when the operation knob 38 is turned in the opposite direction, the inner shaft 5 moves to the right, closing the balloon mounting parts 11, 12.

[0025] As shown in Figs. 1 and 2, one end opening of an air supply tube 41 is attached to the balloon body 14 of the balloon 3 so as to communicate with the inside of the balloon body 14. A two-way stopcock 42 is attached to the other end opening of the air supply tube 41, and a gas supply source such as a syringe (not shown) is connected to this stopcock, making it possible to supply air to and evacuate the balloon body 14. Therefore, the balloon body 14 expands when gas is supplied from the air supply tube 41, and contracts when gas is discharged. In the expanded state, the balloon body 14 presses against the surface tissue of the heart in close contact, and in this close contact state, it is possible to spray with a spray. The medium for expanding and contracting the balloon body 14 may be a fluid such as a liquid in addition to a gas.

[0026] The balloon catheter 1 having the above-described configuration is shipped with the mounting tubes 15, 16 for the balloon 3 mounted on the balloon mounting portions 11, 12 of the catheter body 2. <Explanation of Action>

[0027] Next, the function of the balloon catheter 1 will be described.

[0028] As shown in Figure 5, in coronary artery bypass surgery, when a medicinal solution is sprayed onto the anastomosis between the coronary artery and the graft blood vessel near the heart to prevent blood leakage from the anastomosis, the balloon catheter 1 is inserted into the body cavity, with the balloon 3 at the front, through a small incision (not shown) made in the chest wall near the heart, either with the balloon attachment portions 11, 12 in the closed position or in the normal position.

[0029] When the balloon 3 of the balloon catheter 1 inserted into the body cavity reaches a predetermined position and is in the closed position, the balloon mounting parts 11 and 12 are opened to return to the normal state. Then, gas is injected from a gas supply source such as a syringe (not shown) attached to the two-way stopcock 42 to inflate the balloon body 14.

[0030] Next, the balloon 3 is pressed against the anastomosis, and a medicinal liquid (fibrin glue) is sprayed onto the inside of the balloon 3. The sprayed medicinal liquid pools and accumulates inside the balloon 3, where it is layered and fixed.

[0031] Figure 6 shows the state in which the liquid medicine is layered and formed into a sheet after spraying is complete. If this sheet is left as is, the liquid medicine sheet will adhere to the balloon as in the conventional case, so at this time, the operating member 35 is operated to set the balloon mounting parts 11, 12 in the open position as shown in Figure 7. This prevents the liquid medicine sheet from adhering to the balloon.

[0032] After confirming that the drug solution sheet has been fixed at the anastomosis, the balloon is detached from the area where the drug solution sheet is located, as shown in Figures 8(A) and (B). After the gas inside the balloon body 14 is discharged and the balloon attachment parts 11 and 12 are closed, the balloon catheter 1 is removed outside the body through a small incision.

[0033] As described above, by using the balloon catheter 1, the balloon 3 can be inserted into the body cavity through a small incision and pressed against the anastomosis, which is the affected area, to spray the medicinal solution, and the balloon 3 can also reliably prevent leakage of the sprayed medicinal solution. This leakage prevention effect is possible even when the affected area is soft tissue such as the anastomosis and is a pulsating heart, because the balloon can be pressed against the heart wall to stabilize the pulsation. Furthermore, there is a secondary effect that stabilizing the pulsation makes spraying easier. In addition, even in MICS surgery, the balloon 3 can be inserted into the body cavity through a small incision, making it very easy to use.

[0034] Previously, the balloon was ring-shaped, so the balloon diameter could not be adjusted. This does not cause any major problems when the balloon is small compared to the heart, but if the balloon is larger than the heart, the heart will fit inside the balloon and the device will become unusable. With this structure, it is possible to change the size of the balloon 3 by opening and closing the balloon mounting parts 11 and 12, and it can be adjusted to match the size of the patient's heart. In addition, even if the side of the heart has a smaller area than the surface of the heart, the spray range can be adjusted by adjusting the opening and closing width of the device. In addition, if the target area is the side or back of the heart, the balloon can be removed, so a spray space can be secured and the drug solution can be layered.

[0035] In other words, conventionally, the intended use of this device, CABG, is a surgical procedure for anastomosing a graft blood vessel to a coronary artery embedded in the heart, and since the graft blood vessel is exposed, there was a risk that the blood vessel would be crushed and blood flow cut off when the balloon was pressed against it, but by making the balloon 3 U-shaped or C-shaped, the graft blood vessel is no longer crushed.

[0036] In addition, when spraying medicinal liquid onto the heart wall, the catheter must be operated using the gap in the support legs, which could cause interference between the catheter and the support legs and make it difficult to spray the medicinal liquid. However, since there are no support legs and the frame is flat, there is no interference between the catheter and the support legs.

[0037] Furthermore, after spraying the drug solution inside the ring-shaped balloon and laminating it into a sheet, the balloon must be detached. If the drug solution sheet sticks to the balloon, the problem occurs that the drug solution sheet is peeled off along with the balloon. However, even if the drug solution sheet sticks to the balloon, it can be released from the balloon 3 by opening the balloon mounting parts 11 and 12. Furthermore, it is now possible to press the drug solution sheet onto the surface of the heart without wrinkles.

[0038] Fig. 9 shows another embodiment. In this embodiment, the base ends of balloon mounting parts 51, 52 of the catheter body are shorter than those in Fig. 3, and each base end is attached to the front end of an outer shaft 56 by a pivot pin 53. In addition, each base end of balloon mounting parts 51, 52 that faces pivot pin 53 in the radial direction is attached to one end of links 58, 59 by pivot pins 61, 62. The other ends of links 58, 59 are attached to a protrusion 65 provided at the front end of an inner shaft 55 by a pivot pin 64. The protrusion 65 of the inner shaft 55 corresponds to the locking protrusion in the above embodiment, and is engaged with the inner cavity of the outer shaft 56 so as to be axially movable.

[0039] With the above-mentioned configuration, it is possible to move the balloon mounting parts 51, 52 from the normal state shown in the figure to a state in the closed or open direction by moving the inner shaft 55 back and forth relative to the outer shaft 56. Therefore, according to this embodiment, the link as shown in FIG. 3 does not protrude significantly from the outer circumferential surface of the outer shaft. Therefore, it is possible to suppress the influence on the living body that may occur due to the protrusion. Although not shown in the figure, this embodiment also includes an operating member similar to the operating member in FIG. 1 that moves the inner shaft 55 back and forth relative to the outer shaft 56.

[0040] Figure 10 shows yet another embodiment. In this embodiment, the link mechanism itself is the same as that shown in Figure 9. The outer shaft is composed of a large-diameter outer shaft 76a and a small-diameter outer shaft 76b connected to each other. The base end of the connecting part of the balloon mounting parts 51, 52 is attached to the front end of the large-diameter outer shaft 76a with a pivot pin 53. The front end opening of the small-diameter outer shaft 76b is inserted into the rear end opening of the large-diameter outer shaft 76a and connected. In addition, a connecting member 78 that connects the other ends of the links 58, 59 to the protruding part 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, 59 are attached to the connecting member with a pivot pin 79.

[0041] 9, the above-mentioned configuration can be expected to have the same advantages as the embodiment in Fig. 9, and in addition, by dividing the outer shaft into a large-diameter outer shaft 76a and a small-diameter outer shaft 76b, the outer diameter of the small-diameter outer shaft 76b, which accounts for most of the length, can be made thinner. Also, by providing the connecting member 78, the structure of the inner shaft 75 can be simplified, and the manufacturing cost can be reduced.

[0042] In the above-described embodiments, the balloon mounting parts 11, 12 are illustrated as being U-shaped or C-shaped in plan view, but the present invention is not limited to these illustrated examples and may be slightly modified in shape. In addition, the components including the mounting tubes 15, 16 and the connecting member 7 are also examples, and any other components may be used as long as they have the same effect. It goes without saying that the detailed design of the present invention can be changed or modified as desired within the scope of the claims. [Explanation of symbols]

[0043] 1 Balloon catheter 2 Catheter body 3. Balloon 5 Inner shaft 6 Outer shaft 7 Connecting members 11,12 Balloon attachment part 14 Balloon body 15,16 Mounting tube 17,18 Opening 21,22 Connecting part 23,27,28,29 Pivot pin 25,26 Link 31 Locking protrusion 32 Locking recess 35 Operating member 36 Operation grip part 37 Recess 38 Control knob 39 Recess 41 Air supply tube 42 Two-way stopcock

Claims

1. A balloon catheter for preventing leakage of a drug solution, comprising a catheter body having a predetermined length and a balloon attached to a front end portion of the catheter body, The catheter body has a pair of balloon mounting parts formed in a U-shape or a C-shape on the front end side, and the base ends of these balloon mounting parts are connected to a connecting member so as to be able to advance and retreat, and the tip ends can be opened and closed in opposing directions by advancing and retreating, The balloon comprises a balloon body formed in a U-shape or C-shape similar to that of the balloon mounting portion, and a mounting tube that is provided on the plane of the balloon body and can be accommodated so as to cover the balloon mounting portion, and an opening is formed on the base end side of the mounting tube to receive the balloon mounting portion by inserting it from its tip side.

2. 2. The balloon catheter according to claim 1, wherein the balloon mounting portion is inserted into the balloon catheter through a pair of mounting tubes, the pair of mounting tubes being arranged so that the distal end of the mounting tube is aligned with the distal end of the balloon body and the proximal end of the mounting tube is extended to the proximal end of the balloon body.

3. 3. The balloon catheter for preventing leakage of medicinal solution according to claim 1 or 2, wherein the catheter body has an inner shaft and an outer shaft which are movably inserted into each other at the base end side, and the connecting member connecting these two shafts to the pair of balloon mounting portions has a link mechanism, in which a pivot pin on one side facing in the direction of the longitudinal axis of the link mechanism is pivotally supported on the front end of the inner shaft, and a pivot pin on the other side is pivotally supported on the base end of the pair of balloon mounting portions.

4. 4. The balloon catheter for preventing leakage of drug solution according to claim 3, wherein an operating member for moving the inner shaft relative to the outer shaft is provided at the rear end side of the inner shaft and the outer shaft.

5. The balloon catheter for preventing leakage of drug solution as described in claim 4, wherein the pair of balloon mounting portions are configured to be openable and closable by movement of the inner shaft by the operating member so as to be in a closed state when mounting or removing from the mounting tube, in an open state when releasing the drug solution sheet that has been laminated and attached to the affected area in sheet form by spraying the drug solution, and in a state between the closed state and the open state when spraying the drug solution.

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