JP7680724B2 - Balloon catheter to prevent leakage of drug solution - Google Patents

Description

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 and applying the medicinal liquid to the anastomosis (target area) of a blood vessel or other affected area during surgery.

In the surgical treatment of ischemic heart disease, coronary artery bypass grafting (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, but due to the viscosity of the glue, it may flow and spread from the applied area between the application and hardening of the liquid, 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.

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 inserted 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 so 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 it is slid to the other side, it approaches the catheter body and is collapsed.

However, with the balloon catheter of Patent Document 1, the graft blood vessel is exposed, so when the balloon is pressed against it, the blood vessel may be crushed as shown in Figure 11, which may result in blocking of blood flow. In addition, when spraying the drug solution onto 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 properly, and operability is poor. Furthermore, the treatment requires spraying the drug solution inside the ring-shaped balloon, layering it into a sheet, and then detaching the balloon, but if the drug solution sheet sticks to the balloon as shown in Figure 12, the drug solution sheet may be peeled off along with the balloon.

JP 2018-57567 A

The purpose of this invention is to provide a balloon catheter that can solve the above-mentioned problems of the conventional method, does not block blood flow during treatment, is easy to spray the drug solution, and prevents the drug solution sheet from peeling off together with the balloon.

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.

The invention described in claim 2 is, in claim 1, a pair of mounting tubes, each of which has a tip aligned with the tip of the balloon body and a base end which extends to the base end of the balloon body, with an opening formed at each base end to receive the pair of balloon mounting parts inserted from their tip sides.

The invention described in claim 3 is, in the first or second claim, the catheter body has an inner shaft and an outer shaft which are movably inserted into each other at the base end, and the connecting member connecting these two shafts to the pair of balloon mounting portions has a link mechanism, in which pivot pins on one side facing each other in the direction of the longitudinal axis of the link mechanism are pivotally supported on the front end of the inner shaft, and the pivot pin on the other side is pivotally supported on the base ends of the pair of balloon mounting portions.

The invention described in claim 4 is the same as claim 3, except that an operating member is provided at the rear end of the inner shaft and the outer shaft to move the inner shaft relative to the outer shaft.

The invention described in claim 5 is, in claim 4, configured to be openable and closable by movement of the inner shaft by the operating member, so that the pair of balloon mounting parts are in a closed state when mounting or removing from the mounting tube, in an open state when releasing the medicinal solution sheet that has been layered on the affected area and attached in sheet form by spraying the medicinal solution, and in a state between the closed state and the open state when spraying the medicinal solution.

As described above, 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, and the tips of the balloon mounting parts can be opened and closed in opposite directions, so blood flow is not blocked during treatment as in the past. In addition, the operability of spraying the drug solution is also good. In addition, the drug solution sheet can be released by opening the balloon mounting parts, and it is possible to reliably prevent the drug solution sheet from peeling off together with the balloon as in the past, etc., which are excellent effects.

According to the invention described in claim 2, a pair of balloon mounting parts can be easily inserted into a pair of mounting tubes through their openings and housed therein.

According to the invention described in claim 3, the connecting member has a link mechanism, which allows smooth movement of the inner shaft relative to the outer shaft.

According to the invention described in claim 4, the inner shaft can be easily moved by operating the operating member.

According to the invention described in claim 5, the device can be opened and closed more smoothly when being attached to or removed from the attachment tube, opened when releasing the medicinal solution sheet that has been laminated on the affected area and stuck in sheet form by spraying the medicinal solution, and opened and closed when spraying the medicinal solution.

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. FIG. 2 is an enlarged front cross-sectional view of the balloon portion of the embodiment. FIG. 2 is a cross-sectional plan view showing the main parts such as the balloon mounting part of the embodiment. 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. FIG. 4 is an explanatory diagram showing the state when a chemical solution is sprayed. FIG. FIG. FIG. FIG. 5 is a cross-sectional plan view corresponding to FIG. 3 and showing another embodiment. FIG. 5 is an enlarged cross-sectional plan view of a main portion corresponding to FIG. 3 and showing still another embodiment. 1 is a diagram showing a conventional example. 1 is a diagram showing a conventional example.

The following describes a balloon catheter for preventing leakage of drug solution according to one embodiment of the present invention, with reference to the drawings.

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

The catheter body 2 is made of a hard material such as metal or resin suitable for living organisms, and has an inner shaft 5, an outer shaft 6, and a pair of frame-shaped balloon mounting parts 11, 12 attached to the front ends of both shafts via a connecting member 7. The inner shaft 5 is inserted into the outer shaft 6 so that it can move axially. The balloon mounting parts 11, 12 are bifurcated so that the overall shape of the attached parts is U-shaped or C-shaped in a plan view, and can be opened and closed in opposite horizontal directions via a link mechanism described later, as shown by the arrows in Figure 3. The opening of the balloon mounting parts 11, 12 in Figure 3 indicates the normal state when spraying the medicinal liquid, and is closed from this state when inserting or removing the catheter into the body cavity described later, and is opened when the sheet is released.

The balloon 3 is made entirely 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 in a pair and can be accommodated so as to almost cover the balloon mounting parts 11, 12. The tips of the mounting tubes 15, 16 are positioned almost in line with the tip of the balloon body 14, and the base ends extend close to the base end of the balloon body 14, and the base ends are formed with openings 17, 18 through which the balloon mounting parts 11, 12 are inserted from the tip 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 base end side. In other words, only the base ends of the balloon mounting parts 11, 12 are visible in plan view. The balloon body 14 and the mounting tubes 15, 16 that make up the balloon 3 are integrally formed by gluing or the like. The integrated balloon body 14 and mounting tubes 15, 16 are designed to elastically change in response to the opening and closing movements of the balloon mounting parts 11, 12 housed in the mounting tubes 15, 16.

As shown in detail in Figures 2 and 3, the connecting member 7 is a four-joint link mechanism that can be expanded and contracted horizontally in Figure 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 them 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. In addition, the 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 locked by fitting into 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 Figure 3 to the closed state, the inner shaft 5 is moved to the right relative to the outer shaft 6 so that it is locked to one wall of the locking recess 32. To open the balloon mounting sections 11 and 12, move the connecting member 7 in the opposite direction so that it engages 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 sections 11 and 12 to open and close.

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 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 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 rotating this operating knob, it is possible to move the inner shaft 5 forward and backward 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.

With the above-mentioned configuration, by rotating the operating knob 38 of the operating member 35, the balloon mounting parts 11, 12 open and close in tandem. In other words, when the operating knob 38 is rotated in one direction, the inner shaft 5 moves, for example, to the left in FIG. 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, while when the operating knob 38 is rotated in the opposite direction, the inner shaft 5 moves to the right and the balloon mounting parts 11, 12 close.

As shown in Figures 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 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. In addition to gas, a fluid such as a liquid may be used as a medium for expanding and contracting the balloon body 14.

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>

Next, we will explain the function of the balloon catheter 1.

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 from leaking 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, with the balloon attachment parts 11, 12 in the closed position or in the normal position.

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. After that, 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.

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.

Figure 6 shows the state in which the medicinal liquid has been layered into a sheet after spraying is complete. If this sheet of medicinal liquid is left as is, it 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 medicinal liquid sheet from adhering to the balloon.

After confirming that the drug solution sheet has been fixed at the anastomosis, the balloon is removed 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 is deflated, the balloon attachment parts 11 and 12 are closed, and the balloon catheter 1 is removed from the body through a small incision.

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 affected anastomosis, and the medicinal solution can be sprayed with a spray, 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 extremely easy to use.

Previously, the balloon was ring-shaped, making it impossible to adjust the balloon diameter. This does not pose a major problem when the balloon is small compared to the heart, but if the balloon is larger than the heart, it will fit completely inside the balloon, making the device unusable. With this new structure, it is possible to change the size of the balloon 3 by opening and closing the balloon mounting parts 11 and 12, and 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 used to dislocate the heart, ensuring space for spraying and allowing the drug solution to be layered.

In other words, conventionally, the intended use of CABG is a procedure in which a graft blood vessel is anastomosed 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.

In addition, when spraying the medicinal solution onto the heart wall, the catheter must be operated using the gap in the support legs, which can cause interference between the catheter and the support legs and makes it difficult to spray the medicinal solution. However, since there are no support legs and the device is shaped like a flat frame, there is no interference between the catheter and the support legs.

Furthermore, after spraying the drug solution inside the ring-shaped balloon and layering 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 attachment parts 11 and 12. Furthermore, it is now possible to press the drug solution sheet onto the surface of the heart without wrinkles.

Figure 9 shows another embodiment. In this embodiment, the base ends of the balloon mounting parts 51, 52 of the catheter body are shorter than those shown in Figure 3, and each base end is attached to the front end of the outer shaft 56 by a pivot pin 53. In addition, each base end of the balloon mounting parts 51, 52 that are radially opposed to the pivot pin 53 is attached to one end of links 58, 59 by pivot pins 61, 62. The other end of the links 58, 59 is attached to a protrusion 65 provided at the front end of the 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.

With the above configuration, it is possible to move the balloon mounting sections 51, 52 from the normal state shown in the figure to a closed or open state 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 Figure 3 does not protrude significantly from the outer circumferential surface of the outer shaft. This makes it possible to suppress the effects on the living body that may occur due to protrusion. Although not shown in the figure, this embodiment also has an operating member similar to the operating member in Figure 1 that moves the inner shaft 55 back and forth relative to the outer shaft 56.

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 made up of a large diameter outer shaft 76a and a small diameter outer shaft 76b that are 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.

The above configuration can be expected to provide the same advantages as the embodiment in FIG. 9, and 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 takes up most of the length, can be made thinner. In addition, by providing the connecting member 78, the structure of the inner shaft 75 can be simplified, and manufacturing costs can be reduced.

In the above 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 also include slight changes 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 this invention can be changed or modified as desired within the scope of the claims.

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

Claims (5)

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. 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. 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. 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. 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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