A cutting balloon dilatation device

Abstract

The present invention discloses a cutting-type balloon dilatation device, comprising a balloon, a positioning bracket, a catheter, an inner tube and at least one blade. Since the blade is arranged on the outer peripheral wall of the balloon, when the hard guide wire inserted into the inner tube guides the cutting-type balloon dilatation device to move toward the lesion position, at the opening of the lesion position, even if there is a calcified area, the balloon slides and extends into the opening, and the balloon will not touch the calcified area when it is not inflated; when the balloon is inflated, since the blade is arranged outside the balloon, before the balloon is filled with gas, the blade first encounters the calcified area, and by moving or rotating the catheter, the blade cuts the calcified area, so that the calcified area is reduced, and even after the balloon is filled with gas, when the balloon contacts the calcified area, the probability of the balloon moving forward or backward along the calcified area is reduced, thereby reducing the probability of damage to the adjacent organ tissue.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a cutting-type balloon dilation device. Background Art

[0002] Artificial heart valve replacement surgery is already a mature and safe treatment for heart valve disease. The artificial heart valve is delivered to the aortic valve area through the femoral artery to open the valve balloon, thereby completing the implantation of the artificial valve and restoring the valve function. Currently, before valve replacement surgery, a cutting balloon dilatation device is needed to dilate and clear the opening of the aortic valve disease to facilitate the subsequent implantation of the valve stent, that is, to dilate the opening surrounded by the three leaflets of the aortic sinus.

[0003] The existing balloon dilatation device includes an inner tube and a catheter which are sequentially arranged from the inside to the outside, and a balloon is fixed on the distal end of the catheter, and the balloon is cylindrical; in the initial state, a hard guide wire is inserted into the inner tube, and the distal end of the hard guide wire extends out of the distal end of the inner tube. The hard guide wire guides the entire balloon dilatation device through the femoral artery, passes through the abdominal aorta, thoracic aorta, and aortic arch in sequence to reach the lesion position of the aortic sinus, and passes through the opening surrounded by the three valve leaflets of the aortic sinus, and then the balloon is inflated to dilate the lesion opening.

[0004] However, when there is a calcified area on the inner wall of the opening of the lesion, the calcified area is harder than other areas, and when the calcified area tilts forward or backward, the balloon will slide forward or backward along the tilt direction of the calcified area instantly due to the force of the calcified area, and cannot effectively expand the opening of the lesion. When sliding forward, the distal end of the hard guide wire will hit the myocardium, and when sliding backward, the hard guide wire and the outer sheath will hit the aortic arch as a whole, causing damage to the myocardium and the aortic arch.

[0005] In addition to the above-mentioned defects in valve replacement surgery, if there are calcified areas at the opening of the lesion site of other diseases, it will cause the cutting balloon dilatation device to slide forward or backward instantly, with a high probability of damaging the adjacent organ tissues. Summary of the invention

[0006] Therefore, the technical problem to be solved by the present invention is that when there is a calcified area at the opening of the lesion, the existing balloon dilation device will slide forward or backward as a whole, and cannot effectively expand the opening at the lesion location, which has a high probability of damaging the adjacent organ tissues.

[0007] To this end, the present invention provides a cutting-type balloon dilation device, comprising an inner tube, a catheter sleeved outside the inner tube, and a balloon installed on the distal end of the catheter and sleeved outside the inner tube; the balloon has an inflated working state and an exhausted non-working state;

[0008] At least one blade extends along the axial direction of the balloon and is fixed on the outer wall surface of the balloon.

[0009] Optionally, in the above-mentioned cutting-type balloon dilation device, the number of the blades is at least two, and all the blades are evenly distributed on the outer peripheral wall surface of the balloon along the circumference of the balloon.

[0010] Optionally, the above-mentioned cutting-type balloon dilation device further includes at least one knife seat, each of the blades is fixed on the knife seat, and the knife seat is installed on the outer peripheral wall surface of the balloon.

[0011] Optionally, the cutting-type balloon dilatation device further comprises at least two positioning brackets distributed away from the blades, one end of any of the positioning brackets being fixed to at least one of the catheter and the balloon, and the other end being extended in the air toward the distal end of the balloon as a limiting end; all the positioning brackets are evenly distributed on the outer periphery of the balloon along the circumference of the balloon;

[0012] In the working state, the positioning stent is in an expanded state, expanded outwardly along a first direction perpendicular to the axial direction of the balloon due to the expansion force exerted by the balloon; in the non-working state, the expansion force exerted on the positioning stent is cancelled, and the positioning stent is in a collapsed state, contracted inwardly along the first direction.

[0013] Optionally, the above-mentioned cutting-type balloon dilatation device further includes a traction mechanism having a traction end, wherein the traction end is connected to any one of the positioning brackets and applies a biasing force to the positioning bracket away from the side of the positioning bracket, and the biasing force drives the positioning bracket to tend to maintain a retracted state.

[0014] Optionally, in the above-mentioned cutting-type balloon dilatation device, the traction mechanism comprises a push-pull seat slidably sleeved on the inner tube, at least two traction wires and a biasing member;

[0015] The distal end of at least one of the traction wires serves as the traction end, and the proximal end of the traction wire is fixed on the push-pull seat; the biasing member is connected to the push-pull seat to apply the biasing force to the push-pull seat.

[0016] Optionally, in the above-mentioned cutting-type balloon dilation device, the traction mechanism further comprises a pull rod handle fixed on the proximal end of the push-pull seat;

[0017] The cutting-type balloon dilation device further comprises a handle shell, and the inner tube and the catheter are both inserted into the handle shell;

[0018] The push-pull seat is located inside the handle shell, one end of the biasing member is mounted on the push-pull seat, and the other end is fixedly arranged relative to the handle shell; the pull rod handle is located outside the handle shell.

[0019] Optionally, in the above-mentioned cutting balloon dilation device, the traction mechanism further comprises

[0020] A first guide piece extending along the axial direction of the catheter is provided on one of the inner wall of the handle shell and the push-pull seat, and a first matching piece is provided on the other, and the first matching piece is slidably arranged on the first guide piece.

[0021] Optionally, in the above-mentioned cutting-type balloon dilation device, the traction mechanism further comprises a support ring which is sleeved outside the balloon and can be radially deformed, the proximal end of the support ring is connected to the traction end, and the distal end of the support ring is fixed to the distal end of the balloon;

[0022] One end of the positioning bracket is arranged on the balloon or catheter by being fixed on the support ring, and the traction end is applied to the positioning bracket by applying the biasing force to the support ring;

[0023] The blade is arranged on the outer peripheral wall of the balloon by being arranged on the supporting ring.

[0024] Optionally, in the above-mentioned cutting-type balloon dilatation device, the traction mechanism further comprises at least two connecting wires, at least one connecting wire corresponds to one positioning bracket, any of the connecting wires comprises a body, and a first connecting portion and a second connecting portion formed at two ends of the body, the first connecting portion and the second connecting portion are respectively connected to the positioning bracket and the support ring;

[0025] The connecting wire is made of shape memory material. Under the effect of its own shape memory, the connecting wire forces the main body and at least one of the first connecting part and the second connecting part to maintain a bent connection state to form a bent section, driving the positioning bracket to be suspended on the periphery of the balloon.

[0026] Optionally, in the above-mentioned cutting-type balloon dilatation device, there are at least three positioning brackets, and the three positioning brackets are connected end to end in sequence to form a positioning ring that is deformable along the first direction; the connection between the distal ends of any two adjacent positioning brackets forms the limiting end;

[0027] The proximal end of the positioning bracket is connected to the first connecting portion of the connecting wire.

[0028] Optionally, in the above-mentioned cutting-type balloon dilatation device, the positioning bracket is V-shaped, the closed end of the V-shape is connected to the first connecting portion of the connecting wire, and either end of the V-shaped opening is connected to one end of the V-shaped opening of the adjacent positioning bracket to form the limiting end.

[0029] Optionally, in the above-mentioned cutting-type balloon dilatation device, the positioning stent is in the form of a strip block or a strip column; in a non-working state, the positioning stent is distributed on the same straight line along the axial direction of the balloon; or

[0030] The positioning bracket includes a mounting portion and a limiting portion, the distal end of the mounting portion is fixed to the distal end of the balloon, the proximal end of the limiting portion is bent outward along a first direction and fixed to the proximal end of the mounting portion, and the distal end of the limiting portion serves as the limiting end.

[0031] Optionally, the above-mentioned cutting-type balloon dilatation device also includes an outer sheath, which can be slidably mounted outside the catheter; in a non-working state, the positioning bracket and the balloon can be folded inside the outer sheath; in a working state, the positioning bracket and the balloon extend out of the distal end of the outer sheath and expand.

[0032] The technical solution of the present invention has the following advantages:

[0033] 1. The cutting-type balloon dilation device provided by the present invention comprises an inner tube, a catheter sleeved outside the inner tube, a balloon installed on the distal end of the catheter and sleeved outside the inner tube, the balloon having an inflated working state and an exhausted non-working state; and at least one blade, any of which extends along the axial direction of the balloon and is fixed on the outer wall surface of the balloon.

[0034] The cutting-type balloon dilatation device of this structure has a blade on the outer wall of the balloon. When the hard guide wire inserted in the inner tube guides the cutting-type balloon dilatation device to move toward the lesion position, at the opening of the lesion position, even if there is a calcified area, the balloon slides and extends into the opening, and the balloon will not touch the calcified area when it is not inflated. When the balloon is inflated, since the blade is arranged outside the balloon, the blade first encounters the calcified area before the balloon is filled with gas. By moving or rotating the catheter, the blade cuts the calcified area to reduce the calcified area. Even after the balloon is filled with gas, when the balloon contacts the calcified area, the probability of the balloon moving forward or backward along the calcified area is reduced, thereby reducing the probability of damage to the adjacent organ tissues.

[0035] 2. The cutting-type balloon dilation device provided by the present invention also includes at least two positioning brackets distributed away from the blades, one end of any one of the positioning brackets is fixed on at least one of the catheter and the balloon, and the other end extends in the air toward the distal end of the balloon as a limiting end; all the positioning brackets are evenly distributed on the periphery of the balloon along the circumference of the balloon; in a working state, the positioning bracket is expanded outward along a first direction perpendicular to the axial direction of the balloon by the expansion force exerted by the balloon; in a non-working state, the expansion force exerted on the positioning bracket is canceled and the positioning bracket is in a collapsed state contracted inward along the first direction.

[0036] In the cutting-type balloon dilatation device of this structure, when the hard guide wire inserted in the inner tube guides the cutting-type balloon dilatation device to move toward the lesion position, even if there is a calcified area at the opening of the lesion position, since the limiting end of the positioning bracket faces the distal end of the balloon, when the balloon slides and extends into the opening, the balloon will not touch the calcified area without being inflated; first, the catheter is pushed to the distal end, so that the limiting end of the positioning bracket first abuts against the outer wall of the opening of the lesion position, and the position of the catheter is manually kept unchanged at this time, and the positioning bracket plays a limiting role in the position of the balloon, and then the balloon is filled with gas to expand the opening of the lesion position, and the positioning ring is radially expanded by the expansion force of the balloon. Even if the balloon touches the calcified area after being filled, the balloon will not move forward or backward instantly under the limiting effect of the positioning bracket, and will not damage the adjacent organs or tissues; at the same time, multiple positioning brackets are evenly distributed on the periphery of the balloon, so that the balloon is evenly stressed and will not be twisted, ensuring that the balloon effectively expands the opening of the lesion position. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0038] Figure 1 A schematic diagram of the structure of a cutting-type balloon dilation device provided in Example 1 of the present invention;

[0039] Figure 2 for Figure 1 A schematic diagram of the partial structure of the handle housing of a mid-cutting balloon dilatation device;

[0040] Figure 3 for Figure 1 A schematic diagram of the local structure of the balloon at the distal end of a mid-cutting balloon dilatation device;

[0041] Figure 4 for Figure 2 A schematic diagram of the structure of a mid-cut balloon dilatation device with part of the handle shell removed;

[0042] Figure 5 for Figure 4 A schematic diagram of the structure of the handle housing removed;

[0043] Figure 6 for Figure 4 A schematic diagram of the structure after the coordination of the stop swivel seat, the lead screw nut, the outer sheath tube, the connecting seat, the push-pull seat, the outer sheath tube, the drain pipe, and the catheter;

[0044] Figure 7 for Figure 6 Schematic diagram of the explosion structure;

[0045] Figure 8 This is a schematic structural diagram of a positioning bracket of a cutting-type balloon dilatation device in Example 1 of the present invention;

[0046] Figure 9a for Figure 3 A schematic diagram of a partially enlarged structure of the middle positioning bracket after coordination with the connecting wire and the supporting frame;

[0047] Figure 9b for Figure 9a A schematic diagram of the structure of the connecting wire in FIG.

[0048] Fig.10 for Figure 3 Schematic diagram of the structure of the middle support ring;

[0049] Fig.11 This is a schematic structural diagram of a positioning bracket provided in Example 2 of the present invention;

[0050] Fig.12 This is a schematic structural diagram of another positioning bracket provided in Example 2 of the present invention;

[0051] Fig.13 This is a schematic diagram of the matching structure of another positioning bracket and balloon provided in Example 2 of the present invention;

[0052] Fig.14 This is a schematic diagram of the coordination structure of another positioning bracket and balloon provided in Example 2 of the present invention.

[0053] Description of reference numerals:

[0054] 1-handle housing; 11-connecting seat; 111-annular flange; 112-first protrusion; 12-first annular baffle; 13-second annular baffle; 14-annular mounting seat; 15-first connecting hole; 16-clearance hole;

[0055] 2-outer sheath; 3-inner tube; 4-catheter; 5-balloon; 61-positioning bracket; 611-limiting end; 612-mounting part; 613-limiting part; 614-first mounting hole;

[0056] 7-support ring; 71-support frame; 711-T-shaped notch groove; 72-card slot; 73-second mounting hole;

[0057] 81-blade; 82-blade holder;

[0058] 91-push-pull seat; 911-first guide member; 912-first matching member; 92-pull rod handle; 93-traction wire; 931-T-shaped protrusion; 94-connecting wire; 941-first bending section; 942-second bending section;

[0059] 10-drain pipe; 101-second sealing ring; 102-second pressing piece; 103-three-way valve;

[0060] 201- delivery pipe; 202- lead screw nut; 203- anti-rotation seat; 2011- step head. DETAILED DESCRIPTION

[0061] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0062] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0063] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0064] Example 1

[0065] The present invention provides a cutting type balloon dilation device, such as Figures 1 to 10 As shown, it includes a handle shell 1, a positioning bracket 61, an inner tube 3, an outer sheath tube 2 and a catheter 4.

[0066] The catheter 4 is sleeved on the outer side of the inner tube 3, the outer sheath 2 is sleeved on the outer side of the catheter 4; the balloon 5 is sleeved on the outer side of the inner tube 3, the proximal end of the balloon 5 is fixed on the distal end of the catheter 4, the distal end of the balloon 5 is sealed on the inner tube 3, and the inner cavity of the balloon 5 is connected to the first channel between the catheter 4 and the inner tube 3; a conical head is fixed on the distal end of the inner tube 3. The outer sheath 2, the inner tube 3 and the catheter 4 are all arranged on the handle shell 1.

[0067] There are at least two positioning brackets 61, one end of each positioning bracket 61 is fixed on the catheter 4 or the balloon 5, and the other end serves as a limiting end 611 and extends in the air toward the distal end of the balloon 5; all positioning brackets 61 are evenly distributed on the periphery of the balloon 5 along the circumference of the balloon 5.

[0068] like Figure 3 and Figure 8 As shown, there are three positioning brackets 61, and the three positioning brackets 61 are connected end to end in sequence to form a positioning ring that can be deformed along a first direction perpendicular to the axis of the balloon 5; the connection between the distal ends of any two adjacent positioning brackets 61 forms a limiting end 611, and the proximal end of any positioning bracket 61 is connected to the catheter 4 or the balloon 5.

[0069] For example, the positioning bracket 61 is V-shaped, with the closed end of the V-shaped being its proximal end, and either end of the V-shaped opening being connected to an open end of the V-shaped adjacent positioning bracket 61 to form a limiting end 611. Optimally, the positioning ring is expanded from the proximal end toward the distal end.

[0070] like Figure 2 As shown, a three-way valve 103 is provided at the sealing sleeve at the proximal end of the inner tube 3 and the proximal end of the catheter 4. The first inlet and the second inlet of the three-way valve 103 are respectively connected to the inner cavity of the inner tube 3 and the first channel between the inner tube 3 and the catheter 4. Gas is blown into the first channel through the second inlet, and the gas flows into the inner cavity of the balloon 5 through the first channel to fill and expand the balloon 5, so that the balloon 5 is in a radially expanded working state; on the contrary, after the three-way valve 103 is opened, the gas in the balloon 5 is discharged outward through the first channel and the second inlet, and the balloon 5 becomes flat and is in a non-working state.

[0071] Since all the positioning brackets 61 surround the outer periphery of the circumferential outer wall of the balloon 5, when the balloon 5 is in an inflated working state, the positioning brackets 61 are in an expanded state due to the expansion force exerted by the balloon 5 and are expanded outward along a first direction perpendicular to the axial direction of the balloon 5; in a non-working state, since the gas in the balloon 5 is emptied, the expansion force of the balloon 5 on the positioning brackets 61 is also cancelled, and the positioning brackets 61 are in a collapsed state along the first direction.

[0072] When the hard guide wire inserted in the inner tube 3 guides the cutting-type balloon dilatation device to move toward the lesion position, at the opening of the lesion position, even if there is a calcified area, since the limiting end 611 of the positioning bracket 61 is facing the distal side of the balloon 5, when the balloon 5 slides and extends into the opening, the balloon 5 will not touch the calcified area without being inflated; first push the catheter 4 to the distal end, so that the limiting end 611 of the positioning bracket 61 abuts against the outer side wall of the opening at the lesion position and maintains this abutment, and then fill the balloon 5 with gas to expand the opening at the lesion position, the positioning ring expands radially, and the axial length of the positioning ring is reduced, and further The catheter 4 is pushed to move distally step by step, and the positioning bracket 61 is further kept in contact with the outer side wall of the lesion opening. At this time, the position of the catheter 4 is manually kept unchanged. Even if the balloon 5 touches the calcified area after being filled, the balloon 5 will not move forward or backward instantly. The positioning bracket 61 limits the sliding of the balloon 5, and thus will not damage the organs adjacent to it. At the same time, multiple positioning brackets 61 are evenly distributed on the periphery of the balloon 5, so that when the positioning bracket 61 is in contact with the outer side wall of the opening at the lesion position, the balloon 5 is evenly stressed and will not twist, thereby ensuring the expansion effect of the balloon 5 on the opening at the lesion position.

[0073] Preferably, the positioning bracket is made of a metal material with a memory function, which can not only effectively realize the positioning of the balloon, but also facilitate the folding or recovery of the positioning ring into the outer sheath.

[0074] In order to further assist the positioning bracket 61 to tend to remain in the retracted state, the above-mentioned cutting-type balloon dilatation device also includes a traction mechanism having a traction end, which is connected to any positioning bracket 61 and applies a biasing force to the positioning bracket 61 on the side away from the positioning bracket 61, and the biasing force drives the positioning bracket 61 to tend to remain in the retracted state.

[0075] Preferably, if Figure 4 As shown, the traction mechanism includes a push-pull seat 91 that can be slidably sleeved on the inner tube 3 and is arranged in the handle housing 1; at least two traction wires 93 and a biasing member (not shown in the figure). In this embodiment, the biasing member is a compression spring. When there are three positioning brackets 61, there are at least three traction wires 93 correspondingly, at least one traction wire 93 corresponds to one positioning bracket 61, the distal end of the traction wire 93 serves as the traction end, and the proximal ends of all the traction wires 93 are fixed on the push-pull seat 91.

[0076] For example, the proximal ends of the three traction wires 93 are evenly fixed on the end surface or the outer peripheral wall of the proximal end of the push-pull seat 91, and the distal ends of the traction wires 93 are connected to the positioning bracket 61. The compression spring is sleeved outside the inner tube 3, and the proximal and distal ends of the compression spring are respectively abutted on the push-pull seat 91 and the connecting seat 11 (mentioned below), and the compression spring applies a biasing force to the push-pull seat 91 in the direction away from the positioning bracket 61.

[0077] exist Figure 4 In the example, the biasing force is toward the right side, and the positioning bracket 61 is on the left side ( Figure 4 (not shown in the figure). Since one end of the positioning bracket 61 is fixed on the catheter 4 or the balloon 5, before the balloon 5 is inflated, the biasing force of the compression spring drives the push-pull seat 91 to slide toward the right, and applies a pulling force along the axial direction of the catheter 4 to the positioning bracket 61 through the traction wire 93, thereby causing the positioning bracket 61 to shrink and deform in the first direction, increase the axial length, and the positioning bracket 61 is in a retracted state; when the balloon 5 is inflated, the balloon 5 applies an expansion force along the first direction to the positioning bracket 61 to overcome the above-mentioned biasing force, thereby driving the push-pull seat 91 to move toward the left side, increasing its expansion deformation in the first direction, shortening the axial length, and the positioning bracket 61 is in an expanded state. That is, under the biasing force of the compression spring, the positioning bracket 61 tends to remain in a retracted state, which is convenient for the subsequent storage of the balloon 5 and the positioning bracket 61 as a whole in the outer sheath 2.

[0078] Furthermore, to ensure that the push-pull seat 91 slides back and forth axially along the inner tube 3 in the handle housing 1, a first guide member 911 extending axially along the catheter 4 is provided on the inner wall of the handle housing 1 and one of the push-pull seat 91, and a first matching member 912 is provided on the other, and the first matching member 912 is slidably provided on the first guide member 911.

[0079] For example, the push-pull seat 91 is in a triangular prism or cylindrical shape, and a first guide member 911 is provided on its outer peripheral wall surface. For example, the first guide member 911 is a guide protrusion, such as Figure 5 As shown, the handle housing is provided with a first matching piece 912, which is a guide slot, and the guide protrusion is inserted into the guide slot to play a guiding role. As a variation, the positions of the first guide piece 911 and the first matching piece 912 can be interchanged.

[0080] Further preferably, the above-mentioned traction mechanism further includes a pull rod handle 92 fixed on the proximal end of the push-pull seat 91 ; the pull rod handle 92 is located outside the handle housing 1 .

[0081] For example, the pull rod handle includes a pull rod fixed on the proximal end of the push-pull seat 91, and a button fixed on the proximal end of the pull rod. A step is formed between the button and the pull rod. The button is located outside the proximal end of the handle housing 1. By applying a thrust to the button, the push-pull seat 91 is pushed to slide toward the distal end to overcome the biasing force of the above-mentioned compression spring, and the positioning ring is expanded and deformed in the first direction after the auxiliary balloon 5 is inflated, and quickly switches to the expanded state; of course, a pulling force in the same direction as the biasing force can also be applied to assist the positioning frame to shrink and deform in the first direction after the airbag is deflated, and quickly switch to the retracted state.

[0082] like Figure 3 , Fig.10As shown, the traction mechanism also includes a support ring 7, which is sleeved outside the balloon 5 and can be radially deformed. The proximal end of the support ring 7 is connected to the traction end of the traction wire and sleeved and fixed on the proximal end of the balloon 5, and the distal end of the support ring 7 is sleeved and fixed on the distal end of the balloon 5; the proximal end of the positioning bracket 61 is connected to the balloon 5 or the catheter 4 by being fixed on the support frame 71.

[0083] For the support ring 7, Fig.10 As shown, the support ring 7 includes at least three support frames 71, the distal ends of the multiple support frames 71 are fixed on the limiting ring, and are fixed to the distal end of the balloon 5 through the limiting ring sleeve, and the proximal ends of the multiple support frames 71 converge into a circular ring shape, and are fixed to the proximal end of the balloon 5 through the limiting ring sleeve.

[0084] The biasing force applied by the compression spring is applied to the support ring 7 through the traction wire 93, so that the support ring 7 is contracted or expanded in the radial direction, thereby driving the positioning bracket 61 fixed on the support ring 7 to contract or expand in the first direction. At the same time, the setting of the support ring 7, on the one hand, facilitates the proximal end of the positioning bracket 61 to be installed on the support ring 7, and on the other hand, when the balloon 5 is inflated and in working state, the balloon 5 applies expansion force to the support ring 7, thereby applying expansion force to the positioning bracket 61. The support ring 7 supports the balloon 5, enhances the hardness of the balloon 5, and more effectively expands the opening of the lesion.

[0085] Preferably, a T-shaped notch groove 711 is provided on the proximal end of the support frame 71, and a T-shaped protrusion 931 is provided on the distal end of the traction wire 93 accordingly, and the T-shaped protrusion 931 is hooked in the T-shaped notch groove 711 to achieve a fixed connection between the support frame 71 and the traction wire 93. Of course, other connection methods can be used, such as spot welding or gluing.

[0086] Furthermore, in order to ensure that the positioning bracket 61 is suspended outside the balloon 5 and maintains a certain distance from the balloon 5 when the balloon 5 is inflated and in working state, the radial inner hole diameter of the positioning bracket 61 is increased, and when the balloon 5 slides into the opening of the lesion position and is inflated and expanded, it is ensured that the positioning bracket 61 can abut against the outer side wall of the opening of the lesion position or other tissues adjacent to the opening to achieve positioning. The traction mechanism also includes at least two connecting wires 94. When there are at least three positioning brackets 61, correspondingly, there are at least three connecting wires 94, and at least one connecting wire 94 corresponds to one positioning bracket 61.

[0087] like Figure 9a , Figure 9b and Fig.11As shown, any connecting wire 94 includes a body 944, and a first connecting portion 943 and a second connecting portion 945 formed at both ends of the body, and the first connecting portion 943 and the second connecting portion 945 are respectively connected to the positioning bracket 61 and the support ring 7. The connecting wire 94 is made of shape memory material. Under the effect of its own shape memory, the connecting wire 94 forces the body 944 and the first connecting portion 943 and the second connecting portion 945 to maintain a bent connection state, respectively, and correspondingly form a first bending segment 941 and a second bending segment 942, driving the positioning bracket 61 to be suspended on the periphery of the support ring 7.

[0088] Since the connecting wire 94 is made of a shape memory material, preferably, the shape memory material is a shape memory alloy material, after the connecting wire 94 is prepared, when the connecting wire 94 is not subjected to a force, the connecting wire 94 maintains the above-mentioned first bending segment 941 and the second bending segment 942, and since the positioning bracket 61 is connected to the support ring 7 by the connecting wire 94, when the balloon 5 is in working state, in the first direction, the connecting wire 94 keeps the positioning bracket 61 in a suspended state away from the balloon 5; when the gas in the balloon 5 is discharged, the traction wire 93 shrinks and deforms in the first direction under the biasing force of the compression spring, and as the support ring 7 shrinks and deforms, the second bending segment 942 is finally straightened, and further the first bending segment 941 is straightened, so that the proximal end of the positioning bracket 61 is close to or abuts against the support ring 7, and is finally received in the inner cavity of the outer sheath 2. On the contrary, the outer sheath 2 moves backward, the positioning bracket 61, the balloon 5 and the support ring 7 are exposed as a whole, the balloon is inflated and under the biasing force of the compression spring, the connecting wire 94 is reset to the starting state, maintaining the above-mentioned first bending section 941 and the second bending section 942, so as to achieve that when the balloon 5 is in the working state later, it is suspended at a farther distance from the balloon 5.

[0089] Regarding the connection method of the connecting wire 94, the supporting ring 7 and the positioning bracket 61, optionally, as Figure 9a and Figure 9b As shown, the second connection portion 945 of the connection wire 94 is clamped in the clamping groove 72 of the support ring 7, and the first connection portion is inserted into the plurality of first mounting holes 614 on the positioning bracket 61 along the direction S. For example, Figure 8 As shown, a protrusion is provided on the inner side of the V-shaped closed end, and a plurality of second mounting holes are provided on the protrusion for the first connecting part to pass through. Or other connection methods can be used, which will not be described in detail here.

[0090] As a variation, the first bending section 941 and the second bending section 942 of the connecting wire 94 may only be provided with the first bending section 941 or the second bending section 942, and the connecting wire 94 may also function to support the positioning bracket 61 outward in the first direction, so that the positioning bracket 61 is suspended at a certain distance from the balloon 5.

[0091] The outer sheath 2 can be slidably sleeved outside the catheter 4; in a non-working state, the positioning bracket 61 and the balloon 5 can be folded in the outer sheath 2; in a working state, the positioning bracket 61 and the balloon 5 extend out of the distal end of the outer sheath and expand.

[0092] like Figure 4 As shown, the outer sheath 2 is slidably disposed outside the catheter 4 by being driven by the conveying mechanism. Specifically, the proximal end and the distal end of the handle housing 1 are respectively a first open opening and a second open opening, and the conveying mechanism includes a conveying tube 201, a screw nut 202 and a stop seat 203.

[0093] The delivery tube 201 is rotatably and non-sliply arranged in the inner cavity of the handle housing 1, for example, Figure 5 and Figure 4 A first annular baffle 12 and a second annular baffle 13 are provided on the inner wall surface of the middle handle shell, and two annular flanges are spaced apart on the outer wall surface of the delivery tube, and the two annular flanges are respectively abutted against the first annular baffle and the second annular baffle. A step head 2011 is fixed on the distal end of the delivery tube 201, and the diameter of the proximal end of the step head 2011 is larger than the diameter of the second open port of the handle shell 1, and the diameter of the delivery tube 201 is smaller than the diameter of the second open port of the handle shell 1. The step head 2011 is located outside the second open port of the handle shell 1, and the diameter of the distal end of the step head 2011 is smaller than the diameter of the handle shell 1 to form a contraction port; the screw nut 202 is fixedly sleeved on the outer peripheral wall of the outer sheath tube 2, and the inner wall surface of the delivery tube 201 and the screw nut 202 are matched by threads.

[0094] The connection seat 11 is fixed on the inner wall surface of the handle housing 1. For example, the inner wall surface of the handle housing 1 is provided with a first annular baffle 12 and a second annular baffle 13. The distal end of the connection seat 11 is provided with an annular flange 111, which is clamped between the third annular baffle 17 and the fourth annular baffle 18 to limit the connection seat 11 from sliding along the axial direction of the catheter 4. At the same time, the outer peripheral wall of the connection seat 11 is provided with a first protrusion 112 extending along the axial direction of the catheter 4, and the handle housing 1 is correspondingly provided with a first groove for the first protrusion 112 to be embedded. The clamping arrangement of the first protrusion 112 and the first groove limits the connection seat 11 from rotating along the circumferential direction of the catheter 4. Of course, the setting positions of the first protrusion 112 and the first groove can be swapped, so that the connection seat 11 is fixed to the handle housing 1.

[0095] The proximal end of the anti-rotation seat 203 is inserted into the clearance hole 16 on the connecting seat, and the distal end thereof is fixed on the handle housing 1, for example, the two are fastened and connected by screws; an annular mounting seat 14 is provided on the inner wall surface of the handle housing 1 for the distal end of the anti-rotation seat 203 to pass through, and the inner diameter of the annular mounting seat 14 matches the outer diameter of the anti-rotation seat 203; in addition, the constricted end of the step head 2011 blocks the distal end of the anti-rotation seat 203 in the handle housing 1, and a guide channel extending along the axial direction of the catheter 4 is provided on the anti-rotation seat 203, and the proximal end of the outer sheath tube 2 is located in the guide channel to block the rotation of the outer sheath tube 2 and only allow the outer sheath tube 2 to slide. In order to avoid the lead screw nut 202, an avoidance channel for the anti-rotation seat 203 to pass through is provided on the lead screw nut 202, and the longitudinal cross-sectional shape of the guide channel on the anti-rotation seat 203 is U-shaped.

[0096] When the step head 2011 is rotated to drive the entire delivery tube 201 to rotate, the lead screw nut 202 slides on the thread of the inner wall of the delivery tube 201 to drive the outer sheath tube 2 fixed in its inner hole to slide on the catheter 4, so that the outer sheath tube 2 slides forward (i.e., slides toward the distal end) or slides backward (i.e., slides toward the proximal end). The setting of the outer sheath tube makes the cutting-type balloon dilatation device smoother when entering the human body, reducing vascular complications during surgery. The setting of the above-mentioned handle shell and pull rod handle facilitates the operation of the device, simplifies the structure, and reduces the difficulty of operation.

[0097] In order to reduce the calcified area in the opening of the lesion, preferably, the cutting balloon dilatation device, such as Fig.11 As shown, at least one blade 81 extending along its axial direction is provided on the outer wall surface of the balloon 5, and the blade 81 is distributed away from the positioning bracket 61. Before the balloon 5 is inflated or during the inflation process, the blade 81 first touches the calcified area with the balloon 5. During the movement of the balloon 5 or the balloon 5 can be driven to rotate by the push-pull seat 91, the blade 81 cuts off the calcified area as the balloon 5 moves or rotates. Afterwards, after the balloon 5 is inflated, the balloon 5 is further prevented from contacting the calcified area, thereby reducing the force exerted by the calcified area on the balloon 5, reducing the probability of the balloon moving forward or backward along the calcified area instantly, and thereby reducing the probability of damaging the adjacent organ tissues.

[0098] For the cutting blade 81, Fig.11 As shown, the blade 81 is fixed on the blade holder 82, the support frame 71 of the support ring 7 is provided with a mounting through hole 73, the blade holder 82 is stacked on a side surface of the support frame 71, and the blade 81 extends outward in a first direction through the mounting through hole 73. The blade holder 82 can be fixed on the support frame 71, or the blade holder 82 can be directly fixed on the balloon 5, for example, by bonding.

[0099] There are multiple blades, each of which is fixed to the support frame of the support ring through a blade holder. Optimally, the multiple blades are evenly distributed on the outer wall of the balloon. As a variation, the blade holder can be directly fixed to the outer wall of the balloon. Alternatively, the blade holder can be omitted and the blades can be directly fixed to the outer wall of the balloon.

[0100] In addition, if Figure 3 , Figure 6 and Figure 7 As shown, an exhaust pipe 10 is arranged on the proximal end of the outer sheath tube 2, and the proximal end of the exhaust pipe 10 passes through the inner hole of the screw nut and extends to the inner hole of the connecting seat 11. The exhaust pipe 10 is sleeved on the outside of the catheter 4, and a first sealing ring is sealed between the outside of the exhaust pipe and the inner hole of the screw nut, and a first pressing plate is arranged on the proximal end face of the screw nut to limit the first sealing ring outside the exhaust pipe. A second sealing ring is provided between the inner hole of the connecting seat and the catheter, and the distal end of the second sealing ring faces the proximal end face of the emptying tube. The second sealing ring 101 is sleeved on the outside of the catheter 4 and the traction wire 93, and a second pressing plate 102 is provided on the proximal end face of the connecting seat 11 to seal the proximal end of the inner hole of the connecting seat, so that the inner hole of the emptying tube 10 is sealed and connected with the inner hole of the connecting seat 11. The connecting seat 11 is provided with a first connecting hole 15 along its radial direction, and a second connecting hole connected with the first connecting hole 15 is provided on the handle housing 1. The first connecting hole 15 is located between the second sealing ring 101 and the emptying tube 10. By injecting liquid into the second connecting hole, the liquid enters the emptying tube 10 through the second connecting hole and then empties the cavity between the outer sheath 2 and the catheter 4.

[0101] The process of dilating the opening of the lesion position on the aortic sinus by the cutting balloon dilation device of this embodiment is as follows:

[0102] First, the gas between the outer sheath tube 2 and the catheter 4 is emptied through the evacuation tube 10, and liquid is introduced through the first inlet and the second inlet of the three-way valve 103 to evacuate the gas in the inner cavity of the inner tube 3 and the gas in the channel between the catheter 4 and the inner tube 3 respectively;

[0103] The hard guide wire is passed through the inner tube 3, and the distal end of the hard guide wire extends out of the distal end of the inner tube 3. At this time, the balloon 5 is in a non-working state, and the balloon 5, the positioning stent 61, and the support ring 7 are integrally retracted in the outer sheath tube 2; the hard guide wire drives the entire expansion balloon 5 catheter 4 device through the femoral artery approach, passes through the abdominal aorta and the aortic arch in turn to reach the lesion position of the aortic sinus, and passes through the opening surrounded by the three valve leaflets of the aortic sinus. At this time, the balloon 5, the support ring 7, the positioning stent 61, and the outer sheath tube 2 are integrally passed through the opening;

[0104] By rotating the delivery tube 201, the outer sheath 2 is moved backward toward the proximal end, and the balloon 5, the support ring 7 and the positioning bracket 61 are not released by the force of the outer sheath 2. The positioning bracket 61 is opened and suspended outside the balloon 5. At this time, the balloon 5 has not been inflated yet. Under the biasing pressure of the compression spring at the push-pull seat 91, the support ring 7 remains radially retracted and the connecting wire 94 is not reset.

[0105] Afterwards, first push the handle shell 1 to make the positioning bracket 61 abut against the bottom of the valve sinus, that is, the outer wall of the outer periphery of the opening surrounded by the three leaflets, fix the handle shell 1 to make the positioning bracket 61 always keep abutting against the bottom of the valve sinus to prevent the balloon 5 from moving backward, and then inflate the balloon 5. During the filling process of the balloon 5, the support ring 7 is radially expanded and the biasing force of the compression spring at the push-pull seat 91 is overcome, driving the push-pull seat 91 and the pull rod handle 92 to move toward the distal end. At the same time, the connecting wire 94 resets the first bending section 941 and the second bending section 942 under the action of shape memory, further making the positioning bracket 61 suspended outside the periphery of the balloon 5.

[0106] At this time, even if the filled balloon 5 contacts the calcified area on the inner wall of the opening, the positioning function of the positioning bracket 61 prevents the balloon 5 from moving forward or backward, so that the balloon 5 expands the opening of the lesion.

[0107] At the same time, during the filling or non-filling process of the balloon 5, since the blade 81 is located outside the balloon 5, the blade 81 contacts the calcified area before the balloon 5, and the blade 81 has a cutting effect on the calcified area. After the balloon 5 is filled, the probability of the balloon 5 contacting the calcified area is reduced, so that the balloon 5 can better complete the expansion of the valve, reduce or avoid the phenomenon of the balloon 5 moving forward or backward instantly after touching the calcified area, and reduce the probability of damage to the adjacent organ tissue. In addition, before expansion, the depth of the blade 81 can be selected according to the thickness of the calcified area to cut the calcified area more accurately.

[0108] After the expansion balloon 5 catheter 4 device has expanded the opening surrounded by the leaflets, the gas in the balloon is first emptied. Under the biasing force of the compression spring, the push-pull seat 91 and the pull rod handle 92 as a whole drive the traction wire 93, the support ring 7 and the connecting wire 94 to move toward the proximal end, so that the support ring 7 is radially contracted and the connecting wire 94 is straightened. Finally, the outer sheath 2 is moved forward, and the support ring 7, the connecting wire 94 and the positioning bracket 61 are integrally received into the outer sheath 2, and the handle shell 1 is acted on to remove the expansion balloon 5 catheter 4 device as a whole from the human body.

[0109] The number of the positioning brackets 61 can also be two, four, five, etc. The specific number is determined according to needs and is not limited here.

[0110] As a modified implementation, there are several positioning brackets 61, and two adjacent positioning brackets 61 are arranged so that all positioning brackets 61 form a cylindrical tube and are sleeved outside the balloon 5, which can also play a role in positioning the balloon 5 during expansion.

[0111] Example 2

[0112] This embodiment provides a cutting balloon dilation device, which is different from the dilation balloon 5 catheter 4 device provided in Example 1 only in that:

[0113] The structure of the positioning bracket 61 is different, such as Fig.13 As shown, the positioning bracket 61 is in the form of a strip block or a strip column; in the non-working state, the positioning bracket 61 is distributed on the same straight line along the axial direction of the balloon 5; the proximal end of the positioning bracket 61 is fixed on the proximal end of the balloon 5, and the distal end of the positioning bracket 61 is suspended outside the balloon 5. In the working state, the positioning bracket 61 is expanded and deformed in the first direction along the shape of the balloon 5.

[0114] Or, if Fig.12 As shown, the positioning bracket 61 includes a mounting portion 612 and a limiting portion 613, the distal end of the mounting portion 612 is fixed on the distal end of the balloon 5, the proximal end of the limiting portion 613 is bent outward along a first direction and fixed on the proximal end of the mounting portion 612, and the distal end of the limiting portion 613 serves as a limiting end 611.

[0115] In addition to the several forms of positioning bracket 61 given above, the positioning bracket 61 can also be in other shapes. It only needs to fix one end of the positioning bracket 61 on the balloon 5 or the catheter 4, and the other end faces the distal side of the balloon 5 as a limiting end 611, which can play a limiting role on the balloon 5 during the expansion process.

[0116] For example, Fig.14 As shown, the positioning bracket is directly fixed to the middle part of the balloon, a mounting groove is provided on the balloon, one end of the positioning bracket is clamped in the mounting groove, and the distal end of the positioning bracket serves as a limiting end.

[0117] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A cutting balloon dilatation device, characterized in that: It comprises an inner tube (3), a catheter (4) sleeved outside the inner tube (3), and a balloon (5) installed on the distal end of the catheter (4) and sleeved outside the inner tube (3); the balloon (5) has an inflated working state and an exhausted non-working state; At least one blade (81) extending along the axial direction of the balloon and fixed on the outer wall surface of the balloon; It also includes a traction mechanism with a traction end, the traction mechanism includes a support ring (7) which is sleeved outside the balloon (5) and can be radially deformed, the proximal end of the support ring (7) is connected to the traction end, and the distal end of the support ring (7) is fixed to the distal end of the balloon (5); It also comprises a positioning bracket (61), one end of which is arranged on the balloon (5) or the catheter (4) by being fixed on the supporting ring (7), and the other end of which serves as a limiting end (611) and extends in midair toward the distal end of the balloon (5), the traction end is applied to the positioning bracket (61) by applying a biasing force to the supporting ring (7), and the biasing force drives the positioning bracket (61) to tend to maintain a retracted state; the blade is arranged on the outer peripheral wall of the balloon by being arranged on the supporting ring.

2. The cutting balloon dilatation device according to claim 1, characterized in that: There are at least two blades (81), and all the blades (81) are evenly distributed on the outer peripheral wall surface of the balloon along the circumference of the balloon.

3. The cutting balloon dilatation device according to claim 1, characterized in that: It also includes at least one knife seat (82), each of the blades (81) is fixed on the knife seat (82), and the knife seat (82) is installed on the outer peripheral wall surface of the balloon.

4. The cutting balloon dilatation device according to any one of claims 1 to 3, characterized in that: It also includes at least two positioning brackets (61) distributed away from the blade (81), one end of each positioning bracket (61) being fixed to at least one of the catheter (4) and the balloon (5); all the positioning brackets (61) are evenly distributed on the periphery of the balloon (5) along the circumference of the balloon (5); In the working state, the positioning bracket (61) is in an expanded state in which it is expanded outwardly in a first direction perpendicular to the axial direction of the balloon (5) due to the expansion force exerted by the balloon (5); in the non-working state, the expansion force exerted on the positioning bracket (61) is cancelled and the positioning bracket (61) is in a collapsed state in which it is contracted inwardly in the first direction.

5. The cutting balloon dilatation device according to claim 4, characterized in that: The traction end is connected to any one of the positioning brackets (61) and applies a biasing force to the positioning bracket (61) in a direction away from the positioning bracket (61).

6. The cutting balloon dilatation device according to claim 5, characterized in that: The traction mechanism comprises a push-pull seat (91) slidably mounted on the inner tube (3), at least two traction wires (93) and a biasing member; The distal end of at least one of the traction wires (93) serves as the traction end, and the proximal end of the traction wire (93) is fixed on the push-pull seat (91); the biasing member is connected to the push-pull seat (91) to apply the biasing force to the push-pull seat (91).

7. The cutting balloon dilatation device according to claim 6, characterized in that: The traction mechanism also includes a pull rod handle (92) fixed on the proximal end of the push-pull seat (91); The cutting-type balloon dilation device further comprises a handle shell (1), and the inner tube (3) and the catheter (4) are both inserted into the handle shell (1); The push-pull seat (91) is located inside the handle housing (1); one end of the biasing member is mounted on the push-pull seat (91) and the other end is fixedly arranged relative to the handle housing (1); the pull rod handle (92) is located outside the handle housing (1).

8. The cutting balloon dilatation device according to claim 4, characterized in that: The traction mechanism further comprises at least two connecting wires (94), at least one connecting wire (94) corresponds to one positioning bracket (61), any one of the connecting wires (94) comprises a body, and a first connecting portion (943) and a second connecting portion (945) formed at two ends of the body, the first connecting portion (943) and the second connecting portion (945) being connected to the positioning bracket (61) and the support ring (7) respectively; The connecting wire (94) is made of a shape memory material. Under the effect of its own shape memory, the connecting wire (94) forces the main body and at least one of the first connecting part and the second connecting part to maintain a bent connection state to form a bent section, thereby driving the positioning bracket (61) to be suspended on the periphery of the balloon (5).

9. The cutting balloon dilatation device according to claim 8, characterized in that: There are at least three positioning brackets (61), and the three positioning brackets (61) are connected end to end in sequence to form a positioning ring that is deformable along the first direction; the connection between the distal ends of any two adjacent positioning brackets (61) forms the limiting end (611); The proximal end of the positioning bracket (61) is connected to the first connecting portion of the connecting wire (94).

10. The cutting balloon dilatation device according to claim 8, characterized in that: The positioning bracket (61) is V-shaped, the closed end of the V-shape is connected to the first connecting portion of the connecting wire (94), and either end of the V-shaped opening is connected to one end of the V-shaped opening of the adjacent positioning bracket (61) to form the limiting end (611).

11. The cutting balloon dilatation device according to claim 4, characterized in that: The positioning bracket (61) is in the form of a strip block or a strip column; in a non-working state, the positioning bracket (61) is distributed on the same straight line along the axial direction of the balloon (5); or The positioning bracket (61) includes a mounting portion (612) and a limiting portion (613), the distal end of the mounting portion (612) is fixed to the distal end of the balloon (5), the proximal end of the limiting portion (613) is bent outward along a first direction and fixed to the proximal end of the mounting portion (612), and the distal end of the limiting portion (613) serves as the limiting end (611).

12. The cutting balloon dilatation device according to claim 4, characterized in that: It also includes an outer sheath tube (2), which can be slidably mounted outside the catheter (4); in a non-working state, the positioning bracket (61) and the balloon (5) can be retracted inside the outer sheath tube (2); in a working state, the positioning bracket (61) and the balloon (5) extend out of the distal end of the outer sheath tube and expand.

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