CN113491822A - Balloon dilatation catheter and balloon dilatation catheter assembly - Google Patents

Abstract

The invention provides a balloon dilatation catheter and a balloon dilatation catheter assembly, wherein the balloon dilatation catheter comprises an inner tube, an outer tube and a balloon, and the balloon can be switched between a contraction state and an expansion state; one part of the inner tube penetrates through the inside of the balloon, the outer tube is sleeved outside the inner tube, a gap is formed between the outer tube and the inner tube, and the gap is used for transmitting filling liquid to drive the state conversion of the balloon; the part that the inner tube wore to locate in the sacculus includes first section and a plurality of logical liquid structure, leads to the liquid structure and link up along the axial and set up in first section, leads to the both ends of liquid structure and opens in the inside of sacculus, leads to the liquid structure including seting up in the apparent slot of first section and/or wear to locate the vestibule in the pipe wall of first section. All areas near the far end of the saccule can be synchronously expanded, so that the problems of saccule slippage, expansion failure and the like are avoided.

Description

Balloon dilatation catheter and balloon dilatation catheter assembly

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon dilatation catheter and a balloon dilatation catheter assembly.

Background

Aortic valvuloballoon angioplasty (BAV) has become one of the important methods for treating valvular heart disease, and has the advantages of small wound, safety, obvious curative effect and the like, and can replace surgical thoracotomy to a certain extent. For patients with severe calcified aortic stenosis who are not suitable for surgical operations, transcatheter aortic valve placement (TAVI) is adopted, transfemoral puncture is conducted by a guide wire, the aortic stenosis passes through an aortic arch and is placed at the position of an aortic root valve ring, contrast solution is injected into a balloon to expand the balloon to a required size, the calcified valve ring is expanded, good access conditions are created for implantation of the artificial valve, and meanwhile, the artificial valve can be well expanded and the adherence is improved by expansion after the aortic valve balloon catheter is implanted, so that the treatment effect is improved.

The aortic valve sacculus expansion pipe comprises an expandable valve sacculus, a double-cavity pipe body and two connecting pieces, wherein the size of the inner cavity of the double-cavity pipe body is compatible with a guide wire with a corresponding specification, and the outer cavity and the proximal equipment keep unobstructed so as to ensure that the filling and withdrawing time is as short as possible. Currently, the inner tube of a valve balloon is typically a circular hollow tube. The hollow lumen allows the balloon catheter to move along the guidewire to the focal region.

The balloon is folded and pressed to constrict the outer diameter to the size close to the outer tube, so that the propelling performance of the balloon catheter is improved when the balloon catheter passes through the blood vessel and the focus, and the blood vessel injury and the secondary lesion are reduced. After the sacculus is accurately positioned to the focus, the middle of the straight section of the sacculus corresponds to the aortic valve, and an operator uses filling liquid such as physiological saline and the like to inject into the sacculus to help the sacculus to be unfolded. At this stage, when the balloon is too much constrained by the diseased valve area due to calcification and the like, the balloon is often difficult to be deployed at the near end and the far end simultaneously. When the near end of the saccule is inflated first, the whole saccule catheter slides towards the near end due to the shape factor, so that the saccule is separated from a well-positioned focus area, and the normal operation of the interventional operation is interfered.

Disclosure of Invention

The invention aims to provide a balloon dilatation catheter and a balloon dilatation catheter assembly, which are used for solving the problems of balloon slippage, expansion failure, balloon fracture and the like caused by asynchronous balloon dilatation in the conventional balloon dilatation catheter.

In order to solve the above technical problems, the present invention provides a balloon dilatation catheter comprising: an inner tube, an outer tube and a balloon; the balloon is capable of transitioning between a deflated state and an inflated state; a part of the inner tube penetrates through the inside of the balloon, the outer tube sleeve is arranged outside the inner tube, a gap is formed between the outer tube sleeve and the inner tube, and the gap is used for transmitting filling liquid to drive the state conversion of the balloon;

the part of the inner tube penetrating through the balloon comprises a first section and a plurality of liquid passing structures, the liquid passing structures are axially arranged in the first section in a penetrating mode, two ends of the liquid passing structures are arranged in the balloon in an open mode, and each liquid passing structure comprises a groove arranged on the outer surface of the first section and/or a hole cavity arranged in the tube wall of the first section in a penetrating mode.

Optionally, in the balloon dilation catheter, the plurality of fluid passing structures are distributed circumferentially about an axis of the inner tube.

Optionally, in the balloon dilatation catheter, a portion of the inner tube penetrating through the balloon further includes a second section and a third section, and the second section, the first section and the third section are sequentially arranged from a distal end to a proximal end; the first segment has a radially outer dimension that is greater than a radially outer dimension of the second segment and a radially outer dimension of the third segment.

Optionally, in the balloon dilatation catheter, a portion of the inner tube corresponding to the balloon further comprises a transition section disposed between the second section and the first section, and/or between the first section and the third section; the transition section is provided with a larger end and a smaller end, the larger end is connected with the first section, and the radial outer dimension of the larger end is matched with the radial outer dimension of the first section; the smaller end is connected with the second section and/or the third section, and the radial outer size of the smaller end is matched with the radial outer size of the second section and/or the radial outer size of the third section.

Optionally, in the balloon dilatation catheter, the liquid passing structure extends and penetrates the transition section along the axial direction of the inner tube.

Optionally, in the balloon dilatation catheter, a distance between the bottom of the liquid passing structure and the axis of the first section is equal to half of the radial outer dimension of the second section or the third section.

Optionally, in the balloon dilatation catheter, the first section is provided with a plurality of notches arranged at intervals along the axial direction, the notches extend from the outer surface of the first section to the axis of the first section, and the bottoms of the notches are not deeper than the bottom of the liquid passing structure.

Optionally, in the balloon dilatation catheter, the incision is V-shaped along the axial direction of the first section, and the angle of the V-shape ranges from 10 ° to 40 °.

Optionally, in the balloon dilatation catheter, the liquid passing structure comprises a groove which is arranged on the outer surface of the first section, and the cross section of the groove is a sector part or a circular part; and/or the liquid passing structure comprises a cavity penetrating through the pipe wall of the first section, and the cross section of the cavity is circular.

Optionally, in the balloon dilatation catheter, the wall of the first section comprises a first wall layer and a second wall layer from inside to outside, and the elastic modulus of the second wall layer is greater than that of the first wall layer; the bottom of the liquid passing structure is located on the first wall layer, and the top of the liquid passing structure is located on the second wall layer.

Optionally, the distal end of the balloon is hermetically connected with the distal end of the inner tube, and the proximal end of the balloon is hermetically connected with the distal end of the outer tube.

Optionally, the first section, the second section and the third section are integrally formed; or the second section is integrally formed and is respectively connected with the first section and the third section.

In order to solve the technical problems, the invention provides a balloon dilatation catheter assembly, which comprises the balloon dilatation catheter, a sheath, a liquid through cavity, a wire guide cavity and a connecting piece, wherein the liquid through cavity and the wire guide cavity are respectively arranged on the sheath; the near end of the inner tube is connected with the sheath and is communicated with the guide wire cavity; the proximal end of the outer tube is connected with the sheath, and the gap is communicated with the liquid through cavity; the connecting piece is arranged at the near end of the guide wire cavity and the near end of the liquid through cavity.

In summary, the balloon dilatation catheter provided by the invention comprises an inner tube, an outer tube and a balloon, wherein the balloon can be switched between a contraction state and an expansion state; a part of the inner tube penetrates through the inside of the balloon, the outer tube sleeve is arranged outside the inner tube, a gap is formed between the outer tube sleeve and the inner tube, and the gap is used for transmitting filling liquid to drive the state conversion of the balloon; the part of the inner tube penetrating through the balloon comprises a first section and a plurality of liquid passing structures, the liquid passing structures are axially arranged in the first section in a penetrating mode, two ends of the liquid passing structures are arranged in the balloon in an open mode, and each liquid passing structure comprises a groove arranged on the outer surface of the first section and/or a hole cavity arranged in the tube wall of the first section in a penetrating mode.

So the configuration, through the setting of leading to the liquid structure, even partly by the constraint extrusion of sacculus, full liquid also can make each regional synchronous expansion of nearly distal end of sacculus through the region by the constraint extrusion via leading to the liquid structure, has avoided sacculus slippage or expansion failure scheduling problem, has improved the success rate of intervention operation. Further, when leading to liquid structure including seting up in the apparent slot of first section, even the sacculus is compelled to be attached in the surface of inner tube, the bottom of slot still can be kept away from to the sacculus, and the slot can be supplied sufficient liquid to pass through smoothly, is applicable to the patient of valve area serious calcification. When the liquid passing structure comprises a hole cavity penetrating through the pipe wall of the first section, the outer wall of the first section can support the balloon to prevent the inner wall of the balloon from blocking the hole cavity, and under the condition of large constraint, the sectional area of the hole cavity for liquid passing is stable, and the liquid passing effect is good.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:

FIG. 1 is a partially schematic illustration of a balloon dilation catheter provided in accordance with a preferred embodiment of the present invention;

FIG. 2 is a schematic view of an inner tube provided in accordance with a preferred embodiment of the present invention;

FIG. 3 is a schematic cross-sectional view of a second section of the inner tube provided in accordance with a preferred embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view of a first section of an inner tube provided in accordance with a preferred embodiment of the present invention, wherein the fluid communication structure includes grooves;

FIGS. 5a to 5c are schematic views of cross-sections of trenches provided in a preferred embodiment of the present invention;

FIG. 6 is a schematic cross-sectional view of a first section of an inner tube provided in accordance with a preferred embodiment of the present invention, wherein the fluid passing structure includes a lumen;

FIG. 7 is a partial schematic view of an inner tube provided in accordance with a preferred embodiment of the present invention, wherein the inner tube includes a transition section;

FIG. 8 is a schematic cross-sectional view of a first section of an inner tube in accordance with a preferred embodiment of the present invention, wherein the fluid communication structure includes grooves;

FIG. 9 is a schematic cross-sectional view of a first section of an inner tube in accordance with a preferred embodiment of the present invention, wherein the wall of the first section comprises a two-layer structure;

FIG. 10 is a partial schematic view of an inner tube provided in accordance with a preferred embodiment of the present invention, wherein the first section is provided with a cut-out;

fig. 11 is an overall schematic view of a balloon dilation catheter assembly provided in accordance with a preferred embodiment of the present invention.

In the drawings:

3-development point; 4-a sheath; 5-liquid cavity; 6-a guide wire cavity; 7-a connector;

10-an inner tube; 100-inner tube bore; 11-a second section; 12-first stage; 120-liquid through structure; 121-a first wall layer; 122-a second wall layer; 123-incision; 13-third stage; 14-transition section;

20-a balloon; 21-a closing head; 22-a first conical section; 23-a straight section; 24-a second conical section; 25-a connecting segment; 30-outer tube.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the term "or" is generally employed in its sense including "and/or", the term "proximal" generally being the end closest to the operator, the term "distal" generally being the end closest to the patient's lesion, the terms "end" and "proximal" and "distal" generally referring to the corresponding two parts, including not only the end points, unless the content clearly dictates otherwise.

The core idea of the invention is to provide a balloon dilatation catheter and a balloon dilatation catheter assembly, which are used for solving the problems of balloon slippage, expansion failure or balloon rupture and the like caused by asynchronous balloon expansion in the conventional balloon dilatation catheter.

The following description refers to the accompanying drawings.

Referring to fig. 1 to 11, wherein fig. 1 is a partial schematic view of a balloon dilatation catheter according to a preferred embodiment of the present invention, fig. 2 is a schematic view of an inner tube according to a preferred embodiment of the present invention, fig. 3 is a schematic cross-sectional view of a second section of the inner tube according to a preferred embodiment of the present invention, fig. 4 is a schematic cross-sectional view of a first section of the inner tube according to a preferred embodiment of the present invention, wherein the liquid passage structure comprises a groove, fig. 5a to 5c are schematic cross-sectional views of the groove according to a preferred embodiment of the present invention, fig. 6 is a schematic cross-sectional view of a first section of the inner tube according to a preferred embodiment of the present invention, wherein the liquid passage structure comprises a lumen, fig. 7 is a partial schematic view of the inner tube according to a preferred embodiment of the present invention, wherein the inner tube comprises a tapered section, fig. 8 is a schematic cross-sectional view of a first section of the inner tube according to a preferred embodiment of the present invention, wherein the liquid-passing structure comprises grooves, fig. 9 is a schematic cross-sectional view of a first section of an inner tube according to a preferred embodiment of the present invention, wherein the wall of the first section comprises a two-layer structure, fig. 10 is a schematic partial view of an inner tube according to a preferred embodiment of the present invention, wherein the first section is provided with cuts; fig. 11 is an overall schematic view of a balloon dilation catheter assembly provided in accordance with a preferred embodiment of the present invention.

As shown in fig. 1, a balloon dilation catheter according to one embodiment of the present invention includes: an inner tube 10, an outer tube 30 and a balloon 20, the balloon 20 being capable of being switched between a deflated state and an inflated state; a part (mainly, a part of the distal end) of the inner tube 10 is inserted into the balloon 20, the other part of the inner tube 10 is extended out from the proximal end of the balloon 20 and then extends to the proximal end, and the outer tube 30 is sleeved outside the inner tube 10 and has a gap with the inner tube 10, and the gap is used for transmitting filling liquid to drive the state transition of the balloon 20. Generally, the state of the balloon 20 can be switched by folding or stretching the elastic material forming the balloon 20, and then the balloon 20 can be unfolded into an expanded state by infusing the balloon 20 with the filling liquid, and of course, the balloon 20 can be retracted by further sucking the filling liquid. The material and structure of the balloon 20 can be appropriately configured by those skilled in the art in light of the prior art. The portion of the inner tube 10 penetrating the balloon 20 includes a first section 12 and a plurality of liquid passing structures 120, the liquid passing structures 120 axially penetrate the first section 12, two ends of the liquid passing structures 120 are open inside the balloon 20, and the liquid passing structures 120 include grooves formed on the outer surface of the first section 12 and/or cavities formed in the wall of the first section 12. Optionally, the distal end of the balloon 20 is sealingly connected to the distal end of the inner tube 10, and the proximal end of the balloon 20 is sealingly connected to the distal end of the outer tube 30.

Further, referring to fig. 2-4 and fig. 1, the portion of the inner tube 10 penetrating through the balloon 20 further includes a second section 11 and a third section 13, and the second section 11, the first section 12, and the third section 13 are sequentially arranged from the distal end to the proximal end. Preferably, the inner tube 10 includes an inner tube hole 100 axially penetrating the inner tube 10, and the inner tube hole 100 is mainly used for a guide wire to pass through, so that the balloon dilatation catheter can move to a lesion area along the guide wire.

In an exemplary embodiment, the balloon 20 includes a closed head 21, a first tapered section 22, a straight section 23, a second tapered section 24 and a connecting section 25 connected in sequence from the distal end to the proximal end, the distal end of the closed head 21 is welded to the outer periphery of the distal end of the second section 11, so that the distal end of the balloon 20 is connected with the inner tube 10 in a sealing manner, and the distal end of the outer tube 30 is sleeved outside the connecting section 25. When the balloon 20 is in the expanded state, the straight section 23 remains substantially parallel to the axial direction of the inner tube 20, which is primarily used to expand the valve area. In actual use, the balloon 20 is delivered to the valve area in a deflated state, and inflation fluid is infused into the balloon 20 to expand the balloon 20. However, when the valve area is heavily calcified, it often hinders the expansion of the balloon 20, even the inner wall of the balloon 20 is attached to the inner tube 10, so that the filling fluid infused into the balloon 10 from the proximal end can expand only the proximal end area of the balloon 20 limited by the valve area, which easily causes the balloon 10 to slip. And through the setting of leading to liquid structure 120, even partly by the constraint extrusion of sacculus 20, full liquid also can make each regional synchronous expansion of the nearly distal end of sacculus 20 through the region by the constraint extrusion via leading to liquid structure 120, has avoided sacculus 20 slippage or expansion failure scheduling problem, has improved the success rate of interveneeing the operation. Further, when the liquid passing structure 120 includes the grooves formed on the outer surface of the first section 12, even if the balloon 20 is forced to be attached to the outer surface of the inner tube 10, the balloon 20 can still be far away from the bottom of the grooves, and the grooves can be used for the smooth passage of the filling liquid, which is suitable for the patient with serious calcification in the valve area. When the liquid passing structure 120 includes the hole cavity penetrating through the wall of the first section 12, the outer wall of the first section 12 can support the balloon 20, so as to prevent the inner wall of the balloon 20 from obstructing the hole cavity, and under the condition of large restriction, the sectional area of the hole cavity for liquid passing is stable, and the liquid passing effect is good.

Preferably, the plurality of liquid passing structures 120 are circumferentially distributed, preferably uniformly distributed, around the axis of the inner tube 10. It should be noted that the liquid passing structure 120 is axially disposed through the first section 12, and the extending direction of the liquid passing structure 120 is not limited to be parallel to the axial direction of the first section 12, but means that the liquid passing structure 120 axially passes through the first section 12, and the extending direction of the liquid passing structure 120 may be at an angle with the axial direction of the first section 12, for example, the extending direction of the liquid passing structure 120 is oblique, or spirally extends around the axial direction of the first section 12, or even an irregular shape, and the invention is not limited thereto. While in some embodiments, the liquid passing structure 120 may include both grooves and cavities, for example, the liquid passing structure 120 includes 4 grooves and 4 cavities, which are uniformly distributed at intervals, and this way should also be regarded as that a plurality of liquid passing structures 120 are distributed circumferentially around the axis of the inner tube 10.

In a preferred embodiment, as shown in fig. 4 and 8, the liquid passing structure 120 comprises a groove opening on the outer surface of the first section 12, the cross section of the groove being a sector-shaped portion (as shown in fig. 5a and 5 b) or a circular portion (as shown in fig. 5 c). Of course, those skilled in the art can also configure the shape of the grooves to be other similarly suitable shapes, such as fan-shaped, rounded off the patterns shown in fig. 5a or fig. 5b, irregular shapes, and the like. The grooves are arranged so that the outer surface of the first section 12 forms a plurality of spinous processes, preferably, the number of the grooves is not less than 5, and every two grooves are spaced apart from the opening of the outer surface of the first section 12 by a certain distance. Thus, the adjacent two spinous processes can support the balloon 20 which is closely attached to the surface of the inner tube 10 by an external force. The grooves form a liquid passing structure 120 through which the filling liquid can pass. It will be appreciated that the tip of the spinous process (the end remote from the axis of the inner tube 10) may be chamfered or rounded to avoid sharp points and to avoid damaging the balloon; the number of the grooves is not less than 5, so that more support points can be provided for supporting the balloon 20, and the balloon 20 is far away from the grooves; however, at the same cross-sectional area of the first section 12, more flutes mean more spinous processes and smaller flute cross-sectional area, and too many flutes can cause poor flow of the filling fluid. Therefore, preferably, when the number of the grooves is 5 to 10, the balloon 20 can be effectively supported, and the flow of the filling liquid cannot be adversely affected. Of course, the number of grooves can be set by those skilled in the art according to the thickness of the balloon, the diameter of the inner tube 10, and the hardness of the material of the inner tube 10. Since there is often no difference in direction in the circumferential direction when the balloon catheter is inserted into a human body, it is necessary that the circumferential direction of the balloon catheter has isotropic characteristics. Therefore, the liquid passing structures 120 are uniformly distributed around the axis of the inner tube 10, and the balloon can be effectively ensured to be uniformly unfolded in all radial directions at the same time, i.e. isotropy in the circumferential direction is realized. Can obtain better effect for patients with uneven calcification of certain valve areas.

In another preferred embodiment, as shown in fig. 6, the liquid passing structure 120 comprises a bore, preferably circular in cross-section, formed through the wall of the first section 12. Compared with the previous preferred embodiment, the wall of the first section 12 can better support the balloon 20, avoid the contact between the inner wall of the balloon 20 and the lumen, and the cross-sectional area of the liquid passing structure 120 is more stable under the condition of larger constraint.

Referring to fig. 2, further, the radial outer dimension of the first segment 12 is larger than the radial outer dimension of the second segment 11 and the radial outer dimension of the third segment 13. Here, the radial dimension is the diameter for a circle, the radially outer dimension is the outer diameter, and for other shapes, the distance from the geometric center to the edge of the profile is meant. Alternatively, as shown in fig. 3, the second section 11 and the third section 13 are common cylindrical pipes, the inner diameters and the outer diameters of the two sections are the same, and the two sections are coaxially arranged, while the first section 12 is circular in shape, and the outer diameter thereof is larger than the outer diameters of the second section 11 and the third section 13. Preferably, the portion of the inner tube 10 corresponding to the balloon 20 further comprises a transition 14, the transition 14 being disposed between the first segment 12 and the second segment 11, and/or between the first segment 12 and the third segment 13; the transition section has a larger end and a smaller end, the larger end is connected with the first section 12, and the radial outer dimension of the larger end is matched with the radial outer dimension of the first section 12; the smaller end is connected to the second section 11 and/or the third section 13, and the radial outer dimension of the smaller end is adapted to the radial outer dimension of the second section 11 and/or the radial outer dimension of the third section 13. It is understood that the shape of the second section 11 or the third section 13 is not limited to a circular tube, and the shape may be modified according to some specific requirements, and the invention is not limited thereto.

Specifically, referring to fig. 7, taking the transition section 14 between the second section 11 and the first section 12 as an example for description, the shape of the transition section 14 is approximately a circular truncated cone, the diameter of the top surface (smaller end) is equal to the outer diameter of the second section 11, and the top surface is connected to the second section 11, the diameter of the bottom surface (larger end) is equal to the outer diameter of the first section 12, and the bottom surface is connected to the first section 12. It will be appreciated that when the fluid communication structure 120 comprises a groove, the outer diameter of the first section 12 is twice the spacing between the tip of the spinous process and the axis of the first section 12. So configured, a sharp chamfer on the outer surface of the inner tube 10 can be avoided, thereby avoiding damage to the balloon 20. Preferably, the liquid passing structure 120 extends and penetrates the transition section 14 along the axial direction of the inner tube 10. With continued reference to fig. 7, taking the example where the liquid-passing structure 120 includes cavities, the cavities are disposed parallel to the axial direction of the first section 12, the cavities extend in the wall of the first section 12, and after penetrating into the transition section 14, the cavities gradually approach the outer surface of the transition section 14 due to the gradual shrinkage of the outer surface of the transition section 14 until penetrating out of the outer surface of the transition section 14 to form an oblong opening. Such an arrangement facilitates rapid ingress and egress of the inflation fluid into and out of the venting structure 120. Of course, when the liquid passage structure 120 includes grooves, it can be configured similarly, that is, the outer surface of the transition section 14 is provided with grooves which become gradually shallower to fit the grooves of the first section 12 and the outer surface of the second section 11. Of course, in other embodiments, the radially outer dimensions of the second, first and third sections 11, 12, 13 may be the same, such that the outer surface of the entire inner tube 10 is axially smooth and non-varying. The transition section 14 is also not required, and the outer surface of the inner tube 10 can be prevented from puncturing the balloon 20. In this case, the liquid passing structure 120 may pass through the first section 12 at both ends of the first section 12 in the radial direction to pass through the inside of the balloon 20.

The inventors have found that a larger spacing between the base of the groove and the axis of said first section 12 results in a smaller difference between the base of the groove and the tip of the spinous process, i.e. when the groove is shallower, resulting in a smaller cross-sectional area of the groove and a lower liquid flow capacity. When the distance between the bottom of the groove and the axis of the first section 12 is small, that is, correspondingly, when the groove is deep, the mechanical properties of the first section 12, such as wire holding property, bending resistance and the like, are affected. It should be understood that the bottom of the groove is the closest portion of the groove to the axis of the first section 12. Preferably, the distance between the bottom of the groove and the axis of the first segment 12 is equal to half the radial outer dimension of the second segment 11 or the third segment 13. With such a configuration, the inner pipe hole 100 is not affected and the groove can have a larger cross-sectional area, so that the wire holding performance and the bending resistance of the first section 12 are not adversely affected. Of course, when the liquid passage structure 120 includes a cavity, the principle of construction is similar to that of a groove, and the distance between the bottom of the cavity and the axis of the first section 12 may be configured to be equal to half the radial outer dimension of the second section 11 or the third section 13, so that the cavity has a larger cross-sectional area. Here the bottom of the bore, i.e. the part of the bore closest to the axis of the first section 12. Furthermore, when so configured, it is apparent that the opening of the liquid passage structure 120 at the outer surface of the transition section 14 is adjacent to the proximal end of the second section 11 or the distal end of the third section 13, and does not adversely affect the mechanical properties of the inner tube 10.

Optionally, referring to fig. 9, the pipe wall of the first section 12 includes a first wall layer 121 and a second wall layer 122 from inside to outside, and the elastic modulus of the second wall layer 122 is greater than that of the first wall layer 121; the bottom of the liquid passing structure 120 is located in the first wall layer 121, and the top of the liquid passing structure 120 is located in the second wall layer 122. Here, the bottom of the liquid passing structure 120 refers to the closest part of the liquid passing structure 120 to the axis of the first section 12, and the top of the liquid passing structure 120 refers to the farthest part of the liquid passing structure 120 to the axis of the first section 12. It should be understood that the first wall layer 121 and the second wall layer 122 have a certain thickness, and the bottom of the liquid passing structure 120 is located on the first wall layer 121, which means that the bottom of the liquid passing structure 120 is located within the thickness range of the first wall layer 121. Similarly, the top of the liquid-permeable structure 120 is located on the second wall layer 122, which means that the top of the liquid-permeable structure 120 is located within the thickness range of the second wall layer 122. In some embodiments, the mechanical performance of the first section 12 is reduced due to the penetration of the wall of the first section 12 by the liquid passing structure 120, especially when the grooves are used, the tip of the spinous process is a free end, which has relatively poor stability, and especially when the cross section of the grooves is a circular part (as shown in fig. 5 c), or when the interval between the grooves is close, the spinous process is more vulnerable under the condition of large external force (such as severe calcified valvular lesion stenosis, and difficult passage of the balloon dilatation catheter in a contracted state). In view of the above, the second wall layer 122 (i.e., the outer layer) of the first section 12 is configured as a material having a high modulus of elasticity, i.e., the outer layer of the first section 12 is hard to damage.

The outer diameter of the first section 12 is larger than the outer diameters of the second section 11 and the third section 13, or the second wall layer 122 of the first section 12 is configured to be a harder material, so that the bending stiffness of the first section 12 is larger than that of the second section 11 or the third section 13, thereby affecting the use performance such as trackability and pushability of the balloon dilation catheter during actual use. To solve the above problem, as shown in fig. 10, the first section 12 is preferably provided with a plurality of axially spaced notches 123, the notches 123 extend from the outer surface of the first section 12 to the axis of the first section 12 (i.e., extend radially), and the bottom of the notches 123 is not deeper than the bottom of the liquid passing structure 120. It is understood that the bottom of the notch 123 refers to the position where the notch 123 is closest to the axis of the first section 12, and is not deeper than the bottom of the liquid passing structure 120 refers to the distance between the bottom of the notch 123 and the axis of the first section 12, which is not less than the distance between the bottom of the liquid passing structure 120 and the axis of the first section 12. The form of the notch 123 is not limited in this embodiment, and preferably, the notch 123 is V-shaped along the axial direction of the first section 12, and the angle of the V-shape ranges from 10 ° to 40 °. Alternatively, the V-shaped notch may be formed around the entire circumference of the first section 12, or may be formed only in the radial direction of the first section 12 (i.e., not in a circumferential shape). In a preferred exemplary embodiment, the angle of the V-shape is 25 deg., and 4-30 notches 123 are axially disposed through the first section 12. This configuration can effectively contribute to the improvement of the bending property of the first stage 12 without affecting the construction of the liquid passing structure 120. Of course, the number and arrangement of the slits 123 can be set differently by those skilled in the art according to the material and size of the inner tube 10, and the present invention is not limited thereto.

In an exemplary embodiment, the length of the second section 11 ranges between 10mm and 30mm, the length of the first section 12 ranges between 10mm and 50mm, and the length of the third section 13 ranges between 10mm and 30 mm. Preferably, the location of the midpoint of the first segment 12 corresponds axially to the midpoint of the flat section 23 of the balloon 20 to ensure that the area of calcified lesion compression corresponds to the area of the first segment 12. The length of the part of the inner tube 10 outside the balloon 20 ranges from 450 mm to 1000mm, the proximal end of the inner tube 10 can be connected with other parts of the balloon dilatation catheter, and the inner tube can be arranged by a person skilled in the art according to the prior art, and the invention is not described in detail. Preferably, the material of the inner tube 10 is selected from at least one of polyester, polyamide, polyvinyl chloride, nylon elastomer and polyurethane elastomer, and some metal materials may be further added to the material of the inner tube 10 to improve the strength or other special properties of the inner tube 10. Preferably, the length of the first section 12 can be adapted to the length of the straight section 23 of the balloon 20, or the length of the first section 12 is greater than the length of the straight section 23 of the balloon 20, so as to ensure that when the balloon 20 is compressed, the two ends of the liquid passing structure 120 can effectively communicate with the two areas at the far end and the near end where the balloon 20 is compressed.

The inventor finds that if the liquid passing structure 120 is formed separately from the first section 12 of the inner tube 10 and the two are assembled together, the liquid passing structure is easy to slide or fall off in practical use, and the integrally formed inner tube 10 can avoid the risk of falling off or sliding due to the split design of the components. To this end, in some preferred embodiments, the first section 12 is integrally formed and connected to the second section 11 and the third section 13, respectively. It should be understood that the first section 12 is integrally formed, which means that the body of the first section 12 and the liquid passing structure 120 disposed thereon are integrally formed. For example, in actual manufacturing, the general shape of the first section 12 may be extruded, and then the outer surface of the first section 12 may be knurled to form grooves in a ratchet-like pattern; or a direct single-use extruded multi-lumen or grooved tube having a central lumen as the inner lumen 100 and a surrounding lumen or groove configured as the liquid passing structure 120 may be used as the first segment 12. The integrally formed first section 12 is simple in structure, the complexity and cost of the processing technology are low, the integration level of the whole first section 12 is high, the space is saved, the influence on the profile value of the balloon 20 is reduced (generally, the balloon 20 is generally in a contraction state when being pre-shaped, the outer surface of the balloon 20 is generally in a folding state, and the maximum radial dimension of the folded balloon 20 is called as the profile value of the balloon 20), and the high passing performance of the balloon dilatation catheter can be ensured. Optionally, on the basis of the integral formation of the first section 12, two sections of the first section 12 may be respectively connected to the second section 11 and the third section 13, for example, the second section 11, the first section 12, the third section 13, and the portion of the inner tube 10 outside the balloon 20 may be respectively extruded, and then the two sections are spliced into a whole by welding or the like, so as to form the whole inner tube 10. Preferably, in other embodiments, the second section 11, the first section 12 and the third section 13 are integrally formed, for example, a semi-finished product of the inner tube 10 may be extruded at one time and then processed, for example, the surface of the first section 12 is knurled, grooves with a ratchet-like pattern are formed, and the like. In an alternative embodiment, the outer diameters of the second section 11, the first section 12 and the third section 13 are the same, and the outer surfaces of the second section 11, the first section 12 and the third section 13 are knurled together to form grooves with a ratchet-like pattern, that is, the whole part of the inner tube 10 located in the balloon 20 is homogeneous, and in practical use, the same effect as that of the balloon dilatation catheter described above can be achieved. Thus, the whole inner tube 10 is integrally formed, the connection strength is high, and the processing complexity and the cost are low.

Preferably, referring to fig. 1, the inner tube 10 is further provided with developing points 3, and the developing points 3 are located at two ends of the liquid passing structure 120. For example, when the transition section 14 is provided between the second section 11 and the first section 12, and the third section 13, the openings at both ends of the liquid passing structure 120 are located on the transition section 14, and at this time, the developing points 3 may be located at the connection position of the second section 11 and the transition section 14, and at the connection position of the third section 13 and the transition section 14. The developing point 3 may be, for example, a ring shape, and the developing material may be one commonly used in the art. The arrangement of the developing point 3 can help the operator to visually observe the relative position relationship of the liquid passing structure 120 and the valve ring to the restriction place of the balloon 20, thereby playing a beneficial auxiliary role in the operation.

Referring to fig. 11, the balloon dilatation catheter assembly includes a sheath 4, a fluid passage 5, a guidewire lumen 6, a connector 7 and other accessories, wherein the fluid passage 5 and the guidewire lumen 6 are respectively disposed on the sheath 4; the proximal end of the inner tube 10 is connected with the sheath 4 and is communicated with the guide wire cavity 6; the proximal end of the outer tube 30 is connected with the sheath 4, and the gap between the outer tube 30 and the inner tube 10 is communicated with the liquid through cavity 5; the connecting piece 7 is arranged at the near end of the guide wire cavity 6 and the near end of the liquid through cavity 5. In one example, the interior of the sheath 4 includes a three-way member to which the access lumen 5, the guidewire lumen 6, and the inner and outer tubes 10, 30, respectively, are attached. Optionally, the guide wire cavity 6 and the inner tube 10 are located on a trunk branch of the three-way component and are communicated with each other, and the guide wire cavity and the inner tube are configured in a straight-through manner so as to facilitate the penetration of a guide wire; the cavity 5 is located on the side branch of the three-way component, and the cavity 5 is communicated with the gap between the outer tube 30 and the inner tube 10 so as to infuse or suck the filling liquid. The proximal ends of the liquid passage cavity 5 and the guide wire cavity 6 are respectively connected with a connecting piece 7 for connecting with external adaptive components, and the components of the balloon dilatation catheter can be selected and configured by a person skilled in the art according to the prior art.

In summary, the balloon dilatation catheter provided by the invention comprises the balloon dilatation catheter, the inner tube, the outer tube and the balloon, wherein the balloon can be switched between a contraction state and an expansion state; a part of the inner tube penetrates through the inside of the balloon, the outer tube sleeve is arranged outside the inner tube, a gap is formed between the outer tube sleeve and the inner tube, and the gap is used for transmitting filling liquid to drive the state conversion of the balloon; the part of the inner tube penetrating through the balloon comprises a first section and a plurality of liquid passing structures, the liquid passing structures are axially arranged in the first section in a penetrating mode, two ends of the liquid passing structures are arranged in the balloon in an open mode, and each liquid passing structure comprises a groove arranged on the outer surface of the first section and/or a hole cavity arranged in the tube wall of the first section in a penetrating mode. So the configuration, through the setting of leading to the liquid structure, even partly by the constraint extrusion of sacculus, full liquid also can make each regional synchronous expansion of nearly distal end of sacculus through the region by the constraint extrusion via leading to the liquid structure, has avoided sacculus slippage or expansion failure scheduling problem, has improved the success rate of intervention operation. Further, when leading to liquid structure including seting up in the apparent slot of first section, even the sacculus is compelled to be attached in the surface of inner tube, the bottom of slot still can be kept away from to the sacculus, and the slot can be supplied sufficient liquid to pass through smoothly, is applicable to the patient of valve area serious calcification. When the liquid passing structure comprises a hole cavity penetrating through the pipe wall of the first section, the outer wall of the first section can support the balloon to prevent the inner wall of the balloon from blocking the hole cavity, and under the condition of large constraint, the sectional area of the hole cavity for liquid passing is stable, and the liquid passing effect is good.

It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, similar parts between the embodiments may be referred to each other, and different parts between the embodiments may also be used in combination with each other, which is not limited by the present invention. The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims (12)

1. A balloon dilation catheter, comprising: an inner tube, an outer tube and a balloon; the balloon is capable of transitioning between a deflated state and an inflated state; a part of the inner tube penetrates through the inside of the balloon, the outer tube sleeve is arranged outside the inner tube, a gap is formed between the outer tube sleeve and the inner tube, and the gap is used for transmitting filling liquid to drive the state conversion of the balloon;

the part of the inner tube penetrating through the balloon comprises a first section and a plurality of liquid passing structures, the liquid passing structures are axially arranged in the first section in a penetrating mode, two ends of the liquid passing structures are arranged in the balloon in an open mode, and each liquid passing structure comprises a groove arranged on the outer surface of the first section and/or a hole cavity arranged in the tube wall of the first section in a penetrating mode.

2. The balloon dilation catheter of claim 1 wherein the plurality of liquid passing structures are distributed circumferentially about an axis of the inner tube.

3. The balloon dilation catheter according to claim 2, wherein the portion of the inner tube inserted into the balloon further comprises a second section and a third section, the second section, the first section and the third section are arranged in sequence from a distal end to a proximal end; the first segment has a radially outer dimension that is greater than a radially outer dimension of the second segment and a radially outer dimension of the third segment.

4. The balloon dilation catheter of claim 3, wherein the inner tube further comprises a transition disposed between the second segment and the first segment, and/or between the first segment and the third segment; the transition section is provided with a larger end and a smaller end, the larger end is connected with the first section, and the radial outer dimension of the larger end is matched with the radial outer dimension of the first section; the smaller end is connected with the second section and/or the third section, and the radial outer size of the smaller end is matched with the radial outer size of the second section and/or the radial outer size of the third section.

5. The balloon dilation catheter of claim 4 wherein the fluid passing structure extends over and through the transition in an axial direction of the inner tube.

6. The balloon dilation catheter of claim 3 wherein the distance between the base of the liquid passing structure and the axis of the first segment is equal to half the radially outer dimension of the second or third segment.

7. The balloon dilation catheter of claim 1 wherein the first section is provided with a plurality of axially spaced cuts extending from an outer surface of the first section toward an axis of the first section, and wherein a bottom of the cuts is no deeper than a bottom of the liquid passing structure.

8. The balloon dilation catheter according to claim 7 wherein the cuts are V-shaped in the axial direction of the first section, and the angle of the V-shape ranges between 10 ° and 40 °.

9. The balloon dilation catheter of claim 1 wherein the fluid passing structure comprises a groove opening on an exterior of the first segment, the groove having a cross-section that is a segment of a sector or a segment of a circle; and/or the liquid passing structure comprises a cavity penetrating through the pipe wall of the first section, and the cross section of the cavity is circular.

10. The balloon dilation catheter of claim 1, wherein the wall of the first section includes a first wall layer and a second wall layer from inside to outside, the second wall layer having a modulus of elasticity greater than the modulus of elasticity of the first wall layer; the bottom of the liquid passing structure is located on the first wall layer, and the top of the liquid passing structure is located on the second wall layer.

11. The balloon dilation catheter according to claim 1 wherein a distal end of the balloon is sealingly connected to a distal end of the inner tube and a proximal end of the balloon is sealingly connected to a distal end of the outer tube.

12. A balloon dilatation catheter of a balloon dilatation catheter assembly, comprising the balloon dilatation catheter of claim 1, a sheath, a fluid passage chamber, a guidewire chamber and a connector, wherein the fluid passage chamber and the guidewire chamber are respectively arranged on the sheath; the near end of the inner tube is connected with the sheath and is communicated with the guide wire cavity; the proximal end of the outer tube is connected with the sheath, and the gap is communicated with the liquid through cavity; the connecting piece is arranged at the near end of the guide wire cavity and the near end of the liquid through cavity.

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