CN221130706U - Balloon catheter device - Google Patents

Abstract

The utility model provides a balloon catheter device. The balloon catheter device comprises a balloon, an inner tube and an outer tube, wherein the inner tube extends through the outer tube and penetrates through the balloon, a gap is reserved between the outer wall of the inner tube and the inner wall of the outer tube, the distal end of the inner tube is connected with the distal end of the balloon, and the proximal end of the balloon is connected with the distal end of the outer tube. The inner tube and the outer tube are all of a spliced tube structure, the spliced tube structure comprises a plurality of tube section parts spliced in sequence, the plurality of tube section parts comprise a first tube section and a second tube section with different tensile moduli, and the first tube section and the second tube section are respectively a distal end part of the spliced tube structure and a proximal end part of the spliced tube structure. According to the balloon catheter device, the inner tube and the outer tube are respectively made of the two tubes with different tensile moduli at the proximal end and the distal end and are spliced, so that the balloon catheter device can be beneficial to simultaneously considering traceability, pushability and small size, and the probability of balloon reverse passing through a blood vessel in a coronary artery chronic total occlusion lesion operation is improved.

Description

Balloon catheter device

Technical Field

The utility model relates to the field of medical instruments, in particular to a balloon catheter device.

Background

Chronic total occlusion (Chronic Total Occlusion, CTO) of coronary artery refers to a lesion where the coronary artery is completely occluded and occluded for more than three months, has the characteristics of high reoccurrence rate and high reocclusion rate, and has great treatment difficulty, which is the biggest problem facing coronary intervention treatment at present.

Percutaneous coronary intervention (Percutaneous Coronary Intervention, PCI) refers to a treatment that uses cardiac catheter techniques to open up stenosed and even occluded coronary lumens, thereby improving blood perfusion of the myocardium. Percutaneous coronary intervention has been attempted by physicians and the like for more than thirty years.

In recent years, with the rapid development of technology, the field of CTO-PCI technology has made great progress. Accompanying these tremendous advances are upgrades to the corresponding instruments, the use of new instruments, and a deepened understanding of the pathological anatomy.

Disclosure of utility model

At least one embodiment of the present utility model provides a balloon catheter device comprising: the balloon, inner tube and outer tube, the inner tube extends and wears to locate in the outer tube and run through the balloon, has the clearance between the outer wall of inner tube and the inner wall of outer tube, the distal end of inner tube is connected to the distal end portion of balloon, the distal end of outer tube is connected to the proximal end portion of balloon. The inner tube and the outer tube are all of a spliced tube structure, the spliced tube structure comprises a plurality of tube section parts spliced in sequence, the plurality of tube section parts comprise a first tube section and a second tube section with different tensile moduli, and the first tube section and the second tube section are respectively a distal end part of the spliced tube structure and a proximal end part of the spliced tube structure.

For example, in a balloon catheter device provided by at least one embodiment of the present utility model, a first section of an inner tube is a distal inner tube section and a second section of the inner tube is a proximal inner tube section; the first tube section of the outer tube is a distal outer tube section and the second tube section of the outer tube is a proximal outer tube section; the tensile modulus of the plurality of tube segment portions is arranged to decrease in sequence from the proximal end toward the distal end in the axial direction of the balloon catheter device.

For example, in a balloon catheter device provided by at least one embodiment of the present utility model, the proximal inner tube section has a tensile modulus of 1420.+ -.100 MPa and the distal inner tube section has a tensile modulus of 390.+ -.100 MPa; the tensile modulus of the proximal outer tube segment is 1420+ -100 MPa, and the tensile modulus of the distal outer tube segment is 1100+ -100 MPa.

For example, in a balloon catheter device according to at least one embodiment of the present utility model, the inner tube is a multi-layer tube and the outer tube is a single-layer tube, the strength of the inner tube being greater than the strength of the outer tube.

For example, in a balloon catheter device provided in at least one embodiment of the present utility model, at least one first splice is formed between at least one pair of adjacent two tube segment portions of a plurality of tube segment portions of an inner tube; at least one second splice is formed between at least one pair of adjacent two tube segment portions of the plurality of tube segment portions of the outer tube; the at least one first splice and the at least one second splice are staggered in an axial direction of the balloon catheter device.

For example, in a balloon catheter device according to at least one embodiment of the present utility model, a reinforcing tube is sleeved outside at least one first joint of the inner tube.

For example, in a balloon catheter device provided by at least one embodiment of the present utility model, the balloon catheter device further includes a developing ring disposed on the distal inner tube segment.

For example, in a balloon catheter device provided by at least one embodiment of the present utility model, the balloon includes an inner layer and an outer layer having different tensile moduli.

For example, in a balloon catheter device provided by at least one embodiment of the present utility model, the tensile modulus of the outer layer of the balloon is greater than the tensile modulus of the inner layer of the balloon.

For example, in a balloon catheter device according to at least one embodiment of the present utility model, the tensile modulus of the outer layer of the balloon is 1100±100MPa; the tensile modulus of the inner layer of the balloon was 510.+ -.100 MPa.

For example, in a balloon catheter device according to at least one embodiment of the present utility model, the balloon catheter device further includes a transition tube and a hypotube, a distal end of the transition tube is connected to the outer tube and the inner tube, respectively, a proximal end of the transition tube is connected to the hypotube, and a distal end portion of the hypotube includes a helical cutting region.

For example, in a balloon catheter device according to at least one embodiment of the present utility model, the spiral cutting area has a plurality of spiral cutting pitches that are arranged to sequentially increase from the distal end toward the proximal end in the axial direction of the transition tube.

Compared with the prior art, at least one embodiment of the utility model has the following beneficial effects: the balloon catheter device is formed by respectively selecting and splicing the inner tube and the outer tube by adopting the proximal end and the distal end which are made of two tubes with different tensile moduli, so that the balloon catheter device is beneficial to achieving the effects of simultaneously taking the traceability, the pushability and the small size into consideration, and the probability of balloon reverse passing through a blood vessel in the operation of coronary artery chronic total occlusion lesions is improved.

Drawings

In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the utility model, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIGS. 1-2 are schematic structural views of balloon catheter devices according to some embodiments of the present utility model;

Fig. 3 to fig. 4 are schematic diagrams of splicing inner pipes according to some embodiments of the present utility model, in which fig. 3 shows an effect diagram before splicing the inner pipes is completed, and fig. 4 shows a schematic diagram of a state after splicing the inner pipes is completed;

fig. 5-6 are schematic diagrams of splicing outer tubes according to some embodiments of the present utility model, in which fig. 5 shows an effect diagram before splicing the outer tubes is completed, and fig. 6 shows a schematic diagram of a state after splicing the outer tubes is completed;

FIG. 7 is a schematic cross-sectional view of a balloon provided in some embodiments of the present utility model;

Fig. 8 is a schematic structural diagram of a hypotube according to some embodiments of the present utility model.

Detailed Description

The following description of the embodiments of the present utility model will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present utility model, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of the utility model have the same meaning as commonly understood by one of ordinary skill in the art to which this utility model belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The terms "first," "second," and the like, as used in embodiments of the present utility model, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. Nor does the terms "a," "an," or "the" or similar terms mean a limitation of quantity, but rather that at least one is present. Likewise, the word "comprising" or "comprises", and the like, means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof, but does not exclude other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical or communication connections, whether direct or indirect. A flowchart is used in an embodiment of the present utility model to illustrate the steps of a method according to an embodiment of the present utility model. It should be understood that the steps that follow or before do not have to be performed in exact order. Rather, the various steps may be performed in reverse order or concurrently unless the embodiments of the present utility model are clearly defined. Also, other operations may be added to or removed from these processes.

With the increasing development of CTO-PCI technology, the technology is continuously updated and developed to include normal guidewire upgrade technology (AWE), normal subintimal re-true lumen technology (ADR), reverse guidewire upgrade technology (RWE), reverse subintimal re-true lumen technology (RDR), and the like. The inventors of the present utility model found through analysis that the factors of CTO-PCI surgical failure in these formulae are as follows: the first is that the guidewire is not passed, at a ratio of about 85%, including being unable to penetrate the occlusive proximal/distal fibrous cap, into the prosthetic lumen or puncture; the second is that the balloon cannot pass, accounting for about 10%; third, the lesions are not distensible, accounting for about 5%.

The balloon dilation catheter is used as a common instrument in PCI operation and plays an irreplaceable important role in CTO-PCI operation, so that the balloon dilation catheter also needs to be updated along with time, and the balloon dilation catheter is more in line with the actual use demands of doctors.

The most commonly used in the clinic for chronic total occlusion lesions of the coronary arteries at present is balloon-assisted reverse subintimal re-luminal technique (RDR), the CART technique. The inventor of the present utility model has found through research that, in order to ensure the traceability of the distal end, a general balloon catheter device applied to the CART technology generally needs to use a soft material, but the soft material cannot ensure enough pushing performance; if hard materials are used, the pushing performance is improved, but the distal traceability is reduced and the size is often larger. Therefore, the current technology cannot be well applied to CART technology while keeping track of, pushing performance and small size.

At least one embodiment of the present utility model provides a balloon catheter device, including a balloon, an inner tube and an outer tube, the inner tube extending through the outer tube and penetrating the balloon, a gap being provided between an outer wall of the inner tube and an inner wall of the outer tube, a distal portion of the balloon being connected to a distal end of the inner tube, a proximal portion of the balloon being connected to a distal end of the outer tube; the inner tube and the outer tube are all of a spliced tube structure, the spliced tube structure comprises a plurality of tube section parts spliced in sequence, the plurality of tube section parts comprise a first tube section and a second tube section with different tensile moduli, and the first tube section and the second tube section are respectively a distal end part of the spliced tube structure and a proximal end part of the spliced tube structure.

In the balloon catheter device provided by the embodiment of the utility model, the inner tube and the outer tube adopt the ingenious design that the proximal end and the distal end are respectively made of two tubes with different tensile moduli and are spliced, so that the balloon catheter device is beneficial to achieving the effects of simultaneously taking the traceability, the pushability and the small size into consideration, and the probability of balloon reverse passing through a blood vessel in a coronary artery chronic total occlusion lesion operation is improved.

In some embodiments of the present utility model, the inner tube of the balloon catheter device is formed by splicing a distal inner tube section with a small tensile modulus and a proximal inner tube section with a large tensile modulus, and the outer tube is formed by splicing a distal outer tube section with a small tensile modulus and a proximal outer tube section with a large tensile modulus, so that the distal tensile modulus of the overall balloon catheter device is small and the proximal tensile modulus is large, thus ensuring the tracking performance of the distal end on the guide wire, and ensuring that the pushing force of the proximal end can be transmitted to the distal end in a larger proportion.

Embodiments of the present utility model and examples thereof are described in detail below with reference to the attached drawings.

For convenience of description, the proximal end of the inner tube 200 of the balloon catheter device 1000 in fig. 1 is on the side closer to the operator, and the distal end of the inner tube 200 is on the side farther from the operator. At least one embodiment of the present utility model treats the side near the operator (e.g., physician) as proximal or proximal side (anterior side for the operator) and the side far from the operator as distal or distal side (posterior side for the operator). The distal end, the proximal end, and the like of the embodiment of the present utility model are relative positions, for example, they represent opposite sides of some components themselves, or they represent opposite sides in a certain direction, that is, the proximal end represents one side of the embodiment of the present utility model, and the distal end represents the other side opposite to the proximal end.

Fig. 1-2 are schematic structural views of balloon catheter devices according to some embodiments of the present utility model.

For example, as shown in fig. 1 and 2, at least one embodiment of the present utility model provides a balloon catheter device 1000 including a balloon 100, an inner tube 200, and an outer tube 300. The inner tube 200 penetrates the balloon 100, the inner tube 200 extends through the outer tube 300, a gap is formed between the outer wall of the inner tube 200 and the inner wall of the outer tube 300, and a liquid passing cavity is formed by the gap between the inner tube 200 and the outer tube 300. The distal portion of balloon 100 is attached to the distal end of inner tube 200, e.g., the distal portion of balloon 100 is welded to inner tube 200. The proximal portion of balloon 100 is attached to the distal end of outer tube 300, e.g., the proximal portion of balloon 100 is welded to outer tube 300. For example, the axial direction of the inner tube 200 is parallel to the axial direction of the outer tube 300 or the inner tube 200 is coaxial with the outer tube 300, and the axial direction of the inner tube 200 is parallel to or coaxial with the axial direction of the entire balloon catheter device 1000. The inner tube 200 and the outer tube 300 are each a spliced tube structure.

For example, the spliced tube structure described above includes a plurality of tube segment portions that are sequentially spliced, the plurality of tube segment portions including first and second tube segments having different tensile moduli, the first and second tube segments being a distal end portion of the spliced tube structure and a proximal end portion of the spliced tube structure, respectively. The plurality of tube segment portions may be equal to or greater than two tube segment portions. The first pipe section can be a three-layer co-extruded pipe of polyether block polyamide copolymer (Pebax 7033) or a nylon 12 single-layer pipe, and the second pipe section can be a three-layer co-extruded pipe of nylon 11 or a nylon 11 single-layer pipe.

In embodiments of the utility model, the lower the tensile modulus of the tubing, the higher the compliance of the material, the higher the compliance material, which provides a balloon catheter device with greater tracking and smaller radial dimensions. The greater the tensile modulus of the tubing, the harder the material, the stronger the force transfer capability of the hard material, thereby providing a stronger push performance for the balloon catheter device.

In the balloon catheter device of some embodiments of the present utility model, the inner tube and the outer tube adopt smart designs in which two tubes with different tensile moduli are respectively selected for the proximal end and the distal end and spliced, so that the balloon catheter device is beneficial to achieving the effect of simultaneously achieving traceability, pushability and small size, and thereby improving the probability of balloon reverse passing through a blood vessel in a chronic total occlusion lesion operation of a coronary artery.

In some examples, the inner tube 200 has a guidewire lumen inside for passage of an intraoperative guidewire.

In some examples, the plurality of tube segment portions of the spliced tube structure (e.g., inner tube 200 and/or outer tube 300) are two tube segments, and the first tube segment and the second tube segment are directly joined, i.e., the spliced tube structure is comprised of two segments, a distal tube segment and a proximal tube segment. Therefore, the embodiment of the utility model not only can simultaneously achieve traceability, pushability and small size, but also has simple structure and process and low cost.

In other examples, the plurality of tube segment portions of the spliced tube structure may be three or more tube segments, i.e., the plurality of tube segment portions may include at least one other tube segment located between the first tube segment and the second tube segment in addition to the first tube segment and the second tube segment as the distal end portion and the proximal end portion. It should be noted that, the number of the pipe sections of the spliced pipe structure is not limited in the embodiments of the present utility model, so long as the inner pipe 200 and the outer pipe 300 are spliced pipes having a plurality of pipe sections, and will not be described herein.

In some examples, when the inner tube 200 and the outer tube 300 are both in a spliced tube structure, the number of tube sections spliced in the inner tube 200 may be the same or different, and thus, the embodiments of the present utility model are not limited thereto, and are not repeated herein because they are not the focus of description of the embodiments of the present utility model.

It should be noted that, for clarity and brevity, the following description mainly uses an example in which the inner tube 200 and the outer tube 300 are formed by splicing two tube sections, but the embodiments of the present utility model are not limited thereto, and are not exhaustive and redundant herein.

In some examples, the first section of the inner tube 200 is the distal inner tube section 210 and the second section of the inner tube 200 is the proximal inner tube section 220, the distal inner tube section 210 having a tensile modulus that is less than the tensile modulus of the proximal inner tube section 220, i.e., correspondingly, the distal inner tube section 210 has a hardness that is less than the hardness of the proximal inner tube section 220.

In some examples, the first tube section of outer tube 300 is distal outer tube section 310 and the second tube section of outer tube 300 is proximal outer tube section 320, and the tensile modulus of distal outer tube section 310 is less than the tensile modulus of proximal outer tube section 320, i.e., correspondingly, the hardness of distal outer tube section 310 is less than the hardness of proximal outer tube section 320.

The balloon catheter device of some embodiments of the present utility model is a catheter system for CART technology, the inner tube 200 is formed by splicing a distal inner tube section with a small tensile modulus and a proximal inner tube section with a large tensile modulus, and the outer tube is formed by splicing a distal outer tube section with a small tensile modulus and a proximal outer tube section with a large tensile modulus, so that the distal tensile modulus of the whole balloon catheter device is small and the proximal tensile modulus is large, and thus the tracking performance of the distal end to a guide wire can be ensured, and the pushing force of the proximal end can be transmitted to the distal end in a larger proportion, so that not only the balloon can pass through a tortuous side branch vessel along with the guide wire, but also the front end of the catheter system can have enough pushing force to enable the balloon to enter under an inner membrane after passing through the side branch vessel.

In some examples, the plurality of tube segment portions of the spliced tube structure are welded to one another. For example, the distal inner tube segment 210 and the proximal inner tube segment 220 are welded together. For another example, distal outer tube segment 310 and proximal outer tube segment 320 are welded together. In fig. 2, point C1 represents the connection point of the distal inner tube segment 210 to the proximal inner tube segment 220. Point D1 represents the connection point of the distal outer tube segment 310 to the proximal outer tube segment 320. This is merely exemplary, and is not a limitation of the embodiments of the present utility model, as long as a plurality of pipe segment portions can be completely spliced to form the inner pipe 200 or the outer pipe 300, which is not exhaustive or redundant herein.

In some examples, when the plurality of tube segment portions of the spliced tube structure (e.g., inner tube 200 or outer tube 300) may be three or more tube segments, the tensile modulus of the plurality of tube segment portions of the spliced tube structure may be configured to decrease in sequence from the proximal end toward the distal end in the axial direction of the balloon catheter device 1000. Therefore, the embodiment of the utility model designs the splicing tube structure to be gradually softer from near to far, so that the balloon catheter has strong tracking property, and the front end of the balloon catheter device can be ensured to have good pushing force so that the balloon enters the subintima after passing through the side branch vessel.

For example, as shown in fig. 1, balloon catheter device 1000 further includes a visualization ring 600, visualization ring 600 being disposed on distal inner tube segment 210. Therefore, the embodiment of the utility model can realize that the position of the balloon catheter device in the patient can be observed under the action of external developing equipment through the developing ring, so that all parts in the balloon catheter device can be pushed to a target area, and the accuracy of the balloon catheter device reaching the target position in the body is improved.

Illustratively, the developer ring 600 may be swaged onto the distal inner tube section 210 of the inner tube 200. Of course, this is merely exemplary and is not a limitation of embodiments of the present utility model, as long as the development ring 600 can be secured to the distal inner tube segment 210, and will not be described in detail herein.

For example, as shown in fig. 1 and 2, the balloon catheter device 1000 further includes a tip tube 900, the tip tube 900 being fixedly connected to the distal inner tube section 210 of the inner tube 200, such as by laser welding the tip tube 900 to the distal inner tube section 210 of the inner tube 200. For example, as shown in fig. 1 and 2, the proximal portion of balloon 100 is fixedly attached (including, but not limited to, welding) to the distal end of outer tube 300 (i.e., the integral distal end of outer tube 300 formed by the splicing of distal outer tube segment 310 and proximal outer tube segment 320). In fig. 2, point A1 represents the balloon distal attachment point and point B1 represents the balloon 100 attachment point to the distal outer tubular segment 310.

In some examples, the entirety of outer tube 300 with balloon 100 may be referred to as an outer tube assembly, and the entirety of inner tube 200 with tip tube 900 may be referred to as an inner tube assembly (e.g., the inner tube assembly further comprises a developer ring 600). It should be noted that the description of these technical terms is not to be construed as limiting the scope of the present utility model, but merely for convenience and clarity of presentation herein. In some examples, the outer tube assembly and the inner tube assembly of some embodiments of the present utility model are fixedly attached (including, but not limited to, welded) to the tip tube 900 at the distal end of the balloon 100.

For example, as shown in fig. 1 and 2, the balloon catheter device 1000 further includes a transition tube 800, the transition tube 800 being fixedly connected (e.g., welded) to the proximal end portions of the inner and outer tube assemblies, respectively. For example, as shown in fig. 1 and 2, the distal end of transition tube 800 is connected to outer tube 300 and inner tube 200, respectively.

For example, as shown in fig. 1 and 2, the balloon catheter device 1000 further includes a hypotube 700. The hypotube 700 is connected to the hub 101. For example, as shown in fig. 1 and 2, the balloon catheter device 1000 further includes a catheter stiffener 102, the catheter stiffener 102 being located on a side of the seat 101 proximate to the transition tube 800. In fig. 2, F1 denotes a connection between the seat 101 and the hypotube 700. Illustratively, embodiments of the present utility model bond hypotube 700 with hub 101 and mount catheter stiffener 102 in place. Illustratively, the proximal end of the transition tube 800 is connected to the hypotube 700, and in FIG. 2, the point E1 represents the connection point of the transition tube 800 to the hypotube 700.

For example, as shown in fig. 1 and 2, the embodiment of the present utility model fixedly connects (e.g., welds) the joint formed after the transition tube 800 is fixedly connected to the proximal end portions of the inner tube assembly and the outer tube assembly, respectively, to the hypotube 700 with the seat 101.

For example, as shown in fig. 1, a marker band 710 is also provided on the hypotube 700, and the marker band 710 may be used to indicate whether the push balloon catheter device is full of the balloon catheter device tip and has reached the guide catheter tip.

In some examples, the tensile modulus is different between each two of the proximal inner tube segment 220, the distal inner tube segment 210, the proximal outer tube segment 320, and the distal outer tube segment 310.

In some examples, the tensile modulus of the proximal inner tube segment 220 may be greater than or equal to the tensile modulus of the proximal outer tube segment 320, or may be less than the tensile modulus of the proximal outer tube segment 320. Similarly, in some examples, the tensile modulus of distal inner tube segment 210 may be greater than or equal to the tensile modulus of distal outer tube segment 310, or may be less than the tensile modulus of distal outer tube segment 310, and thus, embodiments of the present utility model are not limited thereto, and may be freely adjusted according to the actual circumstances, and are not described in detail and illustrated herein.

The design of the tensile modulus of the pipe section of the inner and outer splicing pipes is flexible, the adaptability is good, the application range is wide, and the practical use requirements can be met well.

In some examples, inner tube 200 is a multi-layer tube and outer tube 300 is a single-layer tube, the strength of inner tube 200 being greater than the strength of outer tube 300. Therefore, the embodiment of the utility model not only can ensure that the inner tube plays a supporting role meeting the requirements, for example, the deformation of the inner tube caused by excessive pressure when the balloon is pressurized can be prevented; and can also meet the requirement of low cost.

In some examples, the proximal inner tube segment 220 has a tensile modulus of 1420±100MPa and the distal inner tube segment 210 has a tensile modulus of 390±100MPa. This is merely exemplary and is not a limitation of embodiments of the present utility model and is not intended to be exhaustive or redundant.

In some examples, the proximal outer tube segment 320 has a tensile modulus of 1420±100MPa and the distal outer tube segment 310 has a tensile modulus of 1100±100MPa. This is merely exemplary and is not a limitation of embodiments of the present utility model and is not intended to be exhaustive or redundant.

In some examples, the distal inner tube segment 210 may be a three-layer co-extruded polyether block polyamide copolymer (Pebax 7033), the proximal inner tube segment 220 may be a three-layer co-extruded nylon 11, the distal outer tube segment 310 may be a single-layer nylon 12 tube, and the proximal outer tube segment 320 may be a single-layer nylon 11 tube. This is merely exemplary, and is not a limitation of the embodiments of the present utility model, and may be freely adjusted according to actual needs, which will not be described herein.

In some examples, the outer diameter of the distal inner tube segment 210 is approximately equal to the outer diameter of the proximal inner tube segment 220; and/or, the outer diameter of the distal outer tube segment 310 is approximately equal to the outer diameter of the proximal outer tube segment 320.

Fig. 3 to fig. 4 are schematic diagrams illustrating splicing of inner pipes according to some embodiments of the present utility model, fig. 3 shows an effect diagram before splicing of the inner pipes is completed, and fig. 4 shows a schematic diagram illustrating a state after splicing of the inner pipes is completed.

Fig. 5-6 are schematic diagrams of splicing outer tubes according to some embodiments of the present utility model, in which fig. 5 shows an effect diagram before splicing the outer tubes is completed, and fig. 6 shows a schematic diagram of a state after splicing the outer tubes is completed.

In some examples, at least one first splice is formed between at least one pair of adjacent two tube segment portions (also referred to as a tube segment pair) of the plurality of tube segment portions of the inner tube 200, and at least one second splice is formed between at least one pair of adjacent two tube segment portions of the plurality of tube segment portions of the outer tube 300.

For example, the plurality of pipe sections of the inner pipe 200 are N1 pipe sections, N1 pipe sections of the inner pipe 200 have N1-1 pipe section pairs and N1 pipe sections include corresponding N1-1 first splices, N1 being an integer greater than or equal to 2. For example, the plurality of tube segments of the outer tube 300 are N2 tube segments, the N2 tube segments of the outer tube 300 have N2-1 pairs of tube segments and the N2 tube segments include corresponding N2-1 second splices, N2 being an integer greater than or equal to 2.

Illustratively, there is a first splice between the distal inner tube segment 210 and the proximal inner tube segment 220, such as where the distal inner tube segment 210 and the proximal inner tube segment 220 are butt-joined (i.e., are closely end-to-end opposite each other and are fixedly connected), the first splice being where the distal inner tube segment 210 and the proximal inner tube segment 220 are closely end-to-end connected to each other. Illustratively, there is a second splice between the distal outer tube segment 310 and the proximal outer tube segment 320, such as where the distal outer tube segment 310 and the proximal outer tube segment 320 are butt-joined (i.e., are closely end-to-end opposite each other and are fixedly connected), the second splice being where the distal outer tube segment 310 and the proximal outer tube segment 320 are closely end-to-end connected to each other.

For example, distal inner tube segment 210 and proximal inner tube segment 220 may be laser welded to form inner tube 200, and distal outer tube segment 310 and proximal outer tube segment 320 may be laser welded to form outer tube 300. This is merely exemplary and is not a limitation of embodiments of the present utility model.

In some examples, at least one first splice of the inner tube 200 and at least one second splice of the outer tube 300 are staggered in an axial direction of the balloon catheter device 1000.

For example, the first splice between the distal inner tube segment 210 and the proximal inner tube segment 220 and the second splice between the distal outer tube segment 310 and the proximal outer tube segment 320 described above are staggered in the axial direction of the balloon catheter device 1000. Therefore, the splicing points (such as welding spots) of the inner tube and the outer tube are staggered, so that the splicing points of the inner tube and the outer tube are prevented from being overlapped, the balloon catheter device can be maintained in a smaller size, the strength requirement can be met, the pushing smoothness can be ensured, and the practical use requirement of an operator is met.

In some examples, a reinforcing tube 500 is sleeved outside of at least one first splice of the inner tube 200. For example, as shown in fig. 3 and 4, a first joint P1 is provided between the distal inner tube segment 210 and the proximal inner tube segment 220, and the inner tube 200 is sleeved with a reinforcing tube 500 outside the first joint P1.

According to the embodiment of the utility model, the reinforcing pipe is additionally arranged at the joint of the two pipe sections of the inner pipe, so that the two near and far sections of the inner pipe are lapped together, the tensile force of the two sides can be enhanced after the joint is completed, and the joint strength of the inner pipe is improved.

For example, as shown in FIG. 3, in some embodiments disclosed, during the splicing of the inner tube 200, the distal inner tube segment 210 and the proximal inner tube segment 220 are sleeved on the same mandrel 400, and a reinforcing tube 500 is sleeved over a first portion of the distal side (e.g., the Q1-covered portion in FIG. 3) and a second portion of the proximal side of the first splice P1, and a sleeve silicone tube 103 may also be added over the exterior of the reinforcing tube 500. Thus, embodiments of the present utility model splice the distal inner tube segment 210, the proximal inner tube segment 220, and the stiffening tube 500 by means of a splice such that the spliced portions are fused together, thereby making the material having two different tensile moduli into one inner tube. For example, embodiments of the present utility model may weld the distal inner tube segment 210, the proximal inner tube segment 220, and the reinforcement tube 500 by a laser welder such that the spliced portion (i.e., the fused segment) is fused together, thereby making the material having two different tensile moduli into one inner tube. In fig. 4, P2 represents the welding point of the inner tube 200, that is, represents a state where the reinforcing tube 500 is fused with the welding point. This is merely exemplary and is not a limitation of embodiments of the present utility model.

According to the embodiment of the utility model, the reinforcing pipe is additionally arranged on the inner pipe melting section, and the silica gel pipe is utilized for auxiliary processing, so that the welding strength of the inner pipe can be improved, the inner pipe can be uniformly heated during welding, the problem of flying and throwing of materials during melting is avoided, and the whole inner pipe can be shaped.

In some examples, the length of the stiffening tube 500 in the axial direction along the balloon catheter device 1000 may be around 6 mm. This is merely exemplary and is not a limitation of embodiments of the present utility model.

For example, as shown in fig. 5, in some embodiments disclosed, during the splicing of the outer tube 300, the distal outer tube segment 310 and the proximal outer tube segment 320 are sleeved on the same mandrel 400, and an auxiliary process kit silicone tube 103 is sleeved on the outside of the second splice of the outer tube 300. Thus, embodiments of the present utility model splice the distal outer tube segment 310 and the proximal outer tube segment 320 by means of a splice such that the spliced portions merge into one, thereby rendering a material having two different tensile moduli into one outer tube. For example, embodiments of the present utility model may weld the distal outer tube segment 310 and the proximal outer tube segment 320 by a laser welder such that the splice (i.e., the fusion segment Q2) fuses together, thereby turning materials having two different tensile moduli into one outer tube. In fig. 6, a point P3 indicates a welding point of the outer tube 200. This is merely exemplary and is not a limitation of embodiments of the present utility model.

According to the embodiment of the utility model, the silica gel tube is used for auxiliary processing on the melting section of the outer tube, so that the outer tube can be uniformly heated during welding, the problem of flying and throwing of materials during melting is avoided, and the whole outer tube can be shaped.

In some embodiments disclosed, when the welded inner tube 200 and outer tube 300 are combined together, the distal and proximal ends of the balloon catheter device are made of different materials, and the distal flexibility is superior to the proximal end, so that a balloon catheter device with high tracking and high pushing performance at the distal end can be formed.

Fig. 7 is a schematic cross-sectional view of a balloon provided in some embodiments of the utility model.

For example, as shown in fig. 7, balloon 100 includes an inner layer 110 and an outer layer 120 that differ in tensile modulus.

According to the balloon disclosed by the embodiment of the utility model, a double-layer structural design (for example, the balloon comprises a soft material layer and a hard material layer which are relatively speaking) is adopted, so that the balloon has certain flexibility and higher bursting pressure, and the balloon catheter device can smoothly pass through from a tiny blood vessel to an occlusion lesion to reversely and successfully expand the lesion inner membrane.

In some examples, the tensile modulus of outer layer 120 of balloon 100 is greater than the tensile modulus of inner layer 110 of balloon 100.

The balloon of some embodiments of the present utility model adopts a double-layer structure design in which the inner layer is a soft material layer (i.e., the corresponding tensile modulus is smaller) and the outer layer is a hard material layer (i.e., the corresponding tensile modulus is larger), so that the relative softness of the end of the balloon catheter device can be ensured under the condition of relatively smaller overall size, and the balloon can be maintained to have relatively higher pressure to fully complete the expansion of the lesion.

In some examples, outer layer 120 of balloon 100 includes at least one of the following materials: nylon, polyethylene terephthalate, and polyethylene; inner layer 110 of balloon 100 includes at least one of the following materials: polyether block polyamide copolymers, polyvinyl chloride, polyurethane, silicone rubber. Of course, this is merely exemplary, and is not a limitation of the embodiments of the present utility model, and may be freely adjusted according to actual needs, which are not exhaustive or redundant.

In some examples, inner layer 110 of balloon 100 may be selected from polyether block polyamide copolymer (Pebax 7233), and outer layer 120 of balloon 100 may be selected from nylon 12. Thus, the polyether block polyamide copolymer of inner layer 110 may impart some flexibility to balloon 100, facilitating balloon catheter devices to increase the burst resistance of balloon 100 through tortuous lesions and nylon 12 of outer layer 120.

In some examples, the ratio of the polyether block polyamide copolymer of inner layer 110 to nylon 12 of outer layer 120 may be around 3:1. As such, the balloons of embodiments of the present utility model may be well used to treat total occlusion lesions, especially for some tortuosity. Of course, this is merely exemplary, and is not a limitation of the embodiments of the present utility model, and the ratio may be freely adjusted according to actual needs, which is not described herein.

In some examples, the tensile modulus of the outer layer of balloon 100 is 1100±100MPa and the tensile modulus of the inner layer of balloon 100 is 510±100MPa. The soft material promotes the flexibility of the balloon part, so that the vascular injury caused by reversely passing through the side branch vessel is reduced. The hard material improves the overall burst pressure of the saccule, can be directly expanded by using higher pressure, avoids that the lesion can not be opened at the harder occlusion lesion, and reduces the probability of treatment failure.

Fig. 8 is a schematic structural diagram of a hypotube according to some embodiments of the present utility model.

For example, as shown in fig. 1 and 8, the distal end of hypotube 700 includes a helical cutting region 710. Thus, the distal end of the hypotube in the embodiment of the utility model adopts laser spiral cutting, which can ensure that the trafficability of the balloon catheter device is ensured while the balloon catheter device transmits enough force to the front end to pass through the tortuous vessel part, and the trafficability of the balloon catheter device is enhanced.

For example, in the example of fig. 8, hypotube 700 includes region 720, region 720 representing the region of connection (e.g., the region of welded connection) of hypotube 700 with transition tube 800.

In some examples, the helical cutting region 710 has a plurality of helical cutting pitches 711, the plurality of helical cutting pitches 711 being disposed to sequentially increase from the distal end toward the proximal end in the axial direction of the transition tube 800. For example, the helically cut region 710 of hypotube 700 may be laser helically cut. In some embodiments of the present utility model, the smaller the helical cutting pitch 711, the better the flexibility of the hypotube 700, and conversely, the larger the helical cutting pitch 711, the better the pushing force of the hypotube 700. The transition tube 800 may be nylon 11.

In some examples, the initial pitch value (i.e., the most distal cutting pitch) of the plurality of helical cutting pitches 711 of the helical cutting region 710 may be about 1mm, and the pitch variance value (also referred to as a cutting pitch increment value) between two adjacent helical cutting pitches 711 may be about 0.01 mm. This is merely exemplary, and is not a limitation of the embodiments of the present utility model, and the ratio may be freely adjusted according to actual needs, which will not be described herein.

In some examples, the multiple spiral cutting pitches 711 of the spiral cutting area 710 are M spiral cutting pitches 711, and M is greater than 2, and a pitch phase difference value between every two adjacent spiral cutting pitches 711 in the M spiral cutting pitches 711 is denoted as d, so that M-1 pitch phase difference values d existing in the M spiral cutting pitches 711 may be constant or different from each other, which may not be limited by the embodiment of the present utility model, and may be freely adjusted according to actual needs, which will not be repeated herein.

The distal end of the hypotube in the embodiment of the utility model adopts the spiral cutting with gradually changing intervals, so that the pushing property can be well maintained, and meanwhile, the better tracking property of the distal end of the hypotube can be ensured, so that the catheter device can smoothly enter the calcified lesion position from the reverse direction.

For example, as shown in fig. 1-8, at least one embodiment of the present utility model provides a method of operating a balloon-based catheter device, comprising one or more of the following steps:

(1) The balloon catheter device 1000 is prepared for cleaning and the balloon dilation medium is loaded into a luer lock syringe, for example, the balloon dilation medium may be a mixture of contrast and sterile saline or other medium of equal proportion.

(2) The three-way stopcock is connected to the balloon catheter apparatus 1000 and flushing is performed through the three-way stopcock. The syringe is connected to the three-way cock valve, the syringe is held, the mouth of the syringe is downward, the syringe is sucked for a certain time, and the push rod is released.

(3) And closing the three-way plug valve, taking down the syringe, and discharging all the gas in the syringe barrel.

(4) The syringe was reconnected and aspirated until no bubbles appeared during aspiration. As such, embodiments of the present utility model avoid complications by completely purging air from the balloon catheter prior to insertion of the balloon catheter device 1000 into the patient.

(5) The guidewire lumen is flushed with sterile saline through the tip tube 900 of the balloon catheter device 1000 and the filling device is connected to the balloon catheter device 1000.

(6) The air remaining in the distal luer of the filling device is purged and contrast medium is used to remove the air.

(7) The three-way cock valve is closed, and the syringe used in preparation is detached.

(8) The filling device was connected to a three-way stopcock with balloon catheter device 1000 and a coronary artery chronic total occlusion balloon dilation catheter was used.

(9) The guidewire is inserted through a hemostatic valve on the guide catheter and into and through the guide catheter.

(10) Under visualization with an X-ray fluoroscopy device, the guidewire is advanced to the target diseased vessel and then passed through the chronic total occlusion or stenosis of the coronary artery.

(11) The tip of the balloon dilation catheter is threaded into the end of the guidewire, ensuring that the guidewire is threaded out of the rapid exchange port, pushing the balloon catheter device 1000 along the guidewire until it is in proximity to the hemostatic valve. The hemostatic valve is opened and the guidewire position is maintained while the balloon catheter device 1000 is inserted.

(12) The hemostatic valve is closed, and the position with which the balloon dilation catheter is in contact is closed.

(13) The balloon catheter device 1000 is pushed until the marker band 710 on the hypotube 700 is in registry with the seat of the guide catheter, which shows that the tip of the balloon catheter device 1000 has reached the guide catheter tip.

(14) The balloon catheter device 1000 is advanced along the guidewire to the site of the chronic total occlusion or stenosis of the coronary artery, and the balloon working (dilation) region is positioned at the site of the chronic total occlusion or stenosis of the coronary artery under visualization of the fluoroscopic apparatus using the visualization ring 600 of the balloon catheter device.

(15) The balloon 100 should be maintained at a negative pressure between two expansions, with the appropriate expansion pressure selected.

(16) Before balloon catheter device 1000 is removed, a negative pressure must be applied with the balloon filling device to ensure complete evacuation of the liquid within balloon 100.

(17) The emptied balloon dilation catheter is withdrawn from the guide catheter and the hemostatic valve. If additional catheters are required, the guide wire should remain in place. And finally closing the hemostatic valve.

The operation method based on the balloon catheter device can be applied to the scene of the chronic total occlusion calcification lesion, and can improve the probability of balloon reverse passing through the blood vessel in the operation of the chronic total occlusion lesion of the coronary artery.

The operation method of the balloon catheter device according to at least one embodiment of the present utility model is not limited to the above steps, and is not limited to the order of the steps described above, and may be freely adjusted according to the actual situation, and will not be described herein.

The following points need to be described:

(1) The drawings of the embodiments of the present utility model relate only to the structures to which the embodiments of the present utility model relate, and other structures may refer to the general designs.

(2) The embodiments of the utility model and the features of the embodiments can be combined with each other to give new embodiments without conflict.

The above description is only specific embodiments of the present utility model, but the scope of the present utility model should not be limited thereto, and the scope of the present utility model should be determined by the claims.

Claims (12)

1. A balloon catheter device, characterized by comprising a balloon, an inner tube and an outer tube, wherein the inner tube extends through the outer tube and penetrates through the balloon, a gap is reserved between the outer wall of the inner tube and the inner wall of the outer tube, the distal end part of the balloon is connected with the distal end of the inner tube, and the proximal end part of the balloon is connected with the distal end of the outer tube;

The inner tube and the outer tube are all spliced tube structures, the spliced tube structures comprise a plurality of tube section parts which are spliced in sequence, the tube section parts comprise a first tube section and a second tube section which are different in tensile modulus, and the first tube section and the second tube section are respectively a far end part of the spliced tube structures and a near end part of the spliced tube structures.

2. The balloon catheter device of claim 1 wherein,

The first pipe section of the inner pipe is a far-end inner pipe section and the second pipe section of the inner pipe is a near-end inner pipe section;

the first tube section of the outer tube is a distal outer tube section and the second tube section of the outer tube is a proximal outer tube section;

the tensile modulus of the plurality of tube segment portions is arranged to decrease in sequence from the proximal end toward the distal end in the axial direction of the balloon catheter device.

3. The balloon catheter device of claim 2 wherein,

The tensile modulus of the proximal inner tube section is 1420+/-100 MPa, and the tensile modulus of the distal inner tube section is 390+/-100 MPa;

The tensile modulus of the proximal outer tube segment is 1420+ -100 MPa, and the tensile modulus of the distal outer tube segment is 1100+ -100 MPa.

4. The balloon catheter device of claim 1 wherein,

The inner tube is a multilayer tube, the outer tube is a single-layer tube, and the strength of the inner tube is greater than that of the outer tube.

5. The balloon catheter device of claim 1 wherein,

At least one first splicing position is formed between at least one pair of adjacent two pipe section parts in the plurality of pipe section parts of the inner pipe;

At least one second splicing position is formed between at least one pair of adjacent two pipe section parts in the plurality of pipe section parts of the outer pipe;

the at least one first splice and the at least one second splice are staggered along an axial direction of the balloon catheter device.

6. The balloon catheter device of claim 5 wherein,

And a reinforcing pipe is sleeved outside the at least one first splicing part of the inner pipe.

7. The balloon catheter device of claim 2, further comprising a visualization ring disposed on said distal inner tube segment.

8. The balloon catheter device of claim 1 wherein,

The balloon includes inner and outer layers of differing tensile modulus.

9. The balloon catheter device of claim 8 wherein,

The tensile modulus of the outer layer of the balloon is greater than the tensile modulus of the inner layer of the balloon.

10. The balloon catheter device of claim 9 wherein,

The tensile modulus of the outer layer of the balloon is 1100+/-100 MPa;

The tensile modulus of the inner layer of the balloon is 510+/-100 MPa.

11. The balloon catheter device of claim 1, further comprising a transition tube and a hypotube,

The distal end of the transition tube is connected with the outer tube and the inner tube respectively, the proximal end of the transition tube is connected with the hypotube, and the distal end of the hypotube comprises a spiral cutting area.

12. The balloon catheter device of claim 11 wherein,

The helical cutting area has a plurality of helical cutting pitches arranged to sequentially increase from the distal end toward the proximal end in the axial direction of the transition tube.