WO2017185705A1

WO2017185705A1 - Balloon catheter

Info

Publication number: WO2017185705A1
Application number: PCT/CN2016/104192
Authority: WO
Inventors: 蒋翠兰; 卢立中; 周剑钗; 阙志文
Original assignee: 业聚医疗器械(深圳)有限公司
Priority date: 2016-04-26
Filing date: 2016-11-01
Publication date: 2017-11-02
Also published as: CN105664338A; CN106983946A

Abstract

Disclosed is a balloon catheter (1), comprising a needle base (11), a proximal catheter (12), a distal catheter (13), a balloon (14) and a catheter tip (15), wherein same are successively connected. The balloon catheter (1) further comprises two fixed wires (161, 162) and a guide wire (17). The two fixed wires (161, 162) and the guide wire (17) are arranged at a certain angle therebetween and fixed around the balloon (14) so as to increase and stretch the area of a calcified lesion region. The cross section of the two fixed wires (161, 162) are made to be an outwardly protruding polygon, producing a good cutting effect in a highly calcified region. Moreover, comparing with a commonly used clinical cutting balloon catheter containing three fixed wires (161, 162), the present balloon catheter (1) uses the guide wire (17) to serve as one of the fixed wires (161, 162) without decreasing the cutting area and effect, so as to reduce the number of the fixed wires (161, 162), and the two fixed wires (161, 162) cooperate with the guide wire (17) having a guiding function so as to further enhance the advancing of the balloon catheter (1).

Description

Balloon catheter

Technical field

The present invention relates to a medical device, and more particularly to a balloon catheter.

Background technique

Vascular intervention has been rapidly developed since the first percutaneous transluminal coronary angioplasty (PTCA) in 1977. With the advancement of vascular interventional procedures, the application of balloon catheters has become increasingly widespread. The performance and quality of the balloon catheter, the experience of the surgeon, and the proficiency are key factors in the success of the procedure. In some diabetic patients, vascular stenosis is usually severely calcified and is in the form of complete occlusion. In the treatment of intravascular intervention for such vascular restenosis, doctors found that it is difficult for ordinary balloon catheters to open the blood vessels. In order to open the calcified severe and completely occluded lesion area, some new types of balloon catheters have been invented, such as cutting balloon catheters.

The cutting balloon catheter not only has the traversal and pushability of the common balloon catheter, but also has certain mechanical properties, can open the lesion site with severe calcification and complete occlusion, and does not cause blood vessel rupture. Today, many manufacturers of cutting balloon catheters have come up with different designs. At present, the conventionally used cutting balloon catheters all contain three-way intrinsic guide wires, and their penetration has always been defective.

The cutting balloon catheter disclosed by the applicant in the CN201596232U patent is a cutting balloon catheter with a single intrinsic guide wire. The cutting balloon catheter has excellent penetration and is easier to open calcified lesions than a common balloon catheter. . Among the vessels with low calcification lesions, it has excellent ability to cut calcified lesions and expand the area of calcified lesions, but in the vessels with high calcification lesions, its ability to cut calcified lesions and the area of calcified lesions are lacking.

Therefore, there is a need for a balloon catheter that has good cutting ability and ability to open calcified lesions in highly calcified blood vessels, and overcomes the defect of poor distal traversal of a cut balloon catheter with only an intrinsic guidewire. It can reach the tortuous and completely occluded small blood vessels, and retain the basic structure and use of the common balloon catheter, which is convenient for doctors to operate.

Summary of the invention

It is an object of the present invention to provide a balloon catheter to solve the prior art balloon catheter pair The high calcification lesion area has a small expansion area and a poor cutting effect, and a problem that the cutting balloon catheter having only an intrinsic guide wire has poor penetration.

In order to solve the above technical problem, the present invention provides a balloon catheter comprising a needle hub, a proximal catheter, a distal catheter, a balloon, and a catheter tip, which are sequentially connected, and the balloon catheter further includes:

a two-way intrinsic guide wire extending through the interior of the distal catheter, around the exterior of the balloon, and through the interior of the catheter tip to the distal end of the catheter tip, the proximal of the intrinsic guidewire An end is coupled to the distal end of the proximal catheter, the intrinsic guide wire having a convex cross section;

A guide wire is threaded through the distal end of the catheter tip, through the interior of the catheter tip, from the proximal end of the catheter tip to the exterior of the balloon.

Preferably, the guide wire and the two-way intrinsic guide wire are at an angle of 120 degrees between the two portions of the outer portion of the balloon.

Preferably, the intrinsic guide wire has a triangular cross section, and a side near the outer wall of the balloon is a base.

Preferably, the length of the base of the triangular section of the intrinsic guide wire is 0.12-0.45 mm, and the height of the triangular section of the intrinsic guide wire is 0.12-0.45 mm.

Preferably, the length of the base portion of the triangular portion of the intrinsic guide wire is 0.2-0.35 mm, and the length of the triangular portion of the intrinsic guide wire is 0.2-0.35 mm.

Preferably, the two corners of the intrinsic guide wire having a triangular cross section close to the outer wall of the balloon are rounded, and the radius of the rounded corner is 0.01-0.05 mm.

Preferably, the radius of the rounded corner is 0.02-0.03 mm.

Preferably, one of the two intrinsic guide wires is provided with a radiopaque marker ring.

Preferably, the material of the intrinsic guide wire is selected from one of: 316LVM stainless steel, 304LVM stainless steel, nickel titanium alloy, silicon.

Preferably, the guide wire has a diameter of from 0.0105 to 0.035 inches.

Preferably, the guide wire has a diameter of from 0.014 to 0.018 inches.

Preferably, the hub is an inner conical luer, the balloon having a length of 5-150 mm.

Preferably, the proximal catheter comprises a descending end to a distal end: a large hot air duct, a small hot air duct, a hypotube, and the hypotube is further provided with an exit marker ring, the hypotube The surface is coated with Teflon.

Preferably, the material of the distal catheter is nylon.

Compared with the prior art, the present invention has the following beneficial effects:

1. The balloon catheter of the present invention comprises three guide wires: two natural guide wires and one guide wire, and the two inner guide wires and one guide wire are arranged at an angle between the balloons at a certain angle. This arrangement can increase the area of the calcified lesion area and provide a good cutting effect for the high calcification area;

2. The commonly used cutting balloon catheters with inherent guidewires all contain three-way intrinsic guide wires. The cutting balloon catheter of the present invention uses the guide wire as an inherent path without reducing the cutting area and effect. The guide wire reduces the number of the intrinsic guide wires, and the two-way intrinsic guide wire and the guiding guide wire that guides each other cooperate to further enhance the penetration of the balloon catheter;

3. The cross-section of the two-way intrinsic guide wire is made into a convex polygon, and the ability to cut calcified lesions can be significantly enhanced compared with the prior art intrinsic guide wire having a circular cross section.

DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic view showing the structure of a balloon catheter of the present invention.

2 is a schematic transverse cross-sectional view showing a balloon, an intrinsic guide wire, and a guide wire of Embodiment 2 and Example 3 of the balloon catheter of the present invention.

Figure 3-1 is a schematic diagram of a finite element model of the CN201596232U patent publication.

Figure 3-2 is a schematic diagram showing the results of the principal stress of the calcified plaque cut by the finite element model of the CN201596232U patent publication.

Figure 3-3 is a schematic diagram showing the results of the finite element model cutting of the calcified plaque in the CN201596232U patent disclosed product.

Figure 4-1 is a schematic illustration of a finite element model of a balloon catheter of the present invention.

4-2 is a schematic diagram showing the results of the principal stress of cutting a calcified plaque by a finite element model of the balloon catheter of the present invention.

4-3 is a schematic view showing the results of the stenosis distance of the calcified plaque by the finite element model of the balloon catheter of the present invention.

The reference numerals are as follows: 1. Balloon catheter; 11, needle holder; 12, proximal catheter; 121, large hot air tube; 122, small hot air tube; 123, hypotube; 1231, exit marker ring; , distal catheter; 14, balloon; 141, balloon body; 142, proximal pin; 143, distal pin; 15, catheter tip; 151, fast exchange guide wire; 16, inherent guide wire; First intrinsic guide wire; 1611 a first rounded corner; 1612, a second rounded corner; 162, a second inherent guidewire; 163, a marker ring; 17, a guide wire.

detailed description

Exemplary embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It is to be understood that the invention is capable of various modifications in the various embodiments and this invention.

The preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

In describing the orientation, the present invention uses the balloon catheter operator as a reference, the proximal end of the balloon catheter operator, and the distal end away from the balloon catheter operator.

Example 1

Referring to Fig. 1, a balloon catheter 1 of Embodiment 1 of the present invention includes a needle hub 11, a proximal catheter 12, a distal catheter 13, a balloon 14, and a catheter tip 15, which are sequentially connected.

Wherein, the proximal catheter 12 includes a large heat-shrinkable tube 121, a small hot air-shrink tube 122 and a hypotube 123 from the proximal end to the distal end. The hypotube 123 is also provided with an exit marker ring 1231 to further clarify the position of the balloon catheter 1 in the blood vessel. The surface of the hypotube 123 is coated with polytetrafluoroethylene. The friction coefficient of the polytetrafluoroethylene is extremely low, and it has the characteristics of acid and alkali resistance and various organic solvents, and reduces the resistance of the balloon catheter 1 in the blood vessel. Guarantee the stability of the product.

The balloon 14 includes a balloon body 141 and a proximal pin 142 and a distal pin 143 extending outwardly from opposite ends of the balloon body 141. The proximal and

distal pins

142, 143 of the balloon 14 are each between 2 and 5 mm in length.

1 and 2, the balloon catheter 1 further includes two intrinsic guide wires 16 and a guide guide wire 17, which are specifically shown as the first intrinsic guide wire 161 and the second intrinsic guide wire. Wire 162. The first intrinsic guide wire 161 and the second intrinsic guide wire 162 respectively pass through the inside of the distal catheter 13 and then pass through the outside of the balloon 14 and finally pass through the inside of the catheter tip 15 and to the catheter tip 15 . The distal end of the first intrinsic guide wire 161 and the second intrinsic guide wire 162 are connected to the distal end of the hypotube 123, and the connection may be laser welding. The cross section of the first intrinsic guide wire 161 and the second intrinsic guide wire 162 is a convex polygon, and the calcified lesion is cut compared with the circular cross section. The ability is significantly enhanced.

The guide wire 17 is inserted through the distal end of the catheter tip 15 and then passed through the interior of the catheter tip 15 from the quick exchange guide wire 151 of the catheter tip 15 to the outside of the balloon 14.

In the first embodiment, the first intrinsic guide wire 161, the second intrinsic guide wire 162 and the guide guide wire 17 cooperate, and since the guide wire acts as an intrinsic guide wire, the three-way intrinsic guide is commonly used in clinical practice. The wire-cut balloon catheter becomes a cutting balloon catheter containing two intrinsic guide wires, thereby improving the flexibility of the distal end of the balloon catheter 1, while the balloon 14 and the three-way guide wire also ensure that the balloon catheter 1 is in the blood vessel Crossing in the middle.

In the first embodiment, the materials, shapes and dimensions used for the components are as follows:

The needle hub 11 is an inner conical luer connector and is a component connected to an external charging device to ensure that the balloon catheter and the external charging device can be tightly connected under high pressure.

The length of the balloon 14 is 5-150 mm, which is a clinically common size suitable for the balloon 14 to open the stenosis of the coronary artery and peripheral blood vessels and to block the lesion area.

The material of the distal catheter 13 is nylon. The nylon has good abrasion resistance, good self-lubricity and low friction coefficient, which can improve the penetration of the balloon catheter 1 in the blood vessel, slow down the patient's pain and increase the service life of the product.

The material of the first intrinsic guide wire 161 and the second intrinsic guide wire 162 may be selected from one of 316LVM stainless steel, 304LVM stainless steel, nickel titanium alloy, and silicon. The materials of the first natural guiding wire 161 and the second natural guiding wire 162 of the first embodiment are all nickel-titanium alloys, and the nickel-titanium alloy has the advantages of abrasion resistance, corrosion resistance, high damping and superelasticity.

The guide wire 17 is a guide wire used in clinical operations, has a guiding balloon catheter to reach the lesion, and prevents the balloon catheter from bending in a curved lesion. The guide wire 17 has a diameter of 0.0105-0.035 inches. In other preferred embodiments, the guide wire 17 has a diameter of from 0.014 to 0.018 inches. The guide wire 17 in this embodiment 1 has a diameter of 0.014 inches. The setting of this specification conforms to the physiological characteristics of human blood vessels, ensuring the passage and directionality of the balloon catheter 1.

Example 2

Referring to Fig. 2, the balloon catheter 1 of the second embodiment of the present invention is substantially the same as that of the embodiment 1, except that the guide wire 17 and the first natural guide wire 161 and the second natural guide wire 162 are outside the balloon 14. The portion of each of the two is at an angle of 120 degrees, and this arrangement can increase the area of the balloon catheter 1 to open the calcified lesion.

In addition, the cross section of the first intrinsic guide wire 161 and the second intrinsic guide wire 162 are both triangular, and the side of the triangular cross section near the outer wall of the balloon 14 is a bottom edge, and the straight line distance from the bottom edge to the top of the triangle is a triangle. The height of the section. The lengths of the triangular cross-section of the first intrinsic guide wire 161 and the second intrinsic guide wire 162 are both 0.12-0.45 mm and the height is 0.12-0.45 mm. In other preferred embodiments, the first intrinsic guidewire 161 and the second intrinsic guidewire 162 have a length of the base of the triangular section of 0.2-0.35 mm and a height of 0.2-0.35 mm. In the second embodiment, the base and height of the triangular section of the first intrinsic guide wire 161 and the second intrinsic guide wire 162 are both 0.267 mm. The cross-section of the first intrinsic guide wire 161 and the second intrinsic guide wire 162 is triangular, which not only efficiently expands the area of severe occlusion of the diseased blood vessel, but also improves the ability of the balloon catheter 1 to cut calcified lesions.

In addition, as shown in FIG. 2, the two corners of the first intrinsic guide wire 161 having a triangular cross section near the outer wall of the balloon 14 are a first round 1611 and a second round 1612, respectively, and the first round 1611 and the first The radius of the two rounds 1612 is 0.01-0.05 mm. In some preferred embodiments, the radius of the first round 1611 and the second round 1612 are both 0.02-0.03 mm. The radius of the first round corner 1611 and the second round corner 1612 in the second embodiment are both 0.02 mm. The two corners of the second intrinsic guide wire 162 having a triangular cross section near the outer wall of the balloon 14 can also be provided in the same manner. These rounds can prevent the angular intrinsic guidewire 161 and the second intrinsic guidewire 162 from contacting the balloon 14 from damaging the balloon 14 during inflation of the balloon 14.

Example 3

Referring to Fig. 2, the balloon catheter 1 of the third embodiment of the present invention is substantially the same as that of the second embodiment, except that the lengths of the triangular cross-section of the first intrinsic guide wire 161 and the second intrinsic guide wire 162 are both 0.35. Mm, the height is 0.35mm. The radius of the first rounded corner 1611 and the second rounded corner 1612 of the first intrinsic guide wire 161 having a triangular cross section close to the outer portion of the balloon 14 are both 0.03 mm, and the second intrinsic guide wire 162 has a triangular cross section close to the balloon 14 The two corners of the outer wall also do the same. The first intrinsic guide wire 161 and the second intrinsic guide wire 162 and the guide wire 17 are at an angle of 120 degrees between the portions of the outer portion of the balloon 14, since the guide wire acts as an intrinsic guide wire. The commonly used cutting balloon catheter containing three-way intrinsic guide wire becomes a cutting balloon catheter containing two intrinsic guide wires, so that the balloon catheter has good penetration to a severely occluded lesion area, and it is difficult to overcome its distal end. The defect of the bend can reach the tortuous and completely occluded small vessel lesion.

In addition, the first intrinsic guidewire 161 or the second intrinsic guidewire 162 is also mated with a radiopaque marker ring 163 so that the operator can detect the precise position of the balloon catheter 1 during surgery.

The balloon catheter of the above embodiments 1-3 is substantially as follows:

S _1, the proximal end of hypotube 123 extends into a small hot air shrink tube 122, welded using a hot air welding machine into the linker, so that the two tight connection does not leak.

S _2, a small hot air shrink tube 122 with the proximal end of the hypotube connector 123 extending into the needle hub 11, performed by UV glue bonding and sealing, and hot air shrinkage of large sets of opposing two ends 121 in a small reduction of hot air 122, outside the connector body of the hypotube 123 and the needle holder 11, the hot heat shrinkable tube 121 is heat-shrinked by a hot air blower to the transition portion of the needle holder 11 and the small heat-shrink tube 121 and the hypotube 122 connection body to form a Transitional connection.

S ₃ , the radiopaque marker ring 163 is welded to the first natural guiding wire 161 or the second natural guiding wire 162 by a welding machine, and the welding machine can be selected from hot air welding, laser welding, infrared welding or ultrasonic welding. One.

S _4, by the end of the welding machine 162 to the first proximal end of the guidewire passage 161 and the second intrinsic intrinsic guidewire passage welded hypotube 11 with a hub, a large hot air shrink tube 121, a small reduction of hot air 122 123 In the welding machine, one of laser welding, infrared welding or ultrasonic welding may be used. Preferably, the first intrinsic guide wire 161 and the second intrinsic guide wire 162 are respectively welded to the bottom sides of the hypotube 123 at an angle of 120 degrees.

S _5, the proximal end by the distal end of the catheter welder 13 is welded to the hypotube 123, optional hot air welding machine welding, laser welding, infrared bonding or ultrasonic welding of one kind.

S ₆ , the proximal pin 142 and the distal pin 143 of the balloon 14 are kept at a length of 2-5 mm, and an ordinary single-sided or double-sided blade is required to cut off the excess pins. The distal end of the distal catheter 13 is inserted into the proximal pin 142 of the balloon 14, and the two are welded by a welding machine. The welding machine may be one of hot air welding, laser welding, infrared welding or ultrasonic welding.

S _7, the first passage natural guidewire 161, second passage 162 inherent guidewire, balloon 14 and catheter tip 15 are assembled welding.

S _8, finally, the guide wire 17 penetrates from the distal end of the catheter tip 15, through the interior of the catheter tip 15, piercing a rapid exchange catheter tip from the guidewire port 15 of the outer balloon 14 to 151. Preferably, the first intrinsic guidewire 161 and the second intrinsic guidewire 162 and the guidewire 17 are at an angle of 120 degrees between portions of the outer portion of the balloon 14.

Comparative example

The finite element method was used to explore the ability of the products disclosed in CN201596232U and the products of the present invention to cut calcified lesions and expand the area of calcified lesions. Assume the inherent guidewire of the product of the invention The diameter of 16 is the same as the diameter of the cut guide wire of the CN201596232U patented product.

The software used in the finite element model is ABAQUS13-1. The finite element model simulates the intravascular clinical effects of 2.0 x 15 of the above two balloon catheters in hypercalcified lesions.

The vascular material properties of the high calcification lesion in the finite element model are those of Claudio Capelli, Francesca Gervaso et al., "Assessment of tissue prolapsed after balloon-expandable stenting: Influence of stent cell geometry". Attributes. The cutting guide wire of CN201596232U and the intrinsic guide wire of the present invention in the finite element model are both made of 304LVM stainless steel and have a diameter of 0.267 mm. The other finite element model parameters were published by Dr. Yoshiaki Kawase on the "Study of a scoring balloon for a severely calcified lesion: Bench test and finite". Element analysis)) finite element model parameters.

The principal stress and the distance of the calcified plaque are used to characterize the ability of the product to cut calcified lesions and expand the area of calcified lesions, respectively.

Figure 3-1, 3-2, and 3-3 are schematic diagrams of the finite element model of the product disclosed in CN201596232U, the main stress diagram of the calcified plaque, and the calculation result of the distance of the distracted.

Figures 4-1, 4-2, and 4-3 are respectively schematic diagrams of the finite element model of the product disclosed in the present invention, a schematic diagram of the principal stress of the calcified plaque and a calculation result of the distance of the distracted.

Table 1 shows the results of finite element calculation of CN201596232U and the product of the present invention.

Table 1 finite element calculation results of the product of CN201596232U and the invention

It can be seen from the above table that the main stress value of the product of the invention is much larger than the product disclosed in CN201596232U, and the distance of the balloon catheter is also larger than that disclosed in CN201596232U, so the product of the invention has the ability to cut calcified lesions compared with the product disclosed by CN201596232U. If it is better, the area of the calcified lesion area is larger than that disclosed by CN201596232U. In summary, the product disclosed in the present invention has excellent cutting calcification lesions and distracting the open calcified lesions in the blood vessels of high calcification lesions. The ability of the area is also good for crossing in the blood vessels.

The above are only the preferred embodiments of the present invention, and are not intended to limit the scope of the present invention. The equivalent structural changes made by the present invention and the contents of the drawings are included in the scope of the present invention.

Claims

A balloon catheter comprising a needle hub, a proximal catheter, a distal catheter, a balloon, and a catheter tip, which are sequentially connected, wherein the balloon catheter further comprises:

a two-way intrinsic guide wire extending through the interior of the distal catheter, around the exterior of the balloon, and through the interior of the catheter tip to the distal end of the catheter tip, the proximal of the intrinsic guidewire An end is coupled to the distal end of the proximal catheter, the intrinsic guide wire having a convex cross section;

A guide wire is threaded through the distal end of the catheter tip, through the interior of the catheter tip, from the proximal end of the catheter tip to the exterior of the balloon.
The balloon catheter of claim 1 wherein said guidewire and said two-way intrinsic guidewire are at an angle of 120 degrees between portions of said outer portion of said balloon.
The balloon catheter of claim 1 wherein said intrinsic guidewire has a triangular cross section and a side adjacent said outer wall of said balloon is a base.
The balloon catheter according to claim 3, wherein the length of the base portion of the triangular portion of the intrinsic guide wire is 0.12-0.45 mm, and the height of the triangular portion of the intrinsic guide wire is 0.12-0.45 mm.
The balloon catheter according to claim 4, wherein the length of the base portion of the triangular portion of the intrinsic guide wire is 0.2-0.35 mm, and the length of the triangular portion of the intrinsic guide wire is 0.2-0.35 mm.
The balloon catheter according to claim 3, wherein the two corners of the intrinsic guide wire having a triangular cross section adjacent to the outer wall of the balloon are rounded, and the radius of the rounded corner is 0.01-0.05 mm.
The balloon catheter of claim 6 wherein said rounded corner has a radius of 0.02-0.03 mm.
The balloon catheter of claim 1 wherein one of the two intrinsic guidewires is externally mated with a radiopaque marker ring.
The balloon catheter of claim 1 wherein the material of the intrinsic guidewire is selected from the group consisting of: 316 LVM stainless steel, 304 LVM stainless steel, nickel titanium alloy, silicon.
The balloon catheter of claim 1 wherein said guidewire has a diameter of from 0.0105 to 0.035 inches.
The balloon catheter of claim 10 wherein said guidewire has a diameter of from 0.014 to 0.018 inches.
The balloon catheter of claim 1 wherein said hub is an inner conical luer connector, said balloon having a length of 5-150 mm.
The balloon catheter of claim 1 wherein said proximal catheter comprises a proximal end to a distal end: a large heat shrink tube, a small heat shrink tube, a hypotube, said hypotube There is also an exit marker ring, the surface of which is coated with polytetrafluoroethylene.
The balloon catheter of claim 1 wherein the distal catheter is made of nylon.