CN112023230A

CN112023230A - Pulmonary artery balloon dilatation catheter

Info

Publication number: CN112023230A
Application number: CN202010979274.5A
Authority: CN
Inventors: 陶新曹; 王剑锋; 马为; 栾波
Original assignee: Beijing City Kaysers Trading Co ltd
Current assignee: Beijing City Kaysers Trading Co ltd
Priority date: 2020-09-17
Filing date: 2020-09-17
Publication date: 2020-12-04

Abstract

The invention discloses a pulmonary artery saccule dilatation catheter which is of a coaxial double-cavity structure as a whole and comprises a handle, a catheter reinforcement part, a hypotube, an outer tube, an inner tube, a tip and a saccule, wherein the outer tube is provided with a cut, a guide wire cavity is formed from the tip to the cut, the guide wire cavity is a through cavity, and the outer surface of the guide wire cavity is coated with a hydrophilic coating; a pressurizing cavity is formed from the handle to the balloon, and the pressurizing cavity is a closed cavity; the inner wall from the tip end to the near end of the hypotube is coated with a silicone oil coating, the two ends of the balloon are respectively a far end shoulder and a near end shoulder, the far end shoulder is connected with a far end neck, the near end shoulder is connected with a near end neck, the inner tube is arranged at the axis of the balloon, one end of the inner tube penetrates through the far end neck to be connected with the tip end, and the other end of the inner tube penetrates through the near end neck to be connected with the outer tube; the near end of the outer tube is connected with the hypotube through a transition point, the hypotube is fixedly connected with the catheter reinforcement, and the catheter reinforcement is fixedly connected with the handle.

Description

Pulmonary artery balloon dilatation catheter

Technical Field

The invention belongs to the technical field of pulmonary artery high pressure treatment instruments, and particularly relates to a pulmonary artery balloon dilatation catheter.

Background

Pulmonary hypertension refers to a hemodynamic and pathophysiological state in which the pulmonary arterial pressure rises above a certain threshold, can lead to right heart failure, and can be an independent disease, a complication, or a syndrome. The hemodynamic diagnostic criteria are: under the resting state of sea level, the average pulmonary artery pressure detected by the right heart catheter is more than or equal to 25mmHg, the pulmonary arteriolar wedge pressure is less than or equal to 15mmHg, and the pulmonary vascular resistance is more than 3Wood units. Pulmonary hypertension is a common disease and frequently encountered disease, has high disability rate and high fatality rate, and is highly valued by people.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a disease that is fatal by advanced failure due to pulmonary arterial intimal fibrosis remodeling caused by symptomatic or asymptomatic Pulmonary Embolism (PE), mechanical pulmonary artery stenosis or occlusion, and different degrees of remodeling of the small pulmonary artery in the non-obstructed area, both of which together cause Pulmonary Arterial Pressure (PAP) and Pulmonary Vascular Resistance (PVR) to rise. Currently, there are a large number of patients with CTEPH, but there are few centers that can accurately perform diagnosis, evaluation and treatment, and only a very few centers can perform PEA (plasma enhanced angiography) procedures, and the number of patients that can undergo PEA surgery per year is very limited. Therefore, most patients only have Balloon Pulmonary Angioplasty (BPA) and drug therapy for treatment, but the drug therapy has different curative effects and higher cost (the current drug with the CTEPH indication is only lio watermelon, which is high in cost), so BPA becomes an important means for effective treatment of the patients.

BPA treatment is aimed at three purposes: improving the hemodynamics level, improving the exercise endurance and improving the arterial oxygen saturation. Through BPA operation, the narrow or occlusive pulmonary artery is mechanically expanded, the passability of blood flow flowing through the narrow or occlusive pulmonary artery is improved, the pulmonary vascular resistance of a target vascular area is reduced, further more blood flows through the target vascular area, the pressure of the pulmonary artery outside the target vascular area is shared, and finally, the pulmonary artery pressure is reduced, the pulmonary vascular resistance is reduced, the right heart blood discharge is increased, and the hemodynamic level is improved. Currently BPA employs a modified procedure, namely more dilation of the stenotic or occluded distal arteriole, to restore blood perfusion to this blood-poor region. After a plurality of BPA operations, the blood flow of a plurality of vascular regions is recovered, the distribution of blood perfusion is more reasonable, the ventilation/perfusion ratio is improved, and the arterial oxygen saturation is improved. Due to the gravity, the blood flow of the double lower lungs is higher than that of the upper lung, so that the blood perfusion of BPA in the lower lung field is recovered, the hemodynamic level is easier to improve, the gas distribution of the upper lung field is high, and the blood perfusion of BPA in the upper lung field is easier to improve the ventilation perfusion ratio, and the arterial oxygen saturation is improved. After the hemodynamics is improved and the arterial blood sample saturation is improved, the cardiac output is improved, the right heart is gradually reduced, the cardiac function is improved, the exercise endurance is inevitably gradually improved, and the symptom and the physical sign of a patient are gradually improved, thereby achieving the treatment purpose. Due to the specificity of pulmonary hypertension, the disease cannot be completely cured at present, so that the combination therapy is very important. The treatment aims are gradually achieved by treating the residual pulmonary artery stenosis after the PEA operation and BPA operation in combination with medicaments to improve or delay the deterioration of new functions of patients.

However, there is no balloon catheter used for pulmonary arterial hypertension in the prior art, and there is a need to develop a balloon dilatation catheter for pulmonary arterial hypertension.

Disclosure of Invention

In order to overcome a series of defects in the prior art, the invention aims to provide a pulmonary artery balloon dilatation catheter which is of a coaxial double-cavity structure as a whole and comprises a handle 1, a catheter reinforcement part 2, a hypotube 3, an outer tube 4, an inner tube 5, a tip 6 and a balloon 7, wherein the outer tube 4 is provided with a notch 9, a guide wire cavity is formed from the tip 6 to the notch 9 and is a through cavity, and the outer surface of the guide wire cavity is coated with a hydrophilic coating; a pressurizing cavity is formed from the handle 1 to the balloon 7, and the pressurizing cavity is a closed cavity; the inner wall from the tip 6 to the proximal end of the hypotube 3 is coated with a silicone oil coating, wherein,

the two ends of the balloon 7 are respectively a far end shoulder 10 and a near end shoulder 11, the far end shoulder 10 is connected with a far end neck 12, the near end shoulder 11 is connected with a near end neck 13, the inner tube 5 is arranged at the axis of the balloon 7, one end of the inner tube 5 penetrates through the far end neck 12 to be connected with the tip 6, and the other end of the inner tube penetrates through the near end neck 13 to be connected with the outer tube 4; the near end of the outer tube 4 is connected with the hypotube 3 through a transition point 14, the hypotube 3 is fixedly connected with the catheter reinforcement 2, and the catheter reinforcement 2 is fixedly connected with the handle 1.

Preferably, the material of the tip 6 is polyether block amide, and after the excess part of the tip 6 is cut off, a taper or a taper trend is formed in a thermoplastic mode; the catheter reinforcement 2 is made of polyether block amide, the handle 1 is made of polycarbonate, and the hydrophilic coating coated on the outer surface of the guide wire cavity is made of polyvinylpyrrolidone.

Preferably, the distal neck 12 is connected with the outer tube 4 by welding, the proximal neck 13 is connected with the inner tube 5 by welding, the outer tube 4 is connected with the hypotube 3 by welding, and the hypotube 3 is connected with the handle 1 by bonding with the UV glue 15 or integrally injection molding.

Preferably, both ends of the inner tube 5 inside the balloon 7 are provided with developing rings 16; the middle section of the hypotube 3 is uniformly provided with two marking rings 17 made of platinum-iridium alloy, and the distances between the two marking rings 17 and the tip 6 are respectively 90cm and 100 cm.

Preferably, when the hydrophilic coating is coated on the surface of the balloon 7, a process of coating after folding is adopted.

Preferably, the balloon 7 is made of polyamide or polyether block amide, the length of the balloon is 5-40mm, and the diameter of the balloon is 1.0-5.0 mm; the angle of the proximal shoulder 11 or the distal shoulder 10 is 30-50 degrees; the proximal neck 13 has a length of 2-5mm and an inner diameter of 0.8-1.0mm, and the distal neck 12 has a length of 2-5mm and an inner diameter of 0.5-0.7 mm.

Preferably, the outer diameter of the inner pipe 5 is 0.5-0.6mm, the inner diameter is 0.35-0.45mm, and the length is 300-400mm, the inner pipe 5 is divided into an outer layer 18, a middle layer and an inner layer 19, the outer layer 18 is polyether block amide, the middle layer is low-density polyethylene, the inner layer is high-density polyethylene, and the sum of the thicknesses of the outer layer 18 and the middle layer accounts for 60-80% of the total thickness of the inner pipe 5.

Preferably, the material of the outer tube 4 is polyamide or polyether block amide, the length of the outer tube 4 is 300-400mm, the inner diameter is 0.55-0.75mm, the outer diameter is 0.8-1.0mm, and the inner diameter of the guide wire cavity is 0.015 "-0.017".

Preferably, when the outer tube 4 and the hypotube 3 are welded together, the welding length is more than or equal to 10mm, and the welding temperature is 200-260 ℃.

Preferably, when the outer pipe 4 and the inner pipe 5 are welded together, the welding length is more than or equal to 5mm and less than 15mm, and the welding temperature is 200-260 ℃.

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

the pulmonary artery balloon dilatation catheter is applied to an operation for treating pulmonary artery hypertension, the balloon is arranged on the pulmonary artery balloon dilatation catheter, a hydrophilic coating is coated on the surface of the balloon, the coating is firstly folded and then coated, the fact that no coating exists in a certain area in the whole circumferential direction after the balloon dilatation is achieved, smoothness of the balloon is greatly reduced, displacement of the balloon during dilatation is avoided, and meanwhile the surface of the balloon is smooth under the folding condition, and the capacity of the balloon for passing through pathological changes is not affected.

Drawings

FIG. 1 is a schematic view of the overall structure of a pulmonary artery balloon dilatation catheter according to the present invention;

FIG. 2 is a schematic structural view of a balloon of a pulmonary artery balloon dilatation catheter of the present invention;

FIG. 3 is a schematic structural diagram of an outer tube of a pulmonary artery balloon dilatation catheter in accordance with the present invention;

FIG. 4 is a schematic structural diagram of an outer tube of a pulmonary artery balloon dilatation catheter of the present invention;

FIG. 5 is a schematic view of a balloon proximal end weld of a pulmonary artery balloon dilation catheter of the present invention;

FIG. 6 is a schematic view of a balloon distal welding machine of a pulmonary artery balloon dilatation catheter of the present invention;

FIG. 7 is a schematic view of the handle attachment of a pulmonary artery balloon dilation catheter of the present invention;

FIG. 8 is a schematic view of a transition point weld of a pulmonary artery balloon dilation catheter of the present invention;

FIG. 9 is a schematic view of the outer tube and the inner tube of the pulmonary artery balloon dilatation catheter of the present invention being welded together;

FIG. 10 is a schematic view of the tip formation of a pulmonary artery balloon dilation catheter of the present invention;

FIG. 11 is a schematic view of a handle body of a pulmonary artery balloon dilation catheter of the present invention being injection molded;

fig. 12 is a schematic view of the handle reinforcement member of the pulmonary artery balloon dilatation catheter of the present invention during injection molding.

The reference numbers in the figures are:

1-handle, 2-catheter reinforcement, 3-hypotube, 4-outer tube, 5-inner tube, 6-tip, 7-balloon, 8-welded heat shrink tube, 9-notch, 10-distal shoulder, 11-proximal shoulder, 12-distal neck, 13-proximal neck, 14-transition point, 15-UV glue, 16-developing ring, 17-marking ring, 18-outer layer, 19-middle and inner layer, 20-luer needle, 21-welded mandrel, 22-bevel mandrel.

Detailed Description

In order to make the implementation objects, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be described in more detail below with reference to the accompanying drawings in the embodiments of the present invention. In the drawings, the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The described embodiments are only some, but not all embodiments of the invention.

All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The embodiments and the directional terms described below with reference to the drawings are exemplary and intended to be used in the explanation of the invention, and should not be construed as limiting the invention.

A pulmonary artery balloon dilatation catheter of the present invention is described in detail below with reference to the accompanying drawings.

Referring to fig. 1-12, a pulmonary artery balloon dilatation catheter is of a coaxial double-cavity structure as a whole and comprises a handle 1, a catheter reinforcement part 2, a hypotube 3, an outer tube 4, an inner tube 5, a tip 6 and a balloon 7, wherein the outer tube 4 is provided with a notch 9, a guide wire cavity is formed from the tip 6 to the notch 9, the guide wire cavity is a through cavity, and the outer surface of the guide wire cavity is coated with a hydrophilic coating; a pressurizing cavity is formed from the handle 1 to the balloon 7, and the pressurizing cavity is a closed cavity; the inner wall from the tip 6 to the proximal end of the hypotube 3 is coated with a silicone oil coating, wherein,

As shown in fig. 5, the welding process of the proximal neck 13 and the outer tube 4 is as follows: 1 welding mandrel 21 is inserted into the outer tube 4, and the diameter of the welding mandrel is close to the inner diameter of the outer tube 4 and is slightly smaller; the outer tube 4 and the welding mandrel 21 are inserted into the proximal neck part 13 of the balloon 7 together, and cannot enter the proximal shoulder part 11, and then a welding heat shrinkable tube 8 is sleeved on the outer edge, wherein the material of the welding heat shrinkable tube 8 can be polyolefin or FEP material. The welding process comprises the following steps: laser welding or thermal welding, wherein the welding principle is that laser or a heating metal block is used for heating and welding the heat shrinkable tube 8, the welded heat shrinkable tube 8 is deformed by heating, meanwhile, the materials of the near-end neck part 13 and the outer tube 4 are softened, the radial retraction of the welded heat shrinkable tube 8 brings clamping force, finally, the near-end neck part 13 and the outer tube 4 are welded together, and the welded heat shrinkable tube 8 is taken down after the welding is finished;

as shown in fig. 6, when the distal neck portion 12 is welded to the inner tube 5, the inner tube 5 assembly is inserted into the balloon 7, and is passed out of the neck portion of the tip 6, and fixed in place, and then the welded heat-shrinkable tube 8 is sleeved on, wherein the welded heat-shrinkable tube 8 may be made of polyolefin or FEP; the welding process comprises the following steps: laser welding or thermal welding, wherein the welding principle is that laser or a heating metal block is used for heating and welding the heat shrinkable tube 8, the welded heat shrinkable tube 8 is deformed by heating, meanwhile, the materials of the far-end neck part 12 and the inner tube 5 are softened, the radial retraction of the welded heat shrinkable tube 8 brings clamping force, finally, the far-end neck part 12 and the inner tube 5 are welded together, and the welded heat shrinkable tube 8 is taken down after the welding is finished;

as shown in fig. 10, after welding the distal neck 12, the excess tip 6 is cut off, and the cut-off tip 6 will present a right-angled edge to make it smooth and reduce the damage to the blood vessel after entering the human body, so the tip 6 needs to be treated by welding the heat-shrinkable tube 8 on the tip 6 by using a heat-shrinkable tube sleeve 8 and heating the heat-shrinkable tube 8 by using a laser or a heating block, and softening the tip tube, and the welding of the heat-shrinkable tube 8 will shape the tip 6 to form the tip 6 with a conical or tapered trend;

as shown in figure 7, when the hypotube 3 is adhered to the handle 1, the adhering point is coated with UV glue 15, which is medical grade glue, such as DYMAX 1280-M or Letai 3311 glue; the coating can be manually coated or can be performed by a glue dispenser, and the needle base or the hypotube 3 is rotated to make the glue more uniform for the glue to be uniform; then, a UV light machine is used, usually an LED point light source is used for irradiation, the power used is more than 0.5w and less than 10w, the irradiation time is 15-60s, the intensity after curing is very high, and the hypotube 3 can be pulled out from the bonding point by more than 60N;

as shown in fig. 11 and 12, two sets of molds are used to injection mold the main body of the handle 1 and the reinforcement of the handle 1, respectively: when the main body of the handle 1 is injection-molded, a guide wire is manually installed, the head of the guide wire is inserted into the opposite luer needle 20 for injection molding, and the guide wire is sealed by a coating force generated by coating the guide wire with a material in the injection molding process; when 1 reinforcement of handle is moulded plastics, the manual work is installed handle 1 main part into the second set of mould and is moulded plastics, and in this process, the installation of handle 1 main part should target in place, and the phenomenon of droing when paying attention to the compound die to and seal wire extension part avoid receiving the extrusion when the compound die. The injection molding temperature of the needle seat is 250 ℃ and 300 ℃, the injection pressure is 220 ℃ and 260MPa, the pressure maintaining speed is 10-30mm/s, the pressure maintaining pressure is 80-100MPa, and the time is 2-4 s. The injection temperature of the pipe reinforcement 2 is 130 ℃ and 180 ℃, the injection pressure is 120 MPa and 180MPa, the pressure maintaining speed is 10-30mm/s, the pressure maintaining pressure is 20-60MPa, and the time is 2-4 s.

As shown in fig. 8, when the outer tube 4 and the hypotube 3 are welded, the hypotube 3 is inserted into the inner cavity of the outer tube 4, the insertion distance is usually 10-50mm, and then the outer jacket is covered with the welding heat-shrinkable tube 8, the material of the welding heat-shrinkable tube 8 can be polyolefin or FEP; usually, a hot air welding mode is adopted, the outer surface of the heat shrinkable tube 8 is blown and welded through a hot air gun, meanwhile, the outer tube 4 is softened, the welded heat shrinkable tube 8 is heated and shrunk, and the outer tube 4 is tightly held on the hypotube 3; in order to ensure the welding effect, the leakage condition can not occur, the welding length cannot be less than 10mm, and the welding temperature is 200-260 ℃;

as shown in fig. 9, when the outer tube 4 and the inner tube 5 are welded, the inner tube 5 and the welding mandrel 21 are passed out from the notch 9 on the outer tube 4, the bevel mandrel 22 is inserted from the inner cavity of the outer tube 4 until the inner tube cannot enter the position, and the welding heat shrinkable tube 8 is sleeved on the welding heat shrinkable tube 8, wherein the welding heat shrinkable tube 8 can be made of polyolefin or FEP; usually, a hot air welding mode is adopted, the outer surface of the heat shrinkable tube 8 is blown and welded through a hot air gun, meanwhile, the outer tube 4 and the inner tube 5 begin to be softened, the welded heat shrinkable tube 8 is heated and shrunk, and the outer tube 4 and the inner tube 5 are only welded together; in order to ensure the welding effect and avoid leakage, the welding length cannot be less than 5mm, the longest welding length generally does not exceed 15mm, and the welding temperature is 200-; and after welding, taking down the welding heat shrinkable tube 8, and removing the redundant welding part by using a blade.

Preferably, when the hydrophilic coating is coated on the surface of the balloon 7, a process of folding the coating first is adopted; the hydrophilic coating is coated on the surface of the balloon 7 so as to be easier to reach a narrow lesion part, and the balloon 7 is smoother and easy to shift when the balloon 7 is expanded, so that the process of folding and coating is adopted, so that after the balloon 7 is expanded, a certain area of the balloon 7 in the whole circumferential direction is not provided with the hydrophilic coating, the smoothness of the balloon 7 is greatly reduced, and the shift of the balloon 7 during expansion is avoided; meanwhile, the surface of the balloon 7 is smooth in the folded condition, and the capability of the balloon 7 to pass through a lesion is not influenced.

Finally, it should be pointed out that: the above examples are only for illustrating the technical solutions of the present invention, and are not limited thereto. Although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims

1. A pulmonary artery sacculus dilatation catheter is of a coaxial double-cavity structure on the whole and comprises a handle (1), a catheter reinforcement (2), a hypotube (3), an outer tube (4), an inner tube (5), a tip (6) and a sacculus (7), wherein the outer tube (4) is provided with a notch (9), the tip (6) to the notch (9) form a guide wire cavity, the guide wire cavity is a through cavity, and the outer surface of the guide wire cavity is coated with a hydrophilic coating; a pressurizing cavity is formed from the handle (1) to the balloon (7), and the pressurizing cavity is a closed cavity; the inner wall from the tip (6) to the proximal end of the hypotube (3) is coated with a silicone oil coating, wherein,

the two ends of the balloon (7) are respectively a far-end shoulder (10) and a near-end shoulder (11), the far-end shoulder (10) is connected with a far-end neck (12), the near-end shoulder (11) is connected with a near-end neck (13), the inner tube (5) is arranged at the axis of the balloon (7), one end of the inner tube (5) penetrates through the far-end neck (12) to be connected with the tip (6), and the other end of the inner tube penetrates through the near-end neck (13) to be connected with the outer tube (4); the near end of the outer tube (4) is connected with the hypotube (3) through a transition point (14), the hypotube (3) is fixedly connected with the catheter reinforcement (2), and the catheter reinforcement (2) is fixedly connected with the handle (1).

2. The pulmonary artery balloon dilatation catheter as claimed in claim 1, characterized in that the tip (6) is made of polyether block amide, and the tip (6) is formed into a cone or cone trend by means of heat molding after cutting off the redundant part; the catheter reinforcement (2) is made of polyether block amide, the handle (1) is made of polycarbonate, and the hydrophilic coating coated on the outer surface of the guide wire cavity is made of polyvinylpyrrolidone.

3. The pulmonary artery balloon dilatation catheter as claimed in claim 1, wherein the distal neck (12) is connected with the outer tube (4) by welding, the proximal neck (13) is connected with the inner tube (5) by welding, the outer tube (4) is connected with the hypotube (3) by welding, and the hypotube (3) is connected with the handle (1) by UV glue (15) bonding or integral injection molding.

4. A pulmonary artery balloon dilatation catheter according to claim 1 characterized in that both ends of the inner tube (5) inside the balloon (7) are provided with visualization rings (16); the middle section of the hypotube (3) is uniformly provided with two marking rings (17) made of platinum-iridium alloy, and the distances between the two marking rings (17) and the tip (6) are respectively 90cm and 100 cm.

5. The pulmonary artery balloon dilatation catheter as claimed in claim 1, characterized in that the balloon (7) surface is coated with a hydrophilic coating by a process of coating after folding.

6. The pulmonary artery balloon dilatation catheter as claimed in claim 1, characterized in that the balloon (7) is made of polyamide or polyether block polyether amide, having a length of 5-40mm and a diameter of 1.0-5.0 mm; the angle of the proximal shoulder (11) or the distal shoulder (10) is 30-50 degrees; the length of the proximal neck (13) is 2-5mm, the inner diameter is 0.8-1.0mm, the length of the distal neck (12) is 2-5mm, and the inner diameter is 0.5-0.7 mm.

7. The pulmonary artery balloon dilatation catheter as claimed in claim 1, wherein the inner tube (5) has an outer diameter of 0.5-0.6mm, an inner diameter of 0.35-0.45mm and a length of 300-400mm, the inner tube (5) is divided into an outer layer (18), a middle layer and an inner layer (19), the outer layer (18) is made of polyether block amide, the middle layer is made of low density polyethylene, the inner layer is made of high density polyethylene, and the sum of the thicknesses of the outer layer (18) and the middle layer accounts for 60-80% of the total thickness of the inner tube (5).

8. The pulmonary artery balloon dilatation catheter as claimed in claim 1, wherein the outer tube (4) is made of polyamide or polyether block amide, the length of the outer tube (4) is 300-400mm, the inner diameter is 0.55-0.75mm, the outer diameter is 0.8-1.0mm, and the inner diameter of the guidewire lumen is 0.015 "-0.017".

9. The pulmonary artery balloon dilatation catheter as claimed in claim 3, wherein the welding length is more than or equal to 10mm and the welding temperature is 200-260 ℃ when the outer tube (4) and the hypotube (3) are welded together.

10. The pulmonary artery balloon dilatation catheter as claimed in claim 3, wherein the welding length is greater than or equal to 5mm and less than 15mm when the outer tube (4) and the inner tube (5) are welded together, and the welding temperature is 200-260 ℃.