Balloon delivery microcatheter and methods of use

Abstract

The application relates to the technical field of medical devices, in particular to a balloon delivery microcatheter and a use method thereof, which comprises a handle, a first interface and a second interface on the handle, a catheter body connected with the handle, the catheter body comprising a proximal end tube, a balloon tube and a distal end tube from proximal to distal; wherein the catheter body is a double-cavity structure comprising an inner cavity and an outer cavity, the inner cavity is a channel, one end of the inner cavity is communicated with the first interface, the other end of the inner cavity penetrates to the end of the distal end tube, and the inner cavity is used for delivering instruments, therapeutic drugs or diagnostic contrast medium; the outer cavity is a filling cavity, one end of the outer cavity is communicated with the second interface, the other end of the outer cavity is communicated with the balloon tube, and the outer cavity is used for filling and pressure relief of the balloon tube. The application has the functions of the microcatheter and the balloon catheter, can block the proximal end blood vessel, realizes temporary blocking of local blood flow, the balloon tube in the application is also used for expanding the non-adhered part of the blood vessel stent, so that the stent is better attached to the blood vessel wall, and the pain and risk of the patient are reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a balloon delivery microcatheter and a method of using the same. BACKGROUND

[0002] With the continuous maturity of medical technology and the rapid development of interventional equipment, the application range of microcatheters is also expanding, such as coronary intervention, peripheral vascular intervention, and neurovascular intervention.

[0003] The microcatheter in the prior art has various functions, such as delivering a spring coil to achieve aneurysm embolization, delivering a dense mesh stent to achieve blood flow guidance, injecting anesthetic drugs and analgesic drugs to assist in completing surgery, and inserting a microcatheter into the jugular vein or subclavian vein to monitor the central venous pressure and central venous oxygen saturation of a patient, evaluate the patient's circulation function and fluid balance, and provide timely intravenous infusion, drug infusion, and hemodialysis treatment. In addition, the microcatheter can also be used for arterial pressure monitoring and arterial catheterization, by inserting the catheter into the patient's artery, the doctor can monitor the patient in real time and provide individualized treatment and hemodynamic monitoring for the patient.

[0004] However, the existing microcatheter is a single delivery device, and has the functions of contrast medium or therapeutic drug. If the proximal blood flow needs to be blocked during the operation to prevent thrombus escape or deliver drug flow to the proximal blood vessel to achieve local blood flow blockage, other devices need to be used. Such operation during the operation is more cumbersome for the operator, and more devices and operation steps are required to complete the operation, which prolongs the operation time and makes the patient bear a longer operation pain time. At the same time, the use of more treatment devices during the operation also increases the medical expenses of the patient. SUMMARY

[0005] In view of at least one of the above technical problems, the present application provides a balloon delivery microcatheter and a method of using the same, which adopts a structural improvement to increase the function of the microcatheter and reduce the frequency of intraoperative device exchange.

[0006] According to a first aspect of the present application, there is provided a balloon delivery microcatheter, comprising:

[0007] a handle, the handle having a first interface and a second interface thereon;

[0008] a catheter body connected to the handle, the catheter body comprising a proximal tube, a balloon tube, and a distal tube in sequence from proximal to distal;

[0009] The catheter body is a double-cavity structure, including an inner cavity and an outer cavity, the inner cavity is a channel, one end of which is in communication with the first interface, and the other end penetrates to the end of the distal tube for conveying instruments, therapeutic drugs or diagnostic contrast medium; the outer cavity is a filling cavity, one end of which is in communication with the second interface, and the other end is in communication with the balloon tube for filling and pressure relief of the balloon tube.

[0010] In some embodiments of the application, an inner stress dispersion tube is further included, one end of which is sleeved on the proximal tube and the other end of which is connected to the handle, and the inner stress dispersion tube is made of PEBAX material.

[0011] In some embodiments of the application, an outer stress dispersion tube is further included, one end of which is sleeved on the inner stress dispersion tube and the other end of which is connected to the handle, and the outer stress dispersion tube is made of TPE material.

[0012] In some embodiments of the application, the proximal tube comprises, from inside to outside, an inner liner tube, a reinforcing braid layer, an outer tube reinforcing layer and an outer tube layer, wherein,

[0013] The inner liner tube is made of PTFE material, the reinforcing braid layer is a stainless steel wire braid layer, and the outer tube reinforcing layer and the outer tube layer are made of materials with gradually changing hardness from hard to soft from near to far.

[0014] In some embodiments of the application, the material of the outer tube reinforcing layer from near to far is PEBAX72D, PEBAX63D, PEBAX55D, PEBAX35D and TPU material; and the material of the outer tube layer from near to far is NYLON, PEBAX72D, PEBAX63D, PEBAX55D, PEBAX35D and POE material.

[0015] In some embodiments of the application, the balloon tube comprises, from inside to outside, an inner liner tube, a reinforcing braid layer, an outer tube reinforcing layer, an outer tube layer and a balloon layer, the balloon layer is made of TPU material, the gap between the outer tube layer and the outer tube reinforcing layer constitutes the filling cavity, and the outer tube layer has a filling hole inside the balloon layer.

[0016] In some embodiments of the application, a plurality of filling holes are provided and are staggered in the circumferential direction, and the balloon layer is in a cylindrical structure after being filled.

[0017] In some embodiments of the application, the distal tube comprises, from inside to outside, an inner liner tube, a reinforcing braid layer and an outer tube reinforcing layer, and the outer tube reinforcing layer of the distal tube has a developing ring.

[0018] According to the second aspect of the present application, there is also provided a method of using the balloon delivery microcatheter according to any one of the first aspect, comprising the following steps:

[0019] threading a guide wire to a lesion site of a blood vessel;

[0020] threading the catheter body from the proximal end of the guide wire and moving the catheter body to a target position;

[0021] inflating the balloon tube to block the blood vessel and delivering an instrument, contrast medium or therapeutic drug through the catheter body.

[0022] In some embodiments of the present application, when the instrument is a vascular stent, after the stent is delivered to the site and released, the method further comprises the following steps:

[0023] observing the apposition state of the vascular stent, and if the apposition of the vascular stent is poor, moving the balloon tube to the position where the apposition of the vascular stent is poor and inflating the balloon tube to expand the vascular stent.

[0024] The balloon delivery microcatheter of the present application has the following advantages: the balloon tube provided at the distal end of the catheter body is in communication with the second interface on the handle, and after the balloon tube is inflated, it can block the blood vessel and achieve the effect of blocking blood flow. Meanwhile, the catheter body of the present application can also be used to deliver an instrument, therapeutic drug or diagnostic contrast medium, and thus has the functions of both a microcatheter and a balloon catheter. It can block the proximal blood vessel and achieve temporary blockage of local blood flow, thereby preventing thrombus from escaping to the proximal blood vessel or preventing the delivered drug from flowing to the proximal blood vessel. In addition, the balloon tube of the present application can also be used to expand the non-apposition position of the vascular stent, so that the stent can better adhere to the blood vessel wall. The balloon delivery microcatheter of the present application has multiple functions, which saves the cost of raw materials and reduces the frequency of use of multiple instruments by the physician, thereby reducing the pain and risk of the patient. BRIEF DESCRIPTION OF DRAWINGS

[0025] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings described below are only some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0026] Figure 1 FIG. 1 is a structural schematic diagram of the balloon delivery microcatheter in the embodiments of the present application;

[0027] Figure 2 FIG. 2 is an axial cross-sectional structural schematic diagram of the catheter body in the embodiments of the present application;

[0028] Figure 3 FIG. 3 is a structural schematic diagram of the balloon tube in the embodiments of the present application;Figure 2 A-A sectional view structure schematic diagram in the figure;

[0029] Figure 4 A-A sectional view structure schematic diagram in the figure; Figure 2 B-B sectional view structure schematic diagram in the figure;

[0030] Figure 5 B-B sectional view structure schematic diagram in the figure; Figure 2 C-C sectional view structure schematic diagram in the figure;

[0031] Figure 6 C-C sectional view structure schematic diagram in the figure;

[0032] Figure 7 C-C sectional view structure schematic diagram in the figure;

[0033] Figure 8 C-C sectional view structure schematic diagram in the figure;

[0034] Figure 9 C-C sectional view structure schematic diagram in the figure;

[0035] Figure 10 C-C sectional view structure schematic diagram in the figure;

[0036] Figure 11 C-C sectional view structure schematic diagram in the figure;

[0037] Figure 12 C-C sectional view structure schematic diagram in the figure.

[0038] BRIEF DESCRIPTION OF DRAWINGS 1, handle; 2, catheter body; 21, proximal tube; 211, inner lining tube; 212, reinforcing braid layer; 213, outer tube reinforcing layer; 214, outer tube layer; 22, balloon tube; 22a, deflated balloon segment; 22b, fragile hole wall; 221, balloon layer; 222, inflation hole; 23, distal tube; 23a, developing ring; 2a, inner cavity; 2b, outer cavity; 3, inner layer stress diffusion tube; 4, outer layer stress diffusion tube. DETAILED DESCRIPTION

[0039] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all the embodiments of the present application.

[0040] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0042] like Figures 1 to 5 The balloon delivery microcatheter shown includes a handle 1 and a catheter body 2. The distal ends of the catheter body 2 and the handle 1 are connected. In embodiments of the invention, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator. The handle 1 is made of PCTG or PC material. PCTG refers to polyterephthalate copolyester, a modified copolymer of PETG (polyethylene terephthalate). It is a non-crystalline copolyester material with good transparency and mechanical properties. PC refers to polycarbonate, a widely used engineering plastic known for its high load capacity, impact resistance, and thermal stability. The handle 1 has a first interface and a second interface. In some embodiments of the invention, both the first and second interfaces use 6% external locking Luer connectors to achieve connection and locking with the matching instruments, ensuring safety and stability, preventing leakage, and reducing the risk of infection.

[0043] Please continue to refer to Figure 1 In an embodiment of the present invention, the catheter body 2 includes a proximal tube 21, a balloon tube 22 and a distal tube 23 from proximal to distal. In an embodiment of the present invention, the balloon tube 22 is different from a normal balloon. It is not a spherical structure, but a tubular structure, which can become a cylindrical structure after being inflated.

[0044] In an embodiment of the present invention, the catheter body 2 has a dual-lumen structure, including an inner lumen 2a and an outer lumen 2b. The inner lumen 2a is a channel, with one end connected to the first interface and the other end extending to the distal end of the distal tube 23, used for delivering instruments, therapeutic drugs, or diagnostic contrast fluid. The outer lumen 2b is an filling lumen, with one end connected to the second interface and the other end connected to the balloon tube 22, used for inflating and depressurizing the balloon tube 22. With this design, the medium can be delivered through the first interface, and the balloon tube 22 can be inflated and depressurized through the second interface.

[0045] In the above embodiment, by setting the balloon tube 22 at the distal end of the catheter body 2, the balloon tube 22 communicates with the second interface on the handle 1, and when the balloon tube 22 is filled, the blood vessel can be blocked to achieve the effect of blocking blood flow. At the same time, the catheter body 2 in the application can also be used to deliver instruments, therapeutic drugs or diagnostic contrast medium, and has the functions of a microcatheter and a balloon catheter, can block the proximal blood vessel, and achieve temporary blocking of local blood flow, thereby preventing thrombus from escaping to the proximal blood vessel or preventing the flow of delivered drugs to the proximal blood vessel. In addition, the balloon tube 22 in the application is also used to expand the non-adhered part of the blood vessel stent, so that the stent better adheres to the blood vessel wall. The balloon delivery microcatheter of the application has multiple functions, saves the cost of raw materials, and reduces the frequency of use of multiple instruments by doctors, thereby reducing the pain and risk of patients.

[0046] On the basis of the above embodiment, please continue to refer to Figure 1 In the embodiment of the application, the inner stress diffusion tube 3 is sleeved on the proximal tube 21 at one end and connected to the handle 1 at the other end, and the inner stress diffusion tube 3 is made of PEBAX material. In the embodiment of the application, PEBAX material is a high-performance thermoplastic elastomer, which is formed by copolymerization of elastic polyether and rigid polyamide blocks. By setting the inner stress diffusion tube 3, the stress concentration at the connection part of the proximal tube 21 can be buffered.

[0047] Further, please continue to refer to Figure 1 In the embodiment of the application, the outer stress diffusion tube 4 is sleeved on the inner stress diffusion tube 3 at one end and connected to the handle 1 at the other end, and the outer stress diffusion tube 4 is made of TPE material. TPE material is a thermoplastic elastomer, which has rubber elasticity and thermoplastic processing characteristics. The setting of the outer stress diffusion tube 4 can further improve the stress dispersion capacity of the catheter connection part, and forms a double-layer structure with the inner stress diffusion tube 3, thereby providing more comprehensive stress relief effect.

[0048] As Figure 2 and Figure 3As shown in the middle, the proximal tube 21 comprises, from inside to outside, an inner liner tube 211, a reinforcing braid layer 212, an outer tube reinforcing layer 213, and an outer tube layer 214, wherein the inner liner tube 211 is made of PTFE, the reinforcing braid layer 212 is a stainless steel wire braid layer, and the outer tube reinforcing layer 213 and the outer tube layer 214 are made of materials with gradually decreasing hardness from the proximal end to the distal end. Through the arrangement of the structure, the proximal support strength of the catheter body 2 is guaranteed, and the distal end has soft characteristics, which facilitates the penetration into the tortuous blood vessels. In addition, in the embodiment of the application, PTFE is a polytetrafluoroethylene material, which is a material with a low friction coefficient, which can effectively reduce the friction of the guide wire and other medical devices inside the catheter body 2, making the operation more smooth.

[0049] Please continue to refer to Figure 2 In some embodiments of the application, the material of the outer tube reinforcing layer 213 from the proximal end to the distal end is PEBAX72D, PEBAX63D, PEBAX55D, PEBAX35D, and TPU; and the material of the outer tube layer 214 from the proximal end to the distal end is NYLON, PEBAX72D, PEBAX63D, PEBAX55D, PEBAX35D, and POE. In the embodiment of the application, the outer tube reinforcing layer 213 and the outer tube layer 214 are made of materials with gradually decreasing hardness from the proximal end to the distal end, which can further improve the compliance and operation performance of the catheter body 2; wherein PEBAX is a polyether block amide material, and the number before D represents the hardness, and the larger the number, the higher the hardness; TPU is a thermoplastic polyurethane, which is the softest material at the distal end, providing excellent softness and elasticity, ensuring that the distal tube 23 can smoothly pass through the complex blood vessel environment, while reducing the damage to the tissue; on the outer tube layer 214, NYLON is a nylon material with high hardness and wear resistance, which can provide additional mechanical support as a proximal material; POE is a polyolefin elastomer, which is arranged at the balloon tube 22, and can make the balloon tube 22 have good compliance.

[0050] In the embodiment of the present application, the balloon tube 22 comprises, from inside to outside, an inner liner tube 211, a reinforcing braid layer 212, an outer tube reinforcing layer 213, an outer tube layer 214, and a balloon layer 221. The balloon layer 221 is made of TPU material. The gap between the outer tube layer 214 and the outer tube reinforcing layer 213 forms a filling cavity. The outer tube layer 214 has a filling hole 222 inside the balloon layer 221. In the embodiment of the present application, there is a gap between the outer tube reinforcing layer 213 and the outer tube layer 214, which forms a filling cavity. The liquid filled from the second interface can enter the balloon layer 221 through the filling hole 222. The balloon layer 221 is made of TPU material, i.e. thermoplastic polyurethane material. This material has high elasticity, wear resistance, and chemical corrosion resistance, and has good plasticity and biocompatibility. The balloon layer 221 made of TPU material can withstand high pressure filling without bursting, and can also provide sufficient elasticity to quickly restore the balloon to its original shape after the pressure is removed. In addition, the balloon can conform to any uneven blood vessel space. At the same time, the balloon filling pressure is very small, which is more suitable for fragile and small blood vessels. In addition, in the embodiment of the present application, the filling hole 222 is provided in multiple and is distributed in the circumferential direction. The balloon layer 221 is in a cylindrical structure after being filled. In one embodiment of the present application, the filling hole 222 is provided in six, the hole diameter of the filling hole 222 is 0.15mm, and the filling hole 222 is distributed in the circumferential direction. The holes are uniformly distributed in the circumferential direction and are arranged in the axial direction. The arrangement of the filling hole 222 can realize rapid filling and pressure relief of the balloon.

[0051] In the embodiment of the present application, as shown in Figure 2 and Figure 5 , the distal tube 23 comprises, from inside to outside, an inner liner tube 211, a reinforcing braid layer 212, and an outer tube reinforcing layer 213. The outer tube reinforcing layer 213 of the distal tube 23 has a developing ring 23a. In the embodiment of the present application, the material of the inner liner tube 211 and the reinforcing braid layer 212 is the same as that described above. The outer appearance reinforcing layer is made of TPU material, which has excellent toughness, good fluidity, and processability, so that the appearance of the processed distal tube 23 is smooth and smooth, and the catheter dissolution trace strength can be improved. The developing ring 23a is provided, which has good developing effect under X equipment, and can directly and effectively guide the clinician to observe the position of the distal end of the catheter. In addition, in the embodiment of the present application, the developing ring 23a is also provided on at least one end of the balloon tube 22 to confirm the position of the balloon tube 22. The developing ring 23a can be made of 90Pt / 10Ir alloy material.

[0052] In the embodiment of the present application, a use method of the above-mentioned balloon delivery microcatheter is also disclosed, comprising the following steps:

[0053] The guide wire is inserted into the lesion site of the blood vessel;

[0054] Insert the catheter body 2 through the proximal end of the guidewire and move the catheter body 2 to the target position;

[0055] The balloon 22 is inflated to block the blood vessel and to deliver instruments, contrast fluid or therapeutic drugs through the catheter body 2.

[0056] like Figure 6 The diagram shown is a schematic representation of the structure for delivering a vascular stent in an embodiment of the present invention. The physician can select a suitable microcatheter to deliver the corresponding stent according to clinical needs. During the specific operation, the vascular stent is guided through a balloon via the microcatheter handle 1 and lumen 2a to the target blood vessel. When the device is a vascular stent, after the stent is delivered and released, the following steps are also included:

[0057] Observe the stent's apposition to the vessel wall. If the stent apposition is poor, retract the balloon catheter 22 and move it to the area where the stent apposition is poor. Inflate the balloon catheter 22 to expand the stent. During the expansion process, such as... Figure 7 As shown, adjust the position of the balloon catheter 22 so that the area of ​​the vascular stent requiring expansion is located between the two contrast-enhancing rings 23a of the balloon catheter 22. Then, inflate the balloon catheter 22 to expand and massage the area of ​​the vascular stent that has not adhered to the vessel wall, as shown. Figure 8 As shown, when the proximal end of the vascular stent does not adhere well to the vessel wall, the balloon catheter 22 is placed proximally. If the middle or distal portion of the vascular stent does not adhere well to the vessel wall, then... Figure 9 and Figure 10 As shown in the figure, the balloon tube 22 is adjusted to the corresponding position for expansion.

[0058] In embodiments of the present invention, to reduce the need for position adjustments to the balloon tube 22, the structure of the balloon tube 22 has been improved, such as... Figure 11 and Figure 12 As shown, TPU-material contractile balloon segments 22a are provided at both ends of the balloon tube 22. The walls at both ends of the balloon tube 22 also have fragile orifice walls 22b, which are thinner than other parts. When the inflation pressure reaches a certain level, the fragile orifice walls 22b are ruptured, and the inflation fluid enters into the contractile balloon segments 22a, causing the contractile balloon segments 22a to extend axially to both sides. Through this structure, the expansion range of the balloon tube 22 for the vascular stent can be increased, thereby reducing the need to adjust the position of the balloon tube 22 and improving the convenience of operation.

[0059] Those skilled in the art should understand that the present application is not limited to the above-mentioned embodiments, and the above-mentioned embodiments and descriptions in the specification are only to illustrate the principles of the present application, and various changes and improvements can be made without departing from the spirit and scope of the present application, and these changes and improvements all fall within the scope of the claimed present application. The scope of protection of the present application is defined by the appended claims and their equivalents.

Claims

1. A balloon delivery microcatheter, characterized in that, The utility model relates to a kind of medical balloon catheter, including: Handle, first interface and second interface are provided on the handle;Catheter body is connected with the handle, the catheter body includes proximal tube, balloon tube and distal tube in order from near to far;Wherein, the catheter body is double-cavity structure, including inner cavity and outer cavity, the inner cavity is passage, one end is communicated with the first interface, the other end is through to the end of the distal tube, for conveying instrument, therapeutic drug or diagnostic contrast medium;The outer cavity is filling cavity, one end is communicated with the second interface, the other end is communicated with the balloon tube, for filling and pressure relief of the balloon tube; The balloon tube includes inner liner tube, reinforcing braid layer, outer tube reinforcing layer, outer tube layer and balloon layer in order from inside to outside, the balloon layer is TPU material, the gap between the outer tube layer and the outer tube reinforcing layer constitutes the filling cavity, the outer tube layer has filling hole inside the balloon layer; The filling hole is provided with multiple, and staggered distribution in circumferential direction, the balloon layer is filled and is cylindrical structure; The both ends of the balloon tube are also provided with shrinkage balloon section, the both ends wall of the balloon tube also has fragile hole wall, after extrusion breaking of the fragile hole wall, filling liquid enters into the shrinkage balloon section, so that shrinkage balloon section extends towards both sides along axial direction; The proximal tube includes inner liner tube, reinforcing braid layer, outer tube reinforcing layer and outer tube layer in order from inside to outside, wherein, the inner liner tube is PTFE material, the reinforcing braid layer is stainless steel wire braid layer, the outer tube reinforcing layer and the outer tube layer are gradually changed from hard to soft in material from near to far.

2. The balloon delivery microcatheter of claim 1, wherein, It also includes inner layer stress diffusion tube, one end of the inner layer stress diffusion tube is sleeved on the proximal tube, and the other end is connected to the handle, the inner layer stress diffusion tube is made of PEBAX material.

3. The balloon delivery microcatheter of claim 2, wherein, It also includes outer layer stress diffusion tube, one end of the outer layer stress diffusion tube is sleeved on the inner layer stress diffusion tube, and the other end is connected to the handle, the outer layer stress diffusion tube is made of TPE material.

4. The balloon delivery microcatheter of claim 1, wherein, The outer tube reinforcing layer is made of PEBAX72D, PEBAX63D, PEBAX55D, PEBAX35D and TPU material from near to far;The outer tube layer is made of NYLON, PEBAX72D, PEBAX63D, PEBAX55D, PEBAX35D and POE material from near to far.

5. The balloon delivery microcatheter of claim 4, wherein, The distal tube includes inner liner tube, reinforcing braid layer and outer tube reinforcing layer in order from inside to outside, and the outer tube reinforcing layer of the distal tube has developing ring.

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