A balloon microcatheter

Abstract

This invention provides a balloon microcatheter, relating to the field of medical devices. The balloon microcatheter includes an outer tube, a balloon, a connecting tube, and a reducing tube. The balloon is disposed at the distal end of the outer tube, and the connecting tube passes through the outer tube. The wall of the connecting tube has a through hole, and a first channel is defined between the outer wall of the connecting tube and the inner wall of the outer tube. The first channel communicates with the through hole and connects to the balloon. The connecting tube is sleeved on the outside of the reducing tube. When pressure is applied into the reducing tube, the inner diameter of the reducing tube increases, effectively increasing the space of the infusion cavity and improving the infusion efficiency of the balloon microcatheter. When pressure is applied into the first channel, the outer diameter of the reducing tube decreases. At this time, the space of the second channel formed between the outer wall of the reducing tube and the inner wall of the connecting tube increases. The second channel and the first channel together form the filling cavity, effectively increasing the space of the filling cavity and thus improving the balloon inflation efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically, to a balloon microcatheter. Background Technology

[0002] TACE (catheter arterial chemoembolization) is an important clinical treatment for hepatocellular carcinoma (HCC). It mainly works by embolizing the blood supply arteries to the tumor, blocking the tumor's blood supply, causing the tumor to become ischemic and hypoxic, thereby inhibiting tumor growth and promoting tumor cell necrosis and apoptosis.

[0003] Transarterial chemoembolization (TACE) involves injecting a mixture of embolic agents, such as iodized oil and various chemotherapy drugs, into the tumor site via a microcatheter to exert a local killing effect. During the TACE procedure, the surgeon makes a small incision in the femoral artery at the patient's groin. Under X-ray fluoroscopy, the angiography catheter is inserted retrogradely along the inferior vena cava to the celiac trunk and then to the hepatic artery. Contrast agent is injected to observe the blood supply and the condition of the tumor within the liver, and to find a vascular path that can get closer to the tumor. After determining a smaller vascular path, the microcatheter and microguidewire are combined. The microcatheter is then used to superselectively target the lesion site along the selected vascular path, bringing the tip of the microcatheter closer to the tumor site. The microguidewire is then withdrawn.

[0004] The microcatheter mentioned in the aforementioned transcatheter arterial chemoembolization (TACE) procedure is a single-lumen catheter with a perforated end and an outer diameter of less than 3F (1mm). Besides being extremely thin, it requires excellent delivery capability, flexibility, torsion control, and high-pressure resistance to enter tortuous and complex blood vessels without damaging the inner vessels. Most commercially available microcatheters are single-lumen, which lack good anchoring properties. Therefore, balloon microcatheters have emerged as a solution.

[0005] With the advent of balloon microcatheters, the design has also changed, evolving from a single-lumen structure to a dual-lumen structure, thus placing high demands on the space utilization rate of product design.

[0006] Although the push rod of the existing balloon microcatheter adopts a dual-lumen coaxial design, the infusion efficiency and balloon inflation efficiency of the balloon microcatheter are not high. Summary of the Invention

[0007] This invention provides a balloon microcatheter that can improve balloon inflation efficiency and infusion efficiency.

[0008] The embodiments of the present invention can be implemented as follows:

[0009] This invention provides a balloon microcatheter, comprising:

[0010] outer tube;

[0011] A balloon, wherein the balloon is disposed at the distal end of the outer tube;

[0012] A connecting tube, which passes through the outer tube, has a through hole in its wall, and a first channel is defined between the outer wall of the connecting tube and the inner wall of the outer tube. The first channel communicates with the through hole and is also connected to the balloon.

[0013] A reducing pipe, wherein the connecting pipe is sleeved on the outside of the reducing pipe;

[0014] When pressure is applied into the variable diameter tube, the inner diameter of the variable diameter tube increases; or when pressure is applied into the first channel, the outer diameter of the variable diameter tube decreases. The space of the second channel formed between the outer wall of the variable diameter tube and the inner wall of the connecting tube increases, and the second channel is connected to the balloon.

[0015] In an optional embodiment, the outer tube, the connecting tube, and the reducing tube are arranged coaxially.

[0016] In an optional embodiment, the connecting pipe is a sodium hypochlorite tube, and the wall of the connecting pipe is provided with multiple through holes.

[0017] In an optional embodiment, the balloon microcatheter further includes a catheter seat, which is disposed at the proximal end of the outer tube. The catheter seat has an infusion port, a filling port, and an inner lumen. The infusion port is connected to the variable diameter tube, and the filling port, the inner lumen, and the first channel are sequentially connected.

[0018] In an optional embodiment, the balloon microcatheter further includes a Pebax tube, which is sleeved on the proximal end of the connecting tube and disposed within the lumen.

[0019] In an optional embodiment, the inner wall of the proximal end of the connecting pipe contacts the outer wall of the reducing pipe, and the outer wall of the proximal end of the connecting pipe contacts the inner wall of the Pebax pipe.

[0020] In an optional embodiment, the balloon microcatheter further includes a stress protection sleeve fitted over the proximal end of the outer tube.

[0021] In an optional embodiment, the conduit seat is provided with a boss, and the stress protection sleeve is provided with a groove, the boss and the groove cooperating.

[0022] In an optional embodiment, the reducing pipe is a PTFE pipe.

[0023] In an optional embodiment, the balloon microcatheter further includes a radiopaque ring disposed at the distal end of the connecting tube.

[0024] The beneficial effects of the balloon microcatheter of this invention include, for example:

[0025] This invention provides a balloon microcatheter comprising an outer tube, a balloon, a connecting tube, and a reducing tube. The balloon is disposed at the distal end of the outer tube, and the connecting tube passes through the outer tube. The wall of the connecting tube has a through hole, and a first channel is defined between the outer wall of the connecting tube and the inner wall of the outer tube. The first channel communicates with the through hole and connects to the balloon. The connecting tube is sleeved on the outside of the reducing tube. When pressure is applied into the reducing tube, the inner diameter of the reducing tube increases; or when pressure is applied into the first channel, the outer diameter of the reducing tube decreases. That is, when pressure is applied into the reducing tube, the inner diameter increases, which is equivalent to increasing the space of the infusion cavity and improving the infusion efficiency of the balloon microcatheter. When pressure is applied into the first channel, the outer diameter of the reducing tube decreases, and the space of the second channel formed between the outer wall of the reducing tube and the inner wall of the connecting tube increases. The second channel communicates with the balloon, and the space of the second channel and the first channel together form the filling cavity, which is equivalent to increasing the space of the filling cavity and thus improving the balloon inflation efficiency. Attached Figure Description

[0026] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the balloon microcatheter provided in an embodiment of the present invention;

[0028] Figure 2 This is a cross-sectional view of the balloon microcatheter provided in an embodiment of the present invention;

[0029] Figure 3 for Figure 2 Enlarged view of part D in the image;

[0030] Figure 4 for Figure 2 A magnified view of part C in the image;

[0031] Figure 5 This is a first schematic diagram of a connecting pipe provided in an embodiment of the present invention;

[0032] Figure 6 This is a second schematic diagram of the connecting pipe provided in an embodiment of the present invention;

[0033] Figure 7 for Figure 1 A cross-sectional view along the AA direction;

[0034] Figure 8 When the infusion chamber is pressurized Figure 1 Cross-sectional view of the changes in the internal cavity along the AA direction;

[0035] Figure 9 When the filling cavity is compressed Figure 1 Cross-sectional view of the changes in the internal cavity along the AA direction.

[0036] Icons: 1-Catheter seat; 101-Infusion port; 102-Filling port; 103-Inner lumen; 104-Protrusion; 2-Stress protection sleeve; 201-Groove; 3-Outer tube; 4-Connecting tube; 401-Through hole; 5-Reducing tube; 6-Balloon; 601-Proximal pin; 602-Distal pin; 7-Iconizing ring; 701-First imprinting ring; 702-Second imprinting ring; 8-Pebax tubing; A-Infusion lumen; B-Filling lumen. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0038] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0039] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0040] In the description of this invention, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed, they are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0041] Furthermore, the terms "first" and "second" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0042] It should be noted that, where there is no conflict, the features in the embodiments of the present invention can be combined with each other.

[0043] As mentioned in the background section, TACE (catheter arterial chemoembolization) is an important clinical treatment for hepatocellular carcinoma (HCC). It mainly works by embolizing the blood supply arteries to the tumor, blocking the tumor's blood supply, causing the tumor to become ischemic and hypoxic, thereby inhibiting tumor growth and promoting tumor cell necrosis and apoptosis.

[0044] Transarterial chemoembolization (TACE) involves injecting a mixture of embolic agents, such as iodized oil and various chemotherapy drugs, into the tumor site via a microcatheter to exert a local killing effect. During the TACE procedure, the surgeon makes a small incision in the femoral artery at the patient's groin. Under X-ray fluoroscopy, the angiography catheter is inserted retrogradely along the inferior vena cava to the celiac trunk and then to the hepatic artery. Contrast agent is injected to observe the blood supply and the condition of the tumor within the liver, and to find a vascular path that can get closer to the tumor. After determining a smaller vascular path, the microcatheter and microguidewire are combined. The microcatheter is then used to superselectively target the lesion site along the selected vascular path, bringing the tip of the microcatheter closer to the tumor site. The microguidewire is then withdrawn.

[0045] The microcatheter mentioned in the aforementioned transcatheter arterial chemoembolization (TACE) procedure is a single-lumen catheter with a perforated end and an outer diameter of less than 3F (1mm). Besides being extremely thin, it requires excellent delivery capability, flexibility, torsion control, and high-pressure resistance to enter tortuous and complex blood vessels without damaging the inner vessels. Most commercially available microcatheters are single-lumen, which lack good anchoring properties. Therefore, balloon microcatheters have emerged as a solution.

[0046] With the advent of balloon microcatheters, the design has also changed, evolving from a single-lumen structure to a dual-lumen structure, thus placing high demands on the space utilization rate of product design.

[0047] Although the push rod of the existing balloon microcatheter adopts a dual-lumen coaxial design, its balloon inflation efficiency and the infusion efficiency of the inner tube of the balloon microcatheter are not high. Specifically, it can be understood that the space of the chamber used to inflate the balloon and the space of the chamber used to realize the infusion function are fixed and cannot be changed.

[0048] In view of this, please refer to Figures 1-9 The balloon microcatheter provided in the embodiments of the present invention can solve this problem, and will be described in detail below.

[0049] An embodiment of the present invention provides a balloon microcatheter, which includes an outer tube 3, a balloon 6, a connecting tube 4, and a reducing tube 5. The balloon 6 is disposed at the distal end of the outer tube 3, and the connecting tube 4 passes through the outer tube 3. The wall of the connecting tube 4 is provided with a through hole 401. A first channel is defined between the outer wall of the connecting tube 4 and the inner wall of the outer tube 3. The first channel communicates with the through hole 401 and communicates with the balloon 6. The connecting tube 4 is sleeved on the outside of the reducing tube 5.

[0050] When pressure is applied into the variable diameter tube 5, the inner diameter of the variable diameter tube 5 increases; or when pressure is applied into the first channel, the outer diameter of the variable diameter tube 5 decreases. The space of the second channel formed between the outer wall of the variable diameter tube and the inner wall of the connecting tube increases. The second channel is connected to the balloon. In other words, when pressure is applied into the variable diameter tube 5, the inner diameter of the variable diameter tube 5 increases, which is equivalent to increasing the space of the infusion chamber A, thus improving the infusion efficiency of the balloon microcatheter. When pressure is applied into the first channel, the outer diameter of the variable diameter tube 5 decreases. At this time, the space of the second channel formed between the outer wall of the variable diameter tube 5 and the inner wall of the connecting tube 4 increases. The space of the second channel and the space of the first channel together form the filling chamber B, which is equivalent to increasing the space of the filling chamber B, thereby improving the balloon inflation efficiency.

[0051] Furthermore, it is easy to understand that during the use of the balloon microcatheter, even if the outer tube 3 is bent and part of the inner wall of the outer tube 3 comes into contact with the outer wall of the connecting tube 4 due to some narrow and tortuous blood vessels, thus causing the first channel to be blocked and affecting the inflation of the balloon 6, the balloon 6 can still be properly inflated due to the second channel formed between the outer wall of the variable diameter tube 5 and the inner wall of the connecting tube 4.

[0052] It should be noted that in this application, the terms "proximal" and "distal" are commonly used terms in the medical field. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure.

[0053] It should be noted that in this embodiment, the outer tube 3, the connecting tube 4, and the reducing tube 5 are coaxially arranged, and the connecting tube 4 is a thiocyanate tube. The tube wall of the connecting tube 4 is provided with multiple through holes 401, which can be understood as arc-shaped cuts.

[0054] It is easy to understand that some of the through holes 401 on the wall of the connecting tube 4 can connect the first channel and the second channel, and other through holes 401 on the wall of the connecting tube 4 can connect with the balloon 6, thereby realizing the connection between the second channel and the balloon 6.

[0055] In order to facilitate the change of the inner or outer diameter of the reducing pipe 5, in this embodiment, the reducing pipe 5 is selected as a PTFE (polytetrafluoroethylene) pipe, which is a thin-walled pipe, so as to facilitate the change of the inner or outer diameter of the reducing pipe 5.

[0056] In this embodiment, the balloon microcatheter further includes two radiopaque rings 7, which are disposed at the distal end of the connecting tube 4. The two radiopaque rings 7 are a first radiopaque ring 701 and a second radiopaque ring 702.

[0057] It should be noted that the proximal tube 601 of the balloon 6 is connected to the distal end of the outer tube 3, and the distal tube 602 of the balloon 6 is simultaneously connected to the connecting tube 4 and the reducing tube 5. The inner wall of the connecting tube 4 and the outer wall of the reducing tube 5 are in close contact to achieve the distal end sealing of the second channel. The connecting tube 4 also passes through the balloon 6, the stress protection sleeve 2 and the outer tube 3.

[0058] In addition, the balloon microcatheter also includes a catheter seat 1, which is located at the proximal end of the outer tube 3. The catheter seat 1 is provided with an infusion port 101, a filling port 102 and an inner lumen 103. The infusion port 101 is connected to the reducing tube 5, and the filling port 102, the inner lumen 103 and the first channel are connected in sequence.

[0059] Meanwhile, the balloon microcatheter also includes a Pebax (nylon elastomer) tube. The Pebax tube 8 is sleeved on the proximal end of the connecting tube 4 and is placed in the inner lumen 103. The inner wall of the proximal end of the connecting tube 4 contacts the outer wall of the reducing tube 5, and the outer wall of the proximal end of the connecting tube 4 contacts the inner wall of the Pebax tube 8, which can block the proximal end of the second channel.

[0060] It is easy to understand that, such as Figure 3 and Figure 4 As shown, the proximal end and the distal end of the second channel can be blocked to ensure balloon inflation efficiency.

[0061] In addition, the balloon microcatheter also includes a stress protection sleeve 2, which is fitted onto the proximal end of the outer tube 3. The catheter seat 1 is provided with a boss, and the stress protection sleeve 2 is provided with a groove 201. The boss and the groove 201 cooperate with each other.

[0062] The principle of a balloon microcatheter provided in the embodiments of the present invention is as follows:

[0063] Please refer to Figures 7-9 , Figure 7 This can be understood as the normal state of the balloon microcatheter lumen 103, where there is no pressure being pumped into the filling chamber B or the infusion chamber A.

[0064] Continue to refer to Figure 8 , Figure 8 By pressing into the infusion chamber A, the inner diameter of the reducing tube 5 increases until the outer wall of the reducing tube 5 fits against the inner wall of the connecting tube 4, which is equivalent to increasing the space of the infusion chamber A, thereby improving the infusion efficiency of the balloon microcatheter.

[0065] Continue to refer to Figure 9 , Figure 9 By pressing into the first channel, that is, pressing into the filling cavity B, the outer diameter of the reducing pipe 5 decreases. At this time, the space of the second channel formed between the outer wall of the reducing pipe 5 and the inner wall of the connecting pipe 4 increases. The space of the second channel and the space of the first channel together form the filling cavity B, which is equivalent to increasing the space of the filling cavity B.

[0066] In summary, the balloon microcatheter includes an outer tube 3, a balloon 6, a connecting tube 4, and a reducing tube 5. The balloon 6 is disposed at the distal end of the outer tube 3, and the connecting tube 4 passes through the outer tube 3. The wall of the connecting tube 4 is provided with a through hole 401. A first channel is defined between the outer wall of the connecting tube 4 and the inner wall of the outer tube 3. The first channel communicates with the through hole 401 and communicates with the balloon 6. The connecting tube 4 is sleeved on the outside of the reducing tube 5. When pressure is applied into the reducing tube 5, the inner diameter of the reducing tube 5 increases, or when pressure is applied into the first channel, the outer diameter of the reducing tube 5 decreases.

[0067] In other words, when pressure is applied into the variable diameter tube 5, the inner diameter of the variable diameter tube 5 increases, which is equivalent to increasing the space of the infusion chamber A, thereby improving the infusion efficiency of the balloon microcatheter. When pressure is applied into the first channel, the outer diameter of the variable diameter tube 5 decreases. At this time, the space of the second channel formed between the outer wall of the variable diameter tube 5 and the inner wall of the connecting tube 4 increases. The space of the second channel and the space of the first channel together form the filling chamber B, which is equivalent to increasing the space of the filling chamber B, thereby improving the balloon inflation efficiency. The space of the filling chamber B and the infusion chamber A of the balloon microcatheter can change.

[0068] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A balloon microcatheter, characterized in that, include: outer tube; A balloon, wherein the balloon is disposed at the distal end of the outer tube; A connecting tube is inserted through the outer tube. The wall of the connecting tube has a through hole. A first channel is defined between the outer wall of the connecting tube and the inner wall of the outer tube. The first channel communicates with the through hole and communicates with the balloon. as well as A reducing pipe, wherein the connecting pipe is sleeved on the outside of the reducing pipe; When the variable diameter tube is pressed into it, the inner diameter of the variable diameter tube increases; or when the first channel is pressed into it, the outer diameter of the variable diameter tube decreases. The space of the second channel formed between the outer wall of the variable diameter tube and the inner wall of the connecting tube increases, and the second channel is connected to the balloon. The outer tube, the connecting tube, and the reducing tube are coaxially arranged; the connecting tube is a thiocyanate tube, and the tube wall of the connecting tube has multiple through holes.

2. The balloon microcatheter according to claim 1, characterized in that, The balloon microcatheter also includes a catheter seat, which is located at the proximal end of the outer tube. The catheter seat has an infusion port, a filling port, and an inner lumen. The infusion port is connected to the variable diameter tube, and the filling port, the inner lumen, and the first channel are connected in sequence.

3. The balloon microcatheter according to claim 2, characterized in that, The balloon microcatheter also includes a Pebax tube, which is sleeved on the proximal end of the connecting tube and disposed within the lumen.

4. The balloon microcatheter according to claim 3, characterized in that, The inner wall of the proximal end of the connecting pipe contacts the outer wall of the reducing pipe, and the outer wall of the proximal end of the connecting pipe contacts the inner wall of the Pebax pipe.

5. The balloon microcatheter according to claim 2, characterized in that, The balloon microcatheter also includes a stress protection sleeve, which is fitted onto the proximal end of the outer tube.

6. The balloon microcatheter according to claim 5, characterized in that, The conduit seat has a boss, and the stress protection sleeve has a groove, with the boss and the groove engaging.

7. The balloon microcatheter according to claim 1, characterized in that, The reducing pipe is a PTFE pipe.

8. The balloon microcatheter according to claim 1, characterized in that, The balloon microcatheter also includes a radiopaque ring, which is disposed at the distal end of the connecting tube.

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