CN111135433A

CN111135433A - Balloon catheter

Info

Publication number: CN111135433A
Application number: CN202010150924.5A
Authority: CN
Inventors: 胡景就; 黄君仪; 张志军
Original assignee: Brosmed Medical Co ltd
Current assignee: Brosmed Medical Co ltd
Priority date: 2020-03-06
Filing date: 2020-03-06
Publication date: 2020-05-12
Anticipated expiration: 2040-03-06
Also published as: CN111135433B

Abstract

The invention discloses a balloon catheter, which comprises a catheter component with a near end and a far end which are opposite, an expandable balloon positioned at the far end of the catheter component, a first luer locking joint connected with the near end of the catheter component, a folding sleeve movably sleeved outside the expandable balloon, and a second luer locking joint connected with the near end of the folding sleeve; the proximal end and the distal end of the expandable balloon are respectively sleeved on the periphery of the catheter component and sealed. The folding sleeve can be used as a reinforced pipe of the catheter component, and the pushing performance of the pushing rod is improved. Compared with the prior art, if the degree of stenosis of the lesion is heavy and complex, the balloon catheter can more easily convey the balloon at the far end into the middle of the lesion, and can directly retract the balloon at the target lesion position to repeatedly perform the vasodilatation for multiple times, thereby reducing the operation risk and shortening the operation time.

Description

Balloon catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon catheter.

Background

Currently, balloon catheters are widely used for the dilation of stenotic lesions in blood vessels, or for the insertion and dilation of stents. Existing balloon catheters typically include a hub attached to the proximal end of the catheter, a push rod (proximal end of the catheter), a balloon at the distal end of the catheter, and a catheter tip. The catheter has a fill and vent lumen for filling and venting the balloon and a guidewire lumen for receiving and passing a guidewire. The inside of the saccule is communicated with the pressure charging and discharging cavity and the joint.

When the balloon catheter is used, a guide wire enters the tip of the balloon and passes through the guide catheter from the proximal end to the opening of a blood vessel. The guidewire is then passed through the stenosis, and the balloon follows the guidewire into the lesion. If the surgeon encounters difficulty in passing the guidewire, the balloon catheter can be advanced to the target vessel to provide additional support and moment control. If the lesion is still unable to pass, the balloon catheter can be put in place as a delivery catheter and the operator then takes a different approach to manipulate the guidewire or to replace it with a new one if necessary. The method has high requirement on the pushing performance of the pushing rod of the balloon catheter, and is not easy to pass through complicated pathological changes with heavy stenosis degree, so that the balloon catheter is generally required to be expanded for many times in the operation, namely the balloon catheter is taken out, a refolding tool is used for carrying out the recoil contraction of the balloon, so that the balloon enters the target blood vessel again, and the balloon expansion is carried out for many times.

The method has the disadvantages that if the stenosis degree of the lesion is heavy and complex, the push rod cannot convey the balloon at the far end into the middle of the lesion, the balloon catheter needs to be taken out of the body, the balloon is retracted by using a refolding tool, and then the balloon enters the blood vessel again for expansion, so that the surgical risk is increased, and the surgical time is prolonged.

Disclosure of Invention

The technical problem to be solved by the present invention is to provide a balloon catheter, which is designed to overcome the above-mentioned shortcomings of the prior art.

In order to solve the technical problems, the technical scheme adopted by the invention is as follows: a balloon catheter comprises a catheter component with a proximal end and a distal end which are opposite, an expandable balloon positioned at the distal end of the catheter component, a first luer locking joint connected with the proximal end of the catheter component, a folding sleeve movably sleeved outside the expandable balloon, and a second luer locking joint connected with the proximal end of the folding sleeve; the proximal end and the distal end of the expandable balloon are respectively sleeved on the periphery of the catheter component and sealed.

In the above technical solution, the second luer lock connector is provided with a side branch interface for connecting a triplet to inject a drug or a contrast agent into a blood vessel.

In the above technical scheme, the folding sleeve is made of a polymer pipe or a metal pipe.

In the above technical solution, before the expandable balloon is expanded, the folded sleeve is slid towards the proximal end of the catheter assembly to realize the combined locking of the first luer lock connector and the second luer lock connector.

In the above technical solution, the roughness Ra of the inner surface of the folded sleeve is less than or equal to 1.6.

In the above technical solution, the axial length of the folding sleeve is greater than the axial length of the expandable balloon and less than the axial length of the catheter assembly.

In the technical scheme, the near end of the folding sleeve is provided with the necking part, and when the folding sleeve is sleeved on the expandable balloon, the necking part can be relatively attached to the periphery of the catheter assembly.

In the technical scheme, the catheter assembly comprises an inner tube axially penetrating through the expandable balloon and an outer tube communicated with the interior of the expandable balloon, wherein the inner tube is arranged in the outer tube; the lumen of the inner tube can accommodate a guide wire, and the lumen of the outer tube is a pressure charging and discharging cavity which provides a passage for liquid medium to enter and exit from the interior of the expandable balloon; the near end of the expandable saccule is sleeved on the periphery of the outer tube and sealed, and the far end of the expandable saccule is sleeved on the periphery of the inner tube and sealed.

In the above technical scheme, the distal end of the folding sleeve is provided with a sleeve tip which is attached to the expandable balloon.

In the above technical solution, the expandable balloon has at least three flaps, and the flaps are wound to be closely attached to the catheter assembly and are tightly wrapped by the folding sleeve, so that the expandable balloon is in a folded and deflated state before being expanded.

The invention has the beneficial effects that: the invention changes the mode that the traditional balloon dilatation catheter needs to use a refolding tool outside a human body to retract the balloon, and the far end tube and the near end tube of the balloon have stronger pushing capacity by the movable folding sleeve positioned at the far end of the catheter and outside the balloon, and can effectively pass through the pathological changes with heavy stenosis degree and more complexity. Meanwhile, after the balloon is decompressed, the balloon can be directly retracted into the folding sleeve, so that the balloon does not need to enter and exit from the body, the passing capacity of secondary entering lesion is directly realized in the body, the operation time is shortened, and the operation difficulty and risk are reduced.

Drawings

Fig. 1 is a front view of a balloon catheter of the present invention.

Fig. 2 is a cross-sectional view of the catheter assembly of fig. 1 taken along line a-a of fig. 1.

Fig. 3 is an enlarged partial view of the expandable balloon and folded sleeve of fig. 1.

Fig. 4 is another mating state view of the inflatable balloon and the folding sleeve of fig. 3.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings.

To more clearly describe the structure of the balloon catheter, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical field. Specifically, in the field of interventional medicine, "distal" refers to the end that is distal from the operator during a surgical procedure, and "proximal" refers to the end that is proximal to the operator during the surgical procedure. Unless defined otherwise, 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 belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Example one

As shown in fig. 1, the balloon catheter 100 according to the first embodiment includes a catheter assembly 10 having a proximal end and a distal end, an expandable balloon 20 located at the distal end of the catheter assembly 10, a first luer lock connector 30 connected to the proximal end of the catheter assembly 10, a foldable sleeve 40 movably sleeved on the outer portion of the expandable balloon 20, and a second luer lock connector 50 connected to the proximal end of the foldable sleeve 40. The proximal and distal ends of the inflatable balloon 20 are respectively sleeved around the outer circumference of the catheter assembly 10 and sealed.

As shown in fig. 2, the inflatable balloon 20 has three flaps. The three flaps are wrapped snugly against catheter assembly 10 and are closed by folding sleeve 40 so that expandable balloon 20 is in a folded, deflated state. The folded sleeve 40 may be slid toward the first luer lock fitting 30 of the catheter assembly 10 prior to expansion of the expandable balloon 20 to lock the second luer lock fitting 50, which is connected to the proximal end of the folded sleeve 40, into engagement with the first luer lock fitting 30. It will be appreciated that the number of flaps may also be greater than three, depending on the actual requirements. The surface of the expandable balloon 20 is coated with a hydrophilic coating.

The folding sleeve 40 may be made of a polymer or a metal. Specifically, in the present embodiment, the folding sleeve 40 is made of polytetrafluoroethylene (abbreviated as PTFE). It is understood that the foldable sleeve 40 may also be made of other polymer materials, such as High Density Polyethylene (HDPE), Polyamide (PA), etc. which have certain rigidity and a smoother surface. According to actual requirements, a stainless steel wire or a stainless steel wire mesh grid can be added into the pipe, and a certain amount of barium sulfate or bismuth sulfate can be mixed into the pipe, so that the folding sleeve 40 has developing property.

The roughness Ra of the inner surface of the folded sleeve 40 is less than or equal to 1.6 to ensure that the folded sleeve 40 fits tightly over the expandable balloon 20 without scratching the expandable balloon 20 during the process of fitting the folded sleeve 40 over the exterior of the expandable balloon 20. It will be appreciated that the axial length of the folded sleeve 40 may be greater than the axial length of the expandable balloon 20 and less than the axial length of the catheter assembly 10, i.e., the second luer lock connector 50 connected to the proximal end of the folded sleeve 40 may slide to the first luer lock connector 30 and lock into engagement while the folded sleeve 40 covers the entire outer surface of the expandable balloon 20.

As shown in fig. 1, catheter assembly 10 includes an inner tube 11 extending axially through an inflatable balloon 20, and an outer tube 12 in communication with the interior of inflatable balloon 20. The inner tube 11 is disposed inside the outer tube 12. The lumen of the inner tube 11 may accommodate a guidewire (not shown). The lumen of the outer tube 12 is an inflation and deflation lumen that provides a passage for liquid media into and out of the interior of the expandable balloon 20. The proximal end of the inflatable balloon 20 is fitted over the outer circumference of the outer tube 12 and sealed. The distal end of the inflatable balloon 20 is fitted around the outer circumference of the inner tube 11 and sealed.

As shown in fig. 2, the inner surface of the folded sleeve 40 is not closely attached to the outer surface of the outer tube 12, and there is a space therebetween, so that the folded sleeve 40 can slide back and forth on the outer tube 12.

As shown in fig. 3, the folding sleeve 40 has a proximal necked portion 41, and the folding sleeve 40 is sleeved on the expandable balloon 20, and the proximal necked portion 41 can fit the outer tube 12 to perform a positioning function, so as to just cover the completely expandable balloon 20 when the folding sleeve 40 is rolled back on the expandable balloon 20.

As shown in FIG. 3, the folded sleeve 40 has a tip 42 that is conically shaped to allow the tip 42 to more closely conform to the expandable balloon 20, and the tip 42 can be directed over the guidewire toward the lesion entrance as the complex lesion is traversed, allowing the folded sleeve 40 to act as a passageway for the expandable balloon 20 to traverse the complex lesion.

As shown in FIG. 4, the close fit between the tip 42 of the folded sleeve 40 and the expandable balloon 20, while mating with the tip 13 of the catheter assembly, the conical shape, provides for greater pushability and passability of the catheter assembly.

The clinical use process of the balloon catheter 100 according to the first embodiment is described in detail below, and specifically includes the following steps:

the first step is as follows: before the balloon catheter 100 enters the patient, the folding sleeve 40 is slid towards the proximal end of the balloon catheter 100, the expandable balloon 20 is exposed, and the luer connector 50 connected with the proximal end of the folding sleeve 40 is connected and locked with the first luer locking connector 30 of the balloon catheter 100.

The second step is that: flushing of the lumen of the inner tube 11 is performed through the guidewire lumen inlet 31 of the first luer lock fitting 30 of the balloon catheter 100 using a syringe (medium is physiological saline). The lumen irrigation of the folded sleeve 40 is performed through the side branch port 51 of the second luer lock fitting 50 connected to the proximal end of the folded sleeve 40.

The third step: a balloon dilatation pressure pump (not shown) is connected with the side branch interface 32, then a guide wire (not shown) is implanted in the patient lumen through percutaneous puncture, and the balloon catheter 100 is placed into a target position in the patient body along a track established by the guide wire, if the target position is narrow and calcified seriously, and the balloon catheter 100 cannot enter the target position smoothly, the second luer locking connector 50 of the folding sleeve 40 and the first luer locking connector 30 can be unlocked, the folding sleeve 40 is pushed to the target position along the balloon catheter 100, the pushing performance of the balloon catheter 100 is improved, and the balloon catheter 100 can enter the target position smoothly along the guide wire.

The fourth step: the balloon catheter 100 is injected with a liquid medium via a balloon inflation pressure pump to bring the expandable balloon 20 to a nominal diameter, the target site occlusion segment is opened, and negative pressure is pumped via the balloon inflation pressure pump to deflate the expandable balloon 20.

The fifth step: the blood flow at the target site can be observed by connecting the side branch port 51 of the folding cannula 40 with a syringe (medium is contrast medium) and injecting the contrast medium into the blood vessel and performing radioscopy. If the blood flow condition at the target site is not expected, the folded sleeve 40 is slid toward the expandable balloon 20 to make the expandable balloon 20 contract and roll back into the folded sleeve 40, and the second luer lock connector 50 of the folded sleeve 40 is locked with the first luer lock connector 30 to perform a second use, and the fourth step operation is repeated.

And a sixth step: and after the conventional treatment or diagnosis in the fifth step is finished, withdrawing the balloon catheter 100 and the guide wire from the human body, and finishing the whole operation process.

The above examples are intended to illustrate rather than to limit the invention, and all equivalent changes and modifications made by the methods described in the claims of the present invention are intended to be included within the scope of the present invention.

Claims

1. A balloon catheter characterized by: comprises a catheter component with a proximal end and a distal end which are opposite, an expandable balloon positioned at the distal end of the catheter component, a first luer locking joint connected with the proximal end of the catheter component, a folding sleeve movably sleeved outside the expandable balloon, and a second luer locking joint connected with the proximal end of the folding sleeve; the proximal end and the distal end of the expandable balloon are respectively sleeved on the periphery of the catheter component and sealed.

2. The balloon catheter of claim 1, wherein: the second Ruhr locking joint is provided with a side branch interface for connecting a triple tee to inject medicine or developer into the blood vessel.

3. The balloon catheter of claim 1, wherein: the folding sleeve is made of a polymer pipe or a metal pipe.

4. The balloon catheter of claim 1, wherein: before the expandable balloon is expanded, the catheter assembly is slid proximally through the folding sleeve to achieve conjoint locking of the first luer lock fitting with the second luer lock fitting.

5. The balloon catheter of claim 1, wherein: the inner surface roughness Ra of the folding sleeve is less than or equal to 1.6.

6. The balloon catheter of claim 1, wherein: the axial length of the folded sleeve is greater than the axial length of the expandable balloon and less than the axial length of the catheter assembly.

7. The balloon catheter of claim 1, wherein: the proximal end of the folding sleeve is provided with a necking part, and when the folding sleeve is sleeved on the expandable balloon, the necking part can be relatively attached to the periphery of the catheter component.

8. The balloon catheter of claim 1, wherein: the catheter assembly comprises an inner tube axially penetrating through the expandable balloon and an outer tube communicated with the interior of the expandable balloon, wherein the inner tube is arranged in the outer tube; the lumen of the inner tube can accommodate a guide wire, and the lumen of the outer tube is a pressure charging and discharging cavity which provides a passage for liquid medium to enter and exit from the interior of the expandable balloon; the near end of the expandable saccule is sleeved on the periphery of the outer tube and sealed, and the far end of the expandable saccule is sleeved on the periphery of the inner tube and sealed.

9. The balloon catheter of claim 1, wherein: the distal end of the folded sleeve has a sleeve tip that fits over the expandable balloon.

10. The balloon catheter of claim 1, wherein: the expandable balloon has at least three flaps that are wrapped about the catheter assembly and are closed by a folding sleeve such that the expandable balloon is in a folded, deflated state prior to expansion.