CN111449722A

CN111449722A - Intravascular delivery system

Info

Publication number: CN111449722A
Application number: CN202010269389.5A
Authority: CN
Inventors: 何家乐; 刑庭瑀; 吴健平; 曹维拯; 赵杰; 李志刚; 王国辉
Original assignee: Shanghai Xinwei Medical Technology Co ltd
Current assignee: Shanghai Xinwei Medical Technology Co ltd
Priority date: 2020-04-08
Filing date: 2020-04-08
Publication date: 2020-07-28
Anticipated expiration: 2040-04-08
Also published as: CN111449722B

Abstract

The invention discloses an intravascular delivery system, and belongs to the field of medical instruments. The intravascular delivery system comprises a handle, an inner sheath tube of a catheter, an inner tube, an outer tube, an RX rapid exchange port, a developing ring and a balloon; the handle is arranged at the near ends of the inner layer tube and the outer layer tube; the RX fast exchange port, the developing ring and the balloon are arranged at the far ends of the inner layer tube and the outer layer tube; the inner sheath tube of the catheter passes through the inner tube and can be conveyed in the inner tube; the thrombus is pulled into the intravascular delivery system by aspiration, thrombectomy stents, or implants. The invention is applied to the cardiovascular and cerebrovascular embolism operation, has high thrombus extraction efficiency, avoids incomplete thrombus extraction operation or secondary thrombus extraction, and reduces operation danger.

Description

Intravascular delivery system

Technical Field

The invention relates to the field of medical instruments, in particular to an intravascular delivery system.

Background

The acute ischemic stroke has higher disability rate and death rate aiming at the large vessel occlusion caused by the treatment of the cardiovascular and cerebrovascular diseases, and has important significance for prognosis if the tissue perfusion can be effectively recovered in time. In recent years, with the development of interventional materials and technologies, the recanalization rate of the occluded blood vessel is remarkably improved by establishing a blood vessel passage and delivering a stent or an implant for treating the vascular diseases, the treatment time window is prolonged, and good application prospects are displayed.

According to the statistics of the existing interventional treatment cases, the thrombus of the acute ischemic stroke caused by the vascular occlusion is mainly divided into intracranial carotid artery, middle cerebral arteries M1 and M2, basilar artery and branches of the intracranial artery, and each aorta and each branch artery of the coronary artery of the heart. Branches of the artery such as carotid artery bifurcation, middle cerebral artery and cerebral artery bifurcation, posterior circulatory basilar bifurcation, willis circumcision and posterior circulatory artery bifurcation, and bifurcation included angles with different sizes exist among the bifurcations.

After the existing microcatheter enters each artery main branch for thrombus removal, the existing microcatheter is difficult to turn to enter the artery branch, unnecessary damage is caused to blood vessels, even a guide wire, a thrombus removal stent conveying catheter or a thrombus removal stent reaches a lesion part, and the termination or failure of interventional operation is caused.

Meanwhile, because the calcification degree of thrombus fibers is unknown, when the micro catheter or the thrombus taking support is used for taking thrombus, thrombus is easily remained in the micro catheter and flows back into the blood vessel of a human body, so that hidden danger is caused for thrombus taking operation or secondary thrombus taking pain is caused for a patient.

Therefore, those skilled in the art are devoted to develop an intravascular delivery system that can not only divert the microcatheter into the arterial branch, but also avoid the thrombus from falling off or flowing back into the body to cause secondary vessel occlusion.

Disclosure of Invention

In view of the defects of the prior art, the technical problem to be solved by the invention is to provide a diversion channel for the thrombus taking support or the implant to directly reach the thrombus occlusion part, and to avoid secondary vessel occlusion caused by residual thrombus in the thrombus taking delivery catheter flowing back to a human body.

In order to achieve the purpose, the invention provides an intravascular delivery system, which comprises a handle, an inner sheath tube of a catheter, an inner tube, an outer tube, an RX rapid exchange port, a developing ring and a balloon; the handle is arranged at the near ends of the inner layer tube and the outer layer tube; the RX fast exchange port, the developing ring and the balloon are arranged at the far ends of the inner layer tube and the outer layer tube; the inner sheath tube of the catheter passes through the inner tube and can be conveyed in the inner tube; thrombus is drawn into the intravascular delivery system by aspiration, thrombectomy stents, or implants.

Furthermore, the inner sheath tube, the inner tube and the outer tube of the catheter are made of high polymer materials, and can be made of single materials or composite materials.

Furthermore, the catheter inner sheath tube, the inner layer tube and the outer layer tube are respectively formed by splicing a plurality of sections of materials with different hardness, and the hardness of the plurality of sections of materials with different hardness is gradually reduced from the near end to the far end; the inner layer tube, the outer layer tube and the catheter inner sheath tube have good pushing performance; the far ends of the inner layer tube, the outer layer tube and the inner sheath tube of the catheter have good flexibility.

Further, a gap exists between the inner layer pipe and the outer layer pipe.

Further, the inner tube is closed to the distal end of the outer tube.

Furthermore, the far ends of the inner layer tube and the outer layer tube are provided with the RX fast exchange port, and the inner layer tube and the outer layer tube around the RX fast exchange port are closed.

Further, the balloon is arranged on the inner wall of the far end of the inner tube, and the balloon is arranged in a single side or in a double side.

Further, filling of the balloon may be achieved by injecting a liquid or gas into the gap between the inner tube and the outer tube.

Further, the balloon, when inflated, may divert the embolic stent or implant into an arterial vessel branch at the RX rapid exchange port.

Further, the developer ring is disposed adjacent to the RX fast swap port.

Further, the intravascular delivery system can deliver a microcatheter.

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

1. the intravascular delivery system provided by the invention provides an RX rapid exchange port for delivering the thrombus taking support and the implant to the aortic branch, so that the thrombus taking support or the implant can accurately, conveniently and rapidly reach the thrombus position of the cardiovascular and cerebrovascular branch.

2. The intravascular delivery system provided by the invention is provided with the plugging saccule on the inner wall of the catheter, and when the thrombus taking support or the implant needs to be delivered to the cardiovascular and cerebrovascular branch embolism position, the far end of the delivery system is closed, and the thrombus taking support or the implant is enabled to extend out from the RX fast exchange port to reach the cardiovascular and cerebrovascular branch embolism lesion position, so that the operation difficulty of a doctor in the operation process is reduced.

3. After the intravascular delivery system provided by the invention successfully delivers the thrombus extraction stent or the implant, the balloon at the far end of the intravascular delivery system is inflated to avoid backflow of residual thrombus in the catheter, so that incomplete thrombus extraction or secondary thrombus extraction is avoided.

4. Compared with the existing mechanical embolectomy mode, the intravascular delivery system provided by the invention is convenient to operate, safe, reliable and high in success rate.

The conception, the specific structure and the technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, the features and the effects of the present invention.

Drawings

FIG. 1 is a schematic representation of the configuration of an intravascular delivery system according to a preferred embodiment of the present invention;

FIG. 2 is a distal cross-sectional view of the intravascular delivery system of the present invention;

FIG. 3 is a distal cross-sectional view of the intravascular delivery system with a double-sided balloon positioned to the left of the RX rapid exchange port;

FIG. 4 is a cross-sectional view of the distal end of the intravascular delivery system with a single-sided balloon positioned directly over the RX rapid exchange port;

FIG. 5 is a distal end cross-sectional view of the intravascular delivery system with a single-sided balloon positioned to the right of the RX rapid exchange port;

FIG. 6 is a distal cross-sectional view of the intravascular delivery system with a single-sided balloon positioned to the left of the RX rapid exchange port;

FIG. 7 is a schematic diagram of thrombus extraction according to the first embodiment;

FIG. 8 is a schematic diagram of thrombus extraction in example two;

FIG. 9 is a schematic diagram of thrombus extraction in example III;

wherein, 1-handle, 2-conduit inner sheath tube, 3-inner layer tube, 4-outer layer tube, 5-RX rapid exchange port, 6-developing ring, 7-sacculus, 8-microcatheter and 9-thrombus.

Detailed Description

The technical contents of the preferred embodiments of the present invention will be more clearly and easily understood by referring to the drawings attached to the specification. The present invention may be embodied in many different forms of embodiments and the scope of the invention is not limited to the embodiments set forth herein.

In the drawings, structurally identical elements are represented by like reference numerals, and structurally or functionally similar elements are represented by like reference numerals throughout the several views. The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The thickness of the components may be exaggerated where appropriate in the figures to improve clarity.

As shown in fig. 1, 2 and 9, an intravascular delivery system includes a handle 1, an inner sheath tube 2 of a catheter, an inner tube 3, an outer tube 4, an RX rapid exchange port 5, a visualization ring 6, and a balloon 7. The inner layer tube 3 is sleeved in the outer layer tube 4 to form a conveying catheter, the inner sheath tube 2 of the catheter passes through the inner layer tube 3, and the handle 1 is arranged at the near end of the three layers of tubes. An RX rapid exchange port 5, a visualization ring 6 and a balloon 7 are provided at the distal ends of the inner tube 3 and the outer tube 4. The tube body of the three-layer tube is made of high polymer materials, either single materials or composite materials; the tube body of the three-layer tube is formed by splicing a plurality of sections of materials with different hardness, and the hardness of the plurality of sections of materials with different hardness is gradually reduced from the near end to the far end, so that the sheath tube 2 in the catheter is ensured to have good pushing performance. Meanwhile, the distal ends of the three layers of tubes have good flexibility, so that the adaptability of the three layers of tubes to tortuous blood vessels is improved, the damage to the blood vessels is reduced in the conveying process, and the trafficability of the three layers of tubes is improved. A gap is arranged between the inner layer tube 3 and the outer layer tube 4, and the distal ends of the inner layer tube 3 and the outer layer tube 4 are closed. The far ends of the inner layer pipe 3 and the outer layer pipe 4 are provided with an RX fast exchange port 5, and the inner layer pipe 3 and the outer layer pipe 4 around the RX fast exchange port 5 are closed. The far-end inner wall of the inner layer tube 3 is provided with a saccule 7, and the saccule 7 can be filled by injecting liquid or gas into the gap between the inner layer tube 3 and the outer layer tube 4. The thrombus 9 is pulled into the intravascular delivery system by aspiration, thrombectomy stent, or implant. The balloon 7 is in a single or double sided arrangement. The saccule 7 is arranged right above the RX fast exchange port 5, and can make the sheath tube 2 in the catheter turn when being inflated. The distal end of the delivery catheter and the position near the RX fast swap port 5 are provided with developing rings 6 to indicate the positions of the delivery catheter and the RX swap port 5 under the ray, thereby improving the visibility and the maneuverability of the delivery system.

The present invention has five applications to specific different pathologies depending on the relative placement of the balloon 7 and the RX rapid exchange port 5.

In the first mode, as shown in fig. 2, the double-sided balloon 7 is arranged in the intravascular delivery system mode on the right side of the RX rapid exchange port 5, the balloon 7 is arranged on the right side of the RX rapid exchange port 5, the balloon 7 is large at the top and small at the bottom, the inner sheath tube 2 of the catheter can be turned during filling, and the thrombus 9 can be prevented from escaping from the distal port of the delivery catheter after filling.

In the second mode, as shown in fig. 3, the double-sided balloon 7 is arranged in the intravascular delivery system mode on the left side of the RX rapid exchange port 5, the balloon 7 is arranged on the left side of the RX rapid exchange port 5, and the balloon 7 is large in the upper part and small in the lower part, so that the inner sheath 2 of the catheter can be steered when the catheter is inflated. Because the balloon 7 is located to the left of the RX port 5, the thrombus 9 is prevented from escaping from the distal port of the delivery catheter and the RX port 5 after filling.

In the third mode, as shown in fig. 4, the single-side balloon 7 is arranged in the intravascular delivery system mode right above the RX rapid exchange port 5, and the balloon 7 is arranged right above the RX rapid exchange port 5, so that the inner sheath 2 of the catheter can be steered during filling. Because the saccule 7 is positioned right above the RX rapid exchange port 5, the conveying catheter and the RX rapid exchange port 5 can be closed simultaneously after being filled, and the thrombus 9 is prevented from escaping.

In a fourth mode, as shown in fig. 5, the unilateral balloon 7 is arranged in the intravascular delivery system mode on the right side of the RX rapid exchange port 5, and the balloon 7 is arranged on the right side of the RX rapid exchange port 5, so that the inner sheath 2 of the catheter can be turned during filling, and the delivery catheter can be closed at the same time after filling, thereby preventing the thrombus 9 from escaping.

In a fifth mode, as shown in fig. 6, the unilateral balloon 7 is arranged in an intravascular delivery system mode on the left side of the RX rapid exchange port 5, the balloon 7 is arranged on the left side of the RX rapid exchange port 5, the inner sheath 2 of the catheter can be turned during filling, and the delivery catheter can be closed at the same time after filling, so that the thrombus 9 is prevented from escaping.

The following is an example of the embolectomy of three conditions with an intravascular delivery system in one mode of the invention.

Example one

As shown in fig. 7, fig. 1 and fig. 2, the catheter inner sheath 2 is inserted into the main cavity delivery port of the proximal handle 1 of the delivery catheter, the distal end of the delivery system is delivered to the aortic embolism position of a patient, the thrombus 9 is drawn into the catheter inner sheath 2 by suction or thrombus extraction stent, the catheter inner sheath 2 is retracted, and normal saline is injected into the catheter inner delivery system at proper time to fill the balloon 7, so that the thrombus 9 is prevented from falling off or reflowing to the human body to cause secondary vascular occlusion.

Example two

As shown in fig. 8, fig. 1 and fig. 2, the catheter inner sheath tube 2 is inserted into the main cavity delivery port of the proximal handle 1 of the delivery catheter, the distal end of the delivery system is delivered to the embolization part of the arterial bifurcation of a patient, the thrombus 9 is pulled into the catheter inner sheath tube 2 by suction or a thrombus taking stent, the catheter inner sheath tube 2 is retracted, and the normal saline is injected into the blood vessel delivery system at proper time to fill the balloon 7, so that the thrombus 9 is prevented from falling off or flowing back to the human body to cause secondary blood vessel occlusion.

EXAMPLE III

As shown in fig. 9, fig. 1 and fig. 2, the catheter inner sheath tube 2 is inserted into the main lumen delivery port of the proximal handle 1 of the delivery catheter, the delivery system RX rapid exchange port 5 is delivered to the aortic bifurcation of the patient, the catheter inner sheath tube 2 is withdrawn, and the physiological saline is continuously delivered to the infusion port of the side lumen of the handle 1, so that the balloon 7 is inflated. The micro-catheter 8 is pushed, the micro-catheter 8 is turned under the action of the balloon 7, extends out from the RX rapid exchange port 5 to a branch of the artery of the blood vessel, the thrombus 9 is pulled into the micro-catheter 8 through suction or a thrombus taking stent, and the thrombus 9 can be taken out after the micro-catheter 8 is withdrawn.

The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.

Claims

1. An intravascular delivery system is characterized by comprising a handle, an inner sheath tube, an inner tube, an outer tube, an RX rapid exchange port, a developing ring and a balloon; the handle is arranged at the near ends of the inner layer tube and the outer layer tube; the RX fast exchange port, the developing ring and the balloon are arranged at the far ends of the inner layer tube and the outer layer tube; the inner sheath tube of the catheter passes through the inner tube and can be conveyed in the inner tube; thrombus is drawn into the intravascular delivery system by aspiration, thrombectomy stents, or implants.

2. The intravascular delivery system of claim 1, wherein the inner sheath, the inner tube, and the outer tube are polymeric, either single or composite.

3. The intravascular delivery system of claim 1, wherein the catheter inner sheath, the inner tube, and the outer tube are each formed by splicing together a plurality of sections of different durometer materials, the sections of different durometer materials decreasing in durometer from the proximal end to the distal end; the inner layer tube, the outer layer tube and the catheter inner sheath tube have good pushing performance; the far ends of the inner layer tube, the outer layer tube and the inner sheath tube of the catheter have good flexibility.

4. The intravascular delivery system of claim 1, wherein a gap exists between the inner tube and the outer tube.

5. The intravascular delivery system of claim 4, wherein the inner tube is closed to the distal end of the outer tube.

6. The intravascular delivery system of claim 4, wherein the RX flash port is disposed at a distal end of the inner tube and the outer tube, and wherein the inner tube and the outer tube are closed around the RX flash port.

7. The intravascular delivery system of claim 1, wherein the balloon is disposed on an inner wall of the inner tube distal end, the balloon being one-sided or two-sided in configuration.

8. The intravascular delivery system of claim 1, wherein inflation of the balloon is achieved by injecting a liquid or gas into the space between the inner tube and the outer tube.

9. The intravascular delivery system of claim 1, wherein the balloon, when inflated, diverts an embolic stent or implant into an arterial vessel branch at the RX rapid exchange port.

10. The intravascular delivery system of claim 1, wherein the visualization ring is disposed adjacent to the RX rapid exchange port.