CN112472211A

CN112472211A - Catheter device with expandable guide head end

Info

Publication number: CN112472211A
Application number: CN202011481021.1A
Authority: CN
Inventors: 胡文忠; 韩建超; 丁双喜; 李世文
Original assignee: Shanghai Rongmai Medical Technology Co ltd
Current assignee: Shanghai Rongmai Medical Technology Co ltd
Priority date: 2020-12-15
Filing date: 2020-12-15
Publication date: 2021-03-12

Abstract

The invention discloses a catheter device with an expandable guiding head end, belonging to the field of vascular intervention medicine. It includes a three-way connecting seat, a catheter, a connecting seat, a delivery sheath, and an expandable guide head end and an auxiliary expansion tube; the expandable guide head end is an umbrella-shaped mesh cover made of a material with shape memory effect , the expandable guide head includes a thin neck fixed at the suction port at the distal end of the catheter, a tapered expansion part located in the middle and an opening part located at the distal end; the auxiliary expansion tube is sleeved on the catheter, and the initial state assists expansion The tube moves and is sheathed on the expandable guide head end. After the expandable guide head end is inserted into the connection seat, the auxiliary expansion tube is blocked outside the proximal end of the connection seat. A self-expandable expandable guide tip is set at the suction opening at the proximal end of the catheter. The self-expandable expandable guide tip can temporarily block or reduce blood flow, thereby reducing the hemodynamic impact on the blockage and improving the blockage. removal efficiency.

Description

Catheter device with expandable guide head end

Technical Field

The invention relates to a catheter device with an expandable guide head end, and belongs to the technical field of vascular interventional medical treatment.

Background

Abnormal blood flow in blood vessels is caused by abnormal blood vessel passages, and the hemodynamic abnormality can cause a series of adverse effects such as tissue hypoxia, abnormal intravascular pressure, heavy heart load and even heart failure, so that the blood flow in the abnormal blood vessel passages in the blood vessels generally needs to be recovered or rebuilt through a catheter intervention technology. Stenosis or blockage of a blood vessel can cause a number of adverse consequences: turbulent blood flow, a slow flow rate, can lead to blood clot formation, resulting in a restricted blood supply to the downstream regions of the vascular system. Stroke may be initiated when a blood clot is located in the neurovascular system; when a blood clot is located in the pulmonary vasculature, pulmonary embolism can occur, leading to death of the patient. Atherosclerosis and its plaque and other obstructions can also become dangerous as they restrict blood flow, causing abnormal blood flow, causing various vascular diseases. Accordingly, there is a need for an obstruction removal device and system to reduce the likelihood of an obstruction and its fragmented obstructions from remaining in the vascular system while maximizing the probability of capturing the obstruction to reduce the risk of blood flow abnormalities in the blood vessel.

With the development of technology, in recent years, a mechanical thrombus removal (PMT) device has appeared, which is a group of devices for removing blockages in blood vessels, and removes blockages such as thrombus and plaque in blood vessels by dissolving, crushing, aspiration, stent or basket thrombolysis, so as to restore blood circulation function.

A variety of devices and procedures have been used to remove obstructions from blood vessels. For example, a catheter with a balloon on the distal end may be inserted into a blood vessel and passed through the clot, after which the balloon is inflated, and then the balloon may be withdrawn from the blood vessel to remove the clot. Another example of an endovascular occlusion clearing device is a stent having a helical segment or tubular mesh at its distal end that can be delivered to a site of a clot within a blood vessel, and then self-expand to embed within the clot to remove the clot. For example, a segmented intracranial thrombus removal stent structure disclosed in patent CN106580397A, a stent structure with a basket at the tail end of the thrombus removal stent for capturing disclosed in patent CN107198554B, a cerebral thrombus removal device disclosed in patent CN209203427U and the like all adopt a physical method of stent embedding and capturing blood clots in blood vessels to remove the blood clots. Also encompassed are embolectomy techniques that employ a combination of stent and aspiration techniques, including the aspiration detachment embolectomy technique described in US patent 08366735B2, as well as the aspiration catheter embolectomy technique with a self-expanding tip described in US patent 5011488, the obstruction removal system described in patent cn201780084363.x, and the like.

Still further interventional obstruction removal techniques include embedding a thrombectomy stent within the thrombus and then completing the thrombus capture and aspiration removal by pulling the thrombus within the aspiration catheter. The method for capturing thrombus by the stent and removing thrombus by suction (namely negative pressure) of the suction catheter is generally safe and effective, but when the self-expanding thrombus-taking stent embedded in the thrombus passes through a suction opening of the suction catheter, the thrombus is easily cut and broken by the edge of a distal opening of the suction catheter in the process that the diameter of the stent is gradually narrowed from a self-expanding large-diameter state through the suction opening of the catheter, and the thrombus easily escapes to the distal end to block other blood vessel branches. In addition, the diameter of the suction catheter is small relative to the blood vessel, the suction opening at the distal end of the suction catheter is usually attached to the blood vessel wall after the suction catheter passes through the tortuous vascular system to reach a designated position, and the position of the suction catheter in the blood vessel is not fixed, so that the suction catheter is not beneficial to the entering of obstructions such as thrombus and the like into the suction opening of the suction catheter. Moreover, when blood flows towards the distal end of the thrombus, the captured thrombus and other obstructions are easy to break and fall off in the process of transferring the thrombus removal stent, flow to the distal end along the blood flow direction, and accumulate at other parts to block other branch blood vessels. There is therefore a need for a balloon-like catheter that inflates, temporarily blocks or slows down blood flow to reduce the hemodynamic impact on the obstruction and reduce the risk of the obstruction breaking and escaping distally.

One risk with conventional occlusion removal devices is that the clot or plaque may rupture and escape during removal, which may traverse the vascular system and cause traumatic injury elsewhere. Thus, there is also a need to deploy the removal of the obstruction distally of the obstruction, reducing the risk that a portion of the clot or plaque may escape during removal, creating further risk to the patient.

With respect to the known medical devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for making and using medical devices. The present technology provides a catheter device with an expandable guide tip, wherein a self-expanding expandable guide tip is provided at the suction opening of the distal tip of the catheter of the device, and a device and a method for delivering the guide tip to a desired location via a delivery tube. In addition, the conical expansion structure of the expandable guide head end can guide large blocks and massive blockages into the lumen of the suction catheter, and the risk that the blockages such as thrombus are broken and fall off at the suction opening of the catheter is reduced. The device and method are effective in reducing the above-mentioned risks of distal escape of the obstruction and of fragmentation and escape of the obstruction into the suction opening of the catheter. Thus, the aspiration catheter embodiments presented herein can significantly improve patient safety and aspiration effectiveness.

Disclosure of Invention

The technical problem to be solved by the invention is as follows: a catheter device with an expandable guide tip is provided that addresses the risk of current embolectomy catheter devices having distal escape of the obstruction and the risk of fragmentation and escape of the obstruction as it enters the catheter suction opening.

The technical problem to be solved by the invention is realized by adopting the following technical scheme:

a catheter device with an expandable guide head end comprises a three-way connecting seat, a catheter, a connecting seat and a conveying sheath tube, wherein the far end of the three-way connecting seat is connected with the catheter in a sealing mode, the far end of the connecting seat is connected with the conveying sheath tube, a flexible sealing valve used for dynamic sealing is arranged at the near end of the connecting seat, the catheter penetrates through the flexible sealing valve from the far end and is inserted into the connecting seat and the conveying sheath tube, and the catheter device also comprises an expandable guide head end and an auxiliary expansion tube;

the expandable guide head end is an umbrella-shaped mesh enclosure made of a material with a shape memory effect, and comprises a thin neck part fixed at a suction port at the far end of the catheter, a conical expansion part positioned in the middle and an opening part positioned at the far end;

the auxiliary expansion pipe is sleeved on the catheter, the auxiliary expansion pipe moves and is sleeved on the expandable guide head end in an initial state, and after the expandable guide head end is inserted into the connecting seat, the auxiliary expansion pipe is blocked outside the near end of the connecting seat.

As a preferable example, the expandable guide head end adopts a full or partial coating structure, and holes with the diameter of 20-800 mu m or no holes are uniformly formed on the coating.

As a preferred example, the expandable guiding tip is an umbrella-shaped mesh made of a metal tube with shape memory effect by laser cutting and thermal expansion.

As a preferred example, the expandable guide tip is an umbrella-shaped mesh cover woven from a wire having a shape memory effect.

Preferably, the expandable guide head end is an umbrella-shaped mesh cover woven or injection-molded from a high-elasticity polymer material.

Preferably, the opening of the expandable guide head is a planar opening perpendicular to the central axis or an inclined opening having an acute angle with the central axis.

As a preferred example, the edge of the opening of the expandable guide tip is curved inwardly or outwardly, and the outer edge of the opening, which is in contact with the vessel wall, forms a smooth arc-shaped structure.

The invention has the beneficial effects that:

(1) the suction opening at the proximal end of the catheter is provided with a self-expanding expandable guide head end which can temporarily block or reduce blood flow circulation, so that the hemodynamic impact on the blockage is reduced, and the blockage removal efficiency is improved;

(2) the conical expansion part of the expandable guide head end can guide large blocks and a whole block of blocking objects to enter the lumen of the suction opening of the catheter, so that the risks of the blocking objects escaping to the far end and the blocking objects breaking and escaping when entering the suction opening of the catheter can be effectively reduced;

(3) the expandable guide head end is attached to the vessel wall for supporting, so that the risk of position deviation of the catheter can be reduced, the suction opening of the catheter can be placed at the center of the vessel as far as possible, and large thrombi can be conveniently guided into the inner cavity of the catheter;

(4) the device is deployed within the distal region of the obstruction, reducing the risk of further risk to the patient that obstructions such as clots or plaque may escape during the removal process.

Drawings

FIG. 1 is a schematic structural view of the present invention;

FIG. 2 is a schematic perspective view of the present invention;

FIG. 3 is a schematic structural view of an expandable pilot tip;

FIG. 4 is a schematic view of the structure of the direction of the end of the expandable guide head;

FIG. 5 is a side view of an expandable leading end with a planar opening;

FIG. 6 is a perspective view of an expandable leading end employing a planar opening;

FIG. 7 is a schematic structural view of a covering film for a conical expansion part of an expandable guide head end with a planar opening;

FIG. 8 is a schematic view of an expandable pilot tip conical expansion portion cover using an angled opening;

FIG. 9 is a schematic structural view of a covering film for a tapered expanding portion of an expandable guide tip with no extension in the opening portion;

FIG. 10 is a schematic view of an expandable leading end with an integral tapered opening and tapered expansion;

FIG. 11 is a schematic view of the configuration of the open edge of the expandable guide tip bent inward 90;

FIG. 12 is a schematic view of the configuration of the open edge of the expandable guide tip being inturned and folded;

FIG. 13 is a schematic view of the open edge of the expandable guide tip being bent outwardly and folded;

FIG. 14 is a schematic view of an expandable guide tip and catheter securement structure;

FIG. 15 is a schematic view of the auxiliary dilation tube restraining the expandable guide tip leading into the delivery sheath in an initial state;

FIG. 16 is a schematic view of the present invention being advanced into a blood vessel by a guidewire puncture;

FIG. 17 is a schematic view of the catheter of the present invention delivering an expandable guide tip to a thrombus site along a delivery sheath;

FIG. 18 is a schematic view of the construction of the state of the thrombectomy device of the present invention;

FIG. 19 is a schematic view of the thrombus support of the present invention in conjunction with thrombus removal;

figure 20 is a schematic view of the present invention deployed within the distal extent of a thromboembolism.

In the figure: 1. a three-way connecting seat; 2. a conduit; 3. a connecting seat; 4. a delivery sheath; 5. a flexible sealing valve; 6. an expandable leading end; 601. a thin neck portion; 602. a tapered expanding portion; 603. an opening part; 7. an auxiliary dilation tube; 8. a blood vessel; 9. thrombosis; 10. a guide wire; 11. and (4) taking the thrombus.

Detailed Description

In order to make the technical means, the original characteristics, the achieved purpose and the efficacy of the invention easy to understand, the invention is further described with reference to the specific drawings.

The term occlusion herein may include a blood clot, plaque, cholesterol, thrombus 9, naturally occurring foreign matter (i.e., a portion of self tissue left within a lumen), non-naturally occurring foreign matter (i.e., a portion of a medical device or other non-naturally occurring foreign matter left within a lumen). However, the present apparatus is not limited to such applications and may be applied to any number of medical applications including the removal or reduction of the number of obstructions within the blood vessel 8, such as thrombus 9, plaque, etc., that are desired to obstruct blood flow or impair the blood medical mechanism within the blood vessel 8.

For ease of description, the following description uses the terms "proximal" and "distal", where "proximal" refers to the end proximal to the operative end and "distal" refers to the end distal to the operative end.

Examples

The following is further illustrated with reference to specific figures:

as shown in fig. 1 and 2, the device mainly comprises a three-way connecting base 1, a catheter 2 connected with one end of the three-way connecting base 1, an auxiliary expanding tube 7, a connecting base 3, a delivery sheath 4 and an expandable guiding head 6 located at the proximal end of the catheter 2. The three-way connecting seat 1 and the connecting seat 3 are both provided with inner cavities, and one side ends of the three-way connecting seat are both provided with flexible sealing valves 5 (silica gel hemostatic sealing valves) to keep the inlet of the apparatus sealed.

The catheter 2 can enter the tube of the delivery sheath 4 through a flexible sealing valve 5 at one end of the connection base 3 and reach the distal end of the delivery sheath 4. The luer of the three-way connection base 1 can be connected to an external negative or positive pressure generating device to provide positive or negative pressure to the lumen of its catheter 2.

As shown in fig. 3-15, the expandable guiding tip 6 at the proximal end of the catheter 2 is an expandable tip mesh-like skeleton, and a film is coated on the skeleton, and the expandable guiding tip 6 is formed by laser cutting and thermal expansion of a metal tube with a shape memory effect, or by weaving a metal wire with a shape memory effect, or by weaving or injection molding a high-elasticity polymer material. The film is made of polymer materials such as PTFE, ePTFE, PU, TPU and TPE and is covered on the expandable guide head end 6 through the film covering process on the surface of the stent. Fig. 3 and 4 show no coating, and fig. 5 and 6 show coating.

Expandable pilot tip 6 may include an open portion 603 at one end, a tapered flared portion 602, and a narrowed neck 601 at one end. The configured skeleton surface of the expandable guide tip 6 may be wholly or partially coated with a polymer film. The cylindrical extension feature of the opening 603 at the end of the expandable guide head end 6 can expand to fit the wall of the blood vessel 8, thereby better fixing and fitting the wall of the blood vessel 8, the continuous conical expansion part 602 can better play a role in expansion and guide, and the thin neck 601 is convenient for connecting with the catheter 2.

As shown in fig. 7, the surface of expandable pilot tip 6 may include a coating only on the tapered expansion portion 602.

As shown in fig. 8, the surface of the expandable pilot tip 6 may include a partial coating only on the tapered dilating portion 602. The opening 603 at one end of the expandable guide head end 6 can be inclined for guiding, and simultaneously, the contact area with the blood vessel 8 is reduced, and the damage to the wall of the blood vessel 8 caused by movement is reduced.

As shown in fig. 9, the expandable guiding tip 6 may further include a skeleton composed of a thin neck 601 feature narrowed at one end and a tapered expansion portion 602 feature, the opening 603 is not extended, the tapered expansion portion 602 may be wholly or partially covered with a film, and the film is provided with a circular or rectangular aperture structure to facilitate the control of the aperture on the film and change the hemodynamics blocked by the expandable tip.

As shown in fig. 10, the opening 603 of the expandable guide tip 6 is an inclined opening.

As shown in FIG. 11, the edges of opening 603 of expandable leading end 6 are concave to reduce damage to the wall of vessel 8 from the edges of the opening.

As shown in fig. 12, the opening edge 64 of the expandable leading end 6 is folded inwardly to form a concave hem configuration, which reduces damage to the wall of the blood vessel 8 caused by the opening edge.

As shown in fig. 13, the opening edge 64 of the expandable guide tip 6 has an outwardly folded and outwardly folded concave hem configuration to reduce damage to the wall of the vessel 8 from the opening edge.

As shown in fig. 14, the thin-walled skeleton portion of the thin neck 601 of the expandable guide tip 6 is insert-welded to the wall of the catheter 2 by injection molding, hot melt fusion, or the like.

As shown in fig. 15, the expandable guide head end 6 is initially pressed into the lumen of the auxiliary expansion tube 7, and one end of the auxiliary expansion tube 7 passes through the flexible sealing sheet on the flexible sealing valve 5 (connecting seat 3), so that the lumen of the auxiliary expansion tube 7 can communicate with the lumen of the delivery sheath 4; the expandable guide tip 6 can be pushed through the flexible sealing valve 5 by the auxiliary dilation tube 7 under the push of the catheter 2, and thus can enter the lumen of the delivery sheath 4 to the distal end of the delivery sheath 4.

As shown in fig. 16-19, during the procedure, the blood vessel 8 is punctured and a guidewire 10 (otherwise available) is introduced to completely traverse the lesion (thrombus 9) site. The proximal end of the delivery sheath tube 4 is delivered to the proximal end close to the thrombus 9 under the guidance of the guide wire 10, the delivery sheath tube 4 is kept fixed, at the moment, the expandable guide head end 6 is pressed and held in the lumen of the auxiliary expansion tube 7 in the initial state, one end of the auxiliary expansion tube 7 passes through a sealing sheet on the flexible sealing valve 5 (connecting seat 3), and the auxiliary expansion tube 7 is pushed to be in lap joint communication with the lumen of the delivery sheath tube 4; catheter 2 is then advanced to deliver the distal expandable guide tip 6 of catheter 2 through the lumen of delivery sheath 4 near its proximal end.

The catheter 2 and its distal end are held stationary and the delivery sheath 4 is withdrawn to a distance such that the expandable guide tip 6 is radially self-expandable into a deployed state. The external negative pressure aspiration device is activated to provide a continuous negative pressure within the lumen of the catheter 2, and thrombus 9 is aspirated into the lumen of the catheter 2 under the negative pressure at the aspiration opening at the distal tip of the device. The expandable guide tip 6 increases the cross-sectional area of the aspiration opening in the state of being coated with a membrane, and increases the aspiration force on the large thrombus 9 under the same negative pressure.

The thrombus taking stent 11 and the microcatheter thereof can be conveyed through the inner cavity of the catheter 2 and pass through the lesion thrombus 9, then the thrombus taking stent 11 is released to capture the thrombus 9, the thrombus taking stent 11 embedded in the thrombus 9 is withdrawn through the expandable guide head end 6 into the cavity of the catheter 2 (meanwhile, negative pressure suction is carried out in the cavity), and the suction and capture removal of the whole thrombus 9 are completed. (wherein expansible direction head end 6 has better expansion guide effect to getting embolus support 11, the thrombus 9 of being convenient for gets into, and expansible direction head end 6 can block temporarily in addition or reduce the impact of blood flow power to thrombus 9, reduces the thrombus 9 and removes the risk of in-process fracture and drop at getting embolus support 11.

Finally, the thrombus 9 entering the lumen of the catheter 2 is delivered to the outlet end of the three-way connector by negative pressure and is discharged out of the human body. After the thrombus 9 is sucked, all the devices are removed from the human body together.

As shown in fig. 20, expandable guide tip 6 deploys clearing of the obstruction distally within the obstruction, reducing the risk that a portion of the clot or plaque may escape during clearing, creating further risk to the patient.

Reference is made to the above proximally deployed case, in particular, where the expandable guiding tip 6 is placed at the distal end of the obstruction, the surface of the expandable guiding tip 6 is not coated, partially coated, or perforated with a film, and thus, may be used to filter and remove obstructions that may escape distally after the obstruction has fractured or broken during the removal process.

Alternatively, the surface of the expandable guide tip 6 may be coated with a film that, when expanded, abuts the wall of the vessel 8, and the surface may block and occlude branches of the vessel 8, preventing some of the obstruction escaping distally from entering the branches of the vessel 8 and occluding them.

It has the following advantages:

(1) the suction opening at the proximal end of the catheter 2 is provided with a self-expanding expandable guide head end 6, and the self-expanding expandable guide head end 6 can temporarily block or reduce blood flow circulation, so that the hemodynamic impact on an obstruction is reduced, and the obstruction removal efficiency is improved;

(2) the conical expansion part 602 of the expandable guide head end 6 can guide large blocks and massive blockages into the lumen of the suction opening of the catheter 2, and can effectively reduce the risks of breaking and escaping when the blockages escape to the far end and enter the suction opening of the catheter 2;

(3) the expandable guide head end 6 is attached to and supported by the wall of the blood vessel 8, so that the risk of position deviation of the catheter 2 can be reduced, the suction opening of the catheter 2 can be placed at the central position of the blood vessel 8 as far as possible, and the introduction of massive thrombus 9 into the inner cavity of the catheter 2 is facilitated;

The foregoing illustrates and describes the principles, general features, and advantages of the present invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that various changes and modifications may be made without departing from the spirit and scope of the invention as defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. A catheter device with an expandable guide head end comprises a three-way connecting seat (1), a catheter (2), a connecting seat (3) and a conveying sheath tube (4), wherein the distal end of the three-way connecting seat (1) is connected with the catheter (2) in a sealing manner, the distal end of the connecting seat (3) is connected with the conveying sheath tube (4), a flexible sealing valve (5) capable of being used for dynamic sealing is arranged at the proximal end of the connecting seat (3), and the catheter (2) penetrates through the flexible sealing valve (5) from the distal end to be inserted into the connecting seat (3) and the conveying sheath tube (4), and is characterized by further comprising an expandable guide head end (6) and an auxiliary expansion tube (;

the expandable guide head end (6) is an umbrella-shaped mesh cover made of materials with shape memory effect, and the expandable guide head end (6) comprises a thin neck part (601) fixed at a suction port at the far end of the catheter (2), a conical expansion part (602) positioned in the middle and an opening part (603) positioned at the far end;

the auxiliary expansion pipe (7) is sleeved on the catheter (2), the auxiliary expansion pipe (7) moves and is sleeved on the expandable guide head end (6) in an initial state, and after the expandable guide head end (6) is inserted into the connecting seat (3), the auxiliary expansion pipe (7) is blocked outside the near end of the connecting seat (3).

2. The catheter device with the expandable guiding tip as claimed in claim 1, wherein the expandable guiding tip (6) is a full or partial coating structure, and holes with a diameter of 20-800 μm or no holes are uniformly formed on the coating.

3. The catheter device with expandable guiding tip as claimed in claim 1, characterized in that the expandable guiding tip (6) is an umbrella-like mesh made of a metal tube with shape memory effect, laser cut and thermally expanded.

4. The catheter device with an expandable guiding tip according to claim 1, characterized in that the expandable guiding tip (6) is an umbrella-like mesh woven from wires with shape memory effect.

5. The catheter device with an expandable guiding tip according to claim 1, characterized in that the expandable guiding tip (6) is an umbrella-like mesh woven or injection molded from a highly elastic polymer material.

6. The catheter device with an expandable guide tip according to claim 1, wherein the opening (603) of the expandable guide tip (6) is a planar opening perpendicular to the central axis or an angled opening having an acute angle with the central axis.

7. The catheter device of claim 1, wherein the opening (603) of the expandable guide tip (6) is curved inwardly or outwardly at its edge, and the outer edge of the opening (603) that contacts the wall of the vessel (8) is formed in a smooth curved configuration.