CN216021542U

CN216021542U - Device for protecting far end in lower limb artery interventional operation

Info

Publication number: CN216021542U
Application number: CN202121505009.XU
Authority: CN
Inventors: 林长泼; 蒋俊豪; 符伟国; 郭大乔; 原野
Original assignee: Zhongshan Hospital Fudan University
Current assignee: Zhongshan Hospital Fudan University
Priority date: 2021-07-02
Filing date: 2021-07-02
Publication date: 2022-03-15
Anticipated expiration: 2031-07-02

Abstract

The utility model relates to a device for protecting the far end in the lower limb artery intervention operation, belonging to the technical field of medical instruments. Comprises a protective guide wire, a delivery catheter and a recovery sheath, wherein the distal end of the protective guide wire is provided with a filter screen; two ends of the conveying conduit are opened and provided with a channel for penetrating and protecting the guide wire, and the side wall of the conveying conduit is provided with a working guide wire outlet; the two ends of the recovery sheath are provided with openings, a hollow channel is arranged between the openings at the two ends, and the side wall of the recovery sheath is provided with a working guide wire outlet and a protection guide wire outlet. The protective guide wire has long effective working length and large filter screen volume; the recovery sheath can lead the working guide wire to the distal end of the lesion through the guide wire cavity after the filter screen is recovered, so that an important guide wire passage is reserved, and the phenomenon that the guide wire passage is lost after the filter screen is recovered and subsequent operation cannot be carried out is avoided.

Description

Device for protecting far end in lower limb artery interventional operation

Technical Field

The utility model relates to a device for protecting the far end in the lower limb artery intervention operation, belonging to the technical field of medical instruments. In the utility model, one end close to the operator is set as a near end or a rear end, and the other end far away from the operator is set as a far end or a front end.

Background

Clinically, in the course of intraluminal treatment of the lower limbs, it is prone to the detachment of thrombotic emboli or plaque fragments, resulting in distal embolic events. At present, no product specially aiming at the distal embolism protection of the lower limb exists, and the distal protection filter in the carotid artery stenting is used for replacing the distal protection filter for protection. These filters are attached to the tip of the delivery guidewire, are introduced into the body through the delivery sheath and released to the distal end of the lesion for protection, and are retrieved and removed through the retrieval sheath after the procedure is completed. The prior related products are not specially designed for the remote protection in the lower limb intervention, so the defects are obvious: 1. most product delivery guidewires have insufficient working distance: the carotid artery distal protection devices are all rapid exchange systems, so the length of a delivery guide wire is generally only 190cm, and the working distance is not enough to meet the treatment requirement of lower limbs; 2. at present, all related product delivery guide wires are 0.014 inch systems, are too soft and lack of necessary supporting force, so that subsequent interventional therapy is limited, and a filter is easy to displace, so that potential vascular wall injury and thrombus falling to a farther end are caused; 3. when the filter is recovered, the guide wire needs to be withdrawn out of the body together, so that the guide wire channel is lost, and if the subsequent intervention operation is still needed, the guide wire channel needs to be established again; 4. the volume of the distal filter is insufficient, so that the content is easy to overflow to the distal end during recovery to cause distal embolism; 5. in case of distal embolization during the interventional procedure, the filter does not become an ideal embolectomy tool, and the intraluminal treatment of the distal embolization is extremely difficult and ineffective. There is therefore a need in the art for a distal protection device for lower extremity arterial interventions.

Disclosure of Invention

The utility model aims to solve the defects of the prior art and achieve the technical problem of obtaining a distal protection device for lower limb artery intervention.

In order to solve the problems, the technical scheme adopted by the utility model is to provide a device for protecting the far end in the lower limb artery interventional operation, which comprises a protective guide wire, a conveying catheter and a recovery sheath, wherein the far end of the protective guide wire is provided with a filter screen; openings are arranged at two ends of the conveying conduit, a channel for penetrating and protecting the guide wire is arranged between the openings at the two ends, and a working guide wire outlet is arranged on the side wall of the conveying conduit; the two ends of the recovery sheath are provided with openings, a hollow channel is arranged between the openings at the two ends, and the side wall of the recovery sheath is provided with a working guide wire outlet and a protection guide wire outlet.

Preferably, the length of the protective guide wire is set to be more than or equal to 300cm, the diameter of the guide wire is 0.018 inches, the distal end of the protective guide wire is provided with a filter screen, and the surface of the filter screen is provided with a heparin coating.

Preferably, the filter screen is provided with a gradually-changing elongated structure, and the cross-sectional area of the far end of the filter screen is smaller than that of the near end of the filter screen;

preferably, the filter screen is provided with an opening at the proximal end, the opening is in a shape of an oblique ellipse, and the opening is provided with a radiopaque marking ring.

Preferably, the distal end of the recovery sheath is provided with a protective guide wire recovery cavity for recovering a protective guide wire filter screen; a working guide wire outlet and a protective guide wire outlet are sequentially arranged on the side wall of the recovery sheath, which is far away from one end of the recovery sheath close to the operator; the working guidewire exit is closer to the operator than the protection guidewire exit.

Preferably, the end of the retrieval sheath distal to the operator is provided with a radiopaque marker band; a protective guide wire recovery cavity is arranged between the protective guide wire outlet and the tail end of the recovery sheath.

Preferably, the length of the protective guide wire recovery cavity is set to be 10 cm.

Compared with the prior art, the utility model has the following beneficial effects:

1. the working length of the protective guide wire is 300cm, and the support force of the guide wire is similar to that of a V18 guide wire commonly used in lower limb operation, so that the requirement of lower limb interventional operation is completely met, and the problems of difficult conveying appliance or displacement of a filter screen and the like caused by insufficient working distance or insufficient support force are solved;

2. the length of the filter screen is lengthened, and the volume is obviously increased. Therefore, the problem that the content overflows due to large volume of the falling objects and insufficient capacity of the filter screen in the existing lower limb interventional operation can be well solved. Meanwhile, the filter screen adopts a gradual change type slender design, and can be used as a temporary embolectomy device for embolectomy when a distal end embolism occurs in an operation;

3. the recovery sheath can lead the working guide wire to the distal end of the lesion through the guide wire cavity after the filter screen is recovered through the recovery cavity, so that an important guide wire passage is reserved, and the phenomenon that the filter screen is lost after being recovered and the subsequent operation cannot be carried out is avoided.

Drawings

Fig. 1 is a schematic view of the structure of the protective guide wire of the present invention.

Fig. 2 is a schematic view of the structure of the delivery catheter of the present invention.

FIG. 3 is a schematic view of the recycling sheath of the present invention.

Reference numerals: 1. a protective guidewire; 2. a delivery catheter; 3. recovering the sheath; 4. a working guidewire outlet; 5. protecting the guide wire outlet; 6. filtering with a screen; 7. a radiopaque marker band; 8. a radiopaque marker ring; 9. a distal soft guide wire; 10. a working guidewire exit marker band; 11. protecting the guidewire exit marker band.

Detailed Description

In order to make the utility model more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:

as shown in figures 1-3, the technical scheme adopted by the utility model is to provide a device for protecting the far end in the lower limb artery intervention, which comprises a protecting guide wire 1, a conveying catheter 2 and a recovery sheath 3, wherein the far end of the protecting guide wire is provided with a filter screen 6; openings are arranged at two ends of the conveying conduit 2, a channel for penetrating the protection guide wire 1 is arranged between the openings at the two ends, and a working guide wire outlet 4 is arranged on the side wall of the conveying conduit 2; the two ends of the recovery sheath 3 are open, a hollow channel is arranged between the two ends of the recovery sheath, and a working guide wire outlet 4 and a protection guide wire outlet 5 are arranged on the side wall of the recovery sheath 3. The length of the protective guide wire 1 is set to be more than or equal to 300cm, a filter screen 6 is arranged at the far end of the protective guide wire 1, and a heparin coating is arranged on the surface of the filter screen 6. The filter screen 6 is a gradually-changing slender structure, and the cross-sectional area of the far end of the filter screen 6 is smaller than that of the near end of the filter screen 6; the filter screen 6 has an opening at its proximal end, where a radiopaque marker ring 8 is provided. The far end of the recovery sheath 3 is provided with a protective guide wire recovery cavity for recovering a protective guide wire filter screen; a working guide wire outlet 4 and a protection guide wire outlet 5 are sequentially arranged on the side wall of the recovery sheath 3 far away from one end of the operator; the working guidewire exit 4 is closer to the operator than the protection guidewire exit 5. The end of the retrieval sheath 3 away from the operator is provided with a radiopaque marker band 7; a protective guide wire recovery cavity is arranged between the protective guide wire outlet 5 and the tail end of the recovery sheath 3. The length of the protective guide wire recovery cavity is set to 10 cm.

The utility model provides a device specially used for distal protection in lower limb intervention, and avoids the disadvantages related to the current substitute products.

The utility model is composed of the following three components: 1. a protective guide wire 1 with a filter screen 6 at the far end; RX delivery catheter 2; 3. the sheath 3 is recovered.

1) Protection of the guide wire 1: the protective guide wire 1 has a diameter of 0.018 inch and a length of 300cm, has a guide wire support similar to that of the current Boston V18 guide wire, and has a tapered soft head at the head end, namely, a tail end soft guide wire 9 is arranged. The tip of protection seal wire 1 has a nickel titanium alloy metal filter screen 6, and metal filter screen 6 adopts the type structure of weaving, and the surface adopts the heparin coating, avoids forming the thrombus on filter screen 6 surface in the art. The diameter of the filter screen 6 has five sizes of 3mm, 4mm, 5mm, 6mm and 7mm so as to meet the requirements of blood vessels with different diameters. The screen 6 of the present invention is slimmer in appearance, increasing volume, and can be used as an embolectomy device in the event of distal embolization, as compared to previously used alternatives. The protective guide wire 1 is pre-loaded in the RX conveying catheter 2, and a filter screen is arranged at the head end of the conveying catheter 2 and can follow the conveying sheath to reach the far end of the lesion and be released.

2) RX delivery catheter 2: the RX delivery catheter 2 has a working length of 150cm and a tapered design at the tip with a radiopaque marker band 7. A working guide wire outlet 4 is arranged 10cm away from the head end, and a working guide wire outlet mark belt 10 is arranged in front of the working guide wire outlet 4. When in use, the pre-filled protective guide wire 1 can be pumped back, and the filter screen is recovered to the rear of the working guide wire outlet 4. The conveying catheter behind the working guide wire outlet 4 is made of transparent materials, and the filter screen is recovered to the part to be clearly seen.

3) And (3) recovering the sheath: the recovery sheath 3 has a total length of 150cm and is divided into a head-end lumen and a rear-end lumen. Wherein the head end is for retrieving the chamber, and long 10cm is used for holding protection seal wire 1 and retrieving filter screen 6. A protective guide wire outlet 5 is arranged 10cm away from the head end. The rear is the guidewire lumen through which a 0.018 inch guidewire can be passed, with the working guidewire exit 4 on the side opposite the rear of the protective guidewire exit 5.

The embolization during lower limb interventional procedures often causes the aggravation of ischemia of affected limbs and even the failure of treatment, so the idea of embolization protection during lower limb interventional procedures increasingly attracts the attention of vascular surgeons. However, no product specially aiming at the condition is available on the market at present, and the distal filter screen in carotid artery stenting is used for protection instead. The utility model uses the effective idea of protecting the far-end filter screen for reference, and improves related devices according to different conditions in the lower limb intervention and the carotid artery stent, thereby becoming more applicable.

Examples

1. The protective guide wire 1 is a 0.018 inch guide wire with the length of 300cm, and the head end of the guide wire is a soft head, namely the tail end soft guide wire 9. The proximal end of the protective guide wire 1 is provided with a nickel-titanium alloy metal filter screen 6 with the length of 3 cm. The metal filter screen 6 adopts a weaving type structure, and the surface adopts a heparin coating. The protective guide wire 1 is prefilled in the RX delivery catheter 2, and the filter screen 6 is located at the tip of the RX delivery catheter 2. The screen openings are in the form of oblique ovals with opaque markings, i.e. radiopaque marking rings 8.

An RX delivery catheter 2 is 150cm with a radiopaque marker band 7 at the tip. A working guide wire outlet 4 is arranged at a position 10cm away from the head end of the conveying catheter 2. A green mark belt, namely a working guide wire outlet mark belt 10 is arranged in front of the outlet 4; the transparent conduit is arranged at the rear part, and the specific position of the filter screen can be seen clearly.

3. The retrieval sheath 3 is 150cm in length and has a radiopaque marker band 7 at the tip. The head end is a recycling cavity with the length of 10cm and is used for recycling and protecting the guide wire 1 and the filter screen 6. A protective guide wire outlet 5 is arranged 10cm away from the head end. The rear part is a guide wire cavity which can accommodate a guide wire of 0.018 inch to pass through. The guide wire lumen working guide wire outlet 4 is located on the opposite side of the rear of the protective guide wire outlet 5. A blue protective guide wire outlet mark belt 11 is arranged on one side of the front of the protective guide wire outlet 5 far away from the operator.

The working process of the utility model is as follows:

1. preparing a protection device;

1) when the protective device is determined to be used in the interventional operation, the size of the protective device to be used is selected by measuring the diameter of the blood vessel (generally, the size is 1mm larger than the diameter of the blood vessel of a pre-placement part). The protector placement part is generally located at 3-4cm of a diseased distal blood vessel, and 5cm of a normal blood vessel is needed to ensure the complete expansion of the filter screen 6.

2) Taking out the protection device under aseptic operation, soaking the filter screen into aseptic heparin normal saline, and washing and removing all residual air in the filter screen by using the injector. The protective guide wire 1 is pulled backwards, the filter screen is completely collected into the RX conveying catheter 2, and the protective guide wire 1 is continuously pulled until the filter screen reaches the rear part of the working guide wire outlet 4.

2. Transport and placement protection device

1) The head end of the RX conveying catheter 2 is loaded into the working guide wire, and the guide wire is led out from the working guide wire outlet 4. The RX delivery catheter is then guided over the working guidewire, through the arterial sheath, into the body and to the site where the mesh is to be placed. And confirming that the near-end opaque marker point of the delivery catheter 2 is positioned at the pre-placement position under fluoroscopy.

2) And (4) removing the working guide wire, pushing the protective guide wire 1 forwards under fluoroscopy, and pushing the filter screen to the outlet of the conveying catheter 2 and releasing completely. Exits the RX delivery catheter along the protective guidewire. The next interventional procedure and treatment is then performed under the protection of the distal screen.

3. Recovery and extraction protection device

1) After the intervention operation is completed, the protective umbrella is recovered by using a recovery sheath 3. The retrieval sheath 3 retrieval lumen is loaded into the protective guidewire 1 and the retrieval sheath 3 is pushed forward along the protective guidewire 1 until the radiopaque marker ring 8 at the end of the filter screen 6.

2) The recovery sheath 3 is fixed and pulled backwards slightly to pull the protection guide wire 1 until the filter screen 6 is completely collected in the recovery sheath 3. If more contents are captured within the screen, it is also possible to not fully retrieve the screen 6, but only retrieve the proximal end of the screen 6 into the sheath 3, but ensure that the proximal radiopaque marker band 8 is fully received within the sheath 3.

3) A0.018 inch working guidewire was introduced through the guidewire lumen and passed approximately 15cm under fluoroscopy through the working guidewire exit port 4 to the distal end of the lesion. Care should be taken to avoid the passage of the guide wire through the screen 6 without completely recovering the screen 6.

4) The working guide wire is fixed, and the recovery sheath 3 and the protection guide wire 1 are carefully withdrawn from the body as a whole. Leaving the working guidewire passage.

4. Protector cleaning and refilling

1) After the protective device is taken out, the protective guide wire 1 is pushed forwards to stretch the filter screen 6 out from the head end of the recovery sheath 3, and the protective guide wire is completely withdrawn from the recovery sheath. The contents captured within the filter screen were examined. And repeatedly washing and cleaning the contents of the filter screen by using the heparin normal saline. The heparin normal saline washes the recovery sheath 3 and recovers the cavity.

2) And leading the tail end of the protective guide wire 1 into the tail end through the head end of the RX conveying catheter to be led out, and continuously drawing the guide wire until the filter screen 6 reaches the head end of the RX conveying catheter. And immersing the protective guide wire 1, the filter screen 6 and the RX conveying catheter into the heparin physiological saline for standby. And (4) subsequently, if the filter screen is required to be placed again, repeating the steps 1-3 for placing again and recovering the protection device.

While the utility model has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the utility model. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims

1. A device for distal protection in lower extremity arterial interventions, characterized by: comprises a protective guide wire, a delivery catheter and a recovery sheath, wherein the distal end of the protective guide wire is provided with a filter screen; openings are arranged at two ends of the conveying conduit, a channel for penetrating and protecting the guide wire is arranged between the openings at the two ends, and a working guide wire outlet is arranged on the side wall of the conveying conduit; the two ends of the recovery sheath are provided with openings, a hollow channel is arranged between the openings at the two ends, and the side wall of the recovery sheath is provided with a working guide wire outlet and a protection guide wire outlet.

2. The device of claim 1, wherein the distal end of the device is protected during arterial access of the lower limb by: the length of the protection guide wire is set to be more than or equal to 300 cm; the far end of the protective guide wire is provided with a filter screen, and the surface of the filter screen is provided with a heparin coating.

3. The device of claim 2, wherein the distal end of the device is protected during arterial intervention of the lower limb by: the filter screen is designed into a gradual change type slender structure, and the cross section area of the far end of the filter screen is smaller than that of the near end of the filter screen.

4. The device of claim 3, wherein the distal end of the device is protected during arterial intervention of the lower limb by: the filter screen near-end is equipped with the opening, and the opening part is equipped with radiopaque marker ring.

5. The device of claim 4, wherein the distal end of the device is protected during arterial intervention of the lower limb by: the far end of the recovery sheath is provided with a protective guide wire recovery cavity for recovering a protective guide wire filter screen; a working guide wire outlet and a protection guide wire outlet are sequentially arranged on the side wall of the recovery sheath far away from one end of the operator; the working guidewire exit is closer to the operator than the protection guidewire exit.

6. The device of claim 5, wherein the distal end of the device is protected during arterial intervention of the lower limb by: the end of the recovery sheath far away from the operator is provided with a radiopaque marker band; a protective guide wire recovery cavity is arranged between the protective guide wire outlet and the tail end of the recovery sheath.

7. The device of claim 6, wherein the distal end of the device is protected during arterial intervention of the lower limb by: the length of the protective guide wire recovery cavity is set to be 10 cm.