CN209595972U - Conveying device and conveying system - Google Patents

Abstract

The utility model discloses a delivery device and a delivery system, including a hollow long sheath tube, the sheath tube including a first tube body arranged at the distal end of the sheath tube, and a second tube body arranged at the proximal end of the sheath tube and connected to the proximal end of the first tube body, the Shore hardness of the first tube body being lower than the Shore hardness of the second tube body. The sheath tube designed in this way has good flexibility due to the low Shore hardness of the first tube body, ensuring that the distal end of the sheath tube can easily pass through the tortuous blood vessels without causing damage to the blood vessels; and also because the second tube body has high Shore hardness, it has good anti-bending, torsion and support properties, ensuring that the stent implant can be smoothly delivered to the designated lesion location.

Description

Conveying device and conveying system

technical field

The utility model relates to the field of interventional medicine, in particular to a delivery device and a delivery system.

Background technique

The human aorta is divided into ascending aorta, aortic arch, descending thoracic aorta and abdominal aorta. Various pathological lesions such as inflammation and ulcers can cause damage to the aortic intima or vessel wall, and under the joint action of blood flow impact, aneurysm disease is prone to occur. Once the aneurysm ruptures, a large amount of blood will flow out of the blood vessel, and the patient's blood circulation is insufficient, which will cause shock or death.

In recent years, the use of interventional methods to treat cardiovascular diseases has become a new treatment trend. With the continuous development of interventional technology, the advantages of using covered stents in the treatment of aortic aneurysm and arterial dissection become increasingly prominent. The covered stent is an artificial blood vessel adapted to the size of the blood vessel, mainly composed of a membrane and a stent supporting the membrane. The covering film is generally made of polyester or e-PTFE film, and the support bracket is mainly braided by stainless steel wire or nickel-titanium alloy wire. When using a covered stent, first compress and load the stent into the sheath of the stent delivery device, then choose to puncture the blood vessel at the position of the femoral artery or the iliac artery, use a guide wire to establish a track, and pass the delivery device through the iliac artery-abdominal aorta-thoracic aorta The artery-aortic arch-ascending aorta establishes a delivery path to deliver the compressed stent to the designated location of the lesion, and then release the stent. After the stent is deployed, it is close to the inner wall of the vessel where the aneurysm occurs. Isolation, thereby avoiding the impact of blood flow on the aneurysm wall of the lesion, establishing a channel for normal blood circulation, and finally withdrawing the guide wire and delivery device to achieve interventional treatment of aneurysm and arterial dissection.

Interventional therapy using covered stents has low cost, short treatment cycle, and less trauma to the human body, and has gradually become the mainstream for the treatment of aortic aneurysms. However, the stent-graft intervention method has certain requirements for the stent-graft and the conveyor, which are mainly reflected in the following aspects: (1) Whether the indicators of the stent-graft meet the requirements; (2) Whether the conveyor can normally load and transport the stent-graft (3) Whether the clinician can operate the conveyor normally and smoothly to ensure the normal operation; (4) Whether the conveyor can be successfully withdrawn from the body after the release of the stent is completed. It can be seen that the conveyor plays an important role in the interventional treatment of the covered stent.

The stent-graft conveyor includes a TIP head of the conveyor, a sheath core tube, a push rod, and a sheath tube. In the process of entering the blood vessel, the sheath should not only ensure that the transporter has certain bending resistance, torsion, and support, but also ensure the flexibility it should have during the process of passing through the complex blood vessel model. It is difficult for the common delivery sheaths on the market to take into account these characteristics at the same time. In the clinical process, they either have good bending resistance, torsion performance, and support, but are poor in flexibility, and it is difficult to pass through complicated blood vessels. The stent is delivered to the pre-designated position of the blood vessel, and there is also a risk of breaking the blood vessel during delivery. For some conveyors with good flexibility but poor bending resistance, torsion resistance, and support, the doctor feels poor hand feeling when sending the conveyor into the blood vessel model, and it is difficult to smoothly push the conveyor loaded with the stent into the blood vessel model. Vessel pre-assigned location.

Therefore, it is necessary to provide a sheath with good bending resistance, torsion, support and flexibility, which can smoothly deliver the stent graft to the designated lesion without damaging the blood vessel due to tortuous blood vessels.

Utility model content

The utility model provides a delivery device, which comprises a hollow elongated sheath tube, and the sheath tube includes a first tube body arranged at the far end of the sheath tube and a first tube body connected to the proximal end of the first tube body. Two pipe bodies, the Shore hardness of the first pipe body is lower than the Shore hardness of the second pipe body.

In one embodiment, the Shore hardness of the first tube body ranges from 25D to 35D, and the Shore hardness of the second tube body ranges from 55D to 72D.

In one embodiment, the length of the first tube body is shorter than the length of the second tube body.

In one embodiment, the outer diameter of the first pipe body is equal to the outer diameter of the second pipe body.

In one embodiment, the first pipe body and/or the second pipe body are made of polymer pipes or composite pipes.

In one embodiment, the sheath includes a plurality of first tubes and a plurality of second tubes arranged at intervals.

In one embodiment, the Shore hardness of any one of the plurality of first tubes is lower than the Shore hardness of any one of the plurality of second tubes.

The utility model also provides a delivery system, comprising an implant and the delivery device as described above, the delivery device is used to deliver the implant, the implant has a loading length, the first The length of the tubular body is not shorter than the loaded length of the implant.

The delivery device and the delivery system provided by the utility model include a sheath tube, and the sheath tube includes a first tube body located at the far end and a second tube body located at the proximal end, wherein the Shore hardness of the first tube body is low Based on the Shore hardness of the second tube body. The sheath tube designed in this way has good flexibility due to the low Shore hardness of the first tube body, which ensures that the distal end of the sheath tube can easily pass through the tortuous blood vessel without causing damage to the blood vessel; also because the second tube body has high Shore hardness. It has good bending resistance, torsion and support, ensuring that the stent implant can be smoothly delivered to the designated lesion position.

Description of drawings

Fig. 1 is a schematic diagram of the overall structure of a conveying device according to an embodiment of the present invention;

Fig. 2 is a schematic cross-sectional structure diagram of the conveying device shown in Fig. 1;

Fig. 3 is an enlarged view of the partial structure of the conveying device shown in Fig. 2;

Fig. 4 is a schematic diagram of the sheath structure of the delivery device shown in Fig. 1;

FIG. 5 is a schematic diagram of the partial structure of the delivery device shown in FIG. 1 after it enters the curved blood vessel model.

Detailed ways

In order to better understand the technical solutions and beneficial effects of the utility model, the utility model will be further described in detail below in conjunction with specific examples. It should be understood that the following specific examples are only for explaining the utility model, but not limiting the utility model.

It should be understood that the delivery device of the present invention is applicable to various implants, such as stents, occluders, artificial heart valves, etc. For the convenience of understanding, the following specific examples only use stents as examples.

In the field of interventional medicine, the end closer to the operator is called the "proximal end" and the end farther away from the operator is called the "distal end".

As shown in FIGS. 1 to 3 , the delivery device 10 of this embodiment includes a tip 4 , a sheath core 3 , a push rod 2 , a sheath tube 1 , a front handle 5 , a rear handle 6 and a guide 7 . Wherein, the sheath core 3 is an elongated hollow tubular member. The distal end of the tip 4 is tapered, the proximal end is connected to the distal end of the sheath core 3 , and the tip 4 is provided with a through hole communicating with the interior of the sheath core 3 . The tip 4 communicates with the inside of the sheath core 3 to facilitate the passage of the guide wire, so as to establish a delivery path for subsequent stents. The push rod 2 is a tubular member sleeved on the outside of the sheath core 3, and is fixed relative to the sheath core 3. The distal end of the push rod 2 is farther from the tip 4 than the distal end of the sheath core 3 , that is, the distal end of the sheath core 3 is exposed outside the distal end of the push rod 2 .

The sheath tube 1 is hollow and long, sheathed outside the push rod 2 and can move axially relative to the push rod 2 . The outer diameter of the sheath tube 1 is equal to the outer diameter of the proximal end face of the tip head 4 . When the sheath 1 moves toward the distal end and the distal end touches the proximal end surface of the tip 4, an annular lumen is formed between the inner side of the sheath 1 and the outer side of the sheath core 3, which can accommodate implants. When the sheath tube 1 moves toward the proximal end again and the distal part is separated from the proximal end surface of the tip head 4, the annular lumen between the inner side of the sheath tube 1 and the outer side of the sheath core 3 disappears, and the implant placed therein can be freely freed.

Both the front handle 5 and the rear handle 6 are shells with inner chambers, and the rear handle 6 can move axially relative to the front handle 5 . The guide piece 7 is a straight rod with a guide groove, which is installed in the rear handle 6 , and the distal end of the guide piece 7 is connected with the front handle 5 , and the proximal end of the guide piece 7 protrudes from the proximal end of the rear handle 6 . The rear handle 6 can move axially along the guide groove of the guide member 7 . The proximal end of the sheath tube 1 passes through the lumen of the front handle 5 and is connected to the inside of the rear handle 6 , and can move synchronously with the rear handle 6 . The sheath core 3 and the push rod 2 all pass through the front handle 5, the rear handle 6 and the guide 7.

As shown in FIG. 4 , the sheath tube 1 includes a first tubular body 11 disposed at a distal end and a second tubular body 12 disposed at a proximal end. The proximal end of the first tube body 11 is connected to the distal end of the second tube body 12 , and the Shore hardness of the first tube body 11 is lower than that of the second tube body 12 . The lower the Shore hardness value, the softer the tube. The Shore hardness of the first pipe body 11 can be selected within the range of 25D-35D, and the Shore hardness of the second pipe body 12 can be selected within the range of 55D-72D. According to actual needs, the first tube body and the second tube body with different hardness can be selected for blood vessels with different degrees of curvature. Further, in order to ensure that the overall delivery device 10 has better pushing performance, the length of the first tube body 11 should be shorter than the length of the second tube body 12, and the outer diameter of the first tube body 11 is the same as that of the second tube body 12. of the same outer diameter.

The conveying system of the utility model includes a conveying device and an implant, and the conveying system is used for loading and conveying the implant. Usually, the implants that need to be delivered have been shaped and have certain elasticity, that is, the implants can be compressed and deformed under the constraints of external forces, and the implants will return to their original shape when the external forces are removed. When using the delivery device 10 of this embodiment to deliver the implant, it is necessary to compress the implant to a smaller size in advance, and the compressed length of the implant for delivery is called "loading length". In this embodiment, when the sheath tube 1 moves toward the distal end and the distal end touches the proximal end surface of the tip head 4, an annular lumen is formed between the inner side of the first tube body 11 and the outer side of the sheath core 3, and the implant It can be compressed into the annular inner cavity. In order to adapt to tortuous blood vessels, it is necessary to ensure that the compressed implant can be completely placed under the first tube body 11 , so the length of the first tube body 11 is preferably not shorter than the loading length of the implant.

The first pipe body 11 and the second pipe body 12 can be made of the same or different materials, as long as the Shore hardness of the first pipe body 11 is lower than that of the second pipe body 12 . Both the first pipe body 11 and the second pipe body 12 can be made of polymer pipes or composite pipes. Among them, the material of the polymer pipe can be PE, PP, Pebax and PTFE, etc., and the composite pipe is a pipe formed by thermal fusion of polymer material and metal mesh pipe or spring pipe.

It can be understood that, in other embodiments, the sheath tube may also include a plurality of first tube bodies and second tube bodies arranged at intervals, that is, a first tube body is provided at the distal end of the sheath tube, and a first tube body is provided at the proximal end of the sheath tube. A second tube body, at least one second tube body and a first tube body are arranged at intervals between the first tube body at the distal end and the second tube body at the proximal end. Furthermore, the Shore hardness of the multiple first tube bodies and/or the multiple second tube bodies can be the same or different, but it must be ensured that the Shore hardness of any first tube body is lower than that of any second tube body. Shore hardness of the tube body.

The sheath tube 1 of the delivery device 10 of this embodiment includes a first tubular body 11 disposed at the distal end and a second tubular body 12 disposed at the proximal end, wherein the Shore hardness of the first tubular body 11 is lower than that of the second tubular body. The Shore hardness of the body 12 makes the sheath tube 1 have different hardnesses along its length. The first tube body 11 is relatively soft and flexible, and the distal end of the delivery device 10 can easily pass through tortuous blood vessels without causing damage to the blood vessels. The second tube body 12 is relatively hard, and has good bending resistance, torsion resistance and support, which can ensure that the delivery device 10 can smoothly deliver the implant to the designated lesion position.

When using the delivery device 10 of this embodiment to deliver the implant, first hold the front handle 5, keep the sheath core 3, the push rod 2, and the tip 4 relatively fixed, and place the rear handle 6 along the guide groove of the guide member 7. Move toward the proximal end, thereby driving the sheath tube 1 to move toward the proximal end, so that the sheath core 3 is exposed. Then the implant is compressed outside the sheath core 3, at this time, the distal end of the push rod 2 is against the proximal end of the implant, and the proximal end of the tip 4 is against the distal end of the implant. Next, the rear handle 6 is moved to the distal end along the guide groove of the guide member 7, thereby driving the sheath tube 1 to move towards the distal end, and the implant is constrained in the annular lumen formed between the sheath tube 1 and the sheath core 3 . Finally, the delivery device 10 enters the body along the guide wire, and after reaching the target delivery position, the rear handle 6 is moved proximally along the guide groove of the guide member 7, and at the same time, the sheath tube 1 is driven to move towards the proximal end, and the sheath tube 1 is removed. After the implant is restrained, the implant expands and expands by its own elasticity, and the delivery device 10 is withdrawn to complete the implantation of the implant. Fig. 5 shows the schematic diagram of the structure after the distal end of the delivery device 10 of this embodiment enters the curved blood vessel model. It can be seen from the figure that the first tube body 11 is better adapted to the curved blood vessel, and the second tube body 12 plays a role Better support.

The above examples are preferred implementation modes of the present utility model, and are only for better explaining the technical solutions of the present utility model, and are not intended to limit the present utility model. Without departing from the concept of the utility model, those skilled in the art can simply modify and replace the corresponding technical features according to the teaching of the utility model, all of which are within the protection scope of the utility model.

Claims (8)

1. A delivery device comprising a hollow elongated sheath tube, characterized in that the sheath tube includes a first tubular body located at the distal end of the sheath tube and a tube connected to the proximal end of the first tubular body The second pipe body, the Shore hardness of the first pipe body is lower than the Shore hardness of the second pipe body. 2 . The delivery device according to claim 1 , wherein the Shore hardness of the first tube body is in the range of 25D to 35D, and the Shore hardness of the second tube body is in the range of 55D to 72D. 3. The delivery device according to claim 2, wherein the length of the first tube is shorter than the length of the second tube. 4. The delivery device according to claim 3, wherein the outer diameter of the first tube body is equal to the outer diameter of the second tube body. 5. The delivery device according to claim 4, characterized in that, the first tube body and/or the second tube body are made of polymer pipes or composite pipes. 6. The delivery device according to any one of claims 1 to 5, wherein the sheath comprises a plurality of first tubular bodies and a plurality of second tubular bodies arranged at intervals. 7. The delivery device according to claim 6, wherein the Shore hardness of any one of the plurality of first tube bodies is lower than the Shore hardness of any one of the plurality of second tube bodies. 8. A delivery system, comprising an implant and the delivery device according to claim 1, the delivery device is used to deliver the implant, the implant has a loading length, the The length of the first tube body is not shorter than the loading length of the implant.