Drug injection stent and drug injection thrombolytic system containing the same

Abstract

The present invention relates to the field of medical device technology, and discloses a drug injection stent and a drug injection thrombolytic system containing the same. The drug injection stent includes: a drug delivery tube, a radially elastically expandable stent body, and a thrombus filter; the stent body is fixed on the drug delivery tube, the stent body includes a plurality of elastic tubes forming a stent structure, the elastic tubes are connected to the drug delivery tube, and a plurality of drug injection holes are opened on the elastic tubes; the thrombus filter is fixed on the drug delivery tube and located at the distal end of the stent body. This embodiment releases the elastically expandable drug injection stent at the thrombus position, so that the drug injection stent is embedded in the thrombus and then the thrombolytic agent is sprayed, so that the thrombolytic agent acts on the thrombus directly, accurately, and over a large area, thereby improving the thrombolytic efficiency and saving thrombolytic agents and treatment time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a drug injection stent and a drug injection thrombolytic system comprising the same. Background Art

[0002] Pulmonary embolism is a common cardiovascular disease, often caused by the detachment of blood clots from deep vein thrombosis in the lower extremities. It has a high mortality rate and seriously endangers the health and quality of life of patients. Existing treatments for pulmonary embolism mainly include: drug anticoagulation therapy, systemic thrombolytic therapy, interventional local perfusion thrombolytic therapy, and traditional surgical treatment of pulmonary embolism. With the development of intravascular interventional therapy, interventional treatment of pulmonary embolism has become an effective and important treatment method. However, traditional catheter thrombolysis requires the thrombolytic catheter to be placed in the body for a long time, and requires the use of large doses of thrombolytic agents, which has low thrombolytic efficiency and wastes a lot of thrombolytic agents. Summary of the invention

[0003] The object of the present invention is to provide a drug injection stent and a drug injection thrombolytic system containing the same, by releasing an elastically expandable drug injection stent at the location of the thrombus, so that the drug injection stent is embedded in the thrombus and then the thrombolytic agent is sprayed, so that the thrombolytic agent acts directly, accurately and over a large area on the thrombus, thereby improving the thrombolytic efficiency and saving thrombolytic agents and treatment time.

[0004] In order to solve the above technical problems, the embodiment of the present invention provides a drug injection stent, comprising: a drug delivery tube, a radially elastically expandable stent body and a thrombus filter;

[0005] The support body is fixed on the drug delivery tube, and the support body includes a plurality of elastic tubes forming a support structure, the elastic tubes are connected with the drug delivery tube, and a plurality of drug injection holes are opened on the elastic tubes;

[0006] The thrombus filter is fixed on the drug delivery tube and is located at the distal end of the support body.

[0007] The embodiment of the present invention further provides a drug injection thrombolytic system, comprising: a delivery component, an external drug injection component and the drug injection stent as described above;

[0008] The drug delivery assembly includes a sheath tube and a delivery handle, wherein the sheath tube is fixedly connected to the delivery handle;

[0009] The drug injection bracket is received in the inner end of the sheath tube;

[0010] The external drug injection component includes a drug injection connector and a syringe. The drug delivery tube of the drug injection bracket is inserted into the drug delivery component. The outer end of the drug delivery tube is connected to the drug injection connector, and the drug injection connector is connected to the syringe.

[0011] The drug injection stent and the drug injection thrombolysis system including the same provided in the embodiment of the present invention include a stent body fixed on a drug delivery tube, the stent body includes a plurality of elastic tubes forming a stent structure, the elastic tubes are connected to the drug delivery tube, and a plurality of drug injection holes are opened on the elastic tubes. The drug injection thrombolysis system includes a delivery component and an external drug injection component, the delivery component includes a sheath tube for accommodating the drug injection stent and a delivery handle connected to the sheath tube, the external drug injection component includes a drug injection connector and a syringe, the drug delivery tube is passed through the delivery component and connected to the drug injection connector, and the drug injection connector is connected to the syringe. Therefore, the embodiment of the present invention can load the drug injection stent into the sheath, deliver the drug injection stent to the location of the thrombus through the delivery handle, and then withdraw the sheath through the delivery handle, so that the drug injection stent self-expands and expands at the location of the thrombus and then embeds into the thrombus. Then, the thrombolytic agent is injected into the drug injection stent through the syringe, so that the thrombolytic agent is accurately sprayed on the thrombus through the drug injection stent, thereby allowing the thrombolytic agent to act on the thrombus over a large area, thereby improving the thrombolytic efficiency and saving the amount of thrombolytic agent and treatment time.

[0012] As an embodiment, the stent body is a stent unit; and at least one end of each elastic tube of the stent body is connected to the drug delivery tube; or

[0013] The support body includes a plurality of support units, and the plurality of support units are arranged in parallel or staggered along the axial direction of the drug delivery tube.

[0014] As an embodiment, the injection holes are evenly distributed on the elastic tube;

[0015] The injection hole at each opening position is a single hole and / or a symmetrically distributed double hole.

[0016] As an embodiment, a side hole is formed on the drug delivery tube at the position of the stent body.

[0017] As an embodiment, a developing portion for indicating the position of the stent body is provided on the drug delivery tube at the position of the stent body.

[0018] As an embodiment, the elastic tube extends spirally along the axial direction of the drug delivery tube.

[0019] As an embodiment, the stent body is woven from elastic metal tubes or elastic polymer material tubes.

[0020] As an embodiment, the sheath tube is threadedly connected to the delivery handle, and the sheath tube is an elastic and shrinkable sheath tube; the diameter of the sheath tube when it is naturally opened is larger than the diameter of the inlet of the delivery handle.

[0021] As an embodiment, the system further comprises: a recovery handle;

[0022] The recovery handle is slidably connected to the delivery handle, the recovery handle is fixedly connected to the drug injection connector, and the drug delivery tube is passed through the recovery handle. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. It can be understood that the drawings in the following description are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0024] Figure 1 This is a schematic diagram of the structure of the drug injection stent according to an embodiment of the present application;

[0025] Figure 2 A schematic diagram of a partially enlarged structure of a stent body of a drug injection stent provided in an embodiment;

[0026] Figure 3 A schematic diagram of a drug injection state of a drug injection stent provided in an embodiment;

[0027] Figure 4 A schematic structural diagram of a bracket body provided in yet another embodiment;

[0028] Figure 5 A schematic structural diagram of a bracket body provided in yet another embodiment;

[0029] Figure 6 A schematic diagram of the three-dimensional structure of a thrombolytic injection system provided in an embodiment;

[0030] Figure 7 A schematic diagram of the structure of a thrombolytic injection system provided in one embodiment.

[0031] In the figure: a drug injection bracket 1, a drug delivery tube 10, a side hole 100, a bracket body 11, an elastic tube 110, a drug injection hole 111, a thrombus filter 12, a pointed tip 13, a developing part 14, a sheath 20, a delivery handle 21, a recovery handle 3, a drug injection connector 41, and a syringe 42. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, it can be understood by those skilled in the art that in the embodiments of the present invention, many technical details are provided to enable readers to better understand the present invention. However, even without these technical details and various changes and modifications based on the following embodiments, the technical scheme claimed in the present invention can be implemented.

[0033] The present application embodiment provides a drug-injected stent, which is suitable for the removal of pulmonary artery thrombosis, but is not limited thereto. The drug-injected stent of the present embodiment can also be used for the removal of thrombosis in blood vessels in other parts of the human body. Figures 1 to 3 As shown, the drug injection stent 1 comprises: a drug delivery tube 10, a radially elastically expandable stent body 11, and a thrombus filter 12. The stent body 11 is fixed on the drug delivery tube 10, and the stent body 11 comprises a plurality of elastic tubes 110 forming a stent structure, the elastic tubes 110 are connected to the drug delivery tube 10, and a plurality of drug injection holes 111 are opened on the elastic tubes 110, and the thrombus filter 12 is fixed on the drug delivery tube 10 and located at the distal end of the stent body 11.

[0034] The drug injection stent of the present embodiment includes a stent body arranged on a drug delivery tube, the stent body is formed of a plurality of elastic tubes to form a stent structure, a drug injection hole is provided on the elastic tube, and the elastic tube is connected to the drug delivery tube. A thrombus filter is also provided at the inner end of the stent body. The drug injection stent of the present embodiment can be used in conjunction with a delivery component and an external drug injection component. Before use, the drug injection stent can be accommodated in a sheath of the delivery component, and the drug delivery tube can pass through the sheath and the delivery handle, and be connected to the syringe through the drug injection component. When in use, the drug injection stent loaded in the sheath can be delivered to the thrombus position by operating the delivery handle, and then the sheath is withdrawn to release the drug injection stent, and the drug injection stent is embedded in the thrombus after self-expansion and expansion, and a thrombolytic agent is injected through a syringe, and the thrombolytic agent reaches the elastic tube of the drug injection stent through the drug delivery tube, and is sprayed into the thrombus through the drug injection hole on the elastic tube. Therefore, this embodiment allows the thrombolytic agent to act on the thrombus accurately and over a large area, thereby improving the thrombolytic efficiency. It is also beneficial to save the amount of agent used and the treatment time. The thrombus filter can effectively prevent small pieces of thrombus from escaping to the distal blood vessels.

[0035] Optionally, in this embodiment, the stent body 11 may be a stent unit, and at least one end of each elastic tube 110 of the stent body 11 is connected to the drug delivery tube 10. Figure 1 As shown, the main body of the stent unit is approximately cylindrical after being unfolded, surrounding and extending axially along the drug delivery tube 10, but it is not limited to this, and the stent unit can also be other shapes suitable for processing and injection.

[0036] Optionally, in this embodiment, the stent body 11 can be woven from an elastic metal tube or an elastic polymer material tube. However, it is not limited thereto, and the stent body 11 can also be prepared by 3D printing technology. Wherein, both ends of the elastic tube can be connected to the drug delivery tube or only one end of the elastic tube away from the thrombus filter is connected to the drug delivery tube. In this embodiment, if Figure 3 As shown, the end opening of the elastic tube 110 can be directly connected to the lumen of the drug delivery tube 10. However, it is not limited thereto, and the elastic tube can be connected to the drug delivery tube in any other suitable manner.

[0037] Furthermore, in the present embodiment, the elastic tube 110 extends in a spiral along the axial direction of the drug delivery tube 10, which not only facilitates the formation of a stable stent structure, but also facilitates the rapid and smooth flow of the drug in the elastic tube. However, it is not limited to this. In some examples, the stent body 11 may include: an elastic tube extending along the axial direction of the drug delivery tube 10 and an elastic tube surrounding the drug delivery tube 10, wherein the injection hole 111 may be provided on the axially extending elastic tube, while the part of the elastic tube surrounding the drug delivery tube may not have an injection hole. Optionally, in the present embodiment, the injection holes are evenly distributed on the elastic tube, wherein the injection holes at each opening position are single holes and / or symmetrically distributed double holes. For example, Figure 3 As shown, multiple positions on a single elastic tube 110 are uniformly provided with injection holes 111, and each position has an injection hole 111. However, it is not limited thereto. In some examples, each opening position of the elastic tube 110 can also symmetrically provide two injection holes, or the single-hole and double-hole injection holes can also be staggered on the elastic tube. Among them, when the injection hole is a single hole, all the injection holes can be provided on the same side of the elastic tube, or different injection holes can be distributed on different sides of the elastic tube, and no specific restrictions are made here. When two injection holes are symmetrically provided at the same position on the elastic tube 110, it can be avoided that the injection hole at that location is attached to the blood vessel wall and affects the uniformity of the injection. This embodiment does not limit the specific structure of the stent body, as long as the thrombolytic agent can act on the thrombus over a large area.

[0038] Based on the above embodiments, in some examples, the stent body 11 may further include a plurality of stent units, which are arranged in parallel along the axial direction of the drug delivery tube 10, or staggered along the axial direction of the drug delivery tube 10. Figure 4 As shown, the bracket body 11 may include two bracket units, and the two bracket units are arranged in parallel. Figure 5 As shown, the stent body 11 may include three stent units, and the three stent units are staggered along the axial direction of the drug delivery tube. By arranging multiple stent units, the flow path of the drug in the elastic tube can be significantly shortened, thereby facilitating the increase of the flow rate of the drug in the drug injection stent.

[0039] Optionally, in this embodiment, the thrombus filter 12 is disc-shaped, and the thrombus filter 12 can be made of an elastic metal tube or a medical polymer material thin tube. After the thrombus filter 12 expands and opens, it can adapt to the shape and size of the blood vessel. The mesh of the thrombus filter 12 can be a relatively fine rhombus or a mesh that is approximately rhombus-shaped, so that the thrombus that escapes during the thrombolytic agent thrombolysis can be effectively filtered and intercepted. It should be understood that this embodiment does not impose any specific restrictions on the mesh shape and size of the thrombus filter.

[0040] Optionally, in this embodiment, the drug injection bracket 1 may further include a pointed tip 13 disposed at the inner end of the drug delivery tube 10 .

[0041] Optionally, in this embodiment, a side hole 100 is further provided on the drug delivery tube 10 at the position of the stent body 11. The side hole 100 is a through hole connected to the lumen of the drug delivery tube 10, and the thrombolytic agent can be sprayed into the thrombus axis area through the side hole 100 of the drug delivery tube 10.

[0042] Optionally, in this embodiment, if Figure 1 As shown, a developing portion 14 for indicating the position of the stent body is also provided at the position of the stent body on the drug delivery tube 10. As an example but not limitation, the developing portion 14 can be an annular structure, so as to facilitate determining whether the stent body has accurately reached the thrombus position under an X-ray machine.

[0043] The drug-injected stent of this embodiment can automatically unfold and adapt to the shape and size of the blood vessel after being released at the location of the thrombus. The thrombolytic agent can be accurately sprayed onto the thrombus through the injection holes of the stent body and the side holes of the drug delivery tube, thereby directly acting on the thrombus over a large area. A smaller dose of the agent can be used in a shorter time to effectively dissolve and clear the thrombus, thereby reducing the operation time and avoiding the risk of massive bleeding.

[0044] The embodiment of the present application also provides a drug injection thrombolytic system, which can be used for interventional thrombolytic treatment of pulmonary embolism to dredge the pulmonary artery blood vessels and restore smooth blood flow. The system includes: a delivery component, an external drug injection component, and a drug injection bracket 1 as described in the above embodiment, the drug delivery component includes a sheath 20 and a delivery handle 21, the sheath 20 is fixedly connected to the delivery handle 21, the drug injection bracket 1 can be received in the inner end of the sheath 20, the external drug injection component includes a drug injection connector 41 and a syringe 42, the drug delivery tube 10 of the drug injection bracket 1 is inserted into the delivery component, the outer end of the drug delivery tube 10 is connected to the drug injection connector 41, and the drug injection connector is connected to the syringe 42.

[0045] Optionally, in this embodiment, the sheath 20 is threadedly connected to the delivery handle 21, and the sheath 20 is an elastic and shrinkable sheath 21, and the caliber of the sheath when it is naturally opened is larger than the diameter of the inlet of the delivery handle. When loading the drug injection stent 1, the sheath 20 and the delivery handle 21 can be separated. At this time, the caliber of the sheath in a natural state is larger, which is convenient for loading the drug injection stent 1. After the drug injection stent 1 is loaded, the sheath 20 is screwed into the delivery handle 21. Since the diameter of the inlet of the delivery handle 21 is smaller, the caliber of the sheath 20 will gradually become thinner as the length of the sheath screwed into the delivery handle 21 increases, and the caliber of the end of the sheath 20 that accommodates the drug injection stent 1 will also become thinner accordingly. Figure 5As shown, the loading position of the drug injection stent 1 in the sheath 20 is the black tube section at the inner end of the sheath. When in use, the sheath 20 is driven to slide in the axial direction by the delivery handle 21. After the drug injection stent 1 reaches the thrombus position, part of the sheath section is screwed out of the delivery sheath 21. At this time, the caliber of the sheath 20 will automatically become thicker, and then the delivery handle 21 can be pulled back. The sheath 20 will release the drug injection stent 1 therein after the delivery handle 21 retreats. This embodiment controls the thickness of the sheath caliber through the delivery handle, making it more convenient to load and release the drug injection stent 1. However, it is not limited to this. In some examples, the sheath 20 can also be made into an integral part with the delivery handle 21.

[0046] Optionally, the system may further include: a recovery handle 3, the recovery handle 3 is slidably connected to the delivery handle 21, the recovery handle 3 is fixedly connected to the injection connector 41, and the drug delivery tube 10 is passed through the recovery handle 3. The drug delivery tube 10 establishes a drug delivery channel with the syringe 42 through the injection connector 41. This embodiment does not specifically limit the structure of the injection connector, and any connector structure that can connect the drug delivery tube and the syringe belongs to the protection scope of the present invention.

[0047] In conjunction with the accompanying drawings, the method and steps of using the thrombolytic injection system of the embodiment of the present application are as follows:

[0048] In the minimally invasive interventional surgical treatment for pulmonary embolism to clear thrombus, an instrument intervention channel is established in the femoral vein through a puncture needle, a guide wire, a catheter and a puncture sheath. A catheter is introduced into the central pulmonary artery through the intravascular interventional channel technology, and then selective main pulmonary artery angiography is performed to determine the vascular location of the pulmonary artery thrombus. The angiography catheter is replaced with a guide wire (the guide wire is introduced and then withdrawn from the catheter). The sheath tube 20 loaded with the drug injection stent 1 of the present invention is transported along the guide wire to the location of the pulmonary artery thrombus, and under an X-ray machine, the position of the stent body 11 is confirmed to be at the thrombus by the developing performance of the stent body and the developing part. The transport handle 21 can be operated to adjust the position of the stent body 11 so that it completely covers the thrombus. After determining that the drug injection stent is in place, hold the recovery handle 3, and withdraw the transport handle 21 so that the drug injection stent 1 is released and then expanded. The thrombolytic agent is injected into the injection connector 41 through a syringe. Since the injection connector 41 is connected to the drug delivery tube and the injection bracket 1, the thrombolytic agent that reaches the injection bracket 1 can be accurately sprayed from the injection hole of the injection bracket 1 and the side hole of the drug delivery tube and act on the thrombus. The thrombolytic agent can promote fibrinolysis and dissolve the thrombus. During the thrombolysis process, the clotted thrombus may fall off due to the action of blood flow and thrombolytic agent. At this time, the thrombus filter can filter and intercept the clotted thrombus to prevent the detached thrombus from escaping. After the thrombolysis is completed, the injection bracket 1 and the thrombus filter 12 are recovered into the sheath tube 20 by holding the delivery handle and pulling the recovery handle, and then withdrawn from the body.

[0049] The thrombolytic injection system of this embodiment can accurately spray the thrombolytic agent onto the thrombus, thereby directly acting on the thrombus over a large area. A smaller dose of the agent can be used in a shorter time to effectively dissolve and clear the thrombus, thereby reducing the operation time and avoiding the risk of massive bleeding.

[0050] Although this article only describes the use of the drug injection bracket in combination with a syringe, it should be understood that the drug injection bracket disclosed in the embodiment of the present application can also be used in combination with other suitable drug injection devices.

[0051] Those skilled in the art will appreciate that the above-mentioned embodiments are specific examples for implementing the present invention, and in actual applications, various changes may be made thereto in form and detail without departing from the spirit and scope of the present invention.

Claims

1. A drug injection stent, characterized in that: include: A drug delivery tube, a radially elastically expandable stent body, and a thrombus filter; The support body is fixed on the drug delivery tube, and the support body includes a plurality of elastic tubes forming a support structure, the elastic tubes are connected to the drug delivery tube, at least one end of each elastic tube of the support body is connected to the drug delivery tube, and a plurality of drug injection holes are opened on the elastic tube; The thrombus filter is fixed on the drug delivery tube and is located at the distal end of the stent body; The support body is a support unit; or The support body includes a plurality of support units, and the plurality of support units are arranged in parallel or staggered along the axial direction of the drug delivery tube.

2. The drug injection stent according to claim 1, characterized in that: The injection holes are evenly distributed on the elastic tube; The injection hole at each opening position is a single hole and / or a symmetrically distributed double hole.

3. The drug injection stent according to claim 1, characterized in that: A side hole is provided on the drug delivery tube at the position of the support body.

4. The drug injection stent according to claim 1, characterized in that: A developing portion for indicating the position of the stent body is provided on the drug delivery tube at the position of the stent body.

5. The drug injection stent according to claim 1, characterized in that: The elastic tube spirally extends along the axial direction of the drug delivery tube.

6. The drug injection stent according to claim 1, characterized in that: The support body is woven from elastic metal tubes or elastic polymer material tubes.

7. A drug injection thrombolytic system, characterized in that: include: A delivery component, an external drug injection component, and a drug injection bracket as claimed in any one of claims 1 to 6; The delivery assembly comprises a sheath tube and a delivery handle, wherein the sheath tube is fixedly connected to the delivery handle; The drug injection bracket is received in the inner end of the sheath tube; The external drug injection component includes a drug injection connector and a syringe. The drug delivery tube of the drug injection bracket is inserted into the delivery component. The outer end of the drug delivery tube is connected to the drug injection connector, and the drug injection connector is connected to the syringe.

8. The drug injection thrombolytic system according to claim 7, characterized in that: The sheath tube is threadedly connected to the delivery handle, and the sheath tube is an elastic and contractible sheath tube; the diameter of the sheath tube when it is naturally opened is larger than the diameter of the inlet of the delivery handle.

9. The drug injection thrombolytic system according to claim 7, characterized in that: The system also includes: a recovery handle; The recovery handle is slidably connected to the delivery handle, the recovery handle is fixedly connected to the drug injection connector, and the drug delivery tube is passed through the recovery handle.

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