CN109316269B

CN109316269B - Transport protection piece and transport subassembly

Info

Publication number: CN109316269B
Application number: CN201711039528.XA
Authority: CN
Inventors: 张瑞岩; 傅堃; 徐荣; 张楚楚
Original assignee: Enmai Shanghai Medical Technology Co ltd
Current assignee: Sano Shenchang Medical Technology Co.,Ltd.
Priority date: 2017-08-01
Filing date: 2017-10-30
Publication date: 2021-06-22
Anticipated expiration: 2037-10-30
Also published as: CN109316269A

Abstract

The invention discloses a conveying protection piece and a conveying assembly. The transportation protection member includes: the far-end sleeve comprises a side wall and a through hole which is surrounded by the side wall and is used for loading a therapeutic substance, the through hole comprises a first opening and a second opening, the first opening and the second opening are axially opposite, the therapeutic substance penetrates through the through hole, and a developing piece is arranged on the side wall; the first guide wire is fixedly connected to the side wall, and extends towards one side of the distal sleeve far away from the second opening direction; the first opening is configured for passage of a treatment into the through-hole; or a third opening for the therapeutic substance to penetrate into the through hole is arranged on the side wall. One problem to be solved by the present invention is that the treatment is delivered into the body without any protective measures.

Description

Transport protection piece and transport subassembly

Technical Field

The present invention relates to the field of medical devices, and more particularly, to a delivery protector and delivery assembly.

Background

Percutaneous coronary operation (PCI) is a technique for improving and reconstructing coronary blood flow by delivering a balloon, stent or other related therapeutic substances by percutaneous puncture technique to relieve coronary stenosis or infarction. A medical professional typically transports a treatment substance, such as a drug balloon or stent, from the radial artery or femoral artery into the occluded blood vessel of the heart using a guidewire.

The drug balloon is conveyed into a narrow or blocked blood vessel, the narrow or blocked blood vessel in the coronary artery can be expanded, and the drug on the surface of the balloon falls off and adheres to the surface of the inner wall of the blood vessel in the expanding process, so that the treatment purpose is achieved.

Stents are delivered into stenotic or occluded blood vessels, enabling the vessel to be dilated. The existing mainstream stent is a drug stent, but a degradable stent is an important direction in the future.

At present, when a treatment object such as a stent or a drug balloon is directly conveyed into a body in a PCI operation, the outer surface of the treatment object such as the stent or the drug balloon is not provided with any protective measures. There is no prior art for the protection of degradable stents and drug stents. Aiming at the drug balloon, the prior art only carries out self drug protection on the folding balloon.

Therefore, the PCI surgery directly delivers the therapeutic substance into the body, and has the following defects: (1) the problem of drug loss exists in the process of transporting the drug balloon and the drug stent in vivo; (2) the drug stent and the degradable stent are easy to rub with the vessel wall in the conveying process, so that the stent is unloaded; (3) when the stent passes through complex lesion areas such as tortuosity and calcification, the stent can cause damage to the vessel wall, and meanwhile, drugs on the surface of the stent can be damaged. (4) When the medicine saccule passes through calcification lesion, the medicine saccule is easy to damage.

Therefore, there is a need for improvement of a method and a device for delivering a therapeutic material in an interventional treatment such as a percutaneous coronary operation.

Disclosure of Invention

It is an object of the present invention to provide a new solution for transporting protectors and transport assemblies.

According to a first aspect of the invention, a shipping protector is provided. The transportation protection member includes: the far-end sleeve comprises a side wall and a through hole which is surrounded by the side wall and is used for loading a therapeutic substance, the through hole comprises a first opening and a second opening, the first opening and the second opening are axially opposite, the therapeutic substance penetrates through the through hole, and a developing piece is arranged on the side wall; the first guide wire is fixedly connected to the side wall, and extends towards one side of the distal sleeve far away from the second opening direction; the first opening is configured for passage of a treatment into the through-hole; or a third opening for the therapeutic substance to penetrate into the through hole is arranged on the side wall.

Optionally, be equipped with on the lateral wall and be used for letting the treatment penetrate to the third opening in the through-hole, the third opening with the through-hole switches on, the through-hole is including the first portion that is located one end and adjacent to the second portion of first portion, the internal diameter of second portion is greater than the internal diameter of first portion, the second portion has the loading space that is used for loading the treatment, the third opening is followed distal end sheathed tube axial extension sets up, the one end of third opening and second portion directly switch on, the other end extends to towards the direction of first portion the terminal surface of lateral wall.

Optionally, the third opening includes a first through hole directly communicating with the second portion and a second through hole extending from the first through hole to the end surface of the side wall.

Optionally, an extension extending axially outward is provided on a side surface of the sidewall facing the first opening direction, and the first guide wire is connected to the sidewall and/or the extension.

Optionally, the distal sleeve comprises a loading body and a head at one end of the loading body, the outer diameter of the head becomes smaller in a direction away from the body, and the second opening is located on the head.

Optionally, the softness of the head material is less than the softness of the body material.

Optionally, the head is tapered; alternatively, the head is spherical.

Optionally, an inner diameter of the second opening is configured to be smaller than an outer diameter of the treatment.

Optionally, the distal sleeve includes a sleeve base and a stiffener bonded to the sleeve base.

Optionally, the reinforcing rib is a linear structure extending along the axial direction of the distal sleeve, the number of the reinforcing ribs is multiple, and the plurality of reinforcing ribs are distributed at intervals along the circumferential direction of the distal sleeve; or the reinforcing rib is of a spiral structure extending along the axial direction of the distal sleeve.

Optionally, the material of the cannula base body comprises a medical polymer material and/or a metal material.

Optionally, the material of the reinforcing rib comprises a medical polymer material or a metal material.

Optionally, the medical polymer material includes one or more of Pebax, Nylon, PTFE, ETFE, FEP, PET, PEEK, and TPU.

Optionally, the metallic material comprises one or more of stainless steel, nitinol, titanium alloy, cobalt chromium alloy.

Optionally, the material of the first guide wire comprises a metal material and/or a medical polymer material.

Optionally, the medical polymer material includes one or more of Pebax, Nylon, PTFE, ETFE, FEP, PET, PEEK.

Optionally, etching and roughening the inner surface of the through hole; or, carrying out chemical roughening treatment on the inner surface of the through hole; or, a coarsening coating is coated on the inner surface of the through hole.

Optionally, the first guide wire is circular, annular, sheet-like, or thin film.

Optionally, a polymer material with high impact strength and low friction coefficient is coated on the outer surface of the first guide wire.

Optionally, a silicon coating or hydrophilic-based coating is coated on the outer surface of the distal sleeve and/or the first guidewire.

Optionally, the protective sleeve further comprises a handle connected to a surface of the first guide wire on a side away from the distal end of the sleeve.

Optionally, the developer includes one or more of a metal developer ring, a plastic developer ring, a spray developer, a developer added to the distal cannula material.

Optionally, one or more of the visualization members are disposed at both ends of the distal cannula; alternatively, one or more of the visualization elements may be provided at only one of the ends of the distal cannula.

According to a second aspect of the present invention, an interventional therapy method is provided. The interventional therapy method comprises the following steps: providing the transportation protection piece, the guide catheter, the second guide wire and the treatment object connected with the second guide wire, and delivering the treatment object into the guide catheter; loading a therapeutic substance into the through-hole of the distal cannula; pushing the first guide wire and/or the second guide wire, and pushing the distal sleeve and the treatment object into the guide catheter; under X-ray fluoroscopy, the far-end sleeve and the treatment object are pushed through the far end of the guide catheter, the far-end sleeve enters the blood vessel, and the position of the far-end sleeve is observed through the developing piece; the distal cannula and treatment reach the target location within the blood vessel and the treatment exits through the second opening.

Optionally, fixing the second guide wire, and pulling back the first guide wire to enable the therapeutic substance to pass out of the second opening; alternatively, the first guidewire is secured and the second guidewire is advanced to cause the treatment to exit the second opening.

Optionally, the therapeutic substance comprises a drug balloon, a drug stent or a degradable stent, and the therapeutic substance is threaded out of the second opening and then struts the blood vessel to complete interventional therapy.

According to a third aspect of the invention, a transport assembly is provided. The transport assembly includes: the above-mentioned transportation protection member; and a treatment object connected with a second guide wire, wherein the treatment object is configured to penetrate into the through hole through the first opening or the third opening, and the second guide wire extends towards one side of the side wall far away from the second opening.

The inventor of the present invention has found that in the conventional interventional treatment such as percutaneous coronary operation, a treatment object such as a stent or a drug balloon is directly delivered into the body, and the outer surface of the treatment object such as the stent or the drug balloon is not protected at all. In the interventional therapy method, the therapeutic substances are easy to damage, lose and unload, so that the surgical risk is increased; the vessel wall is susceptible to damage caused by friction with the treatment. Therefore, the technical task to be achieved or the technical problems to be solved by the present invention are never thought or anticipated by those skilled in the art, and therefore the present invention is a new technical solution.

According to one embodiment of the present disclosure, a treatment can be passed into the through-hole through the first opening or the third opening on the distal cannula and loaded into the through-hole. The distal sleeve is connected with a first guide wire, and the first guide wire can push and pull the distal sleeve.

The therapeutic substance is conveyed by the protective conveying piece and is positioned in the through hole of the distal sleeve, so that the loss of the drug in the conveying process can be reduced, and more drug acts on a focus area. The support can be protected from unloading due to scratch, and the operation risk is reduced. Can reduce the friction of treatments such as sacculus or support and vascular wall in transportation process for the operation is more smooth, can also protect the vascular wall to receive the damage simultaneously.

In interventional therapy, a therapeutic object connected with a second guide wire is loaded into the through hole of the distal sleeve, and the distal sleeve and the therapeutic object can be pushed to a target position by pushing the first guide wire and/or the second guide wire.

The first guide wire is connected with the distal sleeve, the second guide wire is connected with the treatment object, and the treatment object can pass through the second opening through the relative movement between the first guide wire and the second guide wire to finish the corresponding treatment.

Other features of the present invention and advantages thereof will become apparent from the following detailed description of exemplary embodiments thereof, which proceeds with reference to the accompanying drawings.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention.

FIG. 1 is a schematic view of a shipping protector provided in one embodiment of the present invention;

FIG. 2 is a schematic view of a shipping protector provided in one embodiment of the present invention;

FIG. 3 is a schematic structural view of a distal cannula provided in one embodiment of the present invention;

FIG. 4 is a schematic structural view of a distal cannula provided in one embodiment of the present invention;

FIG. 5 is a schematic view of a shipping protector according to one embodiment of the present invention;

FIG. 6 is a schematic view of a shipping protector constructed in accordance with one embodiment of the present invention;

FIG. 7 is an assembled schematic view of a shipping assembly provided in one embodiment of the present invention;

FIG. 8 is an enlarged schematic view at A in FIG. 7;

fig. 9 is a schematic illustration of an interventional procedure provided in one embodiment of the invention.

Wherein, 1: a distal cannula; 10: a side wall; 100: a loading main body part; 1000: a sleeve substrate; 1001: reinforcing ribs; 101: a head portion; 102: a third opening; 1020: a first perforation; 1021: a second perforation; 11: a through hole; 110: a first opening; 111: a second opening; 112: a first part; 113: a second section; 12: an extension portion; 2: a first guide wire; 3: a handle; 4: a second guide wire; 5: a therapeutic agent.

Detailed Description

Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be noted that: the relative arrangement of the components and steps, the numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless specifically stated otherwise.

The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses.

Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate.

In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.

According to one embodiment of the invention, a shipping protector is provided. The delivery protector can protect a drug balloon, drug stent, degradable stent or other treatment during an interventional procedure. In particular, the delivery protector can protect a treatment in a percutaneous coronary intervention, a peripheral intervention, an intracranial intervention, or other operations.

Referring to fig. 1, the delivery guard comprises a distal cannula 1 and a first guide wire 2. The distal cannula 1 comprises a side wall 10 and a through hole 11 enclosed by the side wall 10. The through hole 11 has a loading space for loading the treatment object. During the interventional therapy, a treatment object can be loaded in the loading space of the through hole 11.

The through-hole 11 includes a first opening 110 at one end and a second opening 111 at the other end. The first opening 110 and the second opening 111 are arranged opposite to each other in the axial direction (z-axis) of the distal cannula 1.

A visualization member is provided on the sidewall 10 to facilitate visualization of the position of the distal cannula 1 during the interventional procedure.

Preferably, the developing member comprises one or more of a metal developing ring, a plastic developing ring, a spray developer, and a developer added to the material of the distal end sleeve 1.

Optionally, one or more of the developing members are disposed at both ends of the distal cannula 1;

optionally, one or more of the visualization elements are provided at only one of the ends of the distal cannula 1.

Alternatively, the developing member may be disposed around the side wall 10 in the circumferential direction of the distal cannula 1.

The first guide wire 2 is fixedly connected to the side wall 10. The first guide wire 2 extends out to the side of the distal sleeve 1 away from the second opening 111. In this way, the distal sleeve 1 can be pushed or pulled back by the first guide wire 2.

The first guide wire 2 can have a certain ability to resist breaking and twisting, while also obtaining a certain compliance and elasticity.

The shape of the first guide wire 2 may be various. For example, the first guidewire 2 may be circular, annular, rod-like, sheet-like, thin film, or other shape.

The connection between the distal cannula 1 and the first guide wire 2 can be varied. For example, the distal sleeve 1 and the first guide wire 2 may be fixedly connected together by heat sealing, adhesion, welding or other means.

The treatment object needs to penetrate into the through hole 11 of the distal cannula 1.

In one embodiment, referring to fig. 5 and 6, a third opening 102 is formed on the sidewall 10. The third opening 102 communicates with the through hole 11. The therapeutic material 5 penetrates into the through hole 11 through the third opening 102.

In this embodiment, referring to fig. 8, the through hole 11 includes at least a first portion 112 at one end and a second portion 113 adjacent to the first portion 112. The inner diameter d2 of second portion 113 is greater than the inner diameter d1 of first portion 112. Specifically, the inner diameter d2 of the second portion 113 can be larger than or equal to the outer diameter of the filled treatment substance, and the inner diameter d1 of the first portion 112 can be smaller than the outer diameter of the filled treatment substance, thereby stopping the treatment substance from entering. The third opening 102 is arranged along the axial extension of the distal cannula 1. One end of the third opening 102 is directly connected to the second portion 113. The other end of the third opening 102 extends through the end surface of the side wall 10 in the direction of the first portion 112.

The second portion 113 has a loading space for loading the treatment object 5, and the treatment object 5 enters the loading space through the third opening 102.

In a specific operation method of this embodiment, referring to fig. 7, a second guide wire 4 is connected to the treatment object 5, and the second guide wire 4 extends out toward one side of the treatment object 5. The treatment object 5 penetrates into the first portion 112 of the through hole 11 through the third opening 102. Since the other end of the third opening 102 penetrates and extends to the end surface of the side wall 10, the second guide wire 4 can also be inserted into the second portion 113 of the through hole 11 through the third opening 102.

In this embodiment, referring to fig. 7 and 8, the third opening 102 may include a first through hole 1020 directly connected to the second portion 113 and a second through hole 1021 extending from the first through hole 1020 to an end surface of the sidewall 10. Treatment 5 may enter into the first portion 112 through the first perforation 1020. A second guide wire 4 on the treatment 5 can be threaded through the second perforation 1021 into the second portion 113.

A second guide wire 4 on the treatment 5 passes through the second perforation 1021 into the second portion 113. Preferably, the length of the second portion 113 can be set longer, so as to ensure a higher coaxiality between the distal sleeve 1 and the second guide wire 4.

The specific shape of the first through hole 1020 and the second through hole 1021 may be various.

For example, as shown in fig. 5 and 8, the third opening 102 is approximately L-shaped. The first through-hole 1020 is approximately square. The second through hole 1021 is in a long strip shape.

For example, as shown in fig. 6, the first perforations 1020 are circular. The second through hole 1021 is in a long strip shape.

In another embodiment, referring to fig. 1, a therapeutic substance is inserted into the through hole 11 through the first opening 110.

In this embodiment, the inner diameter of the first opening 110 may be slightly larger than the outer diameter of the treatment. The treatment substance enters directly into said through hole 11.

In this embodiment, the inner diameter of the first opening 110 can also be smaller than the outer diameter of the treatment. The through hole 11 includes a small diameter portion facing the first opening 110 and a large diameter portion facing the second opening 111. The first opening 110 is located on the small diameter portion. The inner diameter of the large-diameter part is larger than or equal to the outer diameter of the treatment object so as to load the treatment object. The treatment passes through the first opening 110 to the large diameter portion, after which a certain stop can be provided for the treatment in the large diameter portion. Preferably, the small diameter portion may be made of a flexible material to facilitate passage of the treatment.

In one particular method of operation, the treatment may be advanced from the minor diameter portion to the major diameter portion. After the treatment object penetrates into the large-diameter part, the small-diameter part can stop one side surface of the treatment object.

In the above two embodiments, the first guide wire 2 can maintain a high degree of coaxiality with the distal cannula 1 in order to push and pull the distal cannula 1 better. Preferably, referring to fig. 3 and 6, an extension 12 extending outward in the axial direction may be provided on a side surface of the sidewall 10 facing the first opening 110. The extension 12 is connected to the first guide wire 2. In this way, the first guide wire 2 can maintain a high degree of coaxiality with the distal cannula 1.

The extension 12 may match the shape of the second guide wire 2. For example, the extension 12 may be curved or flat or otherwise shaped. For example, the extension 12 may be semi-circular in shape.

The treatment passes out of the second opening 111. To reduce damage to the vessel wall and to reduce resistance to advancement, the distal cannula 1 may preferably include a loading body portion 100 and a head portion 101 at one end of the loading body portion 100, as shown in fig. 5 and 6. The outer diameter of the head portion 101 becomes smaller in a direction away from the body portion 100. The second opening 111 is located on the head 101.

Further, the head 101 may be tapered. For example, the taper may be formed by a right angle inversion at one end of the distal cannula 1.

Further, the head 101 may be spherical. For example, the spherical shape may be formed by rounding off the end of the distal sleeve 1.

During the delivery of the treatment object, if the operation is wrong, the treatment object may pass through the second opening 111 before reaching the target position. Further, referring to fig. 2, the inner diameter of the second opening 111 may be slightly smaller than the outer diameter of the treatment. For example, the inner diameter of the second opening 111 can be made slightly smaller than the outer diameter of the treatment by regulating the tolerance fit between the inner diameter of the second opening 111 and the outer diameter of the treatment. In this way, the second opening 111 can provide a certain stop for the treatment substance. At the same time, after a certain pushing force is applied to the treatment substance, the treatment substance can still pass through the second opening 111.

Referring to fig. 7, a treatment 5 with a second guide wire 4 attached thereto may be loaded into the distal sleeve 1 in the direction of the arrow. After the treatment object 5 is transported to the target location, the treatment object 5 is passed out of the second perforation 1021.

There are various ways in which the treatment 5 passes out of the second perforations 1021.

In one particular method of operation, the treatment 5 is secured by securing the second guidewire 4. The first guide wire 2 is pulled back and the distal sleeve 1 is moved backwards. The treatment 5 passes out of the second opening 111.

In another specific method of operation, the distal cannula 1 is fixed by fixing the first guide wire 2. By advancing the second guidewire 4, the treatment 5 is pushed out of the second opening 111.

To further reduce damage to the vessel wall and reduce resistance to advancement, the head portion 101 may be formed of a material having a softness less than that of the body portion 100. The head 101 is made of a softer material, and the treatment object can easily pass through the second opening 111.

Preferably, referring to fig. 3 and 4, the distal cannula 1 may include a cannula base 1000 and a reinforcing rib 1001 coupled to the tubular base 1000. The cannula base 1000 may be a tubular structure. For example, the reinforcing ribs 1001 may be protrusions provided on an inner ring surface or an outer ring surface of the sleeve base 1000. For another example, the rib 1001 may be a recess provided on the inner ring surface or the outer ring surface of the sleeve base 1000.

The reinforcing ribs 1001 can prevent the distal sleeve 1 from being deformed under force to damage the internally loaded treatment 5.

The reinforcing ribs 1001 prevent the distal cannula 1 from tensile fracture in the axial direction.

By selecting the material of which the ribs 1001 are made, the roughness of the inner or outer surface of the distal cannula 1 can be improved to adjust the amount of friction.

The specific structure of the reinforcing rib 1001 may be various as long as it can prevent the distal cannula 1 from being deformed by a force.

Alternatively, referring to fig. 3, the reinforcing ribs 1001 are linear structures extending in the axial direction of the distal cannula 1. The number of the reinforcing ribs 1001 is plural, and the plurality of the reinforcing ribs 1001 are distributed at intervals in the circumferential direction of the tubular body.

Alternatively, referring to fig. 4, the reinforcing ribs 1001 are a spiral structure extending in the axial direction of the distal cannula 1. The helical reinforcing ribs 1001 preferably prevent the distal sleeve 1 from being deformed by force.

Of course, the ribs 1001 may have other curved structures. The ribs 1001 may also be folded or otherwise configured. It should be noted that, when the distal cannula 1 includes the main body portion 100 and the head portion 101, the reinforcing ribs 1001 may be provided only on the main body portion 100.

The sleeve base 1000 may be integrally formed with the reinforcing bar 1001. The sleeve base 1000 and the reinforcing rib 1001 may be made of the same material.

The sleeve base 1000 may be molded separately from the reinforcing bar 1001, and then the sleeve base 1000 and the reinforcing bar 1001 are assembled together. The sleeve base 1000 and the reinforcing rib 1001 may be made of different materials. The manner of assembling and connecting the sleeve base 1000 and the reinforcing rib 1001 may adopt the prior art, and will not be described herein.

The material of the sleeve base 1000 may be one or more composite.

In one example, the cannula base 1000 may be made of a material that includes a medical grade polymer material. For example, the medical polymer material may include one or more of Pebax (Nylon elastomer), Nylon (Nylon), PTFE (polytetrafluoroethylene), ETFE (ethylene-tetrafluoroethylene copolymer), FEP (fluorinated ethylene propylene copolymer), PET (polyethylene terephthalate), PEEK (polyether ether ketone).

In one example, the material of the sleeve base 1000 may include a metallic material. For example, the metallic material may include one or more of stainless steel, nickel titanium alloy, cobalt chromium alloy.

In this embodiment, a portion of the cannula base 1000 between two adjacent reinforcing ribs 1001 may be filled with a medical polymer material. For example, the medical polymer material may include one or more of Pebax, Nylon, PTFE, ETFE, FEP, PET, PEEK, TPU (thermoplastic polyurethane elastomer rubber).

The material of the cannula base 1000 may include both medical polymer material and metal material.

The material of the reinforcing bar 1001 may have one or more of composite materials.

In one example, the material of the stiffener 1001 may include a medical polymer material. For example, the medical polymer material may include one or more of Pebax, Nylon, PTFE, ETFE, FEP, PET, PEEK, TPU (thermoplastic polyurethane elastomer rubber).

In one example, the material of the stiffener 1001 may include a metal material. For example, the metallic material may include one or more of stainless steel, nickel titanium alloy, cobalt chromium alloy.

The first guide wire 2 can have a certain ability to resist breaking and twisting, while also obtaining a certain compliance and elasticity. The material of the first guide wire 2 may have one or more composites.

In one example, the material of the first guide wire 2 may include a metal material. For example, the metal material may include 304, 304L, 316, 316L, etc. stainless steel. For example, the metal material may include other metals. For example, the metallic material may include a metal alloy.

In one example, the material of the first guide wire 2 may include a medical polymer material. For example, the medical polymer material may include one or more of Pebax, Nylon, PTFE, ETFE, FEP, PET, PEEK.

Of course, the material of the first guide wire 2 may be a composite of a medical polymer material and a metal material.

The treatment substance is loaded in the through hole 11. The treatment object can be well loaded by the friction between the inner surface of the through hole 11 and the treatment object. The inner surface of the through hole 11 can be roughened correspondingly.

In one example, an etching process may be performed on the inner surface of the through hole 11 to roughen the inner surface of the through hole 11. For example, physical impact may be performed on the inner surface of the through-hole 11. For example, the surface of the through hole 11 may be etched to form a depression.

In one example, a chemical treatment may be performed on the inner surface of the through-hole 11 to roughen the inner surface of the through-hole 11. For example, the inner surface of the through hole 11 may be electroless plated.

In one example, a coating may be applied to the inner surface of the through-hole 11 to roughen the inner surface of the through-hole 11.

In order to increase the strength of the first guide wire 2 and reduce the friction between the first guide wire and the inner wall of the blood vessel, it is preferable that a polymer material with high impact resistance and low friction coefficient is coated on the outer surface of the first guide wire 2. For example, the polymer material may include polyethylene or the like.

To reduce the friction between the delivery protector and the inner wall of the vessel, the distal sleeve 1 may be coated on its outer surface with a silicon or hydrophilic based coating. Alternatively, the outer surface of the first guide wire 2 may be coated with a silicon coating or a hydrophilic base coating. Alternatively, both the distal sleeve 1 and the first guide wire 2 may be coated with a silicon coating or a hydrophilic base coating on their outer surfaces.

To facilitate the restraining and handling of the first guide wire 2, the protective sleeve may further comprise a handle 3, preferably with reference to fig. 2. The handle 3 is connected to a surface of one side of the first guide wire 2 far away from the distal sleeve 1.

According to another embodiment of the present invention, there is also provided an interventional therapy method. The interventional therapy method can be peripheral interventional operation, intracranial interventional operation or other interventional operation of percutaneous coronary artery interventional operation.

Referring to fig. 9, the interventional therapy method includes the steps of:

referring to fig. 1 to 8, the above described delivery protector, guide catheter and treatment 5 with attached second guide wire 4 are provided. The guiding catheter is delivered into the body to provide an operation platform for subsequent operations. The arrangement of the guiding catheter and the puncturing method can be implemented by the prior art, and are not described herein. The connection of the treatment 5 to the second catheter 4 can be performed by techniques. For example, the treatment 5 may be sleeved over the second guidewire 4. In particular, the purchased treatment 5 is typically provided with the second catheter 4 directly thereon.

The treatment substance 5 is loaded into the through hole 11 of the distal cannula 1 in vitro. For example, as shown in fig. 1, the treatment 5 and the first guide wire 2 can be threaded through the first opening 110 into the through hole 11 of the distal cannula 1. As further shown in fig. 5, 6, and 7, for example, the treatment object 5 and the first guide wire 2 may also be threaded into the through hole 11 of the distal cannula 1 through the third opening 102. After the treatment substance 5 is loaded into the through hole 11 of the distal cannula 1, the first guide wire 2 and the second guide wire 4 are located on the same side of the distal cannula 1. For example, after the treatment object 5 and the second guide wire 4 are inserted into the through hole 11, the first guide wire 2 and the second guide wire 4 can be attached to each other.

Thereafter, the distal cannula 1 and the treatment 5 are advanced. The distal cannula 1 and treatment 5 are advanced to the guiding catheter.

The manner of advancing the distal cannula 1 and the treatment 5 can be varied.

In one example, the first guide wire 2 and the second guide wire 4 are advanced simultaneously, which enables the distal cannula 1 and the treatment 5 to be advanced.

In one example, the first guidewire 2 is advanced separately to effect advancement of the distal cannula 1 and the treatment 5.

The distal cannula 1 and treatment 5 are then advanced through the distal end of the guiding catheter under fluoroscopy, with the distal cannula 1 entering the blood vessel. And meanwhile, the distal sleeve 1 is accurately observed through the developing piece, and the position of the distal sleeve 1 is judged. It will be understood that the distal end of the guiding catheter refers to the end of the guiding catheter facing the blood vessel, and the distal sleeve 1 and the treatment substance 5 exit the guiding catheter and enter the blood vessel.

After the distal cannula 1 reaches the target location within the blood vessel, the treatment 5 exits through the second opening 111.

The treatment 5 can be passed out of the second opening 111 by relative movement between the first guide wire 2 and the second guide wire 4.

In one example, the second guide wire 4 is fixed, and the treatment 5 is fixed by the second guide wire 4. The first guide wire 2 is pulled back again, and the distal sleeve 1 moves back. The treatment 5 passes out of the second opening 111.

In another example, the first guide wire 2 is fixed, and the distal cannula 1 is fixed by the first guide wire 2. The second guide wire 4 is advanced again, and the treatment object 5 is advanced under the push of the second guide wire 4. The treatment 5 passes out of the second opening 111.

Optionally, the treatment 5 comprises a drug balloon, a drug stent, or a degradable stent, etc. After the therapeutic substance 5 passes out of the second opening 111, the blood vessel is opened to complete the interventional therapy.

Further, the respective parts may be withdrawn after confirming the treatment result by imaging. The second guide wire 4 is separated from the treatment material 5 after the treatment material 5 is released and expanded.

According to yet another embodiment of the present invention, a shipping assembly is also provided. Referring to fig. 1 to 8, the delivery assembly comprises the delivery protection member and the treatment object 5 with the second guide wire 4 attached thereto. The therapeutic material 5 and the second guide wire 4 penetrate into the through hole 11 through the first opening 110 or the third opening 102. The second guide wire 4 and the first guide wire 2 are located on the same side of the distal cannula 1.

Preferably, after the therapeutic substance 5 and the second guide wire 4 are inserted into the through hole 11, the first guide wire 2 connected to the therapeutic substance 5 and the second guide wire 4 of the delivery protection member can be attached to each other.

Alternatively, the treatment 5 in the delivery assembly may be a drug balloon, drug stent, degradable stent or other treatment.

It should be noted that the transport protection can be of different sizes and types. The delivery protection members can be adapted to the size and type of the treatment 5.

The delivery assembly is capable of delivering and protecting a drug balloon, drug stent, degradable stent or other treatment in a percutaneous coronary intervention procedure, a peripheral intervention procedure, an intracranial intervention procedure or other procedures.

Although some specific embodiments of the present invention have been described in detail by way of examples, it should be understood by those skilled in the art that the above examples are for illustrative purposes only and are not intended to limit the scope of the present invention. It will be appreciated by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. A shipping protector, comprising:

the far-end sleeve (1) comprises a side wall (10) and a through hole (11) enclosed by the side wall (10) and used for loading a therapeutic substance, the through hole (11) comprises a first opening (110) and a second opening (111), the first opening and the second opening are axially opposite, the therapeutic substance passes through the through hole (11), and a developing piece is arranged on the side wall (10); and

a first guide wire (2), wherein the first guide wire (2) is fixedly connected to the side wall (10), and the first guide wire (2) extends to one side of the distal sleeve (1) far away from the second opening (111), and the first guide wire (2) is configured to be used for pushing or pulling back the distal sleeve (1);

the through hole (11) comprises a first part (112) at one end and a second part (113) adjacent to the first part (112), the inner diameter of the second part (113) is larger than that of the first part (112), and the second part (113) is provided with a loading space for loading a therapeutic substance;

the first opening (110) is configured for the passage of a treatment into the through hole (11); or a third opening (102) for the therapeutic substance to penetrate into the through hole (11) is arranged on the side wall (10).

2. Transport protection according to claim 1, characterized in that a third opening (102) for the passage of a treatment substance into the through-hole (11) is provided on the side wall (10), the third opening (102) communicating with the through-hole (11),

the through hole (11) comprises a first part (112) at one end and a second part (113) adjacent to the first part (112), the inner diameter of the second part (113) is larger than that of the first part (112), the second part (113) is provided with a loading space for loading the therapeutic material,

the third opening (102) extends along the axial direction of the far-end sleeve (1), one end of the third opening (102) is directly communicated with the second part (113), and the other end of the third opening extends to the end face of the side wall (10) towards the first part (112).

3. Conveyor protection according to claim 2, wherein said third opening (102) comprises a first through hole (1020) in direct communication with said second portion (113) and a second through hole (1021) extending from said first through hole (1020) to an end face of said side wall (10).

4. Transport protection according to one of claims 1 to 3, wherein an extension (12) extending axially outwards is provided on a side surface of the side wall (10) facing the first opening (110), the first guide wire (2) being connected to the side wall (10) and/or the extension (12).

5. Shipping protector according to claim 1, characterized in that said distal sleeve (1) comprises a loading body (100) and a head (101) at one end of said loading body (100), said head (101) having an outer diameter that becomes smaller in a direction away from said body (100), said second opening (111) being located on the head (101).

6. Transport protection according to claim 5, characterized in that the softness of the material of the head (101) is less than the softness of the material of the body (100).

7. Transport protection according to claim 5, wherein the head (101) is conical; alternatively, the head (101) is spherical.

8. Transport protection according to claim 1, 5 or 6, characterized in that the inner diameter of the second opening (111) is configured to be smaller than the outer diameter of the treatment.

9. Shipping protector according to claim 1, characterized by the fact that the distal sleeve (1) comprises a sleeve base (1000) and a reinforcement bar (1001) joined to the sleeve base (1000).

10. The shipping protector as set forth in claim 9, wherein the reinforcing ribs (1001) are linear structures extending in the axial direction of the distal sleeve (1), the number of the reinforcing ribs (1001) is plural, and the plural reinforcing ribs (1001) are spaced apart in the circumferential direction of the distal sleeve (1); alternatively, the first and second electrodes may be,

the reinforcing rib (1001) is of a spiral structure extending along the axial direction of the distal sleeve (1).

11. Transport protection according to claim 9, characterized in that the material of the cannula base (1000) comprises a medical polymer material and/or a metal material.

12. Transport protection according to claim 9, wherein the material of the reinforcement bar (1001) comprises a medical polymer material or a metal material.

13. The shipping protector of claim 12, wherein said medical polymer material includes one or more of Pebax, Nylon, PTFE, ETFE, FEP, PET, PEEK, TPU.

14. Transport protection according to claim 11 or 12, wherein the metallic material comprises one or more of stainless steel, nickel titanium alloy, cobalt chromium alloy.

15. Transport protection according to claim 1, wherein the material of the first guide wire (2) comprises a metallic material and/or a medical polymer material.

16. A shipping protector as claimed in claim 11 or claim 15, in which the medical polymer material includes one or more of Pebax, Nylon, PTFE, ETFE, FEP, PET, PEEK.

17. Transport protection according to claim 1, characterized in that an etching roughening treatment is made on the inner surface of the through hole (11); alternatively, the first and second electrodes may be,

performing chemical roughening treatment on the inner surface of the through hole (11); alternatively, the first and second electrodes may be,

and coating a coarsening coating on the inner surface of the through hole (11).

18. Transport protection according to claim 1, wherein the first guide wire (2) is circular, annular, sheet-like or thin film.

19. Transport protection according to claim 1, characterized in that the outer surface on the first guide wire (2) is coated with a high-molecular material with high impact strength and low friction coefficient.

20. Transport protection according to claim 1, characterized in that a silicon coating or a hydrophilic base coating is applied on the outer surface on the distal cannula (1) and/or the first guide wire (2).

21. Transport protection according to claim 1, wherein the protection further comprises a handle (3), the handle (3) being connected to a side surface of the first guide wire (2) facing away from the distal cannula (1).

22. Transport protection according to claim 1, wherein the development member comprises one or more of a metal development ring, a plastic development ring, a spray developer, a developer added to the material of the distal sleeve (1).

23. Transport protection according to claim 22, wherein one or more of said visualizations are provided at both ends of the distal sleeve (1); alternatively, the first and second electrodes may be,

one or more of the said visualization members are provided only at one of the ends of the said distal cannula (1).

24. A transport assembly, comprising:

the shipping protector of any one of claims 1-23; and

a therapeutic substance (5) connected with a second guide wire (4), wherein the therapeutic substance (5) is configured to penetrate into the through hole (11) through the first opening (110) or the third opening (102), and the second guide wire (4) extends towards one side of the side wall (10) far away from the second opening (111).