Medical delivery devices and medical equipment

Abstract

This invention provides a medical delivery device and medical equipment. The medical delivery device includes an end member, a sheath assembly, and a brush member. The end member has a through-hole extending through its proximal and distal ends. The sheath assembly contains a hollow inner core tube, which has an inner core cavity extending through its proximal and distal ends. The distal end of the inner core tube is connected to the end member. The through-hole and the inner core cavity communicate with each other to form a through channel. The brush member is disposed within the through channel. This medical delivery device of the present invention can prevent debris from entering the human bloodstream, thereby improving the safety of using the medical delivery device.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and more particularly to medical delivery devices and medical equipment. Background Technology

[0002] Aortic disease is a common ailment among the elderly, and its prevalence is increasing year by year due to the aging population. It poses a serious threat to human health. In recent years, minimally invasive interventional treatment for aortic disease has become an increasingly popular choice for patients.

[0003] In minimally invasive treatment of aortic disease, the main process involves first compressing a self-expanding vascular stent and inserting it into a medical delivery device. The stent is then delivered along the lumen of the blood vessel to the lesion site (such as an aortic aneurysm), and finally released at the lesion site for treatment.

[0004] Specifically, the procedure first requires puncturing a blood vessel (such as the femoral artery) to insert a guidewire into the vessel and push it along the vessel to the lesion site. Then, a medical delivery device loaded with a vascular stent is inserted along the guidewire into the lesion site and released. During this process, some surgeons may need to change guidewires due to the complexity of the procedure. When changing guidewires, the inserted guidewire needs to be pulled out from the end of the medical delivery device before a new guidewire is inserted. Because the inner sheath of the medical delivery device is usually a metal tube structure, and the outer surface of the guidewire is coated with a polymer, friction between the end of the metal sheath and the guidewire coating during the advancement of the guidewire can cause the coating to detach. These detached coating fragments may enter the blood vessel along with the guidewire, potentially causing unexpected fever, thrombosis, or vascular blockage in the patient. Summary of the Invention

[0005] This invention provides a medical delivery device and medical equipment that can prevent the coating on the guidewire from entering the human blood vessels, mainly achieved through the following technical solutions.

[0006] The present invention provides a medical delivery device, including an end member, a sheath assembly and at least one brush member. The end member has a through hole extending through its proximal and distal ends. The sheath assembly includes a hollow inner core tube with an inner core cavity extending through its proximal and distal ends. The distal end of the inner core tube is connected to the end member. The through hole and the inner core cavity communicate with each other to form a through channel. The brush member is disposed within the through channel.

[0007] In one embodiment of the present invention, the medical delivery device further includes at least one receiving structure disposed on the inner wall of the through channel. The receiving structure has an opening communicating with the through channel and a receiving cavity communicating with the opening. The receiving cavity is connected to the through channel through the opening.

[0008] In one embodiment of the present invention, when the number of receiving structures is one, the receiving structure is disposed on the proximal side or the distal side of the brush member; when the number of receiving structures is greater than or equal to two, the receiving structure is disposed on the proximal side and / or the distal side of the brush member.

[0009] In one embodiment of the present invention, the maximum width of the opening is less than or equal to the maximum width of the receiving cavity.

[0010] In one embodiment of the present invention, the brush component includes a mounting member and a plurality of brush strips disposed on the mounting member. The mounting member is connected to the inner wall of the through channel, and the brush strips can extend into the through channel.

[0011] In one embodiment of the present invention, the number of brush components is one, and the plane parallel to the radial direction of the inner core tube is used as the projection plane. The central angle formed by the projection of the mounting component in the projection plane is 360°.

[0012] In one embodiment of the present invention, the number of brush components is at least two, with a plane parallel to the radial direction of the inner core tube as the projection plane, and the central angle formed by the projections of the mounting parts of each brush component in the projection plane is less than 360°, and the mounting parts of at least two brush components are arranged along the axial direction of the inner core tube.

[0013] In one embodiment of the present invention, the projections of the mounting parts of at least two brush components in the projection plane together form a continuous, closed annular projection.

[0014] In one embodiment of the present invention, the inner core tube includes a connected proximal tube segment and a distal tube segment along its axial direction, with the direction from the proximal end of the inner core tube to the distal end of the inner core tube as the extension direction, and the inner diameter of the proximal tube segment gradually decreases along the extension direction.

[0015] In one embodiment of the present invention, a medical device is also provided, including an implant and the aforementioned medical delivery device, wherein the implant is delivered to the treatment site via the medical delivery device.

[0016] When the medical delivery device of the present invention is in use, the brush component can brush the surface of the guide wire as the guide wire passes through the through channel. Even if the proximal end of the inner core tube rubs against the polymer material on the surface of the guide wire and generates debris, the brush component located in the through channel can also block the debris and prevent the debris from entering the human blood circulation through the through channel, thereby improving the safety of the medical delivery device. Attached Figure Description

[0017] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0018] Figure 1 This is a schematic diagram of the medical delivery device in the first embodiment of the present invention;

[0019] Figure 2 This is a schematic diagram of the inner core tube and brush component in the first embodiment of the present invention;

[0020] Figure 3 This is a schematic diagram of the brush component in the first embodiment of the present invention;

[0021] Figure 4 This is a schematic diagram of the inner core tube in the first embodiment of the present invention;

[0022] Figure 5 This is a schematic diagram of the brush component in the second embodiment of the present invention. Detailed Implementation

[0023] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0024] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0025] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0026] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0027] First Embodiment

[0028] like Figure 1 As shown, an embodiment of the present invention discloses a medical delivery device 100, including an end member 110, a sheath assembly 130, a brush member 170, and an inner core connector 190 that are connected to each other.

[0029] The tip component 110 can be integrally molded from a polymer material. The outer diameter of the tip component 110 gradually decreases from its proximal end to its distal end, and the side of the tip component 110 has a smooth surface to facilitate the insertion of the tip component 110 into the lumen of the human body (such as a blood vessel).

[0030] The end member 110 has a through hole penetrating its proximal and distal ends. In this embodiment, the through hole can pass through both ends of the end member 110 in a straight line along its axial direction. Of course, in other embodiments, the through hole can also pass through both ends (i.e., the proximal and distal ends) of the end member 110 along a curve or other non-straight trajectory, as long as the through hole passes through both ends of the end member 110.

[0031] The sheath assembly 130 includes a hollow inner core tube 131, an outer core tube 133, and a sheath tube 135. The outer core tube 133 is slidably sleeved outside the inner core tube 131, and the sheath tube 135 is slidably sleeved outside the outer core tube 133.

[0032] The inner core tube 131 can be made of stainless steel or nickel-titanium alloy and other metal materials. The inner core tube 131 is a tubular component and has an inner core cavity 132 extending through its proximal and distal ends. The distal end of the inner core tube 131 is connected to the end member 110. The through hole communicates with the inner core cavity 132 to form a through channel 150, through which a guide wire (not shown) can pass. Those skilled in the art will understand that the outer surface of the guide wire is coated with a layer of polymer material.

[0033] The outer core tube 133 may be made of metal materials such as stainless steel or nickel-titanium alloy, and an anchoring structure (not shown) may be provided on the outer core tube 133 for anchoring the implant.

[0034] The sheath 135 can slide axially relative to the inner core tube 131 and the outer core tube 133. The distal end of the sheath 135 can slide to connect with the proximal end of the end member 110. The sheath 135, the inner core tube 131, the outer core tube 133 and the end member 110 can together form a closed loading cavity, which can be used to load an implant (not shown). When the implant is delivered to the intended site, the sheath 135 slides to separate from the end member, and the implant can be released from the loading cavity.

[0035] The inner core connector 190 is made of a polymer material (e.g.), and is fixed to at least a portion of the outer surface of the inner core tube 131. The inner core connector 190 can be fixed to the outer surface of the inner core tube 131 by injection molding, or it can be molded separately and then fixedly connected to the inner core tube 131 by adhesive or other fixing connectors. The connection method between the inner core connector 190 and the inner core tube 131 is not unique, as long as the inner core connector 190 is fixedly connected to the inner core tube 131 and the inner core connector 190 covers at least a portion of the inner core tube 131.

[0036] The brush component 170 is located within the through channel 150. It should be noted that the brush component 170 being located entirely or only partially within the through channel 150 is considered to be located within the through channel 150.

[0037] During interventional procedures, such as aortic stent implantation in the chest and abdomen, a guidewire is inserted into a blood vessel through percutaneous puncture and advanced along the vessel to the lesion site, establishing a delivery path from inside the body to outside. The exposed portion of the guidewire is then inserted into the through-channel 150 of a medical delivery device 100. The medical delivery device 100 advances the guidewire along the established path to the intended surgical location. Afterward, the original guidewire needs to be withdrawn through the through-channel 150, and a new guidewire is inserted. During this process, the proximal end of the inner core tube 131 is prone to rubbing against the polymer material on the guidewire surface, generating debris. If this debris travels distally with the newly inserted guidewire and enters the bloodstream, it could potentially lead to serious consequences such as thrombosis.

[0038] The medical delivery device 100 of this embodiment has a brush member 170 in its through channel 150. When the guide wire passes through the through channel 150, the brush member 170 can brush the surface of the guide wire. Even if the proximal end of the inner core tube 131 rubs against the polymer material on the surface of the guide wire and generates debris, the brush member 170 located in the through channel 150 can block the debris and prevent the debris from entering the human blood circulation through the through channel 150, thereby improving the safety of using the medical delivery device 100.

[0039] like Figure 2 As shown, the medical delivery device 100 also includes at least one receiving structure 180, which is disposed on the inner wall of the through channel 150. Specifically, the receiving structure 180 may be disposed on the wall of the inner core tube 131, or on the inner wall of the through hole. The receiving structure 180 has an opening 182 communicating with the through channel 150 and a receiving cavity 181 communicating with the opening 182. The receiving cavity 181 is connected to the through channel 150 through the opening 182. The receiving structure is located at least on the proximal or distal side of the brush member 170.

[0040] Even if the surface of the guidewire is scraped by the inner core tube 131 and produces debris, when the guidewire is reinserted and moves in the through channel 150, it can carry the debris within the through channel 150. Since the receiving cavity 181 of the receiving structure 180 is connected to the through channel 150, the debris moving in the through channel 150 can fall into the receiving cavity 181 through the opening 182. Once the debris enters the receiving cavity 181, the guidewire can no longer carry the debris out of the receiving cavity 181, thereby reducing the risk of debris entering the blood circulation and further improving the safety of the medical delivery device 100.

[0041] When there is only one receiving structure 180, the receiving structure 180 is located on the proximal or distal side of the brush member 170. When debris passes through the radial plane where the opening 182 is located, if the debris is circumferentially misaligned with the opening 182, the debris cannot fall into the opening 182. The debris is blocked by the brush member 170, and the brush member 170 can bounce the debris back towards the proximal side (so that the debris moves outward). If the receiving structure 180 is located on the proximal side of the brush member 170, it is possible for debris that passes through the opening 182 again to fall into the receiving cavity 181. When the brush member 170 fails to block the debris, if the receiving structure 180 is located on the distal side of the brush member 170, the debris that escapes from the brush member 170 can fall into the receiving cavity 181, thereby reducing the risk of debris entering the blood circulation.

[0042] When the number of receiving structures 180 is greater than or equal to two, the receiving structures 180 are located on both sides of the brush member 170. For example... Figure 2 As shown, in this embodiment, when the number of receiving structures 180 is greater than or equal to two, the receiving structures 180 are disposed on both sides of the brush member 170, that is, one receiving structure 180 is disposed on the proximal side of the brush member 170, and the other receiving structure 180 is disposed on the distal side of the brush member 170.

[0043] Specifically, the width of the opening 182 is smaller than the width of the receiving cavity 181. The maximum width of the opening 182 is set to be smaller than the maximum width of the receiving cavity 181. For example, the receiving structure can be T-shaped or L-shaped. This increases the containment capacity of the receiving structure 180 and prevents debris located in the receiving cavity 181 from escaping from the receiving cavity 181.

[0044] When the housing structure 180 is manufactured, the outer surface of the inner core tube 131 is laser-cut to process the housing cavity 181 and the opening 182 on the tube wall of the inner core tube 131. Then, the inner core connector 190 is wrapped around the outside of the housing structure 180 so that the housing structure 180 can only communicate with the through channel 150 through the opening 182, while the other side of the housing structure 180 remains sealed.

[0045] In other embodiments, the maximum width of the opening 182 is equal to the maximum width of the receiving cavity 181, which can also contain debris.

[0046] like Figure 2 and Figure 3As shown, the brush member 170 includes a mounting member 171 connected to the through channel 150 and a plurality of brush strips 172 disposed on the mounting member 171. Specifically, the mounting member 171 can be connected to the wall of the inner core tube 131, and the mounting member 171 can also be connected to the inner wall of the through hole. At least one brush strip 172 in the brush member 170 can extend into the through channel 150. When the guide wire passes through the mounting member 171, the plurality of brush strips 172 on the mounting member 171 can brush the outer surface of the guide wire. The brush strips 172 can be made of a smooth, elastic material, so that the brush strips 172 can both brush the surface of the guide wire and allow the guide wire to move in the through channel 150, and can bounce debris back to the proximal side. The radial dimension of the channel formed by the brush strip 172 and the inner core tube 131 is smaller than the outer diameter of the guide wire, or the radial dimension of the channel formed by the brush strip 172 and the inner core tube 131 is smaller than the outer diameter of the guide wire, so that the guide wire can be blocked when passing through the channel. It should be noted that the brush strips 172 are densely distributed on the mounting part 171. In order to facilitate the display of the brush strips 172, only a portion of the brush strips 172 are shown in the figure.

[0047] In this embodiment, there are at least two brush components 170. Using a plane parallel to the radial direction of the inner core tube 131 as the projection plane, the central angle formed by the projections of the mounting parts 171 of each brush component 170 on the projection plane is less than 360°. The mounting parts 171 of at least two brush components 170 are arranged axially along the inner core tube 131, which avoids the mounting parts 171 occupying a large radial space within the through-channel 150, thereby preventing the mounting parts 171 from interfering with the guidewire movement and avoiding increasing the outer diameter of the medical delivery device 100. Furthermore, to avoid the mounting parts 171 occupying the radial space within the through-channel 150, the mounting parts 171 can be embedded in the wall of the inner core tube 131, with only the brush strip 172 on the mounting part 171 extending into the through-channel 150. It should be noted that even if only the brush strip 172 on the mounting part 171 extends into the through-channel 150, this still falls under the category of brush components 170 being located within the through-channel 150.

[0048] The projections of the mounting parts 171 of at least two brush components 170 in the projection plane can jointly form a continuous, closed annular projection. That is to say, there are mounting parts 171 in the 360° circumferential direction of the through channel 150, thereby ensuring that the brush strips 172 on the mounting parts 171 are distributed along the 360° circumferential direction of the through channel 150. When the guide wire enters the through channel 150, the debris in the 360° circumferential direction of the guide wire can be blocked by the brush strips 172.

[0049] like Figure 4As shown, the inner core tube 131 includes a connected proximal section 137 and a distal section 138 along its axial direction. In the illustrated embodiment, the proximal section 137 and the distal section 138 are separated by a boundary line 139, with the portion on the proximal side of the boundary line 139 being the proximal section 137 and the portion on the distal side of the boundary line 139 being the distal section 138. Extending in the direction from the proximal end of the inner core tube 131 to the distal end, the inner diameter of the proximal section 137 gradually decreases along the extending direction. This avoids the proximal end of the inner core tube 131 rubbing against the coating of the guidewire.

[0050] The cavity wall near the proximal end of the inner core cavity 132 is covered with a flexible material (not shown in the figure). The flexibility of the flexible material is greater than that of the material of the inner core tube 131, which can increase the flexibility of the proximal end of the inner core tube 131 and prevent the proximal end of the inner core tube 131 from being too sharp and scraping against the outer surface of the guide wire to generate debris. In this embodiment, the flexible material refers to a material whose flexibility is at least greater than that of stainless steel and nickel-titanium alloys, such as polytetrafluoroethylene (PTFE) and other polymer materials.

[0051] Second Embodiment

[0052] like Figure 5 As shown, the difference between this embodiment and the first embodiment is that the number of brush components 170 is one, which can improve production efficiency. Taking the plane parallel to the radial direction of the inner core tube 131 as the projection plane, the central angle enclosed by the projection of the mounting component 171 in the projection plane is 360°, so that the brush strips 172 on the mounting component 171 are distributed along the 360° circumferential direction of the through channel 150. When the guide wire enters the through channel 150, the debris in the 360° circumferential direction of the guide wire can be blocked by the brush strips 172.

[0053] The annular cavity formed by the mounting member 171 communicates with the through channel 150, allowing the guide wire to pass through. The maximum width of the annular cavity in the radial direction can be less than the maximum width of the through channel 150, for example, by placing the mounting member 171 within the wall of the inner core tube 131. Alternatively, the maximum width of the annular cavity in the radial direction can be greater than or equal to the maximum width of the through channel 150, which is more conducive to the passage of the guide wire, for example, by embedding the mounting member 171 within the wall of the inner core tube 131, and the inner diameter of the mounting member 171 being greater than the inner diameter of the inner core tube 131.

[0054] Third Embodiment

[0055] This embodiment provides a medical device, including an implant (not shown) and the aforementioned medical delivery device 100, wherein the implant is delivered to the treatment site via the medical delivery device 100. The implant in this embodiment may be an interventional medical device such as a vascular stent, a cardiac occluder, or a filter.

[0056] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A medical delivery device, wherein the delivery device pushes along a guide wire, characterized in that, The device includes an end member, a sheath assembly, and at least one brush member. The end member has a through-hole extending through its proximal and distal ends. The sheath assembly includes a hollow inner core tube with an inner core cavity extending through its proximal and distal ends. The distal end of the inner core tube is connected to the end member. The through-hole and the inner core cavity communicate with each other to form a through channel through which the guidewire can pass. The brush member is disposed within the through channel to brush the surface of the guidewire. The medical delivery device also includes at least one receiving structure disposed on the inner wall of the through channel. The receiving structure has an opening communicating with the through channel and a receiving cavity communicating with the opening. The receiving cavity communicates with the through channel through the opening.

2. The medical delivery device as described in claim 1, characterized in that, When the number of the receiving structure is one, the receiving structure is located on the proximal side or the distal side of the brush member; when the number of the receiving structure is greater than or equal to two, the receiving structure is located on the proximal side and / or the distal side of the brush member.

3. The medical delivery device as described in claim 1, characterized in that, The maximum width of the opening is less than or equal to the maximum width of the receiving cavity.

4. The medical delivery device as described in any one of claims 1 to 3, characterized in that, The brush component includes a mounting member and a plurality of brush strips disposed on the mounting member. The mounting member is connected to the inner wall of the through channel, and the brush strips can extend into the through channel.

5. The medical delivery device as described in claim 4, characterized in that, The number of brush components is one, with a plane parallel to the radial direction of the inner core tube as the projection plane, and the central angle enclosed by the projection of the mounting component in the projection plane is 360°.

6. The medical delivery device as described in claim 4, characterized in that, The number of brush components is at least two, with a plane parallel to the radial direction of the inner core tube as the projection plane. The central angle formed by the projections of the mounting parts of each brush component in the projection plane is less than 360°, and the mounting parts of the at least two brush components are arranged along the axial direction of the inner core tube.

7. The medical delivery device as described in claim 6, characterized in that, The projections of the mounting members of the at least two brush components in the projection plane together form a continuous, closed annular projection.

8. The medical delivery device as described in claim 1, characterized in that, The inner core tube includes a connected proximal tube segment and a distal tube segment along its axial direction, with the direction from the proximal end of the inner core tube to the distal end of the inner core tube as the extension direction, and the inner diameter of the proximal tube segment gradually decreases along the extension direction.

9. A medical device comprising an implant and a medical delivery device as described in any one of claims 1 to 8, wherein the implant is delivered to a treatment site via the medical delivery device.

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