Medical Devices

Abstract

The medical device (100) includes a stent graft (110) having an opening (111) defined therein, a catheter (120) configured to be partially disposed within the stent graft (110), and a restraining member (130) configured to apply a radial compressive force to the stent graft (110) until the stent graft (110) is radially compressed into a compressed configuration. The medical device (100) is configured such that the opening (111) corresponds in position to a distal end of the catheter (120) when the stent graft (110) is in the compressed configuration, the distal end referring to the end that first enters a patient's body during use of the medical device (100). The medical device (100) can be used to treat vascular lesions associated with the aortic arch and helps establish access to branch vessels and shorten surgical procedure times.

Description

[Technical field]

[0001] The present invention relates to the field of medical equipment, and more particularly to medical devices. [Background technology]

[0002] Arterial vascular lesions involving the aortic arch are extremely complex and dangerous, and doctors often have to choose between open surgery and minimally invasive interventional techniques. Compared with open surgery, minimally invasive interventional techniques have the advantages of less trauma and faster postoperative recovery, but they also have some problems, especially regarding the treatment of branch vessels, which has always been the focus of the design of various products.

[0003] When doctors perform minimally invasive interventional procedures, most of them use DIY straight tube stent grafts or aortic stent graft systems integrated with branch stents. However, regardless of which stent system is used, establishing access in the branch vessel is crucial. In the prior art, when establishing access in the branch vessel, a procedure is generally performed using a guidewire and a catheter to introduce the branch vessel, for example, from a lower limb artery (e.g., femoral artery) through the aorta to the branch vessel, or from an upper limb artery and a carotid artery through the branch vessel into the aorta. This particular procedure generally includes placing a main stent graft with an opening thereon, selecting a catheter that matches the angle of the branch vessel, guiding the catheter to the vicinity of the branch vessel, aligning the angle of the distal end of the catheter with the branch vessel, introducing a guidewire from the catheter into the branch vessel to complete establishing access in the branch vessel, and then placing a branch stent along the guidewire into the corresponding branch vessel. Summary of the Invention [Problem to be solved by the invention]

[0004] In the process of establishing access within the branch vessel as described above, the opening of the main stent graft needs to be aligned with the branch vessel; otherwise, the opening of the branch vessel will be covered by the main part of the stent graft, which makes it more difficult to introduce the catheter and guidewire into the branch vessel and increases the operation time.

[0005] The object of the present invention is to provide a medical device that can be used for minimally invasive interventional treatment of pathologies involving the aortic arch, which can substantially reduce the difficulties in introducing a guidewire into the branch vessels, which can facilitate the establishment of access in the branch vessels, and which can shorten the operation time. [Means for solving the problem]

[0006] In order to achieve the above objectives, the present invention provides a medical device comprising a stent graft having an opening defined therein, a catheter configured to be partially positioned within the stent graft, and a restraining member configured to apply a radial compressive force to the stent graft until the stent graft is radially compressed into a compressed configuration, wherein the opening is configured to correspond in position to a distal end of the catheter when the stent graft is in the compressed configuration, the distal end referring to the end which first enters a patient's body when the medical device is in use.

[0007] Optionally, the stent graft is further configured to apply pressure to the catheter such that the catheter is maintained stationary relative to the stent graft.

[0008] Optionally, the distal end of the catheter passes through the opening and protrudes from the stent graft.

[0009] Optionally, the catheter includes a main section and a distal section connected at an angle to a distal end of the main section, the main section being partially disposed within the stent graft and the distal section protruding from the stent graft through the opening.

[0010] Optionally, the main portion has an axis parallel to the axis of the stent graft.

[0011] Optionally, an obtuse angle is formed between the axis of the main portion and the axis of the distal portion in the range of 150° to 180°.

[0012] Optionally, the medical device further includes a positioning member having a proximal end connected to the distal end of the catheter and a distal end constrained on the outer surface of the stent graft by a restraining member.

[0013] Optionally, the positioning member and the catheter are separately formed and connected to one another, or the positioning member and the catheter are integrally formed.

[0014] Optionally, a visualization element is provided on the exterior surface of the distal end of the catheter.

[0015] Optionally, the medical device further includes an inner liner configured to be inserted into the catheter.

[0016] Optionally, the medical device further comprises a delivery device comprising an inner tube, the stent graft being fitted over the inner tube and the catheter being disposed between the inner tube and the stent graft.

[0017] Optionally, the catheter is connected to an inner tube.

[0018] Compared with the prior art, the medical device of the present invention has the following advantages: the medical device includes a stent graft, a catheter and a restraining member, the stent graft is defined with an opening, the catheter is used to be partially disposed inside the stent graft, the restraining member is used to apply a radial compressive force to the stent graft until the stent graft is radially compressed into a compressed configuration, the medical device is configured such that the opening corresponds in position to the distal end of the catheter when the stent graft is in the compressed configuration, the distal end refers to the end that first enters the patient's body when the medical device is in use. Also, preferably, the stent graft applies pressure to the catheter such that the catheter is kept stationary relative to the stent graft. In this way, the stent graft and the catheter can be delivered synchronously into the aorta, and the user can introduce a guidewire along the catheter into the aorta before the stent graft is released, and pass the guidewire through the opening on the stent graft to introduce the guidewire into the branch vessel, thereby simplifying the operation for introducing the catheter and the guidewire into the branch vessel. This also avoids the difficulties of hyperselection caused by stent graft release and opening and malalignment with the branch vessel, which aids in establishing access within the branch vessel and shortens the procedure time.

[0019] The invention will be better understood with reference to the accompanying drawings, which show the invention without, however, limiting, the invention. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is a schematic structural diagram showing a medical device according to a first embodiment of the present invention. [Diagram 2] FIG. 1 is a schematic structural diagram showing a catheter of a medical device according to a first embodiment of the present invention. [Diagram 3] 1 is a schematic diagram illustrating an application scenario of a medical device according to a first embodiment of the present invention; [Figure 4]FIG. 2 is a schematic diagram illustrating an application scenario of a medical device according to a first embodiment of the present invention, with a guidewire introduced into a branch vessel. [Diagram 5] FIG. 2 is a schematic structural diagram showing a medical device according to a second embodiment of the present invention. [Figure 6] FIG. 11 is a schematic diagram showing a partial structure of a medical device according to a third embodiment of the present invention. [Figure 7] 7 is a schematic diagram showing a partial structure of a medical device according to a third embodiment of the present invention, from a perspective different from that of FIG. 6. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Hereinafter, the embodiments of the present invention will be described by specific examples, but those skilled in the art can easily understand other advantages and effects of the present invention from the disclosure in this specification. The present invention can also be implemented or applied by other different specific embodiments, and various details in this specification can be modified or changed based on different perspectives and applications without departing from the spirit of the present invention. Please note that the drawings shown in the embodiments only show the basic concept of the present invention in a schematic manner, and therefore the drawings only show components related to the present invention, not the number, shape and dimensions of the components in actual implementation. The type, quantity and ratio of each component can be changed arbitrarily, and the layout of the components may be more complex.

[0022] Furthermore, although each embodiment in the following description has one or more technical features, this does not mean that a person using the present invention needs to simultaneously implement all of the technical features in any embodiment, or can only implement some or all of the technical features in different embodiments separately. In other words, under the premise of possible implementation, according to the disclosure of the present invention and according to design specifications or implementation requirements, a person skilled in the art can selectively implement some or all of the technical features in any embodiment, or selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0023] Unless the specification expressly requires otherwise, the singular forms "a", "one" and "the" as used herein include plural referents, and the plural form "plurality" includes two or more referents. Unless the specification expressly requires otherwise, the term "or" as used herein is generally used in the sense of including "and / or", and the terms "mounted", "coupled", and "connected" should be interpreted broadly, for example, as a fixed connection, a removable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be a direct connection or an indirect connection through an intermediate medium, and can be an internal communication between two elements or an interaction between two elements. Those skilled in the art can understand the specific meaning of the above terms in the present invention according to the specific situation.

[0024] As used herein, "proximal end" and "distal end" are the relative orientation, relative position and direction of elements or actions relative to one another from the perspective of a physician using the medical device. "Proximal end" and "distal end" are not limiting, with "proximal end" generally referring to the end of a medical device that is closest to the physician during normal surgery, while "distal end" generally refers to the end that first enters a patient, which may be a human or other animal.

[0025] The core concept of the present invention is to provide a medical device including a stent graft, a catheter, and a restraining member. An opening is defined in the stent graft, and the catheter is configured to be partially disposed within the stent graft. The restraining member is configured to apply a radial compressive force to the stent graft until the stent graft is radially compressed into a compressed configuration. The opening corresponds in position to a distal end of the catheter when the medical device is in the compressed configuration. The medical device can be used for the treatment of a pathology involving the aortic arch. The catheter can be delivered to the aortic arch together with the stent graft. When the opening on the stent graft is positioned near a branch vessel before the stent graft is released, a user can introduce a guidewire through the catheter to the aortic arch, and then the guidewire can be introduced into the branch vessel. This can avoid a problem in the prior art that the opening of the branch vessel is partially covered due to misalignment between the opening of the stent graft and the branch vessel when the catheter and the guidewire are introduced into the branch vessel after the stent graft is released. Preferably, the stent graft also exerts pressure on the catheter such that the catheter is maintained stationary relative to the stent graft, thereby avoiding misalignment of the distal end of the catheter with the opening that may result from misalignment between the stent graft and the catheter.

[0026] In order to make the objects, advantages and features of the present invention clearer, the present invention will be described in more detail below with reference to the drawings. Please note that the drawings are not necessarily drawn to scale and are drawn in a very simplified form, intended only for convenience and clarity in illustrating the embodiments of the present disclosure. Similar reference numbers throughout the drawings indicate the same or similar components or elements.

[0027] FIG. 1 is a schematic structural diagram of a medical device according to a first embodiment of the present invention. Referring to FIG. 1, the medical device 100 includes a stent graft 110, a catheter 120, and a restraining member 130. The stent graft 110 has an opening 111 defined therein. The catheter 120 is configured to be partially disposed within the stent graft 110. The restraining member 130 is configured to apply a radial compressive force to the stent graft 110 until the stent graft 110 is radially compressed into a compressed configuration. The medical device 100 is configured such that the opening 111 corresponds in position to a distal end of the catheter 120 when the stent graft 110 is in the compressed configuration. Those skilled in the art should know that the catheter 120 has an internal cavity extending through the catheter along its axial direction, and the distal end of the catheter 120 is the distal opening of the internal cavity. Thus, the distal end of the catheter 120 in positional correspondence with the opening 111 herein means that the distal end of the catheter 120 is in positional correspondence with the opening 111 in both the axial and circumferential directions of the stent graft 110, such that the stent graft 110 does not cover the distal opening of the internal cavity of the catheter 120. The distal end of the catheter 120 refers to the end of the catheter 120 that first enters the patient's body. The stent graft 110 may be a self-expanding stent, and the material of the catheter 120 may be a polymeric material such as PA12 or Pebax7233.

[0028] The medical device 100 can be used for the treatment of a pathology involving the aortic arch. During an actual operation, the stent graft 110 is in a compressed form under the action of the restraining member 130 and is loaded into a delivery device (not shown) together with the catheter 120. The delivery device is configured to deliver the stent graft 110 together with the catheter 120 to the aortic arch of a patient so that the opening 111 is located near a branch vessel. As shown in Figures 3 and 4, the distal end of the catheter 120 is positioned in positional correspondence with the opening 111, so that a user can introduce a guidewire 200 into the aortic arch through the inner cavity of the catheter 120 before the stent graft 110 is released, and allow the guidewire 200 to protrude from the distal end of the catheter 120 to enter the branch vessel. This is advantageous in that the stent graft 110 and the catheter 120 are delivered into the body at once, thereby avoiding a second delivery, and avoiding the difficulty of introducing the catheter 120 into the branch vessel due to misalignment of the stent graft 110 with the branch vessel after release, thereby further avoiding the problem of difficulty in introducing the guidewire 200 into the branch vessel, which is beneficial in establishing access in the branch vessel and reducing the procedure time. Preferably, the stent graft 110 applies pressure to the catheter 120 such that the catheter 120 is kept stationary relative to the stent graft 110. This avoids a change in the relative position of the stent graft 110 with the catheter 120, and further avoids misalignment of the distal end of the catheter 120 with the opening 111.

[0029] Optionally, the medical device 100 further comprises a delivery device comprising an inner tube and an outer tube, the stent graft 110 being configured to be fitted over the inner tube and the outer tube being fitted over the inner tube and further covering the stent graft 110.

[0030] Preferably, referring back to FIG. 1 in conjunction with FIG. 2, the outer surface of the distal end of the catheter 120 is provided with a visualization element 140 that facilitates a user in determining the location of the distal end of the catheter 120 and the opening 111.

[0031] Preferably, with continued reference to FIG. 1 and FIG. 2, the distal end of the catheter 120 protrudes from the stent graft 110 through the opening 111. Specifically, the catheter 120 includes a main portion 121 and a distal portion 122. Preferably, the distal portion 122 is connected to the distal end of the main portion 121 at an angle. The main portion 121 is partially disposed in the stent graft 110, and the distal portion 122 protrudes from the stent graft 110 through the opening 111. That is, the end of the distal portion 122 away from the main portion 121 is the distal end of the catheter 120. In this way, it is more convenient for the guidewire 200 to be introduced into the branch vessel. In this embodiment, an obtuse angle θ is formed between the axis of the main portion 121 and the axis of the distal portion 122, and the obtuse angle θ is preferably 150° to 180°, and the axis of the main portion 121 may be parallel to the axis of the stent graft 110.

[0032] Next, a method of operating the medical device will be described, which includes the following steps: First, the stent graft 110 is inserted into the inner tube of the delivery device, and the catheter 120 is partially inserted into the stent graft 110. Specifically, the proximal end of the main part 121 of the catheter 120 is disposed outside the stent graft 110 and extends to the proximal end of the delivery device, the distal end of the main part 121 is disposed between the stent graft 110 and the inner tube, and the distal part 122 of the catheter 120 protrudes out of the stent graft 110 through the opening 111. Next, the restraining member 130 is used to restrain the stent graft 110. In this embodiment, the restraining member 130 can be selected from any kind of binding coil in the prior art, as long as it can radially compress the stent graft 110 and fix it to the inner tube. That is, the restraining member 130 can apply a radial compressive force to the stent graft 110 from outside the stent graft 110 so as to compress and fix the stent graft 110 to the inner tube. Optionally, the stent graft 110 can also apply pressure to the catheter 120 under the action of the restraining member 130, which keeps the stent graft 110 and the catheter 120 stationary relative to each other under the action of the pressure. Alternatively, in practice, the catheter 120 is connected to the inner tube by other means, for example by binding or gluing, such that the catheter 120 is fixed between the stent graft 110 and the inner tube, and furthermore, the catheter 120 is kept stationary relative to the stent graft 110. Finally, an outer tube is covered over the stent graft 110.

[0033] The stent graft 110 and catheter 120 are then delivered in conventional fashion to the patient's aortic arch and the outer tube is withdrawn to expose the stent graft 110 .

[0034] The position of the stent graft 110 is then adjusted so that the opening 111 is adjacent to the branch vessel and the distal end of the catheter 120 is aligned with the branch vessel (as shown in FIG. 3).

[0035] Guidewire 200 is then delivered along the inner lumen of catheter 120 into the patient's body such that guidewire 200 protrudes from the distal end of the inner lumen and is introduced directly into a branch vessel (as shown in FIG. 4).

[0036] The stent graft 110 is then released from the restraining member 130, deploying the stent graft 110. Now that access has been established within the branch vessel, the user may proceed to introduce a bifurcated stent into the branch vessel.

[0037] FIG. 5 is a schematic structural diagram of a medical device according to a second embodiment of the present invention. Referring to FIG. 5, the difference between this embodiment and the first embodiment is that the medical device 100 further includes a positioning member 150. The proximal end of the positioning member 150 is connected to the distal end of the catheter 120, and the distal end of the positioning member 150 is restrained on the outer surface of the stent graft 110 by the restraining member 130. This ensures that the catheter 120 and the stent graft 110 remain stationary relative to each other, and prevents the catheter 120 from shifting position during the delivery process, causing the distal end of the catheter 120 to deviate from the opening 111. It can be seen that the proximal end of the positioning member 150 should not be connected to the side of the catheter 120 away from the central axis of the stent graft 110, so as to avoid interfering with the guidewire 200 and to facilitate the introduction of the guidewire 200 into the branch vessel. Preferably, the proximal end of the positioning member 150 is connected to the side of the catheter 120 close to the central axis of the stent graft 110.

[0038] In this embodiment, the positioning member 150 may be formed separately from the catheter 120 and then connected together, and the positioning member 150 may be a metallic or polymeric wire.

[0039] 6 and 7 are schematic diagrams showing a partial structure of a medical device according to a third embodiment of the present invention. As shown in FIG. 6 and FIG. 7, the difference between this embodiment and the second embodiment is that the positioning member 150 and the catheter 120 are integrally formed. Specifically, the positioning member 150 and the catheter 120 are made of a single tube including a first part and a second part connected in the axial direction. A part of the first part far from the central axis of the stent graft 110 is cut off, and the remaining part of the first part close to the central axis of the stent graft 110 forms the positioning member 150 that can cover 1 / 4 to 1 / 2 of the circumference of the tube. The second part constitutes the catheter 120.

[0040] A portion of the second section is also cut away so that the distal end of the catheter 120 is formed with an inclined surface 123 that is connected to the positioning member 150 by a smooth transition. Thus, stress at the connection between the catheter 120 and the positioning member 150 is reduced and the distal opening of the internal cavity of the catheter 120 can be enlarged, which facilitates adjustment of the direction of the guidewire 200.

[0041] The difference between the medical device provided in the fourth embodiment of the present invention and the first embodiment is that the medical device 100 further includes an inner liner (not shown), which is configured to be inserted into the inner cavity of the catheter 120. The inner liner is used in the process of assembling the medical device 100 and delivering the stent graft 110 to the patient's body. Once the stent graft 110 is positioned, the inner liner is withdrawn. The inner liner is configured to prevent the inner cavity of the catheter 120 from being compressed and closed by the stent graft 110 and from bending and deforming when the catheter 120 is twisted within the stent graft 110.

[0042] The material of the inner liner can be a polymer such as Pebax 7233, PTFE, PA 12, etc. The outer diameter of the inner liner is equal to or smaller than the inner diameter of the catheter 120.

[0043] The present invention has been disclosed above, but is not limited thereto. It is obvious that those skilled in the art can make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Therefore, the present invention is intended to cover all such modifications and variations, provided that such modifications and variations fall within the scope of the appended claims and their equivalents. [Explanation of symbols]

[0044] 100 Medical Devices 110 Stent Graft 111 Aperture 120 Catheter 121 Main part 122 Distal 123 Slope 130 Restraining member 140 Visualization Elements 150 Positioning member 200 Guidewire

Claims

1. A medical device for use in interventional therapy, comprising: a delivery device comprising an inner tube; a stent graft having an opening defined therein and fitted onto the inner tube; a restraining member configured to apply a radial compressive force to the stent graft until the stent graft is radially compressed into a compressed configuration and secured to the inner tube; a catheter connected to the inner tube so as to be partially secured between the stent graft and the inner tube and thereby maintained stationary relative to the stent graft; Including, The medical device is configured such that the opening positionally corresponds to the distal end of the catheter when the stent graft is in the compressed form, the distal end referring to the end that first enters a patient's body when the medical device is in use.

2. The medical device of claim 1 , wherein the stent graft is further configured to apply pressure to the catheter such that the catheter is maintained stationary relative to the stent graft.

3. The medical device of claim 1 , wherein the distal end of the catheter passes through the opening and protrudes from the stent graft.

4. 4. The medical device of claim 3, wherein the catheter includes a main section and a distal section connected at an angle to a distal end of the main section, the main section being partially disposed within the stent graft, and the distal section passing through the opening and protruding from the stent graft.

5. The medical device of claim 4 , wherein the main portion has an axis parallel to an axis of the stent graft.

6. 5. The medical device of claim 4, wherein an obtuse angle is formed between an axis of the main portion and an axis of the distal portion in the range of 150° to 180°.

7. 7. The medical device of claim 1, further comprising a positioning member having a proximal end connected to the distal end of the catheter and a distal end restrained on the outer surface of the stent graft by the restraining member.

8. 8. The medical device of claim 7, wherein the positioning member and the catheter are formed separately and connected to each other, or the positioning member and the catheter are formed integrally.

9. The medical device of any one of claims 1 to 6, wherein an outer surface of the distal end of the catheter is provided with a visualization element.

10. The medical device of any one of claims 1 to 6, further comprising an inner liner configured to be inserted into the catheter.

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