An interventional fixation device

Abstract

The application provides an interventional fixing device, which comprises a fixing part and a channel connected with the proximal end of the fixing part, the interventional fixing device is used for extending into a tubular object, the channel is used for extending a medical instrument into a target position along the channel in an axial direction from inside or outside of the channel, the fixing part can abut against the inner wall of the tubular object, and can be constrained by the inner wall of the tubular object to be temporarily fixed when the fixing part abuts against the inner wall of the tubular object, and the fixing part is used for limiting the displacement of the channel in the radial direction of the tubular object. The application can realize that the medical instrument can avoid colliding with the inner wall of the blood vessel as much as possible after the medical instrument is inserted into the blood vessel, and use safety is ensured.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to an interventional fixation device. BACKGROUND

[0002] Intravascular treatment technology and treatment devices have been rapidly developed. In a conventional vascular surgery, a clinician will select a suitable treatment device according to the actual situation of a lesion area, and will send the treatment device to many important human body parts and organs, such as the heart, brain, lung, and kidney, through the body's vascular channel under the guidance of a medical imaging device, so as to perform diagnosis and treatment. However, the situation of the human body's blood vessels is complex, and the blood vessels of each person are different. For patients whose lesion area is located in a distal blood vessel, the clinician needs to steadily and slowly send the treatment device to the lesion area along the blood vessel, which takes a long time for the surgery, and the patient and the clinician are exposed to radiation for a long time, so that the surgery cannot be quickly and effectively completed, and the probability of adverse events occurs. When a passageway medical device such as a guide wire or a catheter product establishes a passageway, it inevitably needs to contact, rub against, or even squeeze the blood vessel wall. Inappropriate contact can cause possible complications such as vasospasm, damage, and perforation. For patients with poor blood vessels, the target blood vessel or the pathway blood vessel is tortuous or small, and the treatment device is difficult to enter or pass through, and is prone to rub against or collide with the blood vessel during the travel, which can cause injury to the patient's blood vessel.

[0003] Therefore, there is a need for a new intravascular interventional treatment device based on a new structural design to establish a passageway near the center axis of the blood vessel, so that the treatment device used in the intravascular treatment process can travel along the direction of the center axis of the blood vessel, reduce the friction between the device and the blood vessel wall, reduce the possibility of damaging the blood vessel, and improve the treatment efficiency. SUMMARY

[0004] The purpose of the present application is to provide an interventional fixation device to avoid collision between the medical device and the inner wall of the blood vessel as much as possible after the medical device is inserted into the blood vessel, and to ensure safety in use.

[0005] To solve the above technical problems, the present application provides an interventional fixation device, which comprises a fixing member and a passageway, the passageway is connected to the proximal end of the fixing member, the interventional fixation device is used to extend into a tubular object, and the passageway is used to enable a medical device to extend into a target position along the axial direction of the passageway from the inside or outside of the passageway.

[0006] The fixing member can abut against the inner wall of the tubular object, and can be constrained by the inner wall of the tubular object to be temporarily fixed when the fixing member abuts against the inner wall of the tubular object. The fixing member is used to limit the displacement of the passageway in the radial direction of the tubular object.

[0007] Optionally, the fixing member comprises a fixing member body and a constraint member, the channel is connected with a proximal end of the constraint member, and a distal end of the constraint member is connected with a connection point on the fixing member body; the fixing member body can abut against an inner wall of the tubular object, and can be constrained by the inner wall of the tubular object to be temporarily fixed when the fixing member body abuts against the inner wall of the tubular object; and the constraint member is used for limiting the displacement of the channel in the radial direction of the tubular object.

[0008] Optionally, the connection point has a plurality of connection points, and the plurality of connection points are uniformly arranged along the circumference of the fixing member body.

[0009] Optionally, the constraint member comprises an annular member arranged around the fixing member body.

[0010] Optionally, the distal end of the channel is connected with the proximal end of the constraint member.

[0011] Optionally, the connection point has a plurality of connection points, and the end point of the distal end of the channel and the plurality of connection points can form a plurality of first connecting lines, and the included angle between any two first connecting lines ranges from 15 degrees to 110 degrees.

[0012] Optionally, the proximal end of the constraint member is sleeved with the outside of the channel, and the channel passes through the fixing member body.

[0013] Optionally, the connection point has a plurality of connection points, and the end point of the proximal end of the fixing member body and the plurality of connection points can form a plurality of second connecting lines, and the included angle between any two second connecting lines ranges from 15 degrees to 170 degrees.

[0014] Optionally, the volume of the fixing member body can be changed, and when the volume of the fixing member body in the tubular object is increased so as to abut against the inner wall of the tubular object, the connection point can be in contact with the inner wall of the tubular object.

[0015] Optionally, the fixing member and the channel are coaxially arranged.

[0016] The interventional fixing device provided by the application has the following beneficial effects:

[0017] The application provides an interventional fixing device, which comprises a fixing member and a channel, the channel is connected with a proximal end of the fixing member, the interventional fixing device is used for being inserted into a tubular object, the channel is used for enabling a medical instrument to be inserted into a target position along the channel in an axial direction from inside or outside of the channel; the fixing member can abut against an inner wall of the tubular object, and can be constrained by the inner wall of the tubular object to be temporarily fixed when the fixing member abuts against the inner wall of the tubular object; and the fixing member is used for limiting the displacement of the channel in the radial direction of the tubular object.

[0018] In use of the present application, the interventional fixing device is first extended into a target tubular object (such as a blood vessel) so that the fixing member abuts against the inner wall of the tubular object to form a constraint, and then an interventional medical instrument is extended out of the channel. Since the fixing member defines that the proximal end of the constraint member does not exceed the fixing member in the radial direction of the tubular object, the interventional medical instrument can be as far as possible in the middle of the tubular object after being extended out of the channel, so as to avoid the medical instrument colliding with the inner wall of the tubular object as far as possible after the medical instrument is intervented into the tubular object, and ensure the safety in use. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 A side view of the interventional fixing device according to an embodiment of the present application is provided.

[0020] Figure 2 A side view of the interventional fixing device according to an embodiment of the present application in a delivery state in a blood vessel is provided.

[0021] Figure 3 A side view of the interventional fixing device according to an embodiment of the present application in a fixed state in a blood vessel is provided.

[0022] Figure 4 A side view of the interventional fixing device according to a second embodiment of the present application is provided.

[0023] Figure 5 A side view of the interventional fixing device according to a third embodiment of the present application is provided.

[0024] Figure 6 A side view of the interventional fixing device according to a fourth embodiment of the present application is provided.

[0025] The reference signs are as follows:

[0026] 1 - fixing member body; 2 - constraint member; 3 - channel; 4 - blood vessel. DETAILED DESCRIPTION

[0027] In order to make the purpose, advantages and features of the present application clearer, the following will make further detailed description of the present application in combination with the drawings and specific embodiments. It should be noted that the drawings are all very simplified and not drawn in proportion, and are only used to facilitate and clearly assist the purpose of describing the embodiments of the present application. In addition, the structures shown in the drawings are often a part of the actual structures. In particular, the emphasis of each drawing needs to be different, and sometimes different proportions are used.

[0028] It will be understood that when an element or layer is referred to as being "on" or "connected to" another element or layer, it can be directly on or connected to the other element or layer or intervening elements or layers can be present. In contrast, when an element is referred to as being "directly on" or "directly connected to" another element or layer, there are no intervening elements or layers present. Although the terms first, second, third, etc. can be used herein to describe various elements, components, regions, layers and / or sections, these terms are not intended to denote a particular order or hierarchy. These terms are used merely to distinguish one element, component, region, layer or section from another element, component, region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present application. Spatially relative terms such as "beneath", "below", "lower", "above", "upper", and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientations depicted in the figures. For example, if a device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Such a

[0029] As used herein, "proximal" and "distal" are defined as follows: "proximal" generally refers to the proximal end of the medical device that is closest to the operator during normal operation, while "distal" generally refers to the proximal end of the medical device that is first inserted into the patient during normal operation.

[0030] The present application aims to provide an interventional fixation device that can avoid the medical device from colliding with the inner wall of the blood vessel after the medical device is inserted into the blood vessel, thereby ensuring safe use.

[0031] To solve the above technical problems, the present application provides an interventional fixing device, comprising a fixing member and a channel, the channel is connected with the proximal end of the fixing member, the interventional fixing device is used to extend into a tubular object, the channel is used to make medical instruments extend into a target position along the channel from inside or outside of the channel;

[0032] The fixing member can abut against the inner wall of the tubular object, and can be constrained by the inner wall of the tubular object to be temporarily fixed when the fixing member abuts against the inner wall of the tubular object, and the fixing member is used to limit the displacement of the channel in the radial direction of the tubular object.

[0033] In use of the present application, the interventional fixing device is first extended into a target tubular object (such as a blood vessel), the fixing member is abutted against the inner wall of the tubular object to form a constraint, and then an interventional medical instrument is extended from the channel, since the fixing member limits the distal end of the channel from exceeding the fixing member in the radial direction of the tubular object, the interventional medical instrument can be as close as possible to the central axis of the tubular object after being extended from the channel, so that the medical instrument can be as much as possible to avoid colliding with the inner wall of the blood vessel after the medical instrument is intervented into the blood vessel, and the safety in use is ensured.

[0034] Specifically, please refer to Figure 1 , Figure 1 The side view of the interventional fixing device provided by an embodiment of the present application is shown in the figure. Figure 1 As shown in the figure, the fixing member comprises a fixing member body 1 and a constraint member 2, the channel 3 is connected with the proximal end of the constraint member 2, the distal end of the constraint member 2 is connected with a connecting point on the fixing member body 1, and the constraint member 2 is used to limit the displacement of the channel 3 in the radial direction of the tubular object. The interventional fixing device is used to extend into a tubular object, and the channel 3 is used to pass through a medical instrument; the fixing member body 1 can abut against the inner wall of the tubular object, and can be constrained by the inner wall of the tubular object to be temporarily fixed when the fixing member body 1 abuts against the inner wall of the tubular object, and the constraint member 2 is used to limit the displacement of the channel 3 in the radial direction of the tubular object. The channel 3 can be selected from a hollow tube, a solid wire, and a multi-strand wire braid. The surface of the channel 3 can be polished, coated, grafted, or subjected to a deposition reaction to obtain a smooth contact surface.

[0035] In use of the present application, the interventional fixing device is first extended into a target tubular object (such as a blood vessel), so that the fixing member body 1 is abutted against the inner wall of the tubular object to form a constraint, and then an interventional medical instrument is extended out of the channel, since the constraint member 2 is capable of constraining the proximal end of the constraint member 2 from exceeding the fixing member body 1 in the radial direction of the tubular object, so that the interventional medical instrument can be as much as possible in the middle of the tubular object after being extended out of the channel 3, thereby realizing that the medical instrument can be as much as possible avoided from colliding with the inner wall of the tubular object after the medical instrument is intervened into the tubular object, such as a blood vessel, to ensure the safety in use.

[0036] As a preferred embodiment, the fixing member body 1 is coaxially arranged with the channel 3. In this way, the outlet end of the channel 3 can be as much as possible constrained near the axis of the tubular object, so that when the intravascular surgery is performed, a path located at the central axis position of the blood vessel can be established, so that the instrument used in the intravascular surgery can travel along the central axis position of the blood vessel, reducing the contact between the instrument and the blood vessel, reducing the possibility of damaging the blood vessel wall, facilitating the operation of the clinician, improving the treatment efficiency, and reducing the probability of adverse events.

[0037] Further, the connection points are multiple, and the multiple connection points are uniformly arranged in the circumferential direction of the fixing member body 1. In this way, the constraint force on the channel 3 can be better applied from multiple directions, further constraining the part near the outlet end of the channel 3 from being as much as possible close to the inner wall of the tubular object.

[0038] Preferably, the volume of the fixing member body 1 can be changed. Please refer to Figure 2 and Figure 3 , Figure 2 the side view of the interventional fixing device provided by an embodiment of the present application in a delivery state in a blood vessel; Figure 3 the side view of the interventional fixing device provided by an embodiment of the present application in a fixed state in a blood vessel. As shown in Figure 2 and Figure 3 , when the volume of the fixing member body 1 is small, it can be freely moved in the axial direction in the blood vessel 4, so as to be smoothly delivered to the target position; when the volume of the fixing member body 1 is large, it can be abutted against the inner wall of the blood vessel 4 to form a constraint, thereby realizing the fixing function. It should be understood that the constraint member 2 should be capable of corresponding adaptive movement with the volume of the fixing member body 1.

[0039] Further, when the fixing member body 1 is enlarged in the tubular object to abut against the inner wall of the tubular object, the connection points can be in contact with the inner wall of the tubular object. In this way, the constraint effect of the constraint member 2 is ensured, and the constraint member 2 itself is prevented from colliding with the inner wall of the tubular object.

[0040] It should be noted that the connection mode of the channel 3 and the fixing member body 1 can be two kinds, the first kind is that the distal end of the channel 3 is connected with the proximal end of the constraint member 2. At this time, the channel 3 is not directly connected with the fixing member body 1, and at this time, the end point of the distal end of the channel 3 is located at point A in Figure 1 , in this case, in order to achieve good constraint effect, the present application correspondingly provides the following technical scheme: the connection points are multiple, the end point of the distal end of the channel 3 and multiple connection points can form multiple first connecting lines, and the included angle between any two first connecting lines is in the range of 15 degrees to 110 degrees. In Figure 1 , it can be understood that the included angle α between the connecting line AC and the connecting line AC' is in the range of 15 degrees to 110 degrees.

[0041] The second kind of connection mode of the channel 3 and the fixing member body 1 is that the proximal end of the constraint member 2 is sleeved and connected outside the channel 3, at this time, the channel 3 passes through the fixing member body 1, at this time, the end point of the proximal end of the fixing member body 1 is located at point B in Figure 1 , in this case, in order to achieve good constraint effect, the present application correspondingly provides the following technical scheme: the connection points are multiple, the end point of the proximal end of the fixing member body 1 and multiple connection points can form multiple second connecting lines, and the included angle between any two second connecting lines is in the range of 15 degrees to 170 degrees. In Figure 1 , it can be understood that the included angle β between the connecting line BC and the connecting line BC' is in the range of 15 degrees to 170 degrees.

[0042] It should be noted that the fixing member body 1 can be a balloon or a deformable support member (for example, a support frame that can be opened and closed), and the material of the fixing member body 1 can be selected from a metal or a high polymer material having a shape memory function, or a balloon material having an expansion function. The fixing member body 1 can be formed by braiding, laser cutting, additive manufacturing or injection molding, but is not limited thereto. The shape of the constraint member 2 is not limited, please refer to Figures 4 to 5 , Figure 4 is a side view of an interventional fixing device provided by the second embodiment of the present application; Figure 5 is a side view of an interventional fixing device provided by the third embodiment of the present application. As shown in Figure 4 and Figure 5 , the cross section of the constraint member 2 can form an approximate cone shape, which is not a standard cone in strict geometry, and the side surface can be a stepped shape as shown in Figure 4 , a wire shape as shown in Figure 5 , a curved surface or an irregular shape. The constraint member 2 can also include a ring member arranged around the fixing member. Please refer to Figure 6 ,Figure 6 The side view of the interventional fixation device provided by the fourth embodiment of the present application. As shown, the constraint member 2 can also be annular, and the constraint member 2 can also simultaneously include the annular member and the filament structure to further enhance the constraint capability. Figure 6

[0043] The fixation member can also include a component with a contrast or imaging function, which helps the doctor to accurately send the fixation member to the desired position under the contrast device. At least two or more imaging components can be included to identify the position information of the distal end and the proximal end of the fixation member, respectively. The imaging component can be selected from platinum-iridium alloy, platinum-tungsten alloy or platinum-rhodium alloy. The connection mode of the fixation device and the channel can be selected from hot melt pressure bonding, welding, winding and the like.

[0044] The technical solutions of the present application will be described below in conjunction with specific embodiments:

[0045] Embodiment 1

[0046] The distal end of the channel 3 is connected to a self-expanding stent (and the fixation member) through a bifurcated connection point, which is located on the channel 3, and the axial virtual ray of the channel 3 passes through the center position of the self-expanding stent; the self-expanding stent needs to be a whole in circumferential closure; the self-expanding stent is configured to be able to produce elastic deformation and radially self-compliantly contract when subjected to an inward radial force.

[0047] When the self-expanding stent is delivered to the lesion through the microcatheter, the self-expanding stent will gradually expand after being pushed out of the catheter without radial force from the catheter, and when the self-expanding stent expands to contact the blood vessel wall, the self-expanding stent will be subjected to a radial force from the blood vessel wall, thereby tightly adhering to the inner wall of the blood vessel to establish the channel 3 located at the axial position of the blood vessel.

[0048] Embodiment 2

[0049] The fixation member body 1 includes a balloon. The proximal end of the pre-processed balloon is connected and fixed to the channel, and the channel 3 passes through the balloon.

[0050] In the deflated state of the balloon, the interventional fixation device is sent to the lesion, and the balloon is inflated to expand to contact the inner wall of the blood vessel and slightly squeeze the blood vessel, thereby establishing the channel 3 located at the middle position of the blood vessel.

[0051] ​It should also be noted that, although the present application has been described in terms of the preferred embodiments, the embodiments disclosed are not intended to limit the scope of the present application which is limited solely by the claims. Various modifications and alterations to this application can become apparent to those skilled in the art from the preceding description and drawings, and it is intended that all such modifications and alterations fall within the scope of the present application.

[0052] It should also be understood that, unless specifically stated otherwise, references to "a" or "an" or "the" or "at least one" or "one or more" should be construed to mean "one or more" unless otherwise indicated to the contrary. Also, the use of "or" means "and / or" unless stated otherwise.

[0053] It should also be appreciated that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. It is further noted that the use of "a" or "an", "the" or "at least one" or "one or more" are intended to include the plural aspect, unless the context clearly indicates otherwise. For example, reference to "a step" or "a device" is a reference to one or more steps or one or more devices and can include sub-steps and sub-devices. All conjunctions used herein are to be understood in the broadest possible sense, as the conjunction of choice to mean "and / or" unless the context clearly indicates otherwise. Furthermore, embodiments of the present application can be implemented by a method, apparatus, software, or any combination thereof, which can be implemented with or without the use of software.

Claims

1. An interventional fixation device, characterized in that, The device includes a fixation element and a channel, the channel being connected to the proximal end of the fixation element. The interventional fixation device is used to extend into a tubular object, and the channel is used to allow a medical device to extend along the axial direction of the channel from inside or outside the channel to a target location. The fastener can abut against the inner wall of the tubular object. When the fastener abuts against the inner wall of the tubular object, it can be constrained by the inner wall of the tubular object to be temporarily fixed. The fastener is used to limit the radial displacement of the channel in the tubular object. The fastener includes a fastener body and a constraint member. The channel is connected to the proximal end of the constraint member, and the distal end of the constraint member is connected to a connection point on the fastener body. The size of the fastener body can vary, and when the size of the fastener body increases in the tubular structure to the point of abutting against the inner wall of the tubular structure, the connection point can contact the inner wall of the tubular structure.

2. The interventional fixation device as described in claim 1, characterized in that, The fixing body can abut against the inner wall of the tubular object. When the fixing body abuts against the inner wall of the tubular object, it can be constrained by the inner wall of the tubular object to be temporarily fixed. The constraining member is used to limit the radial displacement of the channel in the tubular object. There are multiple connection points, and the multiple connection points are evenly arranged along the circumference of the fixing body.

3. The interventional fixation device as described in claim 2, characterized in that, The constraint member includes an annular member disposed around the body of the fixing member.

4. The interventional fixation device as described in claim 2, characterized in that, The distal end of the channel is connected to the proximal end of the constraint.

5. The interventional fixation device as described in claim 4, characterized in that, There are multiple connection points, and multiple first lines can be formed between the far end of the channel and the multiple connection points. The angle between any two first lines is between 15 degrees and 110 degrees.

6. The interventional fixation device as described in claim 2, characterized in that, The proximal end of the constraint member is sleeved and connected to the outside of the channel, which passes through the body of the fixing member.

7. The interventional fixation device as described in claim 6, characterized in that, There are multiple connection points, and multiple second lines can be formed between the near end of the fastener body and the multiple connection points. The angle between any two second lines is between 15 degrees and 170 degrees.

8. The interventional fixation device as described in claim 1, characterized in that, The fastener is coaxially arranged with the channel.

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