An implantable device delivery system capable of automatic centering

Abstract

The present application relates to the field of medical devices, and in particular to an automatically centered implant delivery system, comprising: a control handle, a delivery catheter, and an implant arranged at the distal end of the delivery catheter, wherein the delivery catheter is provided with an adjustment mechanism, the adjustment mechanism is sleeved on the delivery catheter, and the adjustment mechanism is located at the proximal end of the implant, the adjustment mechanism comprises an expandable support frame and a blood vessel adhesion device arranged on the periphery of the support frame, after the support frame is unfolded in the blood vessel, the blood vessel adhesion device is filled with a medium and swells and adheres to the inner wall of the blood vessel, so that the central axis of the implant approaches or coincides with the central axis of the blood vessel segment where the implant is located; the present application scheme can not only effectively realize the centering adjustment of the implant, but also avoid damage to the blood vessel.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an implant device delivery system capable of automatic centering. Background Art

[0002] Existing implantable device delivery systems, particularly those delivered via vascular access, require alignment during device release to ensure the center of the device aligns with the center of the implant site. This prevents significant device displacement and stabilizes the device. However, due to the tortuous nature of vascular access routes, which often include large bends, achieving centered release of the implantable device upon reaching the target release location can be challenging.

[0003] In response to the above technical problems, most existing technologies rely on two technical paths to solve them. One is to set a balloon at the distal end of the delivery system. When the delivery system carries the implanted device into the blood vessel and reaches the target release position, the balloon is inflated so that the balloon is supported in the blood vessel and the implanted device is centered. However, this solution has an obvious disadvantage: when the balloon is inflated, it will completely block the blood vessel passages, resulting in no blood circulation in the blood vessels, affecting the normal blood supply to the human body and causing more postoperative complications. The second is to use a self-expanding stent to achieve centering adjustment, but because the stent has no protective measures for the blood vessels after expansion, it is easy to cause damage to the blood vessels. Especially when used for aortic treatment, the stent is prone to scratching the blood vessel wall and peeling off the blood clots in the blood vessel wall during positioning, causing the patient to suffer a stroke, and the surgical risk is high.

[0004] Therefore, how to develop an implantable device delivery system that can achieve centering adjustment without affecting blood supply and protecting blood vessel walls has become an urgent problem that needs to be solved. Summary of the Invention

[0005] This application is proposed in view of the above and other more concepts.

[0006] One of the purposes of the present application is to overcome the deficiencies of the prior art and to provide a novel automatically centered implant device delivery system for patients with cardiovascular diseases such as aortic stenosis who require interventional treatment.

[0007] The technical solution adopted to solve the technical problem of the present invention is to provide an automatically centered implant device delivery system, including: a control handle, a delivery catheter, and an implant device arranged at the distal end of the delivery catheter, the delivery catheter is provided with an adjustment mechanism, the adjustment mechanism is sleeved on the delivery catheter, and the adjustment mechanism is located at the proximal end of the implant device, the adjustment mechanism includes an expandable support frame and a blood vessel bonding device arranged on the periphery of the support frame, after the support frame is unfolded in the blood vessel, the blood vessel bonding device is filled with a medium and swells and bonds to the inner wall of the blood vessel, so that the central axis of the implant device approaches or coincides with the central axis of the blood vessel segment where the implant device is located.

[0008] As a further improvement of the present invention, when used for aortic valve treatment, the implantable device is an aortic valve stent. (The embodiment specifically describes the workflow of the device entering the aortic blood vessel.)

[0009] As a further improvement of the present invention, after the support frame is deployed in the blood vessel and the blood vessel fitting device is filled with a medium to swell and fit the inner wall of the blood vessel, the blood in the blood vessel still remains unobstructed.

[0010] As a further improvement of the present invention, the maximum diameter of the support skeleton after expansion is less than or equal to the diameter of the blood vessel segment in which it is located, and after the blood vessel adhesion device is filled with a medium and swells, the blood vessel adhesion device adheres to and supports the interior of the blood vessel.

[0011] As a further improvement of the present invention, a straight section is provided at the distal end of the delivery catheter, and the adjustment mechanism and the implant device are located in the straight section. When the adjustment mechanism is deployed in the blood vessel, the central axis of the straight section is parallel to or coincides with the central axis of the blood vessel section in which the straight section is located.

[0012] As a further improvement of the present invention, the adjustment mechanism also includes a control wire, the distal end of which is connected to the distal end of the delivery catheter, and pulling the control wire can make the central axis of the straight segment parallel to or coincide with the central axis of the straight segment where the implant device is located.

[0013] As a further improvement of the present invention, the straight line segment is a rigid segment.

[0014] As a further improvement of the present invention, the blood vessel bonding device includes an input catheter and a balloon, wherein the input catheter is connected to the balloon, wherein the balloon is sleeved on the outer periphery of the support frame, and filling the medium into the input catheter can cause the balloon to swell and bond to the inner wall of the blood vessel.

[0015] As a further improvement of the present invention, the capsule is provided in a circular ring structure or a circular bar structure, and the medium is physiological saline.

[0016] As a further improvement of the present invention, the support skeleton includes a support bracket, a first connecting member and a second connecting member, the first connecting member connects the proximal end of the support bracket and the delivery catheter, the second connecting member connects the distal end of the support bracket and the delivery catheter, and the support bracket is self-expandable.

[0017] As a further improvement of the present invention, both the first connecting member and the second connecting member are flexible members, and after the support bracket is deployed, the first connecting member and the second connecting member are in a taut state.

[0018] As a further improvement of the present invention, the support frame includes a connector, the proximal end of the support bracket is fixed on the delivery catheter, and the connector connects the distal end of the support bracket and the delivery catheter.

[0019] As a further improvement of the present invention, the connecting member includes a plurality of rigid rods or a plurality of flexible wires.

[0020] As a further improvement of the present invention, the connector is selected from one of the following items: a wire, a rope, a cable, a twisted wire, a strand, a metal wire, a flexible belt and any combination thereof.

[0021] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0022] Existing delivery systems achieve the centering function of implanted devices by expanding the stent. However, after the stent is expanded, it is easy to scratch the blood vessels, leading to aortic dissection. Especially when used for aortic surgery, it is very easy to peel off the thrombus on the blood vessel wall, and there is a risk of stroke. According to one concept of the present application, the adjustment mechanism is composed of a support frame and a blood vessel bonding device. When the implanted device enters the release position, the support frame self-expands and restores the preset shape. Subsequently, the blood vessel bonding device is filled with a medium and bulges to fit the inner wall of the blood vessel, so that the central axis of the implanted device is close to or coincides with the axial axis of the blood vessel segment in which it is located. Moreover, during the centering process, the stent frame combined with the blood vessel bonding device can not only provide sufficient support force so that the implanted device can be effectively adjusted in position, but the blood vessel bonding device can also protect the blood vessels, avoid scratching the inner wall of the blood vessel, effectively avoid postoperative complications, and has great clinical significance.

[0023] According to one concept of the present application, after the vascular bonding device is filled with a medium and swells and adheres to the inner wall of the blood vessel, the blood in the blood vessel can still flow from the inside of the supporting frame, so that the entire blood circulation system can still maintain its original working state, which can effectively reduce postoperative complications.

[0024] According to one concept of the present application, the adjustment mechanism is also provided with a control wire, the distal end of which is connected to the delivery catheter (i.e., the distal end of the straight segment). After the support frame and the vascular bonding device support the blood vessel, the proximal end of the straight segment can be fixed by pulling the control wire, and its distal end can pull the straight segment to achieve swinging, further adjusting the position of its central axis and the central axis of the blood vessel segment. This can cope with the differences between different patients and different blood vessels, so that the centering design can adapt to different working environments and be more adaptable.

[0025] According to one concept of the present application, the first connecting member and the second connecting member in the support skeleton are flexible members, and the support bracket can be self-expanding. After the support bracket is unfolded, the first connecting members and the second connecting members will pull each other and are always in a taut state, ensuring that the straight section is in the center position of the adjustment mechanism. At the same time, the flexible member is easy to compress and sheath, does not occupy the sheath space, does not increase the rigidity of the sheath, and has the advantages of facilitating bending in the blood vessel during transportation.

[0026] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below and can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent, and the embodiments of the present application may be better understood, by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0028] Figures 1a to 1c It is a schematic diagram of the structure of the conveying system of the present invention.

[0029] Figure 2a and 2b This is a schematic structural diagram of the support frame of the conveying system of the present invention including the connecting parts.

[0030] Figures 3a to 3e This is a schematic diagram of the process of the conveying system of the present invention entering the target position.

[0031] The features indicated by the numbers in the accompanying drawings are as follows:

[0032] 1-control handle, 2-delivery catheter, 21-straight segment, 3-implantation device, 4-adjustment mechanism, 41-support skeleton, 411-support bracket, 412-first connecting member, 413-second connecting member, 414-connector, 42-vascular adhesion device, 421-input catheter, 422-capsule, 43-control wire. Implementation Method

[0033] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be described. Other features, purposes and advantages of the present application will be clear from these descriptions, drawings and claims.

[0034] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or executed in various ways. Each example is provided in an explanation of the disclosed embodiments, not in a limiting manner. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, a feature illustrated or described as part of one embodiment may be used in conjunction with another embodiment to still produce another embodiment. Therefore, the present application discloses such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0035] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprising," or "having" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents as well as additional items.

[0036] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0037] In the present application, the term “proximal end” or “proximal side” refers to an end or side closer to a surgical operator, and “distal end” or “distal side” refers to an end or side farther from a surgical operator.

[0038] One purpose of the embodiments described below is to address the above-mentioned drawbacks, as well as other problems. Example

[0039] like Figures 1a to 1cAs shown, an automatically centered implant device 3 delivery system that can be used for aortic valve surgery according to an embodiment of the present application is illustrated, comprising: a control handle 1, a delivery catheter 2, an implant device 3 arranged at the distal end of the delivery catheter 2, the distal end of the delivery catheter 2 is provided with a straight segment 21, the adjustment mechanism 4 and the implant device 3 are located on the straight segment 21, the adjustment mechanism 4 is sleeved on the straight segment 21, and the adjustment mechanism 4 is located at the proximal end of the implant device 3, the adjustment mechanism 4 comprises an expandable support frame 41 and a vascular adhesion device 42 arranged on the periphery of the support frame 41, the vascular adhesion device 42 comprises an input catheter 421 and a balloon 422, the input catheter 421 is connected to the balloon 422, wherein the balloon 422 is sleeved on the The periphery of the support skeleton 41, and the medium filled into the input catheter 421 can make the balloon 422 swell and fit the inner wall of the blood vessel; during the operation, when the implant device 3 enters the target release position, the support skeleton 41 is unfolded in the blood vessel, and the surgeon fills the medium (physiological saline) into the input catheter 421 to make the balloon 422 swell and fit the inner wall of the blood vessel (at the ascending aorta). At this time, the adjustment mechanism 4 is supported at the ascending aorta, and the straight section 21 of the delivery catheter 2 is always at the center position of the adjustment mechanism 4, so that the central axis of the implant device 3 can approach or coincide with the central axis of the blood vessel segment where the implant device 3 is located, thereby realizing the centering adjustment of the implant device 3, which makes the position of the implant device 3 more accurate when released, and can effectively achieve the expected surgical effect.

[0040] In this embodiment, the support frame 41 is unfolded in the blood vessel, and after the blood vessel fitting device 42 is filled with a medium, swells and fits the inner wall of the blood vessel, the blood in the blood vessel remains unobstructed. The advantage of this design is that it will not affect the blood supply of the aorta during the operation, effectively reducing or avoiding some postoperative complications.

[0041] In this embodiment, the maximum diameter of the support frame 41 after expansion is less than or equal to the diameter of the blood vessel segment, and after the blood vessel adhesion device 42 is filled with a medium and swells, the blood vessel adhesion device 42 adheres to and supports the interior of the blood vessel, such as Figure 3b shown.

[0042] In this embodiment, the straight segment 21 is a rigid segment, and the adjustment mechanism 4 further includes a control wire 43, the distal end of the control wire 43 is connected to the distal end of the delivery catheter 2, as shown in FIG. Figure 1a and 1bAs shown, pulling the control wire 43 can fix the proximal end of the straight segment 21, and its distal end can pull the straight segment 21 to achieve swing, further adjusting the position of its central axis and the central axis of the blood vessel segment. This can cope with the differences between different patients and different blood vessels, so that the centering design can adapt to different working environments and is more adaptable.

[0043] In this embodiment, the capsule 422 is provided in a circular ring structure or a circular bar structure. Figure 1c As shown, the balloon 422 is shaped like a tire, and the part where it fits against the inner wall of the blood vessel is an arc surface. After the balloon 422 is filled with physiological saline, it can not only fit the shape of the inner wall of the blood vessel well and be adaptive, but also effectively protect the blood vessel and avoid scratching the inner wall of the blood vessel. Patients who need aortic treatment often have calcification and thrombosis in their aorta. If a stent is used for support, it is very easy to cause the thrombus attached to the inner wall of the blood vessel to peel off, leading to a stroke.

[0044] In this embodiment, the support frame 41 includes a support bracket 411, a first connecting member 412 and a second connecting member 413. The first connecting member 412 connects the proximal end of the support bracket 411 and the delivery catheter 2, and the second connecting member 413 connects the distal end of the support bracket 411 and the delivery catheter 2. In addition, the support bracket 411 can be self-expanding. Figure 1b and 1c shown.

[0045] In this embodiment, the first connecting member 412 and the second connecting member 413 are both flexible members, and after the support bracket 411 is unfolded, the first connecting member 412 and the second connecting member 413 are in a taut state, which can ensure that the straight section 21 is in the center position of the adjustment mechanism 4. At the same time, the flexible member is easy to compress and sheath, does not occupy the sheath space, does not increase the rigidity of the sheath, and is convenient for bending in the blood vessel during transportation.

[0046] In this embodiment, the first connecting member 412 and the second connecting member 413 are both fixedly connected to the delivery catheter 2 .

[0047] In another embodiment, the support frame 41 includes a connector 414, the proximal end of the support frame 411 is fixed to the delivery catheter 2, and the connector 414 connects the distal end of the support frame 411 and the delivery catheter 2, as shown in FIG. Figure 2a and 2b As shown, the connector 414 includes at least three rigid rods or at least three flexible wires or a combination of at least three rigid rods and flexible wires.

[0048] In this embodiment, the connector 414 is fixedly connected to the support bracket 411 , and the connector 414 is slidably connected to the delivery catheter 2 , which is beneficial for the retraction, sheathing and recovery of the support bracket 411 .

[0049] The operation process of the delivery system of the implantable device 3 that can be automatically centered includes the following steps: Figures 3a to 3e shown.

[0050] 1) The delivery system is operated to enter the heart through the vascular approach. The delivery catheter 2 follows the curvature of the aortic arch and enters the ascending aorta until the implant device 3 reaches the aortic valve position. Figure 3a shown.

[0051] 2) Operate the delivery system to gradually expand the support stent 411 from the compressed state and restore the preset shape. Then, fill the input catheter 421 with a medium, and make the balloon 422 swell and fit the inner wall of the ascending aorta. At this time, the straight section 21 of the delivery catheter 2 swings, and the central axis of the implanted device 3 can approach or coincide with the central axis of the blood vessel segment where the implanted device 3 is located. Figure 3b shown.

[0052] 3) Further observe whether the implanted device 3 is aligned. If not, Figure 3b As shown, the control wire 43 is operated to swing the straight section 21 and adjust it to the center position, as shown in FIG. Figure 3c As shown, the implanted device 3 is then released, and the delivery system is finally withdrawn from the body to complete the operation. Figure 3d and 3e shown.

[0053] The foregoing description of several embodiments of the present application has been presented for illustrative purposes. It is not intended to be exhaustive or to limit the present application to the precise configurations, configurations, and / or steps disclosed, and it is apparent that many modifications and variations are possible in light of the above teachings. It is intended that the scope of the invention and all equivalents thereof be defined by the appended claims.

Claims

1. An implantable device delivery system capable of automatic centering, comprising: A control handle, a delivery catheter, and an implant device arranged at the distal end of the delivery catheter, characterized in that: an adjustment mechanism is provided on the delivery catheter, the adjustment mechanism is sleeved on the delivery catheter, and the adjustment mechanism is located at the proximal end of the implant device, the adjustment mechanism includes an expandable support frame and a blood vessel bonding device arranged on the periphery of the support frame, after the support frame is unfolded in the blood vessel, the blood vessel bonding device is filled with a medium and swells and bonds to the inner wall of the blood vessel, so that the central axis of the implant device approaches or coincides with the central axis of the blood vessel segment where the implant device is located, the distal end of the delivery catheter is provided with a straight line segment, the adjustment mechanism also includes a control wire, the distal end of the control wire is connected to the distal end of the delivery catheter, and pulling the control wire can make the central axis of the straight line segment parallel to or coincide with the central axis of the straight line segment where the implant device is located.

2. The implant device delivery system according to claim 1, wherein: The support frame is deployed in the blood vessel, and after the blood vessel fitting device is filled with a medium, swells and fits the inner wall of the blood vessel, the blood in the blood vessel still remains unobstructed.

3. The implant device delivery system according to claim 1, wherein: The maximum diameter of the support frame after expansion is less than or equal to the diameter of the blood vessel segment in which it is located, and after the blood vessel adhesion device is filled with a medium and swells, the blood vessel adhesion device adheres to and supports the interior of the blood vessel.

4. The implant device delivery system according to claim 1, wherein: The adjustment mechanism and the implant device are located in the straight segment. When the adjustment mechanism is deployed in the blood vessel, the central axis of the straight segment is parallel to or coincides with the central axis of the blood vessel segment where the straight segment is located.

5. The implant device delivery system according to claim 1, wherein: The straight line segment is a rigid segment.

6. The implant device delivery system according to claim 1, wherein: The blood vessel adhesion device includes an input catheter and a balloon, wherein the input catheter is connected to the balloon, wherein the balloon is sleeved on the outer periphery of the support frame, and filling the input catheter with a medium can cause the balloon to swell and adhere to the inner wall of the blood vessel.

7. The implant device delivery system according to claim 6, wherein: The capsule is in a circular ring structure or a circular bar structure, and the medium is physiological saline.

8. The implant device delivery system according to claim 1, wherein: The support frame includes a support stent, a first connecting member and a second connecting member. The first connecting member connects the proximal end of the support stent and the delivery catheter, and the second connecting member connects the distal end of the support stent and the delivery catheter. In addition, the support stent is self-expandable.

9. The implant device delivery system according to claim 8, wherein: The first connecting member and the second connecting member are both flexible members, and after the support bracket is deployed, the first connecting member and the second connecting member are in a taut state.

10. The implant device delivery system according to claim 1, wherein: The support frame includes a support bracket and a connector. The proximal end of the support bracket is fixed on the delivery catheter, and the connector connects the distal end of the support bracket and the delivery catheter.

11. The implant device delivery system according to claim 10, wherein: The connector includes a plurality of rigid rods or a plurality of flexible wires.

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