CN115813461A - Medical plugging device - Google Patents

Abstract

The invention relates to a medical plugging device, which comprises a sealing disc and a fixed disc connected to the far end of the sealing disc; the fixed disc comprises an inner frame and an outer frame, and barbs are arranged on the inner frame; the medical occlusion device has a half-deployed state and a fully-deployed state, and when the medical occlusion device is in the half-deployed state, the inner frame and the barbs are both positioned in the outer frame; when medical plugging device is in the complete expanded state, the inner frame is located outer frame is interior, the barb is crossed outer frame so that the free end of barb is outstanding in the outside of outer frame. After the outer frame of the medical occlusion device is unfolded to have a certain supporting force, the barbs extend out and prick tissues, and the barbs can be obliquely inserted into the tissues from the far end to the near end.

Description

Medical plugging device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical plugging device.

Background

The Left Atrial Appendage (LAA) is a long, narrow, curved blind end structure extending forward and downward along the anterior sidewall of the Left Atrium (LA), has active contraction and secretion functions, and has important significance in relieving pressure rise in LA and ensuring filling of the Left Ventricle (LV). In cardiovascular diseases, the special anatomical and functional characteristics of LAA make it the main site of thrombosis. If thrombus causes cerebral infarction, large-area embolism of brain, cause cerebral infarction, brain death, this kind of condition probably can take place anytime and anywhere, seriously threatens patient's life health.

Therefore, patients with high risk of atrial fibrillation embolism need active anticoagulation treatment, the anticoagulation treatment has the risk of bleeding including cerebral hemorrhage, the left auricle plugging operation is used for plugging the left auricle by the plugging device in the interventional operation mode, the left auricle thrombosis is prevented from forming during atrial fibrillation, the dependence of the patients on long-term oral anticoagulation treatment is eliminated, and new treatment options are provided for patients who cannot receive the anticoagulation treatment for a long time, do not want the drug anticoagulation treatment and have high risk of bleeding.

A left atrial appendage closure device typically includes a sealing disc that extends into and is anchored to the inner wall of the left atrial appendage and a holding disc attached to the distal end of the sealing disc that seals against the entrance of the left atrial appendage to prevent blood flow into the left atrial appendage. Some left auricle occluders are provided with the barb, and the barb is used for pricking into the inner wall of left auricle, increases the anchoring performance of left auricle occluder. The barb sets up in the periphery of fixed disk generally, and the barb pricks into the inner wall of left atrial appendage when the fixed disk expandes, because individual difference, the shape of left atrial appendage inner space is regular cylindrical not, and the barb can not prick into left atrial appendage inner wall along distal end to near-end slope as expected, perhaps pricks into left atrial appendage inner wall prematurely, leads to the position that is difficult to real-time adjustment left atrial appendage occluder in the release process.

Disclosure of Invention

The invention aims to provide a medical occlusion device, and barbs of the medical occlusion device can be inserted into tissues along the far end to the near end in an inclined mode according to expectation in the releasing process so as to improve the overall anchoring performance of the medical occlusion device.

The invention provides a medical occlusion device, comprising: the fixing disc is connected to the far end of the sealing disc;

the fixed disc comprises an inner frame and an outer frame, and barbs are arranged on the inner frame;

the medical occlusion device has a half-deployed state and a fully-deployed state, and when the medical occlusion device is in the half-deployed state, the inner frame and the barbs are both positioned in the outer frame; when medical plugging device is in the complete expanded state, the inner frame is located outer frame is interior, the barb is crossed outer frame so that the free end of barb is outstanding in the outside of outer frame.

In one embodiment, the outer frame comprises a plurality of outer support rods, the plurality of outer support rods comprise a plurality of outer leading-out sections formed by extending from the center of the fixed disc towards the far end, and the far end of each outer leading-out section is connected with an outer suspension section bent towards the near end.

In one embodiment, the barbs extend from a proximal side of the end of the outwardly depending section remote from the exit section when the occlusion device is in a fully deployed state.

In one embodiment, the outer suspension section is provided with a through hole, and when the plugging device is in a fully unfolded state, the barbs on the inner frame extend out of the through hole to the outer side of the outer frame.

In one embodiment, the through hole has an inner opening facing the inner side of the outer frame and an outer opening facing the outer side of the outer frame; when the occlusion device is in a fully deployed state, the distal-most end of the inner opening is closer to the distal end of the medical occlusion device than the distal-most end of the outer opening; the proximal most end of the outer opening is closer to the proximal end of the medical occlusion device than the proximal most end of the inner opening.

In one embodiment, the distal end surface of the through hole is in transition connection with the inner side wall surface of the outer support rod through an arc surface.

In one embodiment, the inner frame comprises a plurality of inner support rods, the plurality of inner support rods comprise a plurality of inner lead-out sections formed by extending from the center of the fixed disc towards the far end, and the far ends of the inner lead-out sections are connected with inner suspension sections bent towards the near end; the plurality of inner supporting rods are arranged around the plurality of outer supporting rods, and the inner supporting rods and the outer supporting rods correspond to each other in the radial direction of the medical occlusion device one to one.

In one embodiment, when the occlusion device is in a fully deployed state, an included angle between the inner lead-out section and a central axis of the medical occlusion device is larger than an included angle between the outer lead-out section and the central axis of the medical occlusion device.

In one embodiment, the included angle between the inner connecting section and the outer connecting section is more than 10 degrees.

In one embodiment, the inner suspending section has a smaller curvature than the outer suspending section when the occluding device is in a fully deployed state.

The fixing disc of the medical plugging device is provided with the inner frame and the outer frame, the barbs gradually extend out of the outer frame from the inner side of the outer frame in the unfolding process, the barbs extend out again and prick into tissues after the outer frame is unfolded to have certain supporting force, a doctor can adjust the position of the medical plugging device according to the releasing condition in the process, the position of the medical plugging device after being released is ensured to be in line with expectation, the barbs can be obliquely inserted into the tissues from the far end to the near end, and the anchoring performance of the medical plugging device is improved.

Drawings

Fig. 1 is a front view of a medical occlusion device of the present invention.

Figure 2 is a view of the release process of the medical occluding device of the present invention (only the outer frame is exposed to the delivery device).

Fig. 3 is a diagram showing the release process of the medical occlusion device of the present invention (both the inner frame and the outer frame are exposed to the delivery device).

Figure 4 is a release process diagram of the medical occluding device of the present invention (the medical occluding device is in a semi-released state).

Figure 5 is a release process diagram of the medical occluding device of the present invention (the medical occluding device is in a fully released state).

Figure 6 is a front view of a medical occlusion device in another embodiment of the invention.

Fig. 7 is a front view of the holding pan of the present invention (with the medical occlusion device in a fully released state).

Fig. 8 is an enlarged view of fig. 7 at a.

FIG. 9 is a partial cross-sectional view of the outer suspending section at B of FIG. 8.

Fig. 10 is a front view of a medical occlusion device in another embodiment of the invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and do not limit the invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

To more clearly illustrate the structure of the medical occlusion device, the terms "distal" and "proximal" are defined herein, which are conventional terms used in the field of interventional medical devices. Specifically, "distal" refers to the end of the procedure distal to the operator, and "proximal" refers to the end of the procedure proximal to the operator.

As shown in fig. 1, the present embodiment provides a medical plugging device 1, which includes a sealing disc 11 and a fixing disc 12, the fixing disc 12 is used to enter into the cavity to be plugged and anchored on the inner wall of the cavity to be plugged, the sealing disc 11 is used to plug the opening of the cavity to be plugged, so as to seal the cavity to be plugged. For convenience of understanding, the present embodiment takes the left atrial appendage as an example, and specifically describes the structure of the medical occlusion device 1 of the present invention.

Wherein the fixed tray 12 comprises an inner frame 121 and an outer frame 122, and barbs 123 are arranged on the inner frame 121; the medical occlusion device 1 has a half-deployed state and a fully-deployed state, and when the medical occlusion device 1 is in the half-deployed state, the inner frame 121 and the barbs 123 are both located inside the outer frame 122; when the medical occlusion device 1 is in the fully deployed state, the inner frame 121 is located inside the outer frame 122, and the barbs 123 pass over the outer frame 122 so that the free ends of the barbs 123 protrude outside the outer frame 122.

Before the medical occlusion device 1 is implanted, the medical occlusion device 1 needs to be retracted into the delivery device 2, and the medical occlusion device 1 needs to be released after reaching the target position. The release here refers to the removal of the radial restraining force exerted on the medical occlusion device 1, in this embodiment specifically the withdrawal of the delivery device 2 to remove the radial pressure exerted on the medical occlusion device 1 by the inner wall of the delivery device 2. In other embodiments, the releasing may also refer to releasing a cord that is tied to the medical occlusion device 1, or releasing other constrictions used to radially constrict the medical occlusion device 1.

Referring to fig. 2 to 5, as the delivery device 2 is removed, the end of the outer frame 122 is exposed out of the delivery device 2 (as shown in fig. 2), and then the end of the inner frame 121 is exposed out of the delivery device 2 (as shown in fig. 3), which is in a half-released state (as shown in fig. 4) when the restraining force applied to the medical occlusion device 1 is removed to a certain extent that the outer frame 122 is unfolded but the barbs 123 are still in the outer frame 122, and in a fully released state (as shown in fig. 5) when the restraining force applied to the fixing plate 12 is completely removed.

Since the fixed tray 12 of the medical occlusion device 1 of the present invention has the inner frame 121 and the outer frame 122, when the outer frame 122 is released to the inner wall capable of supporting the implantation position, the outer frame 122 already has a certain anchoring function, the outer frame 122 can help the entire medical occlusion device 1 to be positioned, and when the operator confirms that the outer frame 122 reaches the proper position, the subsequent release of the entire medical occlusion device 1 will not cause the predetermined release position or deflection thereof. Therefore, the operator can adjust the position of the medical occlusion device 1 according to the release condition of the outer frame 122, for example, the operator can control the conveying device to repeatedly constrict and release the medical occlusion device 1, and after confirming that the position of the outer frame 122 meets the expected requirement, the medical occlusion device 1 is further released to enable the barbs 123 to cross the outer frame 122 and to prick into tissues, so that the condition that the inner wall of the left atrial appendage is scratched when the position of the medical occlusion device 1 is adjusted is avoided. For the design without the outer frame 122, the barbs 123 spring out directly when released, and the piercing angle or piercing position of the barbs 123 easily exceeds the expectation, so that the medical occlusion device 1 as a whole deflects or leaves the predetermined position after being implanted, but in the solution described in this embodiment, the outer frame 122 performs the first step of limiting, when the barbs 123 are released, the outer frame 122 can partially limit the movement of the barbs 123, correct the piercing angle of the barbs 123, and also counteract the force in the axial direction caused when the barbs 123 spring out or pierce the predetermined position, so that the phenomenon that the device as a whole deviates from the predetermined position or deflects due to the natural springing out of the barbs 123 is avoided.

It is to be understood that, as shown in fig. 1, the outer frame has a maximum outer diameter D when no binding force is applied to the medical occlusion device 1. In order to ensure that the medical occlusion device 1 has a certain supporting force when in the semi-release state, the maximum outer diameter of the outer frame when in the semi-release state is greater than or equal to 0.8D.

In this embodiment, as shown in fig. 6, the outer frame 122 includes a plurality of outer support rods 1221, the plurality of outer support rods 1221 includes a plurality of outer leading-out sections 1221a extending from the center of the fixed disk 12 toward the distal end, and the distal end of the outer leading-out sections 1221a is connected to an outer suspended section 1221b bent toward the proximal end. The inner frame 121 comprises a plurality of inner struts 1211, the plurality of inner struts 1211 comprises a plurality of inner lead-out sections 1211a formed by extending from the center of the fixed disk 12 towards the far end, and the far end of each inner lead-out section 1211a is connected with an inner suspended section 1211b bent towards the near end; the plurality of inner support rods 1211 are arranged around the plurality of outer support rods 1221, and the inner support rods 1211 and the outer support rods 1221 correspond to each other in a radial direction of the medical occlusion device 1. Since the free ends of the inner support 1211 and the outer support 1221 are both curled proximally during the releasing process, the inner support 1211 needs to be wrapped around the outer support 1221 to wrap the inner support 1211 inside after the outer support 1221 is curled proximally, so as to prevent the barbs 123 of the inner support 1211 from penetrating into the tissue prematurely.

In this embodiment, the inner support rod 1211 and the outer support rod 1221 are both metal rods, such as memory metal like nitinol, titanium alloy, etc. In actual production, a plurality of inner support rods 1211 may be cut from a metal tube and heat set to form the desired shape of the inner frame 121. The metal tube may be formed with a fixing ring 13 for fixing the inner support rods 1211 without cutting one end thereof, or the inner support rods 1211 may be welded or bonded to the fixing ring 13 and then heat-set. Likewise, a plurality of the outer support rods 1221 are also formed by cutting and heat-setting the outer frame 122, and the proximal end of the outer frame 122 is connected to the fixing ring 13 by welding or bonding.

The fixing ring 13 is also used for connecting the sealing disk 11. The sealing part is of a woven net structure, in actual production, a plurality of woven wires or one woven wire is woven into a net pipe, and the two ends of the net pipe close and fix the end parts of the woven wires through a sealing part bolt head respectively. And then, the mesh tube is subjected to heat setting to be in the shape of a disc, a column or a plug, and the like, so that the sealing part for plugging the left atrial appendage opening is obtained. At least one layer of film (not shown) is arranged inside the sealing part, and the edge of the film is fixed on the knitting silk at the edge of the sealing part. The thin film body is used for preventing blood flow from flowing from one side of the sealing part to the other side so as to prevent the blood flow from flowing between the left atrial appendage and the left atrium. The seal portion plug at the distal end of the seal disk 11 is used for welding or bonding with the fixing ring 13 of the fixing disk 12.

In other embodiments, the inner frame or/and the outer frame may be a woven mesh structure, such as the medical occlusion device 3 shown in fig. 7, the inner frame 321 is a framework structure having a plurality of inner support rods, the outer frame 322 is a woven mesh structure, in actual production, the outer frame 322 may be made of a mesh tube woven by a single or a plurality of metal wires (e.g., nickel-titanium wires), one end of the mesh tube is fixed in the fixing ring 33 together with the plurality of inner support rods, then the other end of the mesh tube is folded outwards and then fixed in the fixing ring 33, and finally the mesh tube is heat-set to a desired shape, so as to obtain the fixing ring 32. In other embodiments, the inner frame 321 and the outer frame 322 may both adopt a mesh-woven structure, or the outer frame 322 adopts a skeleton structure, and the inner frame 321 adopts a mesh-woven structure, or the inner support bar and the outer support bar are bars made of woven wires by weaving or winding, and only a structure for the barb 323 to pass through is reserved on the outer frame 322.

Referring back to fig. 6, in the present embodiment, the length of the inner suspended section 1211b is smaller than the length of the outer suspended section 1221 b; when the occlusion device 1 is in a fully expanded state, an included angle β between the inner lead-out section 1211a and a central axis Z of the medical occlusion device 1 is greater than an included angle α between the outer lead-out section 1221a and the central axis Z of the medical occlusion device 1. Therefore, when the distal end of the delivery device 2 is withdrawn to the position where the outer suspended section 1221b meets the outer lead-out section 1221a during the process of releasing the fixed disk 12, the outer suspended section 1221b is fully deployed, the medical occlusion device 1 has a certain supporting capability, and the barb 123 cannot pass over the outer suspended section 1221b at this time because the length of the inner suspended section 1211b is smaller than that of the outer suspended section. As the delivery device 2 continues to be withdrawn, the external force applied to the inner lead-out section 1211a is gradually removed, and because the included angle β is greater than the included angle α, the inner lead-out section 1211a is inclined radially outwardly to a greater extent than the outer lead-out section 1221a, i.e., the barbs 123 move radially outwardly relative to the outer suspension and simultaneously proximally until they pass beyond the outer suspension to penetrate into the tissue, the entire release process ensuring that the outer frame 122 expands to a supportive force after which the barbs 123 re-extend and penetrate into the tissue, and that the barbs 123 can be inserted obliquely into the tissue from distal to proximal.

It will be appreciated that the greater the angle between the inner lead-out section 1211a and the outer lead-out section 1221a, i.e., the greater the angular difference between the angle α and the angle β, the greater the distance the barb 123 moves relative to the overhanging section 1221b when the inner lead-out section 1211a and the outer lead-out section 1221a are released, and preferably the angle between the inner lead-out section 1211a and the outer lead-out section 1221a is greater than 10 degrees to ensure that the barb 123 can traverse a sufficient length of the outer frame 122 to obtain a sufficient anchoring force.

Further, the curvature of the inner suspended section 1211b is less than the curvature of the outer suspended section 1221b when the occluding device 1 is in a fully deployed state. It will be appreciated that, for the same length, the greater the curvature of the inner suspended section 1211b, the smaller the width of the inner suspended section 1211b in the radial direction of the medical occlusion device 1, i.e., the inner lead-out section 1211a with the greater inclination angle β is required to allow the barbs 123 to move in the radial direction a sufficient distance beyond the outer suspended section 1221b during release of the inner lead-out section 1211 a. The too large included angle β increases the difficulty of contracting the medical device during sheathing, so that the curvature of the inner suspended section 1211b is smaller than that of the outer suspended section 1221b, the inclined included angle β required by the inner lead-out section 1211a can be reduced, and the difficulty of contracting the medical device can be reduced.

Further, the outer support rod 1221 in this embodiment further includes a bending section 1221c, the bending section 1221c is connected to an end portion of the outer suspended section 1221b, which is far away from the outer leading-out section 1221a, and the bending section 1221c is bent toward the inner side and the distal end of the medical occlusion device 1, so that the free end of the outer support rod 1221 is bent into the medical occlusion device 1, and the situation that the distal end of the outer support section directly penetrates into a tissue to cause the dislocation of the medical occlusion device 1 is avoided.

Due to the bent sections 1221c, the barbs 123 on the inner support 1211 are difficult to penetrate into the tissue from the edge of the outer frame 122 beyond the outer frame 122, so in this embodiment, as shown in fig. 8, the outer suspended section 1221b is provided with through holes 12211, and when the occlusion device is in the fully deployed state, the barbs 123 on the inner frame 121 protrude from the through holes 12211 to the outside of the outer frame 122. The through hole 12211 is provided, and the inner suspended section 1211b penetrates through the through hole 12211 and then penetrates into the tissue, so that the inner suspended section 1211b and the outer suspended section 1221b are constrained with each other, and the overall structure of the medical occlusion device 1 is further stable. It should be noted that, since the inner support rods 1211 and the outer support rods 1221 are arranged in a one-to-one correspondence in the radial direction, and both the inner support rods 1211 and the outer support rods 1221 are subjected to a heat setting process, the inner support rods 1211 will spread in the same spreading direction as the outer support rods 1221 during the releasing process, that is, the barbs 123 can smoothly enter the through holes 12211. Even if the partial outer support rod 1221 is pressed by the structures in the left atrial appendage when it is unfolded, so that the barbs 123 cannot enter the through holes 12211 after the inner support rod 1211 is unfolded, the barbs 123 can protrude from the side surfaces of the support rod, and can also serve as anchors.

As shown in fig. 9, the through hole 12211 has an inner opening 12211a and an outer opening 12211b, the inner opening 12211a being directed toward the inner side of the outer frame 122, and the outer opening 12211b being directed toward the outer side of the outer frame 122; when the occlusion device 1 is in the fully deployed state, the distal most end of the inner opening 12211a is closer to the distal end of the medical termination device 1 than the distal most end of the outer opening 12211 b; the proximal end of the outer opening 12211b is closer to the proximal end of the medical occlusion device 1 than the proximal end of the inner opening 12211 a. That is, the through hole 12211 is gradually inclined toward the proximal end in the direction from the inside to the outside of the medical occlusion device 1. The angularly disposed through-hole 12211 provides a guide for the barb 123 to penetrate tissue obliquely proximally. Specifically, the distal end face of through-hole 12211 with outside bracing piece 1221's inboard is avoided passing through cambered surface 12211c transitional coupling, sets up cambered surface 12211c has not only enlarged inboard opening 12211a is also right barb 123 has the guide effect, makes barb 123 can get into more easily through-hole 12211. In other embodiments, the inner opening 12211a is the same size as the outer opening 12211b, and the inner opening 12211a is disposed more distally than the outer opening 12211 b.

In other embodiments, as shown in fig. 10, the barbs 423 extend from the proximal side of the end of the outer suspending section 4221b distal to the outer lead-out section 4221a when the occluding device 4 is in a fully deployed state. In such an embodiment, the medical occlusion device 4 does not have the bent segments, so the barbs 423 can protrude directly from the end of the outer suspended segment 4221b to penetrate into the tissue.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that various changes and modifications can be made by those skilled in the art without departing from the spirit of the invention, and these changes and modifications are all within the scope of the invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. A medical occlusion device, comprising: the fixing disc is connected to the far end of the sealing disc;

the fixed disc comprises an inner frame and an outer frame, and barbs are arranged on the inner frame;

the medical occlusion device has a half-deployed state and a fully-deployed state, and when the medical occlusion device is in the half-deployed state, the inner frame and the barbs are both positioned in the outer frame; when medical plugging device is in the complete expanded state, the inner frame is located outer frame is interior, the free end of barb is crossed outer frame so that the barb free end is outstanding in the outside of outer frame.

2. The medical occlusion device of claim 1,

the outer frame comprises a plurality of outer supporting rods, the outer supporting rods comprise a plurality of outer leading-out sections formed by extending from the center of the fixed disc towards the far end, and the far end of each outer leading-out section is connected with an outer suspension section bent towards the near end.

3. The medical occlusion device of claim 2,

when the occlusion device is in a fully deployed state, the free end of the barb protrudes from a proximal side of the end of the outer suspension section remote from the lead-out section.

4. The medical occlusion device of claim 2,

be provided with the through-hole on the outer suspended section, work as when plugging device is in the complete expanded state, the free end of the barb on the inner frame is followed the through-hole stretches out to the outside of outer frame.

5. The medical occlusion device of claim 3,

the through hole is provided with an inner opening and an outer opening, the inner opening faces the inner side of the outer frame, and the outer opening faces the outer side of the outer frame; when the occlusion device is in a fully deployed state, the distal-most end of the inner opening is closer to the distal end of the medical occlusion device than the distal-most end of the outer opening; the proximal most end of the outer opening is closer to the proximal end of the medical occlusion device than the proximal most end of the inner opening.

6. The medical occlusion device of claim 5,

the far end face of the through hole is in transition connection with the inner side wall face of the outer support rod through an arc face.

7. The medical occlusion device of claim 2,

the inner frame comprises a plurality of inner supporting rods, the plurality of inner supporting rods comprise a plurality of inner leading-out sections formed by extending from the center of the fixed disc towards the far end, and the far ends of the inner leading-out sections are connected with inner suspension sections bent towards the near end; the plurality of inner supporting rods are arranged around the plurality of outer supporting rods, and the inner supporting rods and the outer supporting rods correspond to each other in the radial direction of the medical occlusion device one to one.

8. The medical occlusion device of claim 7,

the length of the inner suspension section is smaller than that of the outer suspension section;

when the plugging device is in a completely unfolded state, the included angle between the inner leading-out section and the central axis of the medical plugging device is larger than the included angle between the outer leading-out section and the central axis of the medical plugging device.

9. The medical occlusion device of claim 8,

the included angle between the inner lead-out section and the outer lead-out section is larger than 10 degrees.

10. The medical occlusion device of claim 8,

when the occluding device is in a fully deployed state, the curvature of the inner suspended section is less than the curvature of the outer suspended section.

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