Integrated degradable plugging device set with fixing and releasing device

Abstract

The invention relates to an integrated degradable plugging device set with a fixing and releasing device, which comprises a degradable and expandable releasing plugging device, a sheathing canal, a pushing rod and a fixing wire, the pushing rod is a hollow rod, one end of the pushing rod penetrates through the middle part of one disc surface of the plugging device and penetrates through the waist part of the plugging device, and the other end of the pushing rod penetrates through the other disc surface of the plugging device. One end of the pushing rod is provided with a clamping jaw part which can be expanded outwards or folded inwards, the clamping jaw part is located in the other disc face of the plugging device, a limiting ball is arranged in the clamping jaw part, the fixing wire penetrates through the pushing rod, one end of the fixing wire is connected with the limiting ball, and the fixing wire can move relative to the pushing rod in a drawing mode and push the limiting ball out of the clamping jaw part or pull the limiting ball into the clamping jaw part. The pushing rod is arranged in the sheathing canal, and the plugging device is compressed and stored in one end of the sheathing canal and can be pushed out and released by the pushing rod through one end of the sheathing canal. The device has the advantages that the plugging device can be effectively conveyed to the target position of the atrial septum, and the plugging device can be conveniently and rapidly separated from the plugging device after being conveyed in place and released.

Description

Technical Field

[0001] The present invention relates to the field of medical equipment, and in particular to an integrated degradable occluder kit with fixing and releasing devices. Background Art

[0002] The treatment for congenital heart disease (including patent foramen ovale) is to use an occluder for percutaneous (femoral vein) occlusion. In clinical surgery, the occluder is one of the most important medical devices. At present, most occluders adopt a "double disc and one waist" structural design, and the occluder material can be non-degradable or degradable. For degradable occluders, the current design is to set an internally threaded cap at the center of one of the discs. When the occluder is transported, the cap is connected to the externally threaded connector at the end of the push rod. This structure has the following defects:

[0003] 1) Due to the characteristics of the operation, the push rod and the occluder cannot be connected too tightly. If the two are connected too tightly, when the occluder is delivered into place and released along with the sheath, the push rod will have a longer length entering the body. Since the push rod itself is in a "flexible" state after a long length, it will be very difficult to separate the push rod from the threaded cap of the occluder when the push rod is rotated relative to the occluder in vitro. This requires a long time and experienced doctors to achieve, and the separation failure rate is also relatively high.

[0004] 2) The connection between the push rod and the occluder should not be too loose, otherwise the push rod and the occluder may become detached during the process of the sheath being delivered and the sheath being released by the push rod.

[0005] Based on this, it is necessary to develop an integrated degradable occluder kit with a fixing and releasing device to overcome the above technical problems. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide an integrated degradable occluder kit with a fixing and releasing device, which effectively overcomes the defects of the prior art.

[0007] The technical solution of the present invention to solve the above technical problems is as follows:

[0008] The invention discloses an integrated degradable occluder set with a fixing and releasing device, comprising a degradable and expandable and releasable occluder, a sheath, a push rod and a fixing wire, wherein the push rod is a hollow rod, one end of which passes through the middle of a disk of the occluder and runs through the waist of the occluder, one end of the push rod is provided with a claw portion which can expand outward or contract inward, the claw portion is located in the other disk of the occluder, a limiting ball is provided in the claw portion, the fixing wire runs through the push rod, one end of which is connected to the limiting ball, the fixing wire can be pulled and moved relative to the push rod, and push the limiting ball out of the claw portion, or pull it into the claw portion, the push rod is built in the sheath, the occluder is compressed and accommodated inside one end of the sheath, and can be pushed out and released by the push rod through one end of the sheath, and the diameter of the limiting ball is smaller than the inner diameter of the push rod.

[0009] Based on the above technical solution, the present invention can also be improved as follows.

[0010] Furthermore, the above-mentioned claw portion includes a plurality of elastic and strip-shaped claw strips, and the plurality of claw strips are respectively connected to one end of the above-mentioned push rod at uniform intervals along the circumferential direction, and extend obliquely toward the outside of one end of the above-mentioned push rod. The plurality of claw strips can gather toward the middle under the action of external force, or restore after the external force is removed.

[0011] Furthermore, there are five claw strips.

[0012] Furthermore, the occluder comprises a waist and a degradable hollow disk connected to both ends of the waist, filter membranes are respectively arranged in the disks, and through holes for the push rod to pass through are respectively arranged in the middle of the disk at one end of the occluder and in the middle of the two filter membranes.

[0013] Furthermore, a degradable inner sleeve is sleeved on the waist of the occluder, and the inner diameter of the limiting ball is smaller than or equal to that of the inner sleeve.

[0014] Furthermore, the above-mentioned occluder is a PDO silk thread braided piece.

[0015] Furthermore, the above-mentioned limiting ball is a flexible and hollow braided sphere.

[0016] Furthermore, the above-mentioned limiting ball is a nickel-titanium alloy wire braided part.

[0017] Furthermore, the fixing wire is a nickel-titanium alloy wire.

[0018] Furthermore, it also includes a sterile packaging bag, in which the occluder, sheath, push rod and fixing wire are packaged.

[0019] The beneficial effects of the present invention are: the structural design is simple and reasonable, and the occluder can be effectively delivered to the target position of the atrial septum, and can be quickly separated from the occluder after being delivered and released. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a schematic structural diagram of the integrated degradable occluder set with fixing and releasing devices of the present invention;

[0021] Figure 2 It is a structural schematic diagram of the integrated degradable occluder with a fixing and releasing device of the present invention when the push rod is released from the occluder and the claw part is retracted;

[0022] Figure 3 It is a schematic structural diagram of another embodiment of the integrated degradable occluder kit with fixing and releasing devices of the present invention.

[0023] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0024] 1. Occluder; 2. Sheath; 3. Push rod; 4. Fixing wire; 5. Limiting ball; 11. Inner sleeve; 31. Claw part; 311. Claw strip. DETAILED DESCRIPTION

[0025] The principles and features of the present invention are described below in conjunction with the accompanying drawings. The examples given are only used to explain the present invention and are not used to limit the scope of the present invention.

[0026] Example: Figure 1 and 2 As shown, the integrated degradable occluder set with fixing and releasing device of this embodiment comprises a degradable and expandable and releasable occluder 1, a sheath tube 2, a push rod 3 and a fixing wire 4, wherein the push rod 3 is a hollow rod, one end of which passes through the middle of one disk surface of the occluder 1 and penetrates the waist of the occluder 1, and one end of which is provided with a claw portion 31 which can expand outward or retract inward, and the claw portion 31 is located in the other disk surface of the occluder 1, and the claw portion 31 is provided with a There is a limiting ball 5, the fixing wire 4 passes through the pushing rod 3, one end of which is connected to the limiting ball 5, the fixing wire 4 can be pulled and moved relative to the pushing rod 3, and push the limiting ball 5 out of the claw part 31, or pull it into the claw part 31, the pushing rod 3 is built into the sheath 2, the occluder 1 is compressed and accommodated inside one end of the sheath 2, and can be pushed out and released by the pushing rod 3 through one end of the sheath 2, and the diameter of the limiting ball 5 is smaller than the inner diameter of the pushing rod 3.

[0027] The integrated degradable occluder set with fixing and releasing device of this embodiment is assembled with the push rod 3 and the occluder 1 when it leaves the factory, and is built into the sheath 2, and the occluder 1 is compressed at one end of the sheath 2. During the operation, the occluder 1 is delivered into the patient's heart through the sheath 2 along the minimally invasive incision through the guide wire pre-entered in the blood vessel until one end of the sheath 2 reaches the target position, and then the push rod 3 is operated to slowly push out the occluder 1 and release it at the target position. After release, the occluder 1 will be fixed at the target position, and then the fixing wire 4 is pushed forward a small distance so that the limiting ball 5 at the end of the fixing wire 4 leaves the claw part 31, and then the push rod 3 is pulled outward, and the claw part 31 will enter the waist under the pressure of the waist of the occluder 1, and then the fixing wire 4 is pulled downward, so that the fixing wire 4 and the limiting ball 5 pass through the waist of the occluder 1, and then it is pulled out along the original path of the sheath 2 together with the push rod 3, and finally the sheath 2 can be withdrawn. It should be particularly emphasized that: after the entire set is packaged, the limiting ball 5 is in the claw portion 31 (the fixing wire 4 can be operated to give a tendency to pull outward during the operation, and the limiting ball 5 will be stuck in the claw portion 31), so that the claw portion 31 cannot shrink and deform, and will not withdraw from the occluder 1 (will not be separated from the occluder 1). Overall, the structural design is simple and reasonable, which can ensure that the occluder is effectively delivered to the target position of the atrial septum, and is convenient for rapid separation from the occluder after delivery and release, making the operation safer.

[0028] As a preferred embodiment, the above-mentioned claw portion 31 includes a plurality of elastic and strip-shaped claw strips 311, and the plurality of the above-mentioned claw strips 311 are respectively connected to one end of the above-mentioned push rod 3 at uniform intervals along the circumferential direction, and extend obliquely toward the outside of one end of the above-mentioned push rod 3. The plurality of the above-mentioned claw strips 311 can gather toward the middle under the action of external force, or restore after the external force is removed.

[0029] In the above implementation scheme, multiple claw strips 311 are designed and evenly dispersed around one end of the push rod 3. After packaging and leaving the factory, the claw strips 311 are almost attached to the inner side of a disk of the occluder 1, and the claw strips 311 are bent inwardly near the end of the push rod 3, so that the cross-sectional size formed by the multiple claw strips 311 at this position is smaller than the (diameter) size of the limiting ball 5, and can form a locking position with the limiting ball 5. In this way, the problem of the two being separated from each other will not occur during the transportation process. After being transported to the right position, the limiting ball 5 is pushed to move toward a position away from the center of the claw strip 311, and the limiting ball 5 will no longer "block" the center of the claw strip 311. When the push rod 3 is pulled out by external force, the claw strip 311 will be deformed and shrink inward to exit the occluder 1. After that, the fixing wire 4 and the limiting ball 5 can be pulled out.

[0030] In this embodiment, there are five claw strips 311, which are dispersed like "petals".

[0031] In this embodiment, the above-mentioned occluder 1 includes a waist and a degradable hollow disk connected to the two ends of the waist, and filter membranes are respectively provided in the above-mentioned disks. The middle part of the disk at one end of the above-mentioned occluder 1 and the middle parts of the two above-mentioned filter membranes are respectively provided with through holes for the above-mentioned push rod 3 to pass through. Its structure is consistent with the existing degradable occluder, the difference is that a through hole is provided in the center to pass the push rod 3.

[0032] In this embodiment, Figure 3 As shown, the waist of the occluder 1 is sleeved with a degradable inner sleeve 11, and the inner diameter of the limiting ball 5 is less than or equal to the inner diameter of the inner sleeve 11. The inner sleeve 11 can support the waist of the occluder 1, so that the push rod 3 and the limiting ball 5 can be well withdrawn. The inner sleeve 11 itself is made of degradable material and will automatically degrade over time in the patient's body.

[0033] In this embodiment, the occluder 1 is made of medical-grade PDO silk thread braid.

[0034] In this embodiment, the limiting ball 5 is a medical-grade flexible hollow braided sphere.

[0035] In this embodiment, the above-mentioned limiting ball 5 is made of a medical-grade nickel-titanium alloy wire braid.

[0036] In this embodiment, the fixing wire 4 is made of medical grade nickel-titanium alloy wire.

[0037] In this embodiment, a sterile packaging bag is also included. When leaving the factory, the occluder 1, the sheath tube 2, the push rod 3 and the fixing wire 4 are packaged in the sterile packaging bag.

[0038] In the description of the present invention, it is to be understood that the terms “center”, “longitudinal”, “lateral”, “length”, “width”, “thickness”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “clockwise”, “counterclockwise”, “axial”, “radial”, “circumferential”, etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0039] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0040] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable 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, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0041] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being "above", "above" or "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below", "below" or "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0042] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.

[0043] Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations of the present invention. A person skilled in the art may change, modify, replace and vary the above embodiments within the scope of the present invention.

Claims

1. An integrated degradable occluder kit with a fixing and releasing device, characterized in that: The invention comprises a degradable and expandable occluder (1), a sheath (2), a push rod (3) and a fixing wire (4), wherein the push rod (3) is a hollow rod, one end of which passes through the middle of one disk of the occluder (1) and penetrates the waist of the occluder (1), one end of which is provided with a claw portion (31) which can expand outward or retract inward, the claw portion (31) is located in the other disk of the occluder (1), a limiting ball (5) is provided in the claw portion (31), and the fixing wire (4) is provided with a plurality of holes. The push rod (3) passes through the push rod (3), one end of which is connected to the limit ball (5). The fixing wire (4) can be pulled and moved relative to the push rod (3) to push the limit ball (5) out of the claw part (31) or pull it into the claw part (31). The push rod (3) is built into the sheath tube (2). The occluder (1) is compressed and accommodated inside one end of the sheath tube (2) and can be pushed out and released by the push rod (3) through one end of the sheath tube (2). The diameter of the limit ball (5) is smaller than the inner diameter of the push rod (3).

2. The integrated degradable occluder kit with fixing and releasing devices according to claim 1, characterized in that: The claw portion (31) comprises a plurality of elastic and strip-shaped claw strips (311), wherein the plurality of claw strips (311) are connected to one end of the push rod (3) at even intervals along the circumferential direction and extend obliquely toward the outside of one end of the push rod (3). The plurality of claw strips (311) can gather toward the middle under the action of an external force, or restore after the external force is removed.

3. The integrated degradable occluder kit with fixing and releasing devices according to claim 2, characterized in that: The claw strips (311) are provided with five strips.

4. The integrated degradable occluder kit with fixing and releasing devices according to claim 1, characterized in that: The occluder (1) comprises a waist and a degradable hollow disk connected to both ends of the waist, wherein filter membranes are respectively arranged in the disks, and through holes for the push rod (3) to pass through are respectively arranged in the middle of the disk at one end of the occluder (1) and in the middle of the two filter membranes.

5. The integrated degradable occluder kit with fixing and releasing devices according to claim 4, characterized in that: The waist of the occluder (1) is sleeved with a degradable inner sleeve (11), and the inner diameter of the limiting ball (5) is smaller than or equal to that of the inner sleeve (11).

6. The integrated degradable occluder kit with fixing and releasing devices according to claim 4, characterized in that: The occluder (1) is a PDO silk thread braided piece.

7. The integrated degradable occluder kit with fixing and releasing devices according to claim 1, characterized in that: The limiting ball (5) is a flexible and hollow braided sphere.

8. The integrated degradable occluder kit with fixing and releasing devices according to claim 7, characterized in that: The limiting ball (5) is a nickel-titanium alloy wire braided piece.

9. An integrated degradable occluder kit with a fixing and releasing device according to any one of claims 1 to 8, characterized in that: The fixing wire (4) is a nickel-titanium alloy wire.

10. An integrated degradable occluder kit with a fixing and releasing device according to any one of claims 1 to 8, characterized in that: It also comprises a sterile packaging bag, in which the occluder (1), sheath tube (2), push rod (3) and fixing wire (4) are packaged.

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