A closure device that can provide support

Abstract

The application relates to the field of medical devices, in particular to a supportable closure device which comprises a delivery outer tube, a puncture assembly and a support assembly, the puncture assembly can puncture a tissue to be closed back and forth, the support assembly comprises a fixing rod, a first support rod and a second support rod, the distal ends of the first support rod and the second support rod are respectively provided with a first support section and a second support section, the distal end of the fixing rod is hingedly connected with the middle area of the first support section and the middle area of the second support section, the first support section and the second support section form a first support area and a second support area with the position of the hingedly connected distal end of the fixing rod as a boundary point, and the first support area and the second support area respectively provide support for the puncture assembly when puncturing the tissue to be closed back and forth; the application not only can provide bidirectional support, but also can adjust the angle of the support assembly to make it fit the tissue, thereby guaranteeing the support effect.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a closure device that can provide support. Background Art

[0002] The foramen ovale is a physiological passageway in the atrial septum during the embryonic period. The fetus lacks pulmonary circulation, so oxygenated blood from the umbilical cord flows from the right atrium through the foramen ovale into the left atrium. After birth, as pulmonary circulation establishes, left atrial pressure increases, and the septum secundum and septum primum converge, fuse, and eventually form a permanent atrial septum. However, in some cases, this fusion still occurs, resulting in a patent foramen ovale (PFO). Traditionally, surgical treatment for a PFO is surgical. Surgical treatment requires a thoracotomy. The main disadvantages of surgery are: the need for extracorporeal circulation, the potential for complications and death, the high trauma and scarring, and the high cost. With the advancement of interventional technology, minimally invasive techniques for treating PFO have become highly established. Minimally invasive interventions offer advantages such as no surgery, minimal trauma, fewer complications, faster recovery, better results, a wide range of indications, and relatively low costs. However, these procedures often present challenges.

[0003] Patent CN202211627609.2 discloses a closure device with positioning and guided puncture functions, comprising a delivery catheter, an implant for closing a tissue defect, and a puncture assembly and a positioning member disposed within the delivery catheter. The puncture assembly is capable of reciprocatingly puncturing the tissue to be closed. The positioning member comprises a connecting member and a support device disposed at the distal end of the connecting member, and the support device is capable of providing support for the puncture assembly during reciprocating puncture of the tissue to be closed. In this patented solution, while the positioning member can provide bidirectional support for the puncture assembly during reciprocating puncture of the tissue, its puncture area is not large enough (the H-shaped positioning member does not provide a wide enough support area, and if the positioning member is too large, it will affect the diameter of the delivery sheath). Therefore, it has been very limited in clinical trials and has a narrow indication. Furthermore, after the positioning member is released, the angle at which the positioning member contacts the tissue can only be adjusted by axially moving the tube. However, this adjustment method is not precise enough to control the positioning member, making it difficult for the positioning member to contact the tissue and achieve the desired support effect.

[0004] In summary, the existing technology has the following problems that urgently need to be solved: First, due to the limited diameter of the sheath in the existing technology, the puncture area of ​​its positioning component is not large enough, the puncture is difficult, and when faced with a long suture area, repeated operations are required, which increases the operation time; Second, the positioning component cannot be fine-tuned after release, which makes it difficult for the positioning component to fit the tissue. 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 closing device that can provide support in order to address the problems in the prior art of the puncture device having an insufficient support area and being difficult to retract.

[0007] The object of the present invention is achieved through the following solutions:

[0008] A closing device that can provide support includes a delivery outer tube, a puncture assembly arranged in the delivery outer tube, and a support assembly, wherein the puncture assembly is capable of puncturing the tissue to be closed back and forth, and the support assembly includes a fixed rod, a first support rod and a second support rod connected to the fixed rod, and the distal ends of the first support rod and the second support rod are respectively provided with a first support segment and a second support segment, wherein the distal ends of the fixed rod are hinged to the middle area of ​​the first support segment and the middle area of ​​the second support segment, respectively, and the first support segment and the second support segment cooperate with each other to form a first support area and a second support area with the position where the distal end of the fixed rod is hinged as the dividing point, and the first support area and the second support area respectively provide support for the puncture assembly when puncturing the tissue to be closed back and forth.

[0009] The purpose of the present invention can be further achieved by the following technical solutions:

[0010] As a further improvement of the present invention, the first support segment and the second support segment are in a mirror-symmetrical relationship with respect to the hinged position of the distal end of the fixed rod, so that the first support segment and the second support segment can surround each other and form a first support area and a second support area.

[0011] As a further improvement of the present invention, the first support segment and the second support segment are respectively provided with two arc-shaped structures; the first support segment / the second support segment are arranged in a "3" structure, which enables the support area formed by the cooperation between the first support segment and the second support segment to be wider than the support area in the prior art, and can adapt to the physiological and anatomical differences between different patients, widen the needle insertion area of ​​the puncture assembly, and increase the fault tolerance of the instrument.

[0012] As a further improvement of the present invention, the first supporting section and the second supporting section cooperate with each other and are arranged in an "8"-shaped structure.

[0013] As a further improvement of the present invention, the first support segment and the second support segment are rigid rods, so that when the puncture assembly punctures the tissue to be closed back and forth, the first support segment and the second support segment cooperate to provide support for the puncture assembly.

[0014] As a further improvement of the present invention, the first support segment / second support segment is made of nickel-titanium tube material, and the first support segment / second support segment has a predetermined shape, and the predetermined shape of the first support segment / second support segment can make it fit the tissue to be closed more closely.

[0015] As a further improvement of the present invention, when the first support rod / second support rod is pushed toward the distal end, the first support segment / second support segment rotates around the position where it is hinged to the distal end of the fixed rod, adjusting the angle of the first support segment / second support segment so that the first support segment / second support segment can fit the tissue better.

[0016] As a further improvement of the present invention, the tissue to be closed includes a first tissue and a second tissue, wherein, after the support assembly reaches the predetermined position, when the puncture assembly punctures the first tissue, the first support area provides support for the puncture assembly, and when the puncture assembly punctures the second tissue in a circuitous manner, the second support area provides support for the puncture assembly; when this solution is used for foramen ovale closure surgery, the first tissue is secondary septal tissue, and the second tissue is primary septal tissue.

[0017] As a further improvement of the present invention, when the puncture assembly punctures the secondary septal tissue, the first support area can provide support for the puncture assembly, and when the puncture assembly punctures the primary septal tissue, the second support area can provide support for the puncture assembly.

[0018] As a further improvement of the present invention, when the support assembly reaches the predetermined surgical position, the support assembly is located between the first tissue and the second tissue.

[0019] As a further improvement of the present invention, a clamping mechanism is provided in the outer delivery tube. The clamping mechanism includes a spring piece and a control line. The spring piece is sleeved on the outer delivery tube.

[0020] As a further improvement of the present invention, after the support assembly reaches a predetermined position, the control line is pulled to cause the spring sheet to open and cooperate with the support assembly to clamp the first tissue to achieve positioning.

[0021] As a further improvement of the present invention, the spring piece is made of nickel-titanium alloy material, and a slit is provided on the surface of the spring piece.

[0022] As a further improvement of the present invention, after the puncture assembly has been punctured back and forth, one end of the implant is located on the primary septum side in the right atrium, and the other end is located on the secondary septum tissue side in the right atrium. The implant is pulled and the closure of the foramen ovale is observed through imaging. After observing the closure of the foramen ovale, the delivery system is withdrawn from the body to complete the operation.

[0023] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0024] 1. In the existing closure system, although a support mechanism is provided to provide support when puncturing tissue, due to the limitation of the sheath diameter, the support area is not large enough, and the puncture mechanism may be separated from the support area when puncturing tissue, and the support mechanism cannot be accurately adjusted at an angle after release, resulting in it not being able to fit the tissue well and difficult to provide effective support; according to one concept of the present application, the first support segment and the second support segment can cooperate with each other to form a first support area and a second support area, and the first support area and the second support area can provide support for the puncture assembly when puncturing the tissue to be closed back and forth. At the same time, the distal end of the fixed rod is hinged to the first support segment and the second support segment respectively, so that after the support assembly is released, the first support rod / the second support rod can be pushed to rotate the first support segment / the second support segment around the hinge point, so as to adjust the angle of the first support segment / the second support segment to ensure that the first support segment and the second support segment can fit the tissue to ensure its support effect.

[0025] 2. According to one concept of the present application, the first support segment and the second support segment are in a mirror-symmetrical relationship, and the first support segment and the second support segment are respectively provided with arc structures at both ends. The first support segment / the second support segment are generally arranged in a "3" structure, so that the support area formed by the first support segment and the second support segment after cooperation with each other is wider than the support area in the prior art, can adapt to the physiological and anatomical structure differences between different patients, widen the needle area of ​​the puncture assembly, and the fault tolerance rate of the instrument is higher.

[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 they 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 can be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0028] Figure 1 and Figure 2 Schematic diagram of the structure of the closure device of the present invention.

[0029] Figure 3 Schematic diagram of the structure of the support assembly of the present invention.

[0030] Figures 4-8 Schematic diagram of an exemplary operation process of the closure device of the present invention.

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

[0032] 1-transport outer tube, 2-puncture assembly, 3-support assembly, 31-fixing rod, 32-first support rod, 33-second support rod, 34-first support section, 35-second support section, 36-first support area, 37-second support area, 4-clamping mechanism, 41-shrapnel, 42-control line. 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 phrases and terms used herein are for descriptive purposes only and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents as well as additional items.

[0035] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0036] 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.

[0037] One purpose of the embodiments described below is to address the above-mentioned drawbacks, as well as other problems. Example

[0038] like Figure 1 and 2 As shown, when the present invention is used to close the foramen ovale tissue, a closing device that can provide support according to an embodiment of the present application is illustrated, comprising a delivery outer tube 1, a puncture assembly 2 and a support assembly 3 arranged in the delivery outer tube, wherein the puncture assembly 2 can puncture the tissue to be closed back and forth, and the tissue to be closed includes a first tissue (i.e., secondary septal tissue) and a second tissue (i.e., primary septal tissue), and the support assembly 3 comprises a fixing rod 31, a first support rod 32 and a second support rod 33 connected to the fixing rod 31, and the distal ends of the first support rod 32 and the second support rod 33 are respectively provided with a first support segment 34 and a second support segment 35, wherein the distal end of the fixing rod 31 is hinged to the middle area of ​​the first support segment 34 and the middle area of ​​the second support segment 35, respectively, and the first support segment 34 and the second support segment 35 cooperate with each other to form a first support area 36 and a second support area 37 with the hinged position of the distal end of the fixing rod 31 as the dividing point, as shown Figure 3As shown, after the support assembly 3 reaches the predetermined position, the image is observed to confirm the fit between the first support segment 34 and the second support segment 35 and the tissue. If the fit is not good enough, Figure 4 As shown, the first support rod 32 / the second support rod 33 can be pushed distally to make the first support segment 34 / the second support segment 35 rotate around the position where it is hinged to the distal end of the fixing rod 31, so as to adjust the angle of the first support segment 34 / the second support segment 35 so that the first support segment 34 / the second support segment 35 can fit the tissue closely, as shown in FIG. Figure 5 As shown, when the positions of the first support segment 34 and the second support segment 35 are adjusted appropriately, the puncture assembly 2 punctures the first tissue (i.e., the secondary septal tissue), and the first support area 36 provides support for the puncture assembly 2. Subsequently, the puncture assembly 2 detours and punctures the second tissue (i.e., the primary septal tissue), and the second support area 37 provides support for the puncture assembly. This solution not only provides support for the puncture assembly 2 when puncturing the tissue back and forth, but also allows the support assembly 2 to adjust its angle after being released to ensure the support effect of the support assembly 2.

[0039] In the first embodiment, the first support segment 34 and the second support segment 35 are in a mirror-symmetrical relationship with respect to the hinged position of the distal end of the fixing rod 31, so that the first support segment 34 and the second support segment 35 can surround each other and form a first support area 36 and a second support area 37. Figure 3 shown.

[0040] In the first embodiment of the present invention, the first support segment 34 and the second support segment 35 are respectively provided with two arc-shaped structures; the first support segment 34 / the second support segment 35 are arranged in a "3" structure, which enables the first support segment 34 and the second support segment 35 to cooperate with each other to form a support area that is wider than the support area in the prior art, can adapt to the physiological and anatomical differences between different patients, widen the needle insertion area of ​​the puncture assembly, and have a higher fault tolerance rate for the instrument.

[0041] In the first embodiment, the first support section 34 and the second support section 35 cooperate with each other and are arranged in an "8"-shaped structure.

[0042] In the first embodiment, the first support segment 34 and the second support segment 35 are rigid rods, so that when the puncture assembly 2 punctures the tissue to be closed back and forth, the first support segment 34 and the second support segment 35 cooperate to provide support for the puncture assembly 2.

[0043] In the first embodiment, the first support segment 34 / the second support segment 35 is made of nickel-titanium tube material, and the first support segment 34 / the second support segment 35 has a predetermined shape, and the predetermined shape of the first support segment 34 / the second support segment 35 can make it fit the tissue to be closed better.

[0044] In the first embodiment, when the support assembly 3 reaches the predetermined surgical position, the support assembly 3 is located between the first tissue and the second tissue. Figure 4 shown.

[0045] In the first embodiment, a clamping mechanism 4 is provided in the outer delivery tube 1. The clamping mechanism 4 includes a spring 41 and a control line 42. The spring 42 is sleeved on the outer delivery tube 1. Figure 1 shown.

[0046] In the first embodiment, after the support component 3 reaches the predetermined position, the control line 42 is pulled to open the spring piece 41 and cooperate with the support component 3 to clamp the first tissue to achieve positioning.

[0047] In the first embodiment, the spring piece 41 is made of nickel-titanium alloy material, and a slit is provided on the surface of the spring piece 41 .

[0048] In the first embodiment, after the puncture assembly 2 has been punctured back and forth, one end of the implant is located on the primary septum side in the right atrium, and the other end is located on the secondary septum tissue side in the right atrium. The implant is pulled and the closure of the foramen ovale is observed through imaging. After observing the closure of the foramen ovale, the delivery system is withdrawn from the body to complete the operation.

[0049] The exemplary operation process of the closure device of the first embodiment is as follows:

[0050] (1) The delivery outer tube 1 enters the right atrium through the femoral vein and is then pushed to the patent foramen ovale between the secundum and primum of the atrial septum;

[0051] (2) Retract the outer tube 1 so that the first support rod 32 and the second support rod 33 extend out of the outer tube. At this time, observe the image to confirm the fit between the first support segment 34 and the second support segment 35 and the tissue. If the fit is not good enough, Figure 4 As shown, the first support rod 32 / the second support rod 33 can be pushed distally to make the first support segment 34 / the second support segment 35 rotate around the position where it is hinged to the distal end of the fixing rod 31, so as to adjust the angle of the first support segment 34 / the second support segment 35 so that the first support segment 34 / the second support segment 35 can fit the tissue closely, as shown in FIG. Figure 5 As shown;

[0052] (3) Pull the control line 42 to open the spring sheet 41 and clamp the secondary septal tissue, operate the puncture assembly 2 to pass through the secondary septal tissue along the predetermined route, and continue to operate so that the puncture assembly 2 can detour and puncture the primary septal tissue along the predetermined route. Figure 6As shown, after the puncture is completed, the spring 41 is withdrawn and stored in the outer delivery tube 1;

[0053] (4) Observe the position of the right atrial foramen ovale to release the shunt, and operate the implant to close the foramen ovale tissue to complete the operation. Figure 7 and Figure 8 shown.

[0054] 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. A closure device capable of providing support, comprising a delivery outer tube, a puncture assembly disposed within the delivery outer tube, and a support assembly, wherein: The puncture assembly is capable of puncturing the tissue to be closed back and forth, and is characterized in that: the support assembly includes a fixed rod, a first support rod and a second support rod connected to the fixed rod, and the distal ends of the first support rod and the second support rod are respectively provided with a first support segment and a second support segment, wherein the distal end of the fixed rod is hinged to the middle area of ​​the first support segment and the middle area of ​​the second support segment, respectively, and the first support segment and the second support segment cooperate with each other to form a first support area and a second support area with the position where the distal end of the fixed rod is hinged as the dividing point, and the first support area and the second support area respectively provide support for the puncture assembly when puncturing the tissue to be closed back and forth.

2. A closure device capable of providing support according to claim 1, characterized in that: The first support segment and the second support segment are in a mirror-symmetrical relationship with respect to the hinged position of the distal end of the fixing rod.

3. The support-providing closure device according to claim 1, characterized in that: The first supporting section and the second supporting section are respectively provided with two arc-shaped structures.

4. The support-providing closure device according to claim 1, characterized in that: The first supporting section and the second supporting section cooperate with each other and are arranged in an "8"-shaped structure.

5. The closure device capable of providing support according to claim 1, characterized in that: The first support segment and the second support segment are rigid rods, so that when the puncture assembly punctures the tissue to be closed back and forth, the first support segment and the second support segment cooperate to provide support for the puncture assembly.

6. The closure device capable of providing support according to claim 1, characterized in that: When the first support rod / the second support rod is pushed toward the distal end, the first support segment / the second support segment rotates with the hinged position of the distal end of the fixing rod as the center.

7. The closure device capable of providing support according to claim 1, characterized in that: The tissue to be closed includes a first tissue and a second tissue, wherein after the support assembly reaches a predetermined position, the first support area provides support for the puncture assembly when the puncture assembly punctures the first tissue, and the second support area provides support for the puncture assembly when the puncture assembly punctures the second tissue in a circuitous manner.

8. The closure device capable of providing support according to claim 1, characterized in that: A clamping mechanism is provided in the outer transport tube. The clamping mechanism includes a spring piece and a control line. The spring piece is sleeved on the outer transport tube.

9. The closure device capable of providing support according to claim 8, characterized in that: After the support assembly reaches a predetermined position, the control line is pulled to open the spring sheet and cooperate with the support assembly to clamp the first tissue to achieve positioning.

10. The closure device capable of providing support according to claim 8, characterized in that: The shrapnel is made of nickel-titanium alloy material, and a slit is provided on the surface of the shrapnel.

11. The closure device capable of providing support according to claim 1, characterized in that: The first support segment / the second support segment is made of nickel-titanium tube material, and the first support segment / the second support segment has a predetermined shape.

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