A closed system with support function

Abstract

The application relates to the field of medical devices, in particular to a closed system with a supporting function, which comprises a first delivery tube, an implant for closing a tissue defect, and a puncture assembly and a second delivery tube arranged in the first delivery tube, the puncture assembly can reciprocally puncture the tissue to be closed, the second delivery tube is provided with a first connecting rod and a supporting device arranged at the distal end of the first connecting rod, the supporting device has a preset shape, wherein, when the supporting device restores to the preset shape, the supporting device forms a first supporting area and a second supporting area, and the first supporting area and the second supporting area respectively provide support for the puncture assembly when reciprocally puncturing the tissue to be closed; in the application, the supporting device is simple in structure, large in supporting area and easy to recycle.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a closure system with support function. BACKGROUND

[0002] Oval foramen is a physiological channel in the embryonic period of the atrial septum of the heart. The fetus has no pulmonary circulation, and the oxygen-containing blood from the umbilical cord flows into the left atrium through the oval foramen from the right atrium of the fetus. After birth, with the establishment of pulmonary circulation, the left atrial pressure increases, and the secondary septum and the primary septum approach and adhere to each other and gradually form a permanent atrial septum. However, a portion of the population does not fuse, resulting in patent foramen ovale (PFO). The traditional treatment method for patent foramen ovale is surgical operation. The surgical treatment method requires surgical operation to open the chest. The main disadvantages of surgical operation are: extracorporeal circulation is required during the operation, and the operation may cause complications and death; surgical trauma is large, leaving scars after operation; and the operation cost is high. With the development and improvement of interventional treatment technology, the method of treating PFO through minimally invasive interventional technology has now been very mature. Minimally invasive interventional treatment has the advantages of no incision, small trauma, few complications, rapid recovery, good effect, wide range of indications, and relatively low operation cost, but there are more or less problems in use.

[0003] Patent CN202211627609.2 discloses a closure device with positioning and guiding puncture functions, comprising a delivery catheter, an implant for closing a tissue defect, and a puncture assembly and a positioning member arranged in the delivery catheter, the puncture assembly can reciprocally puncture the tissue to be closed, the positioning member comprises a connecting member and a support device arranged at the distal end of the connecting member, and the support device can provide support force for the puncture assembly when reciprocally puncturing the tissue to be closed. In the patent scheme, the positioning member can provide bidirectional support for the puncture assembly when reciprocally puncturing the tissue, but since the puncture area of the positioning member is not large enough (if the positioning member is set too large, it will affect the diameter of the delivery sheath tube), it is very limited in clinical trials, and the indications are narrow, and at the same time, the positioning member is easy to scratch the sheath tube when being recovered, increasing the difficulty of recovery.

[0004] In summary, the following problems in the prior art need to be solved urgently: first, in the prior art, due to the limitation of the diameter of the sheath tube, the puncture area of the positioning member is not large enough, the puncture difficulty is high, and when facing a long suture area, repeated operations are required, increasing the operation time; second, the positioning member is easy to scratch the sheath tube when being recovered, increasing the recovery difficulty. SUMMARY

[0005] The present application is proposed in view of the above and other more ideas.

[0006] One of the purposes of this application is to overcome the shortcomings of the existing technology. In order to solve the problems in the existing technology such as the support area of ​​the puncture instrument is not large enough and the recovery is difficult, a closed system with a support function is provided.

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

[0008] A closing system with a supporting function comprises a first delivery tube, an implant for closing tissue defects, and a puncture assembly and a second delivery tube arranged in the first delivery tube, wherein the puncture assembly is capable of puncturing the tissue to be closed back and forth, and a first connecting rod and a supporting device arranged at the distal end of the first connecting rod are provided in the second delivery tube, wherein the supporting device has a preset shape, wherein when the supporting device returns to the preset shape, the supporting device forms a first supporting area and a second supporting area, and the first supporting area and the second supporting 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 supporting device has a first form and a second form, wherein the supporting device is in the first form when in the second conveying tube, and after the supporting device extends out of the second conveying tube, the supporting device is converted from the first form to the second form.

[0011] As a further improvement of the present invention, a connection point is provided in the middle area of ​​the support device, and the connection point divides the support device into a first support area and a second support area.

[0012] As a further improvement of the present invention, a first fixing member is provided in the second delivery pipe, wherein the first fixing member is arranged at a connection point, and the distal end of the first connecting rod is connected to the first fixing member.

[0013] As a further improvement of the present invention, a second connecting rod and a second fixing member are provided in the second conveying tube, wherein the second fixing member is arranged at the proximal end of the supporting device, wherein the distal end of the second connecting rod is connected to the second fixing member, and pushing the second connecting rod can make the second supporting area fit the tissue to be closed.

[0014] As a further improvement of the present invention, pushing the first connecting rod can transform the supporting device from the first form to the second form, and pulling the second connecting rod can transform the supporting device from the second form to the first form.

[0015] As a further improvement of the present invention, the support device is arranged in an "8"-shaped structure, wherein when the support device is in the second form, the support device fits the tissue to be closed; and when the support device is in the first form, the support device is stretched into a slender member and pre-installed in the second delivery tube, which allows the support area of ​​the support device (i.e., the first support area and the second support area) to be made very large, which can effectively improve the fault tolerance of the puncture assembly during needle insertion.

[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 device 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 supporting device reaches the predetermined surgical position, the supporting device is located between the first tissue and the second tissue.

[0018] As a further improvement of the present invention, a clamping mechanism is provided in the first conveying tube. The clamping mechanism includes a spring piece and a control line. The spring piece is sleeved on the second conveying tube.

[0019] As a further improvement of the present invention, after the support device reaches a predetermined position, the control line is pulled to cause the spring sheet to open and cooperate with the support device to clamp the first tissue to achieve positioning.

[0020] As a further improvement of the present invention, the stiffness of the first supporting area is greater than the stiffness of the second supporting area.

[0021] As a further improvement of the present invention, the supporting device is formed by winding one or more strands of wire, and the wire is made of memory metal material (for example, nickel-titanium alloy material).

[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. The existing closed system is provided with a support mechanism to provide support when puncturing tissue. However, due to the limitation of the sheath diameter, the volume of the support mechanism is limited, resulting in an insufficient support area. The puncture mechanism may be separated from the support area when puncturing tissue, and the support mechanism may be scratched with the head end of the sheath during recovery, resulting in recovery failure and other problems. According to one concept of the present application, the support device can be compressed into the second delivery tube during pre-installation, and after reaching the surgical position, it can be extended from the second delivery tube and restored to a pre-designed shape. The area of ​​the first support area and the second support area is not limited by the sheath diameter, which effectively increases the support area of ​​the support device and ensures that the puncture assembly can puncture tissue within the support area. At the same time, during recovery, it can be converted from the second shape to the first shape, reducing the difficulty of recovery.

[0025] 2. According to one concept of the present application, when the support device is in the first form, it is stretched into a slender member and pre-installed in the second delivery tube, which allows the support area of ​​the support device (i.e., the first support area and the second support area) to be made very large, which can effectively improve the fault tolerance of the puncture assembly during needle insertion. When in the second form, the support device is arranged in an "8"-shaped structure. When the needle insertion is completed, the support device can be smoothly retracted into the sheath, effectively reducing the difficulty of recovering the support device.

[0026] 3. According to one concept of the present application, pushing the second connecting rod can make the second supporting area of ​​the supporting device fit the tissue to be closed (primary septal tissue), which can effectively ensure the supporting strength during puncture.

[0027] 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

[0028] 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:

[0029] Figure 1a and Figure 1b Schematic diagram of the structure of the closed system of the present invention.

[0030] Figure 2 This is a first form diagram of the support device of the present invention.

[0031] Figure 3 This is a second form diagram of the supporting device of the present invention.

[0032] Figures 4a to 4fSchematic diagram of the operation process of the present invention.

[0033] The features indicated by the numbers in the accompanying drawings are as follows:

[0034] 1-first delivery tube, 11-clamping mechanism, 111-spring clip, 112-control line, 2-implant, 3-puncture assembly, 4-second delivery tube, 41-first connecting rod, 411-support device, 4111-connection point, 4112-first support area, 4113-second support area, 42-first fixing member, 43-second connecting rod, 44-second fixing member, 5-first tissue, 6-second tissue. DETAILED DESCRIPTION

[0035] 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.

[0036] 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.

[0037] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0038] 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.

[0039] In the prior art, the puncture instrument in the prior art does not provide support for the secondary septal tissue and has the problem of deviation from the predetermined position during the operation.

[0040] One purpose of the embodiments described below is to address the above-mentioned drawbacks, as well as other problems. Example

[0041] like Figure 1a and 1bAs shown, when the present invention is used to close the foramen ovale tissue, a closing system with a support function according to an embodiment of the present application is illustrated, including a first delivery tube 1, an implant 2 for closing tissue defects, and a puncture assembly 3 and a second delivery tube 4 arranged in the first delivery tube 1, the puncture assembly 3 can puncture the tissue to be closed back and forth, and the second delivery tube 4 is provided with a first connecting rod 41 and a support device 411 arranged at the distal end of the first connecting rod 41, the support device 411 has a preset shape, wherein, when the support device 411 is restored to the preset shape, the support device 411 is formed with a first support area 4112 and a second support area 4113, and the first support area 4112 and the second support area 4113 respectively provide support for the puncture assembly 3 when puncturing the tissue to be closed back and forth.

[0042] In the first embodiment, the supporting device 411 has a first form and a second form, wherein the supporting device 411 is in the first form when in the second delivery pipe 4. Figure 2 As shown, after the supporting device 411 extends out of the second delivery pipe 4, the supporting device 411 is transformed from the first form to the second form, as shown in FIG. Figure 3 shown.

[0043] In the first embodiment, a connection point 4111 is provided in the middle area of ​​the support device 411, and the connection point 4111 divides the support device 411 into a first support area 4112 and a second support area 4113. Figure 3 shown.

[0044] In the first embodiment, a first fixing member 42 is provided in the second delivery pipe 4 , wherein the first fixing member 42 is provided at the connection point 4111 , and the distal end of the first connecting rod 41 is connected to the first fixing member 42 .

[0045] In this embodiment 1, a second connecting rod 43 and a second fixing member 44 are provided in the second conveying tube 4, wherein the second fixing member 44 is arranged at the proximal end of the supporting device 411, wherein the distal end of the second connecting rod 43 is connected to the second fixing member 44, and pushing the second connecting rod 43 can make the second supporting area 4113 fit the tissue to be closed.

[0046] In the first embodiment, pushing the first connecting rod 41 can transform the supporting device 411 from the first form to the second form, and pulling the second connecting rod 43 can transform the supporting device from the second form to the first form.

[0047] In the first embodiment, the support device 411 is arranged in an "8"-shaped structure, wherein when the support device 411 is in the second form, the support device 411 fits the tissue to be closed; and when the support device 411 is in the first form, the support device 411 is stretched into a slender member and pre-installed in the second conveying tube 4, which allows the support area of ​​the support device 411 (i.e., the first support area 4112 and the second support area 4113) to be made very large, which can effectively improve the fault tolerance of the puncture assembly 3 during needle insertion.

[0048] In another embodiment, the support device 411 can obtain a larger support area after being deployed, so that the closed system can adapt to more physiological and anatomical structures, and continuous puncture at different positions can also be achieved through the puncture assembly 3.

[0049] In the first embodiment, the tissue to be closed includes a first tissue 5 and a second tissue 6, wherein after the support device 411 reaches the predetermined position, when the puncture assembly 3 punctures the first tissue 5, the first support area 4112 provides support for the puncture assembly 3, and when the puncture assembly 3 punctures the second tissue 6 in a circuitous manner, the second support area 4113 provides support for the puncture assembly 3. Figure 4c and 4d As shown; when this solution is used for foramen ovale closure surgery, the first tissue 5 is the secondary septal tissue, and the second tissue 6 is the primary septal tissue, as shown Figure 4a shown.

[0050] In the first embodiment, when the supporting device 411 reaches the predetermined surgical position, the supporting device 411 is located between the first tissue 5 and the second tissue 6. Figure 4b shown.

[0051] In the first embodiment, a clamping mechanism 11 is provided in the first delivery tube 1. The clamping mechanism 11 includes a spring piece 111 and a control line 112. The spring piece 111 is sleeved on the second delivery tube 4. Figure 1a As shown, after the support device 411 reaches the predetermined position, the control line 112 is pulled to open the spring piece 111 and cooperate with the support device 411 to clamp the first tissue 5 to achieve positioning, as shown in FIG. Figure 4c shown.

[0052] In the first embodiment, since the secondary septal tissue is thicker than the primary septal tissue, the stiffness of the first supporting region 4112 is greater than the stiffness of the second supporting region 4113 .

[0053] In the first embodiment, after the puncture assembly 3 punctures back and forth, one end of the implant 2 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 2 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.

[0054] The exemplary operation process of the closed system of the first embodiment is as follows: Figures 4a to 4f As shown:

[0055] (1) The delivery catheter enters the right atrium through the femoral vein and is then pushed to the patent foramen ovale between the secondary septum and the primary septum near the atrial septum. Figure 4a As shown;

[0056] (2) The delivery catheter is withdrawn so that the support device 411 extends out from the delivery catheter and returns to a preset shape. At this time, the support device 411 is located between the secondary septum and the primary septum. Subsequently, the control line 112 is pulled to open the spring 111 and clamp the secondary septum tissue. Figure 4b and 4c As shown;

[0057] (3) Operate the puncture assembly 3 so that it passes through the secondary septum along the predetermined route, continue the operation so that the puncture assembly 3 can detour along the predetermined route and puncture the primary septum. After the puncture is completed, withdraw the shrapnel 111 and store it in the delivery catheter. Figure 4d As shown;

[0058] (4) Observe the position of the right atrial foramen ovale to release the shunt, and operate the implant 2 to close the foramen ovale tissue to complete the operation. Figure 4e and 4f shown.

[0059] 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 system with a support function, comprising a first delivery tube, an implant for closing a tissue defect, a puncture assembly disposed within the first delivery tube, and a second delivery tube, the puncture assembly being capable of reciprocatingly puncturing the tissue to be closed, characterized in that: A first connecting rod and a support device arranged at the distal end of the first connecting rod are provided in the second delivery tube, and the support device has a preset shape, wherein when the support device returns to the preset shape, the support device forms a first support area and a second support area, 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, a connection point is provided in the middle area of ​​the support device, and the connection point divides the support device into the first support area and the second support area, and a first fixing member is provided in the second delivery tube, wherein the first fixing member is provided at the connection point, and the distal end of the first connecting rod is connected to the first fixing member.

2. A closing system with a supporting function according to claim 1, characterized in that: The supporting device has a first form and a second form, wherein the supporting device is in the first form when in the second conveying tube, and after the supporting device extends out of the second conveying tube, the supporting device is converted from the first form to the second form.

3. A closing system with a supporting function according to claim 2, characterized in that: A second connecting rod and a second fixing member are provided in the second delivery tube, wherein the second fixing member is arranged at the proximal end of the supporting device, wherein the distal end of the second connecting rod is connected to the second fixing member, and pushing the second connecting rod can make the second supporting area fit the tissue to be closed.

4. A closing system with a supporting function according to claim 3, characterized in that: Pushing the first connecting rod can transform the supporting device from the first form to the second form, and pulling the second connecting rod can transform the supporting device from the second form to the first form.

5. The closure system with support function according to claim 1, characterized in that: The support device is arranged in an "8"-shaped structure, wherein when the support device is in the second form, the support device fits the tissue to be closed.

6. The closure system with support function according to claim 1, characterized in that: The tissue to be closed includes a first tissue and a second tissue, wherein after the support device reaches a 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.

7. The closure system with support function according to claim 1, characterized in that: A clamping mechanism is provided in the first conveying tube. The clamping mechanism includes a spring piece and a control line. The spring piece is sleeved on the second conveying tube.

8. The closure system with support function according to claim 7, characterized in that: After the support device reaches a predetermined position, the control line is pulled to open the spring sheet and cooperate with the support device to clamp the first tissue to achieve positioning.

9. The closure system with support function according to claim 1, characterized in that: The stiffness of the first support area is greater than the stiffness of the second support area.

10. The closing system with supporting function according to claim 1, characterized in that: The supporting device is formed by winding one or more strands of wire, and the wire is made of memory metal material.

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