Rapid non-exchange puncturing and conveying system for heart patent foramen ovale plugging

Abstract

The utility model provides a rapid non-exchange puncturing and conveying system for heart patent foramen ovale plugging. The rapid non-exchange puncturing and conveying system comprises a conveying sheath body and an expansion inner core. The conveying sheath body comprises a sheath head section, a bending adjusting section, a pipe body section and a connector section which are sequentially arranged. The total length of the sheath head section and the bending adjusting section is 2-3 cm, the length of the bending adjusting section is 0.5-1 cm, and the bending degree of the bending adjusting section is adjustable. The expansion inner core is arranged in the conveying sheath body in a penetrating mode. The conveying sheath body, the expansion core and the plugging device assembly system can smoothly complete the conveying sheath to enter the left atrium through the patent foramen ovale and complete the plugging device release operation, particularly, the bending adjusting section is designed to be adjustable in bending, the conveying sheath is more suitable for right atrium operation of different forms, the instrument exchange step in the existing operation process is reduced, and the operation efficiency is improved. The risk that an atrium and an atrial appendage are damaged by an existing material is reduced, the operation time can be remarkably shortened, and a very simple patent foramen ovale plugging operation is achieved.

Description

Technical Field

[0001] The utility model relates to the technical field of patent foramen ovale closure surgery, in particular to a rapid non-exchange puncture and delivery system for patent foramen ovale closure. Background Art

[0002] The foramen ovale is a physiological passageway in the atrial septum during embryonic development. It typically closes anatomically after birth with the establishment of pulmonary circulation in the newborn. If the foramen ovale remains intact after age 3 years, it is called a patent foramen ovale, with an adult prevalence of up to 25%. Most patients with a patent foramen ovale are asymptomatic, but severe cases, particularly those with right-to-left shunts, can cause paradoxical embolic disorders such as stroke, migraine, peripheral arterial embolism, and decompression sickness. Among cryptogenic stroke patients, 40% to 50% have a patent foramen ovale. Medical treatments for these conditions are ineffective and often have poor clinical outcomes. However, surgical closure can fundamentally address the problem and offer a definitive cure.

[0003] Currently available patent foramen ovale closure devices, particularly the delivery sheath, are modeled on or directly adopt materials and methods from atrial septal defect closure procedures. These devices require several steps, including passage through the foramen ovale via a right coronary angiography tube or pressure gauge combined with a guidewire, replacement of the delivery sheath, connection of the occluder to the delivery sheath, device deployment, and evaluation of the closure efficacy. Patient-to-patient cardiac structural variations and the unfamiliarity of novice surgeons with cardiac anatomy complicate the crucial step of guidewire passage through the foramen ovale into the left atrium, contributing to the high incidence of complications and prolonged procedures. The structural characteristics of currently used delivery sheaths can damage critical left atrial structures. Studies have shown that complications are as high as 3.23%. An early safety and efficacy analysis of patent foramen ovale closure using transthoracic echocardiography alone was conducted. These complications include inability to pass through the foramen ovale, thrombosis and embolism, left and / or right atrial appendage damage and perforation, atrial endothelial injury, hemopericardium, and even tamponade. Severe cases require open thoracotomy.

[0004] To this end, we have developed a minimalist X-ray foramen ovale closure technique, which has been found to significantly shorten the operation time, reduce surgical complications, and has significant operability and popularization. The operation process is briefly described as follows: After local anesthesia, the right femoral vein is punctured, and the guide wire is sent to the superior vena cava. The needle is withdrawn and the skin and subcutaneous tissue are broken. The combined delivery sheath and inner core are sent into the tracheal bifurcation plane of the superior vena cava along the guide wire. The guide sheath and inner core are withdrawn (at an angle of 30-60 degrees to the femoral vein, usually 45 degrees). When the sheath and inner core have obvious bounces, it indicates that the inner core has entered the fossa ovalis. The sheath and inner core are slightly pushed forward about 0.2 cm to the right and fixed. Push the wire forward. If there is no resistance, the inner core will come out easily, indicating that the guidewire is in the left atrium. Push the sheath forward about 0.3-0.5cm and rotate it slightly clockwise. Push the guidewire forward. If the guidewire comes out of the cardiac shadow to the left, it indicates that it has entered the left superior or inferior pulmonary vein. Push the sheath and inner core forward and make sure that the sheath passes through the foramen ovale. Then assemble the occluder and occlude it in parallel. Subsequent operations are the same as conventional methods. If there is resistance when pushing the guidewire forward or the inner core comes out to the right side of the patient, it is still in the right atrium. Push the sheath and inner core forward 0.2-0.5cm, ask the patient to exhale deeply and hold his breath, and push the guidewire forward at the same time. At this time, due to the existence of right-to-left shunt, the guidewire can easily pass through the foramen ovale into the left atrium and continue with subsequent operations.

[0005] This method is relatively simple to operate, has a high success rate (100%), is basically free of complications, can significantly save operating time, and reduce costs (reduce the use of some consumables). However, during the operation, we found that the delivery sheath currently used in the market has many shortcomings. The existing system is too long and its distal curvature is too large, which is not conducive to minimalist passage through the patent foramen ovale. It is necessary to use a single-bend right coronary angiography tube combined with an ultra-slip guide wire to pass through the foramen ovale first, and the guide wire is left in the left superior pulmonary vein for exchange. This increases the operation time and significantly increases the use of radiation. There is a risk of accidentally injuring the right atrial appendage or other structures during right atrial operation. During the exchange process, there is a risk of damaging the left atrial appendage and left atrial wall due to the excessive curvature and high hardness of the front end. These complications have been reported in the literature, and severe cases require thoracotomy. Due to the excessive length of the distal end of the existing delivery sheath, the pulsation is not obvious during the process of sliding down from the superior vena cava to the fossa ovalis. Utility Model Content

[0006] In view of the above problems existing in the prior art, the technical problem to be solved by the present invention is that when adopting X-ray guided minimalist foramen ovale occlusion surgery, the size of the delivery sheath currently used in the market is not conducive to the performance of X-ray guided minimalist foramen ovale occlusion surgery.

[0007] To solve the above technical problems, the present invention adopts the following technical solution: a rapid non-exchange puncture and delivery system for occluding patent foramen ovale, comprising:

[0008] The delivery sheath body comprises a sheath head section, a bending section, a tube body section and a joint section arranged in sequence; the total length of the sheath head section and the bending section is 2-3 cm, the length of the bending section is 0.5-1 cm, and the curvature of the bending section is adjustable; and

[0009] The expansion inner core is inserted into the delivery sheath body.

[0010] Preferably, it also includes an adjustment mechanism, which includes: a bending handle, a knob, an airbag and a transmission assembly; the bending handle is installed on the tube body section; the knob is rotatably installed on the bending handle; a cavity is opened on the bending handle; the airbag is embedded on one side of the bending section; and the airbag is connected to the cavity; the rotation of the knob can transport the gas in the cavity toward the airbag through the transmission assembly, so that the bending section can be pushed to bend by the expansion of the airbag.

[0011] Preferably, the transmission assembly includes: a connecting pipe, an inner ring gear, a gear, a screw rod and a pushing piece; one end of the connecting pipe is connected to the airbag, and the other end of the connecting pipe is connected to the cavity; the knob is coaxially rotatable on the bending adjustment handle; the inner ring gear is coaxially fixedly mounted on the inner side of the knob; the screw rod is rotatably mounted on the bending adjustment handle, and the screw rod extends into the cavity; the pushing piece is slidably mounted in the cavity along the length direction of the screw rod, and the pushing piece is threadedly connected to the screw rod; the gear is coaxially fixedly mounted on the screw rod, and the gear is meshed with the inner ring gear.

[0012] Preferably, the joint section is provided with threads.

[0013] Preferably, it further comprises an occluder, which is detachably connected to the joint segment via the thread.

[0014] Preferably, the tail end of the expansion core is provided with a clamping piece that cooperates with the thread.

[0015] Preferably, an X-ray opaque mark is provided on the sheath head section.

[0016] Preferably, the head end of the expansion core is 4-4.5 cm long, and the head end of the expansion core is bent at 30-45°.

[0017] Preferably, the length of the delivery sheath body is 85 cm.

[0018] Preferably, the length of the expansion core is 87 cm

[0019] Compared with the prior art, the present invention has at least the following advantages:

[0020] 1. The assembly system of the delivery sheath, expansion core, and occluder can smoothly complete the delivery sheath into the left atrium through the patent foramen ovale and complete the occluder release operation. In particular, the adjustable bending section design is more suitable for different forms of right atrial operations, reducing the number of equipment exchange steps in the existing surgical process and the risk of existing materials damaging the atrium and atrial appendage. It can significantly shorten the operation time and achieve a minimalist patent foramen ovale occlusion surgery.

[0021] 2. After the delivery sheath body and the expansion core are combined and fixed, the length of the expansion core tip out of the sheath is 2-2.5 cm, and the entire curvature system is 9 cm shorter than the existing equipment, thereby reducing the damage to the superior vena cava, right atrium and right atrial appendage during the delivery system's sliding down from the superior cavity; the beating characteristics of the delivery system when entering the oval fossa can be more clearly displayed, and the delivery sheath can enter the left atrium more smoothly; after the delivery system enters the left atrium, the risk of damaging the left atrial appendage and left atrial wall is significantly reduced due to the short head end, and it is easier to deliver into the left pulmonary vein. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the specific embodiments of the present invention, the following briefly introduces the drawings required for use in the specific embodiments. In all the drawings, each element or part is not necessarily drawn according to the actual scale.

[0023] Figure 1 This is a three-dimensional diagram of the installation of the delivery sheath body and the expansion inner core provided in an embodiment of the present utility model.

[0024] Figure 2 This is a three-dimensional diagram of the delivery sheath body and the occluder provided in an embodiment of the present utility model.

[0025] Figure 3 This is a structural diagram of the transmission assembly and adjustment mechanism provided in an embodiment of the present utility model.

[0026] Figure 4 This is a partial cross-sectional view of the delivery sheath body provided in an embodiment of the present invention.

[0027] Figure markings: 1-delivery sheath body, 11-sheath head section, 12-bending section, 13-tube body section, 14-connector section, 2-expansion inner core, 3-adjustment mechanism, 31-bending handle, 32-knob, 33-airbag, 4-transmission assembly, 41-connecting pipeline, 42-inner gear ring, 43-gear, 44-screw, 45-pushing member, 5-occluder, 6-clamping member, 7-X-ray opaque mark. DETAILED DESCRIPTION

[0028] The following embodiments of the technical solution of the present invention are described in detail with reference to the accompanying drawings. The following embodiments are only used to more clearly illustrate the technical solution of the present invention and are therefore only examples and are not intended to limit the scope of protection of the present invention.

[0029] In the present invention, it should 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" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation to the present invention.

[0030] In this utility model, unless otherwise specified or limited, the terms "installed," "connected," "connect," "fixed," etc. should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integration; mechanical connection, electrical connection; direct connection, indirect connection through an intermediate medium, internal communication between two components, or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in this utility model based on specific circumstances.

[0031] See also Figure 1-Figure 4 The present invention provides an embodiment of a rapid, non-exchange puncture and delivery system for occluding a patent foramen ovale, comprising a delivery sheath body 1 and an expandable core 2. The delivery sheath body 1 comprises a sheath head section 11, a bend adjustment section 12, a tube body section 13, and a connector section 14, which are sequentially arranged. The sheath head section 11 and the bend adjustment section 12 have a total length of 2-3 cm, the bend adjustment section 12 has a length of 0.5-1 cm, and the curvature of the bend adjustment section 12 is adjustable. The expandable core 2 is inserted into the delivery sheath body 1. Specifically, the expandable core 2 is provided with a straight, hardened guidewire, 120 cm long, and a hardened guidewire, approximately 5 cm long, which is consistent with the design of a conventional hardened guidewire. Furthermore, an X-ray opaque mark 7 is provided on the sheath head section 11; the X-ray opaque mark 7 can indicate the position of the delivery sheath body 1 under X-rays; further, the length of the expansion inner core 2 is 87 cm, the length of the head end of the expansion inner core 2 is 4-4.5 cm, and the head end of the expansion inner core 2 is bent 30-45°; the length of the delivery sheath body 1 is 85 cm; and the inner diameter of the delivery sheath is 8.5F.

[0032] During specific implementation, by adjusting the curvature of the bending section 12, it is possible to conveniently pass through the patent foramen ovale, reducing operation time and reducing the risk of accidentally injuring the right atrial appendage or other structures during operation; and the design of the total length of the sheath head section 11 and the bending section 12 is 2-3 cm, which can effectively reduce the risk of damaging the left atrial appendage and left atrial wall due to excessive curvature and high hardness of the front end during the exchange process; in particular, the design of the adjustable curvature of the bending section 12 is more suitable for right atrial operations of different forms, reducing the equipment exchange steps in the existing surgical process, reducing the risk of existing materials damaging the atrium and atrial appendage, and can significantly shorten the operation time and achieve a minimalist patent foramen ovale closure surgery.

[0033] See also Figure 1-Figure 4 In other embodiments, an adjustment mechanism 3 is further included, comprising: a bending handle 31, a knob 32, an airbag 33, and a transmission assembly 4; the bending handle 31 is mounted on the tube body 13; the knob 32 is rotatably mounted on the bending handle 31; a cavity is defined in the bending handle 31; the airbag 33 is embedded in one side of the bending section 12; and the airbag 33 is in communication with the cavity; the rotation of the knob 32 can transport the gas in the cavity toward the airbag 33 via the transmission assembly 4, so that the airbag 33 expands and pushes the bending section 12 to bend. In specific implementation, the operator holds the bending handle 31 and rotates the knob 32. The knob 32 transports the gas in the cavity toward the airbag 33 via the transmission assembly 4, causing the airbag 33 to expand and push the bending section 12 to bend; the degree of bending of the bending section 12 is controlled by controlling the amount of gas entering the airbag 33; thus, the curvature of the bending section 12 can be adjusted. Specifically, the length of the bending handle is 10 cm.

[0034] See also Figure 1-Figure 4In other embodiments, the transmission assembly 4 includes: a connecting pipe 41, an inner ring gear 42, a gear 43, a screw rod 44 and a pushing member 45; one end of the connecting pipe 41 is connected to the airbag 33, and the other end of the connecting pipe 41 is connected to the cavity; specifically, the connecting pipe 41 can be an external pipe or a pipe opened on the delivery sheath body 1; the knob 32 is coaxially rotatably mounted on the bending adjustment handle 31; the inner ring gear 42 is coaxially fixedly mounted on the inner side of the knob 32; the screw rod 44 is rotatably mounted on the bending adjustment handle 31, and the screw rod 44 extends into the cavity; the pushing member 45 is slidably mounted in the cavity along the length direction of the screw rod 44, and the pushing member 45 is threadedly connected to the screw rod 44; the gear 43 is coaxially fixedly mounted on the screw rod 44, and the gear 43 is meshed with the inner ring gear 42. During specific implementation, the knob 32 is rotated, and the knob 32 drives the inner ring gear 42 to rotate, and the inner ring gear 42 drives the gear 43 meshing with it to rotate, and the gear 43 drives the screw rod 44 coaxially fixed with it to rotate, and the screw rod 44 drives the pusher 45 to slide in the cavity through the thread, and the pusher 45 transports the gas inside the cavity to the inside of the airbag 33 through the connecting pipe 41, so that the curvature of the bending adjustment section 12 can be adjusted; after the curvature of the bending adjustment section 12 is adjusted, the curvature of the bending adjustment section 12 can be fixed by pressing the knob 32 with a finger; and in order to prevent the pusher 45 from rotating on its own, the cross section of the cavity is set to a rectangular structure.

[0035] See also Figure 1-Figure 4 In another embodiment, the connector section 14 is provided with a thread; by providing the thread, it is convenient to connect with other instruments. Furthermore, it also includes an occluder 5, which is detachably connected to the connector section 14 through a thread. Specifically, the delivery cable of the occluder 5 is 130 cm long and is designed in the same manner as conventional. Through the delivery sheath body 1, the expansion core 2 and the occluder 5, the delivery sheath can smoothly pass through the unclosed foramen ovale into the left atrium and complete the release operation of the occluder 5. Furthermore, the tail end of the expansion core 2 is provided with a clamping piece 6 that cooperates with the thread; the expansion core 2 is installed on the delivery sheath body 1 through the thread through the clamping piece 6, so that the length of the head end of the expansion core 2 out of the sheath is 2-2.5 cm.

[0036] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. These modifications or replacements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and description of the present invention.

Claims

1. A rapid, non-exchange puncture and delivery system for occluding patent foramen ovale, characterized in that: include: The delivery sheath body comprises a sheath head section, a bending section, a tube body section and a joint section arranged in sequence; the total length of the sheath head section and the bending section is 2-3 cm, the length of the bending section is 0.5-1 cm, and the curvature of the bending section is adjustable; and The expansion inner core is inserted into the delivery sheath body.

2. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 1, characterized in that: It also includes an adjustment mechanism, which includes: a bending handle, a knob, an airbag and a transmission assembly; the bending handle is installed on the tube body section; the knob is rotatably installed on the bending handle; a cavity is opened on the bending handle; the airbag is embedded on one side of the bending section; and the airbag is connected to the cavity; the rotation of the knob can transport the gas in the cavity into the airbag through the transmission assembly, so that the bending section can be pushed to bend by the expansion of the airbag.

3. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 2, characterized in that: The transmission assembly includes: a connecting pipe, an inner ring gear, a gear, a screw rod and a pushing piece; one end of the connecting pipe is connected to the airbag, and the other end of the connecting pipe is connected to the cavity; the knob is coaxially rotatable on the bending adjustment handle; the inner ring gear is coaxially fixedly mounted on the inner side of the knob; the screw rod is rotatably mounted on the bending adjustment handle, and the screw rod extends into the cavity; the pushing piece is slidably mounted in the cavity along the length direction of the screw rod, and the pushing piece is threadedly connected to the screw rod; the gear is coaxially fixedly mounted on the screw rod, and the gear is meshed with the inner ring gear.

4. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 1, characterized in that: The joint section is provided with threads.

5. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 4, characterized in that: It also includes an occluder, which is detachably connected to the joint segment via the thread.

6. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 4, characterized in that: The tail end of the expansion core is provided with a clamping piece that cooperates with the thread.

7. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 1, characterized in that: An X-ray opaque mark is provided on the sheath head section.

8. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 1, characterized in that: The head end of the expansion core is 4-4.5 cm long, and the head end of the expansion core is bent 30-45°.

9. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 1, characterized in that: The length of the delivery sheath body is 85 cm.

10. A rapid non-exchange puncture and delivery system for occluding patent foramen ovale according to claim 1, characterized in that: The length of the expansion core is 87 cm.

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