Expansion tube adjusting device for PFO plugging

Abstract

The utility model discloses an expansion tube adjusting device for PFO plugging. The expansion tube adjusting device comprises an expansion tube and a telescopic adjuster. The rear end of the expansion tube is arranged in the telescopic regulator in a movable and lockable mode, and the telescopic regulator is used for driving the expansion tube to move forwards to extend out of the front end of the sheathing canal and move backwards to extend into the sheathing canal. By means of the expansion tube adjusting device for PFO plugging, the defect that an operation can only be completed by means of experience and skills of doctors in the prior art is overcome, by means of the telescopic adjuster, the front end of the guide wire can be quickly and accurately found, the purpose of going from the right atrium to the left atrium is smoothly achieved, the difficulty of the doctors in completing the operation is reduced, and meanwhile the accuracy of the operation is remarkably improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical instruments for vascular intervention surgery, and in particular to an expansion tube regulating device for PFO occlusion. Background Art

[0002] PFO closure is a surgical method for treating congenital structural heart disease. It is mainly for patients whose foramen ovale is not completely closed after birth. The principle of the operation is to implant an occluder in the patient's heart to block the foramen ovale, thereby preventing abnormal blood flow in the heart. After determining the occlusion position, the doctor will release and unfold the occluder so that it fits on the foramen ovale to achieve the occlusion effect.

[0003] For PFO closure, after preoperative preparations are completed, the doctor will insert the catheter into the heart cavity through the puncture channel and perform a right heart catheter examination. With the help of the catheter, the doctor can observe the structure inside the heart cavity and determine the specific location of the foramen ovale; a track is established on the basis of the catheter, and a delivery sheath is introduced. This sheath provides a channel for the subsequent implantation of the occluder; the occluder is delivered to the unclosed position of the foramen ovale through the delivery sheath; the position of the occluder is evaluated using transthoracic ultrasound and other technologies; once the position is confirmed to be correct, the doctor will release the occluder so that it fits tightly on the foramen ovale to achieve closure of the foramen ovale.

[0004] The surgical operation process of the prior art is:

[0005] The first step is to puncture the femoral vein, insert the puncture sheath, and insert the guide wire; the guide sheath is inserted along the guide wire through the puncture sheath to perform angiography, measure pulmonary artery pressure, and other operations;

[0006] The second step is divided into two situations: ①, relying on the doctor's experience and technique to pass the guide wire through the oval foramen, that is, to send the guide wire from the right atrium to the left atrium, leave the guide wire in the left atrium, and withdraw the guide sheath;

[0007] ② If step ① cannot be completed, it is necessary to insert a super-smooth guide wire first. The doctor's experience and technique are used to pass the super-smooth guide wire through the foramen ovale, that is, from Figure 2 The ultra-smooth guide wire is sent to the right left atrium through the right atrium gap; then the guide wire is replaced, the guide wire is left in the left atrium, and the guide sheath is withdrawn;

[0008] 3. After the guidewire successfully passes through the oval fossa, the sheath tube containing the occluder is inserted into the left atrium along the guidewire;

[0009] 4. Release the oval fossa occluder and complete the operation.

[0010] Based on the above, the prior art has the following deficiencies:

[0011] 1. The current guide wire method relies on the doctor's experience and skills to try repeatedly, which is time-consuming and laborious, and the surgical process is relatively cumbersome;

[0012] 2. When trying to use a guidewire, safety is difficult to guarantee and the inside of the heart cavity may be damaged;

[0013] 3. When encountering an irregular oval fossa, the guide wire and super-smooth guide wire cannot be inserted normally, and the puncture instrument must be used to assist, which increases the cost of the operation;

[0014] 4. When encountering an irregular oval fossa, more instruments are required and the surgical procedure is more complicated. Utility Model Content

[0015] In view of this, the utility model proposes a dilation tube adjustment device for PFO occlusion to assist the guide wire to enter the left atrium from the foramen ovale or to puncture the fossa ovale to enter the left atrium in a specified direction.

[0016] In order to achieve the above purpose, the utility model adopts the following technical solutions:

[0017] A dilator adjustment device for PFO occlusion comprises a dilator and a telescopic adjuster; the rear end of the dilator is movably and lockably arranged in the telescopic adjuster, and the telescopic adjuster is used to drive the dilator to move forward and extend from the front end of a sheath tube, and move backward and extend into the sheath tube.

[0018] To better implement the above technical solution, optionally, the front end of the expansion tube has a side notch.

[0019] Optionally, the telescopic adjuster comprises:

[0020] A housing, wherein the front and rear ends of the housing have coaxial openings;

[0021] A rack is movably arranged in the housing along the axial direction of the through-port, the rack is provided with a connecting hole coaxial with the through-port, and the rear end of the expansion tube is fixed in the front end of the connecting hole;

[0022] A set screw rotatably extending through one side wall of the housing;

[0023] The gear is fixedly sleeved on the middle part of the set screw and meshed with the rack;

[0024] And an adjusting knob is arranged outside the shell and connected with the end of the set screw extending out of the shell.

[0025] Optionally, the telescopic adjuster further comprises a first connecting cover fixedly sleeved in the front end opening of the shell, the expansion tube slides through the first connecting cover, and the first connecting cover is used to connect to the bending adjuster.

[0026] Optionally, the telescopic adjuster further comprises a connecting tube, the front end of which is fixedly disposed in the rear end of the connecting hole and is axially connected to the expansion tube, and the rear end of the connecting tube is fixedly provided with a Luer seat.

[0027] Optionally, a sealing ring is provided on the mating surface between the connecting tube and the Luer seat.

[0028] Optionally, the maximum unidirectional movement length of the expansion tube along the axial direction of the connecting hole is not less than mm.

[0029] Optionally, a length mark is provided on the surface of the knob, and an indicator arrow is provided on the outer surface of the shell.

[0030] Beneficial effects of the utility model:

[0031] 1. The PFO occlusion expansion tube adjustment device of the utility model, by providing a telescopic adjuster, can push the expansion tube to accurately move forward to directly lift up the primary septum of the unclosed oval fossa, so that the gap at the oval fossa is enlarged, providing convenience for the guide wire to accurately enter the left atrium through the gap at the oval fossa. When the oval fossa is irregular, the guide wire can be pushed to accurately puncture the oval fossa until it is delivered to the left atrium. The use of the PFO occlusion expansion tube adjustment device overcomes the defect that the existing operation can only be completed by relying on the doctor's experience and skills. With the help of the telescopic adjuster, it is not only convenient for the front end of the guide wire to quickly find the correct position and successfully achieve the purpose of going from the right atrium to the left atrium, but also reduces the difficulty of the doctor to complete the operation, and at the same time significantly improves the accuracy of the operation.

[0032] 2. The expansion tube adjustment device for PFO occlusion of the utility model has a side notch at the front end of the expansion tube, which allows the front end of the guide wire to be deployed only at this position, and the direction of the side notch is adjusted and confirmed, ensuring that the guide wire can be accurately extended from a specific position, enhancing the controllability and accuracy of the operation. In this way, the front end of the guide wire is effectively prevented from stabbing the heart cavity, significantly improving the safety of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 This is a three-dimensional structural schematic diagram of a PFO plugging expansion tube adjustment device according to Example 1 of the utility model;

[0034] Figure 2 yes Figure 1 Exploded diagram of

[0035] Figure 3 Figure 1 A partial schematic diagram of

[0036] Figure 4 This is a front view of a PFO occlusion expansion tube adjustment device according to Embodiment 2 of the present utility model;

[0037] Figure 5It is a schematic diagram of the regular oval fossa guiding guidewire;

[0038] Figure 6 It is a schematic diagram of the irregular oval fossa guiding the guide wire;

[0039] Figure 7 yes Figure 1 Schematic diagram of the structure of the guide wire;

[0040] Reference numerals:

[0041] Sheath 10;

[0042] Bending adjuster 20;

[0043] Expansion tube 30, side notch 31;

[0044] Telescopic adjuster 40, sub-shell 41, indication arrow 411, guide groove 412, through hole 413, blind hole 414, through hole 415, rack 42, connecting hole 421, slide rail 422, set screw 43, gear 44, adjusting knob 45, length mark 451, first connecting cover 46, connecting pipe 47, sealing ring 471, Luer seat 48;

[0045] Guide wire 50, nickel-titanium alloy core 501, middle TPU layer 502, outer hydrophilic layer 503, bent end 51, folded end 52; DETAILED DESCRIPTION

[0046] The technical solution of the utility model is described in detail below in conjunction with the accompanying drawings and specific embodiments, wherein the same components are represented by the same reference numerals.

[0047] Example 1

[0048] like Figures 1 to 3 As shown, the embodiment of the utility model discloses a dilating tube adjustment device for PFO occlusion, comprising a dilating tube 30 and a telescopic adjuster 40, wherein the rear end of the dilating tube 30 is movably and lockably arranged in the telescopic adjuster 40, and the telescopic adjuster 40 is used to drive the dilating tube 30 to move forward and extend from the front end of the sheath tube 10, and move backward and extend into the sheath tube 10;

[0049] The PFO occlusion expansion tube adjustment device of the embodiment of the utility model is provided with a telescopic adjuster 30. For a conventional oval fossa, the expansion tube 30 can be pushed to move accurately forward to directly lift up the primary septum of the unclosed oval fossa, so that the gap at the oval fossa is enlarged, providing convenience for the guide wire to accurately enter the left atrium through the gap at the oval fossa. When the oval fossa is irregular, the end of the guide wire can be pushed to accurately puncture the oval fossa and deliver it to the left atrium. The use of the PFO occlusion expansion tube adjustment device overcomes the defect that the existing operation can only be completed by relying on the doctor's experience and skills. With the help of the telescopic adjuster 30, not only can the guide wire smoothly achieve the purpose of going from the right atrium to the left atrium, but also the difficulty of the doctor to complete the operation is reduced, and the accuracy of the operation is significantly improved.

[0050] Specifically, Figure 1 and Figure 3 As shown, the front end of the expansion tube 30 has a side notch 31 for the front end of the guide wire to extend. The side notch 31 can be an arc notch or a trumpet notch, and of course it can also be other shapes. The side notch 31 can be set so that the front end of the guide wire can only be deployed here, and the direction of the side notch 31 is adjusted and confirmed, ensuring that the guide wire can be accurately extended from a specific position, enhancing the controllability and accuracy of the operation. In this way, the front end of the guide wire is effectively prevented from stabbing the heart cavity, significantly improving the safety of the operation.

[0051] like Figures 1 to 3 As shown, the telescopic adjuster 30 includes a shell, a gear 44, a rack 42, a set screw 43 and an adjusting knob 45. The front and rear ends of the shell have coaxial through openings 413. Specifically, the shell is spliced ​​by two sub-shells 41, and the through opening 413 is located at the contact position of the two sub-shells 41. The rack 42 is axially movable along the through opening 413 in the cavity formed by the two sub-shells 41. Specifically, two guide grooves 412 are provided on the opposite side walls of the two sub-shells 41, and both ends of the guide grooves 412 are closed. The opposite sides of the rack 42 are provided with slide rails 422 that slide with the guide grooves 412. Such a design ensures that the gear 44 can only move along the length direction of the guide groove 412, thereby improving the stability and reliability of the adjustment.

[0052] like Figure 2As shown, the rack 42 is provided with a connecting hole 421 which is coaxial with the through hole 413, and the rear end of the expansion tube 30 is fixed in the front end of the connecting hole 421. Specifically, the rear end of the expansion tube 30 and the connecting hole 421 are formed as an integral component together by injection molding, thereby enhancing the firmness of the connection. The set screw 43 can be rotatably passed through one side wall of the shell. Specifically, the inner side wall of one subshell 41 is provided with a blind hole 414, and the inner side wall of the other subshell 41 is provided with a through hole 415 which is coaxial with the blind hole 414. One end of the set screw 43 can be rotatably placed in the blind hole 414, and the other end extends out of the shell from the through hole 415. The adjusting knob 45 is provided outside the shell and is connected to the end of the set screw 43 extending out of the shell. The gear 44 is fixedly sleeved on the middle part of the set screw 43 and meshed with the rack 42.

[0053] In the telescopic adjuster 30, by rotating the adjusting knob 45, the set screw 43 and the gear 44 can be rotated synchronously, thereby controlling the forward or backward movement of the rack 42, thereby accurately adjusting the position of the expansion tube 30, so that the expansion tube 30 moves forward to push the oval fossa or moves backward to separate from the oval fossa.

[0054] In an embodiment of the utility model, the maximum axial movement length of the expansion tube 30 along the connecting hole 421 is not less than 20 mm, that is, the length of the rack 42 moving along the length direction of the guide groove 412 is not less than 20 mm. Preferably, the length of the rack 42 moving along the length direction of the guide groove 412 is 30 mm, and the length of the rack 42 driven to move by one circle of the knob adjustment knob 45 is also 30 mm. The surface of the adjustment knob 45 is provided with a length mark 451, and the outer surface of the shell is provided with an indicator arrow 411, so that the telescopic adjuster 30 has precise displacement control. By adjusting the length mark 451 on the surface of the knob 45 and the indicator arrow 411 on the surface of the shell, the moving length of the rack 42 can be intuitively determined to achieve efficient operation.

[0055] like Figure 3 As shown, the telescopic adjuster 30 also includes a first connecting cover 46 fixedly sleeved in the front end opening 413 of the shell, and the expansion tube 30 slides through the first connecting cover 46, and the first connecting cover 46 is detachably connected to the second connecting cover (not shown in the figure) at the rear end of the bending adjuster 20.

[0056] In an embodiment of the utility model, the telescopic adjuster 30 also includes a connecting tube 47, the front end of the connecting tube 47 is fixedly placed in the rear end of the connecting hole 421, and is axially connected to the expansion tube 30. Specifically, the front end of the connecting tube 47 and the rack 42 are an integral structure, and the rear end of the connecting tube 47 is fixedly provided with a Luer seat 48. The mating surfaces of the connecting tube 47 and the Luer seat 48 are provided with a sealing ring 471. The connecting tube 47 is preferably a stainless steel conduit. The stainless steel conduit is provided so that the Luer seat 48 is always located outside the shell, and the sealing ring 471 can effectively avoid liquid leakage caused by the matching gap between the Luer seat 48 and the connecting tube 47.

[0057] Example 2

[0058] See also Figures 1 to 7 The utility model discloses a PFO adjustable bend guide device, which includes a sheath tube 10, a bend adjuster 20, an expansion tube 30, a telescopic adjuster 30 and a guide wire 50.

[0059] like Figure 4 As shown, the front end of the sheath 10 is used to be inserted into the superior vena cava, the bending regulator 20 is fixedly connected to the rear end of the sheath 10 and is used to adjust the bending degree of the front end of the sheath 10, the front end of the expansion tube 30 is sleeved in the sheath 10, and the rear end of the expansion tube 30 is movably and lockably arranged in the telescopic regulator 30, and the telescopic regulator 30 is used to drive the expansion tube 30 to move forward and extend from the front end of the sheath 10, and move backward and extend into the sheath 10; the front end of the guide wire 50 is a bent end 51 or a folded end 52, and the guide wire 50 is movably sleeved in the expansion tube 30.

[0060] In this embodiment, it should be noted that the sheath tube 10 and the bending adjuster 20 are exactly the same as the sheath tube 10 and the bending adjuster 20 in the patented adjustable bending guide sheath device (application number: 2023235874833) applied for by the applicant, and their specific structures are not repeated here.

[0061] In other optional embodiments, the sheath tube 10 and the bending regulator 20 may also adopt other structures in the prior art, and the specific structures will not be described in detail.

[0062] like Figure 7 As shown, the front end of the guide wire 50 is a bending end 51, and the rear end is a folded end 52, or the front end of the guide wire 50 is a folded end 52, and the rear end is a bending end 51. In this way, a guide wire 50 has both a bending end 51 and a folded end 52, which not only effectively saves materials, but also significantly reduces the operating steps during the operation, greatly shortening the operation time.

[0063] It should be noted in the utility model that the folded end 52 can be a paper clip structure or a structure similar to a paper clip, such as a circular ring structure.

[0064] like Figure 7 As shown, the tip of the bent end 51 is a rounded end. This end design can reduce the risk of tissue damage and improve operational safety. The tip of the folded end 52 is a pointed end to facilitate piercing the oval fossa.

[0065] like Figure 7 As shown, the main body, the bent end 51 and the rear part of the folded end 52 of the guide wire 50 all include a nickel-titanium alloy core 501, an intermediate TPU layer 502 and an outer hydrophilic layer 503 which are compounded in sequence from the inside to the outside. The end of the folded end 52 is the exposed nickel-titanium alloy core 501, and is a pointed end. The intermediate TPU layer 502 and the outer hydrophilic layer 503 are in an arc transition at the folded end 52. The nickel-titanium alloy core has excellent elasticity and shape memory properties. The intermediate TPU layer 502 provides good strength and toughness to ensure the stability of the guide wire 50 during use. The outer hydrophilic layer 503 makes the guide wire 50 have good lubricity, which facilitates its movement in the body and reduces friction and resistance. In summary, this structure greatly improves the reliability of the guide wire 50.

[0066] Based on this, the use of a PFO plugging expansion tube adjustment device in the embodiment of the utility model is as follows:

[0067] like Figure 5 As shown, S10, puncture the femoral vein, and send the bent end 51 of the guide wire 50 into the superior vena cava;

[0068] S20, preparing the sheath tube 10, the bending regulator 20, the dilator tube 30 and the telescopic regulator 30, flushing the above instruments with heparin water, and then sequentially conveying the sheath tube 10, the bending regulator 20, the dilator tube 30 and the telescopic regulator 30 along the guide wire 50 from the femoral vein until they enter the superior vena cava;

[0069] S30, withdraw the guide wire 50 into the dilation tube 30, adjust the bending adjuster 20 to bend the front end of the sheath tube 10, and observe the position of the device through the fluoroscopic device; observe the position of the oval fossa by injecting contrast agent, and adjust the sheath tube 10 according to the position of the oval fossa until it is in a suitable position;

[0070] S40, rotating the adjusting knob 45, so that the dilation tube 30 moves forward to the position of the unclosed oval fossa and is lifted up and then keeps the position unchanged;

[0071] S50, push the guide wire 50 forward until the bent end 51 is exposed from the side notch 31 of the dilator tube 30, passes through the unclosed area of ​​the oval fossa, and continues to push the guide wire 50 until the bent end 51 completely enters the left atrium, then withdraw the sheath 10, the bending adjuster 20, the dilator tube 30 and the telescopic adjuster 30.

[0072] like Figure 6As shown, S60, if the oval fossa is irregular in S50, that is, the bent end 51 cannot pass through, the guide wire 50 needs to be withdrawn and the folded end 52 is used; the tip of the head of the folded end 52 will puncture the oval fossa, and the folded end 52 will directly return to its original shape after puncture to prevent damage to the heart cavity.

[0073] S70, use the device equipped with the occluder to be delivered to the left atrium along the guide wire 50, release the front umbrella and then withdraw it to the right atrium, and then release the rear umbrella.

[0074] S80. Confirm the release effect of the occluder by placing it in multiple body positions, confirm it with ultrasound, remove the device after releasing the occluder, and apply pressure to stop bleeding.

[0075] It should be noted that S70 and S80 are steps for installing the occluder, and the device involved in this patent is an auxiliary procedure for installing the occluder.

[0076] The technical solution of the utility model is described in detail above in combination with specific embodiments, and the described specific embodiments are used to help understand the concept of the utility model. Derivations and variations made by those skilled in the art based on the specific embodiments of the utility model also fall within the protection scope of the utility model.

Claims

1. A PFO occlusion expansion tube adjustment device, characterized in that: The invention comprises an expansion tube (30) and a telescopic regulator (40), wherein the rear end of the expansion tube (30) is arranged in the telescopic regulator (40) in a movable and lockable manner, and the telescopic regulator (40) is used to drive the expansion tube (30) to move forward and extend out from the front end of the sheath tube (10), and move backward and extend into the sheath tube (10).

2. A PFO occlusion expansion tube adjustment device according to claim 1, characterized in that: The front end of the expansion tube (30) has a side notch (31).

3. The PFO occlusion expansion tube adjustment device according to claim 1, characterized in that: The telescopic adjuster (40) comprises: A shell, wherein the front and rear ends of the shell have coaxial through openings (413); A rack (42) is movably arranged in the housing along the axial direction of the through opening (413), the rack (42) is provided with a connecting hole (421) coaxial with the through opening (413), and the rear end of the expansion tube (30) is fixed in the front end of the connecting hole (421); A set screw (43) rotatably penetrates a side wall of the housing; A gear (44) is fixedly sleeved on the middle part of the set screw (43) and meshedly connected with the rack (42); And an adjusting knob (45) is arranged outside the housing and connected to the end of the set screw (43) extending out of the housing.

4. The PFO occlusion expansion tube adjustment device according to claim 3, characterized in that: The telescopic adjuster (40) further comprises a first connecting cover (46) fixedly sleeved in the front end opening (413) of the shell body, the expansion tube (30) slides through the first connecting cover (46), and the first connecting cover (46) is used to connect to the bending adjuster (20).

5. The PFO occlusion expansion tube adjustment device according to claim 4, characterized in that: The telescopic adjuster (40) further comprises a connecting tube (47), the front end of which is fixedly disposed in the rear end of the connecting hole (421) and is axially connected to the expansion tube (30), and the rear end of the connecting tube (47) is fixedly provided with a Luer seat (48).

6. The PFO occlusion expansion tube adjustment device according to claim 5, characterized in that: The mating surfaces of the connecting tube (47) and the Luer seat (48) are provided with a sealing ring (471).

7. The PFO occlusion expansion tube adjustment device according to claim 4, characterized in that: The maximum unidirectional moving length of the expansion tube (30) along the connecting hole (421) in the axial direction is not less than 20 mm.

8. The PFO occlusion expansion tube adjustment device according to claim 4, characterized in that: The surface of the knob is provided with a length mark (451), and the outer surface of the shell is provided with an indication arrow (411).

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