Atrial septum puncture device

Abstract

The atrial septum puncture device provided by the invention comprises a variable catheter provided with a protruding part; the variable catheter is sleeved with the adjusting tube, the far end of the adjusting tube is fixedly connected with the far end of the variable catheter, other parts of the adjusting tube can move relative to the variable catheter so as to change the protruding height of the protruding part, and the dilator can be controlled to abut against the atrial septum by adjusting the protruding height. According to the atrial septum puncture device, the protruding height of the protruding part can be adjusted by pushing and pulling the adjusting tube and the variable catheter so as to drive the dilator and the puncture needle to be attached to the atrial septum, and therefore the atrial septum puncture device does not need to change the bending position of the puncture needle and / or the dilator many times; and therefore, a solution is provided for realizing quick and convenient puncture.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to an atrial septal puncture device. Background Technology

[0002] Transseptal puncture (TSP), a common interventional cardiology procedure, originated in 1958. Initially used for left ventricular catheterization and left ventricular pressure measurement, it was popularized after the 1980s and became a routine technique with the development of percutaneous mitral valve repair and atrial fibrillation catheter ablation. It has rapidly gained widespread use in the 21st century. It is mainly used to treat left ventricular system diseases, such as left atrial appendage closure, percutaneous left ventricular repair, and mitral valve repair.

[0003] The atrial septum is located between the left and right atria and consists of two layers of endocardium, a small amount of myocardium, and connective tissue. The muscular portion, excluding the fossa ovalis, is 3-4 mm thick. The fossa ovalis is the thinnest part, only about 1 mm thick in the central area, making it an ideal puncture site for TSP. However, the position of the fossa ovalis in the heart varies greatly among individuals. For example, in patients with transverse heart, the fossa ovalis is lower than normal, while in patients with vertical heart, it is higher. Patients with a higher left atrium and a lower right atrium have a very small fossa area. The position of the fossa ovalis also differs from normal in patients with atrial septal aneurysm, enlarged aortic sinus, persistent left superior vena cava, congenital heart disease, dextrocardia, or straight back syndrome.

[0004] During atrial septal puncture, the general approach is as follows: the dilator is guided along the guidewire through the femoral vein and inferior vena cava to the right atrium, with the distal end of the dilator resting against the atrial septum to facilitate subsequent needle insertion. To ensure the distal end of the dilator adheres to the atrial septum and is as close as possible to the fossa ovalis, medical staff typically perform a preliminary bending of the dilator before it enters the patient's blood vessel, based on experience or preoperative CT scans. However, due to insufficient precision in CT scans and the pre-bending position of the dilator, multiple adjustments to the bending position and / or curvature are required during the procedure. This not only prolongs the operation time but also increases patient discomfort. Therefore, it is necessary to improve the puncture device for atrial septal puncture. Summary of the Invention

[0005] To address the aforementioned deficiencies in the prior art, this invention provides an atrial septal puncture device and a puncture apparatus, thereby enabling the dilator to quickly adhere to the atrial septum and improving surgical efficiency.

[0006] The guidewire-assisted transvalvular device provided by the present invention includes: A variable conduit, wherein the variable conduit is provided with a protruding portion; An adjustment tube is fitted inside the variable conduit, with its distal end fixedly connected to the distal end of the variable conduit. Other parts of the adjustment tube can move relative to the variable conduit to change the protrusion height of the protruding part. The protrusion height is adjusted to control the dilator to abut against the interatrial septum.

[0007] In other preferred embodiments, the variable conduit further includes a straight section along the axial direction of the variable conduit and a plastic section located at the distal end of the straight section, wherein the proximal and distal ends of the protruding portion are fixedly connected to the straight section and the plastic section, respectively.

[0008] In other preferred embodiments, the plastic portion is bent to one side, and when the protruding portion is in a bulging state, at least a portion of the protruding portion is away from the side where the plastic portion is bent, so as to control the expander against the interatrial septum by adjusting the protrusion height.

[0009] In other preferred embodiments, the structure of the side of the protrusion that bends toward the plastic portion is the same as or different from the structure of the side that bends away from the plastic portion, and preferably different. Furthermore, the protrusion height on the side away from the plastic portion is greater than the protrusion height on the side that bends toward the plastic portion. This design, on the one hand, reduces the diameter of the puncture device during delivery, minimizing damage to the patient's blood vessels. On the other hand, for patients with larger blood vessels, it is necessary to have a larger bulge on the side away from the plastic portion and a smaller bulge on the side that bends toward the plastic portion. This prevents the curved side from affecting the bulge height on the side away from the plastic portion due to its contact with the inner wall of the blood vessel.

[0010] In other preferred embodiments, the protruding portion includes multiple baskets, the baskets being in a straightened state with an angle α of 0°-30° to the axial direction of the variable conduit.

[0011] In other preferred embodiments, the side of the protruding portion that bends toward the plastic portion is not provided with a basket strip.

[0012] In other preferred embodiments, the protruding portion is formed by a woven mesh of intersecting braided threads.

[0013] In other preferred embodiments, the side of the protruding portion that bends toward the plastic portion is not provided with a woven mesh.

[0014] In other preferred embodiments, the proximal end of the regulating tube extends out of the variable conduit, and the proximal end of the variable conduit is provided with a fixing seat that can lock the regulating tube.

[0015] Using the atrial septum puncture device provided by this invention, the protrusion height of the protruding part can be adjusted by pulling and pushing the adjustment tube and the variable catheter, so as to drive the dilator and the puncture needle to fit the atrial septum. Thus, the atrial septum puncture device can fit tightly to the atrial septum without multiple shaping, providing a solution for achieving fast and convenient puncture.

[0016] 1. The device or apparatus provided by the present invention, during the delivery of the variable catheter to the patient, has the protrusion in a retracted state, which does not increase the maximum diameter required for the puncture and does not cause additional pain to the patient.

[0017] 2. Using the device provided by the present invention, by adjusting the protrusion height of the protruding part of the deformable tube, the side of the protruding part away from the bend of the dilator is made to abut against the inner wall of the inferior vena cava, so as to push the distal end of the dilator to abut against the atrial septum, which can adapt to different cardiac anatomy structures.

[0018] 3. The atrial septum puncture device provided by this invention fixes the curvature and / or bending position of the variable catheter and / or dilator. When locating the puncture site (such as the fossa ovalis), only the contact position and / or direction between the protruding part and the inferior vena cava needs to be changed, resulting in higher adjustment precision. Furthermore, the procedure can be completed while all components of the device are inside the patient's body. This avoids the complexity of the procedure caused by simultaneously changing the bending angle of the puncture needle and / or dilator when changing their bending position in existing technologies. Moreover, it eliminates the need to remove the puncture needle or dilator to adjust the curvature and / or bending position, significantly reducing surgical time.

[0019] 3. After the dilator is placed against the interatrial septum, the bulging position of the interatrial septum can be increased by continuing to adjust the diameter of the variable hemispherical basket, which makes it easier to determine the puncture point.

[0020] 4. The side of the protruding portion facing the interatrial septum can be designed as a cut groove instead of a basket strip or woven mesh. This reduces the pulling or pushing force required to adjust the protrusion height. It also allows for a further reduction in the diameter of the device or apparatus at the protruding portion, lessening pressure on the patient's blood vessels during delivery. Furthermore, for patients with larger blood vessels, the side away from the bend of the plastic part needs to bulge at a greater height, while the side facing the bend of the plastic part needs to bulge less. This prevents the bend from pressing against the inner wall of the blood vessel and affecting the bulging height of the side away from the bend of the plastic part.

[0021] 5. The dilator can use existing designs or the fixed curved shape dilator provided by this invention. The puncture needle is an existing design, which has stronger adaptability. Attached Figure Description

[0022] Figure 1A schematic diagram of the room partition puncture device provided by the present invention. Figure 2 A schematic diagram of the variable conduit provided by the present invention. Figure 2A for Figure 2 Enlarged view of a section at point A Figure 2B for Figure 2 Alternative embodiment at point A Figure 3 This is a schematic diagram of the cooperation between the variable conduit and the regulating tube of the present invention. Figure 3A for Figure 3 Enlarged view of part B in the middle Figure 4 A schematic diagram of the expander provided by the present invention. Figure 5 This is a schematic diagram of the puncture needle used in this embodiment; Figure 6A , Figure 6B This is a diagram illustrating the usage state of an interatrial septal puncture device provided by the present invention. Detailed Implementation

[0023] To more clearly illustrate the embodiments of the present invention, specific implementations will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings and other implementations can be obtained based on these drawings without any creative effort.

[0024] It should be noted that in this invention, the proximal end refers to the end closer to the medical staff, and the distal end is the end opposite to the proximal end. Since the components of the atrial septal puncture device provided by this invention are mainly elongated structures, the tubular structure in the prior art is shortened for the purpose of illustrating the inventive point.

[0025] like Figure 1 The image shows an embodiment of the interventricular puncture device provided by the present invention. The puncture device 10 includes a variable catheter 11, an adjustment tube 13, a dilator 14, and a puncture needle 15. Figure 1 The puncture device shown is only for illustrating the use of the atrial septum puncture device provided by the present invention. Although the dilator 14 and puncture needle 15 are shown, in the actual product, the dilator 14 and / or puncture needle 15 may not be included in the device, but may be equipped by the user, such as medical personnel, with the dilator 14 and / or puncture needle 15 in the prior art. Of course, the actual product may also be equipped with the dilator 14 and / or puncture needle 15.

[0026] like Figure 1As shown, the regulating tube 13 is sleeved inside the variable conduit 11, the distal end of the regulating tube 13 is fixedly connected to the distal end of the variable conduit 11, and the other parts of the regulating tube 13 can move relative to the variable conduit 11.

[0027] like Figure 2 , Figure 2A As shown, this is one embodiment of the variable catheter 11. The variable catheter 11 includes a straight section 111 along the axial direction of the variable catheter 11, a plastic section 112 located at the distal end of the straight section 111, and a protruding section 122 located between the straight section 111 and the plastic section 112. The proximal and distal ends of the protruding section 122 are fixedly connected to the straight section 111 and the plastic section 112, respectively. The purpose of providing the plastic section 112 is to ensure that the variable catheter 11 can pass smoothly through the patient's blood vessels, and to allow the dilator 14 and / or the puncture needle 15 to bend when passing through the variable catheter 11 and the adjusting tube 13, so that the distal end of the dilator 14 and / or the puncture needle 15 abuts against the interatrial septum. That is, the plastic section 112 needs to have a certain degree of flexibility, therefore, its hardness should be lower than that of the straight section 111. When the variable catheter 11 passes through the patient's blood vessel, it mainly relies on the rigidity of the straight section 111 to advance. Therefore, it needs to have a certain degree of resistance to bending, but it also needs to adapt to the bending of the patient's blood vessel. Therefore, the straight section 111 can be made of a polymer material, such as PEBAX, PA, PEEK, HDPE, or PTFE, or it can be made of the above materials combined with braided metal wire.

[0028] Continue as Figure 2 and Figure 2A As shown, the side of the protruding portion 12 that bends away from the plastic portion 112 (referred to as the outer side) is composed of multiple basket strips 121, preferably 3-5. When the basket strips 121 are straight, the included angle α of the axial direction of the variable conduit 11 is 0°-30°, preferably 0°, that is, when the basket strips 121 are straight, they extend along the axial direction of the variable conduit 11. The structure of the side of the protruding portion 12 that bends towards the plastic portion 112 (inner side) is different from the structure of the outer side, such as... Figure 2A As shown, the outer side of the protruding part 12 is formed by cutting a semi-circular polymer tubular material along the axial direction of the variable conduit 11, while the inner side of the protruding part 12 is formed by completely removing the semi-circular polymer tubular material, resulting in a rectangular hollow structure on the inner side of the protruding part 12. The side of the protruding part 12 that bends towards the plastic part 112 does not have a basket strip.

[0029] Of course, in other embodiments, the inner structure of the protruding portion 12 can also be the same as the outer structure, such as... Figure 2A As shown, the inner and outer sides of the protruding part 12 are both surrounded by multiple basket strips 121 parallel to the axial direction of the protruding part 12.

[0030] In other embodiments, the inner structure of the protruding portion 12 can also be the same as the outer structure. For example, both the inner and outer sides of the protruding portion 12 are surrounded by a woven mesh formed by intersecting braided wires. However, in these embodiments, the supporting force of the woven mesh is generally weaker than that of the basket strip 121. In order for the inferior vena cava to provide a certain supporting force to the protruding portion 12 so as to push the distal end of the dilator 14 toward the interatrial septum, it is necessary to adjust the diameter of the braided wires.

[0031] In other embodiments, to ensure that the distal end of the expander 14 can abut or even abut against the interatrial septum when the protruding portion 12 is in the bulging state, the protrusion height of the protruding portion 12 in the bulging state is preferably 3mm-45mm, more preferably 5mm-35mm, and even more preferably 10-25mm, such as 13mm, 15mm, 18mm, 20mm, 22mm, etc. Figure 2B In the embodiment shown, the protrusion height H of the protruding portion 12 in the expanded state is the maximum cross-sectional radius of the basket net formed by the basket strips. That is, when the protruding portion 12 is in the expanded state, at least a portion of the protruding portion 12 is away from the side where the plastic portion 112 is bent.

[0032] In other embodiments, the proximal end of the plastic portion 112 is further provided with a straight tube portion 1121, the length of which is preferably 10mm-50mm, and the proximal end of the straight tube portion 1121 is fixedly connected to the protruding portion 12.

[0033] like Figure 3 , Figure 3A The diagram shows the connection between the variable catheter 11 and the adjusting tube 13. The distal end of the adjusting tube 13 is fixedly connected to the inner wall of the variable catheter 11, and the fixed connection point mainly serves as a force-bearing point. The adjusting tube 13 can be fixedly connected to the distal end of the variable catheter 11, or it can be fixedly connected to the distal end of the straight section 111 of the variable catheter 11, and it is preferred to be fixedly connected to the distal end of the straight section 111 of the variable catheter 11. This is because in this embodiment, the adjusting tube 13 will not affect the plasticity or flexibility of the plastic part 112 of the variable catheter 11, and it allows the dilator 14 and the puncture needle 15 to bend towards the interatrial septum more easily after passing through the plastic part 112.

[0034] Continue as Figure 3 As shown, the proximal end of the regulating tube 13 extends through the variable catheter 11, and the proximal end of the variable catheter 11 is provided with a locking seat 113 for locking the regulating tube 13. The structure of the locking seat 113 is prior art, with an elastic sealing gasket on the inner side. The regulating tube 13 and the variable catheter 11 can be locked by rotating the locking seat 113. This is to prevent the protrusion height of the protruding part 12 from changing due to the relative movement of the regulating tube 13 and the variable catheter 11 during subsequent operations, and to prevent the patient's blood from leaking out from the gap between the variable catheter 11 and the regulating tube 13.

[0035] In other embodiments, the septal puncture device may also include a dilator 14, such as Figure 4 As shown, the dilator 14 can pass through the inner lumen of the regulating tube 13 and exit from the distal end of the variable conduit 11. The distal end of the dilator 14 is provided with a bend 141, which is aligned with the bending direction of the plastic part 112. The elasticity of the bend 141 can be similar to that of the plastic part 112 to facilitate the bending of the interatrial septum 14 when passing through the plastic part 112.

[0036] In other embodiments, such as Figure 5 As shown, the interatrial septal puncture device may also include a puncture needle 15, which can pass through the dilator 14 and extend out of the distal end of the dilator 14 so that the puncture needle 15 can pass smoothly through the interatrial septum after the dilator 14 is against the interatrial septum.

[0037] like Figure 6A , 6B As shown, during the surgery of this invention, the protrusion height H of the protruding part 12 can be adjusted as follows: In the initial state, the protruding part 12 is in a retracted state, and the protrusion height of the protruding part 12 is basically the radius of the variable catheter 11, or in a natural raised state. Figure 6A As shown, at this point, one side of the variable catheter 11 is placed against the side furthest from the atrial septum, preventing the atrial septum from adhering to it. After fixing the distal positions of the variable catheter 11 and the adjusting tube 13, the proximal position of the adjusting tube 13 can be kept stationary. Pushing the proximal end of the variable catheter 11 distally causes the protruding part 12 to be compressed and bulge outwards. Once the bulge height H reaches a certain value, the outer side of the protruding part 12 adheres to the medial wall of the inferior vena cava. Continuing to push the proximal end of the variable catheter distally further increases the bulge height of the protruding part 12. The protruding part 12 is compressed by the medial wall of the inferior vena cava, pushing the variable catheter 11 towards the atrial septum until the atrial septum tissue is observed to bulge towards the left atrium through imaging. This indicates that the dilator 14 is firmly against the atrial septum, and the bulge height H of the protruding part 12 has reached the required level. At this point, medical staff use external imaging to observe whether the bulging part of the atrial septum is the fossa ovalis. If so, the puncture preparation is complete. If not, adjust the contact position of the protruding part 12 with the medial wall of the inferior vena cava according to the height and direction of the distance from the fossa ovalis. It should be noted that when adjusting the position of the protruding part 12, the protruding part 12 should be in a retracted state to avoid scratching the patient, until the distal end of the dilator 14 is against the fossa ovalis to complete the puncture preparation.

[0038] Then, insert the puncture needle 15 along the dilator 14 until the distal end of the puncture needle 15 reaches the distal end of the dilator 14, that is, it is against the fossa ovalis of the interatrial septum. Push the puncture needle 15 distally with force, and the puncture needle 15 pierces the interatrial septum, completing the interatrial septal puncture.

[0039] Of course, in other embodiments, the pull-back adjustment tube 13 can also be used to make the protruding part 12 bulge out, so that the diameter of the protruding part 12 increases, thereby allowing the whole device to approach the interatrial septum, or to apply force to the interatrial septum.

[0040] like Figure 2B As shown, the protruding part 12 can also be made of polymer tube. The polymer tube is cut along the axial direction and then welded or bonded to the plastic part 112 and the straight part 111. The basket strip 121 is preferably elongated.

[0041] Preferably, the proximal ends of the variable catheter 11, the adjusting tube 13, and the dilator 14 are all provided with fixing seats 16. The structures of the several fixing seats 16 can be the same, and they are all purchased from the market. They have the function of sealing and stopping bleeding, and at the same time, they can lock the adjusting tube 13 and the dilator 14.

[0042] The following describes the procedure: First, the femoral vein is punctured, and the distal end of the guidewire is advanced along the femoral vein to the superior vena cava. Then, the variable catheter, adjusting tube, and dilator provided by this invention are simultaneously or sequentially inserted along the guidewire into the superior vena cava, and then the guidewire is withdrawn. The distal end of the puncture device is pulled back into the right atrium, so that the distal ends of the dilator and adjusting tube are facing the interatrial septum. The adjusting tube is fixed, and the variable catheter is pushed distally so that the protruding part protrudes outward, moving the central axis of the dilator to one side of the interatrial septum until the distal end of the dilator is close to the interatrial septum, applying pressure to the interatrial septum. The adjusting tube is locked with the fixing seat to maintain the protruding height of the protruding part, ensuring that the dilator can continuously apply pressure to the interatrial septum. External imaging is used to determine whether the distal end of the dilator is against the fossa ovalis. If not, the axial position of the variable catheter is adjusted as described above. If it is, the puncture needle is inserted along the dilator, and the puncture needle is advanced along the dilator to the position of the interatrial septum for puncture. After the puncture needle is inserted, release the locking of the fixing seat to the adjustment tube, pull back the variable catheter so that the protruding part is in the closed state, and continue to push the dilator and deformable catheter distally so that the distal end of the dilator crosses the interatrial septum along the puncture needle. Withdraw the puncture needle, variable catheter and adjustment tube to complete the puncture. The dilator remains in the patient's body to prepare for subsequent surgery.

[0043] The above description is only a preferred embodiment of this patent. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this invention, and these improvements and modifications should also be considered within the scope of protection of this invention.

Claims

1. A transseptal puncture device, characterized in that, The device includes: A variable conduit, wherein the variable conduit is provided with a protruding portion; An adjusting tube is fitted inside the variable conduit, with its distal end fixedly connected to the distal end of the variable conduit. Other parts of the adjusting tube can move relative to the variable conduit to change the protrusion height of the protruding portion.

2. The transseptal puncture device according to claim 1, characterized in that, The variable conduit also includes a straight section along the axial direction of the variable conduit and a plastic section located at the distal end of the straight section, wherein the proximal and distal ends of the protruding portion are fixedly connected to the straight section and the plastic section, respectively.

3. The transseptal puncture device according to claim 2, characterized in that, When the plastic portion bends to one side, and the protruding portion is in a bulging state, at least a portion of the protruding portion is away from the side where the plastic portion bends.

4. The atrial septal puncture device according to claim 3, characterized in that, The structure of the side of the protrusion that bends toward the plastic part may be the same as or different from the structure of the side that bends away from the plastic part.

5. The atrial septal puncture device according to claim 1, characterized in that, The protruding portion includes multiple baskets, and when the baskets are straightened, the angle α between them and the axis of the variable conduit is 0°-30°.

6. The atrial septal puncture device according to claim 5, characterized in that, The side of the protruding portion that bends toward the plastic portion does not have a basket strip.

7. The transseptal puncture device according to claim 1, characterized in that, The protruding portion is formed by a woven mesh made of intersecting braided threads.

8. The transseptal puncture device according to claim 7, characterized in that, The side of the protruding portion that bends toward the plastic portion is not provided with a woven mesh.

9. The transseptal puncture device according to claim 1, characterized in that, The proximal end of the regulating tube extends out of the variable conduit, and the proximal end of the variable conduit is provided with a fixing seat that can lock the regulating tube.

10. The atrial septal puncture device according to claim 3, characterized in that, The device also includes a dilator that extends through the lumen of the regulating tube and exits from the distal end of the variable conduit.

11. The atrial septal puncture device according to claim 9, characterized in that, The distal end of the expander is provided with a bent portion, and the bending direction of the bent portion is consistent with that of the plastic portion.

12. A transseptal puncture device, characterized in that, Includes the interventricular septal puncture device as described in claim 10 or 11, and a puncture needle that can pass through the dilator and exit the distal end of the dilator.

Images