A delivery device for an atrial septal shunt

Abstract

The present invention belongs to the technical field of medical devices, and particularly relates to a delivery device for an atrial septal shunt, which comprises an inner core tube assembly, an inner sheath tube, an outer sheath tube and a handle. The outer sheath tube is connected to the handle. The inner core tube assembly is slidably fitted in the inner sheath tube, and the inner sheath tube is slidably fitted in the outer sheath tube. The proximal ends of the inner core tube assembly and the inner sheath tube are respectively connected to the handle. The handle adjusts the forward and backward feeding of the inner core tube assembly and the inner sheath tube and the curvature of the outer sheath tube to deliver the shunt to the atrial septal ostium. The delivery device of the present invention can adjust the delivery position at any time to improve the positioning accuracy, and the shunt is released precisely and the operation is convenient.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a delivery device for an atrial septal shunt. Background Art

[0002] Heart failure (HF) is a group of syndromes caused by impaired ventricular filling and / or ejection ability due to various heart structural or functional diseases, mainly due to the impaired systolic and diastolic functions of the myocardium, resulting in cardiac pump dysfunction.

[0003] Currently, most heart failures start with left heart failure, that is, it first presents as pulmonary circulation congestion. For chronic heart failure caused by persistent high pressure in the left atrium, the usual solution is to implant a shunt device in the atrial septum between the left atrium and the right atrium to re-distribute the atrial blood volume and reduce the imbalance of atrial pressure.

[0004] In the prior art, the shunt stent is compressed and then delivered into the human body through a delivery device. Due to the complex physiological structure of the human body, the delivery catheter usually cannot adapt to the individualized physiological and anatomical structure, resulting in difficult positioning of the delivery device, inaccurate release. At the same time, during the implantation process, once problems such as positioning deviation are found, it is often very difficult to adjust the delivery device, and it has extremely high requirements for the doctor's operation. Various additional operations will prolong the time of the patient exposed to X-rays, which is not conducive to the health of the patient. Therefore, it is necessary to improve it to overcome the deficiencies in practical applications. Summary of the Invention

[0005] Based on the above-mentioned disadvantages and deficiencies existing in the prior art, one of the purposes of the present invention is to at least solve one or more of the above-mentioned problems existing in the prior art. In other words, one of the purposes of the present invention is to provide a delivery device for an atrial septal shunt that meets one or more of the aforementioned requirements.

[0006] In order to achieve the above-mentioned invention purpose, the present invention adopts the following technical solutions:

[0007] A delivery device for an atrial septal shunt, comprising an inner core tube assembly, an inner sheath tube, an outer sheath tube and a handle. The outer sheath tube is connected to the handle. The inner core tube assembly is slidably fitted in the inner sheath tube, and the inner sheath tube is slidably fitted in the outer sheath tube. The proximal ends of the inner core tube assembly and the inner sheath tube are respectively connected to the handle. The handle adjusts the forward and backward feeding of the inner core tube assembly and the inner sheath tube and the curvature of the outer sheath tube to deliver the shunt to the atrial septal ostium.

[0008] As a preferred solution, the inner core tube assembly includes an inner core tube, a guiding head and a fixing head. The guiding head is fixed to the distal end of the inner core tube. A fixing head is sleeved on the inner core tube, and a shunt is installed between the guiding head and the fixing head.

[0009] As a preferred embodiment, the fixed head is evenly arranged in several positioning grooves along the circumferential direction, and the positioning grooves are coupled with the fixing ears of the diverter.

[0010] As a preferred embodiment, the inner sheath tube is sleeved on the inner core tube assembly. The inner sheath tube includes an inner sheath tube body and a receiving tube. The inner sheath tube body and the receiving tube are integrally connected by thermoplastic molding, and the aperture of the receiving tube is larger than that of the inner sheath tube body.

[0011] As a preferred embodiment, a developing ring is installed at the end of the receiving tube.

[0012] As a preferred embodiment, the outer sheath tube is sleeved on the inner sheath tube. The outer sheath tube includes an inner tube, a clamp, a reinforcing tube, an outer tube and a traction wire. The clamp and the reinforcing tube are sleeved on the inner tube. One end of the traction wire is fixed to the clamp, and the other end extends from the proximal end of the outer tube and is free in the outer tube.

[0013] As a preferred embodiment, the handle includes an outer sheath tube adjustment section, an inner sheath tube adjustment section and an inner core tube adjustment section. The outer sheath tube adjustment section, the inner sheath tube adjustment section and the inner core tube adjustment section are coaxially arranged and communicate with each other.

[0014] As a preferred embodiment, the outer sheath tube adjustment section includes a first outer shell, a bending adjustment knob, a bending adjustment slider and an outer sheath tube fixing seat. A guide rail is provided on the outer sheath tube fixing seat. The bending adjustment slider is slidably fitted on the guide rail. The bending adjustment knob is sleeved on the bending adjustment slider and is rotatably connected to the first outer shell.

[0015] As a preferred embodiment, the inner sheath tube adjustment section is connected to the proximal end of the inner sheath tube and is used to control the telescopic movement of the inner sheath tube.

[0016] As a preferred embodiment, the inner sheath tube adjustment section includes an inner sheath tube slider seat, an inner sheath tube slider, an inner sheath tube slider sleeve and an inner sheath tube adjustment knob. The inner sheath tube slider is sleeved on the inner sheath tube slider seat. The inner sheath tube slider is screwed to the inner sheath tube slider sleeve, and the inner sheath tube slider sleeve is screwed to the inner sheath tube adjustment knob. By rotating the inner sheath tube adjustment knob, the inner sheath tube slider slides axially.

[0017] As a preferred embodiment, the inner core tube adjustment section is connected to the proximal end of the inner core tube and is used to control the telescopic movement of the inner core tube.

[0018] As a preferred embodiment, the inner core tube adjustment section includes an inner core tube slider, an inner core tube slider seat and an inner core tube adjustment knob. The inner core tube slider is slidably fitted with the inner core tube slider seat, and the axial sliding of the inner core tube slider is adjusted by the inner core tube adjustment knob.

[0019] As a preferred embodiment, the sliding strokes of the inner sheath tube slider and the inner core tube slider are greater than the compressed length of the diverter.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0021] The conveying device of the present invention can be adapted to the individualized physiological anatomical structure, with precise release and convenient operation.

[0022] During the implantation process of the shunt in the present invention, when there is a positioning deviation, the conveying device can be adjusted at any time to adjust the conveying position and achieve accurate positioning. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 is a schematic structural diagram of the conveying device according to Embodiment 1 of the present invention;

[0024] Figure 2 is a schematic structural diagram of the inner core tube assembly according to Embodiment 1 of the present invention;

[0025] Figure 3 is a schematic structural diagram of the inner sheath tube according to Embodiment 1 of the present invention;

[0026] Figure 4 is a schematic structural diagram of the outer sheath tube according to Embodiment 1 of the present invention;

[0027] Figure 5 is a schematic diagram of the bending shape of the outer sheath tube according to Embodiment 1 of the present invention;

[0028] Figure 6 is a schematic cross-sectional view of the handle according to Embodiment 1 of the present invention;

[0029] Figure 7 is a partial schematic diagram of the outer sheath tube adjustment section of the handle according to Embodiment 1 of the present invention;

[0030] Figure 8 is a schematic diagram of the outer sheath tube fixing seat according to Embodiment 1 of the present invention;

[0031] Figure 9 is a cross-sectional view of the outer sheath tube fixing seat according to Embodiment 1 of the present invention;

[0032] Figure 10 is a schematic diagram of the bending slider according to Embodiment 1 of the present invention;

[0033] Figure 11 is a partial schematic diagram of the inner sheath tube adjustment section of the handle according to Embodiment 1 of the present invention;

[0034] Figure 12 is a schematic diagram of the inner sheath tube slider seat according to Embodiment 1 of the present invention;

[0035] Figure 13 is a schematic diagram of the inner sheath tube slider according to Embodiment 1 of the present invention;

[0036] Figure 14 is a cross-sectional view of the inner sheath tube slider according to Embodiment 1 of the present invention;

[0037] Figure 15It is a partial schematic view of the adjustment section of the inner core tube of the handle in the first embodiment of the present invention;

[0038] Figure 16 It is a schematic view of the inner core tube slider seat in the first embodiment of the present invention;

[0039] Figure 17 It is a schematic view of the inner core tube slider in the first embodiment of the present invention;

[0040] Figure 18 It is a schematic view of the shunt loader in the first embodiment of the present invention;

[0041] Figure 19 It is a schematic view of the fully loaded shunt in the first embodiment of the present invention;

[0042] Figure 20 It is a schematic view of the shunt release in the first embodiment of the present invention;

[0043] Figure 21 It is a schematic view of the fully released shunt in the first embodiment of the present invention;

[0044] In the figure: 1 - left atrium, 2 - left ventricle, 3 - right atrium, 4 - right ventricle, 5 - interatrial septum, 6 - atrial septostomy, 7 - inferior vena cava, 10 - inner core tube assembly, 11 - inner core tube, 12 - guiding head, 13 - fixing head, 13a - positioning groove, 20 - inner sheath tube, 21 - inner sheath tube body, 22 - receiving tube, 22a - developing ring, 30 - outer sheath tube, 30a - rigid section, 30b - adjustable bending section, 31 - inner tube, 32 - clamp, 33 - reinforcing tube, 34 - outer tube, 35 - traction wire, 36 - metal wire, 40 - shunt, 41 - fixing ear, 42 - inflow tract, 100 - handle, 101 - PU hose, 102 - joint, 110 - inner core tube adjustment section, 111 - inner core tube slider, 111a - guiding groove, 111b - boss, 111c - inner core tube mounting hole, 111d - inner core tube slider glue injection port, 111e - thread, 112 - inner core tube slider seat, 112a - fixing rod, 112b - first guiding rib, 112c - first opening groove, 113 - inner core tube adjustment knob, 120 - inner sheath tube adjustment section, 121 - front housing, 121d - front housing mounting hole, 122 - rear housing, 122c - mounting groove, 122d - threaded hole, 122e - slide rail, 123 - inner sheath tube slider seat, 123a - inner sheath tube slider seat base, 123b - threaded hole, 123c - sharp corner, 123d - second guiding rib, 124 - inner sheath tube slider, 124a - inner sheath tube slider guiding groove, 124b - inner sheath tube adjustment thread, 124c - sliding piece, 124d - inner sheath tube mounting hole, 124e - tapered hole channel, 124f - exhaust hole mounting position, 124g - inner sheath tube exhaust hole, 124h - inner sheath tube sealing ring receiving groove, 124i - locking thread, 125 - inner sheath tube slider sleeve, 125a - bevel gear, 126 - inner sheath tube adjustment knob, 126a - rotating bevel gear, 127 - inner sheath tube sealing ring, 128 - locking cover, 130 - outer sheath tube adjustment section, 131 - first outer shell, 132 - tapered head, 133 - C-type snap ring, 134 - E-type snap ring, 135 - bending adjustment knob, 136 - bending adjustment sleeve, 137 - bending slider, 137a - guiding groove, 138 - outer sheath tube fixing seat, 138a - outer sheath tube fixing seat base, 138b - guide rail, 138c - C-type snap ring mounting groove, 138d - E-type snap ring mounting groove, 138e - mounting thread, 138f - glue injection port, 138g - second opening groove, 138h - outer sheath tube exhaust hole, 138i - receiving groove, 139 - outer sheath tube sealing ring. Detailed implementation mode

[0045] To more clearly illustrate the embodiments of the present invention, the specific implementation manners of the present invention will be described below with reference to the accompanying drawings. Here, the terms "proximal end" and "distal end" are defined as the commonly used terms in the field of interventional medicine. That is, the "distal end" refers to the end far from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation. The specific implementation manners of the present invention will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings, and other implementation manners can also be obtained.

[0046] Embodiment 1:

[0047] As Figure 1 shown, this embodiment provides a delivery device for an atrial septal shunt, including an inner core tube assembly 10, an inner sheath tube 20, an outer sheath tube 30, and a handle 100. Both the inner core tube assembly 10 and the inner sheath tube 20 can slide axially. The proximal ends of the inner core tube assembly 10 and the inner sheath tube 20 are both connected to the handle 100. By adjusting the handle 100, reciprocating sliding of the inner core tube assembly 10 and the inner sheath tube 20 in the axial direction can be achieved.

[0048] As Figure 2 shown, the inner core tube assembly 10 includes an inner core tube 11, a guiding head 12, and a fixing head 13. Both the guiding head 12 and the fixing head 13 are fixed on the inner core tube 11. Among them, the guiding head 12 is located at the most distal end of the inner core tube 11. A fixing head 13 is also sleeved on the distal side of the inner core tube assembly 10. The installation position for the shunt 40 is between the guiding head 12 and the fixing head 13. A positioning groove 13a is provided on the outer periphery of the fixing head 13, and the positioning groove 13a matches the fixing ear 41 of the shunt 40. For convenient installation, the contour of the positioning groove 13a should be slightly larger than the fixing ear 41 of the shunt 40. In this embodiment, the fixing head 13 is provided with three positioning grooves 13a, and the positioning grooves 13a are evenly distributed circumferentially. It can be known that the matching shunt 40 is provided with three fixing ears 41 and the positions correspond to them one by one. To reduce wear, the material of the fixing head 13 is preferably a metal material.

[0049] As Figure 3As shown in the figure, the inner sheath tube 20 includes an inner sheath tube body 21 and a receiving tube 22. The diameter of the receiving tube 22 is larger than that of the inner sheath tube body 21 and is used to restrain the diverter 40. The inner sheath tube body 21 and the receiving tube 22 are formed together by heat shrinkage. The inner sheath tube body 21 is made of a material such as PEBAX that has excellent biocompatibility and a certain degree of hardness. Since the receiving tube 22 needs to restrain the compressed diverter, a material with good transparency and high strength is selected, preferably PC. During the release process of the diverter 40, the radially outward expansion force often causes dilatational deformation at the nozzle position. Therefore, a fluoroscopic ring 22a is provided at the nozzle position of the receiving tube 22 to facilitate positioning under X-ray irradiation and further enhance the strength of the receiving tube 22.

[0050] As Figure 4 and Figure 5 shown in the figure, the outer sheath tube 30 has an adjustable bending function and is divided into a rigid section 30a and an adjustable bending section 30b. The outer sheath tube 30 includes an inner tube 31, a clamp 32, a reinforcing tube 33, an outer tube 34, and a traction wire 35. The inner tube 31 needs to have a certain degree of flexibility, so a flexible material is selected, preferably PTFE.

[0051] Among them, the clamp 32 and the reinforcing tube 33 are sleeved on the inner tube 31. The reinforcing tube 33 is located in the adjustable bending section 30b and is cut from a metal tube. It has a certain degree of rigidity and can be bent in the axial direction. The outer tube 34 is made of a material such as PEBAX that has excellent biocompatibility and a certain degree of hardness. Moreover, the hardness of the outer tube 34 in the adjustable bending section 30b must be less than that of other parts, so that the adjustable bending section 30b is prone to bending. In addition, the outer tube 34 is provided with a wire drawing cavity on the side where the reinforcing tube 33 is hollowed out, starting from the distal part of the adjustable bending section 30b and leading to the proximal position of the tube body, for the traction wire 35 to pass through. The inner tube 31, the clamp 32, the reinforcing tube, and the outer tube 34 are formed together by hot melting or bonding. One end of the traction wire 35 is fixed to the clamp 32, and the other end extends from the proximal position of the outer tube 34 to the outside of the tube along the wire drawing cavity and is finally fixed to the slider of the handle. Pulling the traction wire 35 can achieve the bending adjustment of the outer sheath tube 30. The bending adjustment range of the outer sheath tube 30 can be adjusted arbitrarily between 0° and 90°.

[0052] As Figure 6 shown in the figure, the handle is divided into three parts, including an outer sheath tube adjustment section 130, an inner sheath tube adjustment section 120, and an inner core tube adjustment section 110. The three sections are respectively used to control the bending adjustment of the outer sheath tube 30, the telescopic adjustment of the inner sheath tube 20, and the telescopic adjustment of the inner core tube 11.

[0053] As Figure 7 shown in the figure, the outer sheath tube adjustment section 130 includes a first outer shell 131, a tapered head 132, a C-shaped snap ring 133, an E-shaped snap ring 134, a bending adjustment knob 135, a bending adjustment sleeve 136, a bending adjustment slider 137, an outer sheath tube fixing seat 138, and an outer sheath tube sealing ring 139.

[0054] As Figures 8 to 10 shown, the outer sheath tube fixing seat 138 is in a straight cylindrical shape. The base 138a of the outer sheath tube fixing seat is fixed to the first housing 131 by bolts. The bending adjustment slider 137 is sleeved on the tube body of the outer sheath tube fixing seat 138. The 138b are guide rails distributed on both sides of the tube body of the outer sheath tube fixing seat 138 and are engaged with the guide grooves 137a on both sides of the inner cavity of the bending adjustment slider 137. The bending adjustment sleeve 136 is sleeved on the bending adjustment slider 137, and their threads are mutually engaged. The bending adjustment knob 135 and the bending adjustment sleeve 136 are fixedly connected by bolts. The operator can rotate the knob to achieve the linear sliding of the bending adjustment slider 137. The 138c is a C-ring installation groove for installing the C-ring 133. The C-ring 133 and the end face of the first housing 131 limit the axial freedom of the bending adjustment knob 135 and the bending adjustment sleeve 136, so that they can only rotate circumferentially.

[0055] The top of the outer sheath tube fixing seat 138 is provided with a tapered head installation thread 138e for connecting with the tapered head 132. The 138d is an E-ring installation groove for installing the E-ring 134. When the end face of the internal thread of the tapered head 132 is screwed to the E-ring 134, it is restricted to prevent further screwing from pressing the bending adjustment knob 135 and thus affecting the rotation of the knob.

[0056] The outer sheath tube 30 is connected to the outer sheath tube fixing seat 138. After the proximal part of the outer sheath tube 30 is inserted into the outer sheath tube 30 installation hole, glue is injected through the glue injection port 138f, so that the outer sheath tube 30 and the outer sheath tube fixing seat 138 can be bonded together and at the same time play a sealing role.

[0057] The traction wire 35 can be connected to the bending adjustment slider 137 through the first opening groove 112c and the second opening groove 138g. The traction wire 35 passes through the small hole of the bending adjustment slider 137 and a small section of metal wire 36 can be welded at the tail end or directly prevented from falling off by bonding. In this way, the purpose of controlling the curvature of the outer sheath tube 30 can be achieved by sliding the bending adjustment slider 137.

[0058] The side of the base 138a of the outer sheath tube fixing seat is provided with an outer sheath tube exhaust hole 138h. The evacuation tube assembly is bonded to the outer sheath tube fixing seat 138 through the outer sheath tube exhaust hole 138h. The evacuation tube assembly includes a PU hose 101 and a Luer connector 102. The bottom of the outer sheath tube fixing seat 138 is provided with an outer sheath tube seal ring accommodation groove 138i for placing the outer sheath tube seal ring 139. The material of the outer sheath tube seal ring 139 is preferably medical silica gel.

[0059] When the outer sheath tube adjustment section 130 is connected to the inner sheath tube adjustment section 120, the end surface sharp corner 123c of the inner sheath tube slider seat 123 of the inner sheath tube adjustment section 120 circumferentially presses the outer sheath tube sealing ring 139, and the inner sheath tube 20 passes through the through hole in the middle of the outer sheath tube sealing ring 139. In this way, the outer sheath tube sealing ring 139 plays a sealing role between the outer sheath tube adjustment section 130 and the inner sheath tube adjustment section 120. The operator can fill the Luer connector 102 with physiological saline to remove the gas in the outer sheath tube 30.

[0060] As Figure 11 shown, the inner sheath tube adjustment section 120 includes a front housing 121, a rear housing 122, an inner sheath tube slider seat 123, an inner sheath tube slider 124, an inner sheath tube slider sleeve 125, an inner sheath tube adjustment knob 126, an inner sheath tube sealing ring 127, and a locking cover 128.

[0061] As Figure 12 shown, the inner sheath tube slider seat 123 is in a straight cylinder shape, and a plurality of threaded holes 123b are circumferentially and uniformly distributed on the base 123a of the inner sheath tube slider seat, corresponding one by one to the mounting hole positions of the front housing 121, the rear housing 122, and the outer sheath tube adjustment section 130. Bolts pass through the mounting holes from one side of the outer sheath tube adjustment section 130 and are screwed to the inner sheath tube slider seat 123, so that the inner sheath tube slider seat 123, the front housing 121, the rear housing 122, and the outer sheath tube adjustment section 130 can be fixedly connected.

[0062] A circle of protruding sharp corners 123c is provided on the end surface of the inner sheath tube slider seat 123, and the diameter of the circle formed by the top of the sharp corners is slightly smaller than the diameter of the outer sheath tube sealing ring 139 to ensure that the outer sheath tube sealing ring 139 can be pressed around. The inner sheath tube slider 124 is sleeved on the inner sheath tube slider seat 123, and second guiding ribs 123d are provided on both sides of the outer tube body of the inner sheath tube slider seat 123, and the inner sheath tube slider 124 can slide linearly along the second guiding ribs 123d.

[0063] As Figure 13 shown, the inner sheath tube slider 124 is sleeved on the inner sheath tube slider seat 123. 124a is the inner sheath tube slider guiding groove, which cooperates with the second guiding ribs 123d of the inner sheath tube slider seat 123 to make the inner sheath tube slider 124 slide linearly along the axis. 124b is the inner sheath tube adjustment thread, which cooperates with the internal thread of the inner sheath tube slider sleeve 125. Rotating the inner sheath tube slider sleeve 125 can realize the linear sliding of the inner sheath tube slider 124.

[0064] A bevel gear 125a is provided on the outer surface of the inner sheath tube slider sleeve 125, and the bevel gear 125a meshes with the knob bevel gear 126a on the inner sheath tube adjustment knob 126. The shaft intersection angle between the bevel gear 125a and the knob bevel gear 126a is 90°. Rotating the inner sheath tube adjustment knob 126 can drive the inner sheath tube slider sleeve 125 to rotate synchronously, and further drive the inner sheath tube slider 124 to perform linear sliding in the axial direction.

[0065] On both sides of the inner sheath tube slider 124, there are sliding pieces 124c. The sliding pieces 124c slide on the slide rails 121e and 122e of the front and rear shells, assisting the inner sheath tube slider 124 to ensure that there is no large deviation in the coaxiality with the catheter during the sliding process.

[0066] As Figure 14 As shown, inside the inner sheath tube slider 124, there is an inner sheath tube installation hole 124d. After the inner sheath tube 20 is inserted into the inner sheath tube installation hole 124d, glue is injected through the inner sheath tube slider glue injection port 124e, so that the inner sheath tube 20 can be bonded to the inner sheath tube slider 124, and at the same time, it plays a sealing role.

[0067] The conical hole channel 124e adjacent to the inner sheath tube installation hole 124d is for the inner core tube 11 to pass through. A section of exhaust hole installation position 124f extends laterally from the conical hole channel 124e. The exhaust hole installation position 124f is connected to the PU hose 101, and the PU hose 101 is connected to the Luer connector 102. 124g is the inner sheath tube exhaust hole 124g. The inner sheath tube exhaust hole 124g communicates with the conical hole channel 124e. The evacuation tube assembly is bonded to the inner sheath tube slider 124 through the inner sheath tube exhaust hole 124g and extends out of the handle through the evacuation tube through hole 121e of the front shell 121.

[0068] On the evacuation side end face of the inner sheath tube slider 124, there is an inner sheath tube seal ring accommodation groove 124h for installing the inner sheath tube seal ring 127. The material of the inner sheath tube seal ring 127 is preferably medical silicone; there is a locking thread 124i on the outside of the conical hole channel 124e, and the locking thread 124i is matched with the internal thread of the locking cover 128. By rotating the locking cover 128, the periphery of the inner sheath tube seal ring 127 can be squeezed, so as to achieve the sealing effect. The inner core tube 11 passes through the through hole in the middle of the inner sheath tube seal ring 127. In this way, the inner sheath tube seal ring 127 plays a sealing role between the inner sheath tube adjustment section and the inner core tube adjustment section. The operator can fill the evacuation tube assembly with normal saline to expel the gas in the inner sheath tube 20.

[0069] As Figures 15 to 17 As shown, the inner core tube adjustment section includes an inner core tube slider 111, an inner core tube slider seat 112, and an inner core tube adjustment knob 113.

[0070] The inner core tube slider seat 112 is in a straight tube shape, with fixed rods 112a on both sides, placed in the inner core tube slider seat installation grooves of the front and rear shells. Obviously, the inner core tube slider seat 112 is completely fixed. There is a first guiding rib 112b in the inner cavity of the inner core tube slider seat 112, and a first opening groove 112c on the other side, which are respectively matched with the guiding groove 111a and the boss 111b of the inner core tube slider 111, so that the inner core tube slider 111 slides back and forth on the track of the inner core tube slider seat 112.

[0071] An inner core tube mounting hole 111c is provided inside the inner core tube slider 111. After the inner core tube 11 is inserted into the inner core tube mounting hole 111c, glue is injected through the glue injection port 111d of the inner core tube slider, so that the inner core tube 11 and the inner core tube slider 111 can be bonded together.

[0072] The top of the boss of the inner core tube slider 111 is provided with a screw thread 111e, which exceeds the outer surface of the tube body of the inner core tube slider seat 112 and matches the internal thread of the inner core tube adjustment knob 113. The inner core tube adjustment knob 113 is sleeved on the inner core tube slider seat 112 and installed in the inner core tube adjustment knob installation groove of the front and rear shells. By rotating the inner core tube adjustment knob 113, the inner core tube slider 111 can be driven to slide axially. The front shell 121 is provided with a front shell installation hole 121d, which corresponds to the threaded hole 122d on the rear shell 122, and the assembly of the front and rear shells can be completed by bolt locking.

[0073] like Figures 18 to 19 As shown, the stent material of the shunt 40 is nickel-titanium alloy, which has two states: compression and relaxation. To reduce damage to the human body, we usually need to compress the shunt 40 before surgery and then load it into the delivery device. The sliding stroke of the inner sheath tube slider 124 and the inner core tube slider 111 is greater than the compressed length of the shunt 40.

[0074] The specific operation process is as follows: first, put the diverter 40 into ice water to soften it, and insert the fixing ear 41 into the positioning groove 13a of the fixing head 13. Since the fixing ear 41 of the diverter 40 is a shovel-shaped structure, the axial position of the diverter 40 is constrained; then, turn the inner core tube adjustment knob 113 to pull back the inner core tube 11, so that the fixing head 13 pulls the diverter 40 into the receiving tube 22; finally, continue to turn the knob until the diverter 40 is completely gathered in the receiving tube 22, the guide head 12 covers the tube mouth of the receiving tube 22, and the diverter 40 is constrained to a compressed state, and loading can be achieved.

[0075] like Figures 20 to 21As shown, the cardiac structure includes the left atrium 1, left ventricle 2, right atrium 3, right ventricle 4, and interatrial septum 5. The shunt 40 is delivered into the patient's heart through the inferior vena cava 7 via a catheter. The operator controls the curvature of the distal adjustable section 30b of the outer sheath 30 by rotating the outer sheath bending knob 135, and then delivers the shunt 40 to the targeted atrial septostomy 6. After adjusting the position, the operator can operate the handle to release the shunt 40. By rotating the inner sheath adjustment knob 126 and retracting the inner sheath 20, the stent in the inflow path 42 of the shunt 40 can be released from the constraint of the receiving tube 22 and gradually expand. (During the release process, if it is found that the release position of the shunt 40 is inaccurate, the inner core tube 11 can be retracted by rotating the inner core tube adjustment knob 113 to recover the shunt 40 for re-release.) After the inflow path 42 of the shunt 40 is fully expanded, the delivery device is retracted so that the stent in the inflow path 42 part fits against the inner wall of the interatrial septum 5. Then, continue to rotate the inner sheath adjustment knob 126 and retract the inner sheath 20 until the fixing ear 41 is completely released from the constraint of the receiving tube 22, so that the shunt 40 loses the radial constraint and fully pops open, thus completing the release of the shunt 40. At this time, the shunt 40 starts to work, and the delivery device is withdrawn to complete the operation.

[0076] The delivery device of this embodiment can be adapted to the individualized physiological anatomical structure, with precise release and convenient operation. During the implantation of the shunt, when there is a positioning deviation, the delivery device can be adjusted at any time to adjust the delivery position and achieve accurate positioning.

[0077] The above description only details the preferred embodiments and principles of the present invention. For those of ordinary skill in the art, according to the idea provided by the present invention, there will be changes in the specific implementation manners, and these changes should also be regarded as the protection scope of the present invention.

Claims

1. A delivery device for an atrial septal shunt, characterized in that, The device comprises an inner core tube assembly, an inner sheath tube, an outer sheath tube and a handle, wherein the outer sheath tube is connected to the handle, the inner core tube assembly is slidably matched with the inner sheath tube, the inner sheath tube is slidably matched with the outer sheath tube, and the proximal end of the inner core tube assembly and the proximal end of the inner sheath tube are respectively connected to the handle; the handle is used to adjust the front and rear feeding of the inner core tube assembly and the inner sheath tube and the curvature of the outer sheath tube to deliver the shunt to the atrial septal stoma; The handle comprises an outer sheath tube adjustment section, an inner sheath tube adjustment section and an inner core tube adjustment section, and the outer sheath tube adjustment section, the inner sheath tube adjustment section and the inner core tube adjustment section are coaxially arranged and interconnected; The outer sheath tube adjustment section comprises a first shell, a conical head, a C-shaped clasp, an E-shaped clasp, a bending knob, a bending slider, an outer sheath tube fixing seat, and an outer sheath tube sealing ring. The outer sheath tube fixing seat is provided with a guide rail, the bending slider is slidably matched with the guide rail, the bending knob is sleeved on the bending slider, and is rotatably connected to the first shell; the C-shaped clasp installation groove of the outer sheath tube fixing seat is provided with a C-shaped clasp, and the C-shaped clasp and the end face of the first shell restrict the bending knob and the bending sleeve to only be able to rotate in the circumferential direction; A conical head mounting thread is provided on the top of the outer sheath fixing seat for connecting with the conical head. When the end face of the inner thread of the conical head is screwed to the E-type clamping ring, it is restricted, thereby preventing further screwing from causing pressure on the bending knob and affecting the rotation of the bending knob. The inner sheath tube adjustment section comprises an inner sheath tube slider seat, an inner sheath tube slider, an inner sheath tube slider sleeve and an inner sheath tube adjustment knob, the inner sheath tube slider is sleeved on the inner sheath tube slider seat, the inner sheath tube slider is threadedly connected to the inner sheath tube slider sleeve, and the inner sheath tube slider sleeve is threadedly connected to the inner sheath tube adjustment knob; the inner sheath tube adjustment knob is rotated to make the inner sheath tube slider slide axially; The inner core tube adjustment section comprises an inner core tube slider, an inner core tube slider seat and an inner core tube adjustment knob, the inner core tube slider slidably matches the inner core tube slider seat, and the inner core tube adjustment knob is used to adjust the axial sliding of the inner core tube slider; The inner core tube assembly comprises an inner core tube, a guide head and a fixed head, wherein the guide head is fixed to the distal end of the inner core tube, the fixed head is sleeved on the inner core tube, and a flow divider is installed between the guide head and the fixed head; The fixing heads are evenly arranged at a plurality of positioning grooves along the circumferential direction, and the positioning grooves are coupled with the fixing ears of the diverter.

2. The delivery device for an atrial septal shunt according to claim 1, characterized in that, The inner sheath tube is sleeved on the inner core tube assembly, and the inner sheath tube comprises an inner sheath tube body and a receiving tube, the inner sheath tube body and the receiving tube are integrally connected through thermoplastic molding, and the aperture of the receiving tube is larger than the aperture of the inner sheath tube body.

3. The delivery device for an atrial septal shunt according to claim 2, characterized in that, A developing ring is installed at the end of the storage tube.

4. The delivery device for an atrial septal shunt according to claim 1, characterized in that, The outer sheath tube is sleeved on the inner sheath tube, and the outer sheath tube includes an inner tube, a clamp, a reinforcement tube, an outer tube and a traction wire. The clamp and the reinforcement tube are sleeved on the inner tube. One end of the traction wire is fixed to the clamp, and the other end extends from the proximal end of the outer tube and is free from the outer tube.

5. The delivery device for an atrial septal shunt according to claim 1, characterized in that, The inner sheath tube adjusting section is connected to the proximal end of the inner sheath tube and is used to control the extension and retraction of the inner sheath tube.

6. The delivery device for an atrial septal shunt according to claim 1, characterized in that, The inner core tube adjustment section is connected to the proximal end of the inner core tube and is used to control the expansion and contraction of the inner core tube.

7. The delivery device for an atrial septal shunt according to claim 1, characterized in that, The sliding strokes of the inner sheath tube slider and the inner core tube slider are greater than the compressed length of the diverter.

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