A delivery device for a transcatheter atrial septal shunt based on electrocontrol

Abstract

The present invention belongs to the technical field of medical devices, and particularly relates to a delivery device for an atrial septal shunt based on electric control, comprising an inner core tube assembly, an inner sheath tube, an outer sheath tube, an electric control assembly and a handle. The electric control assembly is installed in the handle, the outer sheath tube is connected to the handle, the proximal ends of the inner core tube assembly and the inner sheath tube are respectively connected to the electric control assembly, 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; by controlling the electric control assembly to adjust the forward and backward feeding of the inner core tube assembly and the inner sheath tube, and by using the handle to adjust the curvature of the outer sheath tube, so as to realize the delivery of the shunt to the atrial septal ostium; the present invention can improve the positioning accuracy by automatically adjusting the delivery position, and at the same time can also achieve precise positioning through manual micro-adjustment, so that 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 based on electric control. 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 diastolic and systolic functions of the myocardium, resulting in cardiac pump dysfunction.

[0003] Currently, most cases of heart failure start with left heart failure, that is, it first shows 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 redistribute the atrial blood volume and reduce the imbalance of atrial pressure. 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 of the delivery device usually cannot adapt to the individualized physiological and anatomical structure, resulting in difficult positioning of the delivery device and inaccurate release.

[0004] During the implantation process of the delivery device, once problems such as positioning deviation are found, it is often very difficult to adjust the delivery device, and the operation requirements for doctors are extremely high. The delivery accuracy cannot be guaranteed, and various additional operations will prolong the time of the patient's exposure 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 drawbacks 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 based on electric control that meets one or more of the foregoing requirements.

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

[0007] A delivery device for an atrial septal shunt based on electric control includes an inner core tube assembly, an inner sheath tube, an outer sheath tube, an electric control assembly, and a handle. The electric control assembly is installed in the handle, the outer sheath tube is connected to the handle, the proximal ends of the inner core tube assembly and the inner sheath tube are respectively connected to the electric control assembly, 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; by controlling the electric control assembly to adjust the forward and backward feeding of the inner core tube assembly and the inner sheath tube, and by adjusting the curvature of the outer sheath tube through the handle, the shunt can be delivered to the atrial septal ostomy.

[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 diverter is installed between the guiding head and the fixing head.

[0009] As a preferred solution, the fixing head is evenly provided with a plurality of positioning grooves in the circumferential direction, and the positioning grooves are coupled with the fixing ears of the diverter.

[0010] As a preferred solution, 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 solution, a developing ring is installed at the end of the receiving tube.

[0012] As a preferred solution, 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 solution, 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 solution, the outer sheath tube adjustment section includes a first housing, 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 matched with the guide rail. The bending adjustment knob is sleeved on the bending adjustment slider and is rotatably connected to the first housing.

[0015] As a preferred solution, the electric control assembly includes an inner core tube motor, an inner sheath tube motor, and a battery. The inner core tube motor and the inner sheath tube motor are respectively electrically connected to the battery. The inner core tube motor is installed in the inner core tube adjustment section, and the inner sheath tube motor is installed in the inner sheath tube adjustment section.

[0016] As a preferred solution, the inner sheath tube adjustment section is connected to the proximal end of the inner sheath tube, and the telescoping of the inner sheath tube is controlled by the inner sheath tube motor.

[0017] As a preferred solution, the inner sheath tube adjustment section includes an inner sheath tube slider seat, an inner sheath tube slider, an inner sheath tube slider sleeve, an inner sheath tube adjustment knob, and an inner core tube gear. 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. The inner sheath tube slider sleeve is screwed to the inner sheath tube adjustment knob. The inner sheath tube motor is rotationally matched with the inner sheath tube sleeve through the inner core tube gear; by controlling the inner sheath tube motor and / or rotating the inner sheath tube adjustment knob, the axial sliding of the inner sheath tube slider is adjusted.

[0018] As a preferred solution, the inner core tube adjustment section is connected to the proximal end of the inner core tube, and the telescopic movement of the inner core tube is controlled by an inner core tube motor.

[0019] As a preferred solution, the inner core tube adjustment section includes an inner core tube slider, an inner core tube slider seat, an inner core tube adjustment knob, and an inner core tube gear. The inner core tube slider is slidably engaged with the inner core tube slider seat. The inner core tube adjustment knob is installed on the inner core tube slider seat. The inner core tube motor is rotationally engaged with the inner core tube slider seat through the inner core tube gear. By controlling the inner core tube motor and / or rotating the inner core tube adjustment knob, the axial sliding of the inner core tube slider is adjusted.

[0020] As a preferred solution, the sliding stroke of the inner sheath tube slider and the inner core tube slider is greater than the compressed length of the diverter.

[0021] As a preferred solution, several buttons are installed on the handle.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0023] The present invention can achieve automatic adjustment through the electric control component to improve the positioning accuracy, and at the same time take into account manual fine adjustment to achieve precise positioning.

[0024] The conveying device of the present invention can be adapted to the individualized physiological anatomical structure, with precise release and convenient operation.

[0025] During the implantation process of the diverter 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 ensure accurate positioning. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a schematic structural diagram of the conveying device according to Embodiment 1 of the present invention;

[0027] Figure 2 is a schematic structural diagram of the inner core tube assembly according to Embodiment 1 of the present invention;

[0028] Figure 3 is a schematic structural diagram of the inner sheath tube according to Embodiment 1 of the present invention;

[0029] Figure 4 is a schematic diagram of the tube body structure of the outer sheath tube according to Embodiment 1 of the present invention;

[0030] Figure 5 is a schematic diagram of the bending form of the outer sheath tube according to Embodiment 1 of the present invention;

[0031] Figure 6 is a schematic structural diagram of the handle according to Embodiment 1 of the present invention;

[0032] 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;

[0033] Figure 8 It is a schematic diagram of the outer sheath tube fixing seat in the first embodiment of the present invention;

[0034] Figure 9 It is a cross-sectional view of the outer sheath tube fixing seat in the first embodiment of the present invention;

[0035] Figure 10 It is a schematic diagram of the bending adjustment slider in the first embodiment of the present invention;

[0036] Figure 11 It is a partial schematic diagram of the inner sheath tube adjustment section of the handle in the first embodiment of the present invention;

[0037] Figure 12 It is a schematic diagram of the front housing in the first embodiment of the present invention;

[0038] Figure 13 It is a schematic diagram of the inner sheath tube slider seat in the first embodiment of the present invention;

[0039] Figure 14 It is a schematic diagram of the inner sheath tube slider in the first embodiment of the present invention;

[0040] Figure 15 It is a cross-sectional view of the inner sheath tube slider in the first embodiment of the present invention;

[0041] Figure 16 It is a partial schematic diagram of the inner core tube adjustment section of the handle in the first embodiment of the present invention;

[0042] Figure 17 It is a schematic diagram of the inner core tube slider seat in the first embodiment of the present invention;

[0043] Figure 18 It is a schematic diagram of the inner core tube slider in the first embodiment of the present invention;

[0044] Figure 19 It is a schematic diagram of the inner core tube knob in the first embodiment of the present invention;

[0045] Figure 20 It is a schematic diagram of the electric control adjustment section in the first embodiment of the present invention;

[0046] Figure 21 It is the circuit diagram of the conveying device in the first embodiment of the present invention;

[0047] Figure 22 It is a schematic diagram of the shunt loader in the first embodiment of the present invention;

[0048] Figure 23 It is a schematic diagram of the fully loaded shunt in the first embodiment of the present invention;

[0049] Figure 24 It is a schematic diagram of the shunt release in the first embodiment of the present invention;

[0050] Figure 25 It is a schematic diagram of the complete release of the flow divider according to the first embodiment of the present invention;

[0051] 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 - radiopaque 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, 104 - inner sheath tube motor, 105 - inner core tube motor, 106 - battery, 107 - power switch, 108a - inner sheath tube retraction button, 108b - inner sheath tube advancement button, 108c - inner core tube retraction button, 108d - inner core tube advancement button, 109 - battery cover, 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, 113a - inner thread of inner core tube adjustment knob, 113b - gear of inner core tube adjustment knob, 114 - inner core tube gear, 120 - inner sheath tube adjustment section, 121 - front housing, 121a - inner sheath tube slider sleeve mounting groove, 121b - inner sheath tube adjustment knob mounting groove, 121c - inner core tube slider seat mounting groove, 121d - front housing mounting hole, 121e - front housing slide rail, 121f - inner sheath tube motor mounting groove, 121g - inner sheath tube motor cover plate, 121h - inner core tube motor mounting groove, 121i - inner core tube motor cover plate, 121j - battery mounting groove, 122 - rear housing, 122d - threaded hole, 122e - rear housing slide rail, 122f - drain pipe through hole, 123 - inner sheath tube slider seat, 123a - base of inner sheath tube slider seat, 123b - threaded hole, 123c - sharp corner, 123d - second guiding rib, 124 - inner sheath tube slider, 124a - guiding groove of inner sheath tube slider, 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 accommodation 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, 129 - inner sheath tube gear, 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 slider137a - Guide groove, 138 - Outer sheath tube fixing seat, 138a - Base of outer sheath tube fixing seat, 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 - Accommodating groove, 139 - Outer sheath tube sealing ring. Detailed implementation mode

[0052] To more clearly illustrate the embodiments of the present invention, the terms "proximal end" and "distal end" are defined herein 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 following will describe the specific implementation modes of the present invention with reference to the drawings. Obviously, the 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 modes can also be obtained.

[0053] Embodiment 1:

[0054] As Figure 1 shown, this embodiment provides a delivery device for an atrial septal shunt based on electric control, 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.

[0055] 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. Between the guiding head 12 and the fixing head 13 is the installation position for the shunt 40. 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 the convenience of installation, the contour of the positioning groove 13a must 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, that is, it can be known that the matching shunt 40 is provided with three fixing ears 41 and the positions correspond one by one. To reduce wear, the material of the fixing head 13 is preferably a metal material.

[0056] 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 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 tube orifice position. Therefore, a radiopaque ring 22a is provided at the tube orifice position of the receiving tube 22 to facilitate positioning under X-ray irradiation and further enhance the strength of the receiving tube 22.

[0057] 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 flexibility, so a flexible material is selected, preferably PTFE.

[0058] 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 stiffness 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 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 easy to bend. 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 handle. Pulling the traction wire 35 can realize 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°.

[0059] 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 movement of the inner sheath tube 20, and the telescopic movement of the inner core tube 11.

[0060] 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.

[0061] As shown Figures 8 to 10 in the figure, the outer sheath tube fixing seat 138 is in a straight tube shape, and 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 matched 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 matched. The bending adjustment knob 135 and the bending adjustment sleeve 136 are fixedly connected by bolts. When the operator rotates the knob, the linear sliding of the bending adjustment slider 137 can be realized. 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 degree of the bending adjustment knob 135 and the bending adjustment sleeve 136, so that they can only rotate circumferentially.

[0062] 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.

[0063] 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, it plays a sealing role.

[0064] 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.

[0065] 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 silicone.

[0066] 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 physiological saline into the Luer connector 102 to expel the gas in the outer sheath tube 30.

[0067] 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, a locking cover 128, an inner sheath tube gear 129, and an inner sheath tube motor 104.

[0068] As Figures 12 to 15 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 installation hole positions of the front housing 121, the rear housing 122, and the outer sheath tube adjustment section 130. Bolts pass through the installation holes from one side of the outer sheath tube adjustment section 130 and are screwed with 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.

[0069] 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.

[0070] 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.

[0071] The outer surface of the inner sheath tube slider sleeve 125 is provided with a bevel gear 125a, which meshes with the knob bevel gear 126a on the inner sheath tube adjustment knob 126 and the inner sheath tube gear 129. The shaft intersection angle between the bevel gear 125a and the knob bevel gear 126a is 90°, and the shaft intersection angle with the inner sheath tube gear 129 is 0°. The inner sheath tube gear 129 is connected to the inner sheath tube motor 104. Rotating the inner sheath tube adjustment knob 126 or starting the inner sheath tube motor 104 can drive the inner sheath tube slider sleeve 125 to rotate synchronously, and further drive the inner sheath tube slider 124 to perform an axial linear slide. The inner sheath tube motor 104 is installed in the inner sheath tube motor installation groove 121f and fixed by the inner sheath tube motor cover plate 121g and bolts.

[0072] Sliding plates 124c are provided on both sides of the inner sheath tube slider 124, and the sliding plates 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.

[0073] An inner sheath tube installation hole 124d is provided inside the inner sheath tube slider 124. 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.

[0074] The conical hole channel 124e adjacent to the inner sheath tube installation hole 124d is for the inner core tube 11 to pass through. An exhaust hole installation position 124f extends from the side of the conical hole channel 124e, and 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, and 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.

[0075] An inner sheath tube seal ring accommodation groove 124h is provided on the evacuation side end face of the inner sheath tube slider 124 for installing the inner sheath tube seal ring 127. The material of the inner sheath tube seal ring 127 is preferably medical silicone; a locking thread 124i is provided outside 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 extruded to achieve a sealing effect. The inner core tube 11 passes through the through hole in the middle of the inner sheath tube seal ring 127, so that 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 physiological saline to remove the gas in the inner sheath tube 20.

[0076] Such as Figures 16 to 19As shown in the figure, the inner core tube adjustment section includes an inner core tube slider 111, an inner core tube slider seat 112, an inner core tube adjustment knob 113, an inner core tube gear 114, and an inner core tube motor 105.

[0077] The inner core tube slider seat 112 is in a straight tube shape, with fixing rods 112a provided on both sides and placed in the first opening groove 112c of the inner core tube slider seat in the front and rear shells. Obviously, the inner core tube slider seat 112 is completely fixed. A first guiding rib 112b is provided in the inner cavity of the inner core tube slider seat 112, and an opening groove is provided on the other side, which cooperate with the guiding groove 111a and the boss 111b of the inner core tube slider 111 respectively, so that the inner core tube slider 111 slides back and forth on the track of the inner core tube slider seat 112.

[0078] An inner core tube installation hole 111c is provided inside the inner core tube slider 111. After the inner core tube 11 is inserted into the inner core tube installation hole 111c, glue is injected through the inner core tube slider glue injection port 111d, and then the inner core tube 11 can be bonded to the inner core tube slider 111.

[0079] A thread 111e is provided at the top of the boss of the inner core tube slider 111, and the thread 111e extends beyond the outer surface of the tube body of the inner core tube slider seat 112 and cooperates with 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.

[0080] An inner core tube adjustment knob gear 113b is provided on the inner core tube adjustment knob 113, which meshes with the inner core tube gear 114, and the inner core tube gear 114 is connected to the inner core tube motor 105. Starting the inner core tube motor 105 causes the inner core tube gear 114 to rotate, which then drives the inner core tube adjustment knob 113 to rotate, and further the inner core tube slider 111 can be driven to slide axially. The inner core tube motor 105 is installed in the inner core tube motor installation groove 121h and fixed by the inner core tube motor cover plate 121i and several bolts. 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 tightening with bolts.

[0081] As Figure 20As shown in the figure, the electric control component includes the inner core tube motor 105, the inner sheath tube motor 104, the battery 106, and 107 is the power switch. The inner core tube motor 105 and the inner sheath tube motor 104 are respectively electrically connected to the battery 106. The inner core tube motor 105 is installed on the inner core tube adjustment section 110, and the inner sheath tube motor 104 is installed on the inner sheath tube adjustment section 120. The inner sheath tube adjustment section 120 and the inner core tube adjustment section 110 can be adjusted electrically. The inner sheath tube motor 104 and the inner core tube motor 105 are respectively powered by the battery 106. The battery 106 is installed in the battery installation groove 121j of the front housing 121, and the battery cover 109 is installed on the battery installation groove 121j. Several buttons are installed on the handle 100, including the inner sheath tube backward button 108a, the inner sheath tube forward button 108b, the inner core tube backward button 108c, and the inner core tube forward button 108d.

[0082] Since it is battery-powered, the inner sheath tube motor 104 and the inner core tube motor 105 are selected as DC motors. The two power lines of the DC motor are not polarized. Assume that the codes of the two power lines are A and B respectively. When line A is connected to the positive pole and line B is connected to the negative pole, the motor rotates forward (backward); then when line B is connected to the positive pole and line A is connected to the negative pole, the motor rotates backward (forward). That is to say, as long as the positive and negative poles of the two power lines are swapped, the forward and reverse rotation of the DC motor can be achieved.

[0083] As Figure 21 shown in the figure, in this embodiment, the method of connecting a diode is adopted to swap the positive and negative poles of the power line, so as to control the forward and reverse rotation of the inner sheath tube motor 104 and the inner core tube motor 105. A diode is a device with two electrodes among electronic components, which only allows current to flow in a single direction (called forward bias), and blocks when reversed (called reverse bias). Therefore, a diode can be thought of as an electronic version of a check valve. When the power switch 107 is pressed, the circuit is connected. The inner sheath tube backward button 108a controls the forward rotation of the inner sheath tube motor 104, thereby driving the inner sheath tube 20 to retreat; the inner sheath tube forward button 108b controls the reverse rotation of the inner sheath tube motor 104, thereby driving the inner sheath tube 20 to advance; the inner core tube forward button 108d controls the forward rotation of the inner core tube motor 105, thereby driving the inner core tube 11 to advance; the inner core tube backward button 108c controls the reverse rotation of the inner core tube motor 105, thereby driving the inner core tube 11 to retreat.

[0084] As Figures 22 to 23 shown in the figure, the stent material of the shunt 40 is nitinol alloy, which has two states of compression and relaxation. To reduce the damage to the human body, before the operation, we usually need to compress the shunt 40 and then load it into the delivery device. Among them, 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.

[0085] The specific operation process is as follows: First, place the shunt 40 in ice water to soften it, and embed the fixing ear 41 into the positioning groove 13a of the fixing head 13. Since the fixing ear 41 of the shunt 40 is in a spatula shape, the axial position of the shunt 40 is restricted. Then, turn on the power switch key 107 to connect the circuit, press the inner core tube retraction button 108c or rotate the inner core tube adjustment knob 113 to retract the inner core tube 11, so that the fixing head 13 pulls the shunt 40 into the receiving tube 22. Finally, long-press the inner core tube retraction button 108c or continue to rotate the inner core tube adjustment knob 113 until the shunt 40 is completely retracted into the receiving tube 22, the guiding head 12 covers the orifice of the receiving tube 22, and the shunt 40 is restricted to a compressed state, then the loading can be achieved.

[0086] As Figures 24 to 25 shown, the heart structure includes the left atrium 1, the left ventricle 2, the right atrium 3, the right ventricle 4, and the interatrial septum 5. The shunt 40 enters 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 adjustment knob 135, and then delivers the shunt 40 to the atrial septostomy 6 at the target position. After adjusting the position, the operator can operate the handle to release the shunt 40. Press the inner sheath retraction button 108a or rotate the inner sheath adjustment knob 126 to retract the inner sheath 20, and the stent of the inflow path 42 part of the shunt 40 can be disengaged from the restraint 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 pressing the inner sheath retraction button 108c or 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 of the inflow path 42 part fits against the inner wall of the interatrial septum 5. Then continue to press the inner sheath retraction button 108a or rotate the inner sheath adjustment knob 126 to retract the inner sheath 20 until the fixing ear 41 is completely disengaged from the restraint of the receiving tube 22, so that the shunt 40 is completely sprung open after losing the radial restraint, 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.

[0087] The delivery device of this embodiment can be automatically adjusted through the electronic control component to improve the positioning accuracy, and at the same time take into account the manual micro-adjustment to achieve precise positioning. At the same time, the delivery device 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 with accurate positioning.

[0088] 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 based on electronic control, characterized in that, It includes an inner core tube assembly, an inner sheath tube, an outer sheath tube, an electric control assembly and a handle. The electric control assembly is installed inside the handle. The outer sheath tube is connected to the handle. The proximal ends of the inner core tube assembly and the inner sheath tube are respectively connected to the electric control assembly. The inner core tube assembly is slidably fitted inside the inner sheath tube, and the inner sheath tube is slidably fitted inside the outer sheath tube; By controlling the electric control assembly to adjust the forward and backward feeding of the inner core tube assembly and the inner sheath tube, and by using the handle to adjust the bending degree of the outer sheath tube, so as to realize the delivery of the shunt device to the atrial septal ostomy; The inner core tube assembly includes an inner core tube, a guiding head and a fixing head. The guiding head is fixed at the distal end of the inner core tube. A fixing head is sleeved on the inner core tube. The shunt device is installed between the guiding head and the fixing head; The fixing head is evenly provided with several positioning grooves in the circumferential direction, and the positioning grooves are coupled with the fixing ears of the shunt device; The handle includes an outer sheath tube adjusting section, an inner sheath tube adjusting section and an inner core tube adjusting section. The outer sheath tube adjusting section, the inner sheath tube adjusting section and the inner core tube adjusting section are coaxially arranged and communicate with each other; The outer sheath tube adjusting 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; The electric control assembly includes an inner core tube motor, an inner sheath tube motor and a battery. The inner core tube motor and the inner sheath tube motor are respectively electrically connected to the battery. The inner core tube motor is installed in the inner core tube adjusting section, and the inner sheath tube motor is installed in the inner sheath tube adjusting section; The inner sheath tube adjusting section is connected to the proximal end of the inner sheath tube, and the telescopic movement of the inner sheath tube is controlled by the inner sheath tube motor; The inner sheath tube adjusting section includes an inner sheath tube slider seat, an inner sheath tube slider, an inner sheath tube slider sleeve, an inner sheath tube adjusting knob and an inner sheath tube gear. 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. The bevel gear on the outer surface of the inner sheath tube slider sleeve meshes with the knob bevel gear of the inner sheath tube adjusting knob. The inner sheath tube motor is rotationally fitted with the inner sheath tube slider sleeve through the inner sheath tube gear. By controlling the inner sheath tube motor and / or rotating the inner sheath tube adjusting knob, the axial sliding of the inner sheath tube slider is adjusted; The bottom of the outer sheath tube fixing seat is provided with an outer sheath tube sealing ring accommodating groove for placing the outer sheath tube sealing ring; When the outer sheath tube adjusting section is connected to the inner sheath tube adjusting section, the end surface sharp corner of the inner sheath tube slider seat of the inner sheath tube adjusting section presses the outer sheath tube sealing ring, and the inner sheath tube passes through the through hole in the middle of the outer sheath tube sealing ring.

2. The delivery device of an atrial septal shunt based on electronic control according to claim 1, characterized in that, 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. The aperture of the receiving tube is larger than that of the inner sheath tube body.

3. The delivery device of an atrial septal shunt based on electric control according to claim 2, wherein, A developing ring is installed at the end of the receiving tube.

4. The delivery device of an atrial septal shunt based on electronic control according to claim 1, characterized in that, 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 at the outer tube.

5. The delivery device of an atrial septal shunt based on electric control according to claim 4, characterized in that, The inner core tube adjusting section is connected to the proximal end of the inner core tube, and the telescopic movement of the inner core tube is controlled by the inner core tube motor.

6. The delivery device of an atrial septal shunt based on electronic control according to claim 5, characterized in that, The inner core tube adjustment section includes an inner core tube slider, an inner core tube slider seat, an inner core tube adjustment knob, and an inner core tube gear. The inner core tube slider is slidably fitted to the inner core tube slider seat. The inner core tube adjustment knob is installed on the inner core tube slider seat. The inner core tube motor is rotationally fitted to the inner core tube slider seat through the inner core tube gear. By controlling the inner core tube motor and / or rotating the inner core tube adjustment knob, the axial sliding of the inner core tube slider is adjusted.

7. The delivery device of an atrial septal shunt based on electric control according to claim 6, 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 flow divider.

8. The delivery device of an atrial septal shunt based on electric control according to claim 1, characterized in that Several buttons are installed on the handle.

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