An implantable device system with a collapsible loading tube diameter

Abstract

The application belongs to the field of medical devices, and particularly relates to an implant device system with a reduced loading tube diameter, comprising an inner tube, an outer sheath tube, an implant device and an anchoring mechanism; the implant device comprises artificial valve leaflets; when preloaded, the implant device and the anchoring mechanism are arranged between the inner tube and the outer sheath tube, and the anchoring mechanism is arranged in axial non-overlapping mode with the artificial valve leaflets; and after the implant device reaches the expected anchoring position, the anchoring mechanism can reach the designated position according to a predetermined route; when preloaded, the distal end of the anchoring mechanism is located on the proximal side of the artificial valve leaflets and does not overlap with the artificial valve leaflets, so that the loading tube diameter of the delivery system is reduced as much as possible, and damage to the blood vessels of a patient during surgery is avoided.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to an implantable device system with a reduced loading tube diameter. Background Technology

[0002] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annular dilation. Clinically, it often presents with symptoms of the underlying cause of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.). After the onset of tricuspid regurgitation, symptoms of right heart failure such as fatigue, ascites, edema, liver pain, indigestion, and loss of appetite worsen. Mild tricuspid regurgitation may not present with obvious clinical symptoms, but severe regurgitation requires surgical treatment.

[0003] Traditional treatments for mitral and tricuspid valve disease include medication for mild to severe regurgitation and surgical procedures when indicated. Surgical procedures include valve replacement and valve repair. However, typical open-heart surgery is highly invasive, requires cardiopulmonary bypass, and carries a high risk of complications and infection. Many patients cannot tolerate the significant surgical risks and are left with no choice but to await death.

[0004] Following the report of the first aortic valve replacement surgery, numerous companies have conducted extensive research in interventional aortic valve technology, which has become increasingly mature. However, a significant gap remains in the field of interventional treatment for atrioventricular valves. Although a few products for interventional treatment of atrioventricular valves have been applied in transcatheter valve repair and angioplasty, no mature products have yet been launched internationally for transcatheter valve replacement.

[0005] Patent CN201410317001.9 discloses a heart valve implantation device with an anchoring mechanism, including a heart implantation device, at least two sets of anchoring needles and their release devices. The proximal end of the anchoring needles is provided with an anti-dislodgement end. The anchoring needle release device is detachably connected to the heart implantation device and includes a delivery tube and a push rod. The distal part of the anchoring needle release device has a preset shape, allowing the distal part of the delivery tube to bend entirely or partially. The bendable part of the delivery tube is a curved section, and a rigid section is provided at the distal end of the delivery tube. The length from the distal end of the delivery tube to the proximal end of the curved section is large. The anchoring needle is pre-installed in the distal portion of the delivery tube, at a radius equal to or equal to 1 / 6 of the circumference of a circle drawn with the smallest radius of the patient's own valve tissue ring. It is located at the distal end of the push rod. Pushing the push rod moves the anchoring needle toward the distal end of the delivery tube, thus fixing the cardiac implantable device between the autologous tissue and the anti-dislodgement end. Although this invention allows the anchoring mechanism to reach the area to be anchored more accurately, the fact that multiple anchoring mechanisms and implantable devices are arranged side by side in the delivery catheter results in a very large diameter delivery catheter. During surgery, this can easily damage the patient's blood vessels, making it particularly unsuitable for transvascular access methods.

[0006] Patent CN201810507308.3 discloses an adjustable bending delivery system for interventional heart valves, including an outer sheath, a core tube assembly that can slide axially relative to the outer sheath, and an operating handle connected to the proximal end of the outer sheath and the core tube assembly. The outer sheath has a distal end and a proximal end. The handle is connected to a traction wire that bends the distal end of the tube. The distal end of the traction wire is connected to the tube body, and the connection point is located at or near the distal end of the tube body. At least one section of the traction wire is a free segment outside the tube body. A floating limiting strip is also provided. The proximal end of the floating limiting strip is the starting end that is fixed relative to the fixing head or the core tube assembly. The floating limiting strip floats between the interventional heart valve installation position and the outer sheath. Although the adjustable bending structure designed on the tube body can meet the bending requirements, in clinical operation, the adjustable tube is prone to circumferential twisting during the bending process, which can cause positional deviations during anchoring and make it inconvenient for anchoring the implanted device.

[0007] Therefore, those skilled in the art are dedicated to developing an implantable device system with a reduced loading tube diameter, mainly addressing the following issues: 1. How to minimize the loading tube diameter of the delivery system to avoid damage to the patient's blood vessels during surgery, while simultaneously guiding the anchoring tube precisely to the anchoring area for accurate positioning; 2. How to solve the problem of circumferential torsion of the bending tube during bending, making its anchoring operation more stable.

[0008] Application content

[0009] The purpose of this application is to provide an implantable device system with a reduced loading tube diameter. This implantable device delivery system has the following advantages: 1. During pre-loading, the distal end of the anchoring mechanism is located on the proximal side of the artificial valve leaflet and does not overlap with the artificial valve leaflet, thereby minimizing the loading tube diameter of the delivery system and avoiding damage to the patient's blood vessels during surgery; 2. Since the distal part of the delivery system needs to be bent during delivery, the anchoring tube and the artificial valve leaflet are not axially overlapped during pre-loading, which necessitates that the anchoring tube have flexible properties or bendable structures to facilitate bending. When the anchoring tube needs to be needled and anchored, if the distal part of the anchoring tube does not have sufficient support, it will lead to instability during the needle insertion process and easy displacement of the position.

[0010] To solve the above-mentioned technical problems, this application provides the following technical solution: an implantable device system with a reduced loading tube diameter, comprising an inner tube, an outer sheath, an implantable device, and an anchoring mechanism; the implantable device includes an artificial valve leaflet; during pre-loading, the implantable device and the anchoring mechanism are disposed between the inner tube and the outer sheath, and the anchoring mechanism and the artificial valve leaflet are arranged without axial overlap; furthermore, after the implantable device reaches the expected anchoring position, the anchoring mechanism can reach the designated position along a predetermined route.

[0011] In one embodiment, after the implanted device reaches the intended anchoring position, the anchoring mechanism passes through the artificial valve leaflet to reach the anchoring area.

[0012] In one embodiment, the implantable device further includes a support member and an anchoring region disposed on the support member, wherein the artificial valve leaflet is connected to the support member; during pre-installation, the distal portion of the anchoring mechanism does not axially overlap or partially overlaps with the support member; and the distal portion of the anchoring mechanism does not axially overlap with the artificial valve leaflet.

[0013] In one embodiment, the anchoring mechanism includes an anchoring tube and a needle assembly, wherein after the implanted device reaches the intended anchoring position, the implanted device is fixed in the designated position by the needle assembly.

[0014] In one embodiment, the anchoring pipe includes a compliant section, a telescopic section disposed at the distal end of the compliant section, and a bending section disposed at the distal end of the telescopic section. During pre-installation, the bending section is disposed within the telescopic section.

[0015] In one embodiment, the rigidity of the telescopic section is greater than that of the bending section, and the axial length of the telescopic section is extendable; and when the implanted device reaches the expected anchoring position, the bending section extends to the distal end of the telescopic section and drives the telescopic section to extend distally until the distal end of the bending section abuts against the anchoring area.

[0016] In one embodiment, the anchoring mechanism includes an anchoring tube, a support kit, and a pin assembly. The distal end of the anchoring tube is provided with a bending adjustment structure, and during pre-installation, the distal end of the anchoring tube is retracted into the support kit.

[0017] In one embodiment, the anchoring mechanism further includes a limiting member connected to the distal end of the anchoring tube and the support kit.

[0018] In one embodiment, the rigidity of the support kit is greater than the rigidity of the distal portion of the anchoring tube, and the support kit is a telescopic structure; when the implanted device reaches the expected anchoring position, the anchoring tube moves distally, causing the limiting member to be in a tensioned state; and further, it drives the support kit to extend distally; wherein, when the support kit extends to its maximum length, the continued distal movement of the anchoring tube can cause the distal portion of the anchoring tube to bend to a predetermined curvature.

[0019] In one embodiment, the outer sheath is further provided with an inner tube, the support kit is sleeved on the inner tube, and the inner tube is provided with a blocking member that restricts the support kit from moving to the distal end.

[0020] In one embodiment, a guiding mechanism is also included, which guides the anchoring mechanism to the anchoring area after the implanted device reaches the intended anchoring position.

[0021] In one embodiment, the guiding mechanism includes a guide wire and a guide member, the guide member being connected to the anchoring mechanism, the guide wire passing through the guide member and being detachably connected to the anchoring area; when the implanted device reaches the intended anchoring position, the anchoring mechanism can reach the anchoring area along the guide wire.

[0022] In a preferred embodiment, the guiding mechanism further includes a control rod. The distal end of the guide wire is provided with a locking hole, and the anchoring area is provided with a connecting hole. During pre-installation, after the locking hole passes through the connecting hole, the distal end of the control rod is inserted into the locking hole. When the control handle is operated to tighten and lock the guide wire, a connection is formed between the anchoring area, the guide wire, the control rod, and the guide tube, fixing their relative positions. When the control rod is operated to move axially to disengage the distal end of the control rod from the locking hole, the anchoring area is released from the guide wire.

[0023] In a preferred embodiment, the distal end of the control lever is provided with an anti-detachment end, which is an inverted conical structure, a Y-shaped structure, a wavy structure, or a compressible circular structure.

[0024] In one embodiment, the anchoring tube is provided with a bending adjustment structure, which includes a plurality of slits. After the slits are unfolded in a plane, the longitudinal spacing of the slits is smaller than the transverse spacing of the slits.

[0025] In one embodiment, the delivery catheter is further provided with a bending member, and the distal end of the bending member is provided with a control release device, which is detachably connected to the implantation device.

[0026] In one embodiment, a tip head is provided at the distal end of the inner tube, and the tip head is provided with an installation groove. During pre-installation, the distal part of the implantable device is placed in the installation groove. This design can effectively shorten the loading length of the implantable device and is more conducive to the delivery and adjustment of the implantable device delivery system in the heart.

[0027] Compared with the prior art, the advantages of this application are:

[0028] 1. Unlike other implantable device delivery systems, in one embodiment of the present invention, the distal end of the bending section of the anchoring mechanism is located on the proximal side of the implantable device during loading, which avoids the anchoring tube from overlapping with the artificial valve leaflet of the implantable device during loading, effectively preventing the anchoring tube from damaging the artificial valve. At the same time, the staggered arrangement can effectively reduce the loading tube diameter, which is more conducive to the transvascular approach and avoids damage to human blood vessels during surgery, which has great clinical significance.

[0029] 2. Unlike other implantable device delivery systems, the anchoring tube in one embodiment of the present invention includes a telescopic section. During pre-installation, the bending section is retracted within the telescopic section. When the implantable device needs to be anchored, the bending section extends from the distal end of the telescopic section and drives the telescopic section to extend distally, which allows the distal end of the bending section to be pushed to the anchoring area for precise positioning. At the same time, the telescopic section is set to be rigid, which facilitates the anchoring mechanism to provide sufficient support force during anchoring and avoids problems such as the distal end of the anchoring tube not being able to press tightly against the anchoring area and the anchoring position being deviated due to the reverse force exerted on the distal end of the anchoring tube when the anchoring needle pierces the tissue during the anchoring process.

[0030] 3. Unlike existing technologies, the bending structure includes several slits. After the slits are unfolded in the plane, the longitudinal spacing of the slits is smaller than the transverse spacing. This design allows the anchoring pipe to bend more easily when bent, as the larger transverse spacing helps with bending adjustment, while the smaller longitudinal spacing prevents the anchoring pipe from twisting circumferentially when bent, thus avoiding deviation of its delivery pipe from the originally preset adjustment direction. Attached Figure Description

[0031] Figures 1 and 1b are schematic diagrams of the overall structure and partial structure of the implantable device system of the present invention during pre-assembly.

[0032] Figures 2a-2f This is a schematic diagram of the anchoring mechanism of the present invention.

[0033] Figures 3a-3d This is a schematic diagram illustrating the process by which the anchoring mechanism of the present invention passes through the artificial valve leaflet to reach the anchoring area.

[0034] Figures 4a-4e This is a schematic diagram illustrating the process by which the guiding mechanism of the present invention guides the anchoring mechanism to the anchoring area and completes the anchoring.

[0035] Figures 5a-5e This is a schematic diagram of another structure of the anchoring mechanism of the present invention.

[0036] The parts referred to by the numbers in the attached diagram are as follows: 1-Inner tube, 11-Tip head, 111-Mounting groove, 12-Blocking component, 2-Outer sheath tube, 3-Anchoring mechanism, 31-Anchoring tube, 311-Compliant section, 312-Telescopic section, 313-Adjusting section, 314-Adjusting structure, 32-Needle assembly, 33-Support kit, 34-Limiting component, 4-Implantable instrument, 41-Artificial valve leaflet, 42-Support component, 421-Anchoring area, 422-Connecting hole, 5-Guiding mechanism, 51-Guide wire, 511-Locking hole, 52-Control rod, 53-Guide component, 6-Adjusting component, 61-Control release device. Detailed Implementation

[0037] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0038] The proximal end, as described in this application, refers to the end closer to the surgical operator, while the distal end refers to the end farther away from the surgical operator. Specific Implementation Example 1:

[0040] like Figure 1a and 1b As shown, when this structure is used for tricuspid valve treatment, an implantable device system with a reduced loading diameter includes an inner tube 1, an outer sheath 2, an implantable device 4, and an anchoring mechanism 3. The implantable device 4 includes an artificial valve leaflet 41 (the artificial valve leaflet 41 is configured according to actual clinical surgical needs and can be a tricuspid, bicuspid, or single artificial valve leaflet). During pre-loading, the implantable device 4 and the anchoring mechanism 3 are positioned between the inner tube 1 and the outer sheath 2, and the anchoring mechanism 3 and the artificial valve leaflet 41 are arranged without axial overlap. Furthermore, after the implantable device 4 reaches the expected anchoring position, the anchoring mechanism 3 can reach the designated position according to a predetermined route. The artificial valve leaflet 41 is a tricuspid valve.

[0041] In this embodiment, after the implantable device 4 reaches the expected anchoring position, the anchoring mechanism 3 passes through the artificial valve leaflet 41 to reach the anchoring area 421, as shown. Figures 3b-3d As shown.

[0042] In this embodiment, the implantable device 4 further includes a support component 42 and an anchoring region 421 disposed on the support component 42, wherein the artificial valve leaflet 41 is connected to the support component 42; during pre-installation, the distal portion of the anchoring mechanism 3 partially overlaps with the support component 42 axially; and the distal portion of the anchoring mechanism 3 does not overlap with the artificial valve leaflet 41 axially.

[0043] In this embodiment, the anchoring mechanism 3 includes an anchoring tube 31 and a needle assembly 32, such as Figure 1b As shown, after the implantation device 4 reaches the expected anchoring position, the implantation device 4 is fixed in the designated position by the needle assembly 32.

[0044] In this embodiment, the anchoring pipe 31 includes a compliant section 311, a telescopic section 312 disposed at the distal end of the compliant section 311, and a bending section 313 disposed at the distal end of the telescopic section 312. During pre-installation, the bending section 313 is retracted within the telescopic section 312, such as... Figures 2a-2f As shown.

[0045] In this embodiment, the rigidity of the telescopic section 312 is greater than that of the bending section 313, and the length of the telescopic section 312 is extendable. Furthermore, when the implanted device 4 reaches the expected anchoring position, the bending section 313 extends to the distal end of the telescopic section 312 and drives the telescopic section 312 to extend distally until the distal end of the bending section 313 abuts against the anchoring area 421. The design of the telescopic section 312 allows the anchoring tube 31 to adapt well to the bending curvature of the delivery system in the blood vessel during pre-installation, and also meets the support force required during anchoring and needle insertion. The design is ingenious and has great clinical significance.

[0046] In this embodiment, a guiding mechanism 5 is also included, such as... Figure 4a As shown, when the implanted device 4 reaches the expected anchoring position, the guiding mechanism 5 can guide the anchoring mechanism 3 to the anchoring area 421.

[0047] In this embodiment, the guiding mechanism 5 includes a guide wire 51, a control rod 52, and a guide member 53. The distal end of the guide wire 51 has a locking hole 511, and the anchoring area 421 has a connecting hole 422. During pre-assembly, after the locking hole 511 passes through the connecting hole 422, the distal end of the control rod 52 is inserted into the locking hole 511. When the control handle is operated to tighten and lock the guide wire 51, a connection is formed between the anchoring area 421, the guide wire 51, the control rod 52, and the anchoring tube 31, fixing their relative positions. When the control rod 52 is moved axially to disengage the distal end of the control rod 52 from the locking hole 511, the anchoring area 421 is released from the guide wire 51. Figures 4a-4d As shown.

[0048] In this embodiment, the distal end of the control rod 52 is provided with an anti-detachment end, which is an inverted conical structure, a Y-shaped structure, a wave-shaped structure, or a compressible circular structure.

[0049] In this embodiment, the anchoring pipe 31 is provided with a bending adjustment structure 314, which includes a plurality of slits. After the slits are unfolded in the plane, the longitudinal spacing of the slits is smaller than the transverse spacing of the slits.

[0050] In this embodiment, the delivery catheter is further provided with a bending adjustment component 6, and the distal end of the bending adjustment component 6 is provided with a control release device 61, which is detachably connected to the implantation device 4.

[0051] In this embodiment, a tip head 11 is provided at the distal end of the inner tube 1, and the tip head 11 is provided with an installation groove 111. During pre-installation, the distal part of the implantable device 4 is placed in the installation groove 111. This design can effectively shorten the loading length of the implantable device 4, which is more conducive to the delivery and bending of the implantable device 4 delivery system in the heart.

[0052] The working process of this first embodiment is as follows:

[0053] 1. The valve delivery system is inserted into the heart via puncture. The control handle is operated to retract the outer sheath, and the distal end of the implanted device 4 is released. Figure 3a and 3b As shown;

[0054] 2. The bending section 313 extends towards the distal end of the telescopic section 312 and drives the telescopic section 312 to extend further towards the distal end until the distal end of the bending section 313 abuts against the anchoring area 421, as shown. Figure 3c and 3d As shown;

[0055] 3. Once the implanted device 4 reaches the intended anchoring position, the guiding mechanism 5 is operated to guide the anchoring mechanism 3 to the anchoring area 421, as follows. Figure 4a and 4b As shown;

[0056] 4. The needle assembly 32 is operated to complete the anchoring work in the anchoring area 421, thereby fixing the implanted device 4 in the heart. Figures 4c-4e As shown. Specific Implementation Example 2:

[0058] like Figure 1a and 1b As shown, when this structure is used for tricuspid valve treatment, an implantable device system with a reduced loading diameter includes an inner tube 1, an outer sheath 2, an implantable device 4, and an anchoring mechanism 3; the implantable device 4 includes an artificial valve leaflet 41; during pre-loading, the implantable device 4 and the anchoring mechanism 3 are positioned between the inner tube 1 and the outer sheath 2, and the anchoring mechanism 3 and the artificial valve leaflet 41 are arranged without axial overlap; and after the implantable device 4 reaches the expected anchoring position, the anchoring mechanism 3 can reach the designated position along a predetermined route.

[0059] In this embodiment, after the implanted device 4 reaches the expected anchoring position, the anchoring mechanism 3 passes through the artificial valve leaflet 41 to reach the anchoring area 421.

[0060] In this embodiment, the implantable device 4 further includes a support component 42 and an anchoring region 421 disposed on the support component 42, wherein the artificial valve leaflet 41 is connected to the support component 42; during pre-installation, the distal portion of the anchoring mechanism 3 partially overlaps with the support component 42 axially; and the distal portion of the anchoring mechanism 3 does not overlap with the artificial valve leaflet 41 axially.

[0061] In this embodiment, the anchoring mechanism 3 includes an anchoring tube 31 and a needle assembly 32. After the implantation device 4 reaches the expected anchoring position, the implantation device 4 is fixed in the designated position by the needle assembly 32.

[0062] In this embodiment, the anchoring mechanism 3 includes an anchoring tube 31, a support kit 33, and a pin assembly 32. The distal end of the anchoring tube 31 is provided with a bending adjustment structure 314. During pre-installation, the distal end of the anchoring tube 31 is retracted into the support kit 33. Figure 5a As shown.

[0063] In this embodiment, the anchoring mechanism 3 further includes a limiting member 34, which connects the distal end of the anchoring tube 31 and the support kit 33, such as... Figure 5b As shown.

[0064] In this embodiment, the rigidity of the support kit 33 is greater than the rigidity of the distal portion of the anchoring tube 31, and the support kit 33 is a telescopic structure; when the implantation device 4 reaches the expected anchoring position, the anchoring tube 31 moves distally, causing the limiting member 34 to be in a tensioned state, such as... Figures 5a-5d As shown; and further, it drives the support assembly 33 to extend distally; wherein, when the support assembly 33 extends to its maximum length, the anchoring tube 31 continues to move distally, causing the distal portion of the anchoring tube 31 to bend to a predetermined curvature, such as... Figure 5e As shown.

[0065] In this embodiment, the outer sheath tube 2 is further provided with an inner tube 1, the support kit 33 is sleeved on the inner tube 1, and the inner tube 1 is provided with a blocking member 12, which restricts the support kit 33 from moving to the distal end.

[0066] In this embodiment, a guiding mechanism 5 is also included. When the implantation device 4 reaches the expected anchoring position, the guiding mechanism 5 can guide the anchoring mechanism 3 to the anchoring area 421.

[0067] In this embodiment, the guiding mechanism 5 includes a guide wire 51, a control rod 52, and a guide member 53. The distal end of the guide wire 51 is provided with a locking hole 511, and the anchoring area 421 is provided with a connecting hole 422. During pre-installation, after the locking hole 511 passes through the connecting hole 422, the distal end of the control rod 52 is inserted into the locking hole 511. When the control handle is operated to tighten and lock the guide wire 51, a connection is formed between the anchoring area 421, the guide wire 51, the control rod 52, and the anchoring tube 31, so that their relative positions are fixed. When the control rod 52 is operated to move axially so that the distal end of the control rod 52 disengages from the locking hole 511, the anchoring area 421 is released from the guide wire 51.

[0068] The working process of this second embodiment is as follows:

[0069] 1. The valve delivery system is inserted into the heart via puncture. The control handle is operated to retract the outer sheath, and the distal end of the implanted device 4 is released. Figure 3a and 3b As shown;

[0070] 2. The anchoring tube 31 moves distally, causing the limiting member 34 to be in a tensioned state, such as... Figures 5a-5d ;

[0071] 3. When the support assembly 33 extends to its maximum length, the anchoring tube 31 continues to move distally, causing the distal portion of the anchoring tube 31 to bend to a predetermined curvature, such as... Figure 5e As shown;

[0072] 4. After the implanted device 4 reaches the intended anchoring position, the guiding mechanism 5 is operated to guide the anchoring mechanism 3 to the anchoring area 421, as follows. Figure 4a and 4b As shown;

[0073] 5. The needle assembly 32 is operated to complete the anchoring work in the anchoring area 421, thereby fixing the implanted device 4 in the heart. Figures 4c-4e As shown.

[0074] The above content is only a preferred embodiment of this application. For those skilled in the art, there will be changes in the specific implementation and application scope based on the ideas of this application. The content of this specification should not be construed as a limitation of this application.

Claims

1. An implantable device system with a reduced loading tube diameter, characterized in that: The device includes an inner tube, an outer sheath, an implantable device, and an anchoring mechanism. The implantable device includes an artificial valve leaflet. During pre-installation, the implantable device and the anchoring mechanism are positioned between the inner tube and the outer sheath, and the anchoring mechanism and the artificial valve leaflet are arranged without axial overlap. After the implantable device reaches the intended anchoring position, the anchoring mechanism can reach the designated position along a predetermined route. The anchoring mechanism includes an anchoring tube and a needle assembly. The anchoring tube includes a compliant section, a telescopic section located at the distal end of the compliant section, and a bending section located at the distal end of the telescopic section. During pre-installation, the bending section is positioned within the telescopic section. The rigidity of the telescopic section is greater than that of the bending section, and the axial length of the telescopic section is extendable.

2. The implantable device system with a reduced loading tube diameter according to claim 1, characterized in that: After the implanted device reaches the intended anchoring position, the anchoring mechanism passes through the artificial valve leaflet to reach the anchoring area.

3. The implantable device system with a reduced loading tube diameter according to claim 1, characterized in that: The implantable device further includes a support component and an anchoring region disposed on the support component, wherein the artificial valve leaflet is connected to the support component; during pre-installation, the distal portion of the anchoring mechanism does not overlap axially with the support component or partially overlaps axially; and the distal portion of the anchoring mechanism does not overlap axially with the artificial valve leaflet.

4. The implantable device system with a reduced loading tube diameter according to claim 1, characterized in that: After the implantation device reaches the intended anchoring position, the implantation device is fixed in the designated position by the needle assembly.

5. The implantable device system with a reduced loading tube diameter according to claim 1, characterized in that: Once the implanted device reaches the intended anchoring position, the bending section extends to the distal end of the telescopic section and drives the telescopic section to extend distally until the distal end of the bending section abuts against the anchoring area.

6. The implantable device system with a reduced loading tube diameter according to claim 1, characterized in that: The anchoring mechanism includes an anchoring tube, a support kit, and a pin assembly. The distal end of the anchoring tube is provided with a bending adjustment structure. During pre-installation, the distal end of the anchoring tube is retracted into the support kit.

7. An implantable device system with a reduced loading tube diameter according to claim 6, characterized in that: The anchoring mechanism further includes a limiting member that connects the distal end of the anchoring tube to the support kit.

8. An implantable device system with a reduced loading tube diameter according to claim 7, characterized in that: The rigidity of the support kit is greater than that of the distal portion of the anchoring tube, and the support kit is a telescopic structure. When the implanted device reaches the expected anchoring position, the anchoring tube moves distally, causing the limiting member to be in a tensioned state; and further, it drives the support kit to extend distally; wherein, when the support kit extends to its maximum length, the anchoring tube continues to move distally, causing the distal portion of the anchoring tube to bend to a predetermined curvature.

9. An implantable device system with a reduced loading tube diameter according to claim 6 or 7, characterized in that: The outer sheath is further provided with an inner tube, the support kit is sleeved on the inner tube, and the inner tube is provided with a blocking member, which restricts the support kit from moving to the distal end.

10. An implantable device system with a reduced loading tube diameter according to claim 1, characterized in that: It also includes a guide mechanism that guides the anchoring mechanism to the anchoring area after the implanted device reaches the intended anchoring position.

11. An implantable device system with a reduced loading tube diameter according to claim 10, characterized in that: The guiding mechanism includes a guide wire and a guide member. The guide member is connected to the anchoring mechanism. The guide wire passes through the guide member and is detachably connected to the anchoring area. When the implanted device reaches the expected anchoring position, the anchoring mechanism can reach the anchoring area along the guide wire.

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