A conveying system with a centering device

Abstract

The present application relates to the field of medical devices, and in particular to a delivery system with a centering device, comprising a first delivery tube and a second delivery tube, wherein the centering device is pre-installed between the first delivery tube and the second delivery tube, and the centering device comprises a pushing structure, a deformation structure and a recovery structure, wherein the pushing structure and the recovery structure are respectively connected to the two ends of the deformation structure, and the radial dimension of at least a part of the area of ​​the deformation structure in the released state is greater than the diameter of the ascending aorta.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to a delivery system with a centering device. Background Art

[0002] With the extension of human life expectancy and the aging of society, aortic valve disease has become an increasingly common valvular disease. Globally, the number of patients with aortic valve disease increased from 42.9 million in 2015 to 46.1 million in 2019. It is estimated that by 2025, the combined number of AS and AR will reach 52 million worldwide, with a compound annual growth rate of 2.0% from 2019 to 2025.

[0003] TAVR involves the transcatheter placement of a fully assembled artificial aortic valve into the affected aortic valve via a vascular / cardiac apex approach, functionally replacing the aortic valve and benefiting patients who are not suitable for traditional surgical treatment. However, problems are often encountered during TAVR procedures. For example, when implanting a device with a clamp, the delivery system cannot ensure that the implanted device is aligned with the center of the aortic valve, resulting in difficulty in accurately placing the clamp into the sinus and releasing the implanted device.

[0004] Patent CN202023323169.0 discloses an implant delivery system with a centering adjustment device, including an implant, a control handle, an inner tube, an inner core tube, a fixed tube, an outer sheath, an adjustment mechanism and a control release device. The adjustment mechanism is connected to the inner core tube, the proximal end of the implant and the distal end of the adjustment mechanism are connected, the control release device limits the radial expansion of the distal part of the implant, and a centering adjustment device is provided between the fixed tube and the outer sheath. The design defects of this scheme are: first, the centering adjustment device is filled between the inner core tube and the outer sheath during pre-installation. Since the self-expanding mesh centering adjustment device has a certain self-expansion property, the space between the inner core tube and the outer sheath is large, resulting in a designed outer sheath diameter that is too large; secondly, the adjustment mechanism is connected to the inner core tube, so that the delivery system has no pipe to control the rotation of the adjustment mechanism, and the implant cannot be rotated to adjust the position of the clamp.

[0005] Therefore, technicians in this field are committed to developing a delivery system with a centering device, mainly to solve the following problems: first, it is difficult to place the implant device in the center of the valve, and it is difficult for the clamp to enter the sinus accurately; second, the setting of the centering adjustment device expands the diameter of the delivery system; third, the setting of the centering adjustment device affects the functions of other components, such as: rotating the adjustment mechanism to align the clamp with the sinus floor. Summary of the Invention

[0006] The object of the present invention is to provide a conveying system with a centering device to solve the problems raised in the above background technology.

[0007] In order to solve the above technical problems, the present application solves them through the following technical solutions: a delivery system with a centering device, comprising a first delivery tube and a second delivery tube, the centering device being pre-installed between the first delivery tube and the second delivery tube, and the centering device comprising a pushing structure, a deformation structure and a recovery structure, the pushing structure and the recovery structure being respectively connected to the two ends of the deformation structure, and the radial dimension of at least a part of the area of ​​the deformation structure in the released state is greater than the diameter of the ascending aorta.

[0008] In one embodiment, the first conveying tube includes a limiting track, and the deformation structure is at least partially pre-installed in the limiting track.

[0009] In one embodiment, the first delivery tube is an outer sheath tube; and the limiting track is provided at the distal end portion of the outer sheath tube.

[0010] In one embodiment, the deformation structure includes a first deformation portion, a second deformation portion and a third deformation portion, which are arranged from far to near; and the second deformation portion includes a support unit, and the radial length of the support unit is greater than the diameter of the ascending aorta.

[0011] In one embodiment, the support unit is rectangular when viewed from the side.

[0012] In one embodiment, the first deformation portion, the second deformation portion, and the third deformation portion are in a filamentous shape.

[0013] In another embodiment, the supporting unit is in a strip shape.

[0014] In one embodiment, the pushing structure and the retrieving structure are connected to the distal end and the proximal end of the deformable structure, respectively.

[0015] In one embodiment, the projection surface of the deformation structure is in the shape of a mosquito coil.

[0016] In one embodiment, the recovery structure includes a connecting ring and an actuating member, wherein the connecting ring is connected to the third deformation portion; and the axial movement of the connecting ring does not exceed the distal end of the first conveying tube.

[0017] In one embodiment, the connecting ring includes a fitting portion connected to the third deformation portion; and the fitting portion is confined within the limiting track.

[0018] In one embodiment, the matching portion is block-shaped, and the cross-sectional area of ​​the matching portion is larger than the cross-sectional area of ​​the centering device.

[0019] In one embodiment, the pushing structure includes a connecting member and a control member, and the connecting member is respectively connected to the control member and the first deformation part; and when the control member is pushed toward the distal end, the first deformation part, the second deformation part and the third deformation part are successively disengaged from the limiting track, and at the same time, the action member automatically moves toward the distal end under the pull of the third deformation part.

[0020] In another embodiment, the control member is pushed toward the distal end while pushing the actuating member.

[0021] In one embodiment, when the deformable structure is in a released state, pushing the control member causes the centering device to be displaced as a whole. The advantage of this design is that the position variability of the centering device can adapt to the ascending aorta size of different patients.

[0022] In one embodiment, center lines of the first deformation portion, the second deformation portion, and the third deformation portion coincide with each other.

[0023] In one embodiment, when the deformed structure is in a released state, the support unit is subjected to a radial support force, and the centering device is centrally located in the ascending aorta.

[0024] In one embodiment, the centering device is sleeved outside the second conveying tube, and the center line of the second conveying tube coincides with the center lines of the first deformation portion and the second deformation portion.

[0025] In one embodiment, when the control member is operated to rotate the connecting member, the first deformation portion, the second deformation portion and the third deformation portion are twisted, thereby changing the shape of the second deformation portion to fit the wall of the ascending aorta.

[0026] In one embodiment, the deformable structure is linear when pre-installed and spiral after being released; and the centering device is sleeved outside the second delivery tube.

[0027] In one embodiment, the limiting track is in a straight line or a spiral line.

[0028] In one embodiment, the delivery system further comprises an implantation device, the distal end of the second delivery tube is provided with a restraint device, and the restraint device is connected to the proximal end of the implantation device.

[0029] In one embodiment, the delivery system further comprises an inner tube and a withdrawal member, wherein the withdrawal member is connected to the distal end of the inner tube, and the distal end of the implant device is pre-installed in the withdrawal member.

[0030] In one embodiment, the implant device further includes a clamping member, and the position of the clamping member is obtained by angiography during the operation; and, if the clamping member is not aligned with the sinus bottom of the aortic valve, the operator can operate the second delivery tube to rotate so that the restraint device drives the implant device to rotate, and at this time the clamping member rotates with the rotation of the implant device, thereby aligning with the sinus bottom of the aortic valve.

[0031] In one embodiment, after the centering device is released, the second delivery tube is rotated to rotate the implantation instrument.

[0032] In one embodiment, after the implant device is fixed to the aortic valve, the actuating member is pulled to retract the centering device, and the third deformation portion, the second deformation portion, and the first deformation portion are sequentially returned to the limiting track.

[0033] In one embodiment, the implantation device and the centering device are loaded simultaneously into the delivery system.

[0034] In one embodiment, the control member is made of metal material and has high rigidity.

[0035] In one embodiment, the shape of the deformation structure is formed by splicing two pagoda-shaped springs as a whole.

[0036] In one embodiment, the radial length of the deformation structure increases gradually from the first deformation portion to the second deformation portion.

[0037] In one embodiment, the radial length of the deformation structure decreases gradually from the second deformation portion to the third deformation portion.

[0038] In one embodiment, the deformable structure has a symmetrical shape.

[0039] In one embodiment, the limiting track is provided on the inner wall surface of the first conveying pipe.

[0040] In one embodiment, a limiting structure is provided at the distal end of the first delivery tube, and the limiting structure limits the connecting ring from extending beyond the distal end of the first delivery tube.

[0041] Compared with the prior art, the advantages of the present invention are:

[0042] 1. In the prior art, in order to make the implanted device align with the center of the aortic valve, some scholars use a self-expanding mesh centering adjustment device. However, the self-expanding design easily leads to the expansion of the outer sheath diameter, which is not conducive to surgical intervention. At the same time, the centering adjustment device eliminates the space for the adjustment tube. Without the adjustment tube, the adjustment structure cannot be rotated, resulting in the inability to adjust the position of the clamp, which reduces the success rate of the operation. The technical solution of the present application avoids the above problems. First, the centering device of the present invention is set between the first delivery tube and the second delivery tube when pre-installed, and is generally in the shape of a wire or strip. By arranging the pre-installed centering device only in the axial direction, the centering device is avoided. The problem of radial arrangement and enlarging the diameter of the delivery tube is that it will not cause excessive burden on the delivery tube in terms of space, and will not affect the function of the second delivery tube to adjust the rotation of the implanted device; secondly, the first delivery tube includes a limiting track, and the deformation structure of the centering device is pre-installed in the limiting track, which will not increase the outer diameter of the first delivery tube and ensure the size of the interventional trauma; thirdly, it is worth mentioning that the centering device of the present application also includes a pushing structure and a recovery structure, which ensure that the deformation structure can adjust the position and shape of the deformation structure in any surgical step, with high flexibility, which is convenient for the surgeon to adjust the centering state at any time, thereby improving the success rate of the operation and having great promotion significance.

[0043] 2. Different from the prior art, the deformation structure includes a first deformation part, a second deformation part and a third deformation part, wherein the second deformation part includes a support unit, and the radial length of the support unit is greater than the diameter at the position of the ascending aorta. When the support unit is in contact with the inner wall of the ascending aorta, the support unit is subjected to a radial support force, and the center of the support unit coincides with the center of the aorta at its position. Since the center lines of the first deformation part, the second deformation part and the third deformation part coincide, the second delivery tube sleeved in the centering device is facing the center of the aortic valve. In this case, the clamping part is facing the bottom of the aortic valve sinus, which is convenient for the implantation of the implant device. In summary, the deformation structure of the present application is cleverly designed and has a good centering effect.

[0044] 3. Different from the prior art, the recovery structure of the present application includes a connecting ring and an actuating part, wherein the connecting ring includes a fitting part. First, the fitting part is restricted within the limiting track and will not rotate at will, thereby facilitating the release of the deformation structure. Secondly, the fitting part is also connected to the third deformation part, thereby ensuring that the fitting part and the third deformation part move along the limiting track at the same time, thereby promoting the stable release and recovery of the deformation structure with high safety. In addition, the axial movement of the connecting ring does not exceed the far end of the first conveying tube, thereby ensuring the recyclability of the deformation structure.

[0045] 4. Different from the existing technology, the pushing structure includes a connecting part and a control part. The rigidity of the control part is greater than that of the control part. Operating the control part facilitates the axial movement of the centering device. At the same time, after the deformation structure is released, the distal end of the control part has a large space for movement in the heart. The operating control part can drive the connecting part to rotate, thereby facilitating the twisting of the first deformation part, the second deformation part and the third deformation part. In summary, the design of the control part is very convenient for adjusting the position of the centering device in the aorta.

[0046] 5. Different from the existing technology, the matching part is set in the limiting track, and the matching part will not rotate. When the second conveying pipe is adjusted, the deformable structure will not rotate easily, and can maintain the centering state with strong stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figures 1a to 1c It is a structural diagram of the conveying system of the present invention, wherein: Figure 1b It is a structural schematic diagram of the centering device of the present invention. Figure 1c It is a structural schematic diagram of the centering device of the present invention in a pre-installed state.

[0048] Figures 2a to 2i Schematic diagram of the process of the conveying system of the present invention entering the target position.

[0049] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-first conveying tube, 11-limiting track, 12-limiting structure, 2-second conveying tube, 21-constraint device, 3-centering device, 4-pushing structure, 41-connecting part, 42-control part, 5-deformation structure, 51-first deformation part, 52-second deformation part, 521-support unit, 53-third deformation part, 6-recovery structure, 61-connecting ring, 611-matching part, 62-acting part, 7-implantation instrument, 71-clamping part, 8-inner tube, 9-withdrawal part. Implementation Method

[0050] The present application is further described in detail below with reference to the accompanying drawings and embodiments.

[0051] In this application, the end closer to the surgical operator is defined as the "proximal end", and the end farther from the surgical operator is defined as the "distal end". Specific embodiments

[0052] like Figures 1a to 1cAs shown, during aortic interventional treatment, a delivery system with a centering device 3 includes a first delivery tube 1 and a second delivery tube 2, wherein the centering device 3 is pre-installed between the first delivery tube 1 and the second delivery tube 2, and the centering device 3 includes a pushing structure 4, a deformation structure 5 and a recovery structure 6, wherein the pushing structure 4 and the recovery structure 6 are respectively connected to the two ends of the deformation structure 5, and the radial dimension of at least a part of the area of ​​the deformation structure 5 in the released state is greater than the diameter of the ascending aorta.

[0053] In this embodiment, the first conveying pipe 1 includes a limiting track 11 , and the deformation structure 5 is at least partially pre-installed in the limiting track 11 .

[0054] In this embodiment, the first delivery tube 1 is an outer sheath tube; and the limiting track 11 is provided at the distal end portion of the outer sheath tube.

[0055] In this embodiment, the deformation structure 5 includes a first deformation portion 51, a second deformation portion 52 and a third deformation portion 53, which are arranged from far to near; and the second deformation portion 52 includes a support unit 521, the radial length of the support unit 521 is greater than the diameter of the ascending aorta, such as Figure 1b shown.

[0056] In this embodiment, the support unit 521 is rectangular when viewed from the side.

[0057] In this embodiment, the first deformation portion 51 and the second deformation portion 52 are in a wire shape, and the supporting unit 521 is in a strip shape.

[0058] In this embodiment, the pushing structure 4 and the recovering structure 6 are connected to the distal end and the proximal end of the deformation structure 5 respectively.

[0059] In this embodiment, the recovery structure 6 includes a connecting ring 61 and an action member 62. The connecting ring 61 is connected to the third deformation portion 53. Figure 1a and 1b As shown; and, the axial movement of the connecting ring 61 does not exceed the distal end of the first conveying tube 1 at most.

[0060] In this embodiment, the overall length of the second adjustment portion 52 is greater than the overall length of the first adjustment portion 51 .

[0061] In this embodiment, the connecting ring 61 includes a matching portion 611, and the matching portion 611 is connected to the third deformation portion 53; and the matching portion 611 is limited in the limiting track 11, as shown in FIG. Figure 1c shown.

[0062] In this embodiment, the matching portion 611 is block-shaped, and the cross-sectional area of ​​the matching portion 611 is larger than the cross-sectional area of ​​the centering device 3 .

[0063] In this embodiment, the pushing structure 4 includes a connecting member 41 and a control member 42, and the connecting member 41 is connected to the control member 42 and the first deformation portion 51 respectively; and when the control member 42 is pushed toward the distal end, the first deformation portion 51, the second deformation portion 52 and the third deformation portion 53 are separated from the limiting track 11 in sequence, as shown in FIG. Figure 2c and 2d As shown, at the same time, the actuating member 62 automatically moves toward the distal end under the pulling of the third deformation portion 53 .

[0064] In this embodiment, the deformable structure 5 is in a released state, and the control member 42 is pushed to cause the centering device 3 to be displaced as a whole. The advantage of this design is that the position variability of the centering device 3 can adapt to the ascending aorta size of different patients.

[0065] In this embodiment, center lines of the first deformation portion 51 , the second deformation portion 52 , and the third deformation portion 53 coincide with each other.

[0066] In this embodiment, the deformable structure 5 is in the released state, the support unit 521 is subjected to radial support force, and the centering device 3 is centrally located in the ascending aorta. Figure 2d shown.

[0067] In this embodiment, the centering device 3 is sleeved outside the second conveying pipe 2 , and the center line of the second conveying pipe 2 coincides with the center lines of the first deformation portion 51 and the second deformation portion 52 .

[0068] In this embodiment, when the control member 42 is operated to rotate the connecting member 41, the first deformation portion 51, the second deformation portion 52 and the third deformation portion 53 are twisted, thereby changing the shape of the second deformation portion 52 to fit the wall of the ascending aorta.

[0069] In this embodiment, the deformation structure 5 is linear when pre-installed and spiral after being released; and the centering device 3 is sleeved outside the second delivery pipe 2 .

[0070] In this embodiment, the limiting track is in a straight line shape.

[0071] In this embodiment, the delivery system further includes an implantation device 7 , and a restraining device 21 is provided at the distal end of the second delivery tube 2 , and the restraining device 21 is connected to the proximal end of the implantation device 7 .

[0072] In this embodiment, the delivery system further comprises an inner tube 8 and a retracting member 9, wherein the retracting member 9 is connected to the distal end of the inner tube 8, and the distal end of the implant device 7 is pre-installed in the retracting member 9. Figure 1a shown.

[0073] In this embodiment, the implant device 7 further includes a clamping member 71, such as Figure 2b As shown, the position of the clamping member 71 is obtained by angiography during the operation; and if the clamping member 71 is not aligned with the sinus bottom of the aortic valve, as shown Figure 2d As shown, the operator can operate the second delivery tube 2 to rotate so that the restraining device 21 drives the implant device 7 to rotate. At this time, the clamping member 71 rotates with the rotation of the implant device 7, thereby aligning with the sinus bottom of the aortic valve, as shown in FIG. Figure 2e shown.

[0074] In this embodiment, after the centering device 3 is released, the second delivery tube 2 is rotated to rotate the implantation instrument 7 .

[0075] In this embodiment, after the implant device 7 is fixed to the aortic valve, the action member 62 is pulled to retract the centering device 3, and the third deformation portion 53, the second deformation portion 52 and the first deformation portion 51 are sequentially returned to the limiting track 11. Figure 2h shown.

[0076] In this embodiment, the implantation device 7 and the centering device 3 are loaded into the delivery system at the same time.

[0077] In this embodiment, the shape of the deformation structure 5 is composed of two pagoda-shaped springs.

[0078] In this embodiment, the radial length of the deformation structure 5 increases gradually from the first deformation portion 51 to the second deformation portion 52; and the radial length of the deformation structure 5 decreases gradually from the second deformation portion 52 to the third deformation portion 53. Figure 1b shown.

[0079] In this embodiment, the limiting track 11 is provided on the inner wall of the first delivery pipe 1; and a limiting structure 12 is provided at the distal end of the first delivery pipe 1. Figure 1a As shown, the limiting structure 12 limits the connecting ring 61 from exceeding the distal end of the first conveying tube 1 .

[0080] The exemplary operation process of the conveying system of this embodiment is as follows: Figures 2a to 2i As shown:

[0081] (1) The delivery system enters the aorta through a minimally invasive femoral artery retrograde puncture. The implantable device 7 crosses the aortic arch after the delivery system is bent, and then reaches the ascending aorta and enters the aortic root lesion. Figure 2a As shown;

[0082] (2) withdraw the first delivery pipe 1 to expose the clamping member 71, and continue withdrawing the first delivery pipe 1 to expose the restraining device 21 and part of the second delivery pipe 2, as shown in FIG. Figure 2b As shown;

[0083] (3) The control member 42 of the pushing structure 4 is pushed toward the distal end, and the first deformation portion 51, the second deformation portion 52 and the third deformation portion 53 are gradually released along the limiting track 11 to the inner wall of the ascending aorta. Figure 2c As shown;

[0084] (4) Adjust the control member 42 so that the supporting unit 521 of the second deformation portion 52 fits the inner wall of the ascending aorta, as shown in FIG. Figure 2d As shown, the center of the second delivery tube 2 is aligned with the sinus bottom of the aortic valve;

[0085] (5) Rotate the second delivery tube 2 so that the clamping members 71 are facing the aortic valve leaflets respectively. Figure 2e As shown;

[0086] (6) Operate the delivery system so that the clamping member 71 enters the sinus bottom of the aortic valve, operate the retraction member 9 to release the distal end of the implant device 7, operate the restraint device 21 to release the proximal end of the implant device 7, and complete the implantation of the implant device 7. Figure 2f and 2g As shown;

[0087] (7) Pull the action member 62, retract the deformable structure 5, withdraw the delivery system, and complete the operation. Figure 2h and 2i shown.

[0088] The above content is only a preferred embodiment of the present application. For ordinary technicians in this field, according to the concept of the present application, there may be changes in the specific implementation method and application scope. The content of this specification should not be understood as limiting the present application.

Claims

1. A conveying system with a centering device, comprising a first conveying pipe and a second conveying pipe, characterized in that: The centering device is pre-installed between the first conveying tube and the second conveying tube, and the centering device includes a pushing structure, a deformation structure and a recovery structure. The pushing structure and the recovery structure are respectively connected to the two ends of the deformation structure, and the radial dimension of at least part of the area of ​​the deformation structure in the released state is greater than the diameter of the ascending aorta. The first conveying tube includes a limiting track, and the deformation structure is at least partially pre-installed in the limiting track. The deformation structure includes a first deformation part, a second deformation part and a third deformation part, which are arranged from far to near; and the second deformation part includes a support unit, and the radial length of the support unit is greater than the diameter of the ascending aorta. The deformation structure is linear when pre-installed and spiral after release; and the centering device is sleeved on the outside of the second conveying tube.

2. A conveying system with a centering device according to claim 1, characterized in that: The recovery structure includes a connecting ring and an actuating member, wherein the connecting ring is connected to the third deformation portion; and the axial movement of the connecting ring does not exceed the distal end of the first conveying tube at most.

3. A conveying system with a centering device according to claim 2, characterized in that: The connecting ring includes a matching portion connected to the third deformation portion; and the matching portion is confined within the limiting track.

4. A conveying system with a centering device according to claim 1, characterized in that: The pushing structure includes a connecting member and a control member, and the connecting member is connected to the control member and the first deformation part respectively; and when the control member is pushed toward the distal end, the first deformation part, the second deformation part and the third deformation part sequentially disengage from the limiting track.

5. A conveying system with a centering device according to claim 4, characterized in that: When the deformation structure is in a released state, pushing the control member causes the centering device to be displaced as a whole.

6. A conveying system with a centering device according to claim 1, characterized in that: Center lines of the first deformation portion, the second deformation portion, and the third deformation portion coincide with each other.

7. A conveying system with a centering device according to claim 1, characterized in that: When the deformed structure is in a released state, the support unit is subjected to a radial support force, and the centering device is centrally located in the ascending aorta.

8. A conveying system with a centering device according to claim 4, characterized in that: When the control member is operated to rotate the connecting member, the first deformation portion, the second deformation portion and the third deformation portion are twisted.

9. The conveying system with a centering device according to claim 1, characterized in that: The delivery system also includes an implantation device. The distal end of the second delivery tube is provided with a restraint device, and the restraint device is connected to the proximal end of the implantation device.

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