Occluder conveying system and occluder applied to system
By designing a sealer delivery system with elastic and flexible structure, the combination of sheath tube, push components and interventional instruments is used to solve the problem of fixing and adjustment during the sealing process of left atrial ear, achieving a more efficient sealing effect and reducing the density of the sealing effect. The operation time and complication risk increased success rate.
Patent Information
- Application Number
- CN202420869773.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-25
- Publication Date
- 2025-01-10
- Estimated Expiration
- 2034-04-25
AI Technical Summary
In the prior art, due to the complex structure and insufficient space during the sealing process of left atrial atrium, the occluder is difficult to fix, resulting in difficult operation, long operation time, high complication risk, and often cannot be completely sealed, leaving residual shunt.
An occluder delivery system is designed, including a occluder and a conveyor device. The occluder has an elastic and flexible structure. Through the combination of sheath, push assembly and interventional instrument, it can be switched between multiple states to ensure fixation. The support of the disc in the ideal position and the stable adjustment of the disc blocking disc reduces repeated operations.
It reduces the number of repeated adjustments during the operation, shortens the operation time, reduces the risk of complications, improves the success rate of surgery, and achieves complete blockade of the left atrial appendage.
Smart Images
Figure CN222323600U_ABST
Abstract
Description
Technical Field
[0001] The utility model belongs to the technical field of interventional medical devices, and more specifically, relates to an occluder delivery system and an occluder applied to the system. Background Art
[0002] The use of catheter technology to treat cardiovascular diseases through interventional methods is currently a common treatment method. Specifically, it refers to the use of catheter interventional treatment methods to place various materials, instruments, etc. into the heart, arteries, veins and other parts of the human body to treat cardiovascular diseases.
[0003] Taking non-valvular atrial fibrillation as an example, 90% of the thrombi in non-valvular atrial fibrillation come from the left atrial appendage. Blocking the left atrial appendage can reduce embolic events caused by atrial fibrillation. Currently, the most widely used method in clinical practice is to place an occluder into the left atrial appendage of the heart through catheter intervention to complete the blockage of the left atrial appendage.
[0004] Due to the variability of the left atrial appendage morphology, the internal structure of the left atrial appendage is often complex, which sometimes causes great difficulties in occlusion. Taking the shallow atrial appendage or early lobed atrial appendage as an example, there is insufficient space in the landing area during occlusion, and the occluder is difficult to fix, and it often needs to be sent to a deeper part or lobed area. As for the commonly used plug occluders and disc occluders, the Secchi occluder can often only block one of the lobes, and multiple Secchi occluders or Secchi disc occluders are needed for hybrid occlusion, otherwise there may be a large residual shunt; and for disc occluders, refer to Figure 1 The structure diagram of the disc occluder shown in the figure includes an occluding disc 110 and a fixing disc 120, which are connected by a waist. When in use, the fixing disc is generally released first, and then the sheath is withdrawn to release the outer disc to complete the occlusion. In the specific operation, the coin method is often used for the atrial appendage with insufficient space. Figure 2 to Figure 4 ,in, Figure 2 The diagram shows the situation where the common trunk is too shallow to be fixed when using a disc occluder for left atrial appendage occlusion. Figure 3 The diagram shows the position adjustment of the occlusion disc when using the disc occluder for left atrial appendage occlusion. Figure 4 The diagram shows the displacement of the fixed disc when the occluding disc is pulled back and adjusted during the left atrial appendage occlusion using a disc occluder. The fixed disc is sent obliquely into the inner space farther away and compressed into a coin shape. At this time, when the outer disc is released, the outer disc is often also embedded in the left atrial appendage in an oblique shape, and cannot completely block the left atrial appendage opening, so the outer disc often needs to be pulled back or adjusted. Since the occluder becomes a whole after release, the inner disc is often pulled and displaced during the process of pulling back and adjusting the outer disc, resulting in the need for multiple adjustments or even recovery and re-release. The disadvantages are that the adjustment operation is more difficult, the operation time is increased, and the repeated operation brings the risk of complications.
[0005] Moreover, reference Figure 5 As shown in the arrow position, whether it is a plug-type occluder or a disc-type occluder, due to the different positions and depths of the occluders during the occlusion process, there is still a common phenomenon that the occluder cannot be completely blocked, leaving residual shunts.
[0006] Therefore, how to provide an occluder that is easy to operate, convenient to adjust, and can block the left atrial appendage as completely as possible has become a difficult problem that needs to be solved urgently. Utility Model Content
[0007] 1. Problems to be solved
[0008] In view of the defect in the prior art that disc occluders require repeated adjustments many times during operation, the present application designs an occluder delivery system and an occluder applied to the system, which can enable interventional instruments such as guide wires or catheters to enter the interior of the occluder through a delivery rod. After the inner disc is released during the operation, the inner disc will not shift easily even if the outer disc is pulled back to adjust, thereby reducing the number of repeated adjustments, reducing operation time and surgical complications, and increasing the success rate of the operation.
[0009] 2. Technical solution
[0010] To solve the above problems, the utility model adopts the following technical solutions.
[0011] An occluder delivery system includes an occluder and a delivery device, wherein the occluder includes an occluding disk and a fixing disk connected to the occluding disk and located on one side of the occluding disk, and the delivery device includes:
[0012] Sheath;
[0013] A pushing assembly is arranged in the sheath tube, and the distal end is connected to the occluding disk. The pushing assembly can move axially and rotate around the axial direction relative to the sheath tube;
[0014] and an interventional instrument, which is disposed in the pushing assembly and has a distal end connected to the fixing plate, and the interventional instrument can move axially and rotate around the axial direction relative to the pushing assembly;
[0015] The sheath tube, the pushing assembly and the interventional instrument can all be operated independently, and the occluder can be switched between multiple states under different operation modes; wherein:
[0016] In the first state, the occluder can be stretched and deformed and accommodated in the sheath tube in a smaller size;
[0017] In the second state, the occluder can be moved to the target area of the occluder under the push of the sheath;
[0018] In the third state, the fixing disk of the occluder can be released in the target area and restored to its original shape, at which time the occluding disk is not released and is constrained by force;
[0019] In the fourth state, the occluding disk of the occluding device can be released in the target area and restored to its original shape, at which time the fixing disk is completely released and supported by force.
[0020] Preferably, the distal end of the pushing assembly is detachably connected to the proximal end of the occluding disk, and the distal end of the interventional instrument is detachably connected to the proximal end or the distal end of the fixing disk.
[0021] Preferably, the pushing component is a hollow pushing rod, and the interventional instrument is a guide wire or a catheter with a balloon at the tip.
[0022] As another aspect of the present application, an occluder is provided, which is applied to any of the above occluder delivery systems, wherein at least a part of the main structure of the occluding disk or the fixing disk is elastic and flexible, and the main structures of the occluding disk and the fixing disk both have a transverse axis and a longitudinal axis;
[0023] When a force is applied roughly along the transverse axis or the longitudinal axis, the shape of the occluding disk or the fixing disk itself can be compressed or stretched, and return to its original shape when the effect of the applied force disappears.
[0024] 3. Beneficial effects
[0025] Compared with the prior art, the beneficial effects of the utility model are:
[0026] The occluder delivery system of the utility model can enable interventional instruments to enter the interior of the occluder by designing a new delivery system. After the fixed disc is released during the operation and it is determined that the fixed disc is in a relatively ideal position, the interventional instrument is used to provide strong support for the released fixed disc, and the fixed disc will not be easily displaced when the occluder is pulled back for adjustment, thereby reducing the number of repeated adjustments, reducing the operation time and surgical complications, and increasing the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] Figure 1 It is a structural schematic diagram of a disc-type occluder in the prior art;
[0028] Figure 2 This is a schematic diagram of the situation where the common trunk is too shallow and the occluder cannot be fixed when using a disc occluder for left atrial appendage occlusion;
[0029] Figure 3 This is a schematic diagram of adjusting the position of the occlusion disc when using a disc occluder for left atrial appendage occlusion;
[0030] Figure 4This is a schematic diagram of the fixed disc being pulled and displaced when the occluding disc is pulled back and adjusted when the disc occluder is used for left atrial appendage occlusion;
[0031] Figure 5 The schematic diagram of the residual shunt position during the occlusion process of the traditional occluder is shown;
[0032] Figure 6 This is a schematic diagram of the structure of the occluder delivery system in this application;
[0033] Figures 7-10 It is a schematic diagram of the structure of the occluder delivery system in different states when the occluder delivery system of the present application is used for occlusion;
[0034] In the figure: 100, occluder; 110, occluding disc; 111, occluding disc connector; 120, fixing disc; 121, fixing disc connector; 200, delivery device; 210, sheath; 220, push rod; 221, push rod thread; 230, guide wire; 231, guide wire thread; 300, left atrial appendage. DETAILED DESCRIPTION
[0035] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thoroughly understood.
[0036] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.
[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.
[0038] In the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of a medical device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device that is perpendicular to its "axial direction", and the "axial" and "radial" of any component of a medical device are defined based on this principle.
[0039] Figure 6 A delivery system of an occluder 100 is shown. Figure 6 The occluder 100 delivery system includes an occluder 100 and a delivery device 200 .
[0040] The occluder 100 includes an occluding disk 110 and a fixing disk 120 connected to the occluding disk 110 and located on one side of the occluding disk 110. The occluding disk 110 and the fixing disk 120 may be directly connected or may be connected as shown in FIG. Figure 6 As shown in the figure, they are connected by a waist. The occluding disc 110 is mainly used to occlude the opening of the left atrial appendage 300 after being deployed, and the fixing disc 120 is mainly used to fix the occluder 100 in the cavity of the left atrial appendage 300.
[0041] In one embodiment, at least a portion of the main structure of the occluding disk 110 or the fixing disk 120 is elastic and flexible. In a preferred embodiment, the main structure of the occluding disk 110 or the fixing disk 120 can be made of elastic material or flexible material. For example, the occluding disk 110 can be a nickel-titanium woven mesh disk, and the fixing disk 120 can be a nickel-titanium woven mesh disk, or can be cut from nickel-titanium.
[0042] In one embodiment, a polymer flow-blocking membrane, such as a flow-blocking membrane made of polyester material, is disposed inside the sealing disk 110 .
[0043] In one embodiment, a polymer protective film is disposed on the outer side of the fixing disk 120 , which can better prevent the fixing disk 120 from causing friction damage to the inside of the left atrial appendage 300 .
[0044] In one embodiment, a plurality of small barb devices are disposed around the fixing plate 120 to facilitate better embedding into the left atrial appendage 300 tissue.
[0045] The main structure of the occluding disk 110 and the fixing disk 120 has a transverse axis and a longitudinal axis. These axes are generally parallel or coaxial with the forces applied to each. When a force is applied in a direction generally along the transverse axis or the longitudinal axis, the occluding disk 110 or the fixing disk 120 itself can be compressed or stretched, and return to its original shape when the applied force disappears. In a specific example, refer to Figure 6 In the illustrated structure of the occluder 100, since the transverse axes of the occluding disk 110 and the fixing disk 120 are coaxial, when the occluder 100 is acted upon by a force coaxial with the transverse axes of the main structures of the occluding disk 110 and the fixing disk 120, the occluder 100 can be stretched and lengthened under the action of the force.
[0046] It is understandable that the changes in the shapes of the blocking disk 110 or the fixing disk 120 should be independent, and the deformation of one of them will not have a significant effect on the other, that is, will not force the other to deform as well.
[0047] In one embodiment, reference Figures 6-7 The delivery device 200 includes a sheath tube 210, a push assembly, and an interventional instrument. The push assembly is disposed in the sheath tube 210, the distal end of which is connected to the occluding disk 110, and the push assembly can move axially and rotate around the axial direction relative to the sheath tube 210. The interventional instrument is disposed in the push assembly, the distal end of which is connected to the fixing disk 120, and the interventional instrument can move axially and rotate around the axial direction relative to the push assembly.
[0048] In a more specific embodiment, the push assembly can be a hollow push rod 220, which can be made of stainless steel, nickel titanium or other polymer materials; the interventional instrument can be a guide wire 230 or a catheter with a balloon at the tip. In this embodiment, the guide wire 230 is selected. The guide wire 230 can be made of metal materials such as stainless steel and nickel titanium. The reason for choosing metal is that the guide wire 230 is relatively thin and requires a certain amount of support force, so that when the occluding disk 110 is adjusted by pulling the push rod 220, the guide wire 230 will not bend.
[0049] The positional relationship and coordination between the push rod, the sheath 210 and the guide wire 230 determine that the push rod, the sheath 210 and the guide wire 230 can be operated independently and will not interfere with each other. The sheath 210, the push assembly and the interventional instrument can all be operated independently, and the occluder 100 can be switched between multiple states under different operation modes.
[0050] refer to Figures 7-10In the first state, the occluder 100 can be elongated and deformed and accommodated in the sheath 210 in a smaller size; in the second state, the occluder 100 can be moved to the target area of the occluder 100 under the push of the sheath 210; in the third state, the fixing disk 120 of the occluder 100 can be released in the target area and restored to its original shape, at which time the occluding disk 110 is not released and is constrained by force; in the fourth state, the occluding disk 110 of the occluder 100 can be released in the target area and restored to its original shape, at which time the fixing disk 120 is completely released and supported by force.
[0051] Since the pushing rod is housed in the sheath 210 and can move along the axial direction of the sheath 210, the distal end of the pushing rod can extend from the distal end of the sheath 210; the distal end of the pushing rod is connected to the occluding disk 110, so when the proximal end of the pushing rod is operated, the occluder 100 can move axially in the sheath 210 along with the pushing rod, thereby pushing the occluder 100 toward the distal end of the sheath 210 or pulling the occluder 100 toward the proximal end of the sheath 210. When moving toward the proximal end of the sheath 210, the occluder 100 can be stretched to enter the sheath 210; when moving toward the distal end of the sheath 210, the occluder 100 extends from the distal end of the sheath 210, thereby realizing the release of the occluder 100 outside the sheath 210.
[0052] Specifically, when the occluder 100 is accommodated in the sheath 210, the proximal end or the distal end of the occluding disc 110 is connected to the distal end of the push rod, and the occluder 100 can be delivered to the left atrial appendage 300 with the help of the push rod and the sheath 210. The occluder 100 gradually extends from the distal end of the sheath 210, and the occluding disc 110 and the fixing disc 120 of the occluder 100 are gradually released, thereby completing the occlusion of the left atrial appendage 300.
[0053] The above explanations have well explained the first state and the second state of the occluder 100 claimed in this application, and the third state and the fourth state exist in the process of the occluder 100 being released in the target area to perform occlusion.
[0054] After the occluder 100 is delivered to the designated position and the distal end of the sheath 210 penetrates into the left atrial appendage 300, when the sheath 210, the pushing assembly and the interventional instrument are all able to operate independently, the position of the guide wire 230 can be kept unchanged first, and the pushing rod 220 and the sheath 210 can be operated to withdraw toward their respective proximal ends, so that the fixed disk 120 of the occluder 100 is gradually and completely extended from the sheath 210, released and restored to its original shape. At this time, since the occluding disk 110 is still constrained in the sheath 210, the occluding disk 110 is not released and is always constrained by the force from the sheath 210; in this case, by operating the introduced guide wire 230 or catheter, the fixed disk 120 can also be guided into a deeper internal space of the left atrial appendage 300 to find a more ideal landing area.
[0055] After the fixing disk 120 finds a relatively ideal landing area, that is, the target area of the occluder 100, continue to operate the guide wire 230, the push rod and the sheath 210. First, keep the positions of the guide wire 230 and the push rod 220 unchanged, operate the sheath 210 to withdraw toward the proximal end of the sheath 210, until the occluding disk 110 of the occluder 100 leaves the sheath 210, is released and restored to its original shape; gently pull back the occluder 100 as a whole, confirm that the position of the occluder 100 is fixed satisfactorily, then keep the positions of the guide wire 230 and the push rod 220 unchanged, operate the sheath 210 to withdraw toward the distal end to release the occluding disk 110, and if the position of the occluding disk 110 needs to be adjusted after release, the push rod 220 can be operated to move repeatedly toward the distal end or the proximal section until the occluding disk 110 is completely released and fits at the root of the left atrial appendage 300, achieving a complete occlusion effect. During the stage of repeatedly moving the push rod 220 toward the distal end or the proximal end, since the position of the guide wire 230 does not change, even if the position of the occluding disk 110 is moving, the fixed disk 120 is always supported by the guide wire 230, and will not be easily displaced even if the occluding disk 110 is repeatedly pulled back for adjustment. This overcomes the problem in the prior art that the fixed disk 120 is always pulled and displaced when the occluding disk 110 is pulled back for adjustment, resulting in a high risk of complications due to excessive number of repeated adjustments.
[0056] In one embodiment, the distal end of the push assembly is detachably connected to the proximal end of the occluding disk 110, and the distal end of the interventional instrument is detachably connected to the proximal end or the distal end of the fixing disk 120. More specifically, the distal end of the push rod 220 is provided with a first thread 221, and the proximal end of the occluding disk 110 is provided with a first connector 111, and the push rod 220 and the occluding disk 110 are detachably connected by the first thread 221 and the first connector 111 that are threaded together; similarly, the distal end of the guide wire 230 is provided with a second thread 231, and the distal end of the fixing disk 120 is provided with a second connector 121, and the guide wire 230 and the fixing disk 120 are detachably connected by the second thread 231 and the second connector 121 that are threaded together.
[0057] By means of the detachable connection between the pushing assembly and the occluding disk 110, and the detachable connection between the interventional instrument and the fixing disk 120, after the occluder 100 completes complete occlusion, the delivery device 200 and the occluder 100 are released by twisting the guide wire 230 and the pushing rod 220.
[0058] In order to ensure the complete occlusion of the occluder 100, in one embodiment, after the occluding disc 110 is completely attached to the root of the left atrial appendage 300, it is also possible to inject a developer into the sheath 210 to observe whether there is a developer in the left atrial appendage 300. If a small amount of developer appears in the left atrial appendage 300, keep the guide wire 230 in the same position, withdraw the push rod 220, and push the sheath 210 to the far end, so that the occluding disc 110 re-enters the sheath 210, adjust the angle and position of the sheath 210, withdraw the sheath 210 again, and re-fix the occluding disc 110 to achieve complete occlusion of the left atrial appendage 300.
[0059] The present application designs an occluder 100 delivery system so that interventional instruments such as a guidewire 230 or a catheter can enter the interior of the occluder 100 through a delivery rod. After the inner disk is released during the operation, the inner disk will not be easily displaced even if the outer disk is pulled back to adjust, thereby reducing the number of repeated adjustments, reducing operation time and surgical complications, and increasing the success rate of the operation.
[0060] The examples described in the present invention are merely descriptions of the preferred implementation modes of the present invention, and are not intended to limit the concept and scope of the present invention. Without departing from the design concept of the present invention, various modifications and improvements made to the technical solutions of the present invention by engineers and technicians in this field shall fall within the protection scope of the present invention.
Claims
1. An occluder delivery system, comprising an occluder and a delivery device, wherein the occluder comprises an occluding disk and a fixing disk connected to the occluding disk and located on one side of the occluding disk, characterized in that: The conveying device comprises: Sheath; A pushing assembly is arranged in the sheath tube, and the distal end is connected to the occluding disk. The pushing assembly can move axially and rotate around the axial direction relative to the sheath tube; and an interventional instrument, which is disposed in the pushing assembly and has a distal end connected to the fixing plate, and the interventional instrument can move axially and rotate around the axial direction relative to the pushing assembly; The sheath tube, the pushing assembly and the interventional instrument can all be operated independently, and the occluder can be switched between multiple states under different operation modes; wherein: In the first state, the occluder can be stretched and deformed and accommodated in the sheath tube in a smaller size; In the second state, the occluder can be moved to the target area of the occluder under the push of the sheath; In the third state, the fixing disk of the occluder can be released in the target area and restored to its original shape, at which time the occluding disk is not released and is constrained by force; In the fourth state, the occluding disk of the occluding device can be released in the target area and restored to its original shape, at which time the fixing disk is completely released and supported by force.
2. The occluder delivery system according to claim 1, characterized in that: The distal end of the pushing component is detachably connected to the proximal end of the occluding disk, and the distal end of the interventional instrument is detachably connected to the proximal end or the distal end of the fixing disk.
3. The occluder delivery system according to claim 1, characterized in that: The pushing component is a hollow pushing rod, and the interventional instrument is a guide wire or a catheter with a balloon at the head end.
4. An occluder, characterized in that: Applicable to the occluder delivery system according to any one of claims 1 to 3, the main structure of at least a part of the occluding disk or the fixing disk is elastic and flexible, and the main structures of the occluding disk and the fixing disk each have a transverse axis and a longitudinal axis; When a force is applied roughly along the transverse axis or the longitudinal axis, the shape of the occluding disk or the fixing disk itself can be compressed or stretched, and return to its original shape when the effect of the applied force disappears.