Patent Application
20240041468
The embodiments relate to the field of interventional medical instruments and an occlusion device.
As for the existing umbrella-shaped left atrial appendage occluder, each of supporting bodies on a fixing disc is a single rod independent from each other and suspended, and the fixing disc is formed by cutting metal alloy tubes to form each of supporting bodies before heat-setting. Therefore, the supporting force of the umbrella-shaped left atrial appendage occluder to the inner wall of the left atrial appendage is relatively large. In addition, since the ravines between pectinate muscles in the left atrial appendage are weakest and irregularly distributed, it is possible that the single rod on the fixing disc will abut against these ravines upon release and spreading. As the heart continues to contract and relax, these single rods tend to grind or rupture the left atrial appendage at the ravines, causing symptoms such as pericardial effusion and endangering the patient's life.
Based on this, an improved occlusion device is desired to address the problem that the independent and suspended single rod of the existing left atrial appendage occluder is easy to wear or break through the left atrial appendage in the groove between the pectinate muscles.
An occlusion device includes a fixing portion. The fixing portion includes a plurality of supporting bodies. The plurality of supporting bodies includes a plurality of supporting sections spaced apart along a circumferential direction of the fixing portion. Tail ends of at least two adjacent supporting sections bend and extend towards the interior of the fixing portion to form a convergence section, by which the tail ends of the at least two adjacent supporting sections are connected. The at least two adjacent supporting sections and the corresponding convergence section form a set of suspended sections, all of which are spaced apart and suspended along the circumferential direction of the fixing portion.
In one embodiment, the plurality of supporting sections inclines circumferentially around a central axis of the fixing portion.
In one embodiment, at least two of the supporting sections within at least one set of the suspended sections incline in the same or different directions along the circumferential direction of the fixing portion.
In one embodiment, at least two adjacent sets of the suspended sections incline in different directions along the circumferential direction of the fixing portion.
In one embodiment, each of the supporting sections includes a first supporting area and a second supporting area connected to each other; the first supporting area deforms along the circumferential direction of the fixing portion upon release of the fixing portion; and a maximum width of the first supporting area along the circumferential direction of the fixing portion after deformation is greater than a maximum width of the second supporting area along the circumferential direction of the fixing portion.
In one embodiment, the second supporting area deforms along the circumferential direction of the fixing portion upon release of the fixing portion.
In one embodiment, an innermost end portion of the convergence section is connected with an internally hollow woven mesh.
In one embodiment, the occlusion device further includes a sealing portion connected to the fixing portion, where one end of each of the plurality of supporting bodies is connected to the sealing portion and the other end extends away from the sealing portion.
In one embodiment, the fixing portion further includes a central end portion, and the occlusion device further includes a sealing portion connected to the central end portion and disposed at one side of the fixing portion; one end of each of the plurality of supporting bodies is connected to the central end portion, and the other end extends radially outward from the central end portion and flipping towards the sealing portion so as to form an flipping section; each of the plurality of supporting bodies continues to extend from a tail end of the flipping section towards the sealing portion so as to form the supporting section.
In one embodiment, the sealing portion includes a distal disc surface facing the fixing portion, at least a part of the distal disc surface being coated with at least one thin-film body.
Compared with the related art, the suspended sections of the above occlusion device retain the advantages of being independent from each other and with a large active space circumferentially of single supporting bodies circumferentially spaced apart and suspended, which can adaptively deform according to different internal tissue structures, and thus has flexible environmental adaptability. In addition, the suspended sections enable the tail ends of two adjacent supporting sections to be connected to form a closed loop structure bending towards the interior of the fixing portion, which not only has a better anti-damage effect, but also can prevent a single supporting section from being locally deformed to a too large extent, and buffer the supporting section with a single rod and the ends thereof being not closed from greater pressure on the inner wall of the left atrial appendage, so as to enhance the fatigue resistance of the occlusion device, and at the same time, reduce the stimulation, wear, or even rupture to the inner wall of the left atrial appendage.
In order to make the objects, solutions, and advantages of the embodiments clear, further detail with reference to the drawings and embodiments is provided. It is understood that the particular embodiments described herein are illustrative only and are not intended as limiting.
It is noted that in the field of interventional medical instruments, generally, an end of the medical instrument implanted in a human body or animal body, is defined as a “proximal end” in response to being closer to an operator, and an end is defined as a “distal end” in response to being farther from the operator, where the “proximal end” and “distal end” of any component of medical instruments are defined according to this principle. The term “axial” generally refers to a length direction of the medical instruments when they are transported, and the term “radial” generally refers to the direction of medical instruments perpendicular to their “axial direction,” where “axial” and “radial” of any component of the medical instruments are defined according to this principle. The term “connect” referred to in embodiments includes instances where two components are directly connected to each other and indirectly connected via other components. While not specifically stated, the following description is directed to the device in its natural state free from external forces or upon release and spreading in the body.
The solutions are further explained in detail in combination with embodiments as follows.
The occlusion device according to Embodiment 1 may be used to occlude the left atrial appendage as well as other internal tissues with openings, such as atrial septal defects. The occlusion device is hereinafter described in detail using the occluding of the left atrial appendage as an example.
Referring to
The sealing portion 110 is woven into a mesh tube by a plurality of woven wires 111, and end portions of the woven wires 111 are closed and fixed by a sleeve at both ends of the mesh tube. The mesh tube is then heat-set into a disc, column, or plug shape to obtain the sealing portion 110 for occluding the opening of the left atrial appendage. The sealing portion 110 includes a distal disc surface 112 facing the fixing portion 120, and a proximal disc surface 113 opposite to the distal disc surface 112. At least one thin-film body 114 is provided inside the sealing portion 110, and the edge of the thin-film body 114 is fixed on the woven wires 111 at the edge of the sealing portion 110. The thin-film body 114 serves to block the flow of blood from one side of the sealing portion 110 to the other side, and further to block the flow of blood between the left atrial appendage and the left atrium.
The fixing portion 120 includes a plurality of supporting bodies 122, and a central end portion 121, to which a distal sleeve 115 of the sealing portion 110 is connected. The supporting bodies 122 on the fixing portion 120 may be rods obtained by cutting metal alloy tubes or polymer tubes or may be rods made by weaving or winding woven wires.
As shown in
Compared with the related art, the suspended sections 126 retain the advantages of being independent from each other and with a large active space circumferentially of single supporting bodies circumferentially spaced apart and suspended, which can adaptively deform according to different internal tissue structures, and thus has flexible environmental adaptability. In addition, the suspended sections 126 enable the tail ends of two adjacent supporting sections 124 to be connected to form a closed loop structure bending towards the interior of the fixing portion 120, which not only has a better anti-damage effect, but also can prevent a single supporting section 124 from being locally deformed to a too large extent, and buffer the supporting section with a single rod and the ends thereof being not closed from greater pressure on the inner wall of the left atrial appendage, so as to enhance the fatigue resistance of the occlusion device 100, and at the same time, reduce the stimulation, wear, or even rupture to the inner wall of the left atrial appendage.
In the embodiment, each the supporting body 122 of the fixing portion 120 includes a lead-out section 127 radially radiating from the central end portion 121 towards the distal end, two branch sections 128 with a certain angle connected to a distal end of the lead-out section 127, and a supporting section 124 connected to the two branch sections 128 in the middle of two adjacent supporting bodies 122. Each of the lead-out sections 127 surrounds and radially radiates from the central end portion 121 towards the distal end, cooperating with each other to form a recessed area. A proximal end of each of the two branch sections 128 is connected to the distal end of the corresponding lead-out section 127, and a distal end of each of the two branch sections 128 flipping towards the direction of the sealing portion 110. The lead-out section 127 of each of the supporting bodies 122 and the two branch sections 128 connected thereto form part of the flipping section 123. Each of the supporting section 124 is parallel or approximately parallel to a central axis Y of the fixing portion 120. The supporting sections 124 may be provided with an anchor 129, and a distal end of the anchor 129 faces towards the sealing portion 110. The anchor 129 penetrates to internal tissue upon release of the fixing portion 120, to assist in fixing the occlusion device 100 and preventing the occlusion device 100 from being displaced. The fixing portion 120, with a plurality of branch sections 128, prevents the local region of the flipping section 123 from deforming excessively to affect the fixed effect, and also reduces the stimulation by the over-deformed portion to the internal tissue.
The convergence section 125 is V-shaped or U-shaped, or may be other shapes, as desired. One end of the convergence section 125 is connected to a distal end of one supporting section 124, and the other end of the convergence section 125 is connected to a distal end of another supporting section 124, and the two supporting sections 124 are adjacent to each other and disposed at the same suspended section 126. The convergence section 125 bends overall from the two end portions towards the interior of the fixing portion 120, to prevent an innermost end portion of the convergence section 125 from scratching the internal tissue when the fixing portion 120 spreads in the body. At the same time, it is possible to avoid a large local deformation of the single supporting section 124, buffering the greater pressure of the supporting section 124 on the inner wall of the left atrial appendage.
When the convergence section 125 is in a V-shape, it includes a first convergence rod 1251 and a second convergence rod 1252 connected to each other, where the first convergence rod 1251 and the second convergence rod 1252 are both linear rods. The convergence section 125 is in a U-shape, includes a first convergence rod 1251, a second convergence rod 1252, and a connecting rod connecting the first convergence rod 1251 and the second convergence rod 1252, where the first convergence rod 1251 and the second convergence rod 1252 are both linear rods, and the connecting rod is an arc-shaped rod. In another embodiment, as shown in
Further, in other embodiments, at least a part of the distal disc surface 112 of the sealing portion 110 is coated with at least one thin-film body, the one thin-film body coating the entire region of the distal disc surface 112, or coating a part region opposite to one or more of convergence sections 125 in an axial direction; alternatively, the multilayer thin-film bodies may be superimposed or connected to each other to coat the entire region of the distal disc surface 112 or to coat the part region opposite to one or more of convergence sections 125 in an axial direction. In this way, the sealing property of the sealing portion 110 can be enhanced, and the convergence section 125 of the fixing portion 120 can be prevented from hooking to the sealing portion 110 and interfering with the proper performance of the sealing procedure.
In other embodiments, as shown in
The occlusion device 100 may be configured to provide transportation and release using a sheath and a transporting rod. The proximal sleeve of the sealing portion 110 is detachably connected to a distal end of the transporting rod. During the occluding operation, the sealing portion 110 and the transporting rod are contained within the sheath after connected and are transported to the target position in the body along with the sheath. The transporting rod is then transported towards the distal end so that the fixing portion 120 extends from a distal end of the sheath for release. The transporting rod continues to be transported towards the distal end upon the fixing portion 120 releasing and being fixed at a target position in the body, so that the sealing portion 110 extends from the distal end of the sheath for release to occlude the opening in the internal tissue. Finally, the transporting rod is disconnected from the sealing portion 110, and the transporting rod and the sheath are retrieved outside the body, thereby completing the occluding operation.
In other embodiments, the number of supporting bodies 122 may be set as desired, as may the number of branch sections 128 corresponding to each of the lead-out sections 127. For example, as shown in
In other embodiments, as shown in
The occlusion device 100 in Embodiment 2 is generally similar to the occlusion device 100 in Embodiment 1, and the same features will not be repeated here. Embodiment 2 differs, for example, from Embodiment 1 in that the plurality of supporting sections 124 on the fixing portion 120 incline circumferentially around the central axis Y of the fixing portion 120, that is, the supporting sections 124 are neither parallel to nor coplanar with the central axis Y of the fixing portion 120. Therefore, it is possible to increase the contact area between the supporting sections 124 and pectinate muscles on the inner wall of the left atrial appendage and reduce the possibility of a part of the supporting sections 124 abutting against thin ravines between pectinate muscles, thereby reducing the probability of rupturing the left atrial appendage.
As shown in
In other embodiments, at least two supporting sections 124, within at least one set of suspended sections 126 on the fixing portion 120, incline differently along the circumferential direction of the fixing portion 120. As shown in
In other embodiments, at least two adjacent sets of suspended sections 126 on the fixing portion 120 incline differently along the circumferential direction of the fixing portion 120. Further, the two sets of sections 126 may incline in different degrees. The fixing portion 120 can form a particular shape by virtue of the inclination of the two adjacent sets of suspended sections 126 in different directions and degrees, which can not only increase the contact area with the internal tissue, but also avoid with a greater probability that a part of the supporting section 124 abuts against the ravines between pectinate muscles, reducing the risk of rupturing the left atrial appendage to a greater extent.
The occlusion device 100 in Embodiment 3 is generally similar to the occlusion device 100 in the Embodiments 1 and 2, and the same features will not be repeated here. Embodiment 3 differs, for example, from Embodiments 1 and 2 in that the supporting section 124 includes a first supporting area 1243 and a second supporting area 1244 connected to each other, and both the first supporting area 1243 and the second supporting area 1244 are compressed and constrained to be approximately straight in response to the fixing portion 120 being contained within the sheath. As shown in
The deformation of the first supporting area 1243 may be a folded linear shape and a wave shape as shown in
Further, in other embodiments, the second supporting area 1244 also deforms along the circumferential direction of the fixing portion 120 upon release of the fixing portion 120. The deforming shape of the second supporting area 1244 may or may not be the same as that of the first supporting area 1243. Since the first supporting area 1243 is generally a region where the fixing portion 120 contacts most with the internal tissue, the maximum width of the second supporting area 1244 along the circumferential direction of the fixing portion 120 after deformation is generally smaller than the maximum width of the first supporting area 1243 along the circumferential direction of the fixing portion 120 after deformation. The specific width of both may be adjusted as desired, but is not limited thereto.
An occlusion device 200 in Embodiment 4 is generally similar to the occlusion device 100 in the Embodiments 1, 2 and 3, and the same features will not be repeated here. Embodiment 4 differs, for example, from Embodiments 1, 2 and 3 in that each of a plurality of supporting bodies 221 of a fixing portion 220 has one end directly connected to a sealing portion 210 and the other end extending away from the sealing portion 210.
For example, as shown in
Compared with the related art, the suspended sections 225 retain the advantages of being independent from each other and with a large active space circumferentially of single supporting bodies circumferentially spaced and suspended, which can adaptively deform according to different internal tissue structures, and thus has flexible environmental adaptability. In addition, the suspended sections 225 enable tail ends of two adjacent supporting sections 223 to be connected to form a closed loop structure bending towards the interior of the fixing portion 220, which not only has a better anti-damage effect, but also can prevent a single supporting section 223 from being locally deformed to a large extent, and buffer the supporting section 223 with a single rod and ends not closed from greater pressure on the inner wall of the left atrial appendage, so as to enhance the fatigue resistance of the occlusion device, and at the same time, reduce the stimulation, wear, or even rupture to the inner wall of the left atrial appendage.
Although a distal end portion of each of the supporting bodies 221 in Embodiment 4 extends towards the distal direction, and the distal end portion of each of the supporting bodies 121 in Embodiments 1, 2 and 3 extends towards the sealing portion 110 (that is, towards the proximal direction), the supporting sections 223 in Embodiment 4 may also adopt the relevant solutions of inclining circumferentially around the central axis Y of the fixing portion 120 in Embodiment 2 and the relevant solutions of the first supporting area 1243 in Embodiment 3, but not limited thereto. Unless there is no conflict in the combination of features in different embodiments of any of the above-mentioned embodiments, the description thereof will not be repeated here.
Each of the features of the above-mentioned embodiments can be arbitrarily combined. For the sake of concise description, all possible combinations of each of the features in the above-mentioned embodiments have not been described. However, unless there is no contradiction between the combinations of these features, they should be considered within the scope of the embodiments.
The embodiments described above, with more specific and detailed descriptions, represent only several embodiments, which cannot be interpreted as a limitation on the scope of the embodiments. It should be noted that for those ordinarily skilled in the art, several changes and improvements can be further made without deviating from the principle of the embodiments, which shall fall within the scope of the present embodiments.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202011436103.4 | Dec 2020 | CN | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/CN2021/130920 | 11/16/2022 | WO |
