Intracapsular neck bridging device

Abstract

An occlusion device includes a woven mesh body and at least one clamping member. The mesh grid body includes a plurality of strands each having a first end and a second end. And the multiple strands are folded, so that the second end parts of the multiple strands are close to the first end parts of the multiple strands, and a double-layer woven mesh main body is formed. In an exemplary occlusion device, at least one strand of the plurality of strands is radiopaque, and the at least one clamping member is non-radiopaque.

Description

Cross-reference to related applications

[0001] This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 410,630, filed September 28, 2022, entitled “Intracapsular Neck Bridging Device”; U.S. Provisional Patent Application No. 63 / 481,663, filed January 26, 2023, entitled “Intracapsular Neck Bridging Device”; and U.S. Patent Application No. 18 / 476018, filed September 27, 2023, entitled “Intracapsular Neck Bridging Device”, the entire disclosure of which is incorporated herein by reference.

[0002] This application is a divisional application of the patent application filed on September 28, 2023, with the application number 202311274955.1 and the invention title "Intracapsular Neck Bridging Device". Technical Field

[0003] This disclosure generally relates to medical devices and methods of manufacturing and using medical devices. In particular, various embodiments of intracapsular devices or occlusion devices for deployment within the vascular system of the human body and methods of manufacturing and / or using occlusion devices are described. Background Technology

[0004] Occlusion devices are known and have been used to treat vascular diseases such as aneurysms. An aneurysm is a bulge or swelling that forms on the wall of an artery in the brain or other parts of the body. Cerebral aneurysms can cause severe pain and, if ruptured, can lead to fetal stroke. In non-invasive or minimally invasive treatment of aneurysms, an occlusion device can be placed in or at the aneurysm to isolate it from blood flow and / or promote thrombosis at that site. Placement of the occlusion device is typically achieved using a delivery system that manipulates the device through the patient's vascular system to the location of the aneurysm. Once positioned at or within the aneurysm, the occlusion device is detached from the delivery system by applying electrolytic or thermoelectric current or by activating a mechanical disengagement mechanism.

[0005] One widely used type of occlusion device is a coil system that includes a flexible, helically wound coil. Coil embolization has become the gold standard for the care of aneurysms. However, procedures, especially those for larger and giant aneurysms, often require excessive coil usage. This can prolong the procedure and result in greater radiation exposure for physicians, support staff, and patients.

[0006] Therefore, there remains a widespread need for medical devices to treat aneurysms and other vascular diseases. The desired outcome is to provide an intrasac device that, through implantation, can achieve the required closure of an aneurysm by stopping blood flow at the wall of the aneurysm to promote clotting and subsequent healing. Summary of the Invention

[0007] In one aspect, embodiments of the present disclosure are characterized by a blocking device. Generally, embodiments of the blocking device include a braided mesh body and at least one clamping member. The braided mesh body includes multiple strands, each having a first end and a second end. At least one of the multiple strands is opaque. The multiple strands are folded so that the second end of the multiple strands is close to the first end of the multiple strands, forming a double-layered braided mesh body. The at least one clamping member clamps the first end and the second end of the multiple strands. The at least one clamping member may be non-opaque.

[0008] In various embodiments of this aspect, the woven mesh body has a bowl-shaped unfolded configuration with a recessed portion at the bottom, and the at least one clamping member is supported in the recessed portion.

[0009] In various embodiments of this aspect, the occlusion device further includes a coupler attached to the at least one clamping member. The coupler is configured to couple the occlusion device to the delivery device. The coupler may be non-transparent and capable of being mechanically or electrolytically disconnected from the delivery device. At least a portion of the coupler may be supported within the recessed portion.

[0010] In various embodiments of this aspect, the at least one clamping member includes a first clamping member clamping a first end of a plurality of strands; and a second clamping member clamping a second end of a plurality of strands. In embodiments where the woven mesh body has a bowl-shaped unfolded configuration with a recessed portion at the bottom, the first clamping member may be supported in the recessed portion. The closure device may also include a coupler attached to the first clamping member. The coupler may be configured to couple the closure device to a delivery device. The coupler may be non-transparent and capable of being mechanically or electrolytically disconnected from the delivery device. The coupler or at least a portion thereof may be supported in the recessed portion. In some embodiments, the second clamping member may include a perforated ring defining a gap, and at least a portion thereof may be supported within the gap. In some embodiments, the ends of the second ends of the plurality of strands extend out of the second clamping member and terminate in an outward flip, thereby forming a flower-like end geometry of the woven mesh body.

[0011] In various embodiments of this aspect, the multiple strands may be coated with an antithrombotic material. In embodiments, the multiple strands may be coated with a material comprising glycosaminoglycans (heparin) or phosphorycholine (PC).

[0012] In one aspect, embodiments of the present disclosure are characterized by a blocking device. Generally, embodiments of the blocking device include a braided mesh body and a second end. The braided mesh body includes multiple strands, each strand having a first end and a second end. The multiple strands are folded inward so that the second end of the multiple strands is close to the first end, thereby forming a double-layered braided mesh body. A clamping member clamps the first end of the multiple strands. The second end of the multiple strands is not clamped.

[0013] In various embodiments of this aspect, at least one of the plurality of strands is non-transparent.

[0014] In various embodiments of this aspect, the clamping member is non-transparent.

[0015] In various embodiments of this aspect, the second ends of the multiple strands terminate by an outward flip, forming a flower-like end geometry of the woven mesh body. The flower-like end geometry may define a gap, and at least a portion of the clamping member is supported within the gap. In embodiments, a coupler may be attached to the clamping member. The coupler may be configured to be coupled to and detachable from the delivery device, and at least a portion of the coupler may be supported within the gap.

[0016] In various embodiments of this aspect, the blocking device may further include a coupler attached to the clamping member, wherein the coupler is configured to be coupled to and disconnectable from the delivery device and is non-transparent.

[0017] In various embodiments of this aspect, the multiple strands of the occlusion device may be coated with an antithrombotic material. The coating material may include glycosaminoglycans (heparin) or phosphorycholine (PC).

[0018] In various embodiments of this aspect, the woven mesh body may have a generally bowl-shaped unfolded configuration.

[0019] In embodiments of this aspect, at least one of the multiple strands is opaque, the clamping member is non-opaque, the second ends of the multiple strands terminate by an outward flip to form a flower-shaped end geometry of the woven mesh body, the woven mesh body having a generally bowl-shaped unfolded configuration with a concave bottom, and the unclamped second ends of the multiple strands defining a gap, and at least a portion of the clamping member being supported within the gap.

[0020] In one aspect, embodiments of the present disclosure are characterized by a blocking device. Generally, embodiments of the blocking device include a braided mesh body and a clamping member. The braided mesh body includes multiple strands, each having a first end and a second end. The multiple strands are folded outwards such that the second ends of the multiple strands are close to the first ends, thereby forming a double-layered braided mesh body. The clamping member clamps the first ends of the multiple strands. The second ends are not clamped to define an opening around the clamping member, such that at least a portion of the clamping member can be supported within a gap defined at least by the opening.

[0021] In various embodiments of this aspect, the blocking device may further include a ring structure, wherein the second ends of the plurality of strands are attached to the ring structure.

[0022] In various embodiments of this aspect, the clamping member is non-transparent.

[0023] In various embodiments of this aspect, at least one of the plurality of strands is non-transparent.

[0024] In various embodiments of this aspect, the blocking device may further include a coupler attached to the clamping member and configured to be coupled to and disconnected from the delivery device. The coupler is non-transparent. At least a portion of the coupler may be supported within the gap.

[0025] In one aspect, embodiments of the present disclosure are characterized by a blocking device. Generally, embodiments of the blocking device include a braided mesh body, a clamping member, and a flexible filler layer. The braided mesh body includes multiple strands, each having a first end and a second end. The multiple strands are folded so that the second end of the multiple strands is adjacent to the first end, thereby forming a double-layered braided mesh body. The clamping member clamps the first end and the second end of the multiple strands. The flexible filler layer is located between the double-layered braided mesh bodies.

[0026] In various embodiments of this aspect, the flexible packing layer may have a hole at its geometric center to allow the flexible packing layer to be centered on the clamping member. The flexible packing layer may be constructed of a polymer material or metal foil. The flexible packing layer may include two or more portions of the same or similar shape to facilitate folding of the flexible packing layer. The flexible packing layer may include an unfolded configuration whose maximum size is smaller than the size of the neck of the aneurysm to be treated. In one embodiment, the flexible packing layer may include an unfolded configuration whose maximum size is larger than the size of the neck of the aneurysm to be treated.

[0027] In various embodiments of this aspect, the clamping member may be non-transparent.

[0028] In various embodiments of this aspect, at least one of the plurality of strands may be non-transparent.

[0029] In various embodiments of this aspect, the blocking device may further include a coupler configured to couple the braided mesh body to or disconnect the braided mesh body from the delivery device. The coupler may include: a spherical body that is interference-fitted with a clamped second end of the braided mesh body; a first thread having a distal end attached to the spherical body and a proximal end attached to the clamping member; and a second thread having a distal end attached to the spherical body and a proximal end configured to couple the braided mesh body to the delivery device. The clamping member may have a slot on one side such that the proximal end of the first thread can be pulled through and secured to the clamping member.

[0030] In one aspect, embodiments of the present disclosure are characterized by a blocking device. Generally, embodiments of the blocking device include a braided mesh body and a clamping member. The braided mesh body includes a plurality of strands, each strand having a first end and a second end. The plurality of strands are folded so that the second end of the plurality of strands is close to the first end of the plurality of strands, thereby forming a double-layered braided mesh body. The clamping member clamps the first end and the second end of the plurality of strands. When the braided mesh body is unconstrained in an unfolded configuration, the braided mesh body has an unfolding angle ranging from about 30 degrees to about 135 degrees. In some embodiments, when the braided mesh body is unconstrained, the braided mesh body has an unfolding angle ranging from about 50 degrees to about 135 degrees. In some embodiments, when the braided mesh body is unconstrained, the braided mesh body has an unfolding angle ranging from about 90 degrees to about 135 degrees. In some embodiments, when the braided mesh body is unconstrained, the braided mesh body has an unfolding angle ranging from about 125 degrees to about 135 degrees.

[0031] In various embodiments of this aspect, when the woven mesh body is unconstrained, the woven mesh body has a maximum width ranging from about 5 mm to about 15 mm.

[0032] In various embodiments of this aspect, when the woven mesh body is unconstrained, the woven mesh body has a maximum width ranging from about 5 mm to about 15 mm and an unfolding angle ranging from about 90 degrees to about 135 degrees.

[0033] In various embodiments of this aspect, the woven mesh body has a first unfolding angle at a first temperature and a second unfolding angle at a second temperature.

[0034] In various embodiments of this aspect, the clamping member is non-transparent. In one embodiment, the clamping member is constructed of nitinol.

[0035] In various embodiments of this aspect, the multiple strands are constructed of a material including shape memory material.

[0036] In various embodiments of this aspect, the woven mesh body or a portion thereof has pores with a diameter ranging from about 20 micrometers to about 500 micrometers in the unfolded configuration.

[0037] In various embodiments of this aspect, the porosity of the woven mesh body or a portion thereof in the unfolded configuration ranges from about 5% to about 95%.

[0038] In various embodiments of this aspect, the woven mesh body or a portion thereof is coated with an antithrombotic material.

[0039] In various embodiments of this aspect, the woven mesh body or a portion thereof is coated with a material comprising glycosaminoglycans (heparin) or phosphorylcholine (PC).

[0040] In another aspect, embodiments of this disclosure are characterized by a blocking device. A braided mesh body comprising a plurality of strands, each strand having a first end and a second end, the plurality of strands being folded so that the second end of the plurality of strands is close to the first end of the plurality of strands, thereby forming a double-layered braided mesh body; and at least one clamping member clamping the first end and the second end of the plurality of strands, wherein the ratio between the straight-line distance between the base end of the outline of the braided mesh body near the at least one clamping member and the end away from the at least one clamping member and the length of the outline is greater than or equal to 0.8.

[0041] In various embodiments of this aspect, the ratio between the straight-line distance between the base end and the end end of the outline of the woven mesh body and the length of the outline is greater than or equal to 0.9.

[0042] In various embodiments of this aspect, when the woven mesh body is unconstrained and in an unfolded configuration, the inclination of the woven mesh body gradually increases and then gradually decreases from the base end to the end end.

[0043] In various embodiments of this aspect, the line connecting the base end and the end end of the contour line intersects with the contour line, and the position of the intersection point in the contour line is defined as a first position, wherein the ratio of the width of the first position to the maximum width of the woven mesh body is greater than or equal to 0.5.

[0044] In various embodiments of this aspect, the inclination of the woven mesh body at the base end ranges from about 10 degrees to about 40 degrees.

[0045] In various embodiments of this aspect, the inclination of the woven mesh body at the end ranges from about 15 degrees to 70 degrees.

[0046] In various embodiments of this aspect, the woven mesh body includes a second position with a maximum inclination between the base end and the end end, wherein the inclination at the second position ranges from about 70 degrees to 100 degrees.

[0047] In various embodiments of this aspect, the ratio of the width of the second position to the maximum width of the woven mesh body is greater than or equal to 0.5.

[0048] In various embodiments of this aspect, the maximum width of the woven mesh body ranges from about 5 mm to about 15 mm.

[0049] In various embodiments of this aspect, the angle between the left and right outlines of the woven mesh body ranges from about 90 degrees to about 170 degrees.

[0050] In various embodiments of this aspect, the at least one clamping member is non-transparent.

[0051] In various embodiments of this aspect, the at least one clamping member is made of nitinol.

[0052] In various embodiments of this aspect, the multiple strands are made of a material including shape memory material.

[0053] In various embodiments of this aspect, the woven mesh body or a portion thereof has pores with apertures ranging from about 20 micrometers to about 500 micrometers in the unfolded configuration.

[0054] In various embodiments of this aspect, the woven mesh body has at least partially a porosity ranging from about 5% to about 95% in its unfolded configuration.

[0055] In various embodiments of this aspect, the woven mesh body is at least partially coated with an antithrombotic material.

[0056] In various embodiments of this aspect, the woven mesh body is at least partially coated with a material comprising glycosaminoglycans or phosphorylcholine PC, wherein the glycosaminoglycans are heparin.

[0057] According to one aspect of this disclosure, a blocking device is provided. The blocking device includes: at least one clamping member; and a braided mesh body including a base end attached to the at least one clamping member and an end end remote from the at least one clamping member. The ratio between the straight-line distance between the base end and the end end of the outline of the braided mesh body and the length of the outline is greater than or equal to 0.8. In various embodiments of this aspect, the ratio may be further set to be greater than or equal to 0.9.

[0058] In various embodiments of this aspect, when the woven mesh body is unconstrained and in an unfolded configuration, the inclination of the woven mesh body gradually increases and then gradually decreases from the base end to the end end.

[0059] The content of this invention is provided to present selected aspects and embodiments of this disclosure in a simplified form and is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter. The presented aspects and embodiments are merely intended to provide the reader with a brief overview of certain forms the invention may take, and are not intended to limit the scope of this disclosure. Other aspects and embodiments of this disclosure are described in the Detailed Description section.

[0060] These and various other aspects, embodiments, features, and advantages of this disclosure will become better understood after reading the following detailed description in conjunction with the accompanying drawings. Attached Figure Description

[0061] Figure 1A A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 1B It shows Figure 1A A top view of an exemplary blocking device shown. Figure 1A and Figure 1BIn the middle, the proximal and distal ends of multiple braided strands of the blocking device are clamped by a single clamping member. Figure 1C It shows when Figures 1A to 1B The diagram shows the unfolding angle (θ) of the main body of the grid when the blocking device is unrestrained.

[0062] Figure 2 A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 2 In the process, the first end or proximal end of the multiple braided strands of the blocking device is clamped by the first clamping member or the proximal clamping member, and the second end or distal end of the multiple braided strands of the blocking device is clamped by the second clamping member or the distal clamping member.

[0063] Figure 3 A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 3 In the process, the distal ends of multiple braided strands of the occlusion device are clamped, and the ends of these distal ends terminate by flipping outward, thereby forming a flower-shaped tip geometry.

[0064] Figure 4 A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 4 In the middle, the distal ends of multiple braided strands of the blocking device were not clamped.

[0065] Figure 5 A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 5 In the process, the distal ends of multiple braided strands of the blocking device are not clamped and are turned outward, thus forming a flower-shaped end geometry.

[0066] Figure 6 A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 6 In the closure device, the proximal and distal ends of multiple braided strands are held by a single clamping member, and the closure device includes a recessed portion at the bottom to allow the disengagement zone to be supported within the device or pulled away from the mother tube.

[0067] Figure 7 A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 7 In the process, the first end or proximal end of the multiple braided strands of the closure device is clamped by a first clamping member or a proximal clamping member, the second end or distal end of the multiple braided strands of the closure device is clamped by a second clamping member or a distal clamping member, and the closure device includes a recessed portion at the bottom to allow the disengagement area to be pulled closer to the distal clamping member or pulled away from the mother tube.

[0068] Figure 8 A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 8 In the process, the distal ends of multiple braided strands of the blocking device are not clamped and are turned outward, thereby forming a flower-like end geometry and defining a gap to allow the disengagement zone to be supported within the gap.

[0069] Figure 9A A side cross-sectional view of an exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 9A In the process, the distal ends of multiple braided strands of the blocking device are held by distal clamping members in the form of perforated rings to allow the disengagement zone to be supported within the gap defined by the perforated rings. Figure 9B It shows Figure 9A A top view of an exemplary blocking device is shown.

[0070] Figure 10 A method for folding an exemplary occlusion device into a contractile configuration for transfer into a catheter, according to an embodiment of the present disclosure, is illustrated.

[0071] Figure 11A and Figure 11B A method for stretching an exemplary occlusion device into a contractile configuration for transfer into a catheter, according to an embodiment of the present disclosure, is illustrated.

[0072] Figure 12 A method for deploying an exemplary occlusion device in an aneurysm according to embodiments of the present disclosure is shown.

[0073] Figure 13A , Figure 13B and Figure 13C An exemplary blocking device in an deployed configuration according to an embodiment of the present disclosure is shown. Figure 13A A side cross-sectional view of the blocking device in its deployed configuration is shown. Figure 13B An enlarged view of a portion of the blocking device is shown. Figure 13C A bottom view of the blocking device in its deployed configuration is shown. Figures 13A to 13C In the process, the proximal ends of multiple braided strands of the occlusion device are not clamped, thus forming an opening or hole to allow the disengagement zone to retract into it.

[0074] Figure 14A and Figure 14B An exemplary closure device comprising a packing layer located between two closure devices is shown according to an embodiment of the present disclosure. Figure 14A A side cross-sectional view of an exemplary blocking device is shown, and Figure 14B A top view of an exemplary blocking device is shown.

[0075] Figure 15A and Figure 15BAn exemplary closure device including a packing layer and a disengagement mechanism is shown according to an embodiment of the present disclosure. Figure 15A A side cross-sectional view of an exemplary blocking device is shown. Figure 15B An enlarged view of the detached mechanism is shown.

[0076] Figure 16A and Figure 16B A side cross-sectional view of a blocking device in an unfolded configuration according to an embodiment of the present disclosure is shown. For ease of explanation, the specific construction of the braided mesh body of the blocking device is omitted, and only the outline is shown. Detailed Implementation

[0077] Overview Embodiments of this disclosure provide an intrasac device or occlusion device for treating aneurysms and other vascular diseases. Implanting a single intrasac device of this disclosure within an arterial balloon enables the necessary occlusion and bridging of the neck of the aneurysm to impede blood flow at the aneurysm wall and promote coagulation and subsequent healing. The intrasac device of this disclosure may include multiple braided strands heat-set to provide a geometry that facilitates three-dimensional (3D) unfolding to impede blood flow at the aneurysm wall. The braided strands may have flower-shaped distal ends to form injury-resistant ends, thereby reducing the risk of tissue damage when the device is pushed upwards within the aneurysm.

[0078] Occlusion devices may include drawn-filled tubing (DFT) threads or cords to provide radiopaque linearity for visibility during delivery and deployment. The radiopaque DFT threads or strands can be clamped together by non-radiopaque clamping members, eliminating the need for radiopaque markers on the device that often protrude into the mother tube, thus putting the patient at risk of thromboembolic events.

[0079] The optional use of radiopaque material in the disengagement zone allows physicians to visualize the delivery and deployment of the occlusion device, further reducing or eliminating the need for radiopaque marker bands on the device. The radiopaque material can be present on the delivery system side of the disengagement zone. Alternatively or additionally, the radiopaque material can be present on the occlusion device side of the disengagement zone. As an example, for mechanical disengagement systems, separate couplers are typically present on the occlusion device and the delivery system. Either or both couplers can be made of radiopaque material to improve visibility.

[0080] The occlusion device can have a recessed portion to allow the disengagement zone to be supported within it. This reduces the amount of device remaining in the main tube, thereby lowering the risk of thromboembolic events. The embedded disengagement zone also helps to concentrate the mesh density near the center of the device, which is particularly desirable in designs where the distal braid of the device is not clamped. The embedded disengagement zone can fill gaps created by unclamped braid.

[0081] Occlusion devices can be coated or coated with various materials to enhance their performance. For example, antithrombotic coatings containing glycosaminoglycans (heparin) or phosphorycholine (PC) can be applied to occlusion devices to reduce thromboembolic events in the event that any part of the device remains in the mother tube. Lubricating coatings containing polytetrafluoroethylene (PTFE) can be applied to occlusion devices to improve lubrication during delivery and reduce the risk of injury.

[0082] The occlusion device may include a double-layered mesh body comprising an inner braid and an outer braid. The inner braid may be clamped at its ends by clamping members, while the outer braid is not clamped, thereby creating a hole or opening that allows the inner braid to fold through. This design allows the disengagement area to retract inward or be embedded within the created hole, thereby reducing or avoiding the risk of thromboembolic events that may occur if part of the device remains in the mother tube.

[0083] The occlusion device may include a filler layer between the inner and outer braids of the double-layered mesh body of the occlusion device. The filler layer may be configured or constructed to increase coverage of the aneurysm neck and to facilitate folding of the occlusion device when it contracts or retracts into the catheter.

[0084] Exemplary blocking devices and systems Various embodiments of occlusion devices, systems, and methods will be described with reference to the accompanying drawings. The drawings are intended for illustrative purposes and are not necessarily drawn to scale. Certain specific details may be set forth in the drawings and description to provide a full understanding of this disclosure. It will be apparent to those skilled in the art that embodiments of this disclosure can be practiced without some of these specific details. In other instances, structures, materials, components, systems, and / or operations typically associated with endovascular procedures have not been shown or described in detail to avoid unnecessarily obscuring the description of embodiments of this disclosure.

[0085] It should be noted that while some embodiments of this disclosure have been shown and described in conjunction with surgical procedures for treating cerebral aneurysms, the devices, systems, and methods described herein can be configured to treat other conditions, such as coronary and peripheral vascular diseases in which there are undesirable blood flow pathways extending into the heart or vascular tissue. The term "intra-sac device" may be used interchangeably with the term "occlusion device."

[0086] Figure 1A and Figure 1B An exemplary intracapsular device or occlusion device 100 according to an embodiment of the present disclosure is shown. Figure 1A It is a side section view, and Figure 1B This is a top view depicting the closure device 100 in either an extended or relaxed configuration. (As shown) Figure 10 As shown in Figure 11 and described further below, the occlusion device 100 can also be in a constricted configuration for transfer into a catheter for delivery. Generally, the occlusion device 100 includes a mesh body 110 and at least one clamping member 150. The mesh body 110 may be composed of multiple strands 112. The multiple strands 112 may be woven to form a woven mesh body 110. As shown, the mesh body 110 may be a double-layered mesh body, comprising a first or outer layer 114 and a second or inner layer 116 as shown. For example, the double-layered mesh body 110 can be formed by folding the multiple strands 112 over itself, such that, for example, the distal ends 120 of the multiple strands 112 are close to the proximal ends 118 of the multiple strands 112. Figures 1A to 1B In the illustrated embodiment, a single clamping member 150 clamps both the proximal end 118 and the distal end 120 of multiple strands 112. When in a deployed or open configuration, the mesh body 110, or at least a portion thereof, has pores whose pore size and / or porosity are such that they can divert or inhibit blood flow through the mesh body 110 into an aneurysm or other treatment site to a degree sufficient to cause thrombosis and healing of aneurysms or other tissues. Generally, the mesh body 110, or at least a portion thereof, in the deployed configuration may have pores with a pore size ranging from, for example, from about 20 micrometers to about 500 micrometers. As an example, the mesh body 110, or at least a portion thereof, in the deployed configuration may have pores with a pore size ranging from about 50 to 200 micrometers. The porosity of the mesh body 110, or at least a portion thereof, in the deployed configuration can range from about 5% to about 95%. As an example, the mesh body 110 or at least a portion thereof may have a porosity of about 50 to 80%.

[0087] The occlusion device 100 can have a three-dimensional (3D) unfolding geometry, particularly suitable for treating wide-necked aneurysms. As an example, the occlusion device 100 can have an unfolding configuration that is bowl-shaped or parabolic. The large-span 3D geometry allows a single occlusion device to bridge or seal the neck of the aneurysm, thereby reducing the amount of mesh material required to fill the aneurysm or eliminating the need to fill the entire aneurysm. When unfolded, the mesh body 110 can typically conform to at least a portion of the inner wall of the aneurysm or adhere tightly to the wall of the aneurysm to stop blood flow and promote coagulation and subsequent healing. It should be noted that embodiments of the occlusion device of this disclosure can have a variety of other 3D geometries, including, for example, spherical, cylindrical, conical, elliptical, oval shapes, or any other suitable shape, to treat aneurysms of various shapes and other vascular diseases.

[0088] refer to Figures 1A to 1B The mesh body 110 may be a woven mesh body comprising multiple strands 112. The strands 112 may comprise shape memory materials, which may be metallic, polymeric, or a combination of metallic and polymeric materials. Shape memory materials tend to have temperature-induced phase transitions, thereby giving the material a preferred configuration or shape that can be set by heating the material above a specific transition temperature. The occlusion device "remembers" the shape set during heat treatment and tends to exhibit this shape unless constrained, for example, in a conduit. Suitable metallic shape memory materials for constructing the occlusion device of this disclosure include, but are not limited to, nickel-titanium (NiTi) or alloys of nickel-titanium such as CuZnAl, FeNiAl, etc. Suitable polymeric shape memory materials for constructing the occlusion device of this disclosure include, but are not limited to, polytetrafluoroethylene (PTFE), polylactide (PLA), ethylene... Vinyl acetate (EVA), etc.

[0089] The multiple strands 112 used to construct the occlusion device 100 of this disclosure may include a single filament, a thread, a strand, or two or more filaments, threads, or strands bundled together. According to embodiments of this disclosure, the multiple strands 112 may include drawn-filled tube (DFT) wires comprising a core metal and an outer sheath surrounding the core metal. According to embodiments of this disclosure, the core metal of the DFT wire may include a radiopaque material such as platinum, gold, tantalum, tungsten, etc. The outer sheath of the DFT wire may include a non-radiopaque material such as nitinol or other metal alloys. While the core metal of the DFT wire provides radiopaque linearity, the outer sheath of the DFT wire can provide shape memory and other desired properties such as strength, flexibility, elasticity, etc. As will be further described below, the use of DFT wire can eliminate or reduce the need for radiopaque marking tape on the occlusion device.

[0090] refer to Figure 1Aand Figure 1B The clamping member 150 clamps the ends 118, 120 of the multiple strands 112 constituting the mesh body 110. According to embodiments of this disclosure, the clamping member 150 may be made of a material invisible to imaging systems conventional in the art (e.g., invisible to X-ray imaging). As an example, the clamping member may be non-transparent. The clamping member may be made of a polymeric non-transparent material or a metallic non-transparent material. The use of transparent strands or transparent DFT filaments eliminates the need for transparent marker tapes or other types of markers. Conventional occlusion devices use markers such as transparent marker tapes to help physicians visualize the device for delivery, deployment, and monitoring. Transparent markers are typically made of heavy metals such as platinum, gold, tantalum, and tungsten, which tend to protrude into the mother tube, thereby increasing the risk of unwanted thromboembolic events. Suitable non-transparent materials for constructing the clamping member 150 include, but are not limited to: polymers such as epoxy resins, metals, or materials such as nitinol, stainless steel, AgSn alloys, and Pb. Metal alloys such as Sn alloy.

[0091] refer to Figure 1A and Figure 1B The clamping member 150 can clamp the ends 118, 120 of the multiple strands 112 by various means, including bonding with suitable adhesives such as epoxy resin, welding, forging, and any other suitable means known in the art. The clamping member 150 can be in any suitable form, such as an annular band, ring, or collar capable of securing the ends 118, 120 of the multiple strands 112.

[0092] refer to Figure 1A and Figure 1B The blocking device 100 may include a coupler 160 configured or constructed to couple the blocking device 100 to a delivery system for delivery. Figures 1A to 1B (Not shown in the diagram), and disengages the occlusion device 100 from the delivery system upon deployment. The coupler 160 can be attached or attached to the clamping member 150 by any suitable means, such as by joining, welding, etc., and remains in the aneurysm or other treatment site after the occlusion device 100 is deployed. For ease of illustration, the coupler 160 is shown in... Figure 1AThe couplings in this and other figures are shown as having hook-like features. However, this disclosure and the appended claims are not limited thereto. The couplings in this embodiment or other embodiments may be configured such that the blocking device of this disclosure can be disconnected or disengaged from the delivery system by applying electrolytic, thermal, or electromagnetic energy or hydraulic pressure and by actuating a mechanical system. For electrolytic disengagement, the couplings on the blocking device and the delivery system may comprise metals with different standard electrode potentials to form a joint that can be disintegrated by applying electrolytic energy. As a coupling, a mechanical disengagement system may comprise a separating hook, a separating screw and thread, a separating key and groove, a separating ball and socket. It should be noted that although the couplings are shown as separate pieces or components in the figures for illustrative purposes, the couplings may be integrated with clamping members as a single unit.

[0093] Therefore, the term "coupler" as used in the specification and appended claims includes, but is not limited to, specific mechanical coupling features. As used herein, the term "coupler" broadly refers to a component or element on the occlusion device that can be attached to another coupler on the delivery system and is detachable from the delivery system upon application of electrolytic, thermal, or electromagnetic energy, hydraulic pressure, or when the mechanical system is actuated. The term "detachment zone" may be used herein to aid in describing various embodiments of the present disclosure and refers to a combination of a coupler on the occlusion device and a complementary coupler on the delivery system. According to embodiments of the present disclosure, the detachment zone may include markers made of, for example, a radiopaque material to help a physician make the deployment of the occlusion device visible. As an example, the coupler on the delivery system side may be constructed of a radiopaque material. Using a radiopaque material in the detachment zone can eliminate or reduce the need for markers such as radiopaque marker strips on the occlusion device. Alternatively or additionally, the coupler on the occlusion device side may be constructed of a radiopaque material.

[0094] refer to Figure 1A and Figure 1B When the net body 110 is unconstrained, the net body 110 of the blocking device 100 has an unfolded configuration with a three-dimensional (3D) geometry. For ease of description of various embodiments, Figure 1C The spread angle (θ) of the net body 110 when unconstrained is shown. As used herein, the term "unconstrained" or its equivalents refer to a state in which the net body of the closure device is not compressed by radial forces, is unconstrained in a capillary, packaging device, or body cavity, or is in "free air" as commonly understood by those skilled in the art. The term "spread angle" refers to the common endpoint (Z) at the common clamping member. Figure 1C The two lines () Figure 1CThe angle formed by A and B in the figure, wherein one of the two lines (e.g., line A) extends from the common endpoint (Z) to one endpoint (X) of the maximum diameter or width (W) of the net body of the closure device when unconstrained, as measured by, for example, across the open end of the net body, and the other line (B) extends from the common endpoint (Z) to the other endpoint (Y) of the maximum diameter or width (W).

[0095] According to embodiments of the present disclosure, the deployment angle of the net body 110 of the blocking device 100 can range from about 30 degrees to about 135 degrees. In some embodiments, the deployment angle of the net body 110 of the blocking device 100 can range from about 50 degrees to about 135 degrees, or from about 90 degrees to about 135 degrees, or from about 125 degrees to about 135 degrees. In various embodiments of the present disclosure, the deployment angle of the net body 110 of the blocking device 100 can be any angle between 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, 85 degrees, 90 degrees, 95 degrees, 100 degrees, 105 degrees, 110 degrees, 115 degrees, 120 degrees, 125 degrees, 130 degrees, and 135 degrees. It should be noted that the above exemplary deployment angles are provided for the purpose of fully understanding the present disclosure. The scope of the appended claims is not limited to the specific angle. Alternatively, the deployment angle of the net body 110 of the blocking device 100 may be less than 30 degrees, such as 25 degrees or 20 degrees, and / or the deployment angle of the net body 110 may be greater than 135 degrees, such as 140 degrees, 150 degrees, 160 degrees or 170 degrees.

[0096] In various embodiments, when the net body 110 is unconstrained, the width of the net body 110 of the blocking device 100 can range from about 5 mm to about 15 mm. As an example, the width of the net body 110 of the blocking device 100 can be 5 mm, 7 mm, 9 mm, 11 mm, 14 mm, 15 mm, or any width in between. Alternatively, the width of the net body 110 of the blocking device 100 can be less than 5 mm and / or greater than 15 mm.

[0097] In various embodiments, the mesh body 110 of the blocking device 100 may have an opening angle ranging from about 30 degrees to about 135 degrees and a width ranging from about 5 mm to about 15 mm, or an opening angle ranging from about 50 degrees to about 135 degrees and a width ranging from about 5 mm to about 15 mm, or an opening angle ranging from about 90 degrees to about 135 degrees and a width ranging from about 5 mm to about 15 mm, or an opening angle ranging from about 125 degrees to about 135 degrees and a width ranging from about 5 mm to about 15 mm. In some embodiments, the mesh body 110 of the blocking device 100 may have an opening angle of about 130 or about 135 degrees and a width ranging from about 5 mm to about 15 mm, or an opening angle of about 120 or about 125 degrees and a width ranging from about 5 mm to about 15 mm, or an opening angle of about 100 or 105 degrees and a width ranging from about 5 mm to about 15 mm, or an opening angle of about 90 or 95 degrees and a width ranging from about 5 mm to about 15 mm.

[0098] Depending on the shape and / or size of the aneurysm or other vascular disease to be treated, the occlusion device 100 can be selected to have a suitable deployment angle and / or size for treatment. For example, a larger deployment angle may be desirable for treating aneurysms with a wide neck. A smaller deployment angle may be desirable for treating aneurysms with deeper internal structures or for other vascular diseases. A smaller deployment angle can improve the delivery capability of the device. With a smaller deployment angle, a more gradual increase in the diameter or width of the mesh body or device can be achieved, which can facilitate the encapsulation and recapsulation of the device during delivery. Generally, it is desirable to reduce frictional forces at various steps during the procedure. Furthermore, due to the smaller strain on the device, a smaller deployment angle allows the device to be recapsulated more times, thereby allowing the user or physician to reposition the device more frequently as needed.

[0099] According to embodiments of this disclosure, when the net body 110 is unconstrained, the net body 110 of the occlusion device 100 can have a variable deployment angle, such as a first deployment angle at a first temperature and a second deployment angle at a second temperature. For example, at ambient temperature when the net body is unconstrained, the net body 110 can have a smaller deployment angle, and at elevated temperatures such as 37 degrees Celsius (normal body temperature), it can have a larger deployment angle. As an example, at normal body temperature (37 degrees Celsius), the net body 110 of the occlusion device 100 can have a deployment angle of about 130 degrees or 135 degrees, while at ambient temperature, when the occlusion device is unconstrained, the net body 110 can have a deployment angle of less than 130 degrees or 135 degrees, respectively. One advantage of an occlusion device with a variable deployment angle is that the relatively small deployment angle at ambient temperature allows for easy packaging of the device into capillaries or containers after manufacturing, and thus reduces the risk of damage to the device during packaging or delivery. Once the occlusion device deploys within the patient, such as in an aneurysm, it will have an increased deployment angle at elevated body temperatures, which may be desirable for bridging wider aneurysm necks. According to embodiments of this disclosure, a variable deployment angle can be achieved by constructing a mesh body from a shape memory material such as nickel-titanium strands or filaments. The mesh body constructed from the shape memory material can be thermoformed on a suitable mold, such that when the mesh body is unconstrained, for example at ambient temperature, the device will have a smaller deployment angle. When unconstrained at elevated temperatures, the device will have a larger deployment angle. Alternatively or additionally, the mesh body constructed from the shape memory material can be contained within a tubular device of a predetermined size to shape the mesh body, such that when the mesh body is removed from the tubular device or unconstrained, the device has a smaller deployment angle at ambient temperature. At elevated temperatures, the device will recover or have a larger deployment angle.

[0100] According to embodiments of this disclosure, the occlusion device 100 may include various materials to enhance the performance of the occlusion device. Polymer and / or monomeric materials and bioactive agents may be coated on the occlusion device to provide desired properties, including reduced thrombotic activity, lubrication, drug delivery, etc.

[0101] According to embodiments of this disclosure, a layer of antithrombotic material may be coated onto the braided mesh body 110 of the occlusion device 100 or at least a portion thereof to reduce thromboembolic events. Suitable antithrombotic substances include, but are not limited to, naturally occurring glycosaminoglycans (heparin), phosphorylcholine (PC) such as methacryloyloxyethyl phosphorylcholine, acryloyloxyethyl phosphorylcholine, and phosphorylcholine-based monomers. Heparin materials are, for example, commercially available from Pfizer, New York. Phosphorylcholine materials are, for example, commercially available from NOF, Tokyo, Japan. The antithrombotic material can be applied to the occlusion device by various methods including, for example, spraying, impregnation, and combinations thereof. The preparation of solutions of antithrombotic materials and the application of solutions to occlusion devices are well known, and therefore their detailed descriptions are omitted herein to focus on the description of various embodiments of this disclosure. Depending on the application, the thickness of the antithrombotic material layer on the occlusion device 100 can range from 1 nanometer to 2000 nanometers.

[0102] According to embodiments of this disclosure, a lubricating material layer may be coated on the braided mesh body 110 of the closure device 100 or on at least a portion of the braided mesh body 110 to improve lubricity during delivery and reduce the risk of damage to the device. Suitable lubricating materials include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), and other suitable polymeric materials. PTFE and FEP materials are commercially available, for example, from E.I. du Pont deNemours and Company in Wilmington, Delaware. The lubricating material can be applied to the mesh body 110 by various methods, including, for example, spraying, dipping, and combinations thereof. The preparation of lubricating material solutions and the application of solutions to closure devices are well known, and therefore their detailed descriptions are omitted herein to focus on the description of the various embodiments of this disclosure. Depending on the application, the thickness of the lubricating material layer on the closure device 100 can range from 1 nanometer to 2000 nanometers.

[0103] According to embodiments of this disclosure, the mesh body 110 is a double-layered mesh body comprising a first or outer layer 114 and a second or inner layer 116 as shown. In the unfolded configuration, the first or outer layer 114 and the second or inner layer 116 may be spaced apart by a distance, for example from about 0.001 inches to about 0.040 inches. The advantage of the spaced-apart double-layered structure of the mesh body 110 is that it provides an increased surface area for smaller clot volumes in the spaces between the layers, thereby promoting thrombus nucleation and stabilization.

[0104] Now for reference Figure 2 An exemplary blocking device 200 according to an alternative embodiment of the present disclosure will now be described. Figure 2The blocking device 200 shown includes a double-layer mesh body 210, which includes a first or outer layer 214 and a second or inner layer 216. The double-layer mesh body 210 is formed by folding a plurality of braided strands 21, initially in a cylindrical shape, over itself along a circumferential line, thereby bringing one end or second end 220 of the plurality of braided strands 212 close to the other end or first end 118 of the plurality of braided strands. Figure 2 As shown, the end 218 of the outer braid 214 can be held by a first clamping member or a proximal clamping member 250. The end 220 of the inner braid 216 can be held by a second clamping member or a distal clamping member 252. Either or both of the first clamping member 250 and the second clamping member 252 can be constructed of, for example, a non-transparent material or a material invisible to imaging systems (including X-ray imaging). The braided strands 212 can include transparent strands, such as transparent DFT threads. The use of transparent threads allows visualization of the occlusion device 200, particularly at clamping points 250, 252 where the threads 212 are bundled and clamped and where the density of the transparent material is high, thereby eliminating the need for separate or independent transparent marker tapes. Figure 2 As shown, the blocking device 200 may further include a coupler 260 attached to the proximal clamping member 250 for coupling to the delivery system. The coupler 260 may be configured or constructed as a complementary coupler attached to the delivery system and is detachable mechanically, electrolytically, or by any other suitable means. The coupler 260 on the blocking device 200 may be non-transparent, while the coupler on the delivery system may be transparent. Alternatively, the coupler 260 on the blocking device 200 may be transparent.

[0105] refer to Figure 2 The mesh body 210 of the blocking device 200 may have an unfolding angle ranging from about 30 degrees to about 160 degrees. In some embodiments, the mesh body 210 of the blocking device 200 may have an unfolding angle ranging from about 30 degrees to about 135 degrees. In some embodiments, the mesh body 210 of the blocking device 200 may have an unfolding angle ranging from about 50 degrees to about 135 degrees, or from about 90 degrees to about 135 degrees, or from about 125 degrees to about 135 degrees. In various embodiments, when the mesh body is unconstrained, the mesh body 210 of the blocking device 200 may have a width ranging from about 5 mm to about 15 mm.

[0106] refer to Figure 3 An exemplary blocking device 300 according to an alternative embodiment of the present disclosure will now be described. Figure 3 The blocking device 300 shown is similar in many respects to Figure 2The occlusion device 200 shown is distinguished in that the end or tip 318 of the inner braid 316 extends into a distal clamping member 352 and terminates in an outward flip-out configuration, thereby forming a floral shape. The floral tip can serve as a damage-resistant end of the occlusion device 300, thereby reducing or avoiding the risk of aneurysm or other tissue rupture during deployment when the occlusion device 300 is pushed upward.

[0107] refer to Figure 4 An exemplary blocking device 400 according to an alternative embodiment of the present disclosure will now be described. Figure 4 The occlusion device 400 shown includes a double-layer mesh body 410, which includes a first braided layer or outer braided layer 414 and a second braided layer or inner braided layer 416. The double-layer mesh body 410 is formed by folding a plurality of braided strands, initially in a cylindrical shape, over itself along a circumferential line, such that one end or second end 420 of the plurality of braided strands 412 is close to the other end or first end 418 of the plurality of braided strands 412. When unfolded, the mesh body 410 or at least a portion thereof has apertures that can deflect or inhibit the flow of fluids such as blood flow to a degree sufficient to cause thrombosis and healing of aneurysms or other tissues.

[0108] like Figure 4 As shown, the end 418 of the first braid or outer braid 414 can be held by a clamping member 450. The clamping member 450 can be invisible to imaging systems commonly used in the art, such as non-transparent material. The end 420 of the second braid or inner braid 416 is not clamped. The braided strands 412 may include transparent strands, such as transparent DFT threads. The use of transparent threads allows visualization of the occlusion device, particularly at clamping points 450 where the threads are bundled and clamped and where the density of the transparent material is high, thus eliminating the need for separate or independent transparent marker strips. Figure 4 As shown, the blocking device 400 may further include a coupler 460 attached to the clamping member 450. The coupler 460 may be configured or constructed as a complementary coupler attached to the delivery system and is detachable mechanically, electrolytically, or by other suitable means. The coupler 460 on the delivery system may be radiopaque. The coupler 460 on the blocking device 400 may be non-radiopaque. Alternatively, the coupler 460 on the blocking device 400 may be radiopaque.

[0109] refer to Figure 4The mesh body 410 of the blocking device 400 may have an unfolding angle ranging from about 30 degrees to about 160 degrees. In some embodiments, the mesh body 410 of the blocking device 400 may have an unfolding angle ranging from about 30 degrees to about 135 degrees. In some embodiments, the mesh body 410 of the blocking device 400 may have an unfolding angle ranging from about 50 degrees to about 135 degrees, or from about 90 degrees to about 135 degrees, or from about 125 degrees to about 135 degrees. In various embodiments, when the mesh body is unconstrained, the mesh body 410 of the blocking device 400 may have a width ranging from about 5 mm to about 15 mm.

[0110] refer to Figure 5 An exemplary blocking device 500 according to an alternative embodiment of the present disclosure will now be described. Figure 5 The blocking device 500 shown is similar in many respects to Figure 4 The occlusion device 400 shown is distinguished by the fact that the end 520 of the second braid or inner braid 516 terminates with an outwardly turned portion, thereby forming a floral configuration. The floral end can serve as a damage-resistant end of the occlusion device 500, thereby avoiding or reducing the risk of aneurysm or other tissue rupture during deployment when the occlusion device is pushed upward.

[0111] refer to Figure 6 An exemplary blocking device 600 according to an alternative embodiment of the present disclosure will now be described. Figure 6 The blocking device 600 shown is similar in many respects to Figure 1A The occlusion device 100 shown differs in that the mesh body 610 includes a recessed portion 611 at its bottom. The recessed portion 611 allows the clamping member 650 and the coupler 660, or at least a portion of the coupler 660, to be embedded within or surrounded by the occlusion device 600 upon deployment, or allows at least a portion of the disengagement area to be pulled away from the mother tube. Therefore, the coupler 660 attached to the clamping member 650 can remain within the aneurysm rather than protrude into the mother tube, thereby avoiding or reducing the risk of thrombotic events. The geometry of the recessed portion 611 can be formed during the heat setting of the occlusion device.

[0112] refer to Figure 7 An exemplary blocking device 700 according to an alternative embodiment of the present disclosure will now be described. Figure 7 The blocking device 700 shown is similar in many respects to Figure 2The occlusion device 200 shown differs in that the mesh body 710 includes a recessed portion 711 at its bottom. The recessed portion 711 allows at least a portion of the proximal clamping member 750 and coupler 760, or the attachment of the clamping member 750 and coupler 760 to the proximal clamping member 750, to be embedded within the occlusion device 700 upon deployment, or allows at least a portion of the disengagement area to be pulled away from the mother tube. The proximal clamping member 750 or the coupler 760, or the attachment of the coupler 760 to at least a portion of the proximal clamping member 750, can therefore remain within the aneurysm rather than protrude into the mother tube, thereby avoiding or reducing the risk of thrombotic events. The recessed portion 711 also allows the proximal clamping member 750 to be positioned close to the distal clamping member 752, thereby increasing the density of the braided strands 712 near the disengagement area. The increased density of the nontransparent strands 712 near the decoupling zone allows for better visualization of the occlusion device 700 during delivery and deployment of the device.

[0113] refer to Figure 8 An exemplary blocking device 800 according to an alternative embodiment of the present disclosure will now be described. Figure 8 The blocking device 800 shown is similar in many respects to Figure 5 The occlusion device 500 shown is distinguished by a recessed portion 811 at the bottom of the mesh body 810. The recessed portion 811 allows the clamping member 850 and the coupler 860, or at least a portion of the coupler 860 attached to the clamping member 850, to be embedded within the occlusion device 800 upon deployment. Therefore, the clamping member 850 and the coupler 860, or at least a portion of the coupler 860 attached to the clamping member 850, can be held within the aneurysm rather than protruding into the mother tube, or allow at least a portion of the detachment area to be pulled away from the mother tube, thereby avoiding or reducing the risk of thrombotic events. The recessed portion 811 also allows the end of the outer braid to be positioned close to the end of the inner braid, thereby increasing the density of the braided strands near the detachment area. The increased density of the radiopaque strands near the detachment area allows for better visualization of the occlusion device 800 during delivery and deployment.

[0114] Now for reference Figures 9A to 9B An exemplary blocking device 900 according to an alternative embodiment of the present disclosure will now be described. Figures 9A to 9BThe occlusion device 900 shown may include a double-layer mesh body 910, which includes a first braided layer or outer braided layer 914 and a second braided layer or inner braided layer 916. The double-layer mesh body 910 is formed by folding a plurality of braided strands, for example in an initial cylindrical form, along a circumferential line, such that one end of the plurality of braided strands is close to the other end of the plurality of braided strands. When unfolded, the mesh body 910, or at least a portion thereof, has apertures such that they can divert or inhibit the flow of fluids such as blood flow to a degree sufficient to cause thrombosis and healing of aneurysms or other tissues, to the aneurysm or other treatment site.

[0115] like Figures 9A to 9B As shown, the end 918 of the outer braid 914 can be clamped by the first clamping member or the proximal clamping member 950. Figure 9B The end 920 of the inner braid 916 may be held by a second clamping member or a distal clamping member 952. Either or both of the first clamping member 950 and the second clamping member 952 may be constructed of a material not visible to the imaging mode, such as a non-transparent material. The braided strands 912 may include transparent strands, such as transparent DFT yarns. The use of transparent yarns allows visualization of the occlusion device 900, particularly at clamping points 950, 922 where the yarns are bundled and clamped and where the density of the transparent material is high, thus eliminating the need for separate or independent transparent marker tapes. The occlusion device 900 may also include a coupler 960 attached to the proximal clamping member 950 for coupling to the delivery system. The coupler 960 may be configured as a complementary coupler coupled to the delivery system and capable of disengaging mechanically, electrolytically, or otherwise suitably. The coupler 960 on the delivery system may be transparent. The coupler 960 on the blocking device 900 may be non-transparent. Alternatively, the coupler 960 on the blocking device 950 may be non-transparent.

[0116] Still referencing Figures 9A to 9B The distal clamping member 952 may include an annular band or ring defining a gap. Figure 9B The size of the annular band 952 can be determined or constructed such that the gap defined by the annular band 952 can accommodate at least a portion of the proximal clamping member 950 and / or the coupler 960. This design allows the proximal clamping point 950 and the distal clamping point 952 to be closer together, thereby further increasing the density of the braided strands 912 near the disengagement area. The increased density of the translucent strands near the disengagement area allows for better visualization of the closure device during delivery and deployment.

[0117] Still referencing Figures 9A to 9BThe main body 910 includes a recessed portion 911 at its bottom. The recessed portion 911 allows the proximal clamping member 950 and the coupler 960, or at least a portion of the coupler 960 attached to the clamping member 950, to be embedded within the occlusion device 900 upon deployment. Therefore, the proximal clamping member 950, or the coupler 960 attached to the proximal clamping member 950, can remain within the aneurysm rather than protrude into the mother vessel, or allow at least a portion of the detachment area to be pulled away from the mother vessel, thereby avoiding or reducing the risk of thrombotic events.

[0118] refer to Figure 9A The mesh body 910 of the blocking device 900 may have an unfolding angle ranging from about 30 degrees to about 160 degrees. In some embodiments, the mesh body 910 of the blocking device 900 may have an unfolding angle ranging from about 30 degrees to about 135 degrees. In some embodiments, the mesh body 910 of the blocking device 900 may have an unfolding angle ranging from about 50 degrees to about 135 degrees, or from about 90 degrees to about 135 degrees, or from about 125 degrees to about 135 degrees. In various embodiments, when the mesh body is unconstrained, the mesh body 910 of the blocking device 900 may have a width ranging from about 5 mm to about 15 mm.

[0119] refer to Figure 10 A method for transferring an occlusion device (e.g., occlusion device 100) into a catheter is now described. The mesh body 110 of the occlusion device 100, which has a 3D geometry, can be folded into a contracted configuration for transfer into the catheter. For example, the 3D geometry mesh body 110 can be compressed into a contracted configuration toward the central axis 111 of the occlusion device 100 as indicated by the arrow. This method can be used to deliver various embodiments of the occlusion devices of this disclosure, including occlusion devices 100, 200, 300, 400, 500, 600, 700, 800, and 900, regardless of whether the distal and proximal ends of the braided strands are secured by a single clamping member or by two separate clamping members.

[0120] refer to Figure 11A and Figure 11B Alternative methods for transferring an occlusion device (e.g., occlusion device 300) into a catheter are now described. The mesh body 310 of the occlusion device 300, which has a 3D geometry, can be stretched into a contractile configuration for transfer into the catheter. For example, the 3D geometry mesh body 310 can be stretched in opposite directions between a proximal clamping point 350 and a distal clamping point 352, as indicated by the arrows, to form a contractile configuration. This method can be used for occlusion devices, such as… Figures 2 to 3 The blocking device shown in the figure, etc., wherein the distal end and proximal end of the braided strand are not fastened by a single clamping member.

[0121] refer to Figure 12An example method for deploying an exemplary occlusion device 600 according to embodiments of the present disclosure will now be described. As shown, a delivery system 170 can be used to deliver and deploy the occlusion device 600 at a target site for treating, for example, an aneurysm 180 formed on the wall of a vessel 182 in a patient's neurovascular system. Various delivery systems are known and readily available in the art, and therefore detailed descriptions of them are omitted herein to focus on the description of embodiments of the present disclosure. Generally, the delivery system 170 includes a catheter or microcatheter 172 for delivering the occlusion device 600 in a contracted or delivery configuration through the vascular system to the treatment site, a filament element 174 for pushing and / or retracting the occlusion device 600, and a coupler 176 for coupling a complementary coupler 660 to the occlusion device 600. The coupling between the delivery system 170 and the occlusion device 600 can be disconnected by various mechanisms known in the art, including but not limited to mechanical, electrolytic, and hydraulic mechanisms.

[0122] In order to deliver, such as Figure 10 and Figures 11A to 11BAs shown, the occlusion device 600 can be folded into a contracted configuration and restrained within the catheter 172 of the delivery system 170. Once the delivery system 170 is guided and reaches the neck of the aneurysm 180, the occlusion device 600 can be pushed away from the catheter 172 and into the aneurysm 180 by the filament element 174. Once released from the catheter 172, the occlusion device 600 can present a 3D configuration within the aneurysm 180. The occlusion device 600 can be disengaged from the delivery system 170 by applying electrolytic power or by actuating a mechanical disengagement mechanism or other suitable means. For illustration, the occlusion device 600 includes a coupler 660 attached to a clamping member 650 on the occlusion device 600 and connected to a complementary coupler 176 on the delivery system 170. The coupler 176 on the delivery system 170 may be radiopaque or include markers to facilitate visualization of the occlusion device 600 during delivery and deployment by imaging the disengagement area. The coupler 660 on the occlusion device 600 may be invisible to the imaging system, for example, being non-transparent, and remains in the aneurysm 180 after the occlusion device 600 is disconnected from the delivery system 170 and unfolded in the aneurysm 180. Because the braided strands 612 or at least some of the strands are transmissive, the occlusion device 600 can still be visualized at the clamping point 650, for example, by X-ray fluoroscopy, particularly due to the increased density of the strands clamped at the ends. Alternatively, the coupler 660 on the occlusion device 600 may be constructed of a transmissive material. As shown, the mesh body 610 of the deployed occlusion device 600 may have a recessed portion 611 at the bottom, allowing the coupler 660 or at least a portion thereof to be embedded within the occlusion device 600 in the aneurysm 180 or pulled away from the mother tube 182. This reduces or avoids the risk of thrombotic events that may result from the coupler 650 protruding into the mother tube. After deployment, the delivery system 170 and the coupler 176 on the delivery system 170 can be removed from the vascular system. The occlusion device 600 exhibits its 3D geometry. The deployed occlusion device 600 in its 3D geometry may be generally conformable to the shape of the aneurysm 180 or a portion of the aneurysm near its neck, allowing the mesh body 610 to contact the inner wall and cover or bridge the neck of the aneurysm. Thus, a single occlusion device can block and / or cover the aneurysm, thereby inhibiting blood flow into the aneurysm and promoting coagulation and subsequent healing.

[0123] Now for reference Figures 13A to 13CAn exemplary blocking device 1300 according to embodiments of the present disclosure will now be described. Typically, the blocking device 1300 includes a mesh body 1310 and a clamping member 1350. The mesh body 1310 may be constructed from multiple strands 1312. The multiple strands 1312 may be woven to form the mesh body 1310. As shown, the mesh body 1310 may be a double-woven mesh body comprising a first braid or first layer or outer braid or outer layer 1314 and a second braid or second layer or inner braid or inner layer 1316. The double-woven mesh body 1310 may be formed by folding, for example, multiple strands 1312, initially in a cylindrical form, outwards onto themselves such that one end of the multiple strands is close to the other end of the multiple strands, or by bringing the end 1318 of the outer braid 1314 close to the end 1320 of the inner braid 1316. The end 1320 of the inner braid 1316 can be clamped by the clamping member 1350, while the end 1318 of the outer braid 1318 is not clamped, thereby defining an opening or hole 1319 around the clamping member 1350. In some embodiments, the end 1318 of the outer braid 1314 can be attached to the annular structure 1321, such as Figures 13B to 13C This is better observed in the text.

[0124] refer to Figure 13A The net body 1310 of the blocking device 1300 may have an unfolding angle ranging from about 30 degrees to about 160 degrees. In some embodiments, the net body 1310 of the blocking device 1300 may have an unfolding angle ranging from about 30 degrees to about 135 degrees. In some embodiments, the net body 1310 of the blocking device 1300 may have an unfolding angle ranging from about 50 degrees to about 135 degrees, or from about 90 degrees to about 135 degrees, or from about 125 degrees to about 135 degrees. In various embodiments, when the net body is unconstrained, the net body 1310 of the blocking device 1300 may have a width ranging from about 5 mm to about 15 mm.

[0125] Still referencing Figures 13A to 13C Similar to some embodiments in other examples, the multiple strands 1312 may include threads constructed of a radiopaque material. For example, the multiple strands 1312 used to construct the occlusion device 1300 may include drawn filler tube (DFT) threads comprising a core metal of a radiopaque material such as platinum, gold, tantalum, tungsten, etc., and an outer sheath of a shape memory material such as nitinol or other elastic metal alloys. Using radiopaque DFT threads for braiding can reduce or eliminate the need for radiopaque marking strips on the occlusion device. The clamping member 1350 that holds the ends 1320 of the inner braid or layer 1316 may be constructed of a non-radiopaque material.

[0126] Still referencing Figures 13A to 13CThe blocking device 1300 may include a coupler 1360 attached to a clamping member 1350 for coupling the blocking device 1300 to a delivery system. The coupler 1360 attached to the clamping member 1350 may also be constructed of a non-transparent material. The coupler 1360 on the blocking device 1300 may be coupled to a complementary coupler on the delivery system. The complementary coupler on the delivery system may be transparent to facilitate visualization of the blocking device 1300 during delivery and deployment. The coupler 1360 on the blocking device 1300 and the coupler on the delivery system may be configured or constructed such that they can disengage from each other upon application of electrolytic power or by an actuated mechanical disengagement mechanism. According to embodiments of this disclosure, the delivery system may include a flap 1362 at its distal end. Figure 13A This allows the blocking device 1300 to fold or retract back into the delivery system. The wing 1362 can be constructed from a flexible and / or smooth material such as PTFE, ePTFE, or any other suitable polymer material.

[0127] Advantageously, the occlusion device 1300 of this disclosure allows the clamping member 1350 and the disengagement area to retract inward or be embedded within a hole or opening 1319 defined or created by the unclamped end 1318 of the outer braid 1314. Thus, the clamping member 1350 and the coupler 1360, or at least a portion thereof, can remain together with the occlusion device 1300 within the aneurysm to be treated, rather than protruding into the mother vessel, thereby reducing or avoiding the risk of thrombotic events.

[0128] refer to Figures 14A to 14B and Figures 15A to 15B An exemplary blocking device 1400 according to embodiments of the present disclosure will now be described. Figures 14A to 14B and Figures 15A to 15B The blocking device 1400 shown is similar in many respects to Figures 1A to 1B The blocking device 100 shown in the figure is different in that Figures 14A to 14B and Figures 15A to 15B The closure device 1400 shown includes a flexible filler layer 1430 between a first braided layer or outer braided layer 1414 and a second braided layer or inner braided layer 1416, and a unique coupling system 1460.

[0129] refer to Figures 14A to 14BThe filler layer 1430 can be configured or constructed to facilitate the folding of the braided mesh body 1410 when it retracts into the catheter or outer sheath. The filler layer 1430 can have a geometry that allows it to be easily folded and retracted into the catheter or outer sheath, such as a cloverleaf, three-lobed, slit disc, or other suitable form. The filler layer 1430 may have an aperture 1432 at its geometric center and be aligned with the clamping point of the clamping member 1450 or the braid, so that the filler layer 1430 can remain centered. The filler layer 1430 can be configured or constructed to increase coverage of the aneurysm neck or to redirect fluid flow away from treatment sites such as the aneurysm. The filler layer 1430 can be constructed from a flexible polymer such as PTFE, ePTFE, or other suitable polymers. The flexible filler layer 1430 can also be constructed from suitable metal foil. The size and shape of the filler layer 1430 can be determined such that it does not completely cover the neck of the aneurysm to avoid compressing the aneurysm. Alternatively, the size and shape of the packing layer 1430 can be formed to completely cover the neck of the aneurysm. For example, the size of the packing layer 1430 can be formed larger than the neck of the aneurysm to isolate the aneurysm from the mother vessel to produce immediate clotting. The packing layer can be in the form of a disc without incisions. This is applicable to the treatment of ruptured aneurysms to provide immediate protection against re-rupture. Those skilled in the art will understand that, although this document references… Figures 14A to 14B as well as Figures 15A to 15B Examples of filler layers have been described, but Figures 1A to 13C as well as Figures 15A to 16B All of these blocking devices shown in the figures may also include or be modified to include the packing layer as described herein.

[0130] refer to Figure 14A The net body 1410 of the blocking device 1400 may have an unfolding angle ranging from about 30 degrees to about 160 degrees. In some embodiments, the net body 1410 of the blocking device 1400 may have an unfolding angle ranging from about 30 degrees to about 135 degrees. In some embodiments, the net body 1410 of the blocking device 1400 may have an unfolding angle ranging from about 50 degrees to about 135 degrees, or from about 90 degrees to about 135 degrees, or from about 125 degrees to about 135 degrees. In various embodiments, when the net body is unconstrained, the net body 1410 of the blocking device 1400 may have a width ranging from about 5 mm to about 15 mm.

[0131] refer to Figures 15A to 15BAccording to embodiments of this disclosure, the closure device 1400 may include a coupler 1460 configured to couple the closure device 1400 to the delivery system 1470. As shown, the coupler 1460 may include, for example, a spherical body 1462 and two threads 1464, 1466, each having a distal end attached to the spherical body 1462. The spherical body 1462 may be located at the clamped end or clamping point of the inner braid 1416 and is configured to have an interference fit with the clamped end. For example, the first thread 1464 may be attached to the clamping member 1450 by threading through a slot at the side of the clamping member 1450. The proximal end of the first thread 1464 may be further attached to the clamping member 1450 by adhesive, welding, or other suitable means. The second thread 1466 may extend through the clamping member 1450 and be coupled to the delivery system 1470. The proximal end of the second wire 1466 and the distal end of the delivery system 1470 can form an ablation zone 1468 that can be decomposed by applying electrolytic power. Alternatively, the proximal end of the second wire 1466 can have mechanical features such as hooks, slots, threads, etc., which are configured to be coupled to complementary mechanical features on the distal end of the delivery system 1470, and this coupling can be broken by an actuating mechanical mechanism.

[0132] like Figure 16A and Figure 16B As shown, an exemplary deployment configuration of a blocking device 1600 according to an alternative embodiment of the present disclosure will now be described. Figure 16A and Figure 16B The difference between the blocking device 1600 shown below and the embodiments described above lies in the shape of the braided mesh body 1610 of the blocking device 1600, which will be described below as follows. Figure 16A and Figure 16B The shape of the outline (outer outline) of the woven mesh body 1610 shown is explained. It is necessary to refer to the diagram as shown in the instruction manual. Figure 16A and Figure 16B In the outline of the woven mesh body 1610 shown, the end (base end) located on the side away from the clamping member 1650 is located at the highest point of the entire woven mesh body 1610, and the end (end end) located on the side close to the clamping member 1650 is located at the adjacent point of the woven mesh body 1610 to the clamping member 1650.

[0133] Specifically, such as Figure 16A As shown, the outline of the braided mesh body 1610 of the blocking device 1600 according to an embodiment of the present disclosure is formed as a curved shape extending from the base end to the end end, and as... Figure 16BAs shown, in the unfolded configuration, the inclination of the woven mesh body 1610 gradually increases and then gradually decreases as it extends from the base end to the end. The inclination is defined as the degree of inclination of the tangent direction at any point on the woven mesh body 1610 relative to the vertical direction, and the magnitude of the inclination can be represented by the angle between the tangent direction and the vertical direction.

[0134] The woven mesh body 1610 is constructed such that (the description of the shape of the "outline" below generally refers to a single-sided outline): the ratio Lc / La between the length of the line segment L connecting the two ends (base end and end end) of the outline (i.e., the straight-line distance between the two ends of the outline, hereinafter referred to as the "chord length Lc of the outline") and the length of the outline itself (hereinafter referred to as the "arc length La of the outline") is greater than or equal to about 0.8, that is, not less than 0.8, for example, it can be in the following ranges: 0.8 to 0.99, 0.8 to 0.95, etc. Hereinafter, for ease of explanation, the ratio between the chord length Lc and the arc length La of the outline is defined as the "chord-arc ratio Lc / La".

[0135] By setting the chord-to-arc ratio as described above, compared to the case where the chord and arc are far apart, resulting in a large difference in length, the embodiment of this disclosure, by setting the chord-to-arc ratio Lc / La as described above, results in a smaller gap between the chord and arc. This makes the overall shape of the braided mesh body 1610 tend to be flatter, thus making it easier to fit snugly against the inner wall of the aneurysm and allowing the mesh body to bridge more stably to the neck of the aneurysm. Furthermore, it can prevent the braided mesh body 1610 from shifting entirely from the neck of the aneurysm. Therefore, it helps to seal and / or cover the aneurysm to inhibit blood flow into the aneurysm and promote coagulation and subsequent healing.

[0136] In one embodiment of this disclosure, preferably, the chord-to-arc ratio Lc / La can be greater than or equal to about 0.9. For example, it can be about 0.90 to 0.99, and more preferably, the chord-to-arc ratio Lc / La can be about 0.95 to 0.99. For example, the chord-to-arc ratio Lc / La can be about 0.91, 0.92, 0.93, 0.94, 0.95, 0.96, or 0.97.

[0137] In embodiments of this disclosure, such as Figure 16A As shown, since the outline of the braided mesh body 1610 of the blocking device 1600 of the present disclosure is formed with an inclination that gradually increases from the base end to the end end as described above, there is an intersection point P (also called "first position") between the outline of the braided mesh body 1610 and the straight line L connecting the base end and the end end of the outline.

[0138] like Figure 16AAs shown, the ratio Wp / W0 of the distance or width Wp (i.e., the width of point P (first position)) between the aforementioned intersection points P on the left and right contour lines to the overall maximum width W0 of the woven mesh body 1610 of the blocking device 1600 is greater than or equal to 0.5. For example, it can be in the range of 0.5 to 0.95, or in the range of, for example, 0.5 to 0.9.

[0139] In one embodiment of this disclosure, by setting the Wp / W0 range as described above, point P is positioned closer to the outer side in the left-right direction compared to a relatively small Wp / W0. Therefore, the mesh body as a whole tends to have a flatter shape, especially in the outer part of the mesh body in the left-right direction, making it easier to closely adhere to the inner wall of the aneurysm. This allows the mesh body to bridge more stably to the neck of the aneurysm, and further, prevents the mesh body from shifting away from the neck of the aneurysm. This helps to seal and / or cover the aneurysm, inhibiting blood flow into the aneurysm and promoting coagulation and subsequent healing.

[0140] In one embodiment of this disclosure, preferably, the range of Wp / W0 can be from about 0.8 to 0.9, and more preferably, the range of Wp / W0 can be from about 0.85 to 0.9. Furthermore, the value of Wp / W0 can also be from about 0.4 to about 0.6, or even, for example, from 0.1 to 0.6, depending on the specific application.

[0141] In addition, such as Figure 16B As shown, since the inclination of the woven mesh body 1610 gradually increases and then gradually decreases from the base to the end, there is a point Q (also called the "second position") with the maximum inclination in the unfolded configuration of the woven mesh body 1610. In this paper, the inclination at the base of the woven mesh body 1610 in the unfolded configuration is defined as the base inclination β1, and the inclination at point Q is defined as the maximum inclination β. max And the inclination at the end is defined as the end inclination β2.

[0142] In embodiments of this disclosure, such as Figure 16B As shown, the braided mesh body 1610 is configured such that its inclination in the unfolded configuration gradually increases from the base end toward point Q. Compared to cases where the inclination remains constant or gradually decreases, the shape near the base end of the braided mesh body 1610 configured in this way better conforms to the inner wall around the neck of the aneurysm, thereby helping the braided mesh body to bridge the neck of the aneurysm to further seal and / or cover the aneurysm, inhibit blood flow into the aneurysm, and promote coagulation and subsequent healing.

[0143] On the other hand, such as Figure 16BAs shown, in the unfolded configuration, the braided mesh body 1610 is constructed such that its inclination gradually decreases from point Q to the end, causing the braided mesh body 1610 to contract inward in the left and right directions near the end, thereby minimizing interference between the end of the braided mesh body 1610 and, for example, the inner wall of an aneurysm, and preventing wear or damage to the device and the inner wall of the aneurysm due to such interference, thus improving the compliance of the braided mesh body 1610.

[0144] In embodiments of this disclosure, such as Figure 16B As shown, in the unfolded configuration, the base inclination β1 ranges from about 10 degrees to about 40 degrees, the end inclination β2 ranges from about 15 degrees to about 70 degrees, and the maximum inclination β... max The range is approximately 70 to 100 degrees.

[0145] In embodiments of this disclosure, by constructing the braided mesh body 1610 as described above, such that its base inclination β1 in the unfolded configuration ranges from about 10 degrees to about 40 degrees, compared to the case where the base inclination β1 is larger, it is helpful to constrain (shrink) the braided mesh body 1610 within the conduit 172 of the delivery system 170 during use (see reference). Figure 10 and Figure 11A and Figure 11B ).

[0146] In embodiments of this disclosure, by constructing the woven mesh body 1610 as described above, its maximum tilt β in the unfolded configuration is achieved. max The range is approximately 70 to 100 degrees, which, compared to cases with a smaller maximum inclination, further makes the braided mesh body 1610 tend to be flattened to fit close to, for example, the inner wall of an aneurysm and to be erected or bridged to the neck of the aneurysm, thereby helping to block and / or cover the aneurysm to inhibit blood flow into the aneurysm and promote coagulation and subsequent healing.

[0147] In embodiments of this disclosure, by constructing the braided mesh body 1610 as described above, such that its end tilt angle β2 in the unfolded configuration ranges from about 15 degrees to about 70 degrees, the end of the braided mesh body 1610 can be close to, for example, the inner wall of an aneurysm and interference between the end and the inner wall of the aneurysm can be prevented, thereby preventing damage to the braided mesh body 1610 and damage to the inner wall of the aneurysm.

[0148] In one embodiment of this disclosure, preferably, the base inclination β1 ranges from about 10 degrees to about 30 degrees. More preferably, the base inclination β1 ranges from about 15 degrees to about 30 degrees.

[0149] In one embodiment of this disclosure, preferably, the maximum tilt angle β maxThe range is approximately 85 degrees to approximately 95 degrees, or approximately 80 degrees to 90 degrees. More preferably, the maximum value of the inclination β... max The range is approximately 85 degrees to approximately 90 degrees or approximately 90 degrees to 95 degrees.

[0150] In one embodiment of this disclosure, preferably, the end tilt angle β2 ranges from about 40 degrees to about 70 degrees. More preferably, the end tilt angle β2 ranges from about 40 degrees to about 60 degrees.

[0151] In addition, such as Figure 16B As shown, the ratio Wq / W0 of the distance or width between the points Q with the maximum inclination on the left and right contour lines (i.e., the "width of point Q (second position)") to the overall maximum width W0 of the braided mesh body 1610 of the blocking device is greater than or equal to 0.5. For example, Wq / W0 can range from 0.5 to 0.9, or from 0.5 to 0.98.

[0152] In the embodiments of this disclosure, by constructing the braided mesh body 1610 as described above, compared to the case where the value of Wq / W0 is slightly smaller, the point Q of maximum inclination of the braided mesh body 1610 is closer to the outer side in the left-right direction; that is, the point Q of maximum inclination, which is the inclination transition point, is closer to the outer side in the left-right direction. Therefore, the mesh body can be made to tend towards a flat shape, especially in the outer portion of the mesh body in the left-right direction, making it easier to fit snugly against the inner wall of the aneurysm, and allowing the mesh body to bridge more stably to the neck of the aneurysm. Furthermore, it can prevent the mesh body from shifting away from the neck of the aneurysm. This helps to seal and / or cover the aneurysm to inhibit blood flow into the aneurysm and promote coagulation and subsequent healing.

[0153] In one embodiment of this disclosure, preferably, the range of Wq / W0 can be from about 0.7 to 0.95, and more preferably, the range of Wq / W0 can be from about 0.8 to 0.95.

[0154] According to the embodiments described above, in an unrestricted unfolded configuration, the maximum width W0 of the woven mesh body 1610 ranges from approximately 5 mm to approximately 15 mm. As an example, the mesh body 110 of the blocking device 100 can have a width of 5 mm, 7 mm, 9 mm, 11 mm, 14 mm, 15 mm, or any width in between. Alternatively, the mesh body 110 of the blocking device 100 can have a width less than 5 mm and / or greater than 15 mm.

[0155] According to the embodiments described above, in an unconstrained unfolded configuration, the angle between the line L connecting the two ends (base end and end end) of the left contour line of the woven mesh body 1610 and the line L connecting the two ends (base end and end end) of the right contour line is defined as the contour line angle α between the left and right contour lines of the woven mesh body 1610 (see...). Figure 16A In embodiments of this disclosure, the included angle α of the contour line ranges from about 90 degrees to about 170 degrees. In some embodiments, the woven mesh body 1610 of the blocking device 1600 may have an included angle α ranging from about 100 degrees to about 170 degrees, or from about 120 degrees to about 170 degrees, or from about 120 degrees to about 160 degrees. In various embodiments of this disclosure, the mesh body 1610 of the blocking device 1600 may have an included angle of 90 degrees, 100 degrees, 110 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degrees, 160 degrees, 170 degrees, or any angle therebetween. It should be noted that the above exemplary included angles of the contour line are provided for the purpose of fully understanding this disclosure. The scope of the appended claims is not limited to the specific angle. Alternatively, the mesh body 1610 of the blocking device 1600 may have a profile angle of less than 90 degrees, such as a profile angle of 60 or 70 degrees, and / or a profile angle of greater than 170 degrees, such as a profile angle of 172 or 175 degrees.

[0156] In the embodiments of this disclosure, by constructing the braided mesh body 1610 as described above, compared to the case with a slightly smaller contour angle, setting the contour angle of the braided mesh body 1610 as described above further flattens the braided mesh body 1610, making it easier to adhere tightly to the inner wall of the aneurysm and allowing the mesh body to bridge more stably to the neck of the aneurysm. Furthermore, it can prevent the entire mesh body from shifting from the neck of the aneurysm. Therefore, it helps to seal and / or cover the aneurysm to inhibit blood flow into the aneurysm and promote coagulation and subsequent healing.

[0157] It should be noted that the woven mesh body 1610 having the structure described above is not limited to the double-layer mesh body structure described above, but may also have, for example, a single-layer mesh, or a three- or more-layer mesh structure.

[0158] Coating on the blocking device According to embodiments of this disclosure, the occlusion device may include various materials to enhance its performance. Polymer and / or monomeric materials and bioactive agents may be coated onto the occlusion device to provide desired properties, including reduced thrombotic activity, lubrication, drug delivery, etc.

[0159] According to embodiments of this disclosure, an antithrombotic material layer can be coated onto the braided mesh body of an occlusion device or at least a portion thereof to reduce thromboembolic events. Suitable antithrombotic materials include, but are not limited to, naturally occurring glycosaminoglycans (heparin), such as methacryloxyethyl phosphorylcholine, acryloyloxyethyl phosphorylcholine, and phosphorylcholine (PC) based on phosphorylcholine monomers. Heparin materials are, for example, commercially available from Pfizer, New York. Phosphorylcholine materials are, for example, commercially available from NOF, Tokyo, Japan. The antithrombotic material can be applied to the occlusion device by various methods including, for example, spraying, impregnation, and combinations thereof. The preparation of solutions of antithrombotic materials and the application of solutions to occlusion devices are well known, and therefore their detailed descriptions are omitted herein to focus on the description of various embodiments of this disclosure. Depending on the application, the thickness of the antithrombotic material layer on the occlusion device can range from 1 nanometer to 2000 nanometers.

[0160] According to embodiments of this disclosure, a lubricating material layer can be coated on the braided mesh body of the closure device or at least a portion thereof to increase lubricity during delivery and reduce the risk of damage to the device. Suitable lubricating materials include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), and other suitable polymeric materials. PTFE and FEP materials are commercially available, for example, from E.I. du Pont de Nemours and Company in Wilmington, Delaware. The lubricating material can be applied to the closure device by various methods, including, for example, spraying, impregnation, and combinations thereof. The preparation of lubricating material solutions and the application of solutions to closure devices are well known, and therefore their detailed descriptions are omitted herein to focus on the description of the various embodiments of this disclosure. Depending on the application, the thickness of the lubricating material layer on the closure device can range from 1 nanometer to 2000 nanometers.

[0161] Various embodiments of the blocking devices, systems, and methods have been described with reference to the accompanying drawings. It should be noted that the aspects described in connection with a particular embodiment are not necessarily limited to that embodiment and can be practiced in any other embodiment. The drawings are intended to illustrate the embodiments and are not intended as an exhaustive description or limitation of the scope of this disclosure. Alternative structures, components, and materials will readily be considered feasible without departing from the principles of the claimed invention.

[0162] Unless otherwise expressly defined, all technical and scientific terms used herein have the meanings commonly understood by one of ordinary skill in the art. As used in the specification and appended claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context explicitly specifies otherwise. The term “or” means a non-exclusive “or” unless the context explicitly specifies otherwise. The term “proximal” and its grammatical equivalents refer to a position, direction, or orientation toward the user or physician. The term “proximal” and its grammatical equivalents refer to a position, direction, or orientation away from the user or physician. The terms “first” or “second,” etc., can be used to distinguish one element from another when describing various similar elements. It should be noted that the terms “first” and “second” as used herein include references to two or more. Furthermore, the use of the terms “first” or “second” should not be construed as indicating any particular order unless the context explicitly specifies otherwise. The term “about” can be used to indicate a value that may include a variation of ±15% of the value modified by the term. Enumerating numerical ranges by endpoints includes all numerical values ​​within that range (e.g., 5 to 15 includes 5, 5.5, 7, 9, 11, 14, 14.5, and 15).

[0163] Those skilled in the art will understand that various other modifications can be made. All such and other variations and modifications have been conceived by the inventors, and all such and other variations and modifications are within the scope of this invention.

Claims

1. A blocking device, the blocking device comprising: A woven mesh body comprising multiple strands, each strand having a first end and a second end, wherein the multiple strands are folded so that the second end of the multiple strands is close to the first end, forming a double-layered woven mesh body; and Clamping member, the clamping member clamping the first end and the second end of the plurality of strands; and A flexible filler layer is located between the two-layer woven mesh body.

2. The blocking device according to claim 1, wherein, The flexible packing layer has a hole at its geometric center so that the flexible packing layer can be centered on the clamping member.

3. The blocking device according to claim 2, wherein, The flexible filler layer is made of polymer material or metal foil.

4. The blocking device according to claim 3, wherein, The flexible filler layer comprises two or more segments of the same or similar shape to facilitate folding of the flexible filler layer.

5. The blocking device according to claim 3, wherein, The flexible filler layer includes an unfolded configuration, the maximum size of which is smaller than the size of the neck of the aneurysm to be treated.

6. The blocking device according to claim 3, wherein, The flexible filler layer includes an unfolded configuration, the maximum size of which is larger than the size of the neck of the aneurysm to be treated.

7. The blocking device according to claim 1, wherein, The clamping member is non-transparent.

8. The blocking device according to claim 7, wherein, At least one of the multiple strands is non-transparent.

9. The blocking device according to claim 1, further comprising a coupler configured to couple the braided mesh body to the delivery device or disconnect the braided mesh body from the delivery device.

10. The blocking device according to claim 9, wherein, The coupler includes: a spherical body that is interference-fitted with a second end portion of the woven mesh body that is clamped; a first thread, the distal end of which is attached to the spherical body and the proximal end of which is attached to the clamping member; and a second thread, the distal end of which is attached to the spherical body and the proximal end of which is configured to couple the woven mesh body to a delivery device.

11. The blocking device according to claim 10, wherein, The clamping member has a slot on one side so that the proximal end of the first thread is pulled through the clamping member and secured to it.

12. A blocking device, the blocking device comprising: A woven mesh body comprising multiple strands, each strand having a first end and a second end, wherein the multiple strands are folded so that the second end of each strand is close to the first end, thereby forming a double-layered woven mesh body; and A clamping member clamps the first end and the second end of the plurality of strands, wherein, when the woven mesh body is unconstrained in the unfolded configuration, the unfolding angle of the woven mesh body ranges from about 30 degrees to about 135 degrees.

13. The blocking device according to claim 12, wherein, When the woven mesh body is unrestrained, the unfolding angle of the woven mesh body ranges from about 50 degrees to about 135 degrees.

14. The blocking device according to claim 12, wherein, When the woven mesh body is unrestrained, the unfolding angle of the woven mesh body ranges from approximately 90 degrees to approximately 135 degrees.

15. The blocking device according to claim 12, wherein, When the woven mesh body is unrestrained, the unfolding angle of the woven mesh body ranges from approximately 125 degrees to approximately 135 degrees.

16. The blocking device according to claim 12, wherein, When the woven mesh body is unrestrained, the maximum width of the woven mesh body ranges from about 5 mm to about 15 mm.

17. The blocking device according to claim 16, wherein, The unfolding angle of the woven mesh body ranges from approximately 90 degrees to approximately 135 degrees.

18. The blocking device according to claim 16, wherein, The unfolding angle of the woven mesh body ranges from approximately 125 degrees to approximately 135 degrees.

19. The blocking device according to claim 12, wherein, The woven mesh body has a first unfolding angle at a first temperature and a second unfolding angle at a second temperature.

20. The blocking device according to claim 12, wherein, The clamping member is non-transparent.

21. The blocking device according to claim 12, wherein, The clamping member is constructed of Nitinol.

22. The blocking device according to claim 12, wherein, The multiple strands are constructed from materials including shape memory materials.

23. The blocking device according to claim 12, wherein, The woven mesh body or a portion thereof has holes, the diameter of which ranges from about 20 micrometers to about 500 micrometers in the unfolded configuration.

24. The blocking device according to claim 12, wherein, The porosity of the woven mesh body or a portion thereof in the unfolded configuration ranges from about 5% to about 95%.

25. The blocking device according to claim 12, wherein, The main body of the woven mesh or a portion thereof is coated with an antithrombotic material.

26. The blocking device according to claim 12, wherein, The woven mesh body or a portion thereof is coated with a material containing glycosaminoglycans or phosphorylcholine PC, wherein the glycosaminoglycans are heparin.

27. A blocking device, the blocking device comprising: The woven mesh body includes multiple strands, each strand having a first end and a second end. The multiple strands are folded so that the second end of the multiple strands is close to the first end of the multiple strands, thereby forming a double-layered woven mesh body. as well as At least one clamping member clamps the first end and the second end of the plurality of strands. Wherein, when the woven mesh body is unrestrained and in an unfolded configuration, the ratio between the straight-line distance between the base end of the outline of the woven mesh body near the at least one clamping member and the end away from the at least one clamping member and the length of the outline is greater than or equal to 0.

8.

28. The blocking device according to claim 27, in, The ratio between the straight-line distance between the base end and the end end of the outline of the woven mesh body and the length of the outline is greater than or equal to 0.

9.

29. The blocking device according to claim 27 or 28, in, When the woven mesh is in the unfolded configuration, the inclination of the main body of the woven mesh gradually increases from the base end to the end end and then gradually decreases.

30. The blocking device according to claim 29, in, The line connecting the base end and the end end of the contour line intersects the contour line at a point, and the position of the intersection point within the contour line is defined as a first position. Wherein, the ratio of the width of the first position to the maximum width of the woven mesh body is greater than or equal to 0.

5.

31. The blocking device according to claim 29, in, The inclination of the woven mesh body at the base end ranges from about 10 degrees to about 40 degrees.

32. The blocking device according to claim 29, in, The inclination of the woven mesh body at the end ranges from approximately 15 degrees to 70 degrees.

33. The blocking device according to claim 29, in, The woven mesh body includes a second position with the maximum inclination between the base end and the end end, and The inclination at the second position ranges from approximately 70 degrees to 100 degrees.

34. The blocking device according to claim 33, in, The ratio of the width of the second position to the maximum width of the woven mesh body is greater than or equal to 0.

5.

35. The blocking device according to claim 27, in, The maximum width of the woven mesh body ranges from approximately 5 mm to approximately 15 mm.

36. The blocking device according to claim 27, in, The angle between the left and right outlines of the woven mesh body ranges from approximately 90 degrees to approximately 170 degrees.

Images