Steerable left atrial appendage occlusion device

Abstract

Medical devices and methods of manufacturing and using the medical devices are disclosed. Example medical devices may include a left atrial appendage device. An occlusion medical device includes an expandable frame configured to switch between a first configuration and an expanded configuration, and a fabric disposed along at least a portion of the expandable frame. The occlusion medical device may cooperate with a delivery device to allow for rotation of the occlusion medical device.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 601,894, filed November 22, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to medical devices and methods of manufacturing medical devices. More specifically, this disclosure relates to occlusion devices, such as those extending adjacent to the left atrial appendage. Background Technology

[0004] A wide variety of in-vivo medical devices have been developed for medical applications, such as intravascular applications. Some of these devices include guidewires, catheters, etc. These devices are manufactured using any of a variety of different manufacturing methods and can be used according to any of a number of methods. Each of the known medical devices and methods has its own advantages and disadvantages. There is a continued need to provide alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the Invention

[0005] This disclosure provides designs, materials, manufacturing methods, and alternative uses for medical devices. One example can be found in a medical assembly for treating the left atrial appendage (LAA). The medical assembly includes a delivery device adapted to deliver an occlusion implant to the LAA and an occlusion implant adapted to be delivered via the delivery device. The delivery device includes one or more deflecting leads adapted to releasably engage the occlusion implant and an engagement member movable between an engagement position and a disengagement position, in which the one or more deflecting leads remain engaged with the occlusion implant and in the disengagement position, the one or more deflecting leads are released from engagement with the occlusion implant. The occlusion implant includes an expandable frame configured to switch between a first configuration and an expanded configuration, an occlusion cover extending over at least a portion of the expandable frame, and a deflecting mating portion coupled to the expandable frame, the deflecting mating portion being adapted to releasably engage one or more deflecting leads when the engagement member is in the engagement position.

[0006] Alternatively or additionally, the steering dock may include at least a hemispherical dock.

[0007] Alternatively or additionally, at least the hemispherical mating portion may include an outer surface and one or more recesses formed within the outer surface, each of the one or more recesses being adapted to releasably engage the distal end of one or more steering guides.

[0008] Alternatively or additionally, the distal end of each of one or more steering guides may include a distal end with an enlarged diameter.

[0009] Alternatively or additionally, the conveying device may further include an external shaft through which one or more steering guides extend.

[0010] Alternatively or additionally, the conveying device may further include a deploying member extending through an external shaft.

[0011] Alternatively or additionally, the joining member may include a helical structure extending distally from the distal end of the unfolding member.

[0012] Alternatively or additionally, the unfolding member may include an intermediate shaft extending through the outer shaft.

[0013] Alternatively or additionally, the joining member may include a cylindrical coil extending distally from the unfolding member.

[0014] Another example can be found in a medical component for treating the left atrial appendage (LAA). This medical component includes an occlusion implant and a delivery device adapted to deliver the occlusion implant to the LAA. The occlusion implant includes an expandable frame configured to switch between a first configuration and an expanded configuration, an occlusion cover extending over at least a portion of the expandable frame, and a spherical abutment coupled to the expandable frame. The delivery device includes: an elongated deployment mechanism having a distal anchor point; a basket-like member fixed to the distal anchor point of the elongated deployment mechanism, movable between an engaged position and a disengaged position, in which the spherical abutment is retained within the basket-like member, and in the disengaged position, the spherical abutment is released from the basket-like member; and a sheath slidably disposed relative to the basket-like member, which, when extended over the basket-like member, holds the basket-like member in the engaged position, and is adapted to retract proximally to allow the basket-like member to return to the disengaged position.

[0015] Alternatively or additionally, the delivery device may be adapted to allow the occluded implant to be passively pivoted relative to the delivery device.

[0016] Alternatively or additionally, the conveying device may be adapted to allow active turning at the distal anchor point.

[0017] Alternatively or additionally, the delivery device may be adapted to allow the occlusion implant to passively pivot relative to the distal anchor point, and also allow the distal anchor point to deflect.

[0018] Alternatively or additionally, when the basket is in the engaged position, the spherical mating portion may be adapted to rotate freely within the basket, thereby allowing the occluded implant to pivot relative to the delivery device.

[0019] Alternatively or additionally, the conveying device may further include one or more steering guides adapted to engage the distal anchor point.

[0020] Alternatively or additionally, one or more steering guides may be fixed to the distal anchor point.

[0021] Another example can be found in a left atrial appendage occlusion (LAAC) device. This LAAC device includes an expandable frame configured to switch between a first configuration and an expanded configuration, an occlusion cover extending over at least a portion of the expandable frame, and a spherical docking portion coupled to the expandable frame, the spherical docking portion being adapted to allow the LAAC device to pivot relative to the delivery device.

[0022] Alternatively or additionally, the spherical mating portion may include an outer surface and one or more recesses formed within the outer surface, each of the one or more recesses being adapted to releasably engage each of one or more steering guides.

[0023] Alternatively or additionally, the spherical mating portion may include a non-transparent material.

[0024] Alternatively or additionally, the spherical mating part may include titanium.

[0025] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation of this disclosure. The following drawings and detailed description illustrate these embodiments in more detail. Attached Figure Description

[0026] This disclosure will be more fully understood in light of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0027] Figure 1 This is a schematic diagram of an illustrative left atrial appendage occlusion (LAAC) device extending through an example heart;

[0028] Figure 2 yes Figure 1 A schematic diagram of an illustrative LAAC device, shown as another view extending through an exemplary heart;

[0029] Figure 3 This is a perspective view of an illustrative LAAC apparatus;

[0030] Figure 4 This is a perspective view of an illustrative LAAC device, including the steering docking section;

[0031] Figure 5 It is used for conveying Figure 4 A perspective view of a portion of the illustrative steerable conveyor of the illustrative LAAC device, wherein the illustrative steerable conveyor is shown in the engaged position.

[0032] Figure 6 yes Figure 5 A perspective view of a portion of the illustrative rotatable conveyor.

[0033] Figure 7 yes Figure 5 A perspective view of a portion of an illustrative steerable conveyor, shown in the disengaged position;

[0034] Figure 8 This is a schematic side view of a part of an illustrative steerable conveyor.

[0035] Figure 9 yes Figure 8 A schematic end view of an illustrative, steerable conveyor.

[0036] Figure 10 yes Figure 8 A schematic side view of an illustrative steerable conveyor, showing a spiral structure including the connecting members;

[0037] Figure 11 yes Figure 10 A schematic top view of the illustrative steerable conveyor, shown disengaged from the illustrative LAAC device;

[0038] Figure 12 yes Figures 8 to 11 A schematic diagram illustrating a steerable conveyor device;

[0039] Figure 13 This is a schematic diagram of an illustrative steerable conveyor shown in a linear position;

[0040] Figure 14 yes Figure 13 An illustrative schematic diagram of a steerable conveyor, shown in an articulated position;

[0041] Figure 15 yes Figure 13 A schematic diagram of the combination of the illustrative steerable conveyor and the illustrative LAAC device, shown in a double-hinged position;

[0042] Figure 16 This is a schematic diagram illustrating the conveying device;

[0043] Figure 17 yes Figure 16 A schematic diagram of the combination of the illustrative conveying device and the illustrative LAAC device, shown in a pivot position;

[0044] Figure 18 This is a schematic diagram of a part of an illustrative medical component that includes a retaining wire;

[0045] Figure 19 This is a schematic diagram of a part of an illustrative medical component, which includes a curved wire engaging a spherical docking portion on an illustrative LAAC device;

[0046] Figure 20 This is a schematic diagram of a part of an illustrative medical component, which includes angled guide wires that engage a spherical docking portion on an illustrative LAAC device;

[0047] Figure 21 This is a schematic diagram illustrating a medical component, shown in a linear configuration; and

[0048] Figure 22 yes Figure 21 A schematic diagram of an illustrative medical component, shown in a hinged configuration.

[0049] While this disclosure is open to various modifications and alternatives, its details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the invention to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0050] The terms defined below shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0051] All numerical values ​​herein are assumed to be modified by the term "approximately," whether explicitly stated or not. The term "approximately" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant digit.

[0052] The range of numbers represented by the endpoints includes all numbers in that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0053] As used in this specification and the appended claims, the singular forms “a (an)” and “the” include plural indicators unless otherwise clearly indicated. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or” unless otherwise clearly indicated.

[0054] It should be noted that references to "embodiments," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily imply that all embodiments include the specific features, structures, and / or characteristics. Furthermore, when specific features, structures, and / or characteristics are described in conjunction with an embodiment, it should be understood that, unless clearly stated to the contrary, these features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether explicitly described or not.

[0055] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered the same. The drawings (which are not necessarily to scale) depict illustrative embodiments and are not intended to limit the scope of the invention.

[0056] The left atrial appendage (LAA) is a small sac attached to the left atrium of the heart, acting as a pouch-like extension. In patients with atrial fibrillation, the LAA may not contract properly with the left atrium, causing blood to pool within it, which can lead to the formation of unwanted blood clots within the LAA. Blood clots formed in the LAA can detach from the area and enter the bloodstream. These clots, migrating through blood vessels, can eventually block smaller downstream vessels, leading to a stroke. Clinical studies have shown that most blood clots in patients with atrial fibrillation are located in the LAA. As a treatment approach, a medical device has been developed that is positioned within the LAA and deployed to close the opening of the LAA. Over time, the exposed surface across the opening of the LAA is covered with tissue (a process called endothelialization), effectively removing the LAA from the circulatory system and reducing or eliminating the number of blood clots that can enter the bloodstream from the LAA. To reduce thrombosis within the laminar thrombosis area (LAA) and prevent thrombi from entering the bloodstream from the LAA, it may be necessary to develop medical devices and / or occlusive implants that isolate the LAA from the heart and / or circulatory system, thereby reducing the risk of stroke due to thrombolytic substances entering the bloodstream from the LAA. This article discloses example medical devices and / or occlusive implants that seal the LAA (or other similar openings).

[0057] Figure 1 An example occlusion implant 10 (e.g., a left atrial appendage medical device) is shown positioned within the LAA 50. Figure 1 The diagram further illustrates that the occlusion implant 10 can be inserted and advanced through the body cavity via the occlusion implant delivery system 20. In some cases, the occlusion implant delivery system 20 may include a delivery catheter 24 that is directed toward the left atrium via various chambers and lumens of the heart (e.g., inferior vena cava, superior vena cava, right atrium, etc.) to a location adjacent to the LAA 50. The combination of the occlusion implant 10 temporarily fixed relative to the occlusion implant delivery system 20 can be considered as medical component 26.

[0058] Delivery system 20 may include a hub 22. Hub 22 may be manipulated by a clinician to guide the distal end region of delivery catheter 24 to a location adjacent to the left atrial appendage 50. In some cases, occlusion implant delivery system 20 may include a core lead 18. Furthermore, the proximal end region 11 of occlusion implant 10 may be configured to releasably attach, engage, connect, interlock, or otherwise connect to the distal end of core lead 18. In some cases, the proximal end region 11 of occlusion implant 10 may include a threaded insert coupled thereto. In some cases, the threaded insert may be configured and / or adapted to engage, connect, interlock, or otherwise engage with a threaded member disposed at the distal end of core lead 18. Other structures for releasably engaging and / or interlocking the proximal end of occlusion implant 10 to the distal end of core lead 18 are also contemplated.

[0059] Figure 1 The occlusion implant 10, positioned adjacent to the left atrial appendage 50 via delivery catheter 24 (described above), is further illustrated. It will be understood that in some examples, the occlusion implant 10 may be configured to switch between a first or collapsed configuration and a second or expanded configuration. For example, in some cases, the occlusion implant 10 may be in a collapsed configuration during delivery via the occlusion implant delivery system 20, thereby expanding to an expanded configuration once deployed from the occlusion implant delivery system 20.

[0060] in addition, Figure 1 The occlusion implant 10 is shown to include an expandable frame or framework 12. The expandable framework 12 may be compliant and thus substantially conform to and / or seal against the shape and / or geometry of the lateral walls of the LAA 50 in an expanded configuration. In some embodiments, the occlusion implant 10 may expand to a size, range, or shape smaller than or different from the maximum unconstrained extent defined by the surrounding tissue and / or lateral walls of the LAA 50. Furthermore, it is understood that the elements of the expandable framework 12 may be tailored to increase the flexibility of the expandable framework 12 and / or the occlusion implant 10, thereby allowing the expandable framework 12 and / or the occlusion implant 10 to conform to the surrounding tissue, rather than forcing the tissue to conform to the expandable framework 12 and / or the occlusion implant 10. Additionally, in some cases, it may be desirable to design the occlusion implant 10 to include various features, components, and / or configurations that enhance the sealing capability of the occlusion implant 10 within the LAA.

[0061] Figure 1It is shown that the distal end region 13 of the expandable framework 12 can extend deeper into the left atrial appendage 50 compared to the proximal end region 11. It is understood that the distal end region 13 can engage with the tissue defining the left atrial appendage 50 as the expandable framework 12 is advanced into the LAA 50. In other words, in some examples, the distal end region 13 can be considered as a “pilot” region of the expandable framework 12 as it enters the LAA 50. However, this is not intended to be restrictive. Conversely, in some examples, the proximal end region 11 can be considered as a “pilot” region of the expandable framework 12 as it enters the LAA 50.

[0062] Figure 2 Another view is provided of the occlusion implant 10 positioned within the LAA 50 via the occlusion implant delivery system 20. Figure 2 This provides a slightly different view of the heart's interior, including the right atrium (RA), left atrium (LA), right ventricle (RV), and left ventricle (LV). The heart comprises an atrial septum 40 separating the RA from the LA and an interventricular septum 42 separating the RV from the LV. In some cases, the atrial septum 40 and the interventricular septum 42 may simply be referred to as a septum, or sometimes as the atrioventricular septum. Regardless of the terminology, the atrial septum 40 and the interventricular septum 42 separate the right side of the heart from the left side. In many cases, access to the left side of the heart (whether LA or LV) is achieved by navigating through the vascular system to the right side of the heart and then puncturing the septum to reach the left side. For example, to reach the LV, the interventricular septum 42 may be disrupted to advance a device from the RV, through an opening formed in the interventricular septum 42, and into the LV. To reach the LA, the atrial septum 40 may be disrupted to advance a device from the RA, through an opening formed in the atrial septum 40, and into the LA. As shown in the figure, an opening 44 has been formed within the interatrial septum 40, allowing the occluded implant delivery system 20 to pass through the opening 44 and reach the LA, and subsequently to the LAA 50.

[0063] Figure 3 An example occlusion implant 10 is shown. The occlusion implant 10 may include an expandable framework 12. The expandable framework 12 may include a proximal end region 11 and a distal end region 13. Figure 2 Further illustration shows that the expandable frame 12 may include one or more protrusions 17 extending in a direction from proximal to distal. In some cases (e.g.) Figure 3 In the case shown, multiple protrusions 17 can extend circumferentially around the longitudinal axis 52 of the expandable frame 12. In other words, in some examples, the protrusions 17 can resemble the apex of a "coronation" extending circumferentially around the longitudinal axis 52 of the expandable frame 12. Although the above discussion (and Figure 3The illustration shows multiple protrusions 17, but it is conceivable that the occlusive implant 10 may include one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve or more individual protrusions 17 arranged in a variety of configurations along the expandable frame 12.

[0064] in addition, Figure 3 The proximal end region 11 of the expandable frame 12 is shown to include a plurality of support members 19 extending circumferentially around the longitudinal axis 52 of the expandable frame 12. Figure 3 The diagram shows that multiple support members 19 may include one or more curved portions shaped such that they define "recesses" 21 extending distally into the expandable frame 12. Figure 3 As shown, the recess 21 can extend circumferentially around the longitudinal axis 52. Furthermore, Figure 3 It is shown that each of the plurality of support members 19 may include a first end 25 attached to a central hub 23. It will be understood that the central hub 23 may be aligned along the longitudinal axis 52 of the expandable frame 12. As will be described in more detail below, Figure 3 It is shown that the hub 23 can be positioned such that it is located within the recess 21 defined by a plurality of support members 19.

[0065] The occlusion implant 10 may further include an occlusion member 14 disposed on, disposed on, surrounding, or covering at least a portion of the expandable frame 12. In some cases, the occlusion member 14 may be disposed on, disposed on, surrounding, or covering at least a portion of the outer (or outward-facing) surface of the expandable frame 12. Figure 3 It is further shown that the occlusion member 14 may extend only partially along the longitudinal extent of the expandable frame 12. However, this is not intended to be restrictive. Rather, the occlusion member 14 may extend to any extent along the longitudinal extent of the expandable frame 12 (e.g., the entire longitudinal extent of the expandable frame 12).

[0066] In some embodiments, the occlusion member 14 may be permeable or impermeable to blood and / or other fluids (such as water). In some embodiments, the occlusion member 14 may include woven fabrics / materials or webs, nonwoven fabrics / materials or webs, woven and / or knitted materials, fibers, sheet materials, fabrics, webs, woven meshes, polymer membranes, metal meshes or polymer meshes, porous filter-like materials, coverings, and / or other suitable constructions. In some embodiments, the occlusion member 14 may prevent thrombi (i.e., blood clots, etc.) from passing through the occlusion member 14 and exiting from the left atrial appendage into the bloodstream. In some embodiments, the occlusion member 14 may promote endothelialization after implantation, thereby effectively removing the left atrial appendage from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusion member 14 will be discussed below.

[0067] Figure 3 Further illustrated, the expandable frame 12 may include a plurality of anchoring members 16 disposed around the periphery of the expandable frame 12. The plurality of anchoring members 16 may extend radially outward from the expandable frame 12. In some embodiments, at least some of the plurality of anchoring members 16 may each have and / or include a body portion and an end portion projecting circumferentially from the body portion, such as... Figure 2 As shown. Some suitable, but non-limiting, examples of materials for the expandable frame 12 and / or the plurality of anchoring members 16 will be discussed below.

[0068] In some examples, the expandable frame 12 and the plurality of anchoring members 16 may be integrally formed and / or cut from a monolithic member. In some embodiments, the expandable frame 12 and the plurality of anchoring members 16 may be integrally formed and / or cut from a monolithic tubular member, and subsequently formed and / or heat-set into a desired shape in an expansion configuration. In some embodiments, the expandable frame 12 and the plurality of anchoring members 16 may be integrally formed and / or cut from a monolithic flat member, and then rolled or formed into a tubular structure, and subsequently formed and / or heat-set into a desired shape in an expansion configuration. Some exemplary means and / or methods for manufacturing and / or forming the expandable frame 12 include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical melting, etc. Other means and / or methods are also contemplated.

[0069] like Figure 3 As shown, the plurality of anchoring members 16 arranged along the expandable frame 12 may include two rows of anchoring members 16. However, this is not intended to be limiting. Instead, the expandable frame 12 may include a single row of anchoring members 16. In other examples, the expandable frame 12 may include more than two rows of anchoring members 16. For example, in some cases, the expandable frame 12 may include one, two, three, four, or more rows of anchoring members 16.

[0070] Although Figure 3 An expandable frame 12 that can be formed from a single integral component is shown, but this is not intended to be limiting. Rather, it is conceivable that the expandable frame 12 can include a variety of different configurations that can be formed via various manufacturing techniques.

[0071] As indicated above, the occlusion member 14 may include woven fabrics / materials or webs, nonwoven fabrics / materials or webs, braided and / or knitted materials, fibers, sheet materials, fabrics, webs, woven meshes, polymer membranes, metal meshes or polymer meshes, porous filter-like materials, coverings, and / or other suitable constructions. The occlusion member 14 may be formed of suitable materials, such as polyethylene terephthalate, polyester, nylon, acrylic materials, polyolefins and / or the like, combinations thereof, and / or other materials disclosed herein. In other cases, the occlusion material may include a metal mesh formed of nickel-titanium alloys, stainless steel, titanium, other materials disclosed herein, combinations thereof, and / or the like.

[0072] In some cases, the opening 44 formed within the atrial septum 42 may not be easily aligned with the LAA 50. In some cases, the exact location of the LAA 50 may vary from patient to patient, and therefore an optimal location across the atrial septum 42 may not always exist. In some cases, other devices may be advanced from the RA, across the atrial septum 42, and into the LA before the occlusion implant delivery system 20 is advanced into the RA. Therefore, the opening 44 formed within the atrial septum 42 can be positioned according to the location requirements of another device (such as, but not limited to, a visualization device). Other devices may also be advanced through the opening 44 formed within the atrial septum 42 before the occlusion implant delivery system 20 is advanced. This may mean that the opening 44 is not properly aligned with the LAA 50. In some cases, the occlusion implant delivery system 20 itself can be advanced via a steerable catheter. In some cases, the occlusion implant delivery system 20 itself may be adapted to allow passive or even active swerving of the occlusion implant 10, enabling better alignment of the occlusion implant 10 within the LAA 50, regardless of the location of the opening 44 within the interatrial septum 42. In some cases, as will be discussed, the occlusion implant 10 may be able to passively pivot relative to the occlusion implant delivery system 20 as it begins to enter and be placed within the LAA 50. In some cases, as will be discussed, the occlusion implant delivery system 20 may include features that allow the occlusion implant 10 to swerve as it passes through the RA.

[0073] Figure 4An occlusion implant 10 including a steering docking portion 54 is shown. In some cases, the steering docking portion 54 may be secured to an expandable frame or structure 12. As an example, the steering docking portion 54 may be welded, brazed, or adhesively secured to the expandable frame or structure 12. As another example, the steering docking portion 54 may be integrally formed as part of the expandable frame or structure 12. In some cases, the steering docking portion 54 may be adapted to releasably engage the core lead 18 to secure the occlusion implant 10 relative to the occlusion implant delivery system 20 until the occlusion implant 10 is released from the occlusion implant delivery system 20.

[0074] In some cases, as will be discussed, the steering docking portion 54 may be adapted to engage a basket-like structure formed as part of the occlusion implant delivery system 20, and the steering docking portion 54 may be adapted to pivot relative to the basket-like structure. In some cases, as will be discussed, the steering docking portion 54 may include additional features that allow one or more steering leads to releasably engage with the steering docking portion 54. In some cases, the steering docking portion 54 may be considered spherical in shape. In some cases, the steering docking portion 54 may be considered hemispherical or even hemispherical in shape. In some cases, the steering docking portion 54 may be made of a radiopaque material, coated with a radiopaque material, or otherwise include a radiopaque material to make the steering docking portion 54 fluorescently visible. For example, the steering docking portion 54 may be made of titanium, or may be coated with gold or other radiopaque materials. In some cases, this may allow one or more radiopaque marking strips that may otherwise be disposed within the occlusion implant delivery system 20 to be excluded.

[0075] Figure 5 , Figure 6 and Figure 7 This is a perspective view of a portion of an example of medical component 26. While medical component 26 includes occlusion implant 10, however... Figure 5 , Figure 6 and Figure 7 In the diagram, the steering docking portion 54 is the only part of the occlusion implant 10 shown. The steering docking portion 54 includes an outer surface 56, such as... Figure 7As seen, the outer surface includes one or more recesses 58 adapted to releasably receive a steering guide 60, which is part of the occlusion implant delivery system 20. Although referred to as a steering guide 60, in some cases, the steering guide 60 may also be used to releasably secure the occlusion implant 10 relative to the occlusion implant delivery system 20. In some cases, each of the recesses 58 may include a primary recess 58a and a secondary recess 58b. The primary recess 58a may be adapted to releasably receive an enlarged distal end 62 of each of the steering guides 60. When the enlarged distal end 62 is disposed within the primary recess 58a, the secondary recess 58b may be adapted to releasably receive the steering guide 60 itself.

[0076] The joining member 64 can be in the joining position (e.g. Figure 5 (as shown) and disengagement position (as shown) Figure 7 The engagement member 64 moves between the steering guide 60 and the corresponding recess 58 formed in the outer surface 56 of the steering dock 54 in the engaged position, and in the disengaged position, the steering guide 60 is released from engagement with the recess 58 formed in the outer surface 56 of the steering dock 54. In this example, the engagement mechanism 64 may take the form of a cylindrical coil 65 adapted to be mounted on the steering adapter 54 and sized to hold the enlarged distal end 62 of each of the steering guides 60 engaged with the recess 58 when the engagement member 64 is positioned on the enlarged distal end 62 of each of the steering guides 60 and the recess 58. In some cases, the occlusion implant delivery system 20 may include a deployment member 66. In some cases, the engagement member 64 is fixed relative to the distal end 68 of the deployment member 66. In some cases, the engagement member 64 may be the distal portion of an elongated sheath (not shown), and the deployment member 66 may be the corresponding proximal portion of the elongated sheath.

[0077] Figure 8 , Figure 9 , Figure 10 and Figure 11 This is a schematic diagram of another example of medical component 26. Figure 8 This is a side view showing the interaction between the steering guide 60 and the steering docking part 54. Figure 9 This is the corresponding end view. Figure 10 Additionally, the joining member 64 is shown. Figure 11 The engagement member and steering guide 60 are shown released from engagement with steering docking portion 54. Although medical component 26 includes occlusion implant 10, however... Figure 8 , Figure 9 and Figure 10In this design, the steering docking portion 54 is the only part of the occlusion implant 10 shown. The steering docking portion 54 includes an outer surface 56 that includes one or more recesses 58 adapted to releasably receive a steering guide 60. Although referred to as steering guide 60, in some cases, steering guide 60 may also be used to releasably secure the occlusion implant 10 relative to the occlusion implant delivery system 20. Figure 12 Details of the catheter shaft 74 are shown, with an elongated shaft 72 and a steering guide 60 extending through it. It should be understood that... Figures 7 to 7 The version of the medical component 26 shown can be similarly positioned within the slender shaft 72.

[0078] In some cases, the engagement member 64 may take the form of a screw retainer 70, which is fixed to the distal end of the elongated shaft 72. The elongated shaft 72 can be considered as a deploying member, which can be advanced distally to advance the occluded implant 10 into a position within the LAA 50 before releasing the occluded implant 10. In some cases, the screw retainer 70 can be retracted proximally from engagement with the steering dock 54 by simply retracting the elongated shaft 72 proximally. In some cases, the screw retainer 70 can be retracted proximally by rotating the elongated shaft 72 in the appropriate direction, such that the screw retainer 70 is retracted proximally in a nearly threaded manner.

[0079] The engagement mechanism 64 can be in the engagement position (e.g.) Figure 5 (as shown) and disengagement position (as shown) Figure 7 The engagement mechanism 64 moves between the steering guide 60 and the corresponding recess 58 formed in the outer surface 56 of the steering dock 54 in the engaged position, and in the disengaged position, the steering guide 60 is released from engagement with the recess 58 formed in the outer surface 56 of the steering dock 54. In this example, the engagement mechanism 64 may take the form of a cylindrical coil adapted to be mounted on the steering adapter 54 and sized to hold the enlarged distal end 62 of each of the steering guides 60 engaged with the recess 58 when the engagement mechanism 64 is positioned on the enlarged distal end 62 of each of the steering guides 60 and the recess 58. In some cases, the occlusion implant delivery system 20 may include a deployment member 66. In some cases, the engagement mechanism 64 is fixed relative to the distal end 68 of the deployment member 66. In some cases, the engagement mechanism 64 may be the distal portion of an elongated sheath (not shown), and the deployment member 66 may be the corresponding proximal portion of the elongated sheath.

[0080] Figure 13 and Figure 14This is a schematic diagram of an illustrative delivery device 80 that can be used to deliver an occluded implant 10. The illustrative delivery device 80 includes an elongated deployable member 82, which can be considered as a core lead wire 18. Figure 1 Example of an elongated deployable member 82. The elongated deployable member 82 includes a distal anchor point 84 formed at a suitable location at or otherwise secured to the distal end of the elongated deployable member 82. A basket-like member 86 extends distally from the distal anchor point 84. In some cases, the basket-like member 86 may be adapted to accommodate a steering docking portion 54 within the basket-like member 86, such that the steering docking portion 54 is pivotable relative to the basket-like member 86. In some cases, this relative movement is independent of any applied steering. As shown, the conveying device 80 includes two steering guides 88 secured to the distal anchor point 84 and extending proximally from it. Figure 14 (As shown in the figure, an elongated deployable member 82 extending distally from the sheath 90 and a steering guide 88) can be turned in a specific direction by pulling or pushing one or both of the steering guides 88.

[0081] In some cases, the basket 86 may be adapted to allow the swivel docking portion 54 to remain rotatably captured within the basket 86, such that translation of the basket 86 in the proximal or distal direction results in a corresponding movement of the occlusion implant 10 in the same proximal or distal direction. In some cases, the basket 86 may be adapted such that slight movement of the basket 86 relative to the swivel docking portion 54 allows the swivel docking portion 54 to remain rotatably captured within the basket 86, while stronger movement of the basket 86 allows the swivel docking portion 54 to move freely from the basket 86. In some cases, a movable sheath may be provided on the basket 86 to maintain engagement of the basket 86 with the swivel docking portion 54, and the movable sheath may be retracted from the basket 86 to allow the basket 86 to open and release the swivel docking portion 54.

[0082] Figure 15This is a schematic diagram of an illustrative medical component 92, which can be considered another example of medical component 26. The illustrative medical component 92 includes an occlusion implant 10 coupled to a delivery device 80 by means of a steering docking portion 54 disposed within a basket-like member 86. As can be seen, the medical component 92 allows for various positioning or angles of the occlusion implant 10 relative to the delivery device 80. As indicated by the dotted lines, a first angle α1 is formed between the sheath 90 and the elongated deployment member 82, and a second angle α2 is formed between the elongated deployment member 82 and the longitudinal axis 52 of the expandable frame 12. By changing these two angles, greater flexibility can be achieved in aligning the occlusion implant 10 with the LAA 50. In some cases, the first angle α1 can be adjusted using a steering guide 88. In some cases, the second angle α2 can be passively changed as the occlusion implant 10 begins to impact and interact with the LAA 50.

[0083] Figure 16 This is a schematic diagram of an illustrative delivery device 100 that can be used to deliver an occluded implant 10. The delivery device 100 includes an elongated deployable member 82, which can be considered as a core lead 18. Figure 1 Example of an elongated deployment member 82. The elongated deployment member 82 includes a distal anchor point 84 formed at a suitable location at or otherwise secured to the distal end of the elongated deployment member 82. A basket-like member 86 extends distally from the distal anchor point 84. In some cases, the basket-like member 86 may be adapted to receive a steering docking portion 54 within the basket-like member 86, such that the steering docking portion 54 is pivotable relative to the basket-like member 86. The delivery device 100 includes a sheath 102 adapted to receive the occlusion implant 10 and the delivery shaft 104. Figure 17 This is a schematic diagram of an illustrative medical component 110, which can be considered as an example of medical component 26. The illustrative medical component 110 includes an occlusion implant 10 fixed relative to the delivery device 100 via an interaction between a steering docking portion 54 and a basket-like member 86. Because the steering docking portion 54 pivots freely within the basket-like member 86, the occlusion implant 10 pivots freely relative to the delivery device 100 when it begins to engage the LAA 50.

[0084] Figure 18 This is a schematic diagram of a portion of an illustrative medical component 120, which includes a retention guide 122 extending through a steering docking portion 54 to engage with the frame 12 of the occlusion implant 10. In some cases, the retention guide 122 provides improved retention control of the occlusion implant 10. The retention guide 122 can be combined with any delivery device described herein. Figure 19This is a schematic diagram of a portion of the illustrative component 130, which includes wires 132 wound around the steering dock 54 and ball ends 134 located at the distal ends of each of the wires 132. The wires 132 can be used, for example, to retain and allow the steering component 54 (and thus the occluder implant 10) to pivot freely. Figure 20 This is a schematic diagram of a portion of the illustrative component 140, which includes wires 142 wound around the steering dock 54 and includes angled forks 144 located at the distal ends of each of the wires 142. The wires 142 can be used, for example, to retain and allow the steering component 54 (and thus the occluder implant 10) to pivot freely.

[0085] Figure 21 This is a schematic diagram of a portion of an illustrative medical component 150, showing an occlusion implant 10 fixed relative to a delivery device 152. In some cases, as shown, the occlusion implant 10 includes a central rod 154 extending into the occlusion implant 10. For example, the central rod 154 may be fixed relative to an expandable frame or framework 12 (not visible in this view). The central rod 154 extends from a proximal end 156 to a distal end 158. In some cases, the distal end 158 is fixed to the expandable frame or framework 12. In some cases, the central rod 154 may be additionally fixed relative to the expandable frame or framework 12 at two or more points along the central rod 154, between the proximal end 156 and the distal end 158. The proximal end 156 of the central rod 154 has a spherical shape, which may be at least hemispherical, and thus functions in a manner similar to the steering docking portion 54 shown in the previous figure.

[0086] The delivery device 152 includes a central core member 158 extending proximally from a distal end 160. The distal end 160 of the central core member 158 includes a socket 162 that rotatably engages a ball-shaped proximal end 156 of the central rod 154. In some cases, once the occlusion implant 10 is implanted within the LAA 50, the central core member 158 can be abruptly withdrawn proximally to release the ball-shaped proximal end 156 of the central rod 154 from the distal end 160, leaving the central rod 154 fixed relative to the occlusion implant 10. In some cases, the central rod 154 can remain fixed to the central core member 158, and the central rod 154 itself can disengage from the expandable frame or framework 12.

[0087] The delivery device 152 includes a first traction wire 164 and a second traction wire 168. The distal end 166 of the first traction wire is fixed to a first side of the central rod 154, and the distal end 170 of the second traction wire is fixed to a second side of the central rod 154. Pulling the first traction wire 164 causes the central rod 154 (and therefore the occlusion implant 10) to pivot in a first direction indicated by arrow 172. Pulling the second traction wire 168 causes the central rod 154 (and therefore the occlusion implant 10) to pivot in a second direction indicated by arrow 174. Therefore, it can be seen that the occlusion implant 10 can be steered. Figure 21 An occlusion implant 10 is shown in a linear configuration in which the occlusion implant 10 does not turn or otherwise pivot. Figure 22 The diagram shows the occlusion implant 10 pivoting in the direction indicated by arrow 172 as the first traction lead 164 has been pulled proximally. Alternatively, this position of the occlusion implant 10 can also be achieved by pushing the second traction lead 168 in the distal direction if the second traction lead 168 is stiff enough to achieve this.

[0088] It should be understood that this disclosure is illustrative in many respects. Changes may be made in details, particularly in the shape, size, and arrangement of steps, without departing from the scope of this disclosure. Where appropriate, this may include using any features employed in one exemplary embodiment in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A medical component for treating left atrial appendage (LAA), the medical component comprising: Delivery device adapted to deliver an occluded implant to the LAA, the delivery device comprising: One or more swivel leads adapted to releasably engage the occluded implant; An engaging member that is movable between an engaging position and a disengaged position, wherein in the engaging position the one or more steering guides remain engaged with the occlusive implant, and in the disengaged position the one or more steering guides are released from engagement with the occlusive implant; An occlusion implant, adapted for delivery via the delivery device, the occlusion implant comprising: An extensible framework that is configured to switch between a first configuration and an extended configuration; An occluding covering that extends over at least a portion of the expandable frame; and A steering docking section, which is connected to the expandable frame, is adapted to releasably engage one or more steering guides when the engagement member is in the engagement position.

2. The medical component according to claim 1, wherein, The steering docking section includes at least a hemispherical docking section.

3. The medical component according to claim 2, wherein, The at least hemispherical mating portion includes an outer surface and one or more recesses formed within the outer surface, each of the one or more recesses being adapted to releasably engage the distal end of one or more steering guides.

4. The medical component according to any one of claims 1 to 3, wherein, The distal end of each of the one or more steering guides includes a distal end with an enlarged diameter.

5. The medical component according to any one of claims 1 to 4, wherein, The conveying device further includes an outer shaft through which one or more steering guides extend.

6. The medical component according to claim 5, wherein, The conveying device further includes an unfolding member extending through the outer shaft.

7. The medical component according to claim 6, wherein, The joining member includes a helical structure extending distally from the distal end of the unfolding member.

8. The medical component according to any one of claims 6 or 7, wherein, The unfolding member includes an intermediate shaft that extends through the outer shaft.

9. The medical component according to any one of claims 1 to 5, wherein, The joining member includes a cylindrical coil extending distally from the unfolding member.

10. A medical component for treating left atrial appendage (LAA), the medical component comprising: Occlusion implant, the occlusion implant comprising: An extensible framework that is configured to switch between a first configuration and an extended configuration; An occluding covering that extends over at least a portion of the expandable frame; and A spherical docking section, which is connected to the expandable frame; and Delivery device adapted to deliver the occlusion implant to the LAA, the delivery device comprising: A slender unfolding mechanism with a distal anchor point; A basket-shaped member, fixed to a distal anchor point of the elongated deployment mechanism, is movable between an engaged position and a disengaged position, in which the spherical mating portion is retained within the basket-shaped member, and in the disengaged position, the spherical mating portion is released from the basket-shaped member; and A sheath, which is slidably disposed relative to the basket-like member, holds the basket-like member in the engaged position when the sheath extends over the basket-like member, and is adapted to retract proximally to allow the basket-like member to return to the disengaged position.

11. The medical component of claim 10, wherein, When the basket-shaped member is in the engagement position, the spherical docking portion is adapted to rotate freely within the basket-shaped member, thereby allowing the occlusive implant to pivot relative to the delivery device.

12. The medical component according to any one of claims 10 or 11, wherein, The conveying device further includes one or more steering guides adapted to engage the distal anchor point.

13. A left atrial appendage occlusion (LAAC) device, comprising: An extensible framework that is configured to switch between a first configuration and an extended configuration; A closure covering that extends over at least a portion of the expandable frame; and A spherical docking section, which is connected to the expandable frame, is adapted to allow the LAAC device to pivot relative to the conveying device.

14. The LAAC device according to claim 13, wherein, The spherical mating portion includes an outer surface and one or more recesses formed within the outer surface, each of the one or more recesses being adapted to releasably engage each of the one or more steering guides.

15. The LAAC device according to any one of claims 13 or 14, wherein, The spherical joint portion comprises a non-transparent material.

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