Exclusion Devices and Related Methods

Abstract

Disclosed is an exclusion device for an anatomical structure, as well as related instruments and methods. The exclusion device for an anatomical structure can include a first beam, a second beam, and / or at least one spring operably coupled to the first beam and the second beam for exerting a closing force on the first beam and the second beam and for biasing the first beam and the second beam in a closing direction. The spring can be operably coupled to the first beam by a crimp connection.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 243,313, filed September 13, 2021, U.S. Provisional Application No. 63 / 243,322, filed September 13, 2021, U.S. Provisional Application No. 63 / 243,329, filed September 13, 2021, and U.S. Provisional Application No. 63 / 243,335, filed September 13, 2021, each of which is incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to medical instruments and devices, and more particularly to exclusion devices for anatomical structures, as well as related instruments and methods. [Background technology]

[0003] The present disclosure contemplates that atrial fibrillation is a common cardiac arrhythmia that affects millions of people in the United States. In some patients with atrial fibrillation, stagnant blood in the left atrial appendage ("LAA") of the heart can be a source of blood clots that can enter the blood circulation and increase the risk of stroke. Eliminating the LAA, which can create electrical and / or fluid isolation of the LAA, is beneficial in terms of reducing the burden of atrial fibrillation and / or reducing the risk of stroke in some patients. Therefore, it is desirable to eliminate the LAA in some patients by tightly sealing the LAA orifice at the base of the LAA using an occlusion device.

[0004] The present disclosure contemplates that some LAA occlusion clips may be relatively large, such that they (or associated applicators) may tend to obstruct the surgeon's view (e.g., the surgeon's view of potentially interfering nearby structures). Also, some relatively large LAA occlusion clips may be difficult or impossible to use in conjunction with minimally invasive surgical approaches. Thus, the present disclosure contemplates that in some circumstances, some users may prefer an exclusion device having a relatively smaller profile.

[0005] While known exclusion devices for anatomical structures have been used safely and effectively, the present disclosure contemplates that improvements in the construction and operation of occlusion devices and related instruments and methods may be beneficial to users (e.g., surgeons) and patients. Accordingly, the present disclosure includes various improvements that may enhance the construction, operation, and use of exclusion devices and related instruments and methods. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 10,166,024 [Patent Document 2] US Patent Application Publication No. 2019 / 0142428 [Patent Document 3] US Patent Application Publication No. 2018 / 0036007 Summary of the Invention [Means for solving the problem]

[0007] One aspect of the present disclosure is to provide an exclusion device for an anatomical structure, the exclusion device including a first beam, a second beam, and / or at least one spring operably coupled to the first beam and the second beam for exerting a closing force on the first beam and the second beam and for biasing the first beam and the second beam in a closing direction, The at least one spring can be operably coupled to the first beam by a first crimp connection.

[0008] In a detailed embodiment, the first crimp connection can include a plastically deformed portion of at least one spring engaged with a plastically deformed portion of the first beam. The spring can be generally U-shaped and / or can include a first end portion and / or a second end portion generally opposite the connection portion.

[0009] In a detailed embodiment, the first beam can include a spring cavity that receives a first end portion of the spring. The spring cavity can be generally longitudinally oriented within the first beam.

[0010] In a detailed embodiment, the first beam can include a spring stress reducing feature proximate the first cavity. The spring stress reducing feature can include an outwardly facing rounded spring contact surface configured to reduce stress concentrations in the spring when the first beam is separated from the second beam.

[0011] In a detailed embodiment, the first beam can include an outer wall generally opposite the clamping surface. The clamping surface can generally face the second beam. The outer wall can include an outwardly facing recess proximate the cavity. The outwardly facing recess can be configured to receive a tool therein for crimping the first beam and the spring. A thickness of the outer wall proximate the outwardly facing recess can be less than a thickness of the outer wall adjacent the outwardly facing recess.

[0012] In a detailed embodiment, the first beam may include an inner wall generally disposed toward the clamping surface. The clamping surface may generally face the second beam. The inner wall may include a cavity recess within the spring cavity. At least a portion of the first end portion of the spring may at least partially occupy the cavity recess. The cavity recess may be generally partially spherical in shape. The cavity recess may include a through hole.

[0013] In a detailed embodiment, the first beam can include a longitudinal slot between the spring cavity and an end of the first beam. At least a portion of the spring can be slidably received in the slot. The slot can be configured to cooperate with the spring to reduce the likelihood of the first beam and the second beam moving out of generally coplanar alignment.

[0014] In a detailed embodiment, the at least one spring can be operably coupled to the second beam by a second crimp connection. The at least one spring can include a first spring and a second spring. The first spring can be operably coupled to the first beam by the first crimp connection and / or can be operably coupled to the second beam by the second crimp connection. The second spring can be operably coupled to the first beam by a third crimp connection and / or can be operably coupled to the second beam by a fourth crimp connection.

[0015] In a detailed embodiment, at least one of the first beam and the second beam can include a clamping surface that includes at least one gripping feature.

[0016] An aspect of the present disclosure is to provide a method of making an exclusion device for an anatomical structure, the method including obtaining a first beam, a second beam, and a first spring. The first beam can include a generally longitudinally oriented spring cavity. The first spring can be generally U-shaped and / or include a first end portion and / or a second end portion generally opposite a connecting portion. The method can include inserting a first end portion of the first spring into the first beam spring cavity. The method can include crimping the first beam and the first spring to secure the first end portion of the first spring in the first beam spring cavity.

[0017] In a detailed embodiment, crimping the first beam and the first spring may include plastically deforming a portion of the first beam and a portion of the first spring.

[0018] In particular embodiments, obtaining the first beam may include at least one of 3D printing the first beam, metal injection molding the first beam, and / or machining the first beam.

[0019] In a detailed embodiment, inserting the first end portion of the first spring into the first beam spring cavity may include positioning the first end portion of the first spring through a generally longitudinal slot between the spring cavity and the end of the first beam, the slot being configured to prevent rotation of the first spring about the first end portion of the first spring.

[0020] In a detailed embodiment, the first beam can include an outer wall at least partially defining the spring cavity. The outer wall can include an outwardly facing recess. Crimping the first beam and the first spring can include at least partially receiving a tool in the outwardly facing recess of the outer wall. The outer wall can be disposed generally opposite the clamping surface of the first beam.

[0021] In a detailed embodiment, the first beam can include an inner wall at least partially defining a spring cavity. The inner wall can include a cavity recess within the spring cavity. Crimping the first beam and the first spring can include deforming at least a portion of a first end portion of the first spring into the cavity recess. The inner wall can be disposed generally toward the clamping surface of the first beam.

[0022] In a detailed embodiment, the method may include obtaining a second spring. The second spring is generally U-shaped. The method may include crimping a second beam and the first spring to secure the first spring to the second beam. The method may include crimping the first beam and the second spring to secure the second spring to the first beam. The method may include crimping the second beam and the second spring to secure the second spring to the second beam. The method may include crimping the second beam and the second spring to secure the second spring to the second beam.

[0023] An aspect of the present disclosure is to provide a method of occluding an anatomical structure, the method comprising delivering an exclusion device to a surgical site in a closed configuration. The exclusion device can include a first beam, a second beam, and at least one spring, the at least one spring operably coupled to the first beam and / or the second beam for exerting a closing force on the first beam and / or the second beam. The at least one spring can be operably coupled to the first beam by a crimp connection. The method can include reconfiguring the exclusion device from the closed configuration to an open configuration. The method can include positioning the exclusion device around the anatomical structure. The method can include reconfiguring the exclusion device to a closed configuration to at least partially occlude the anatomical structure, which can include reconfiguring the exclusion device to a closed configuration using the closing force exerted by the at least one spring.

[0024] In a detailed embodiment, reconfiguring the exclusion device to the closed configuration can include allowing a closing force exerted by at least one spring to move the first beam and the second beam to the closed configuration.

[0025] In particular embodiments, the method may include the steps of detaching the exclusion device from the application tool; withdrawing the application tool; and / or maintaining the exclusion device in a closed configuration using at least one spring.

[0026] In a detailed embodiment, the exclusion device may include a left atrial appendage occlusion clip. Positioning the exclusion device about the anatomical structure may include positioning the left atrial appendage occlusion clip about the left atrial appendage. At least partially occluding the anatomical structure may include at least partially occluding the left atrial appendage.

[0027] One aspect of the present disclosure is to provide an exclusion device for an anatomical structure, the exclusion device including a first beam, a second beam, and a first spring operatively coupled to the first beam and the second beam for exerting a closing force on the first beam and the second beam. The first spring can be generally U-shaped and / or can include first and second end portions generally opposite a connecting portion.

[0028] In a detailed embodiment, the spring can include a first counterbend portion between the connecting portion and the first end portion. The spring can include a second counterbend portion between the connecting portion and the second end portion. The first beam, the second beam, and / or the first spring can be configured such that a closed bias pre-load is provided by the first counterbend portion and / or the second counterbend portion.

[0029] In a detailed embodiment, the first spring can be generally converging between the connection portion and the first and second counterbend portions. Between the first counterbend portion and the first end portion, and between the second counterbend portion and the second end portion, the spring can be generally diverging. In a detailed embodiment, the spring can be substantially coplanar.

[0030] In a detailed embodiment, the closure force can vary with the temperature of the first spring. The first spring can be constructed from at least one of Nitinol, stainless steel, or a polymer, or any other suitable biocompatible elastic material.

[0031] In a detailed embodiment, a first end portion of the first spring can be operably connected to a first beam by a first pivot. The first pivot can be rotatable relative to the first beam. A second end portion of the second spring can be operably connected to a second beam by a second pivot. The second pivot can be rotatable relative to the second beam.

[0032] In a detailed embodiment, a first spring can be rigidly coupled to at least one of the first beam and the second beam, and the first spring can be configured to exert a closing force through a bending and / or torsional load.

[0033] One aspect of the present disclosure is to provide a method of making an exclusion device for an anatomical structure, the method including operatively connecting a first spring between a first beam and a second beam for exerting a closing force on the first beam and the second beam. The first spring can be generally U-shaped and / or can include a respective first end portion and a respective second end portion generally opposite a connecting portion.

[0034] In detailed embodiments, the method may further include operatively connecting a second spring between the first and second beams for exerting a closing force on the first and second beams. The second spring may be generally U-shaped and / or may include respective first and second end portions generally opposite the respective connecting portions.

[0035] In a detailed embodiment, operably connecting the first spring between the first beam and the second beam may include pivotally connecting a first end portion of the first spring to the first beam and / or pivotally connecting a second end portion of the first spring to the second beam.

[0036] An aspect of the present disclosure is to provide a method of occluding an anatomical structure, the method comprising delivering an exclusion device to a surgical site in a closed configuration. The exclusion device can include a first beam, a second beam, and / or a first spring, the first spring operatively coupled to the first beam and the second beam for exerting a closing force on the first beam and the second beam. The first spring can be generally U-shaped and / or can include a first end portion and a second end portion generally opposite a connecting portion. The first spring can include a first reverse bend portion between the connecting portion and the first end portion and / or a second reverse bend portion between the connecting portion and the second end portion. The method can include reconfiguring the exclusion device from the closed configuration to an open configuration. The method can include positioning the exclusion device around the anatomical structure. The method can include reconfiguring the exclusion device to a closed configuration to at least partially occlude the anatomical structure.

[0037] In detailed embodiments, the method may further include removing the exclusion device from the application tool, withdrawing the application tool, and / or maintaining the exclusion device in a closed configuration using a first spring. The closing force exerted by the first spring may vary with a temperature of the first spring. The method may include increasing the closing force exerted by the first spring by increasing a temperature of the first spring.

[0038] In a detailed embodiment, the exclusion device may include a left atrial appendage occlusion clip. Positioning the exclusion device about the anatomical structure may include positioning the left atrial appendage occlusion clip about the left atrial appendage. At least partially occluding the anatomical structure may include at least partially occluding the left atrial appendage.

[0039] One aspect of the present disclosure is to provide an exclusion device, the exclusion device including a first clamping portion; a second clamping portion opposite the first clamping portion, and / or a biocompatible fabric cover at least partially covering at least one of the first clamping portion and the second clamping portion. The cover can be generally tubular and / or can define a relaxed perimeter when the first clamping portion and the second clamping portion are in a closed configuration. At least a portion of the cover can be configured to stretch from about 2X to about 3X the relaxed perimeter to a stretched perimeter when the first clamping portion and the second clamping portion are reconfigured from the closed configuration to an open configuration.

[0040] In a detailed embodiment, the exclusion device may include a closed biased left atrial appendage occlusion clip. The covering may be configured to promote tissue ingrowth. The covering may include a circular knit warp weave fabric. The covering may include woven polyethylene terephthalate yarn. The covering may include at least one weld securing the covering onto at least one of the first clamping portion and the second clamping portion. The at least one weld may include at least one ultrasonic weld. The at least one weld may include at least one thermal weld. The at least one weld may be configured and / or arranged to promote tissue ingrowth into the covering proximate the at least one weld.

[0041] One aspect of the present disclosure is to provide a method of making an exclusion device for an anatomical structure. The method can include assembling a clamping portion of the exclusion device including a beam and a biocompatible fabric cover, and / or fixing the cover over the beam by ultrasonically welding a first portion of the cover to a second portion of the cover.

[0042] In a detailed embodiment, the ultrasonic welding operation may include overlapping the first portion of the covering and the second portion of the covering and / or applying ultrasonic energy to the overlapped first portion of the covering and the second portion of the covering to create at least one ultrasonic weld, the at least one ultrasonic weld being configured and arranged to promote tissue ingrowth into the covering adjacent the at least one ultrasonic weld. Overlapping the first portion of the covering and the second portion of the covering may include positioning the second portion of the covering within the first portion of the covering in a generally radial direction. Applying ultrasonic energy to the overlapped first portion of the covering and the second portion of the covering may include applying ultrasonic energy at about 40 kHz.

[0043] One aspect of the present disclosure is to provide a method of making an exclusion device for an anatomical structure. The method can include assembling a clamping portion of the exclusion device including a beam and a biocompatible fabric cover, and / or fixing the cover over the beam by heat welding a first portion of the cover to a second portion of the cover.

[0044] In a detailed embodiment, the heat welding operation may include overlapping a first portion of the cover and a second portion of the cover, and / or applying heat to the overlapped first portion of the cover and the second portion of the cover to create at least one heat weld, the at least one heat weld being configured and arranged to promote tissue ingrowth into the cover proximate the at least one heat weld. The heat welding operation may include positioning a protective sheet between a heat source and the cover, and / or applying heat to the first portion of the cover and the second portion of the cover through the protective sheet using a heat source. The protective sheet may include polytetrafluoroethylene.

[0045] An aspect of the present disclosure is to provide a method of occluding an anatomical structure. The method can include delivering an exclusion device to a surgical site in a closed configuration and / or reconfiguring the exclusion device from the closed configuration to an open configuration. The exclusion device can include a first clamping portion, a second clamping portion, and / or a biocompatible fabric cover, the cover at least partially covering at least one of the first clamping portion and the second clamping portion. The cover can be generally tubular and / or can define a relaxed perimeter when the first clamping portion and the second clamping portion are in the closed configuration. Reconfiguring the exclusion device from the closed configuration to the open configuration can include stretching at least a portion of the cover to a stretched perimeter about 2X to about 3X of the relaxed perimeter.

[0046] In a detailed embodiment, the exclusion device may include at least one spring operably coupled to the first and second clamping portions for exerting a closing force on the first and second clamping portions. The method may further include positioning the exclusion device about the anatomical structure and / or at least partially occluding the anatomical structure by reconfiguring the exclusion device to a closed configuration using the closing force exerted by the at least one spring. The exclusion device may include a left atrial appendage occlusion clip. Positioning the exclusion device about the anatomical structure may include positioning a left atrial appendage occlusion clip about the left atrial appendage. At least partially occluding the anatomical structure may include at least partially occluding the left atrial appendage.

[0047] An aspect of the present disclosure is to provide a biocompatible cover for an exclusion device that extends from about 2X to about 3X of its original circumference. An aspect of the present disclosure is to provide a biocompatible cover for an exclusion device that includes at least one ultrasonic weld that secures the cover over the exclusion device. An aspect of the present disclosure is to provide a biocompatible cover for an exclusion device that includes at least one thermal weld that secures the cover over the exclusion device. An aspect of the present disclosure is to provide a biocompatible cover for an exclusion device that is configured to promote tissue ingrowth. An aspect of the present disclosure is to provide a left atrial appendage occlusion clip. An aspect of the present disclosure is to provide a cover for an exclusion device that includes a circular knit warp weave fabric.

[0048] One aspect of the present disclosure is to provide an application instrument for an exclusion device for an anatomical structure, the application instrument including an end effector, the end effector including a head configured to be distally disposed on a shaft, a stationary jaw, the stationary jaw fixedly disposed on the head and configured to releasably couple to a first clamping portion of the exclusion device for the anatomical structure, the exclusion device being biased in a closing direction, and a movable jaw, the movable jaw movably disposed on the head and configured to releasably couple to a second clamping portion of the exclusion device. The movable jaw may be movable relative to the stationary jaw to reconfigure the exclusion device from a closed configuration to an open configuration. The movable jaw is generally oriented parallel to the stationary jaw when the exclusion device is in the open and closed configurations.

[0049] In detailed embodiments, the displacement device can include at least one spring disposed to exert a closing force on the first clamping portion and the second clamping portion, and the end effector can be configured to facilitate reconfiguration of the displacement device from an open configuration to a closed configuration using the closing force exerted by the at least one spring.

[0050] In a detailed embodiment, the application instrument can include a shaft and the head can be disposed distally on the shaft. The application instrument can further include a handle portion disposed proximally on the shaft. The handle portion can include a first actuator operable by a user to reconfigure the displacement device from a closed configuration to an open configuration. The handle portion can include a second actuator operable by a user to deploy the displacement device from the first jaw and the second jaw. The second actuator can be operably coupled to the end effector by an indwelling cable. The end effector can include a cable management element disposed to permit movement of the movable jaw without relative movement of the indwelling cable. The cable management element can include a cable management pin.

[0051] In a detailed embodiment, the end effector can include a cover secured to the head by at least one of a rivet, an orbital rivet, a weld, or a threaded fastener.

[0052] In a detailed embodiment, the movable jaw can be disposed on a traveler. The traveler can be movably disposed on the head. The end effector can include at least one friction reducing element operably interposed between the traveler and the head. The at least one friction reducing element can include at least one ball bearing, at least one roller, or at least one low-friction slider.

[0053] One aspect of the disclosure is to provide a method of making an application tool for an exclusion device for an anatomical structure, the method including assembling an end effector. The end effector can include a head configured to be disposed distally on a shaft; a stationary jaw, the stationary jaw fixedly disposed on the head and configured to releasably couple to a first clamping portion of an exclusion device for an anatomical structure, the exclusion device being biased in a closing direction; and / or a movable jaw, the movable jaw movably disposed on the head and configured to releasably couple to a second clamping portion of the exclusion device, the movable jaw remaining generally parallel to the stationary jaw when the exclusion device is in an open configuration and a closed configuration. The method can include coupling the end effector distally onto the shaft. The method can include coupling a handle portion proximally onto the shaft.

[0054] In detailed embodiments, the method may further include operably connecting a first actuator on the handle portion to the end effector such that the first actuator is operative to move the movable jaw to reconfigure the displacement device from a closed configuration to an open configuration. The method may further include operably connecting a second actuator on the handle portion to the end effector such that the second actuator is operative to deploy the displacement device from the first jaw and the second jaw. The step of operably connecting the second actuator on the handle portion to the end effector may include routing the retention cable around at least one cable management element configured to enable movement of the movable jaw without relative movement of the retention cable.

[0055] In a detailed embodiment, assembling the end effector may include attaching a cover to the head. Attaching the cover to the head may include riveting the cover to the head.

[0056] One aspect of the disclosure is to provide a method of using an application instrument for an exclusion device for an anatomical structure, the method including the steps of: operating a first actuator on a handle portion of the application instrument carrying the exclusion device to reconfigure the exclusion device to an open configuration; positioning an end effector of the application instrument to position the exclusion device over the anatomical structure; operating the first actuator to reconfigure the exclusion device to a closed configuration over the anatomical structure; and / or operating a second actuator on the handle portion of the application instrument to deploy the exclusion device from the end effector. The end effector can include a head configured to be disposed distally on the shaft, a stationary jaw fixedly disposed on the head and configured to releasably couple to a first clamping portion of the exclusion device, the exclusion device being biased in a closing direction, and / or a movable jaw movably disposed on the head and configured to releasably couple to a second clamping portion of the exclusion device. The step of operating a first actuator on a handle portion of the application instrument carrying the exclusion device to reconfigure the exclusion device to an open configuration can include moving the movable jaw relative to the stationary jaw while the movable jaw and the stationary jaw are oriented generally parallel to reconfigure the exclusion device from a closed configuration to an open configuration.

[0057] In a detailed embodiment, operating a second actuator on a handle portion of the application instrument to deploy the expulsion device from the end effector can include moving the retention cable around at least one cable management element configured to allow movement of the movable jaw without relative movement of the retention cable.

[0058] An aspect of the present disclosure is to provide any method, process, apparatus, or system that includes one or more elements described herein. An aspect of the present disclosure is to provide any combination of any one or more elements described herein.

[0059] Exemplary embodiments are described with reference to the accompanying drawings. [Brief description of the drawings]

[0060] [Figure 1] FIG. 1 is an elevational view of an exemplary exclusion device for an anatomical structure in a closed configuration. [Diagram 2] FIG. 2 is a perspective view of the exclusion device of FIG. 1 in a closed configuration and without a cover. [Diagram 3] FIG. 2 is a perspective view of the exclusion device of FIG. 1 in an open configuration and without a cover. [Figure 4] 2 is an elevational view of an exemplary exclusion device application tool with the exclusion device of FIG. 1 in a closed configuration. [Diagram 5] 5 is an elevational view of the exemplary exclusion device application tool of FIG. 4 with the exclusion device of FIG. 1 in an open configuration. [Figure 6] 2 is a longitudinal cross-sectional view of the exclusion device of FIG. 1 in a closed configuration and without a cover. [Figure 7] FIG. 2 is a detailed longitudinal cross-sectional view of a portion of the first beam proximate the second end. [Figure 8] FIG. 2 is a detailed longitudinal cross-sectional view of a portion of the first beam proximate the second end. [Figure 9]2 is a transverse cross-sectional view of an exemplary beam 106 of the exclusion device 100 of FIG. 1. [Figure 10] 13A-13C are perspective views of alternative exemplary clamping surface gripping features; [Figure 11] FIG. 13 is a perspective view of an alternative exemplary clamping surface gripping feature. [Figure 12] 13A-13C are perspective views of alternative exemplary clamping surface gripping features; [Figure 13] FIG. 2 is a detailed perspective view of a portion of the first beam proximate the second end. [Figure 14] FIG. 2 is a detailed elevation view of an exemplary first spring. [Figure 15] FIG. 13 is a perspective view of an alternative exemplary exclusion device in a closed configuration and without a cover. [Figure 16] 5 is a detailed elevational view of a jaw of the exclusion device applicator of FIG. 4 with the exclusion device of FIG. 1 in an open configuration. [Figure 17] FIG. 2 is an elevational view of the exclusion device of FIG. 1 in an open configuration and without a cover. [Figure 18] FIG. 2 is a perspective view of an exemplary cover. [Figure 19] FIG. 13 is a detailed view of an exemplary ultrasonic weld in an exclusion device cover. [Figure 20] FIG. 13 is a detailed view of an exemplary ultrasonic weld in an exclusion device cover. [Figure 21] FIG. 13 is a detailed perspective view of a portion of a cover including an exemplary heat weld. [Figure 22] FIG. 6 is an exploded view of the end effector of FIGS. 4 and 5. [Diagram 23] 14A-14C are perspective views of alternative exemplary exclusion device application instruments; all according to at least some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0061] Exemplary embodiments according to the present disclosure are described and illustrated below to encompass devices, methods, and techniques related to medical devices and treatments. Of course, it is clear to those skilled in the art that the embodiments discussed below are examples and can be reconfigured without departing from the scope and spirit of the present disclosure. It should also be understood that variations of the exemplary embodiments contemplated by those skilled in the art shall also constitute part of the present disclosure. However, for clarity and precision, the exemplary embodiments as discussed below may include optional steps, methods, and features that those skilled in the art should recognize as not necessary to fall within the scope of the present disclosure.

[0062] The present disclosure includes, among other things, medical instruments and devices, and more particularly, exclusion devices for anatomical structures, as well as related instruments and related methods. Some exemplary embodiments according to at least some aspects of the present disclosure may be useful as a left atrial appendage occlusion clip for exclusion of a patient's left atrial appendage, such as to reduce the burden of atrial fibrillation in the patient and / or to reduce the patient's risk of stroke. However, it should be understood that various exemplary embodiments according to the present disclosure may also be utilized in connection with anatomical structures other than the left atrial appendage. The following description begins with an overview of exemplary exclusion devices and application instruments, followed by a detailed description of certain aspects of various exemplary embodiments.

[0063] Generally, some exemplary exclusion devices according to at least some aspects of the present disclosure can be delivered to a surgical site in a closed configuration using an application instrument. The application instrument can be actuated to reconfigure the exclusion device to an open configuration. The application instrument can be manipulated to position the exclusion device about an anatomical structure. The application instrument can be actuated to reconfigure the exclusion device to the closed configuration to at least partially occlude the anatomical structure. The application instrument can be actuated to remove the exclusion device, and the application instrument can be withdrawn from the surgical site.

[0064] 1 is an elevational view of an exemplary exclusion device 100 for an anatomical structure in a closed configuration, according to at least some embodiments of the present disclosure. The exemplary exclusion device 100 is generally in the form of an occlusion clip including a first clamping portion 102 and an opposing second clamping portion 104. The first clamping portion 102 and the second clamping portion 104 are biased in a closing direction (e.g., generally toward one another).

[0065] The illustrated exclusion device 100 includes a cover 200 that at least partially covers one or both of the clamping portions 102, 104. The exemplary cover 200 is constructed from a woven fabric that can initiate a body's healing response and / or promote tissue ingrowth. In the illustrated embodiment, the cover 200 is generally tubular and individually covers each of the clamping portions 102, 104 in a generally toroidal fashion. In some exemplary embodiments, the cover 200 can substantially surround other components of the exclusion device 100.

[0066] Some exemplary exclusion devices 100 according to at least some aspects of the present disclosure can be configured such that in a closed configuration, the envelope of the exclusion device 100 can be less than about 5 mm laterally. Thus, some exemplary embodiments can be configured to fit through a relatively small port (e.g., a 5 mm trocar, etc.). The present disclosure contemplates that some other implantable exclusion devices can have a device envelope that is about 12 mm laterally. See, for example, some devices described in U.S. Patent No. 10,166,024, issued January 1, 2019 (incorporated by reference). Thus, some exemplary exclusion devices 100 according to at least some aspects of the present disclosure can be advantageous when used in connection with minimally invasive surgical approaches. Additionally, some exemplary exclusion devices 100 according to at least some aspects of the present disclosure can tend to obstruct the surgeon's view to a lesser extent than relatively larger exclusion devices, thus allowing the surgeon to better visualize nearby structures (e.g., nearby structures that may potentially interfere with the procedure, etc.).

[0067] FIG 2 is a perspective view of the exclusion device 100 of FIG 1 in a closed configuration and without the cover 200, and FIG 3 is a perspective view of the exclusion device 100 of FIG 1 in an open configuration and without the cover 200, all according to at least some embodiments of the present disclosure. With reference to FIGS. 1-3, in this exemplary exclusion device 100, the first clamping portion 102 includes a first beam 106 and the second clamping portion 104 includes a second beam 108. The first beam 106 and the second beam 108 are coupled together by a generally U-shaped first spring 110 and a generally U-shaped second spring 112. Generally, the first spring 110 is coupled to the beams 106, 108 inwardly from the first ends 114, 116 of the beams 106, 108, respectively. Similarly, a second spring 112 is coupled to the beams 106, 108 inwardly from second ends 118, 120 of the beams 106, 108, respectively.

[0068] In this exemplary embodiment, the beams 106, 108 include opposed clamping surfaces 122, 124 that are configured to engage the anatomical structure 10 positioned therebetween. For example, the exclusion device 100 can be positioned to at least partially occlude the anatomical structure 10, including the left atrial appendage, by clamping the LAA between the clamping surfaces 122, 124 of the clamping portions 102, 104. Some embodiments can be configured to accommodate an LAA that is about 24 mm to about 50 mm wide, for example.

[0069] In the illustrated embodiment, the springs 110, 112 are arranged to bias the first beam 106 and the second beam 108 toward one another (e.g., in a closing direction). In this embodiment, the first clamping portion 102 and the second clamping portion 104 are substantially in contact in the closed configuration when the exclusion device 100 is empty. In particular, the clamping surfaces 122, 124 (which may be covered by the cover 200) may be substantially in contact with one another in the closed configuration when the exclusion device 100 is empty. Some alternative exemplary embodiments may be configured such that the springs 110, 112 bias the beams 106, 108 in a closing direction, but do not draw the clamping portions into full contact with one another in the closed configuration when the exclusion device 100 is empty. Thus, in some such embodiments, a gap may exist between the clamping portions 102, 104 in the closed configuration, even though no other structure is interposed between the clamping portions 102, 104. As used herein, a "closed configuration" can refer to a configuration in which the displacement device 100 maintains its clamping portions 102, 104 substantially independently in a configuration closer together than in a fully open configuration, regardless of whether the clamping portions are in contact with one another and regardless of whether any other objects (e.g., anatomical structures) are interposed between the clamping portions. In the illustrated embodiment, in the fully open configuration, the beams 106, 108 are spaced approximately 14 mm apart.

[0070] In the illustrated embodiment, the springs 110, 112 are selected such that the clamping portions 102, 104 are spaced apart when the anatomical structure 10 is in a closed configuration with the anatomical structure 10 resting against the clamping surfaces 122, 124. As a result, the anatomical structure 10 can be substantially occluded, but generally not severed.

[0071] 4 is an elevational view of an application tool 300 of the exemplary exclusion device 100 of FIG. 1 in a closed configuration, and FIG. 5 is an elevational view of an application tool 300 of the exemplary exclusion device 100 of FIG. 4 in an open configuration, all according to at least some embodiments of the present disclosure. The exemplary application tool 300 includes a generally proximal handle portion 302, an elongated flexible shaft 304 extending distally from the handle portion 302, and an end effector 306 disposed distally on the shaft 304. As used herein, "distal" may refer to a direction generally away from an operator (e.g., a surgeon) of a system or device (e.g., a direction toward a distal-most end of a device that may be inserted into a patient's body, etc.). As used herein, "proximal" may refer to a direction generally toward an operator (e.g., a surgeon) of a system or device (e.g., a direction away from a distal-most end of a device that may be inserted into a patient's body, etc.).

[0072] In the illustrated embodiment, the exclusion device 100 is releasably secured to the application instrument 300 by an end effector 306. The end effector 306 is arranged to reconfigure the exclusion device 100 between an open configuration and a closed configuration, and to release the exclusion device 100, based on actuation of one or more actuators 308, 310 on the handle portion 302 by a user. For example, the handle portion 302 and / or the actuators 308, 310 can be generally similar in construction and operation to those described in U.S. Patent Application Publication No. 2019 / 0142428, published May 16, 2019, which is incorporated herein by reference in its entirety.

[0073] In the illustrated embodiment, the end effector 306 includes a distal stationary jaw 312 and a proximal movable jaw 314. Each of the clamping portions 102, 104 of the exclusion device 100 is releasably coupled to a respective one of the jaws 312, 314. Operation of the first actuator 308 causes the end effector 306 to reconfigure the exclusion device 100 between an open configuration and a closed configuration by moving the movable jaw 314 away from and toward the stationary jaw 312. In some exemplary embodiments, the first actuator 308 can be operable to open the exclusion device 100, and a closing biased nature of the exclusion device 100 can be operable to close the exclusion device 100 when the first actuator 308 is released by a user. In some exemplary embodiments, the end effector 306 can be configured for substantially parallel opening of the first clamping portion 102 and the second clamping portion 104 of the exclusion device 100. Operation of the second actuator 310 can cause the end effector 306 to release (e.g., deploy) the displacement device 100 by removing the clamping portions 102, 104 from the jaws 312, 314. For example, the clamping portions 102, 104 can be releasably secured to the respective jaws 312, 314 by respective sutures 316, 318, which can be released by operation of the second actuator 310. Exemplary mechanisms arranged to deploy the displacement device from the end effector are described in U.S. Patent Application Publication No. 2018 / 0036007, published February 8, 2018 (incorporated by reference). In some exemplary embodiments, the sutures 316, 318 (or other attachment elements) can be positioned generally centered longitudinally along the clamping portions 102, 104.The actuators 308, 310 can be operatively coupled to the end effector 306 by one or more mechanical linkages (eg, one or more rods and / or cables, etc.).

[0074] The present disclosure contemplates that a cover for an implantable exclusion device can promote tissue ingrowth and / or provide a barrier between a relatively rigid component of the device (e.g., the beam) and adjacent tissue (e.g., the heart). Some implantable exclusion devices can be configured such that the cover generally does not move relative to the structural components. That is, the cover can remain substantially in place over the structural components and / or does not stretch when the exclusion device is being reconfigured. Other implantable exclusion devices (such as, for example, exclusion device 100) can include a biocompatible cover 200 that is configured to move (e.g., stretch) relative to the underlying components.

[0075] FIG. 6 is a longitudinal cross-sectional view of the exclusion device 100 of FIG. 1 in a closed configuration and without the cover 200, and FIGS. 7 and 8 are detailed longitudinal cross-sectional views of a portion of the first beam 106 proximate its second end 118, all according to at least some embodiments of the present disclosure. The following description generally focuses on features of the first beam 106 proximate its second end 118. However, it should be understood that the first end 114 of the first beam 106 can be substantially similar to the second end 118 (e.g., in a mirror image fashion). Additionally, the second beam 108 can be substantially similar to the first beam 106 (e.g., in an inverted fashion). Thus, the description of features of the first beam 106 proximate its second end 118 can be applicable to other portions of the exemplary exclusion device 100, but will not be repeated for brevity.

[0076] 2, 3, and 6-8, in the illustrated embodiment, the second spring 112 is generally U-shaped and includes a first end portion 126 and a second end portion 128 generally opposite a connecting portion 130. At least a portion of the first end portion 126 is received in a generally longitudinally oriented spring cavity 132 formed in the first beam 106. The spring cavity 132 opens toward the second end 118 of the first beam 106 and receives the first end portion 126 of the second spring 112 from that direction.

[0077] 2, 3, and 7, in the illustrated embodiment, when the exclusion device 100 is reconfigured from the closed position (FIGS. 2 and 7) to the open configuration (FIG. 3), the first end portion 126 of the second spring 112 remains secured within the cavity 132 of the first beam 106. The portion of the second spring 112 proximate the cavity 132 bends from a generally longitudinally slightly outward orientation (FIGS. 2 and 7) to a significantly inward orientation (FIG. 3). In some exemplary embodiments, the first beam 106 can include a spring stress reducing feature proximate the cavity 132. For example, in the illustrated embodiment, the beam 106 includes an outwardly facing rounded spring contact surface 134 that is configured to reduce stress concentrations in the second spring 112 when the exclusion device 100 is in the open configuration. In some exemplary embodiments, the spring contact surface 134 may also facilitate assembly of the exclusion device 100, such as by funneling the first end portion 126 of the second spring 112 into the cavity 132 of the first beam 106.

[0078] 2, 3, 6, and 7, in the illustrated embodiment, at least a portion of the beam 106 between the cavity 132 and the second end 118 can include a longitudinal slot 136 extending generally outward from the clamping surface 122. At least a portion of the second spring 112 is slidably received within the slot 136. In general, the slot 136 can help maintain a generally coplanar alignment of the first beam 106, the second spring 112, and the second beam 108. Thus, the second spring 112 and the slot 136 can cooperate to reduce the likelihood that the beams 106, 108 will be substantially out of alignment (e.g., out of plane), such as during opening and / or closing of the displacement device 100.

[0079] 2, 3, 6, and 8, in some exemplary embodiments, the first beam 106 and / or the second spring 112 can be plastically deformed to secure the second spring 112 to the first beam 106. In the illustrated embodiment, a tool (such as, for example, a punch 138) can be used to crimp the beam 106 and the first portion 126 of the second spring 112 to secure them together.

[0080] 8, in the exemplary embodiment, an outer wall 140 of the first beam 106 at a crimp location proximate the cavity 132 (e.g., generally opposite the clamping surface 122) is thinner than adjacent portions of the beam 106. For example, the outer wall 140 can include an outwardly facing recess 142 that can be configured to receive the punch 138 therein. In some exemplary embodiments, the outwardly facing recess 142 can act as an alignment location for the punch 138 and / or can at least partially define the thinner portion of the outer wall 140.

[0081] Still referring to FIG. 8 , in this exemplary embodiment, the inner wall 144 of the first beam 106 (e.g., generally toward the clamping surface 122) can include a cavity recess 146 in the cavity 132. This cavity recess 146 can be generally aligned with the desired crimping motion of the punch 138. In some exemplary embodiments, the cavity recess 146 can provide a space to allow deformation of the outer wall 140 of the first beam 106 and / or the first end portion 126 of the second spring 112 beyond the desired permanent deformation to achieve the desired permanent deformation. That is, the cavity recess 146 can provide a relief to accommodate elastic deformation of the second spring 112 during the crimping operation, such as due to, for example, a relatively high yield strength of the second spring 112 material. In some exemplary embodiments, at least a portion of the first end portion 126 of the second spring 112 can remain at least partially in the cavity recess 146 after the crimping operation. The exemplary cavity recess 146 shown in FIG. 8 is generally in the form of a partial sphere, which can be formed, for example, when the first beam 106 is 3D printed. In alternative exemplary embodiments, the cavity recess 146 can have a different shape. For example, the cavity recess 146 can generally have the form of a through hole, such as in a metal injection molded first beam 106.

[0082] Generally, during an exemplary crimping operation, the punch 138 can deform at least a portion of the outer wall 140 of the first beam 106 at least partially into the cavity 132, which can deform at least a portion of the first end portion 126 of the second spring 112 at least partially into the recess 146. Depending on the extent of deformation, the strength of the materials making up the first beam 106 and the second spring 112, etc., at least a portion of the outer wall 140 of the first beam 106 and / or at least a portion of the first end portion 126 of the second spring 112 can be plastically deformed to form a crimp connection between the first beam 106 and the second spring 112. That is, the crimp connection can include, for example, a plastically deformed portion of the second spring 112 engaged with a plastically deformed portion of the first beam 106.

[0083] 9 is a transverse cross-sectional view of an exemplary beam 106 of the displacement device 100 of FIG. 1, in accordance with at least some aspects of the present disclosure. In the illustrated embodiment, the beam height 148 is about 2 mm and the beam width 150 is about 2.5 mm. In some exemplary embodiments, the clamping surface 122 can be configured to provide a generally uniform pressure to the anatomical structure 10 (FIG. 3) across the width of the clamping surface 122. Various clamping surface 122 shapes (e.g., profiles) can be utilized to achieve a desired tradeoff between increasing tissue surface contact area and / or reducing tissue stretching and / or trauma when the displacement device 100 is closed over the anatomical structure 10. Exemplary curves of the clamping surface 122 can include, but are not limited to, a curve generally in the form of the curve of the surface of a water drop, a natural logarithmic decay curve, a semicircular shape (e.g., constant radius), an ellipse, a parabola, and / or generally flat.

[0084] 10-12 are perspective views of gripping features 152, 154, 156 of an alternative exemplary clamping surface 122, according to at least some embodiments of the present disclosure. FIG. 10 illustrates a clamping surface 122 including an exemplary rough surface finish 152. As used herein, a "rough surface finish" may refer to a surface that is generally uniformly rough at a fine scale, but that lacks easily individually identifiable surface features and / or that presents a generally smooth surface curvature at a larger scale. FIG. 11 illustrates a clamping surface 122 including gripping features that include protrusions 154. The protrusions 154 can extend generally orthogonally from the clamping surface 122. The protrusions 154 can be shaped, for example, generally conically and / or cylindrically. In various exemplary embodiments, the protrusions 154 can be arranged in a regular pattern (e.g., in clusters or lines), and / or generally randomly and / or generally uniformly distributed. For example, grit media can be generally randomly embedded into the clamping surface 122. In alternative exemplary embodiments, gripping features including holes or recesses can be similarly arranged. FIG. 12 illustrates a clamping surface 122 that includes gripping features including ridges 156. In this exemplary embodiment, the ridges 156 are oriented generally longitudinally along the beam 106 (FIG. 2).

[0085] Generally, in some exemplary embodiments, the gripping features 152, 154, 156 can be configured to aid in anchoring the exclusion device 100 and the cover 200 after the exclusion device is placed on the anatomical structure 10. For example, the gripping features 152, 154, 156 can increase friction and / or gripping strength between the beams 106, 108 and the cover 200 and / or between the beams 106, 108 and the anatomical structure 10. Thus, the gripping features 152, 154, 156 can reduce the likelihood of the cover 200 moving relative to the beams 106, 108 (e.g., rolling circumferentially around the beams 106, 108) and / or the exclusion device 100 moving relative to the anatomical structure 10. The various gripping features 152, 154, 156 can be formed by 3D printing and / or other manufacturing processes.

[0086] 2, 3, 5, 7, and 8, in some exemplary embodiments, the beams 106, 108 can be configured to have sufficient bending strength to allow the displacement device 100 to be releasably secured to the respective jaws 312, 314 of the end effector 306 of the application instrument 300 using a single attachment point for each clamping portion 102, 104. For example, the beams 106, 108 can be configured to have sufficient bending strength to allow the displacement device 100 to be releasably coupled to the jaws 312, 314 by individual sutures 316, 318 (or other attachment elements), which can be positioned generally centered longitudinally along the clamping portions 102, 104. In particular, the beams 106, 108 can be designed such that the beam moments of inertia provide sufficient strength and / or limited deflection when subjected to a generally longitudinally, centrally applied opening force sufficient to overcome the closing force exerted by the springs 110, 112.

[0087] 13 is a detailed perspective view of a portion of the first beam 106 proximate the second end 118, according to at least some aspects of the present disclosure. With reference to FIGS. 1, 6, 7, and 13, some exemplary beams 106, 108 can include one or more portions configured to act as a mandrel for a welding operation involving the cover 200. For example, in the illustrated embodiment, the first beam 106 includes outwardly facing surfaces 158, 160 that can be configured to cooperate with an externally applied ultrasonic and / or thermal welding device to join portions of the cover 200. In some exemplary embodiments, the outwardly facing surfaces 158, 160 can be generally solid (e.g., without substantial recesses or cavities) and / or generally flat.

[0088] In some exemplary embodiments, the beams 106, 108 may be constructed from one or more metals and / or metal alloys (e.g., titanium and / or titanium alloys, etc.). For example, the beams 106, 108 may be constructed from grade 5 and / or grade 23 titanium. Alternative exemplary embodiments may be constructed from other titanium alloys (e.g., grade 2, etc.). Further alternative exemplary embodiments may be constructed from other materials, such as plastic, stainless steel, magnesium, iron, other titanium grades, nitinol, or other biocompatible materials having desired material properties.

[0089] Some exemplary beams 106, 108 can be constructed by 3D printing. Alternative embodiments can be constructed by metal injection molding, chemical etching, and / or stamping. Some exemplary embodiments can be machined.

[0090] In some exemplary embodiments, the beams 106, 108 can include features configured to promote tissue ingrowth after placement of the exclusion device 100. For example, with reference to FIG. 6, the beams 106, 108 can include one or more holes or cavities 162 arranged to promote tissue ingrowth. In some exemplary embodiments, the beams 106, 108 can be formed from a generally porous material to promote tissue ingrowth. For example, the beams 106, 108 can be 3D printed in a manner that forms them to have a generally porous nature.

[0091] Some exemplary methods of making an exclusion device 100 for an anatomical structure 10 according to at least some aspects of the present disclosure may include one or more of the following operations: A first beam 106, a second beam 108, and a first spring 110 may be obtained. Obtaining the first beam 106 may include at least one of 3D printing the first beam 106, metal injection molding the first beam 106, and machining the first beam 106. The first beam 106 may include a generally longitudinally oriented spring cavity 132 and / or the first spring 110 may be generally U-shaped and / or may include a first end portion 126 and a second end portion 126 generally opposite a connecting portion 130.

[0092] In some exemplary embodiments, the first end portion 126 of the first spring 110 can be inserted into the spring cavity 132 of the first beam 106. Inserting the first end portion 126 of the first spring 110 into the spring cavity 132 of the first beam 106 can include positioning the first end portion 126 of the first spring 110 through a generally longitudinal slot 136 between the spring cavity 132 and the end 118 of the first beam 106. The slot 136 can be configured to cooperate with the spring 110 to reduce the likelihood that the first beam 106 and the second beam 108 move out of generally coplanar alignment.

[0093] The first beam 106 and the first spring 110 can be crimped to secure the first end portion 126 of the first spring 110 in the spring cavity 132 of the first beam 106. Crimping the first beam 106 and the first spring 110 can include plastically deforming a portion of the first beam 106 and / or a portion of the first spring 110. The first beam 106 can include an outer wall 140 that at least partially defines the spring cavity 132. The outer wall 140 can be disposed generally opposite the clamping surface 122 of the first beam 106. The outer wall 140 can include an outwardly facing recess 142. Crimping the first beam 106 and the first spring 110 can include receiving a tool 138 at least partially in the outwardly facing recess 142 of the outer wall 140. The first beam 106 can include an inner wall 144 that at least partially defines the spring cavity 132. The inner wall 144 can be disposed generally toward the clamping surface 122 of the first beam 106. The inner wall 144 can include a cavity recess 146 in the spring cavity 132. Crimping the first beam 106 and the first spring 110 can include deforming at least a portion of the first end portion 126 of the first spring 110 into the cavity recess 146. Similar operations for assembling and securing the components can be performed for other connections (e.g., crimp connections) between beams and springs, and a repetitive description will be omitted for brevity.

[0094] Some exemplary methods of occluding the anatomical structure 10 according to at least some aspects of the present disclosure can include one or more of the following operations: The exclusion device can be delivered to the surgical site in a closed configuration. The exclusion device can include a first beam, a second beam, and at least one spring operably coupled to the first beam and the second beam to exert a closing force on the first beam and the second beam, the at least one spring being operably coupled to the first beam by a crimp connection. The exclusion device can be reconfigured from the closed configuration to an open configuration. The exclusion device can be positioned about the anatomical structure. The exclusion device can be reconfigured to the closed configuration to at least partially occlude the anatomical structure.

[0095] Reconfiguring the exclusion device to the closed configuration can include allowing a closing force exerted by at least one spring to move the first beam and the second beam to the closed configuration. The method can further include removing the exclusion device from the application instrument, withdrawing the application instrument, and / or maintaining the exclusion device in the closed configuration using at least one spring.

[0096] The exclusion device can include a left atrial appendage occlusion clip. Positioning the exclusion device about the anatomical structure can include positioning the left atrial appendage occlusion clip about the left atrial appendage. At least partially occluding the anatomical structure can include at least partially occluding the left atrial appendage.

[0097] FIG. 14 is a detailed elevational view of an exemplary first spring 110 according to at least some embodiments of the present disclosure. While the following description focuses on the first spring 110 of the exclusion device 100 (FIG. 1), the second spring 112 can be substantially similar to the first spring 110. Thus, the following description can also generally apply to the second spring 112. For the avoidance of doubt, FIG. 14 illustrates the exemplary first spring 110 in a relaxed condition (e.g., in the absence of any externally applied force). Dimensions, which are merely exemplary, are given in inches.

[0098] In the illustrated embodiment, the first spring 110 is generally U-shaped and includes a first end portion 164 and a second end portion 166 generally opposite a connecting portion 168. Interposed between the connecting portion 168 and the first end portion 164 is a first reverse bend portion 170. Interposed between the connecting portion 168 and the second end portion 166 is a second reverse bend portion 172. Between the connecting portion and the reverse bend portions 170, 172, the first spring 110 can be generally converging. Between the reverse bend portions 170, 172 and the end portions 164, 166, the first spring 110 can be generally diverging. In the illustrated embodiment, the reverse bend portions 170, 172 can be configured to provide a spring preload (e.g., a closed bias preload) when the displacement device 100 is assembled.

[0099] In some exemplary embodiments, the first spring 110 can be substantially coplanar. That is, other than the thickness of the spring material forming the first spring 110, the spring can be substantially two-dimensional. Thus, the first spring 110 can only exert a force in substantially two dimensions, and there is generally no shear action when the first spring 110 returns to its relaxed condition. In alternative embodiments, the first spring 110 can be non-coplanar. For example, a portion of the first spring 110 can cross over another portion of the first spring 110. In some such embodiments, the displacement device 100 can be configured to provide additional stability due to the spring force in a third dimension.

[0100] In operation, some exemplary first springs 110 can act as a combination of spring types. For example, the generally rounded connecting portion 168 of the first spring 110 can generally act as a torsion spring. The torsion moment associated with this portion of the first spring 110 is indicated by arrow 174. The elongated leg portions 176, 178 (e.g., the portions extending from the connecting portion 168 and including the first end portion 164 and the second end portion 166) can act as cantilever springs. The bending moment associated with these portions of the first spring 110 is indicated by arrows 180, 182.

[0101] The first spring 110 can include a first bend at the connecting portion 168. Each side of the first bend can be at an angle 186 with respect to the reference line 184. For example, the angle 186 can be about 98 degrees. The first spring 110 can include a second bend at the first reverse bend portion 170. The second bend can be at an angle 188 with respect to a portion adjacent the first bend. For example, the angle 188 can be about 23 degrees. The second reverse bend portion 172 can be generally similar but in the opposite direction. Between the bends, the first spring 110 can be generally straight.

[0102] 15 is a perspective view of an alternative exemplary exclusion device 500 in a closed configuration and without a cover, according to at least some embodiments of the present disclosure. The exclusion device 500 is generally similar to the exclusion device 100 described above, and a repeated description of common components has been omitted for brevity.

[0103] In the illustrated embodiment, the displacement device includes a first beam 502 and a second beam 504. Each beam 502, 504 has a respective first end 506, 508 and a respective second end 510, 512. The first beam 502 and the second beam 504 are coupled together by generally U-shaped springs 514, 516, 518, 520. The first spring 514 and the second spring 516 are coupled inwardly from their respective first ends 506, 508 to the beams 502, 504. The third spring 518 and the fourth spring 520 are coupled inwardly from their respective second ends 510, 512 to the beams 502, 504. Thus, each end 506, 508, 510, 512 of each beam 502, 504 is connected to the other beam 502, 504 by two springs 514, 516, 518, 520, for a total of four springs 514, 516, 518, 520 connecting the beams 502, 504 together.

[0104] In the illustrated embodiment, the springs 514, 516, 518, 520 are coupled to the beams 502, 504 by pivots 522, 524, 526, 528 that extend laterally through and / or are rotatable relative to the beams 502, 504. Specifically, the first spring 514 and the second spring 516 are coupled to the first beam 502 by a first pivot 522 and to the second beam 504 by a second pivot 524. The third spring 518 and the fourth spring 520 are coupled to the first beam 502 by a third pivot 526 and to the second beam 504 by a fourth pivot 528. In some alternative exemplary embodiments, the springs 514, 516, 518, 520 may be coupled to the beams 502, 504 by posts generally similar to the pivots 522, 524, 526, 528, but that are fixed against rotation relative to the beams 502, 504. In some such embodiments, the beams 502, 504 may be less likely to move out of alignment (e.g., parallelogramming).

[0105] In general, the four-spring displacement device 500 of Figure 15 may enable the use of smaller springs that are subject to lower stress than the two-spring displacement device 100 of Figure 2 to achieve a similar acceptable clamping force. Additionally, in some exemplary embodiments, some four-spring displacement devices 500 may utilize simpler beam geometries as compared to the two-spring displacement device 100. Thus, some beams 502, 504 of the four-spring displacement device 500 may be manufactured using stamping, laser cutting, water jet cutting, and / or machining processes.

[0106] In some exemplary embodiments, the springs can be constructed from Nitinol. The present disclosure contemplates that some Nitinol alloys can have superelastic properties, which can be advantageous for some spring applications. The present disclosure contemplates that some springs constructed from some Nitinol alloys can exert a higher force when opening than when closing. That is, the unloading force can be less than the loading force.

[0107] The present disclosure contemplates that some springs constructed from some Nitinol alloys may exert a higher force at typical body temperature (e.g., about 37° C.) than at typical room temperature (e.g., about 20° C.). For example, in the illustrated embodiment, the spring exerts about 60% more force at typical body temperature than at typical room temperature. As a result, some exemplary exclusion devices are capable of exerting a greater force on the anatomical structure 10 after implantation (e.g., at about body temperature) than the force applied by the application instrument 300 to release the exclusion device prior to implantation (e.g., at about room temperature).

[0108] The present disclosure contemplates that the strength of Nitinol may degrade when it is cycled, particularly when it is cycled near its yield strength. Thus, the springs 110, 112, 514, 516, 518, 520 may be designed such that an expected number of reconfigurations (e.g., 100 cycles) between closed and open configurations will not reduce the strength of the springs 110, 112, 514, 516, 518, 520 below the desired specifications. Furthermore, the present disclosure contemplates that Nitinol strength degradation due to cycling may be reduced with rest time. For example, some Nitinol components may recover approximately 90% of their full strength after a few days. Thus, most of any strength degradation caused by cycling during manufacture of the exclusion device 100, 500 may be recovered by the time the exclusion device 100, 500 is accepted by a user.

[0109] In other exemplary embodiments, the springs may be constructed from stainless steel, polymer, or any other suitable biocompatible elastic material.

[0110] Some exemplary methods of making the exclusion device 100 for an anatomical structure can include one or more of the following operations: A first spring 110 can be operatively connected between the first beam 106 and the second beam 108 and can exert a closing force on the first beam 106 and the second beam 108. The first spring 110 can be generally U-shaped and include a respective first end portion 164 and a respective second end portion 166 generally opposite a connecting portion 168.

[0111] In some exemplary embodiments, the method may further include operably connecting a second spring 112 between the first beam 106 and the second beam 108 for exerting a closing force on the first beam 106 and the second beam 108. The second spring 112 may be generally U-shaped and may include a respective first end portion 164 and a respective second end portion 166 generally opposite a respective connecting portion 168.

[0112] Some exemplary methods of occluding an anatomical structure may include one or more of the following actions: The exclusion device 100 may be delivered to the surgical site in a closed configuration. The exclusion device 100 may include a first beam 106, a second beam 108, and a first spring 110 operably coupled to the first beam 106 and the second beam 108 to exert a closing force on the first beam 106 and the second beam 108. The first spring 110 may be generally U-shaped and / or may include a first end portion 164 and a second end portion 166 generally opposite a connecting portion 168. The first spring 110 may include a first reverse bend portion 170 between the connecting portion 168 and the first end portion 164, and may include a second reverse bend portion 172 between the connecting portion 168 and the second end portion 166. The method can include reconfiguring the exclusion device 100 from a closed configuration to an open configuration. The method can include positioning the exclusion device 100 about the anatomical structure 10. The method can include reconfiguring the exclusion device 100 to the closed configuration to at least partially occlude the anatomical structure 10.

[0113] In some exemplary embodiments, the method may further include removing the exclusion device 100 from the application instrument 300. The method may include withdrawing the application instrument 300. The method may include maintaining the exclusion device 100 in a closed configuration using the first spring 110.

[0114] In some exemplary embodiments, the closing force exerted by the first spring 110 may vary with the temperature of the first spring 110. The method may include increasing the closing force exerted by the first spring 110 by increasing the temperature of the first spring 110.

[0115] In some exemplary embodiments, the exclusion device 100 can include a left atrial appendage occlusion clip. Positioning the exclusion device 100 about the anatomical structure 10 can include positioning the left atrial appendage occlusion clip about the left atrial appendage. At least partially occluding the anatomical structure 10 can include at least partially occluding the left atrial appendage.

[0116] Figure 16 is a detailed elevational view of the jaws 312, 314 of the exclusion device applicator 300 of Figure 4 with the exclusion device 100 of Figure 1 in an open configuration, and Figure 17 is an elevational view of the exclusion device 100 of Figure 1 in an open configuration and without the cover 200, all according to at least some aspects of the present disclosure. With reference to Figures 1 and 4 (closed configuration) and Figures 5, 16, and 17 (open configurations), in the illustrated embodiments, a portion of the cover 200 is stretched when the exclusion device 100 is reconfigured from the closed configuration to the open configuration. Notably, in this exemplary embodiment, the portion of the generally tubular cover 200 generally between the ends 114, 116, 118, 120 of the beams 106, 108 and the springs 110, 112 is stretched circumferentially to a stretched perimeter 201 that is a multiple of the relaxed perimeter 203, as shown by arrows 202, 204, 206, 208. As used herein, "perimeter" may refer to the perimeter of a cross-section of the generally tubular body taken generally perpendicular to the local longitudinal direction. For example, the cross-section may be non-circular, such as when the cover 200 is stretched between the beams 106, 108 and the springs 110, 112, as shown in Figures 5 and 6. In the illustrated embodiment, a portion of the cover 200 is stretched to a stretched perimeter 201 that is about two times (2X) to about three times (3X) its relaxed perimeter 203 when the exclusion device 100 is in the open configuration. In the illustrated embodiment, in the open configuration, the circumference of the entire generally toroidal cover 200 is allowed to stretch to less than about 2X its relaxed perimeter, even when a particular generally tubular portion of the cover 200 is stretched to a stretched perimeter 201 that is about 2X to about 3X its relaxed perimeter 203.

[0117] 18 is a perspective view of an exemplary cover 200 according to at least some aspects of the present disclosure. In the illustrated embodiment, the cover 200 is constructed from a woven fabric (such as, for example, a circular knit fabric). For example, a fabric having a circular warp knit braid of about 35 courses per inch (CPI) to about 45 CPI (such as, for example, about 38 CPI) can be utilized. The fabric can be woven from a biocompatible material (such as, for example, a textured polyethylene terephthalate (PET) yarn).

[0118] In some exemplary embodiments, the fabric of the cover 200 can define a generally tubular shape configured to extend generally toroidally around the beams 106, 108 and springs 110, 112. The fabric of the cover 200 can be heat set over a mandrel to maintain its generally tubular form. In some exemplary embodiments, the fabric can be generally flexible and pliable, such that the cross-section of the generally tubular shape can change with the configuration of the exclusion device 100 and / or with the shape of the components within the cover 200.

[0119] In alternative exemplary embodiments, the cover 200 can be constructed from other woven fabrics having different weave patterns and / or from nonwoven fabrics. In alternative exemplary embodiments, the cover 200 can include multiple layers (plies) of textured yarn, for example. The present disclosure contemplates that multiple layers can add bulk to the fabric and / or reduce flexibility. Thus, some exemplary embodiments that provide a relatively small profile exclusion device 100 can include a cover 200 that includes relatively few layers of fabric.

[0120] 18, in some exemplary embodiments, the cover 200 can be constructed from two or more sections 210, 212 that can be joined together to secure the cover 200 over the underlying structure of the exclusion device 100 in a generally toroidal fashion. For example, the first section 210 can be welded to the second section 212 at a first joint 214 and / or at a second joint 216. Similarly, a cover 200 formed from a single section of tubular fabric can be welded to itself at a similar joint to form a generally toroidal shape. In some exemplary embodiments, one of the first section 210 and the second section 212 (or the ends of a single section) can be overlapped over the other, and one or more welds can extend generally radially to join the first section 210 and the second section 212. Exemplary welding methods include, but are not limited to, ultrasonic welding and heat welding. More generally, the various exemplary attachment methods (e.g., welding) can be selected and configured to minimize thickness and / or to minimize impairment of the tissue ingrowth function of the cover 200.

[0121] 19 and 20 are detailed views of an example ultrasonic weld 218 in the cover 200 of the exclusion device 100, all in accordance with at least some aspects of the present disclosure. With reference to FIGS. 18-20, the ultrasonic weld 218 can be used at one of the joints 214, 216 to connect the first section 210 and the second section 212. Generally, the ultrasonic weld 218 can be relatively small in size and / or have an irregular perimeter 220, which can promote tissue ingrowth into the cover 200 proximate the weld 218. The ultrasonic weld 218 can be relatively small compared to the relaxed diameter 205 of the cover 200. For example, in one embodiment, the relaxed diameter 205 of the cover 200 can be about 3.0 mm and the size 222 of the ultrasonic weld 218 can be about 2.0 mm. 2 Thus, tissue ingrowth into the covering 200 and / or beams 106, 108 may be minimally affected adjacent the joints 214, 216. The ultrasonic weld 218 may be created adjacent a generally flat portion of one of the beams 106, 108, such as by using the beams 106, 108 in cooperation with an ultrasonic horn to create the weld 218. In various exemplary embodiments, the pressure, power, duration, and horn geometry may be tailored to create the desired ultrasonic weld 218.

[0122] Some exemplary methods of making the exclusion device 100 for the anatomical structure 10 may include one or more of the following operations: The clamping portions 102, 104 of the exclusion device 100, including the beams 106, 108, and the biocompatible fabric cover 200 may be assembled. The cover 200 may be secured over the beams 106, 108 by ultrasonically welding the first portion of the cover 200 to the second portion of the cover 200. The ultrasonic welding operation may include overlapping the first portion of the cover 200 and the second portion of the cover 200. The ultrasonic welding operation may include applying ultrasonic energy to the overlapped first portion of the cover 200 and the second portion of the cover 200 to generate at least one ultrasonic weld 218 configured and arranged to promote tissue ingrowth into the cover 200 proximate the ultrasonic weld 218. The operation of overlapping the first portion of the cover and the second portion of the cover may include generally radially positioning the second portion of the cover within the first portion of the cover. The ultrasonic welding operation can include applying ultrasonic energy at about 40 kHz.

[0123] In other exemplary embodiments, alternative methods of connecting the portions of the cover 200 may be used. For example, some embodiments may utilize hand-sewn stitching to connect the portions of the cover 200. In other exemplary embodiments, heat welding may be utilized.

[0124] FIG. 21 is a detailed perspective view of a portion of the cover 200 including an exemplary heat weld 224, according to at least some aspects of the present disclosure. In this exemplary embodiment, an externally applied heat source (e.g., heating element 226) can be used in cooperation with an inner mandrel 228 (e.g., a generally flat portion of the beams 106, 108 (FIG. 3), such as the outwardly facing surfaces 158, 160 (FIG. 13)) to form the heat weld 224. In some exemplary embodiments, a protective sheet 230 can be positioned between the heating element 226 and the fabric of the cover 200. The protective sheet 230 can include polytetrafluoroethylene. The use of the protective sheet 230 in the heat welding operation can reduce overheating, stringing, discoloration, and / or burns. In this exemplary embodiment, a portion of the second section 212 of the cover 200 is generally radially positioned within a portion of the first section 210 of the cover 200 in an overlapping manner. Heat welds 224 are formed in the overlapped portions of cover 200 .

[0125] Some exemplary methods of making the exclusion device 100 for the anatomical structure 10 may include one or more of the following operations: The clamping portions 102, 104 of the exclusion device 100, including the beams 106, 108, and the biocompatible fabric cover 200 may be assembled. The cover 200 may be secured to the beams 106, 108 by heat welding the first portion of the cover 200 to the second portion of the cover 200. The heat welding operation may include overlapping the first portion of the cover 200 and the second portion of the cover 200. The heat welding operation may include applying heat to the overlapped first portion of the cover 200 and the second portion of the cover 200 to generate at least one heat weld 224 configured and arranged to promote tissue ingrowth into the cover 200 proximate the at least one heat weld 224. The thermal welding operation may include positioning a protective sheet 230 between a heat source 226 and the cover 200 and / or applying heat to a first portion of the cover 200 and a second portion of the cover 200 through the protective sheet 230 using the heat source 226.

[0126] 22 is an exploded view of the end effector 306 of FIGS. 4 and 5 in accordance with at least some aspects of the present disclosure. In the illustrated embodiment, the end effector 306 includes a head 320 that is configured to be distally disposed on the shaft 304. A stationary jaw 312 is fixedly disposed on the head 320, and a movable jaw 314 is movably disposed on the head 320. In this exemplary embodiment, the stationary jaw 312 is integrally formed with the head 320. In alternative embodiments, the stationary jaw 312 can include a separately formed component that is affixed to the head 320.

[0127] In the illustrated embodiment, the movable jaw 314 is integrally formed with the traveler 322. In an alternative exemplary embodiment, the movable jaw 314 can include a separately formed component that is secured to the traveler 322. The traveler 322 is movably disposed on the head 320 to create a generally parallel opening movement of the exclusion clip 100. The end effector 306 can include at least one friction reducing element operably interposed between the traveler 322 and the head 320. For example, in this embodiment, the traveler 322 includes posts 324, 326 with one or more friction reducing elements (e.g., ball bearings 328, 330, etc.) coupled to the posts 324, 326. The ball bearings 328, 330 engage tracks 332 on the head 320 to provide a generally low friction proximal-distal movement of the second jaw 314. Other embodiments may include one or more alternative friction reducing elements (eg, one or more rollers and / or one or more low friction sliders, etc.).

[0128] The present disclosure generally contemplates that it may be desirable to reduce friction and / or other forces opposing the opening and / or closing of the exclusion device 100. For example, a relatively lower force application requirement for the user may be more comfortable and / or more controllable for the user. Additionally, in the illustrated embodiment, the springs 110, 112 of the exclusion device 100 provide the primary force moving the exclusion device 100 from the open configuration to the closed configuration. Thus, smooth operation of the application instrument 300 in the closing direction can be improved when resistance to closure (e.g., friction at the end effector 306) is reduced.

[0129] 4, 5, 16, and 22, in the illustrated embodiment, the opening cable 334 extends through the shaft 304 and operably couples the first actuator 308 and the end effector 306. Specifically, the opening cable 334 is operably coupled to the traveler 322 for pulling the traveler 322 generally proximally to open the expulsion device 100. The opening cable 334 can include, for example, a multi-strand stainless steel cable. The opening cable 334 can be constructed with pre-attached balls and / or loops to facilitate assembly of the application instrument 300, for example, without crimp fasteners. The present disclosure contemplates that variations in the length of the opening cable 334 may affect the aperture of the jaws 312, 314 and / or the expulsion device 100. Thus, manufacturing tolerances can be established to ensure proper operation of the application instrument 300.

[0130] In the illustrated embodiment, a retention cable 336 extends through the shaft 304 and operably couples the second actuator 310 and the end effector 306. Specifically, the retention cable 336 is operably coupled to the sutures 316, 318 to retain the exclusion device 100. The retention cable 336 can include, for example, a multi-strand stainless steel cable. The retention cable 336 can include individual portions that extend to the respective jaws 312, 314. In some exemplary embodiments, movement of the movable jaw 314 between an open configuration and a closed configuration can affect the tension, slack, and / or routing of the retention cable 336. Accordingly, some exemplary embodiments can include one or more cable management elements. For example, the illustrated embodiment includes a cable management pin 338 disposed on the head 320. The indwelling cable 336 is routed around a cable management pin 338 such that when the moveable jaw 314 is in an open configuration, excessive slack is not created in the indwelling cable 336. More generally, a cable management element (such as, for example, the cable management pin 338) can allow the moveable jaw 314 to move without causing relative movement of the indwelling cable 336.

[0131] 22, in the illustrated embodiment, the end effector 306 includes a cover 340 positioned generally over the traveler 322 and track 332 mechanisms. In some exemplary embodiments, the cover 340 can engage the head 320 and provide the end effector 306 with a generally smooth exterior surface. The cover 340 can be secured to the head 320 by one or more threaded fasteners (e.g., screws), one or more welds, and / or one or more rivets 342. In the illustrated embodiment, the rivets 342 are secured using swage and / or orbital riveting techniques, which can provide a generally smooth exterior surface (e.g., lacking sharp edges that may act as catch points for cutting or hooking tissue), which can minimize the risk of loose parts. In the illustrated embodiment, the rivets 342 are built into the head 320. However, in some alternative embodiments, the rivet 342 may be provided as a separate component.

[0132] 23 is a perspective view of an application instrument 600 of an alternative exemplary exclusion device 100, according to at least some aspects of the present disclosure. This exemplary application instrument 600 is generally similar to the application instrument 300 of FIGS. 4 and 5, and a repeated description of similar components and features has been omitted for brevity. In the illustrated embodiment, the application instrument 600 includes a generally proximal handle portion 602, an elongated flexible shaft 604 extending distally from the handle portion 602, and an end effector 606 disposed distally on the shaft 604.

[0133] In this exemplary embodiment, the end effector 606 includes a generally loop-shaped frame 608 that is configured to hold the exclusion device 100. In contrast to the arrangement of the movable jaw 314 of FIGS. 4 and 5, in this exemplary embodiment, the frame 608 is generally rigid and non-movable. In the illustrated embodiment, one clamping portion 102 of the exclusion device 100 is releasably secured to a first segment 612 of the frame (e.g., the distal segment in this embodiment). The other clamping portion 104 is releasably secured to a second segment 614 of the frame 608 (e.g., the proximal segment in this embodiment), which can be generally opposite the first segment 612 and form a generally rectangular opening for the exclusion device 100.

[0134] In the illustrated embodiment, the end effector 606 is arranged to reconfigure the exclusion device 100 between an open configuration and a closed configuration and to release the exclusion device 100 based on the actuation of one or more actuators 616, 618 on the handle portion 602 by a user. For example, actuation of the first actuator 616 can pull one or more connecting elements 620 to reconfigure the exclusion device 100 to the open configuration. In some exemplary embodiments, the end effector 606 can be configured for substantially parallel opening of the first clamping portion 102 and the second clamping portion 104 of the exclusion device 100. In some exemplary embodiments, one or more strongback elements 622 can be operably interposed to the frame 608 and the exclusion device 100. In the illustrated embodiment, the exclusion device 100 is releasably held within the frame 608 by sutures 624, 626, 628, 630. Actuation of the second actuator 618 can release the sutures 624 , 626 , 628 , 630 , which can deploy the exclusion device 100 .

[0135] In some exemplary embodiments, various components of the end effector 306 can be constructed from one or more metals and / or metal alloys (e.g., 17-4 stainless steel, etc.). Some components can be formed using a metal injection molding process. The present disclosure contemplates that metal injection molding is generally a cost-effective option for close tolerance parts with good surface finish that minimizes secondary finishing. Additionally, metal injection molding allows for a variety of metal choices.

[0136] In alternative exemplary embodiments, various components of the end effector 306 can be constructed from one or more plastics. For example, various components of the end effector 306 can be constructed from plastics with high strength and low deflection characteristics. Some exemplary plastic materials can include filler materials (e.g., glass or carbon fiber, etc.) to improve structural capabilities. Thermoplastics (e.g., glass-filled polyamide and / or polyetherimide, etc.) can be utilized. In some situations, thermoplastic parts can be less expensive than similar metal parts. However, plastics may not be as strong as metals (e.g., 17-4 stainless steel), and therefore plastic components may need to be larger than corresponding metal components to provide similar strength.

[0137] Some exemplary methods of making an application instrument 300 for an exclusion device 100 for an anatomical structure 10 can include one or more of the following operations: An end effector 306 can be assembled, where the end effector 306 includes a head 320 configured to be distally disposed on the shaft 304, a stationary jaw 312 fixedly disposed on the head 320 and configured to releasably couple to a first clamping portion 102 of the exclusion device 100 for an anatomical structure 10, the exclusion device 100 being biased in a closing direction, and a movable jaw 314 movably disposed on the head 320 and configured to releasably couple to a second clamping portion 104 of the exclusion device 100 for an anatomical structure 10. The end effector 306 can be distally coupled onto the shaft 304. Handle portion 302 may be proximally coupled onto shaft 304 .

[0138] In some exemplary embodiments, a first actuator 308 on the handle portion 302 can be operatively connected to the end effector 306, where the first actuator 308 is operable to move the movable jaw 314 to reconfigure the exclusion device 100 from a closed configuration to an open configuration. In some exemplary embodiments, a second actuator 310 on the handle portion 302 can be operatively connected to the end effector 306, where the second actuator 310 is operable to deploy the exclusion device 100 from the first jaw 312 and the second jaw 314. Operatively connecting the second actuator 314 on the handle portion 302 to the end effector 306 can include routing the retention cable 336 around at least one cable management pin 338 configured to allow movement of the movable jaw 314 without relative movement of the retention cable 338. Assembling the end effector 306 can include attaching a cover 340 to the head 320. Attaching the cover 340 to the head 320 may include riveting the cover 340 to the head 320 .

[0139] Some exemplary methods of using an application instrument 300 for the exclusion device 100 for an anatomical structure 10 may include one or more of the following operations: A first actuator 308 on a handle portion 302 of the application instrument 300 carrying the exclusion device 100 may be operated to reconfigure the exclusion device 100 to an open configuration. An end effector 306 of the application instrument 300 may be positioned to position the exclusion device 100 over the anatomical structure 10. The first actuator 308 may be operated to reconfigure the exclusion device 100 to a closed configuration over the anatomical structure 10. A second actuator 310 on the handle portion 302 of the application instrument 300 may be operated to deploy the exclusion device 100 from the end effector 306.

[0140] In some exemplary embodiments, the end effector 306 can include a head 320 configured to be disposed distally on the shaft 304, and a stationary jaw 312 fixedly disposed on the head 320 and configured to releasably couple to a first clamping portion 102 of the exclusion device 100. The exclusion device 100 can be biased in a closing direction. The movable jaw 314 can be movably disposed on the head 320 and configured to releasably couple to a second clamping portion 104 of the exclusion device 100. To reconfigure the exclusion device 100 to an open configuration, operating a first actuator 308 on a handle portion 302 of an application instrument 300 carrying the exclusion device 100 can include moving the movable jaw 314 relative to the stationary jaw to reconfigure the exclusion device 100 from the closed configuration to the open configuration while the movable jaw 314 and the stationary jaw 312 are generally oriented parallel. To deploy the removal device 100 from the end effector 306, operating the second actuator 310 on the handle portion 302 of the application instrument 300 can include moving the deployment cable 336 around at least one cable management pin 338 configured to allow movement of the movable jaw 314 without relative movement of the deployment cable 336.

[0141] Unless specifically indicated, it will be understood that the structural, functional, and / or methodological description of any exemplary embodiment herein may also be applied to any other exemplary embodiment. More generally, it is within the scope of the present disclosure to utilize any one or more features of any one or more exemplary embodiments described herein in conjunction with any other one or more features of any other one or more other exemplary embodiments described herein. Thus, any combination of any of the features or embodiments described herein is within the scope of the present disclosure.

[0142] Following the above description and summary of the invention, it should be apparent to one skilled in the art that the methods and apparatus described herein constitute exemplary embodiments according to the present disclosure, but that it should be understood that the scope of the disclosure contained herein is not limited to the precise embodiments described above, and that modifications may be made without departing from the scope of the present disclosure. Likewise, it should be understood that it is not necessary to meet any or all of the identified advantages or objectives disclosed herein in order to fall within the scope of the present disclosure, since there may be inherent and / or unforeseen advantages, even if they may not be expressly discussed herein. [Explanation of symbols]

[0143] 10 Anatomical Structure 100 Exclusion Device 102 First clamping part 104 Second Clamping Part 106 First Beam 108 Second Beam 110 First Spring 112 Second Spring 114 First end 116 First end 118 Second End 120 Second end 122 Clamping Surface 124 Clamping Surface 126 first end portion 128 Second end portion 130 Connection part 132 Spring cavity 134 Spring Contact Surface 136 Longitudinal Slot 138 Punch 140 Outer wall 142 Outward facing recess 144 Inner wall 146 Cavity recess 148 Beam Height 150 Beam Width 152 Gripping Features, Rough Surface Finish 154 Gripping Features, Protrusions 156 Gripping Features, Raised Parts 158 Outer Facing Surface 160 Outward Facing Surface 162 Hole, cavity 164 First end portion 166 Second end portion 168 Connection Part 170 First reverse bend 172 Second reverse bend 174 Torsional moment 176 Long and slender legs 178 Long and slender legs 180 bending moment 182 Bending moment 184 Reference Line 186 angle 188 angle 200 Cover 201 Stretched Periphery 202 Arrow 203 Relaxed periphery 204 Arrow 205 Relaxed diameter 206 Arrow 208 Arrow 210 First Section 212 Second Section 214 First Joint 216 Second Joint 218 Ultrasonic Welding 220 Irregular Periphery 222 Size 224 Heat-welded parts 226 Heating elements, heat sources 228 Inner Mandrel 230 Protective Sheet 300 Applicable Equipment 302 Handle part 304 Shaft 306 End Effector 308 First Actuator 310 Second Actuator 312 Stationary Joe 314 Movable Jaw 316 Sutures 318 Sutures 320 Head 322 Traveler 324, 326 Post 328, 330 Ball bearings 332 Tracks 334 Open Cable 336 Cable in Dwelling 338 Cable Management Pin 340 Cover 342 Rivet 500 Exclusion Device 502 First Beam 504 Second Beam 506 First End 508 First End 510 Second End 512 Second End 514 First Spring 516 Second Spring 518 Third Spring 520 The Fourth Spring 522 Pivot 524 Pivot 526 Pivot 528 Pivot 600 Applicable Equipment 602 Handle part 604 Shaft 606 End Effector 608 Frames 612 First Segment 614 Second Segment 616 First Actuator 618 Second Actuator 620 Connection Elements 622 Strong Back Element 624, 626, 628, 630 Sutures

Claims

1. An exclusion device for an anatomical structure, the exclusion device comprising: a first beam; a second beam; at least one spring operably coupled to the first beam and the second beam for applying a closing force to the first beam and the second beam and for biasing the first beam and the second beam in a closing direction; wherein the at least one spring is operably coupled to the first beam by a first crimp connection, the exclusion device.

2. The exclusion device of claim 1, wherein the first crimp connection includes a plastically deformed portion of the at least one spring engaged with a plastically deformed portion of the first beam.

3. The spring is substantially U-shaped and includes a first end portion and a second end portion substantially opposite from the connection portion, the exclusion device of claim 1, wherein the first beam includes a spring cavity for receiving the first end portion of the spring.

4. The exclusion device of claim 3, wherein the spring cavity is oriented substantially longitudinally within the first beam.

5. The exclusion device of claim 3, wherein the first beam includes a spring stress reduction feature proximate the first cavity.

6. The spring stress reduction feature includes an outwardly facing rounded spring contact surface configured to reduce stress concentration in the spring when the first beam is separated from the second beam, the exclusion device of claim 5.

7. The first beam includes an outer wall portion substantially opposite the clamping surface, the clamping surface generally facing the second beam, the outer wall portion includes an outwardly facing recess proximate the cavity, the exclusion device of claim 3, wherein the outwardly facing recess is configured to receive a tool therein for crimping the first beam and the spring.

8. The exclusion device of claim 7, wherein the thickness of the outer wall portion proximate the outwardly facing recess is less than the thickness of the outer wall portion adjacent the outwardly facing recess.

9. ​ The first beam includes an inner wall portion generally disposed toward the clamping surface, and the clamping surface generally faces the second beam. The inner wall portion includes a cavity recess within the spring cavity. The exclusion device according to claim 3, wherein at least a portion of the first end portion of the spring at least partially occupies the cavity recess.

10. The exclusion device according to claim 9, wherein the cavity recess is in a generally partially spherical form.

11. The exclusion device according to claim 9, wherein the cavity recess includes a through hole.

12. The first beam includes a longitudinal slot between the spring cavity and an end of the first beam. At least a portion of the spring is slidably received within the slot. The exclusion device according to claim 3, wherein the slot is configured to cooperate with the spring to reduce the possibility of the first beam and the second beam moving out of alignment in a generally coplanar alignment.

13. The exclusion device according to claim 1, wherein the at least one spring is operably connected to the second beam by a second crimping connection.

14. The at least one spring includes a first spring and a second spring. The first spring is operably connected to the first beam by the first crimping connection and operably connected to the second beam by the second crimping connection. The exclusion device according to claim 13, wherein the second spring is operably connected to the first beam by a third crimping connection and operably connected to the second beam by a fourth crimping connection.

15. The exclusion device according to claim 1, wherein at least one of the first beam and the second beam includes a clamping surface including at least one gripping feature.

16. A method of fabricating an exclusion device for an anatomical structure, the method comprising: Obtaining a first beam, a second beam, and a first spring, wherein the first beam includes a spring cavity oriented in a substantially longitudinal direction, and the first spring is substantially U-shaped and includes a first end portion and a second end portion generally opposite from the connection portion, the step of Inserting a first end portion of the first spring into the first beam spring cavity; Crimping the first beam and the first spring to fix the first end portion of the first spring within the first beam spring cavity A method comprising.

17. The method according to claim 16, wherein the step of crimping the first beam and the first spring includes the step of plastically deforming a portion of the first beam and a portion of the first spring.

18. The method according to claim 16, wherein the step of obtaining the first beam includes at least one of the steps of 3D printing the first beam, metal injection molding the first beam, and machining the first beam.

19. The step of inserting a first end portion of the first spring into the first beam spring cavity includes positioning the first end portion of the first spring through a generally longitudinal slot between the spring cavity and an end of the first beam, the slot being configured to prevent rotation of the first spring around the first end portion of the first spring. The method according to claim 16.

20. The first beam includes an outer wall portion that at least partially defines the spring cavity, The outer wall portion includes a recess facing outward, The method according to claim 16, wherein the step of crimping the first beam and the first spring includes at least partially receiving a tool in the recess facing outward of the outer wall portion.

21. The method according to claim 20, wherein the outer wall portion is disposed generally opposite to the clamping surface of the first beam.

22. The first beam includes an inner wall portion that at least partially defines the spring cavity, The inner wall portion includes a cavity recess within the spring cavity, The step of crimping the first beam and the first spring includes the step of deforming at least a portion of the first end portion of the first spring into the cavity recess, the method of claim 16. **Claim 23** The method of claim 22, wherein the inner wall portion is generally disposed toward the clamping surface of the first beam. **Claim 24** Obtaining a second spring, the second spring being substantially U-shaped, and Crimping the second beam and the first spring to fix the first spring to the second beam, and Crimping the first beam and the second spring to fix the second spring to the first beam, and Crimping the second beam and the second spring to fix the second spring to the second beam The method of claim 16, further comprising. **Claim 25** A method of occluding an anatomical structure, the method comprising: Delivering an exclusion device to a surgical site in a closed configuration, the exclusion device including a first beam, a second beam, and at least one spring, the at least one spring being operably coupled to the first beam and the second beam to exert a closing force on the first beam and the second beam, the at least one spring being operably coupled to the first beam by a crimp connection, and Reconfiguring the exclusion device from the closed configuration to an open configuration, and Positioning the exclusion device around the anatomical structure, and Reconfiguring the exclusion device to the closed configuration to at least partially occlude the anatomical structure A method comprising. **Claim 26** The step of reconfiguring the exclusion device to the closed configuration includes the step of enabling the closing force exerted by the at least one spring to move the first beam and the second beam to the closed configuration, the method of claim 25. **Claim 27** Removing the exclusion device from the application instrument, The step of pulling out the applicator device, The step of maintaining the exclusion device in the closed configuration using the at least one spring The method according to claim 25, further comprising.

28. The exclusion device includes a left atrial appendage occlusion clip, The step of positioning the exclusion device around the anatomical structure includes the step of positioning the left atrial appendage occlusion clip around the left atrial appendage, The method according to claim 25, wherein the step of at least partially occluding the anatomical structure includes the step of at least partially occluding the left atrial appendage.

29. An exclusion device for an anatomical structure, the exclusion device comprising: A first beam, A second beam, A first spring operably coupled to the first beam and the second beam to apply a closing force to the first beam and the second beam Including, The first spring is generally U-shaped and includes a first end portion and a second end portion generally opposite the connection portion, an exclusion device.

30. The spring includes a first bending portion between the connection portion and the first end portion, The exclusion device according to claim 29, wherein the spring includes a second bending portion between the connection portion and the second end portion.

31. The exclusion device according to claim 30, wherein the first beam, the second beam, and the first spring are configured such that a closed bias preload is provided by the first bending portion and the second bending portion.

32. Between the connection portion and the first bending portion and the second bending portion, the first spring is generally converging, The exclusion device according to claim 30, wherein between the first bending portion and the first end portion and between the second bending portion and the second end portion, the spring is generally diverging.

33. The exclusion device according to claim 29, wherein the spring is generally in the same plane.

34. The exclusion device according to claim 29, wherein the closing force varies with the temperature of the first spring.

35. The exclusion device according to claim 29, wherein the first spring is constructed of at least one of nitinol, stainless steel, or a polymer.

36. The first end portion of the first spring is operably connected to the first beam by a first pivot, The first pivot is rotatable relative to the first beam, The second end portion of the second spring is operably connected to the second beam by a second pivot, The second pivot is rotatable relative to the second beam, the exclusion device according to claim 29.

37. The first spring is rigidly connected to at least one of the first beam and the second beam, the exclusion device according to claim 29.

38. The first spring is configured to exert the closing force by both a bending load and a torsional load, the exclusion device according to claim 29.

39. A method of manufacturing an exclusion device for an anatomical structure, the method comprising: operably connecting a first spring between the first beam and the second beam to exert a closing force on the first beam and the second beam, The first spring is generally U-shaped and includes a respective first end portion and a respective second end portion generally on opposite sides of the connection portion.

40. further comprising operably connecting a second spring between the first beam and the second beam to exert the closing force on the first beam and the second beam, The second spring is generally U-shaped and includes a respective first end portion and a respective second end portion generally on opposite sides of the respective connection portion, the method according to claim 39.

41. The step of operably connecting the first spring between the first beam and the second beam includes pivoting the first end portion of the first spring to the first beam and pivoting the second end portion of the first spring to the second beam. The method according to claim 39, which comprises the step of connecting to the beam.

42. An exclusion device, the exclusion device comprising: a first clamping portion; a second clamping portion facing the first clamping portion; A biocompatible fabric cover that at least partially covers at least one of the first clamping portion and the second clamping portion, the cover being generally tubular and defining a relaxed peripheral portion when the first clamping portion and the second clamping portion are in a closed configuration, cover and including An exclusion device, wherein at least a portion of the cover is configured to extend from the relaxed peripheral portion to an extended peripheral portion of about 2X to about 3X when the first clamping portion and the second clamping portion are reconfigured from the closed configuration to an open configuration.

43. The exclusion device according to claim 42, wherein the exclusion device includes a closed-biased left atrial appendage occlusion clip.

44. The exclusion device according to claim 42, wherein the cover is configured to promote in-growth into tissue.

45. The exclusion device according to claim 42, wherein the cover includes a circular knit warp weave fabric.

46. The exclusion device according to claim 42, wherein the cover includes woven polyethylene terephthalate yarn.

47. The exclusion device according to claim 42, wherein the cover includes at least one weld for securing the cover over at least one of the first clamping portion and the second clamping portion.

48. The exclusion device according to claim 47, wherein the at least one weld includes at least one ultrasonic weld.

49. The exclusion device according to claim 47, wherein the at least one weld includes at least one thermal weld.

50. The exclusion device according to claim 47, wherein the at least one weld is configured and arranged to promote in-growth into the cover and into tissue near the at least one weld.

51. A method of fabricating an exclusion device for an anatomical structure, the method comprising: assembling a clamping portion of an exclusion device and a biocompatible fabric cover including a beam; and securing the cover over the beam by ultrasonically welding a first portion of the cover to a second portion of the cover. method including

52. The ultrasonic welding operation is Overlapping the first portion of the cover and the second portion of the cover; Applying ultrasonic energy to the first portion of the cover and the second portion of the cover that are overlapped to generate at least one ultrasonic weld, wherein the at least one ultrasonic weld is configured and arranged to promote ingrowth of tissue into the cover proximate the at least one ultrasonic weld; The method according to claim 51, comprising: **Claim 53** The method according to claim 52, wherein the step of overlapping the first portion of the cover and the second portion of the cover comprises positioning the second portion of the cover substantially radially within the first portion of the cover. **Claim 54** The method according to claim 52, wherein the step of applying ultrasonic energy to the first portion of the cover and the second portion of the cover that are overlapped comprises applying ultrasonic energy at about 40 kHz. **Claim 55** A method of fabricating an exclusion device for an anatomical structure, the method comprising: Assembling a clamping portion of an exclusion device including a beam and a biocompatible fabric cover; Securing the cover over the beam by thermally welding a first portion of the cover to a second portion of the cover; The method comprising: **Claim 56** The thermally welding operation comprises: Overlapping the first portion of the cover and the second portion of the cover; Applying heat to the first portion of the cover and the second portion of the cover that are overlapped to generate at least one thermal weld, wherein the at least one thermal weld is configured and arranged to promote ingrowth of tissue into the cover proximate the at least one thermal weld; The method according to claim 55, comprising: **Claim 57** The thermally welding operation comprises: Positioning a protective sheet between a heat source and the cover; Applying heat to the first portion of the cover and the second portion of the cover through the protective sheet using the heat source; The method according to claim 55, comprising: **Claim 58** The method according to claim 57, wherein the protective sheet contains polytetrafluoroethylene.

59. An application instrument for an exclusion device for an anatomical structure, the application instrument comprising: an end effector; wherein the end effector comprises: a head configured to be disposed distally on a shaft; a stationary jaw fixedly disposed on the head and configured to releasably couple to a first clamping portion of an exclusion device for an anatomical structure, the exclusion device being biased in a closing direction; a movable jaw movably disposed on the head and configured to releasably couple to a second clamping portion of the exclusion device; wherein the movable jaw is movable relative to the stationary jaw to reconfigure the exclusion device from a closed configuration to an open configuration; wherein the movable jaw is generally parallel to the stationary jaw when the exclusion device is in the open and closed configurations.

60. The exclusion device includes at least one spring disposed to exert a closing force on the first clamping portion and the second clamping portion; wherein the end effector is configured to facilitate reconfiguration of the exclusion device from the open configuration to the closed configuration using the closing force exerted by the at least one spring.

61. The application instrument according to claim 59, further comprising the shaft, wherein the head is disposed distally on the shaft.

62. The application instrument according to claim 61, further comprising a handle portion disposed proximally on the shaft.

63. The application instrument according to claim 62, wherein the handle portion includes a first actuator operable by a user to reconfigure the exclusion device from the closed configuration to the open configuration.

64. The application instrument according to claim 62, wherein the handle portion includes a second actuator operable by a user to retain the exclusion device from the first jaw and the second jaw.

65. ​ The second actuator is operably connected to the end effector by a retention cable, The end effector includes a cable management element arranged to enable movement of the movable jaw without relative movement of the retention cable, the applicator according to claim 64. **Claim 66** The cable management element includes a cable management pin, the applicator according to claim 65. **Claim 67** The end effector includes a cover fixed to the head, the applicator according to claim 59. **Claim 68** The cover is fixed to the head by at least one of a rivet, an orbital rivet, welding, or a threaded fastener, the applicator according to claim 67. **Claim 69** The movable jaw is disposed on a traverser, The traverser is movably disposed on the head, The end effector includes at least one friction reducing element operably interposed between the traverser and the head, the applicator according to claim 59. **Claim 70** The at least one friction reducing element includes at least one ball bearing, at least one roller, or at least one low friction slider, the applicator according to claim 69. **Claim 71** A method of fabricating an applicator for an exclusion device for an anatomical structure, the method comprising: assembling an end effector, The end effector includes a head configured to be distally disposed on a shaft, a stationary jaw, the stationary jaw being fixedly disposed on the head and configured to releasably connect to a first clamping portion of an exclusion device for an anatomical structure, the exclusion device being biased in a closing direction, the stationary jaw; a movable jaw, the movable jaw being movably disposed on the head and configured to releasably connect to a second clamping portion of the exclusion device, the movable jaw remaining generally parallel to the stationary jaw when the exclusion device is in the open and closed configurations, the movable jaw and The method further includes connecting the end effector distally on the shaft, connecting a handle portion proximally on said shaft; A method comprising the steps of: **Claim 72** The method of claim 71, further comprising operably connecting a first actuator on said handle portion to said end effector such that said first actuator moves said movable jaw so as to reconfigure said exclusion device from said closed configuration to said open configuration. **Claim 73** The method of claim 72, further comprising operably connecting a second actuator on said handle portion to said end effector such that said second actuator operates to lodge said exclusion device from said first jaw and said second jaw. **Claim 74** The method of claim 73, wherein the step of operably connecting said second actuator on said handle portion to said end effector includes routing said retention cable around at least one cable management element configured to allow movement of said movable jaw without relative movement of said retention cable. **Claim 75** The step of assembling the end effector includes attaching a cover to said head, The method of claim 71, wherein the step of attaching said cover to said head includes riveting said cover to said head.

Images