Patent ID: 12213681

DETAILED DESCRIPTION

Example embodiments according to the present disclosure are described and illustrated below to encompass devices, methods, and techniques relating to medical procedures. Of course, it will be apparent to those of ordinary skill in the art that the embodiments discussed below are examples and may be reconfigured without departing from the scope and spirit of the present disclosure. It is also to be understood that variations of the example embodiments contemplated by one of ordinary skill in the art shall concurrently comprise part of the instant disclosure. However, for clarity and precision, the example embodiments as discussed below may include optional steps, methods, and features that one of ordinary skill should recognize as not being a requisite to fall within the scope of the present disclosure.

The present disclosure includes, inter alia, surgical instruments and devices and related methods, and, more specifically, mechanisms for rotating and/or articulating end effectors of surgical devices, and related methods. Some example embodiments according to at least some aspects of the present disclosure may be particularly useful in connection with clip appliers, such as clip appliers that may be used to apply occlusion clips to left atrial appendages.

FIG.1is an elevation view of an example surgical device, such as a clip applier100,FIG.2is a detailed elevation view of an end effector positioning mechanism120in an articulated configuration,FIG.3is a detailed elevation view of the end effector positioning mechanism120in a generally straight configuration,FIG.4is an isometric view of the clip applier100, andFIG.5is a cross-section view of the clip applier100, all according to at least some aspects of the present disclosure. Referring toFIGS.1-5, the clip applier100may include an elongated shaft102, a handle (not shown) disposed at a proximal end of the shaft102, and/or an end effector104disposed at a distal end of the shaft102. The shaft102may malleable or flexible, or it may be substantially rigid. In other embodiments, the shaft102may be steerable. The end effector104may include, for example, a pair of articulating jaws106,108which may be configured to releasably hold an occlusion clip110. The occlusion clip110may be configured for placement on a target tissue, such as a left atrial appendage112of a heart. For example, the occlusion clip110may include the PRO V clip available from AtriCure, Inc., of Mason, Ohio. U.S. Pat. Nos. 8,636,754; 9,017,349; 9,861,371; 9,883,867; 9,901,351; 9,901,352; and 10,201,352; and U.S. Patent Application Publication No. 2019/0142428, relate to LAA occlusion devices and methods and are incorporated by reference herein.

The shaft102may include a shaft longitudinal axis114. The end effector104may include an end effector longitudinal axis116. In some example embodiments, the end effector104may be articulatable (e.g., pivotable) with respect to the shaft longitudinal axis114so that the end effector longitudinal axis116is disposed at an angle118with respect to the shaft longitudinal axis114. In various example embodiments, the end effector104may be articulatable with respect to the shaft longitudinal axis114in one or more planes. In some example embodiments, the end effector104may be rotatable about the end effector longitudinal axis116.

Generally, the articulation and/or rotation of the end effector104may be facilitated by an end effector positioning mechanism120, which may interpose the shaft102and the end effector104. In some example embodiments, the end effector positioning mechanism120may include an articulation mechanism122and/or a rotation mechanism124.

FIG.6is an exploded view of a portion of the articulation mechanism122,FIG.7is an isometric view of a segment130, andFIG.8is a plan view of the segment130, all according to at least some aspects of the present disclosure.

Referring toFIGS.1-8, an example articulation mechanism122may include a one or more segments126,128,130,132,134,136,138,140, which may be disposed generally in a longitudinal row (e.g., proximally/distally with respect to each other). In this example embodiment, each of the segments126,128,130,132,134,136,138,140is substantially similar to the other segments126,128,130,132,134,136,138,140; however, in other example embodiments, one or more of the segments126,128,130,132,134,136,138,140may differ from one or more of the other segments126,128,130,132,134,136,138,140. The proximal-most segment126may be disposed on the distal end of the shaft102. Generally, increasing the number of segments126,128,130,132,134,136,138,140in the row will increase the maximum angle118to which the end effector104may be articulated. Generally, reducing the number of segments126,128,130,132,134,136,138,140in the row will decrease the maximum angle118to which the end effector104may be articulated.

Referring toFIGS.6-8, an example segment130is described in detail. It will be appreciated that, in this example embodiment, the other segments126,128,132,134,136,138,140may be substantially similar in structure and/or function. The segment130may be generally in the form of a flattened disk having a diameter141and a central axis142. The proximal surface144of the segment130may be substantially planar and/or may be oriented substantially orthogonally with respect to the central axis142. The distal surface146of the segment130may include two transversely oriented, generally planar surfaces148,150that meet along a substantially diametric peak152. For example, the surfaces148,150of the distal surface146may be disposed at about 22.5 degrees with respect to the proximal surface144. In other example embodiments, the surfaces148,150of the distal surface146may be disposed at a greater angle with respect to the proximal surface144, facilitating greater articulation, or the surfaces148,150of the distal surface146may be disposed at a lesser angle with respect to the proximal surface144, facilitating less articulation. The surfaces148,150of the distal surface146may be arranged so that the thickest portion of the segment130(e.g., in the longitudinal/proximal-distal direction) lies along the peak152, where the segment130has a first thickness154. The thinnest portions of the segment130may be where the surfaces148,150intersect the circular perimeter of the segment130at positions generally orthogonally distant from the peak152, where the segment130has a second thickness156. The first thickness154may be greater than the second thickness156.

The segment may include a plurality of longitudinal through bores, such as holes158,160,162,164. The holes158,160,162,164may be disposed generally circumferentially evenly spaced apart and/or near the outer periphery of the segment130. For example, two holes158,162may extend through the peak152and/or two holes160,164may extend through the segment130at positions orthogonally distant from the peak152. Generally, the segment130may be substantially symmetrical about the peak152.

Referring toFIGS.1-8, the articulation mechanism122may be assembled so that each segment126,128,130,132,134,136,138,140is oriented at about 90 degrees of rotation about the central axis142with respect to the adjacent segment(s)126,128,130,132,134,136,138,140. Referring toFIG.6, a tension line166may extend longitudinally through the holes158,160,162,164of the segments126,128,130,132,134,136,138,140. Because of the alternating orientations of the segments126,128,130,132,134,136,138,140, the tension line166may extend through hole164of segment126, hole162of segment128, hole164of segment130, hole162of segment132, etc. Accordingly, the tension line166may extend alternately through the thick portions and the thin portions of segments126,128,130,132,134,136,138,140. InFIG.3, the tension line166is visible in gaps167between the proximal surfaces144and the sloped distal surfaces146of adjacent segments126,128,130,132,134,136,138,140.

The tension line166may be secured distally, such as to the end effector104and/or the rotation mechanism124. Accordingly, upon tensioning the tension line166, such as from the handle at the proximal end of the shaft102, the gaps167between the adjacent segments126,128,130,132,134,136,138,140may become smaller. This may tilt the segments126,128,130,132,134,136,138,140generally toward the tension line166, which may articulate the end effector104generally toward the tension line166as shown inFIG.2.

Referring toFIG.6, in this example embodiment, the articulation mechanism122includes four tension lines166,168,170,172, one corresponding to each of the holes158,160,162,164through the segments126,128,130,132,134,136,138,140. Accordingly, the articulation mechanism122may be articulated (e.g., tilted) in any of the four directions corresponding to the four tension lines166,168,170,172by tensioning the respective tension line166,168,170,172. Tensioning two adjacent tension lines166,168,170,172may allow the articulation mechanism122to articulate generally in a direction between the two tensioned tension lines166,168,170,172.

Referring toFIGS.6-8, in some example embodiments, the segments126,128,130,132,134,136,138,140may include a longitudinal channel176. For clarity, the channel176is shown only on segment128inFIG.6; however, any segment126,128,130,132,134,136,138,140may include a similar channel176. In some example embodiments, one or more wires or other actuator members (e.g., a torque tube) may extend from within the shaft102, through the channels176, and to the rotation mechanism124and/or the end effector104, such as to facilitate articulation of the jaws106,108, deployment of the occlusion clip110, etc. For example, a jaw opening/closing cable may extend longitudinally from the handle to the end effector104via the internal lumen of the shaft102and/or the channels176of the segments126,128,130,132,134,136,138,140.

Although the example embodiment illustrated inFIGS.1-8includes segments126,128,130,132,134,136,138,140having substantially flat proximal surfaces144and sloped distal surfaces146, other embodiments within the scope of this disclosure may include alternative configurations. For example, one or more of the segments may include a substantially flat distal surface and a sloped proximal surface. In other embodiments, both the proximal and distal surfaces may be sloped. In other embodiments, a sloped surface may include a single slope extending diametrically across the segment, rather than two sloped surfaces meeting at a central peak.

Referring toFIGS.1-5, the rotation mechanism124may interpose the articulation mechanism122and the end effector104. The rotation mechanism124may include a bearing assembly174that facilitates rotation of the end effector104about its longitudinal axis116. For example, the bearing assembly174may comprise a ball bearing having an inner race coupled to the end effector104and/or an outer race coupled to the distal portion of the articulation mechanism122. Rotation of the end effector104about its longitudinal axis116may be controlled from the handle. For example, a torque tube178may extend from the handle to the rotation mechanism124, such as within and/or coaxial with the shaft102. The torque tube178may be rotatable with respect to the shaft102. The torque tube178may comprise a laser-cut hypotube and/or may be coupled for rotation with the end effector104. The torque tube178may be generally flexible in bending to facilitate shaft flexibility while having sufficient rotational stiffness to allow control of the rotation of the end effector104relative to the shaft102. The rotation mechanism124may include a sleeve180around the bearing assembly174and a proximal plate182. The plate182may include holes corresponding to the tension lines166,168,170,172, which may receive and secure the tension lines166,168,170,172distally. For example, each hole may have a distal counter-bore that seats a cable ball affixed to the distal end of the respective tension line.

Referring toFIGS.1-3, the end effector positioning mechanism120including the articulation mechanism122and/or the rotation mechanism124may allow the end effector104to articulate in substantially any plane parallel with the shaft longitudinal axis114(e.g., 360 degree articulation) and/or may allow the end effector to rotate to any angle about the end effector longitudinal axis116. Accordingly, the clip applier100including the end effector positioning mechanism120may facilitate positioning of the occlusion clip106, such as on a left atrial appendage.

FIG.9is an elevation view of an example surgical device300, according to at least some aspects of the present disclosure. The surgical device may include an elongated shaft302, a handle304disposed at a proximal end of the shaft302, and/or an end effector306disposed at a distal end of the shaft302. The shaft302may malleable or flexible, or it may be substantially rigid. In other embodiments, the shaft302may be steerable. The end effector306may include, for example, a pair of articulating jaws308,310which may be configured to releasably hold an occlusion clip. The occlusion clip may be configured for placement on a target tissue, such as a left atrial appendage of a heart. For example, the occlusion clip may include the PRO V clip available from AtriCure, Inc., of Mason, Ohio.

The shaft302may include a shaft longitudinal axis312. The end effector306may include an end effector longitudinal axis314. In some example embodiments, the end effector306may be articulatable (e.g., pivotable) with respect to the shaft longitudinal axis312so that the end effector longitudinal axis314may be pivoted at an angle316with respect to the shaft longitudinal axis312. In various example embodiments, the end effector306may be articulatable with respect to the shaft longitudinal axis312in one or more planes, the end effector306may be rotatable about the end effector longitudinal axis314, and/or the end effector306may be rotatable about the shaft longitudinal axis312.

Generally, the articulation and/or rotation of the end effector306may be facilitated by an end effector positioning mechanism318, which may be generally similar to end effector positioning mechanism120and/or which may include an articulation mechanism320and/or a rotation mechanism322. The articulation mechanism320may include a pivotable connection324by which the end effector306is mounted to the shaft302. The end effector306may be articulated about the pivotable connection324by moving an actuator326, which may be disposed on the handle304. For example, the actuator326may be pivoted to articulate the end effector306. The rotation mechanism322may allow the end effector306to be rotated about the shaft longitudinal axis312by rotating the hub328on the handle304, such as by rotating the actuator326.

In some example embodiments, the hub328may be operatively connected to the end effector positioning mechanism318to rotate the end effector306about the shaft longitudinal axis312. For example, the shaft302may be slotted to allow for a pin to connect the hub328to a torque tube, which may be generally similar to the torque tube178described above. When the hub328is rotated, the pin couples that rotational motion to the torque tube. The torque tube is coupled to the inner race of the bearing assembly (e.g., similar to bearing assembly174) at the distal end, and that inner race is also connected to the distal end effector306. The outer race of the bearing assembly is connected to the shaft302, which may not rotate relative to the handle304.

Following from the above description and invention summaries, it should be apparent to those of ordinary skill in the art that, while the methods and apparatuses herein described constitute example embodiments according to the present disclosure, it is to be understood that the scope of the disclosure contained herein is not limited to the above precise embodiments and that changes may be made without departing from the scope as defined by the following claims. Likewise, it is to be understood that it is not necessary to meet any or all of the identified advantages or objects disclosed herein in order to fall within the scope of the claims, since inherent and/or unforeseen advantages may exist even though they may not have been explicitly discussed herein.