Esophageal Size Adjustment Instrument

Abstract

The present invention discloses a device, which includes a handle assembly, a shaft assembly, and an end effector. The handle assembly includes a body and an actuator. The actuator includes a rotating member, which is configured to be driven by fingers of a hand grasping the handle body. The shaft assembly includes an outer sheath fixed to the handle body and an inner shaft coupled to the actuator. The inner shaft is configured to longitudinally slide relative to the outer sheath in response to rotation of the first rotating member relative to the handle body. The end effector is configured to surround a body cavity and includes a flexible member extending distally from the inner shaft. A first coupling element is fixed to the distal tip of the flexible member. A second coupling element is fixed to the outer sheath. The flexible member defines an adjustable loop.

Description

BACKGROUND OF THE INVENTION

[0001] In some instances, it may be desirable to place a medical implant within or around a biological lumen / channel to improve or assist the function of the biological lumen / channel or otherwise affect the biological lumen / channel. Examples of such biological lumens / channels include, but are not limited to, the esophagus, fallopian tube, urethra, or blood vessel. Some biological channels typically function by actively or passively expanding and contracting to regulate the flow of solids, liquids, gases, or combinations thereof. The ability of a biological channel to expand and contract can be impaired by a defect or disease. One merely illustrative example of a condition associated with reduced function of a body channel is gastroesophageal reflux disease (or "GERD") that affects the esophagus.

[0002] A normal, healthy esophagus is a muscular tube that carries food from the mouth through the chest cavity and into the upper stomach. A small valve opening in the esophagus, called the lower esophageal sphincter (or "LES"), regulates the passage of food from the esophagus into the stomach, as well as the passage of acidic fluids and food from the stomach back toward the esophagus. The LES also can regulate the pressure within the stomach. A healthy LES can contain an intragastric gas pressure that is greater than the normal intragastric pressure by about 10 mmHg, thereby impeding the reflux of acidic gas / fluids from the stomach back into the esophagus. When functioning properly, a pressure differential greater than 10 mmHg can regulate when the LES opens to allow gas to exit the stomach toward the esophagus.

[0003] If the LES relaxes, atrophies, or degenerates for any reason, the LES can stop functioning properly. As a result, the LES may not be able to adequately restrain the pressure of the gas within the stomach, such that the acidic contents of the stomach may travel back into the esophagus, resulting in reflux symptoms. The two main components that control the LES are the intrinsic smooth muscle of the distal esophageal wall and the skeletal muscle of the crural diaphragm or esophageal hiatus. The cause of esophageal reflux, which can be associated with GERD, is the relaxation of one or both of the smooth muscle of the distal esophageal wall or the hiatal diaphragm sphincter mechanism. Chronic or excessive acid reflux exposure can cause esophageal damage. Conventionally, the treatment of GERD can involve open surgery or endoscopic surgery. Some surgeries can include fundoplication, which moves the stomach relative to the lower esophagus; or plication of the tissue between the LES and the stomach to make the lower esophagus tighter.

[0004] Examples of devices and methods developed for treating an anatomical lumen by providing sphincter augmentation are described in the following patents: U.S. Patent No. 7,175,589, entitled "Methods and Devices for Luminal and Sphincter Augmentation," published on February 13, 2007, the disclosure of which is incorporated herein by reference; U.S. Patent No. 7,695,427, entitled "Methods and Apparatus for Treating Body Tissue Sphincters and the Like," published on April 13, 2010, the disclosure of which is incorporated herein by reference; U.S. Patent No. 8,070,670, entitled "Methods and Devices for Luminal and Sphincter Augmentation," published on December 6, 2011, the disclosure of which is incorporated herein by reference; and U.S. Patent No. 8,734,475, entitled "Medical Implant with Floating Magnets," published on May 27, 2014, the disclosure of which is incorporated herein by reference.

[0005] Although various categories and types of instruments have been fabricated and used to treat or otherwise engage an anatomical lumen, it is believed that no one prior to the present inventors has made or used the inventions as described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Although this specification concludes with claims particularly pointing out and distinctly claiming such technology, it is believed that the technology will be better understood from the following examples described in conjunction with the accompanying drawings, in which like reference numerals indicate the same elements, and in which:

[0007] Figure 1 A cross-sectional side view of a biological passage taken along the coronal plane of the human body is depicted;

[0008] Figure 2 A cross-sectional isometric view of the human esophagogastric junction taken along the coronal plane of the human body is depicted;

[0009] Figure 3 Depicts a perspective view of an exemplary sizing instrument for a biological passage that can be used to measure Figure 1 ;

[0010] Figure 4 Depicts Figure 3 [[ID=,28]]A side elevation view of the instrument is depicted;

[0011] Figure 5 DepictsFigure 3 Perspective view of the handle assembly of the instrument;

[0012] Figure 6 Depicts Figure 3 Side elevation view of the outer sheath of the shaft assembly of the instrument;

[0013] Figure 7 Depicts the inner shaft of the shaft assembly of the instrument with an associated actuation assembly Figure 3 Side elevation view;

[0014] Figure 8 Depicts Figure 7 Perspective view of the inner shaft;

[0015] Figure 9 Depicts a cross-sectional perspective view of the inner shaft taken along line 9-9 of Figure 8 of Figure 7 the inner shaft;

[0016] Figure 10 Depicts Figure 3 Cross-sectional perspective view of the shaft assembly and end effector of the instrument;

[0017] Figure 11 Depicts Figure 7 Side elevation view of the actuation assembly;

[0018] Figure 12 Depicts Figure 7 Perspective view of the rack of the actuation assembly;

[0019] Figure 13 Depicts a top plan view of a stop assembly engaged with the rack of Figure 12 the rack;

[0020] Figure 14A Depicts a top plan view of the end effector and shaft assembly of Figure 10 placed adjacent to the lower esophageal sphincter, with the end effector in the distal closed position;

[0021] Figure 14B Depicts a top plan view of the end effector and shaft assembly of Figure 10 placed adjacent to the lower esophageal sphincter, with the end effector in the distal open position;

[0022] Figure 14C Depicts Figure 10 a top plan view of the end effector and shaft assembly of

[0023] Figure 14D Depicts Figure 10Top plan view of the end effector and shaft assembly, where the end effector is in a retracted closed position as the end effector surrounds the lower esophageal sphincter.

[0024] The figures are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology can be implemented in many other ways, including those not necessarily shown in the figures. The figures incorporated in and forming a part of this specification illustrate several aspects of the technology and, together with the description, are used to explain the principles of the technology; however, it is to be understood that the technology is not limited to the precise arrangements shown. Detailed Description

[0025] The description of certain examples of the technology herein is not intended to limit the scope of the technology. From the following description, other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art. The following description is given by way of example, which is one of the best ways contemplated for implementing the technology. As will be appreciated, the technology described herein is capable of having other different and obvious aspects, all of which do not depart from the technology. Accordingly, the figures and description are to be regarded as illustrative in nature and not restrictive.

[0026] I. Overview

[0027] Figures 1 to 2 A selected portion of the human anatomy is shown, which includes the esophagus (2), which extends from the oral cavity through the hiatus (8) defined by the diaphragm (10) and into the stomach (4). The esophagus (2) also includes the distal esophagus (3) and the LES (6). The LES (6) is positioned along the distal esophagus (3) adjacent to the junction of the esophagus (2) and the stomach (4). The portion of the LES (6) that extends through the hiatus (8) is supported by the diaphragm (10). When operating normally, the LES (6) is configured to be able to transition between an occluded state and an open state (as Figure 2 shown). As can also be seen from Figure 2 , the LES (6) includes a plurality of circumferential fibers (12). The circumferential fibers (12) are smooth muscle tissues that can help regulate the transition of the LES (6) between the occluded state and the open state. The hiatus (8) of the diaphragm (10) can also help the LES (6) transition between the occluded state and the open state.

[0028] The healthy LES (6) transitions between an occluded state and an open state so as to act as a valve. In other words, the healthy LES (6) can transition from the occluded state to the open state to allow solids, liquids, and / or gases to selectively travel between the esophagus (2) and the stomach (4). For example, the healthy LES (6) can transition from the occluded state to the open state to allow a bolus of food to travel from the esophagus (2) into the stomach (4) during peristalsis; or to vent gastric pressure from the stomach (4) towards the esophagus (2). Additionally, in the occluded state, the healthy LES (6) can prevent digested food and acidic fluid from leaving the stomach (4) and returning to the esophagus (2).

[0029] If the LES (6) ceases to function properly due to premature relaxation and thereby inappropriately transitions the esophagus (2) from the occluded state to the open state, undesirable consequences may occur. Examples of such undesirable consequences can include acidic reflux from the stomach (4) into the esophagus (2), esophageal injury, mucosal inflammation or ulceration, hiatal hernia, other GERD symptoms, or other undesirable consequences as would be apparent to one of ordinary skill in the art in light of the teachings herein. Thus, if an individual has a prematurely relaxed LES (6) that results in an inappropriate transition from the occluded state to the open state, it may be desirable to insert an implant around the malfunctioning LES (6) such that the implant and / or the LES (6) can transition correctly between the occluded state and the open state.

[0030] Such an implant can include a circumferential array of magnetic elements that magnetically attract towards adjacent magnetic elements. Such magnetic elements can expand and contract relative to each other while surrounding the exterior of the malfunctioning LES (6). Thus, the magnetic attraction between adjacent magnetic elements can help the malfunctioning LES (6) to correctly remain in the occluded state; while the ability of the magnetic elements to expand and contract relative to each other can allow the LES (6) to appropriately transition to the open state. While magnetic elements are used to bias the malfunctioning LES (6) towards the occluded state and also allow the malfunctioning LES (6) to appropriately transition to the open state, any other type of biasing element can also be used, as would be apparent to one of ordinary skill in the art in light of the teachings herein. Merely illustrative examples of implants that can be used to surround the exterior of a malfunctioning LES (6) are disclosed in U.S. Patent 7,695,427, the disclosure of which is incorporated herein by reference, and in U.S. Publication 2019 / 0029689, titled "Method for Assisting a Sphincter" and published on January 31, 2019, the disclosure of which is incorporated herein by reference.

[0031] II. Exemplary Sizing Instruments

[0032] As described above, certain implants can be placed around a malfunctioning LES (6) in the body to appropriately assist such a sphincter in correctly transitioning between an occluded state and an open state. Since the diameter of the LES (6) can vary from patient to patient, it may be necessary or otherwise desirable to vary the length of the implant to correspond to the diameter of the LES (6) of the patient at hand, thereby maximizing the likelihood of a successful outcome. The appropriate length of the implant (e.g., the circumference of the implant when attached to the outer diameter of the LES (6)) can be determined by measuring the outer diameter of the LES (6) of the patient at hand. For example, if the implant includes an array of magnetic elements, the number of magnetic elements used for a particular implant can be determined by the outer diameter of the LES (6). The larger the outer diameter, the more magnetic elements will be used; and the smaller the outer diameter, the fewer magnetic elements will be used.

[0033] Since the outer diameter of the LES (6) can vary from patient to patient and this can affect the configuration of the implant to be placed around the LES (6), it may be desirable to use a sizing instrument having an end effector configured to be able to encircle and measure the outer diameter of the LES (6) of an individual patient. The operator can utilize the measurement of the LES (6) to determine what size implant should be used for the individual patient. In identifying the appropriate size of the implant, the operator can select an appropriately sized implant from a plurality of available implants. Alternatively, the operator can modify the length of the implant to achieve the appropriate size.

[0034] An exemplary sizing instrument (100) is described below that can be used to provide proper engagement between the end effector (170) of the sizing instrument (100) and the outer diameter of the LES (6). The sizing instrument (100) is described in the context of measuring the LES (6) of the esophagus (2), and variations of the sizing instrument (100) can be used to measure the outer circumference of any other anatomical passageway, including but not limited to the pylorus, the intestinal region around the ileocecal sphincter, the passageway associated with the sphincter of Oddi, the region of the urethra around the urethral sphincter, the region of the rectum, the region around the upper esophageal sphincter, or any other anatomical passageway.

[0035] As Figures 3 to 4 shown, the sizing instrument (100) of the present example includes a handle assembly (102), a shaft assembly (160) extending distally from the handle assembly (102), and an end effector (170) extending distally from the shaft assembly (160).

[0036] As Figure 5As best seen, the handle assembly (102) includes a grip portion (110), an actuator (130), and a feedback feature (150). The grip portion (110) is formed by a housing (112) and is operable to be grasped by an operator with one hand using a power grip. The actuator (130) includes a drive wheel (132) that is positioned to be manipulated by the thumb of the hand grasping the housing (112) such that the instrument (100) can be fully operated by only one hand of the operator. Additional components of the actuator (130) will be described in more detail below. The feedback feature (150) of the present example includes a series of windows (152) formed through the housing (112) at the distal end of the grip portion (110). The windows (152) are longitudinally spaced from each other. Each window (152) extends over an angular range such that the windows (152) can be visually observed by an operator viewing from either side of the handle assembly (102). As will be described in more detail below, an indicator (146) of the actuator (130) can be observed through the windows (152) to discern the size of the LES (6) being measured by the instrument (100). The windows (152) are formed on each side of the handle assembly (102) such that the operator can easily observe the windows (152) regardless of which side of the handle assembly (102) the operator's eyes are facing. Additionally in the present example, the windows (152) are simply openings without any kind of transparent cover. Thus, there is nothing that might provide glare or otherwise make it difficult to view through the windows (152) during certain procedures.

[0037] Figures 6 to 10 The components of the shaft assembly (160) are shown in more detail. The shaft assembly (160) of the present example includes an outer sheath (162)( Figure 6 ) and an inner shaft (164) that is slidably received within the outer sheath (162)( Figure 7 and Figure 10 ). The outer sheath (162) includes an open distal end (165) and a proximal end (166) that is securely fixed to the handle assembly (102). The inner shaft (164) is securely fixed to a rack (140) of the actuator (130), as will be described in more detail below. In the present example, both the outer sheath (162) and the inner shaft (164) are rigid. By way of example only, the outer sheath (162) and the inner shaft (164) can each be formed of a rigid metallic material (e.g., 304 stainless steel, 316 stainless steel, etc.) and / or a rigid polymeric material. By way of another example only, even in versions where the outer sheath (162) and the inner shaft (164) are formed of metallic materials, the outer sheath (162) and the inner shaft (164) can each be non-ferrous.

[0038] The end effector (170) includes an elastically flexible tube (172) extending distally from an inner shaft (164), a first magnet (174) attached to the distal tip (178) of the elastically flexible tube (172)( Figure 9 and Figure 10 ), and a second magnet (176) located at the distal end (165) of the outer sheath (162)( Figure 10 ). The first magnet (174) and the second magnet (176) attract each other such that the distal tip (178) of the elastically flexible tube (172) is biased toward engagement with the open distal end (165) of the outer sheath (162). In some variations, the distal end (165) of the outer sheath (162) simply includes an iron sleeve or other iron element configured to be magnetically coupled with the first magnet (174); rather than including the second magnet (176). The elastically flexible tube (172) defines an adjustable loop and is elastically biased to assume the loop configuration shown in Figures 3 to 4 . Although the current example includes an elastically flexible tube (172), any other type of elongate elastically flexible member may be used, as will be apparent to those skilled in the art in light of the teachings herein.

[0039] The elastically flexible tube (172) is configured to be able to transition between a closed position (e.g., as shown in Figure 14A , Figure 14C and Figure 14D ) and an open position (e.g., as shown in Figure 14B ) so as to selectively surround the LES (6). In the present example, the first magnet (175) and the second magnet (176) may help ensure that the distal tip (178) of the elastically flexible tube (172) remains in contact with the open distal end (165) of the outer sheath (162), even after the diameter of the loop defined by the elastically flexible tube (172) is reduced, as described below. In other words, the first magnet (174) and the second magnet (176) may help ensure that the elastically flexible tube (172) remains in the closed position when the diameter of the loop defined by the elastically flexible tube (172) is reduced due to manipulation (130) of the actuator by the operator. In other words, the first magnet (174) and the second magnet (176) may help ensure that the elastically flexible tube (172) remains fully surrounding the LES (6) such that the elastically flexible tube (172) can properly engage the outer diameter of the LES (6) during use of the instrument (100).

[0040] The actuator (130) is operable to reduce the diameter of the adjustable loop defined by the elastically flexible tube (172) until the elastically flexible tube (172) sufficiently engages the outer diameter of the LES (6) (as shown in Figure 14D ). Figure 11Shows components of the actuator (130) for effecting adjustment of a loop defined by the resilient tube (172). In this example, the actuator (130) includes a drive wheel (132), a pair of idler gears (136, 138), and a rack (140). The drive wheel (132) includes a set of teeth (134) that are exposed relative to the housing (112) of the handle assembly (102), as Figures 3 to 5 best seen in. Thus, when the operator grasps the grip portion (110), the operator's thumb can engage the teeth (134) and thereby rotate the drive wheel (132) relative to the housing (112) to drive the actuator (130). The idler gear (136) meshes with the teeth (134) of the drive wheel (132) such that rotation of the drive wheel (132) rotates the idler gear (136). The idler gear (136) meshes with the idler gear (138) such that rotation of the idler gear (136) rotates the idler gear (138). The idler gear (138) meshes with the teeth (142) of the rack (140) such that rotation of the idler gear (138) causes longitudinal translation of the rack (140). As Figure 12 shown, the rack (140) includes a distally projecting tip (149). The proximal end of the inner shaft (164) is fixedly secured to the tip (149) such that translation of the rack (140) causes translation of the inner shaft (164).

[0041] Thus, the actuator (130) is operative to convert rotational motion of the drive wheel (132) into longitudinal motion of the inner shaft (164). As the inner shaft (164) translates distally, the diameter of the loop defined by the resilient flexible tube (172) increases. As the inner shaft (164) translates proximally, the diameter of the loop defined by the resilient flexible tube (172) decreases. In other words, as Figures 14C to 14D will be described in more detail below between, the motion of the resilient flexible tube (172) relative to the outer sheath (162) affects the size of the loop defined by the resilient flexible tube (172). Specifically, the loop defined by the tube (172) can become larger in response to distal rotation of the drive wheel (132); while the loop defined by the tube (172) can become smaller in response to proximal rotation of the drive wheel (132). The size of the loop defined by the resilient flexible tube (172) can be determined by the longitudinal position of an indicator (146) on the actuator (130) relative to a window (152) and adjacent markings on the handle assembly (102). In this example, the drive wheel (132) and the gears (136, 138) are sized such that the longitudinal motion of the inner shaft (164) has an approximately 1:1 relationship with the rotation of the drive wheel (132). In some other versions, the drive wheel (132) and the gears (136, 138) can be configured to be able to proportionally adjust (e.g., magnify or reduce) the longitudinal motion of the inner shaft (164) relative to the rotational motion of the drive wheel (132).

[0042] As Figures 11 to 12 best shown, the distal portion of the rack (140) includes a flange (146), where an indicator (148) is fixedly secured to the flange (146). By way of example only, the indicator (148) may take the form of a brightly colored strip or some other easily distinguishable visual feedback feature. The indicator (148) is positioned such that it can be seen through a window (152) of the housing (112) when the actuator (130) is operated to translate the rack (140) through the range of motion of the rack (140). Thus, an operator can visually observe the position of the indicator (148) through the window (152) and adjacent markings to easily determine the longitudinal position of the rack (140) relative to the housing (112). This longitudinal position of the rack (140) relative to the housing (112) will further indicate the diameter of the loop defined by the elastomeric flexible tube (172). This diameter of the loop defined by the elastomeric flexible tube (172) can further indicate the diameter of the LES (6) of the patient at hand, such that the operator can visually observe the position of the indicator (148) through the window (152) and adjacent markings to easily determine the diameter of the LES (6) of the patient at hand. This information can enable the operator to determine the size of the device mounted around the LES (6) and / or make any other determination that may be relevant to the treatment of the patient. For example, if the indicator (148) is aligned within the window (152) marked "15" when the end effector (170) fully engages the outer diameter of the LES (6), an implant of the corresponding size "15" can be used in combination with the measured LES (6).

[0043] While the actuator (130) of the present example is driven by a drive wheel (132), other versions of the actuator (130) can be driven by some other type of user input feature. For example, some variants of the actuator (130) can be driven by a slider that translates longitudinally relative to the housing (112). In some such versions, the slider can be directly fixed to the rack (140). In some other versions, the slider can be coupled to the rack (140) via one or more pinions such that the slider includes a rack that engages the pinion to rotate the pinion, and the resulting rotation of the pinion is converted into longitudinal movement of the rack (140). As another merely illustrative example, the drive wheel (132) can be replaced by a pivot rod or rocker arm. Again, one or more pinions can be used to convert the pivoting motion of the rod or rocker arm into longitudinal movement of the rack (140). Other suitable arrangements will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that any of these variants can still provide single-handed operability of the instrument (100) such that the operator can still manipulate the user input feature for the actuator (130) with the thumb (or other finger) of the same hand that grasps the grasping portion (110).

[0044] In addition, as Figures 11 to 13 shown, one side of the rack (140) includes a longitudinally spaced array of transverse recesses (144). As Figure 13 shown, the recesses (144) are sized and positioned to receive the balls (176) of the stop assembly (170). The stop assembly 170 of this example includes a housing (172) having an elastic member (174). The housing (172) is securely fixed to the housing (112) such that the housing (172) remains stationary within the handle assembly (102) during operation (100) of the instrument. The elastic member (174) is in the form of a helical spring in this example, although the elastic member (174) could alternatively be in the form of a leaf spring or have any other configuration, as would be apparent to those skilled in the art in accordance with the teachings herein. The elastic member (174) is configured to be able to elastically urge the ball (176) towards the rack (140); while the housing (172) is configured to be able to guide and support the ball (176). When the rack (140) is positioned to receive the ball (176) in one of the recesses (144), the ball (176) will seat in the recess (144), as Figure 13 shown.

[0045] When the ball (176) is seated in the recess (144), the cooperation between the ball (176) and the recess (144) will be sufficient to hold the longitudinal position of the rack (140) relative to the housing (112) such that an operator can easily obtain a visual reading of the position of the indicator (148) through the window (152) and adjacent markings. The cooperation between the ball (176) and the recess (144) will prevent unintentional movement of the rack (140) relative to the housing (112), including when the operator disengages his thumb (or other finger) from the drive wheel (132). However, the ball (176) and the recess (144) will still allow the operator to intentionally adjust the longitudinal position of the rack (140) relative to the housing (112) by driving the drive wheel (132), as described above. Thus, the stop assembly (170) substantially holds the longitudinal position of the rack (140) relative to the housing (112) while still allowing intentional adjustment of the longitudinal position of the rack (140) relative to the housing (112). Those skilled in the art will recognize that the stop assembly (170) will allow distal and proximal translation of the rack (140) such that the stop assembly (170) serves as a bi-directional translation resistance feature. Those skilled in the art will also recognize that the stop assembly (170) is merely one exemplary example of the form that a bi-directional translation resistance feature can take. Other suitable components that can be used to form a bi-directional translation resistance feature with a similar function will be apparent to those skilled in the art in reference to the teachings herein.

[0046] In this example, the distance between the recesses (144) corresponds to the distance between the windows (152). The indicator (148) is positioned such that each time the ball (176) seats in a given recess (144), the indicator (148) will be centered within the corresponding window (152). Thus, in addition to resisting translation of the rack (140), when the rack (140) is at certain predetermined longitudinal positions, the stop assembly (170) ensures that the indicator (148) is meaningfully positioned relative to the window (152) when the stop assembly (170) prevents translation of the rack (140). In other words, when the ball (176) and the recess (144) cooperate to prevent translation of the rack (140), the indicator (148) will be positioned relative to the window (152) to provide a very clear reading for the operator, thereby preventing possible confusion as to whether the indicator (148) is more accurately seen through one window (152) or the other window (152). The position of the indicator (148) relative to the window (152) will be discrete and binary. In addition to providing resistance to translation of the rack (140) when the rack (140) is at certain predetermined longitudinal positions and ensuring that the indicator (148) is properly centered within the window (152) when translation of the rack (140) is prevented, the stop assembly (170) can provide tactile and / or audible feedback to the operator, thereby indicating when the rack (140) has reached a position at which the indicator (148) is properly centered within the window (152).

[0047] Figures 14A to 14D An exemplary use of the sizing instrument (100) is shown. First, as Figure 14A shown, the operator can insert the end effector (170) and the distal portion (160) of the shaft assembly into the patient laparoscopically such that the elastomeric flexible tube (172) is adjacent to the LES (6). During initial insertion of the end effector (170) into the patient, the flexible tube (172) can be deformed into a straight configuration to enable the flexible tube (172) to freely pass through the cannula of a trocar or some other passageway into the patient. By way of example only, the flexible tube (172) can be contained within an outer sheath (162), wherein the proximal edge of the distal tip (178) abuts the distal edge of the distal end (165) while the end effector (170) is inserted into the patient. As another merely illustrative example, the operator can grasp the flexible tube (172) and substantially straighten the flexible tube (172) to assist in feeding the flexible tube (172) through the passageway without having to retract the inner shaft (164) to its most proximal position when inserting the end effector (170) into the patient.

[0048] As Figure 14AAs shown, after the end effector (170) has been inserted into the patient's body, the end effector (170) is located near the LES (6). As shown, the elastic flexible tube (172) is in the closed position at this stage. The actuator (130) is in a state where the inner shaft (164) is in the most distal position, such that the elastic flexible tube (172) forms a maximum loop. To the extent that the inner shaft (164) is in the most proximal position when the end effector (170) is inserted into the patient's body, the actuator (130) can be manipulated to advance the inner shaft (164) distally to achieve Figure 14A the configuration shown.

[0049] Next, as Figure 14B shown, the operator can grasp and pull a portion of the elastic flexible tube (172) in order to simultaneously overcome the biasing forces of the tube (172) and the magnets (174, 176), thereby transitioning the elastic flexible tube (172) from the closed position to the open position. In this example, the operator can use a conventional grasping instrument (50) to pull the tube (172) to the open position. Alternatively, any other suitable instrument that can be used will be apparent to those skilled in the art, referring to the teachings herein. When the elastic flexible tube (172) is in the open position, the operator can adjust the position of the end effector (170) such that the LES (6) is close to the distal end (165) of the opening of the outer sheath (162).

[0050] Next, as Figure 14C shown, the operator can release the elastic flexible tube (172) from the grasping instrument (50), such that the tube (172) elastically returns to the closed position. The magnetic attraction between the magnets (174, 176) can further ensure that the distal tip (178) of the tube (172) properly engages the distal end (165) of the outer sheath (162). At this time, the LES (6) is surrounded by the elastic flexible tube (172). However, the tube (172) has not yet been properly engaged with the LES (6) to the point where the feedback feature (150) can be observed to measure the outer diameter of the LES (6).

[0051] When the elastic flexible tube (172) properly surrounds the LES (6) in the closed position, the operator can manipulate the actuator (130) to retract the flexible tube (172) proximally to the point where the flexible tube (172) is in full contact with the LES (6), as Figure 14D shown. At this time, the operator can visually observe the position of the indicator (148) relative to the window (152) and the adjacent markings in order to determine the appropriate size of the implant.

[0052] After obtaining a measurement of the LES (6) by observing the feedback feature (150) as described above, the operator may remove the instrument (100) from the patient by any suitable technique that would be apparent to one of ordinary skill in the art in light of the teachings herein. For example, the operator may use a grasping instrument (50) to grasp the tube (172) and thereby transition the tube (172) to the open position, separate the tube (172) from the LES (6), manipulate the actuator (130) to retract the tube (172) into the outer sheath (162), and then remove the instrument (100) from the patient. Alternatively, the operator may begin retracting the tube (172) into the outer sheath (162) by manipulating the actuator (130) to a point where the proximal edge of the distal tip (178) abuts the distal edge of the distal end (165), and then remove the instrument (100) from the patient.

[0053] It should be understood from the foregoing that by using the instrument (100) as described above and observing the measured dimensions of the LES via the feedback feature (150), the operator may use the measurement of the LES (6) to select the most suitable implant for the patient at hand, modify the implant such that the implant is in the most appropriate configuration for the patient at hand, and / or for any other purpose.

[0054] III. Exemplary Combinations

[0055] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or in any subsequent filings of this patent application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features recited in the following examples. Accordingly, none of the aspects or features recited below should be considered decisive, unless expressly so indicated otherwise, for example, by the inventors or their successors in interest at a later date. If any claims presented in this patent application or in any subsequent filings related to this patent application include additional features beyond those recited below, such additional features should not be assumed to have been added for any reason related to patentability.

[0056] Example 1

[0057] An apparatus, the apparatus comprising: (a) a handle assembly, wherein the handle assembly comprises: (i) a handle body, and (ii) an actuator, the actuator comprising a first rotating member, wherein the first rotating member is rotatable relative to the handle body, and wherein the first rotating member is configured to be driven by fingers of a hand grasping the handle body; (b) a shaft assembly, the shaft assembly extending distally from the handle assembly, wherein the shaft assembly comprises: (i) an outer sheath, the outer sheath being fixed to the handle body, and (ii) an inner shaft, the inner shaft being coupled to the actuator, wherein the inner shaft is configured to longitudinally slide relative to the outer sheath in response to rotation of the first rotating member relative to the handle body; and (c) an end effector, the end effector being configured to surround a body cavity, wherein the end effector comprises: (i) a flexible member, the flexible member comprising a distal tip, wherein the flexible member extends distally from the inner shaft, (ii) a first coupling element, the first coupling element being fixed to the distal tip of the flexible member, and (iii) a second coupling element, the second coupling element being fixed to the outer sheath, wherein the first coupling element and the second coupling element are configured to magnetically attract each other, and wherein the first coupling element and the second coupling element are biased towards each other such that the flexible member defines an adjustable loop, and wherein the actuator is operable to adjust the size of the loop in response to movement of the first rotating member.

[0058] Example 2

[0059] The apparatus according to embodiment 1, wherein the handle assembly defines a plurality of windows.

[0060] Example 3

[0061] The apparatus according to embodiment 2, the apparatus further comprising an indicator, wherein the indicator is configured to move relative to the windows in response to movement of the inner shaft relative to the handle assembly, and wherein the indicator is positioned to be visible through the windows of the handle assembly.

[0062] Example 4

[0063] The apparatus according to any one or more of embodiments 1 to 3, wherein the actuator further comprises a rack coupled to the inner shaft, and wherein the rack is configured to translate in response to rotation of the first rotating member.

[0064] Example 5

[0065] The device according to embodiment 4, wherein the actuator further includes a second rotating member coupled to the rack and the first rotating member, and the second rotating member is configured to transmit the rotation of the first rotating member to the rack.

[0066] Example 6

[0067] The device according to any one or more of embodiments 4 to 5, the device further includes an indicator fixed to the rack, wherein the handle assembly defines a plurality of windows, and the indicator is configured to move relative to the windows in response to the movement of the inner shaft relative to the handle assembly, and the indicator is positioned to be visible through the windows of the handle body.

[0068] Example 7

[0069] The device according to any one or more of embodiments 1 to 6, the device further includes a bi-directional translation resistance feature, wherein the bi-directional translation resistance feature is configured to allow the distal translation and proximal translation of the inner shaft relative to the outer sheath, and the bi-directional translation resistance feature is further configured to limit the translation of the inner shaft relative to the outer sheath at a plurality of predetermined longitudinal positions.

[0070] Example 8

[0071] The device according to embodiment 7, wherein the bi-directional translation resistance feature includes a stop assembly.

[0072] Example 9

[0073] The device according to embodiment 8, wherein the stop assembly includes an elastically biased ball.

[0074] Example 10

[0075] The device according to embodiment 9, wherein the actuator includes a series of recesses configured to receive the ball.

[0076] Example 11

[0077] The device according to embodiment 10, wherein the actuator further includes a rack coupled to the inner shaft, and the rack defines the recesses.

[0078] Example 12

[0079] According to any one or more of Examples 7 to 11, the device further includes an indicator, wherein the handle assembly defines a plurality of windows, wherein the indicator is configured to move relative to the windows in response to movement of the inner shaft relative to the handle assembly, and wherein the indicator is positioned to be visible through the windows of the handle assembly.

[0080] Example 13

[0081] A device as in embodiment 12, wherein the plurality of predetermined longitudinal positions correspond to respective positions at which the indicator is centered within the window.

[0082] Example 14

[0083] Embodiment 1: The apparatus of any one or more of embodiments 1-13, wherein the shaft assembly is rigid.

[0084] Example 15

[0085] Embodiment 14: The apparatus of any one or more of embodiments 1-14, wherein the shaft assembly is non-ferrous.

[0086] Example 16

[0087] Embodiment 1: The apparatus of any one or more of embodiments 1 to 15, wherein the first coupling element comprises a magnet.

[0088] Example 17

[0089] Embodiment 16: The apparatus of embodiment 16, wherein the second coupling element comprises a magnet.

[0090] Example 18

[0091] An apparatus, the apparatus comprising: (a) a handle assembly, wherein the handle assembly comprises: (i) a handle body, and (ii) an actuator, wherein the actuator comprises a user input feature configured to be actuated by a finger of a hand grasping the handle body; (b) a shaft assembly extending distally from the handle assembly, wherein the shaft assembly comprises: (i) an outer sheath fixed to the handle body, and (ii) an inner shaft coupled to the actuator, wherein the inner shaft is configured to longitudinally slide relative to the outer sheath in response to actuation of the actuator; (c) a bi-directional translation resistance feature configured to permit distal and proximal translation of the inner shaft relative to the outer sheath, wherein the bi-directional translation resistance feature is further configured to limit translation of the inner shaft relative to the outer sheath at a plurality of predetermined longitudinal positions; and (d) an end effector configured to encircle a body cavity, wherein the end effector comprises: (i) a flexible member including a distal tip, wherein the flexible member extends distally from the inner shaft, (ii) a first coupling element fixed to the distal tip of the flexible member, and (iii) a second coupling element fixed to the outer sheath, wherein the first coupling element and the second coupling element are configured to magnetically attract one another, wherein the first coupling element and the second coupling element are biased toward one another such that the flexible member defines an adjustable loop, wherein the actuator is operable to adjust the size of the loop in response to movement of the first rotational member.

[0092] Example 19

[0093] The apparatus according to embodiment 18, wherein the user input feature comprises a rotatable drive wheel.

[0094] Example 20

[0095] An apparatus, the apparatus comprising: (a) a handle assembly, wherein the handle assembly includes: (i) a handle body, (ii) a first set of windows positioned along a first side of the body, the windows of the first set being longitudinally spaced from each other, (iii) a second set of windows positioned along a second side of the body, the windows of the second set being longitudinally spaced from each other, and (iv) an actuator, wherein the actuator includes a user input feature configured to be actuated by a finger of a hand grasping the handle body; (b) a shaft assembly extending distally from the handle assembly, wherein the shaft assembly includes: (i) an outer sheath fixed to the handle body, and (ii) an inner shaft coupled to the actuator, wherein the inner shaft is configured to longitudinally slide relative to the outer sheath in response to actuation of the actuator; (c) an indicator configured to move relative to the first set of windows and relative to the second set of windows in response to movement of the inner shaft relative to the handle assembly, wherein the indicator is positioned to be visible through the first set of windows and the second set of windows of the handle assembly; and (d) an end effector configured to encircle a body cavity, wherein the end effector includes: (i) a flexible member including a distal tip, wherein the flexible member extends distally from the inner shaft, (ii) a first coupling element fixed to the distal tip of the flexible member, and (iii) a second coupling element fixed to the outer sheath, wherein the first coupling element and the second coupling element are configured to magnetically attract each other, wherein the first coupling element and the second coupling element are biased toward each other such that the flexible member defines an adjustable loop, wherein the actuator is operable to adjust the size of the loop in response to movement of the first rotating member.

[0096] IV. Miscellaneous

[0097] It should also be understood that any one or more of the teachings, expressions, embodiments, examples, etc., described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Accordingly, the foregoing teachings, expressions, embodiments, examples, etc., should not be viewed in isolation. Various suitable ways in which the teachings herein may be combined will be apparent to one of ordinary skill in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0098] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, allegedly incorporated herein that conflicts with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.

[0099] Various embodiments of the present invention have been shown and described, and further improvements to the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and should be understood not to be limited to the details of construction and operation shown and described in the specification and drawings.

Claims

1. An apparatus, the apparatus comprising: (a) a handle assembly, wherein the handle assembly comprises: (i) a handle body, and (ii) an actuator, the actuator comprising a first rotating member, wherein the first rotating member is rotatable relative to the handle body, wherein the first rotating member is configured to be driven by fingers of a hand grasping the handle body, wherein the actuator further comprises a rack coupled to an inner shaft, wherein the rack is configured to translate in response to rotation of the first rotating member; (b) a shaft assembly extending distally from the handle assembly, wherein the shaft assembly comprises: (i) an outer sheath fixed to the handle body, and (ii) an inner shaft coupled to the actuator, wherein the inner shaft is configured to longitudinally slide relative to the outer sheath in response to rotation of the first rotating member relative to the handle body; and (c) an end effector configured to surround a body cavity, wherein the end effector comprises: (i) a flexible member comprising a distal tip, wherein the flexible member extends distally from the inner shaft, (ii) a first coupling element fixed to the distal tip of the flexible member, and (iii) a second coupling element fixed to the outer sheath, wherein the first coupling element and the second coupling element are configured to magnetically attract each other, wherein the first coupling element and the second coupling element are biased toward each other such that the flexible member defines an adjustable loop, wherein the actuator is operable to adjust the size of the loop in response to movement of the first rotating member.

2. The device according to claim 1, wherein, The handle assembly defines a plurality of windows.

3. The apparatus of claim 2, the apparatus further comprising an indicator, wherein the indicator is configured to move relative to the windows in response to movement of the inner shaft relative to the handle assembly, wherein the indicator is positioned to be visible through the windows of the handle assembly.

4. The apparatus according to claim 1, wherein, The actuator further comprises a second rotating member coupled to the rack and the first rotating member, wherein the second rotating member is configured to transmit rotation of the first rotating member to the rack.

5. The apparatus of claim 1, the apparatus further comprising an indicator fixed to the rack, wherein the handle assembly defines a plurality of windows, wherein the indicator is configured to move relative to the windows in response to movement of the inner shaft relative to the handle assembly, wherein the indicator is positioned to be visible through the windows of the handle body.

6. The apparatus of claim 1, the apparatus further comprising a bi-directional translation resistance feature, wherein the bi-directional translation resistance feature is configured to permit distal and proximal translation of the inner shaft relative to the outer sheath, wherein the bi-directional translation resistance feature is further configured to limit translation of the inner shaft relative to the outer sheath at a plurality of predetermined longitudinal positions.

7. The device according to claim 6, wherein The bidirectional translation resistance feature portion includes a stop assembly.

8. The apparatus according to claim 7, wherein The stop assembly includes an elastically biased ball.

9. The device according to claim 8, wherein, The actuator includes a series of recesses configured to receive the ball.

10. The device according to claim 9, wherein, The actuator further includes a rack coupled to the inner shaft, wherein the rack defines the recesses.

11. The device according to claim 6, the device further including an indicator, wherein the handle assembly defines a plurality of windows, wherein the indicator is configured to move relative to the windows in response to movement of the inner shaft relative to the handle assembly, and wherein the indicator is positioned to be visible through the windows of the handle assembly.

12. The device according to claim 11, wherein, The plurality of predetermined longitudinal positions correspond to respective positions at which the indicator is centered within the window.

13. The device according to claim 1, wherein, The shaft assembly is rigid.

14. The device according to claim 1, wherein, The shaft assembly is non-ferrous.

15. The device according to claim 1, wherein, The first coupling element includes a magnet.

16. The device according to claim 15, wherein, The second coupling element includes a magnet.

17. A device, the device comprising: (a) a handle assembly, wherein the handle assembly includes: (i) a handle body, and (ii) an actuator, wherein the actuator includes a user input feature configured to be driven by fingers of a hand grasping the handle body, and wherein the actuator further includes a rack coupled to an inner shaft, wherein the rack is configured to translate in response to rotation of the user input feature; (b) a shaft assembly extending distally from the handle assembly, wherein the shaft assembly includes: (i) an outer sheath fixed to the handle body, and (ii) an inner shaft coupled to the actuator, wherein the inner shaft is configured to longitudinally slide relative to the outer sheath in response to actuation of the actuator; (c) a bidirectional translation resistance feature portion configured to permit distal and proximal translation of the inner shaft relative to the outer sheath, and further configured to restrict translation of the inner shaft relative to the outer sheath at a plurality of predetermined longitudinal positions; and (d) an end effector configured to surround a body cavity, wherein the end effector includes: (i) a flexible member including a distal tip, wherein the flexible member extends distally from the inner shaft, (ii) a first coupling element fixed to the distal tip of the flexible member, and (iii) a second coupling element fixed to the outer sheath, wherein the first coupling element and the second coupling element are configured to magnetically attract each other, and wherein the first coupling element and the second coupling element are biased towards each other such that the flexible member defines an adjustable loop, and wherein the actuator is operable to adjust the size of the loop in response to movement of the user input feature.

18. The apparatus according to claim 17, wherein, The user input feature includes a rotary drive wheel.

19. A device, the device comprising: (a) a handle assembly, wherein the handle assembly includes: (i) a handle body, (ii) A first set of windows, the first set of windows being positioned along a first side of the body, the windows of the first set being longitudinally spaced apart from each other, (iii) A second set of windows, the second set of windows being positioned along a second side of the body, the windows of the second set being longitudinally spaced apart from each other, and (iv) An actuator, wherein the actuator includes a user input feature configured to be actuated by a finger of a hand grasping the handle body; (b) A shaft assembly extending distally from the handle assembly, wherein the shaft assembly includes: (i) An outer sheath fixed to the handle body, and (ii) An inner shaft coupled to the actuator, wherein the inner shaft is configured to longitudinally slide relative to the outer sheath in response to actuation of the actuator; (c) An indicator, wherein the indicator is configured to move relative to the first set of windows and relative to the second set of windows in response to movement of the inner shaft relative to the handle assembly, wherein the indicator is positioned to be visible through the first set of windows and the second set of windows of the handle assembly, wherein the actuator further includes a rack coupled to the inner shaft, wherein the rack is configured to translate in response to rotation of the user input feature; and (d) An end effector configured to surround a body cavity, wherein the end effector includes: (i) A flexible member including a distal tip, wherein the flexible member extends distally from the inner shaft, (ii) A first coupling element fixed to the distal tip of the flexible member, and (iii) A second coupling element fixed to the outer sheath, wherein the first coupling element and the second coupling element are configured to magnetically attract each other, wherein the first coupling element and the second coupling element are biased towards each other such that the flexible member defines an adjustable loop, wherein the actuator is operable to adjust the size of the loop in response to movement of the user input feature.

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