Periscope device for forward observation using a duodenoscope
The periscope device addresses the lack of direct visualization in duodenal endoscopes by providing a forward field of view, thereby reducing the risk of damage and improving safety during ERCP procedures, especially in pediatric patients.
Patent Information
- Application Number
- JP2024564461
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-04-29
- Filing Date
- 2023-04-28
- Publication Date
- 2025-05-02
AI Technical Summary
Duodenal endoscopes lack direct visualization of forward movement during insertion and advancement, increasing the risk of scope-related or perforated damage to the patient, especially in pediatric populations with smaller and more vulnerable organ systems.
A periscope device is introduced that can be used with duodenal endoscopes, featuring an elongated body with a folding portion and a deployment mechanism. The device is inserted into the working lumen of the duodenoscope and deployed to provide a forward field of view by reflecting the lateral field of view from the optical lens.
The periscope device reduces the risk of mucosal damage and perforation by providing anterior visualization during ERCP procedures, thereby enhancing the safety and efficacy of duodenal endoscope operations, especially in pediatric patients.
Smart Images

Figure 2025514429000001_ABST
Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 336,740, filed April 29, 2022, the contents of which are incorporated by reference in their entirety herein.
[0002] The present disclosure relates to duodenoscopes and endoscopes for use in medical procedures. In particular, the present disclosure relates to a periscope device that allows for temporary forward viewing while using a duodenoscope. [Background technology]
[0003] A duodenoscope is a specialized endoscope used by gastroenterologists to perform endoscopic retrograde cholangiopancreatography (ERCP) procedures. An endoscope is a device used in multiple fields for minimally invasive procedures, with a forward-looking camera at the end of a flexible tube. The endoscope includes a forward-looking camera that provides the practitioner with direct visualization of the forward motion as the endoscope advances into the patient. Additionally, instruments (e.g., tools) introduced into the instrument channel of the endoscope exit the distal end of the endoscope parallel to the line of sight of the forward-looking camera. On the other hand, a duodenoscope includes a side-looking camera that is ideal for ERCP procedures utilized in the treatment of biliary and pancreatic diseases. Additionally, instruments introduced into the instrument channel exit the distal end of the duodenoscope perpendicular to the line of sight of the camera. In some cases, the elevator can be adjusted to provide variability in the instrument exit angle. However, when using a duodenoscope, the practitioner is not given direct visualization of the forward motion as the duodenoscope is inserted or otherwise advanced. Instead, the practitioner must rely on the lateral view from the side-looking camera and the feel of the resistance as the duodenoscope crosses the lumen or abuts the lumen wall. Although the practitioner is highly skilled, the lack of forward visualization while manipulating the scope during ERCP increases the chance of scope-related or perforating injury to the patient. On the other hand, when using an endoscope, the practitioner is given direct visualization of the forward movement as the endoscope is inserted or otherwise advanced. However, the practitioner is given no lateral visualization.
[0004] With the increasing incidence of obesity in children, there is a higher incidence of bile duct disease (e.g., gallstones) in the adolescent subpopulation. Similarly, the utilization of ERCP is increasing in the pediatric population. Because children generally have smaller and more fragile organ systems, it is best to mitigate procedural risks as much as possible. Temporarily diverting a side-viewing duodenoscope to provide a forward-looking view would be useful in the pediatric population, where the gastrointestinal tract may be at higher risk for endoscope- and procedure-related trauma. Summary of the Invention
[0005] Some aspects of the present disclosure provide a periscope device and methods of use thereof. One aspect of the present disclosure encompasses a periscope device for use with an elongated medical instrument, such as an endoscope or duodenoscope. The periscope device includes an elongated body and a deployment mechanism. The elongated body has a proximal end, a distal end opposite the proximal end, and an outer surface, and the elongated body defines a longitudinal axis. The elongated body can be configured to be inserted into and advanced through a working lumen of a duodenoscope. The elongated body includes a folding portion having a speculum coupled thereto. The folding portion can rotate about a folding axis of the elongated body. In some aspects, deploying a deployment mechanism, which can be coupled to a proximal end of the elongated body, causes the folding portion of the elongated body to rotate about the folding axis.
[0006] In some aspects, the elongated portion of the elongated body is defined by a folding axis (e.g., the elongated portion extends from a proximal end of the elongated body to the folding axis and the folding portion extends from a distal end of the elongated body to the folding axis). In some aspects, the elongated portion is comprised of a flexible material and the folding portion is comprised of a rigid or semi-rigid material.
[0007] In some embodiments, the pin defines a folding axis and the folding portion rotates about the pin. In some embodiments, the folding portion includes one or more knuckles and the elongated portion includes one or more knuckles corresponding to the one or more knuckles of the folding portion. The one or more knuckles of the folding portion and the one or more knuckles of the elongated portion together include a pin therein such that the folding portion can rotate about the pin relative to the elongated portion. In some embodiments, the elongated body has a substantially circular cross-section. In some embodiments, the folding portion and the elongated portion each include one or more recesses to accommodate rotation of the folding portion about the folding axis.
[0008] In some embodiments, the deployment mechanism can rotate the folding portion about the folding axis through a rotation angle relative to the elongated portion. In some examples, the rotation angle is between 0 degrees and 180 degrees. In some embodiments, the folding axis defines a folding axis angle with respect to the longitudinal axis of the elongated body. In some examples, the folding axis angle is about 45 degrees.
[0009] In some embodiments, the folding portion is a first folding portion and the folding axis is a first folding axis. In some examples, the periscope device may include a second folding portion configured to rotate about the second folding axis when the deployment mechanism is deployed. In some examples, the periscope device may include a third folding portion configured to rotate about a third folding axis when the deployment mechanism is deployed. In some examples, the first folding axis, the second folding axis, and the third folding axis are each approximately perpendicular to a longitudinal axis of the elongated body. In some examples, the longitudinal axis of the first folding portion is approximately coplanar with the longitudinal axis of the second folding portion and the longitudinal axis of the second folding portion is approximately coplanar with the longitudinal axis of the third folding portion. In some examples, the longitudinal axis of the first folding portion is perpendicular to the longitudinal axis of the optical lens of the duodenoscope.
[0010] In some embodiments, the elongate body defines a height after the deployment mechanism rotates the folding portion about the folding axis. In some examples, the height is less than 4 millimeters. In some embodiments, the mirror is configured to reflect a field of view of an optical lens of the duodenoscope.
[0011] In some aspects, the deployment mechanism transitions the elongate body from a non-deployed position to a deployed position. When the periscope device is in the non-deployed position, the periscope device does not obstruct a side-facing view from the optical lens of the duodenoscope. When the periscope device is in the deployed position, the folding portion reflects the side-facing view from the optical lens to provide a forward-facing view. In some examples, the longitudinal axis of the forward-facing view is approximately perpendicular to the longitudinal axis of the optical lens.
[0012] In some aspects, the periscope device includes a light source coupled to a folding portion of the elongate body, hi some examples, the light source defines a longitudinal axis configured to be approximately parallel to a longitudinal axis of the duodenoscope after the folding portion rotates about the folding axis.
[0013] In some embodiments, the angle of rotation of the folded portion relative to the elongated portion of the elongated body is between 0 degrees and 180 degrees. In some embodiments, the elongated body defines a length between a proximal end and a distal end. In some examples, the length is at least 124 centimeters. In some examples, the length is greater than 124 centimeters. In some examples, the length is at least 124 centimeters. In some embodiments, the exterior surface of the elongated body has a circular cross-section defining a diameter. In some examples, the diameter is less than 4.2 millimeters. In some embodiments, the folding axis of the elongated body is oriented at an angle of about 45 degrees relative to the longitudinal axis of the elongated body. In some embodiments, the length of the folded portion of the elongated body is about 0.5 centimeters. In some embodiments, the mirror has a width of about 0.4 centimeters and a length of about 0.4 centimeters.
[0014] In some embodiments, the elongate body is comprised of one or more plastics. In some examples, the folded portion of the elongate body is generally rigid and the elongate portion of the elongate body is generally flexible. For example, the flexible elongate portion can be curved, bent, or otherwise manipulated along the longitudinal axis.
[0015] Another aspect of the present disclosure encompasses a system for providing forward viewing with a duodenoscope. The system includes a periscope device and a duodenoscope. The periscope device is configured for use with the duodenoscope. The duodenoscope can include an optical lens, a working lumen, and / or an elevator associated with a distal end of the working lumen. The optical lens is attached to an exterior surface near the distal end of the duodenoscope body and configured to provide imaging (e.g., side view imaging). The distal end of the working lumen is located near the optical lens. The elevator is associated with the distal end of the working lumen and is operable to adjust to an elevation angle.
[0016] Also disclosed is a method of using a periscope device to provide forward viewing through a duodenoscope. The method includes inserting a distal end of an elongated body of the periscope device into a proximal end of a working lumen of the duodenoscope. The elongated body may include a folding axis that defines an elongated portion of the elongated body and a folded portion of the elongated body. The folded portion of the elongated body may include a mirror coupled thereto. The method includes advancing the elongated body of the periscope device until the folded portion of the elongated body extends from the distal end of the working lumen of the duodenoscope. Additionally, the method includes actuating a deployment mechanism coupled to a proximal end of the elongated body of the periscope device, thereby rotating the folded portion of the elongated body at a rotational angle relative to the elongated portion of the elongated body about the folding axis. The method further includes orienting the mirror to reflect a field of view from an optical lens of the duodenoscope at a field of view angle.
[0017] In some embodiments, the rotation angle is between 0 degrees and 180 degrees. In some embodiments, the viewing angle is about 45 degrees.
[0018] In some aspects, the method further includes inserting a distal end of the duodenoscope into the patient. In some aspects, the method further includes advancing the distal end of the duodenoscope to a desired location within the patient.
[0019] In some embodiments, the method further includes raising an elevator of the duodenoscope to an elevation angle to correspondingly raise at least a portion of the folded portion, hi some embodiments, the elevation angle is about 90 degrees.
[0020] In some aspects, the method further includes removing the duodenoscope from the patient. In some aspects, the method further includes removing the elongate body of the periscope device from the working lumen of the duodenoscope.
[0021] In some aspects, the method further includes inserting a distal end of the duodenoscope into the patient's mouth. In some aspects, the method further includes advancing the duodenoscope through the patient's mouth, through the patient's throat, through the patient's stomach, and into the patient's duodenum.
[0022] The present description will be more fully understood with reference to the following figures and data graphs, which are presented as various embodiments of the present disclosure and should not be construed as a complete recitation of the scope of the present disclosure. It should be noted that for clarity of illustration, certain elements of the various figures may not be drawn to scale. With the understanding that these figures represent only exemplary embodiments of the present disclosure and therefore should not be considered as limiting its scope, the principles of the present specification will be explained and elaborated with additional specificity and detail using the accompanying drawings. [Brief description of the drawings]
[0023] [Figure 1A] 1A and 1B are top views of a periscope device in a non-deployed and deployed configuration, respectively, according to one embodiment. [Figure 1B] 1A and 1B are top views of a periscope device in a non-deployed and deployed configuration, respectively, according to one embodiment. [Figure 2A] 1 shows an overview of a duodenoscope in a perspective view, a top view of the distal end of the duodenoscope, and a perspective view of the distal end. [Figure 2B]1 shows an overview of a duodenoscope in a perspective view, a top view of the distal end of the duodenoscope, and a perspective view of the distal end. [Figure 2C] 1 shows an overview of a duodenoscope in a perspective view, a top view of the distal end of the duodenoscope, and a perspective view of the distal end. [Figure 3A] 1 shows a perspective view of the distal end of the duodenoscope after the distal end of the periscope device has been advanced through the working lumen of the duodenoscope with the duodenoscope elevator in a lowered position and the periscope device in a non-deployed configuration. [Figure 3B] 1 shows a perspective view of the periscope device after the elevator has been actuated to a raised position, with the periscope device remaining in a non-deployed configuration, thereby raising the distal end of the periscope device. [Figure 3C] FIG. 2 shows a perspective view after the periscope device has been deployed, with the elevator still in the raised position. [Figure 4A] 1 illustrates a side view of a periscope device in a deployed position relative to a duodenoscope, according to one embodiment. [Figure 4B] FIG. 13 illustrates the field of view of the duodenoscope alone without the periscope device deployed, according to one embodiment. [Figure 4C] FIG. 1 illustrates the field of view of a duodenoscope having a periscope device in a deployed position, according to one embodiment. [Figure 5A] 1A-1C show left, front, and right side views, respectively, of a periscope device according to one embodiment. [Figure 5B] 1A-1C show left, front, and right side views, respectively, of a periscope device according to one embodiment. [Figure 5C] 1A-1C show left, front, and right side views, respectively, of a periscope device according to one embodiment. [Figure 6A] FIG. 1 illustrates a perspective view of one embodiment of a periscope device for use with a duodenoscope. [Figure 6B] FIG. 1 illustrates a perspective view of one embodiment of a periscope device for use with a duodenoscope. [Figure 6C] FIG. 1 illustrates a perspective view of one embodiment of a periscope device for use with a duodenoscope. [Figure 6D]FIG. 1 illustrates a perspective view of one embodiment of a periscope device for use with a duodenoscope. [Figure 7A] FIG. 1 illustrates a perspective view of one embodiment of a periscope device for use with a duodenoscope. [Figure 7B] FIG. 1 illustrates a perspective view of one embodiment of a periscope device for use with a duodenoscope. [Figure 7C] FIG. 1 illustrates a perspective view of one embodiment of a periscope device for use with a duodenoscope. [Figure 7D] FIG. 1 illustrates a perspective view of one embodiment of a periscope device for use with a duodenoscope. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] Reference characters indicate corresponding elements in each of the figures of the drawings. Headings used in the drawings do not limit the scope of the claims.
[0025] Various embodiments of the present disclosure are described in detail below. Although specific embodiments are described, it should be understood that this is done for illustrative purposes only. Those skilled in the art will recognize that other components and configurations may be used without departing from the spirit and scope of the present disclosure. Thus, the following description and drawings are illustrative and should not be construed as limiting. Numerous specific details are described in order to provide a thorough understanding of the present disclosure. However, in certain instances, well-known or conventional details are not described in order to avoid obscuring the description. Reference to an embodiment or embodiments in the present disclosure may be a reference to the same embodiment or any embodiments. Such a reference means at least one of the embodiments.
[0026] Reference to "one embodiment," "embodiment," or "aspect" means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment of the disclosure. The appearances of the phrases "in one embodiment" or "in one aspect" in various places in the specification are not necessarily all referring to the same embodiment, or to separate or alternative embodiments that are mutually exclusive from other embodiments. Moreover, various features are described that may be exhibited by some embodiments and not by other embodiments.
[0027] The terms used herein generally have their ordinary meaning in the art, within the context of this disclosure and within the specific context in which each term is used. Alternative words and synonyms may be used for any one or more of the terms discussed herein, and no special importance should be placed on whether a term is detailed or discussed herein. In some cases, synonyms are provided for a particular term. The listing of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification, including examples of any term discussed herein, is illustrative only and is not intended to further limit the scope and meaning of the disclosure or any exemplary term. Similarly, this disclosure is not limited to the various embodiments shown in this specification.
[0028] Additional features and advantages of the present disclosure will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the principles disclosed herein. The features and advantages of the present disclosure may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the present disclosure will become more fully apparent from the following description and the appended claims, or may be learned by practice of the principles as described herein.
[0029] FIELD OF THE DISCLOSURE One aspect of the present disclosure encompasses a periscope device for use with an elongated medical instrument, such as an endoscope or duodenoscope. While endoscopes exist, there is a need for a periscope device that temporarily converts a side-viewing duodenoscope into a forward-viewing device, particularly while a practitioner (e.g., an endoscopist) is manipulating, advancing, or positioning the duodenoscope. By providing a forward view, the periscope device can reduce the risk of mucosal injury, including perforation, to the patient by allowing the practitioner to more safely manipulate (e.g., advance) the duodenoscope. For example, when deployed to provide a forward view, the periscope device can provide a forward-looking view that includes at least a portion of a view of the travel path of the duodenoscope (e.g., when advancing the duodenoscope).
[0030] Provided herein is a periscope device and method of use for providing forward viewing when using a duodenoscope. The periscope device includes an elongated body and a deployment mechanism at a proximal end of the elongated body. The elongated body includes a folding axis near a distal end of the elongated body, the folding axis defining an elongated portion of the elongated body proximal to the folding axis and a folded portion of the elongated body distal to the folding axis. In some embodiments, the folded portion includes multiple folding axes such that the folded portion includes two or more folded subportions. A mirror is attached to an outer surface of the folded portion of the elongated body. When the deployment mechanism is actuated, the folded portion of the elongated body rotates about the folding axis to a rotation angle, thereby repositioning the mirror.
[0031] The duodenoscope includes a duodenoscope body including a working lumen. A distal end of the working lumen exits the duodenoscope body near the distal end of the duodenoscope. An elevator is associated with the distal end of the working lumen and is configured to allow a practitioner to raise or lower the elevator to achieve a desired angle (e.g., an elevation angle). An optical lens is disposed on an exterior surface (e.g., a top surface) near the distal end of the duodenoscope and is configured to provide imaging (e.g., side-view imaging).
[0032] The periscope device can be used with a duodenoscope to provide a forward-facing field of view for a side-viewing duodenoscope. A distal end of the elongated body of the periscope device can be inserted into a proximal end of the working lumen of the duodenoscope. The elongated body can be advanced at least until a folded portion of the elongated body including a mirror passes the distal end of the working lumen of the duodenoscope. In some embodiments, an elevator associated with the distal end of the working lumen of the duodenoscope can be elevated to an elevation angle to optimize the position (e.g., angle) of the folded portion of the elongated body of the periscope device. In some aspects, the elevator can be elevated until the folded portion of the elongated body of the periscope device is approximately perpendicular to the duodenoscope body. In other embodiments, the folded portion includes two or more portions (e.g., a first folded portion, a second folded portion, and a third folded portion), each rotating about a respective axis of rotation when the deployment mechanism is actuated. Activation of the deployment mechanism can cause the folding portion (or folding portions) of the elongated body to rotate about their respective folding axis (or axes). As the folding portions rotate, the mirrors on the elongated body of the periscope device are repositioned to approximately align with the optical lens on the exterior surface of the duodenoscope. The device can be configured such that the viewing angle, the angle between the optical lens and the mirror of the duodenoscope, provides forward viewing through the duodenoscope.
[0033] Periscope devices can have significant advantages over conventional duodenoscopes. As previously mentioned, an endoscope is a device that has a camera at the end of a flexible tube and is used in multiple fields for minimally invasive procedures. In gastroenterology, these devices can be broadly divided into forward-looking endoscopes (e.g., used for standard upper endoscopies, small intestine endoscopies, or colonoscopies) and side-looking duodenoscopes (e.g., used for cases related to pancreatic diseases). Standard endoscopes include a forward-looking camera. Thus, when the practitioner inserts and positions the endoscope, the practitioner is given direct visualization of where the device is going and whether it is abutting another tissue (e.g., the back of the throat, the stomach wall, etc.). Devices that pass through the working lumen (e.g., port) of the endoscope exit approximately parallel to the longitudinal axis of the distal end of the endoscope (e.g., the longitudinal axis of the tip of the endoscope). On the other hand, standard duodenoscopes include a side-looking camera. Thus, when the practitioner inserts and positions the duodenoscope, the practitioner is given no direct visualization of the movement. Instead, the practitioner must rely on a lateral view and a feel for resistance to know if the duodenoscope is abutting another tissue (i.e., the back of the throat, the stomach wall, etc.) Additionally, duodenoscopes have a dial to control an elevator that allows instruments passed through the working lumen to exit the endoscope at different angles.
[0034] Periscope devices can reduce the risk of perforation during endoscopic retrograde cholangiopancreatography (ERCP) procedures. Currently, all ERCP procedures are performed with a duodenoscope, as the side-viewing camera is ideal for the treatment of certain bile duct and pancreatic disorders. However, during the time it takes to advance the duodenoscope from the mouth into the duodenum, the practitioner is manipulating the device without forward visualization, which increases the likelihood of endoscope-related injury or perforation. Although practitioners are skilled, there is a risk of perforation due to manipulation of the scope. Studies suggest that the overall perforation risk from ERCP due to scope manipulation is approximately 0.1%, while the typical perforation rate with forward-looking endoscopy is approximately 0.01%. Thus, by temporarily converting a side-viewing duodenoscope to a forward-facing endoscope during the positioning phase, the risk of perforation during ERCP due to duodenoscope manipulation can be reduced ten-fold. In other words, by temporarily providing forward viewing with a periscope device, the practitioner can safely manipulate the duodenoscope until ideal positioning is achieved, at which point the device can be subsequently removed and put away. The U.S. Food and Drug Administration (FDA) estimates that over 500,000 ERCPs are performed annually in the United States.
[0035] The periscope device can reduce the difficulties associated with duodenal intubation. Given the peristaltic nature of the stomach, the pyloric orifice may be small or buried under the gastric folds, making entry into the duodenum difficult without direct anterior visualization. Thus, intubating the duodenum with only a duodenoscope can result in increased procedure time and risk of mucosal injury due to multiple blind attempts. Utilizing a periscope device to temporarily enable forward viewing can expedite duodenal intubation and make it safer by ensuring that the orifice is always within the field of view during forward advancement of the duodenoscope.
[0036] A periscope device can provide a useful training tool for learners. Most gastroenterology procedures are performed using forward-looking endoscopes and colonoscopes. Thus, gastroenterology trainees are often more familiar with the safer forward-looking scopes. To progress training to ERCP, it is beneficial for gastroenterology trainees to experience using a side-looking duodenoscope. This transition can be made easier by augmenting the duodenoscope to have forward-looking capabilities by utilizing a periscope device.
[0037] 1A and 1B, in which one embodiment of a periscope device 100 is shown. The periscope device 100 includes an elongated body 102 and a deployment mechanism 118. The elongated body 102 and / or the deployment mechanism 118 may be made of a biocompatible material. The elongated body 102 of the periscope device 100 is configured to be inserted into an elongated medical device (e.g., an endoscope, a duodenoscope). For example, FIGS. 2A-2C show a duodenoscope 10, where FIG. 2A shows an overview of the duodenoscope 10, and FIGS. 2B-2C show top and perspective views of the distal end 16 of the duodenoscope 10, respectively. In one aspect, as shown, for example, in FIGS. 3A-3C, the periscope device 100 can be used with a duodenoscope 10 such that the periscope device 100 can provide a forward-looking view using a side-viewing duodenoscope 10.
[0038] 1A-1B, the elongate body 102 includes a proximal end 104, a distal end 106, and an exterior surface 108. The elongate body 102 includes a longitudinal axis LAP (e.g., LAP', LAP'') between the proximal end 104 and the distal end 106 that points along an axis along a centerline of the elongate body 102. Although the longitudinal axis LAP of the elongate body 102 is shown in FIG. 1A as being substantially straight, the longitudinal axis LAP of the elongate body 102 follows an orientation of the elongate body 102 that may be bent, curved, or otherwise manipulated. Thus, as the elongate body 102 is manipulated during use, the longitudinal axis LAP changes along with the centerline of the elongate body 102. As one example, when elongate body 102 is inserted into and advanced through an instrument channel of a duodenoscope, a longitudinal axis LAP of elongate body 102 can bend or curve to correspond to the longitudinal axis of the instrument channel of the duodenoscope. As another example, the longitudinal axis LAP (e.g., LAP', LAP'') can bend or fold along a folding axis FA, e.g., as shown in FIG. 1B , such that elongate portion 112 (also referred to as a first portion) defines longitudinal axis LAP' and folded portion 114 (also referred to as a second portion) defines longitudinal axis LAP''.
[0039] The elongated body 102 (or a portion of the elongated body 102) can be made of a flexible material such that the elongated body 102 is flexible. In this manner, the elongated body 102 of the periscope device 100 (e.g., as shown in FIGS. 1A-1B) can be inserted into and advanced through the instrument channel 22 of the duodenoscope 10 (e.g., as shown in FIGS. 2A-2C). In some embodiments, a portion or portions of the elongated body 102 (e.g., the elongated portion 112, the folded portion 114) can be made of different materials. For example, the elongated portion 112 can be made of a flexible material and the folded portion 114 can be made of a rigid or semi-rigid material. In one embodiment, the elongated body 102 (or a portion of the elongated body 102) is made of one or more polymers, such as, for example, one or more natural polymers and / or one or more synthetic polymers. By way of non-limiting example, the elongate body 102 may be made from one or more plastics, silicone, rubber, latex, polyurethane elastomers, polyester elastomers, or combinations thereof. The elongate body 102 may be made from a biocompatible material. For example, the elongate body 102 may be made from a biocompatible plastic.
[0040] In some embodiments, a portion of elongate body 102 may be constructed from metal (e.g., stainless steel). In some aspects, one or more pins (e.g., at fold line 110), such as shown as pins 510 (e.g., 510a, 510b, 510c) in FIGS. 5A-5C, may be constructed from metal. In some aspects, one or more internal wires or springs (e.g., along at least a portion of the longitudinal axis of elongate body 102), as described below, may be constructed from metal.
[0041] The elongate body 102 defines a length, which may be measured from the proximal end 104 to the distal end 106 along a longitudinal axis LA of the elongate body 102. By way of example, the length of the elongate body 102 may include both the length of the elongate portion 112 and the length of the folded portion 114, as shown, for example, in FIGS. 1A-1B. In some embodiments, the length of the elongate body 102 is between about 124 centimeters and about 240 centimeters. In some embodiments, the length is between about 124 centimeters and about 200 centimeters. In some embodiments, the length is between about 124 centimeters and about 160 centimeters. In one embodiment, the length is about 124 centimeters. In one embodiment, the length is at least 124 centimeters. In one embodiment, the length is greater than 124 centimeters.
[0042] Elongated body 102 can define one or more cross-sectional shapes (e.g., semicircular, circular, oval, triangular, rectangular, square). In some embodiments, elongated body 102 defines one cross-sectional shape. In other embodiments, elongated body 102 defines multiple cross-sectional shapes. For example, a portion or portions of elongated body 102 (e.g., elongated portion 112, folded portion 114) may define different cross-sectional shapes. In some examples, elongated portion 112 has a generally circular cross-section and folded portion 114 has a generally semicircular cross-section.
[0043] In one embodiment, the elongated body 102 includes a generally circular and / or generally semicircular cross-section such that the elongated body 102 is substantially cylindrical in shape and has a rounded outer surface 108, as shown, for example, in the elongated body 502 of the periscope device 500 of FIGS. 5A-5C described below. In some aspects, the diameter of the elongated body 102 is equal to or less than the diameter of the instrument channel (also referred to as the working lumen or working channel) of the duodenoscope such that the elongated body 102 can be inserted into the instrument channel and advanced and / or retracted through the instrument channel. In some aspects, the diameter is between about 0.35 centimeters (3.5 millimeters) and 0.42 centimeters (4.2 millimeters). In some aspects, the diameter is between about 0.38 centimeters and 0.42 centimeters. In some aspects, the diameter is about 0.42 centimeters. In some aspects, the diameter is less than 0.42 centimeters.
[0044] In other embodiments, the cross section of the elongate body 102 may be oval, triangular, rectangular, or square. For example, the elongate body may be a sheet or sheet-like such that its cross section is rectangular. In one embodiment, the elongate body 102 includes a substantially square cross section defining a width and a length approximately equal to the width. In one embodiment, the elongate body 102 includes a substantially rectangular cross section defining a width and a length less than the width. In some aspects, the width of the square or rectangular cross section of the elongate body 102 is equal to or less than the diameter of the working lumen of the duodenoscope such that the elongate body 102 can be inserted and advanced into the working lumen. In some aspects, the width may be between about 0.35 centimeters and 0.42 centimeters. In some aspects, the width may be between about 0.38 centimeters and 0.42 centimeters. In some aspects, the width may be about 0.42 centimeters. In some aspects, the width may be less than 0.42 centimeters.
[0045] 1A-1B, the elongated body 102 may incorporate fold lines 110 that define a fold axis FA. The fold lines 110 are generally formed across the width of the elongated body 102, and the fold lines 110 may be oriented at various angles relative to the longitudinal axis LAP of the elongated body 102 (e.g., the longitudinal axis LAP' of the elongated portion 112, the longitudinal axis LAP'' of the folded portion 114). In some embodiments, the fold lines 110 may define a fold axis angle between the fold axis FA of the fold lines 110 and the longitudinal axis LAP of the elongated body 102. In some aspects, the fold axis angle may be within a range of 0 degrees (e.g., the fold axis FA is approximately perpendicular to the longitudinal axis LAP) to 45 degrees. For example, the fold axis angle may be approximately 0 degrees, 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, or 45 degrees. For example, FIGS. 1A-1B show a fold axis angle of the fold line 110 of approximately 45 degrees. In some embodiments, the fold axis angle may be within the range of 30 degrees to 45 degrees. In some embodiments, the fold line 110 may be prefabricated in the elongate body 102. In other words, the fold line 110 is fabricated as part of the elongate body 102.
[0046] In some embodiments, the elongate body 102 includes one fold line 110, as shown, for example, in FIGS. 1A-1B. In other embodiments, the elongate body 102 includes multiple fold lines 110. In some aspects, the elongate body 102 may have two fold lines 110. In some aspects, the elongate body 102 may have three fold lines 110. In some embodiments, as shown, for example, in FIGS. 5A-5C, the periscope device 500 includes multiple fold axes FA (e.g., FA′, FA″, FA′″), each of which may be defined by a pin 510 (e.g., 510a, 510b, 510c), as described below.
[0047] In some embodiments, the fold line 110 is disposed near the distal end 106 of the elongate body 102 and defines an elongate portion 112 of the elongate body 102 proximal to the fold line 110 and a folded portion 114 of the elongate body 102 distal to the fold line 110. In some embodiments, the folded portion 114 of the elongate body 102 is disposed near the distal end 106 of the elongate body 102. The folded portion 114 of the elongate body 102 defines a length (e.g., measured along a longitudinal axis LAP (e.g., LAP'') of the folded portion 114). In one embodiment, the length of the folded portion 114 is about 0.5 centimeters.
[0048] When the periscope device 100 is deployed, the folding portion 114 rotates about the fold line 110 (e.g., rotates about a fold axis FA) at a rotation angle relative to the elongated portion 112 of the elongated body 102. The periscope device 100, including the elongated body 102 and the fold line 110, can be configured to have an angle of rotation between 0 degrees and 180 degrees. In one embodiment, the rotation angle is up to 180 degrees (e.g., less than or equal to 180 degrees). 1A-1B, for example, show rotation angles of about 0 degrees and 180 degrees, respectively. In one embodiment, the rotation angle is up to 90 degrees. For example, FIG. 3C shows a rotation angle of about 90 degrees (e.g., less than 90 degrees).
[0049] In some embodiments, the elongated body 102 or a portion of the elongated body 102 (e.g., the elongated portion 112, the folded portion 114) may include a wire extending therethrough. The wire can be configured to allow the longitudinal axis LAP of the elongated body 102 to be bent, curved, or otherwise manipulated. Additionally, the wire can be configured to rotate the folded portion 114 about the fold line 110 (e.g., the fold axis FA) relative to the elongated portion 112 of the elongated body 102 when the periscope device 100 is deployed. For example, the wire can be connected to the deployment mechanism 118 such that activating the deployment mechanism 118 activates the wire to deploy the periscope device 100. In some aspects, the wire is metallic (e.g., stainless steel).
[0050] A mirror 116 is attached to the exterior surface 108 of the folded portion 114 of the elongated body 102. In some aspects, the mirror 116 is located near the distal end 106 of the elongated body 102. In one embodiment, the mirror 116 may be integrated (e.g., permanently attached) to the elongated body 102. In other embodiments, the mirror 116 may be removably attached to the elongated body 102. In one embodiment, the mirror 116 is square. In other embodiments, the mirror may be rectangular, circular, oval, or triangular. The size of the mirror 116 can vary depending on the size (e.g., width, diameter) of the elongated body 102. For example, the width of the mirror 116 can be equal to or less than the diameter (for an elongated body 102 having a circular cross-section) or width (for an elongated body 102 having a square or rectangular cross-section) of the elongated body 102. In some aspects, the mirror 116 is square and has a width of about 0.4 centimeters (i.e., 4 millimeters) and a length of about 0.4 centimeters. In some aspects, the mirror 116 is square and has a width of less than 0.4 centimeters and a length of less than 0.4 centimeters. In some examples, multiple mirrors may be attached to the folding portion 114 of the elongated body 102. In some embodiments, a rotation mechanism may be incorporated into the elongated body 102 such that the elongated body 102 (or a portion of the elongated body 102) can be rotated to orient the mirror 116 to a desired location on the exterior surface 108 of the elongated body 102. In other words, the rotation mechanism allows the practitioner (also referred to as an operator) to rotate at least a portion of the elongated body 102 to adjust the axial direction in which the mirror 116 is facing.
[0051] 1A-1B, the disclosure now turns to the deployment mechanism 118. The deployment mechanism 118 is coupled to the proximal end 104 of the elongated body 102. In one embodiment, the deployment mechanism 118 is integrated into the periscope device 100 (e.g., permanently attached to the elongated body 102). In other embodiments, the deployment mechanism 118 is removably coupled to the elongated body 102 such that the deployment mechanism 118 can be removed from the elongated body 102. In one embodiment, the deployment mechanism 118 includes a plunger 120 and an associated housing 126. The plunger 120 can include a rod 124 and a knob 122, which is disposed at the proximal end of the rod 124. The knob 122 defines a surface that a technician or other practitioner (e.g., an endoscopist) can grasp to actuate the plunger 120. Additionally, a surface of the knob 122 closest to the proximal end of the housing 126 can be configured to contact the proximal end of the housing 126 when the plunger 120 is deployed (e.g., pushed inward along the longitudinal axis). The rod 124 can be configured such that deployment of the periscope device 100 (e.g., rotation of the folding portion 114 about the folding axis FA relative to the elongated portion 112) occurs when the surface of the knob 122 closest to the proximal end of the housing 126 contacts the proximal end of the housing 126. In one embodiment, the rod 124 is cylindrical and the knob 122 is spherical.
[0052] The housing 126 of the deployment mechanism 118 includes an internal channel that receives the rod 124 of the plunger 120 and actuates the rod 124 (i.e., moves inward and outward along the longitudinal axis of the housing 126). The housing 126 may include one or more flanges 128 extending radially outward from the housing. In one embodiment, one flange 128 is disposed at a proximal end of the housing 126 and one flange 128 is disposed at a distal end of the housing 126. The periscope device 100 is configured to deploy (e.g., the folded portion 114 rotates about the fold line 110) when an operator actuates the plunger 120 (e.g., moves the rod 124 inward or outward along the longitudinal axis of the housing 126). The periscope device 100 (e.g., the elongated body 102) is configured to unfold and return to a substantially straight configuration when an operator actuates the plunger 120 in the opposite direction. In one embodiment, an operator must hold the position of the plunger 120 relative to the housing 126 to maintain the deployed configuration. For example, a spring (e.g., an internal spring) can bias the plunger 120 relative to the housing 126 such that when an operator releases the plunger 120, the periscope device 100 automatically transitions from the deployed configuration (e.g., plunger pushed inward) to the undeployed configuration. In other embodiments, the plunger and housing can be configured such that the periscope device 100 remains in the deployed configuration until an operator manually moves the plunger 120 from the deployed position to the undeployed position, thereby transitioning the periscope device 100 from the deployed configuration to the undeployed configuration. For example, the plunger 120 and housing 126 can include protrusions and corresponding recessed areas that allow the plunger 120 and housing to maintain a particular configuration through a frictional fit.
[0053] The periscope device 100 is shown in a non-deployed configuration in Figure 1A, for example. The rod 124 of the plunger 120 is visible in the figure because the deployment mechanism 118 is not actuated (e.g., not deployed) and therefore the rod 124 is not advanced into the housing 126. Because the deployment mechanism 118 is not actuated, the folding portion 114 of the elongated body 102 is not rotated about the fold line 110 (e.g., the folding axis FA) relative to the elongated portion 112 of the elongated body 102. Thus, the mirror 116 is visible because Figure 1A shows a top view of the periscope device 100.
[0054] The periscope device 100 is shown in a deployed configuration in FIG. 1B, for example. The deployment mechanism 118 is actuated (i.e., deployed), and thus the rod 124 of the plunger 120 is not visible in the figure because the deployment mechanism 118 is actuated (i.e., deployed), and thus the rod 124 is advanced into the housing 126. Because the deployment mechanism 118 is actuated, the folding portion 114 of the elongated body 102 is rotated about the fold line 110 (e.g., the folding axis FA) relative to the elongated portion 112 of the elongated body 102. Thus, FIG. 1B shows a top view of the periscope device 100, and the mirror 116 is not visible, because the folding portion 114 of the elongated body 102 has been rotated about 180 degrees about the fold line 110 from the orientation shown in FIG. 1A. The movement and rotation of the distal end 106 of the elongated body 102 from the undeployed configuration to the deployed configuration is made clear by the annotated point "A" and the annotated point "B" shown in both FIG. 1A and FIG. 1B. The annotated points "A" and "B" are not physically labeled as such on the periscope device 100, but rather are shown to provide additional visualization of the rotation of the folding portion 114.
[0055] The periscope device 100 can be inserted into an elongated medical instrument such as a duodenoscope 10, for example, as shown in Figures 2A-2C. For example, Figures 3A-3C show the elongated body 102 of the periscope device 100 in conjunction with the duodenoscope 10. In one embodiment, the periscope device 100 (e.g., the elongated body 102) is inserted into the duodenoscope 10 (e.g., the instrument channel 22, as shown in Figure 2A), advanced until the distal end 106 of the elongated body 102 exits the distal end of the instrument channel 22, and deployed to reflect a view from the optical lens 26 (also called the objective lens) of the duodenoscope 10 to provide a forward-looking view. In another embodiment, the periscope device 100 can be inserted into a conventional forward-looking endoscope and configured to provide a side-looking view from the optical lens of the endoscope.
[0056] In one embodiment, as shown, for example, in FIGS. 1A-1B, the fold axis angle of the fold line 110 (defined between the fold axis FA of the fold line 110 and the longitudinal axis LAP of the elongated body 102) is about 45 degrees measured relative to the longitudinal axis of the elongated body 102 when the elongated body 102 is substantially straight (e.g., when the longitudinal axis of the elongated body 102 is approximately straight). As mentioned above, when the deployment mechanism 118 is actuated, the folding portion 114 of the elongated body 102 rotates about the fold line 110 to a rotation angle. In one example, the rotation angle is up to about 180 degrees. In other words, the fold line 110 and the deployment mechanism 118 are configured such that deployment of the periscope device 100 causes the folding portion 114 of the elongated body 102 to rotate about the fold line 110 relative to the elongated portion 112 by about 180 degrees. Because the fold line is approximately 45 degrees, when the folding portion 114 rotates through a rotation angle of approximately 180 degrees, the longitudinal axis LAP'' of the folding portion 114 becomes oriented at an angle of approximately 90 degrees (e.g., approximately perpendicular) relative to the longitudinal axis LAP' of the elongated portion 112. In other words, when the folding portion 114 of the elongated body 102 rotates 180 degrees about the fold line 110, the substantially straight elongated body 102 is transformed from a substantially straight orientation to a substantially L-shaped orientation. In one embodiment, the mirror 116 is oriented on the outer surface 108 of the folding portion 114 of the elongated body 102 such that when the periscope device 100 is deployed, the mirror 116 flips both horizontally and vertically, and correspondingly, the folding portion 114 of the elongated body 102 rotates approximately 180 degrees relative to the elongated portion 112 about the fold line 110. In other embodiments, the folding portion 114 may be configured to rotate less than 180 degrees about the fold line 110. Depending on one or more of the following: the length of the folding portion 114 of the elongate body 102, the angle of the elevator of the duodenoscope 10 (described below), the position of the mirror 116 on the folding portion 114, and the angle of the optical lens 26 relative to the longitudinal axis LAD of the duodenoscope 10, the rotation angle can be adjustable to position the mirror 116 to provide a forward view when the periscope device 100 is used with the duodenoscope 10.
[0057] In some embodiments, the periscope device 100 includes one or more light sources that can be configured to project light therefrom (e.g., to illuminate an area within the patient's duodenum). In some embodiments, the light sources can be illuminated (e.g., turned on) to illuminate or otherwise provide light to an area, such as an area visible when the periscope device 100 is deployed (e.g., a forward field of view). The one or more light sources may define a longitudinal axis. The one or more light sources can be configured such that, when illuminated, the longitudinal axis of the one or more light sources is approximately parallel to the longitudinal axis of the duodenoscope (e.g., the longitudinal axis of the distal end of the duodenoscope), such that the one or more light sources can illuminate a forward-looking field of view provided when the periscope device 100 is deployed. FIG. 6D illustrates an example of a light source 513 disposed near a second folding axis FA″ (which is not visible in FIGS. 6A-6C), as described below, for example. In some embodiments, when one or more light sources of the periscope device 100 are illuminated (e.g., turned on), the light of the duodenoscope 10 (e.g., the light-guiding lens 28 of the duodenoscope 10, as shown in Figures 2B-2C and 3A-3C) can be unilluminated (e.g., turned off) so that the forward field of view provided by the periscope device 100 is not obscured by the light of the duodenoscope.
[0058] In some embodiments, the light source may be incorporated into or otherwise coupled to the elongated body 102 and configured to shine light outwardly therefrom. One or more controllers in communication with the one or more light sources may be located at or near the proximal end of the periscope device 100. The one or more controllers may control (e.g., on, off) the light source and, in some aspects, adjust (e.g., dimmer) the intensity of the light source. In other words, in some aspects, when the one or more light sources are illuminated (e.g., turned on), the intensity may be adjusted (e.g., brightened, dimmed). The light source may receive power from an external power source (not shown). The external power source may be, by way of non-limiting examples, a battery, a wall outlet (e.g., connected to a power grid), and / or a USB port (e.g., a computer USB port on an endoscope cart).
[0059] Reference is now made to Figures 2A-2C, in which a duodenoscope 10 is shown. A schematic view of the duodenoscope 10 is shown in a perspective view in Figure 2A. A distal end 16 of the duodenoscope 10 is shown in top and perspective views in Figures 2B-2C, respectively. The duodenoscope 10 is an elongated medical instrument including a body 12 that defines a longitudinal axis LAD, as shown, for example, in the schematic view of the duodenoscope 10 alone (e.g., without the periscope device 100) in Figure 2A, and has a proximal end 14, a distal end 16, and an outer surface 18. The longitudinal axis LAD refers to an axis along the centerline of the body 12 of the duodenoscope 10 between the proximal end 14 and the distal end 16. The longitudinal axis LAD follows the direction of the body 12 of the duodenoscope 10, which may be bent, curved, or otherwise manipulated. Thus, as the body 12 of the duodenoscope 10 is manipulated during use, the longitudinal axis LAD changes with the centerline of the duodenoscope 10. When the periscope device 100 is within the instrument channel 22 of the duodenoscope 10, the longitudinal axis LAP of the periscope device 100 can bend or curve relative to the longitudinal axis LAD of the duodenoscope 10.
[0060] 2A , the duodenoscope 10 can include an elevator 20 and an instrument channel 22 (which may also be referred to as a working channel or working lumen). In some aspects, the elevator 20 is disposed at the distal end 16 of the duodenoscope 10, and the elevator 20 can be actuated (e.g., raised, lowered). In some examples, an elevator wire channel 24 extends through at least a portion of the length of the body 12 of the duodenoscope 10. For example, an elevator wire can extend through the elevator wire channel 24 and be coupled to the elevator 20, and actuating the elevator wire (e.g., advancing, retracting) correspondingly actuates (e.g., raises, lowers) the elevator 20. In some aspects, the instrument channel 22 extends through at least a portion of the length of the body 12 of the duodenoscope 10 and is configured to receive an instrument (e.g., a tool) therethrough such that the instrument can be advanced or retracted within the instrument channel 22.
[0061] 2B-2C show top and perspective views, respectively, of the distal end 16 of the duodenoscope 10. In some embodiments, the elevator 20 is aligned with the instrument channel 22 (e.g., the longitudinal axis of the elevator 20 is coplanar with the longitudinal axis of the instrument channel 22). In this manner, an instrument (e.g., a tool) advancing out of the distal end of the instrument channel 22 (e.g., the instrument channel exit) can contact a surface of the elevator 20. The elevator 20 can then be actuated (e.g., raised or lowered) to raise or lower the instrument accordingly, thereby adjusting the position of the instrument extending from the instrument channel 22. For example, Figures 2B-2C show the elevator 20 in a lowered (e.g., lower position).
[0062] In some embodiments, the distal end of the instrument channel 22 is adjacent to an optical lens 26 (also referred to as an objective lens). Thus, the distal end of an instrument (e.g., device, tool) is adjacent or near the optical lens 26 after the distal end of the instrument is advanced through the distal end of the instrument channel 22 of the duodenoscope 10.
[0063] In some examples, the distal end 16 of the duodenoscope 10 may include an optical lens 26, a light directing lens 28, and / or an air / water nozzle 30, as shown, for example, in FIGS. 2B-2C. In some aspects, the optical lens 26 is associated with a camera that provides viewing in a direction radially outward from the distal end 16 of the duodenoscope 10 (e.g., a side view). For example, the camera can provide viewing through the optical lens 26. In some aspects, the light directing lens 28 is associated with a light source to provide illumination (e.g., radially outward) at the distal end 16 of the duodenoscope 10. In some aspects, the air / water nozzle 30 is associated with a source of air and / or water. For example, air and / or water (e.g., provided from a corresponding air and / or water source) can be ejected through the air / water nozzle 30. The air / water nozzle 30 can be configured to eject air and / or water to clean (e.g., remove, flush) the optical lens 26.
[0064] In some embodiments, the distal end of the instrument channel 22 exits through the exterior surface 18 of the body 12 of the duodenoscope 10 near the distal end 16 of the duodenoscope 10. In other words, the duodenoscope 10 includes an instrument channel 22 that extends from a proximal end (e.g., at or near the proximal end 14 of the duodenoscope 10) along or generally parallel to the longitudinal axis LAD of the duodenoscope 10 and exits from one end of the body 12 of the duodenoscope 10 near the distal end 16 of the duodenoscope 10. The instrument channel 22 can be configured to allow a practitioner to pass an instrument or tool therethrough (e.g., from the proximal end 14 of the duodenoscope 10 to the distal end 16 of the duodenoscope 10). For example, a practitioner can insert a distal end 106 of a periscope device 100, such as the periscope device 100 shown in Figures 1A-1B, into the proximal end of the instrument channel 22 of a duodenoscope 10. The practitioner can then advance the periscope device 100 (e.g., the elongated body 102) until the folded portion 114 (or at least a portion of the folded portion 114) emerges from the distal end of the instrument channel 22.
[0065] In some aspects, the elevator 20 is associated with the distal end of the instrument channel 22. The elevator 20 is configured to rise or fall to provide an elevation angle. In some embodiments, the elevator 20 controls the elevation angle at the distal end of the instrument channel 22 (e.g., when the practitioner raises or lowers the elevator 20, the device, instrument, or tool extending through the distal end of the instrument channel 22 correspondingly rises or falls). For example, the device, instrument, or tool exiting the distal end of the instrument channel 22 can be connected to or otherwise in contact with the elevator 20. The elevator 20 directly raises or lowers the angle of the device passing through the distal end of the instrument channel 22. In this manner, adjustments to the elevator 20 (e.g., changing the elevation angle) correspondingly adjust the angle of the device. The device can then exit the distal end of the instrument channel 22 at approximately the same angle as the elevation angle of the elevator 20. For example, the elevator 20 can be lowered so that the device can advance from the distal end of the instrument channel 22 approximately parallel to the longitudinal axis LAD of the duodenoscope 10 (e.g., the longitudinal axis of the distal end 16 of the duodenoscope 10). The elevator 20 can be raised to approximately 90 degrees so that the device can advance from the distal end of the instrument channel 22 approximately perpendicular (e.g., approximately 90 degrees) to the longitudinal axis LAD of the duodenoscope 10. In some examples, the position of the elevator 20 can be controlled by a button, lever, or dial (e.g., the button, lever, or dial is in communication with the elevator 20) that can be located at or near the proximal end 14 of the duodenoscope 10. In some embodiments, the elevation angle configured to be controlled by the practitioner can be adjusted to any angle between approximately 0 degrees (e.g., the elevation angle when the elevator 20 is in the lowered position) and approximately 90 degrees (e.g., the elevation angle when the elevator 20 is in the raised position).
[0066] Various components or accessories that aid the operator in inserting, advancing, positioning, operating, or otherwise manipulating the duodenoscope 10 can be located at or near the distal end 16 of the duodenoscope 201, as previously described. First, an optical lens 26 can be located near the distal end 16 of the duodenoscope 10. The optical lens 26 is configured to provide imaging radially outward away from the longitudinal axis LAD of the duodenoscope 10. For example, the optical lens 26 can be used with a camera configured to provide imaging. In one embodiment, the optical lens 26 is near the distal end of the instrument channel 22 and associated elevator 20. Second, a light directing lens 28 can be located near the distal end 16 of the duodenoscope 10. The light directing lens 28 can be configured to provide illumination radially outward away from the longitudinal axis LAD of the duodenoscope 10. For example, the light directing lens 28 can be used with a light configured to provide illumination. The light can be configured to assist the practitioner in obtaining an image from the optical lens 26. In some embodiments, the light directing lens 28 is a separate component from the optical lens 26 (e.g., located near the optical lens 26). However, in other embodiments, the light directing lens 28 may be integrated into the optical lens 26 and / or an associated camera. Third, an air / water nozzle 30 can be located near the distal end 16 of the duodenoscope 10. The air / water nozzle 30 can be configured to flow water across the optical lens 26 to remove overlying mucus or debris. For example, the air / water nozzle 30 can be in fluid communication with a water source (which can be located at the proximal end 14 of the duodenoscope 10) and can include a control device (which can be controlled by the practitioner) for controlling when the air / water nozzle 30 flows water over the optical lens 26.
[0067] 3A-3C, a periscope device 100 (e.g., as shown in FIGS. 1A-1B) is shown for use with a duodenoscope 10 (e.g., as shown in FIGS. 2A-2C). For example, the distal end 106 of the periscope device 100 can be advanced through the instrument channel 22 of the duodenoscope 10, e.g., as shown in FIG. 3A, such that the distal end 106 of the periscope device 100 extends from the distal end of the instrument channel 22. For example, as shown in FIG. 3B, the elevator 20 of the duodenoscope 10 can be actuated (e.g., raised) from a lowered position to an elevated position, such that a portion of the elongated body 102 of the periscope device 100 is correspondingly raised by the elevator 20. For example, as shown in FIG. 3C , the periscope device 100 can be deployed such that the folding portion 114 rotates about a folding line 110 (e.g., a folding axis FA) and the mirror 116 is positioned to reflect the field of view from the optical lens 26 of the duodenoscope 10 (e.g., to reflect the side field of view and provide a forward-facing field of view).
[0068] The duodenoscope 10 may be inserted into and advanced through a digestive lumen (e.g., esophagus), also referred to as the digestive tract, of a subject (e.g., a patient). During an ERCP procedure, a practitioner (also referred to as an operator of the duodenoscope 10) inserts a distal end 16 of the duodenoscope 10 into the patient's mouth. The operator may advance the distal end 16 of the duodenoscope 10 to a desired location within the patient. For example, the operator may advance the distal end 16 of the duodenoscope 10 through the patient's mouth, through the patient's throat, and into the patient's stomach. The operator can further advance the distal end 16 of the duodenoscope 10 so that it passes through the patient's stomach and into the patient's duodenum. The operator can advance or position the distal end 16 of the duodenoscope 10 into the patient's duodenum using the optical lens 26 (e.g., with an associated camera), the light directing lens 28 (e.g., with an associated light), the air / water nozzle 30 (e.g., with an associated water supply), or a combination thereof, as needed. For example, the operator can use the optical lens 26 and associated camera to observe (e.g., a side-facing view when the periscope device 100 is not deployed, a forward-looking view when the periscope device 100 is deployed). As another example, the operator can use the light directing lens 28 and associated light to provide illumination to the area being observed. As another example, the operator can use the air / water nozzle 30 to eject water to clean the optical lens 26, which can also clean the mirror 116 when the periscope device 100 is deployed.
[0069] In some embodiments, the periscope device 100 may be advanced, positioned, and / or deployed within the duodenoscope 10 before the duodenoscope 10 is inserted into a patient. For example, the duodenoscope 10 can be prepared with the periscope device 100 advanced, positioned, and / or deployed within the duodenoscope 10 before a practitioner (e.g., gastroenterologist, endoscopist) intubates the duodenoscope 10 into the patient's mouth.
[0070] In other embodiments, the periscope device 100 may be positioned and / or deployed within the duodenoscope 10 after the duodenoscope 10 has been inserted into the patient. For example, at any time during advancement, positioning, or other positioning of the duodenoscope 10, the operator may deploy the periscope device 100. The operator inserts the distal end 106 of the elongated body 102 of the periscope device 100 into the proximal end of the instrument channel 22 of the duodenoscope 10. The operator then advances the elongated body 102 of the periscope device 100 until the distal end 106 of the elongated body 102 exits the distal end of the instrument channel 22 of the duodenoscope 10, as shown, for example, in FIG. 3A. The elevator 20 may be in a lowered position. In one embodiment, the operator advances the elongated body 102 until the folded portion 114 of the elongated body, including the mirror 116, exits the distal end of the instrument channel 22 of the duodenoscope 10. The mirror 116 can be configured such that when the distal end 106 of the elongated body 102 of the periscope device 100 exits the distal end of the instrument channel 22 of the duodenoscope 10, the mirror 116 faces radially outward, away from the longitudinal axis LAD of the duodenoscope 10. Thus, after the folded portion 114 of the elongated body 102 is elevated by the elevator 20 and the folded portion 114 is rotated about the fold line 110 (e.g., when the periscope device is deployed), the mirror 116 generally faces the optical lens 26 of the duodenoscope 10. In some embodiments, such as shown in Figures 6A-6D, the folding portion 114 (or a portion of the folding portion 114) can be elevated without the elevator 20. For example, as shown in Figures 5A-5C, the periscope device 500 can include multiple folding axes FA, such as a first folding axis FA', a second folding axis FA'', and a third folding axis FA'''. Rotation about one or more of the folding axis FA (or multiple axes) can properly position the periscope device 500 within the duodenoscope 10 without the use of the elevator 20.
[0071] An operator can raise the elevator 20 to impart an elevation angle to the elevator 20, such as by manipulating a button, lever, or dial associated with the elevator 20 (which can be located at or near the proximal end 14 of the duodenoscope 10), as shown in FIG. 3B. As the operator raises the elevator 20, the distal end 106 of the elongated body 102 of the periscope device 100 correspondingly rises (e.g., the elevator 20 raises the distal end 106 of the elongated body 102). As the distal end 106 rises, the longitudinal axis LAP (e.g., LAP'') of the distal end 106 of the periscope device 100 becomes less parallel and more perpendicular to the longitudinal axis LAD of the duodenoscope 10. In one embodiment, the elevator 20 rises until the longitudinal axis LAP of the distal end 106 of the elongated body 102 of the periscope device 100 is approximately 90 degrees (e.g., approximately perpendicular) from the longitudinal axis LAD of the duodenoscope 10 (e.g., the longitudinal axis of the distal end 16 of the duodenoscope 10). For example, the longitudinal axis LAP'' of the folded portion 114 of the elongated body 102 can be approximately perpendicular to the longitudinal axis LAD of the duodenoscope 10. In other embodiments, the elevation angle of the elevator 20 may be less than 90 degrees. For example, the elevation angle of the elevator 20 can be adjusted to provide forward viewing through the duodenoscope 10 depending on one or more of the following: the length of the folding portion 114 of the elongated body 102 of the periscope device 100, the position of the mirror 116 on the folding portion 114, and the degree to which the folding portion 114 rotates about the elongated portion 112 of the elongated body 102.
[0072] The operator may deploy the periscope device 100, for example, as shown in Figure 3C. In other words, the operator actuates the deployment mechanism 118 (e.g., by pushing the plunger 120 into the housing 126 of the deployment mechanism 118), as shown in Figures 1A-1B. This causes the folding portion 114 of the elongated body 102 of the periscope device 100 to rotate about the fold line 110, as shown in Figure 3C, for example, to orient the mirror 116 of the periscope device 100 so that the mirror 116 generally faces toward the optical lens 26 of the duodenoscope 10.
[0073] The viewing angle is defined by the angle measured between the plane of the optical lens 26 (e.g., the plane is perpendicular to the longitudinal axis of the optical lens 26) and the plane of the mirror 116 (e.g., the flat surface of the mirror) relative to the forward viewing direction. In one embodiment, the viewing angle may be in the range of about 25 degrees to 75 degrees. In one embodiment, the viewing angle is about 45 degrees (e.g., the surface of the mirror 116 faces forward relative to the distal end 16 of the duodenoscope 10 at an angle of about 45 degrees relative to the optical lens 26). In other words, the length of the folding portion 114 of the elongated body 102 of the periscope device 100, the degree to which the folding portion 114 rotates about the fold line 110, the angle of the elevator 20 of the duodenoscope 10, and the position of the mirror 116 on the folding portion 114 are configured such that the viewing angle (e.g., the angle of the mirror 316 relative to the optical lens 307) provides a forward-facing view when the periscope device 100 is deployed.
[0074] When the periscope device 100 is deployed, the mirror 116 provides a forward view to the duodenoscope 10. This provides the operator with a forward view similar to that which would be provided by a conventional forward-looking endoscope when using a conventional side-looking duodenoscope 10. In effect, forward viewing enhances the operator's ability to advance, manipulate, or otherwise move the duodenoscope 10. In one embodiment, the periscope device 100 is only temporarily deployed, thereby temporarily converting the duodenoscope 10 into a forward-looking device. For example, once the distal end 16 of the duodenoscope 10 is positioned at a desired location within the patient's body, the operator can undeploy (i.e., deactivate) the periscope device 100. In some cases, the operator can remove the periscope device 100 from the duodenoscope 10 (e.g., by retracting the elongated body 102 of the periscope device 100 through the instrument channel 22 of the duodenoscope 10).
[0075] 3A shows the periscope device 100 in a non-deployed position and the elevator 20 in a lowered position as the distal end 106 of the elongated body 102 of the periscope device 100 exits the distal end of the instrument channel 22 of the duodenoscope 10. Because the deployment mechanism is not actuated, the folded portion 114 of the elongated body 102 of the periscope device 100 has not rotated about the fold line 110 relative to the elongated portion 112 of the elongated body 302. Thus, FIG. 3A shows a perspective view, with a portion of the top view, of the distal end 106 of the periscope device 100 advanced to the distal end 16 of the duodenoscope 10, such that the mirror 116 is visible.
[0076] 3B shows the elevator 20 in a raised position and the distal end 106 of the elongated body 102 of the periscope device 100 in a corresponding raised position. The longitudinal axis LAP of the distal end 106 of the elongated body 102 of the periscope device 100 is oriented approximately perpendicular to the longitudinal axis LAD of the distal end 16 of the duodenoscope 10. The mirror 116 is not visible (and therefore is shown in dashed lines). However, due to the orientation of the perspective view, the underside of the folded portion 114 of the elongated body 102 of the periscope device 100 is visible.
[0077] 3C shows the periscope device 100 in the deployed position. The elevator 20 is in the raised position, so that when the periscope device 100 is deployed, the folding portion 114 of the elongated body 102 of the periscope device 100 rotates about the folding line 110 (e.g., folding axis FA). In other words, the folding portion 114 of the elongated body 102 of the periscope device 100 changes to form an L-shape relative to the elongated portion 112 of the elongated body 102. After the folding portion 114 rotates relative to the elongated portion 112, the face of the mirror 116 generally faces toward the optical lens 26.
[0078] Reference is now made to Figures 4A-4C, which show side views of one embodiment of a periscope device 400. The periscope device 400 is shown in a deployed position relative to the duodenoscope 10 in the side view shown in Figure 4A. A view of only the duodenoscope 10 (e.g., without the periscope device 400) and a view with the periscope device 400 in the deployed position are shown in the side views of Figures 4B-4C, respectively. The periscope device 400 shown in Figures 4A-4C may include one or more of the same or similar features as the periscope device 100 shown in Figures 1A-3C. Due to the same or similar features, the reference numerals and corresponding descriptions given above for the various components, elements, parts, etc. included in the periscope device 100 of Figures 1A-3C may generally be applied to the same or similar components, elements, parts, etc. included in the periscope device described in Figures 4A-4C. However, the reference numbers in Figures 4A to 4C are in the 400 range instead of the 100 range.
[0079] The periscope device 400 (e.g., elongated body 402) shown in FIGS. 4A-4C can be advanced through the working channel of the duodenoscope 10. The periscope device 400 can then be deployed (as shown in FIGS. 4A and 4C) such that the mirror 416 reflects the field of view from the optical lens 26 of the duodenoscope 10. In some embodiments, deploying the periscope device 400 causes the second portion 414 of the elongated body 402 of the periscope device 400 to rotate about a folding axis FA, which may be defined by a pin 410. FIG. 4A shows the periscope device 400 in a deployed position such that the distal end 406 of the second portion 414 and the outer surface 408 of the first portion 412 are visible in the figure. In some embodiments, in the deployed position, the longitudinal axis of the second portion 414 is approximately perpendicular to the longitudinal axis of the first portion 412. When deployed, the periscope device 400 can provide a forward-looking field of view (e.g., a reflected field of view) using the optical lens 26 of the side-viewing duodenoscope 10. In FIGS. 4A and 4C, the second portion 414 of the elongated body 402 of the periscope device 400 is shown with a generally rectangular cross-section. As previously mentioned, the cross-sectional shape of the elongated body 402 (e.g., first portion 412, second portion 414) can be a variety of shapes (e.g., circular, rectangular). In some examples, the first portion 412 of the elongated body 402 can have a generally circular cross-section and the second portion 414 can have a generally rectangular cross-section.
[0080] 4A shows a side view of the periscope device 400 in a deployed position relative to the duodenoscope 10. The duodenoscope 10 itself defines a height HD measured from the bottom outer surface 18 to the top outer surface 18 of the duodenoscope 10. In some aspects, the height HD can be referred to as the diameter of the duodenoscope 10. For example, as shown in FIG. 4A, when the periscope device 100 is deployed, the periscope device 100 can define a height HP measured from the top outer surface 18 of the duodenoscope 10 to the most radially outer point (e.g., the highest point) on the periscope device 400. The height HD of the duodenoscope 10 and the height HP of the periscope device 400 together define a total height HT.
[0081] In some embodiments, the periscope device 400 is configured such that the overall height HT is less than the diameter of the digestive tract lumen (e.g., esophagus). In some embodiments, when the periscope device 400 is deployed, the height HP of the periscope device 400 (e.g., elongated body 402) is less than 4 millimeters (mm). In some embodiments, the height HP is less than 2 mm. In some embodiments, the height HP of the periscope device 400 is configured such that the air and / or water discharge from the air / water nozzle 30 cleans (e.g., dislodges, flushes) the mirror 416. As previously described, the air / water nozzle 30 can discharge air and / or water to clean the optical lens 26 of the duodenoscope 10. As such, in some embodiments, the air and / or water discharge from the air / water nozzle 30 cleans both the mirror 416 of the periscope device 400 and the optical lens 26 of the duodenoscope 10. For example, the discharged air and / or water may define a longitudinal axis LAAW of the air / water nozzle 30. The height HP of the periscope device 400 may be configured such that, upon discharging water from the air / water nozzle 30, the discharged water flows over both a surface of the mirror 416 and a surface of the optical lens 26 due to the proximity and / or position of the mirror 416 relative to the optical lens 26.
[0082] Figures 4B-4C respectively show representative fields of view for both the duodenoscope 10 alone (e.g., with the periscope device 400 in a non-deployed position) and the duodenoscope 10 in combination with the periscope device 400 (e.g., with the periscope device 400 in a deployed position). The fields of view in Figures 4B-4C are indicated by dashed lines extending from the outer edge of the optical lens 26 of the duodenoscope 10 to points "A" and "B". 4B-4C, the distal end 16 of the duodenoscope 10 is shown within the GI lumen 32 (e.g., the esophagus). As previously described, with the periscope device 400 in the non-deployed position, the duodenoscope 10 can be advanced to a desired location within the GI lumen 32. The periscope device 400 can then be deployed after the duodenoscope 10 reaches the desired location.
[0083] For example, as shown in FIG. 4B, with the periscope device 400 in the undeployed position, the field of view from the optical lens 26 of the duodenoscope 10 (represented by dashed lines extending from the optical lens 26 to points "A" and "B") is a lateral-oriented field of view. In this manner, the optical lens 26 (e.g., associated camera) provides a view of the inner wall of the gastrointestinal lumen 32. In some embodiments, with the periscope device 400 in the undeployed position, the longitudinal axis of the field of view is approximately perpendicular to the longitudinal axis LAD of the duodenoscope 10. The longitudinal axis of the field of view may coincide with the longitudinal axis of the optical lens 26. In some embodiments, with the periscope device 400 in the undeployed position, the longitudinal axis of the field of view is approximately perpendicular to the inner wall of the gastrointestinal lumen 32.
[0084] For example, as shown in FIG. 4C, when the periscope device 400 is in the deployed position, the field of view of the optical lens 26 of the duodenoscope 10 reflected by the mirror 416 of the periscope device 400 (represented by the dashed lines extending from the optical lens 26 to points "A" and "B") is a forward-looking field of view. In this manner, the mirror 416 of the periscope device 400 provides a reflected field of view (e.g., a forward field of view) from the optical lens 26 (e.g., an associated camera) of the duodenoscope 10. Note that the first portion 412 (as shown in FIG. 4A) is not shown in FIG. 4C to clearly show the field of view. However, the second portion 414 is supported by the first portion 412. Note also that points "A" and "B" represent a forward or reflected field of view for a distance. In some embodiments, with the periscope device 400 in the deployed position, the longitudinal axis of the field of view is approximately perpendicular to the longitudinal axis of the optical lens 26. In some embodiments, with the periscope device 400 in the deployed position, the longitudinal axis of the field of view is approximately parallel to the longitudinal axis LAD of the duodenoscope 10. In some embodiments, with the periscope device 400 in the deployed position, the longitudinal axis of the field of view is approximately parallel to the inner wall of the gastrointestinal lumen 32.
[0085] In some embodiments, the display monitor can display a view provided by the optical lens 26 of the duodenoscope 10 (e.g., via an associated camera). That is, the field of view through the optical lens 26 can be displayed on the monitor. For example, points "A" and "B" can be displayed on the monitor as shown in FIG. 4B with the periscope device 400 undeployed and in FIG. 4C with the periscope device 400 deployed. In one example, the monitor can display point "A" as the top point of the view on the display and point "B" as the bottom point of the view on the display. In some aspects, the monitor can display a view (e.g., a monitor view) that is inverted on the vertical axis. For example, the monitor view can be inverted with respect to the field of view.
[0086] Reference is now made to Figures 5A-5C, in which an embodiment of a periscope device 500 is shown. The periscope device 500 is shown in left side view, front view, and right side view in Figures 5A-5C, respectively. The periscope device 500 shown in Figures 5A-5C may include one or more same or similar features as the periscope device 100 shown in Figures 1A-3C and / or the periscope device 400 shown in Figures 4A-4C. Due to the same or similar features, the reference numbers and corresponding descriptions given above for the various components, elements, parts, etc. included in the periscope device 100 of Figures 1A-3C and the periscope device 400 of Figures 4A-4C may generally be applied to the same or similar components, elements, parts, etc. included in the periscope device described in Figures 5A-5C. However, the reference numbers in Figures 5A-5C are in the 500 series rather than the 100 or 400 series.
[0087] The periscope device 500 includes an elongate body 502 extending from a proximal end to a distal end 506 and having an outer surface 508. The elongate body 502 defines a longitudinal axis LAP. In some embodiments, the proximal end of the elongate body 502 includes a deployment mechanism, such as, for example, the deployment mechanism 118 shown in FIGS. 1A-1B. The deployment mechanism can be configured to actuate the elongate body 502 (e.g., transition from a non-deployed position to a deployed position) when the deployment mechanism is actuated.
[0088] The elongated body 502 of the periscope device 500 includes an elongated portion 512 and a folded portion 514 (e.g., 514a, 514b, 514c). In some aspects, the elongated body 502 (e.g., elongated portion 512, folded portion 514) defines a substantially circular cross-section. In some aspects, the elongated portion 512 is constructed of a flexible material such that the longitudinal axis of the elongated portion 512 can be bent, curved, or otherwise manipulated. In some aspects, the folded portion 514 is constructed of a rigid or semi-rigid material such that the longitudinal axis of the folded portion 514 remains substantially straight even when the longitudinal axis of the folded portion 514 is rotated as described below.
[0089] The folding portion 514 of the elongated body 502 of the periscope device 500 includes three folding portions 514 (e.g., 514a, 514b, 514c) that can be referred to as a first folding portion 514a, a second folding portion 514b, and a third folding portion 514c, as shown in FIGS. 5A-5C. The periscope device 500 includes three folding axes FA (e.g., FA', FA'', FA''') that can be referred to as a first folding axis FA', a second folding axis FA'', and a third folding axis FA'''. Each of the folding portions 514 can rotate about a corresponding folding axis FA. In some embodiments, each folding axis FA is defined by a pin 510 (e.g., 510a, 510b, 510c). For example, each pin 510 can be a cylinder (e.g., a rod) that secures the elongate body 502 (e.g., each folded portion 514) to one another while also allowing rotation of the folded portions 514 of the elongate body 502 about the pin 510. In some aspects, each pin 510 is disposed within a knuckle 511 (e.g., 511a, 511b, 511c) of an adjacent folded portion 514. In some aspects, each pin 510 is constructed of a metal, such as, for example, stainless steel.
[0090] Continuing to refer to FIGS. 5A-5C, the disclosure now turns to the first folding portion 514a. The first folding portion 514a can include a mirror 516, which is configured to provide a reflected field of view when the periscope device 500 is unfolded to position the mirror over the optical lens of the duodenoscope. The first folding portion 514a is rotatably coupled to the second folding portion 514b along a first folding axis FA'. In this manner, the first folding portion 514a can rotate about the first folding axis FA' relative to the second folding portion 514b. In some embodiments, the first folding axis FA' is approximately perpendicular to the longitudinal axis LAP of the periscope device 500 (e.g., the longitudinal axis of the folding portion 514). For example, the first folding axis FA' may be approximately perpendicular to the longitudinal axis of the first folding portion 514a and / or may be approximately perpendicular to the longitudinal axis of the second folding portion 514b. As mentioned above, the first folding portion 514a may be constructed of a rigid or semi-rigid material such that the longitudinal axis of the first folding portion 514a remains approximately straight as the first folding portion 514a rotates about the first folding axis FA'.
[0091] In some embodiments, the first folding axis FA' is defined by the first pin 510a. In other words, the first pin 510a secures the first folding portion 514a to the second folding portion 514b while rotating the first folding portion 514a about the first folding axis FA'. In some embodiments, as best shown in FIG. 5B, a proximal end of the first folding portion 514a can include one or more knuckles 511a and a distal end of the second folding portion 514b can include one or more knuckles 511b. The first pin 510a can join the knuckles 511a, 511b (e.g., the knuckles 511a, 511b can receive the first pin 510a therethrough) to rotatably couple the first folded portion 514a to the second folded portion 514b.
[0092] The first rotation angle can be defined as the angle between the longitudinal axis of the first folding portion 514a and the longitudinal axis of the second folding portion 514b. In other words, the first rotation angle is changed by the first folding portion 514a rotating about the first folding axis FA' relative to the second folding portion 514b. In some embodiments, the first rotation angle can range from 180 degrees (i.e., the longitudinal axis of the first folding portion 514a is approximately parallel or collinear with the longitudinal axis of the second folding portion 514b) to about 90 degrees (i.e., the longitudinal axis of the first folding portion 514a is approximately perpendicular to the longitudinal axis of the second folding portion 514b). In some embodiments, the first rotation angle is approximately 180 degrees when the periscope device 500 is in the undeployed position. In some embodiments, the first rotation angle is between 60 degrees and 120 degrees when the periscope device 500 is in the deployed position. In some embodiments, the first rotation angle is approximately 90 degrees when the periscope device 500 is in the deployed position.
[0093] In some embodiments, the first folding axis FA' is approximately perpendicular to both the longitudinal axis of the first folding portion 514a and the longitudinal axis of the second folding portion 514b, regardless of the first rotation angle. For example, when the first rotation angle is approximately 180 degrees (e.g., when the periscope device 500 is undeployed), the first folding axis FA' is approximately perpendicular to both the longitudinal axis of the first folding portion 514a and the longitudinal axis of the second folding portion 514b. When the first rotation angle is approximately 90 degrees (e.g., when the periscope device 500 is deployed), the first folding axis FA' is approximately perpendicular to both the longitudinal axis of the first folding portion 514a and the longitudinal axis of the second folding portion 514b. In some embodiments, the longitudinal axis of the first folded portion 514a is approximately coplanar with the longitudinal axis of the second folded portion 514b regardless of the first rotation angle. For example, when the first rotation angle is approximately 180 degrees, the longitudinal axis of the first folded portion 514a is approximately coplanar with the longitudinal axis of the second folded portion 514b. When the first rotation angle is approximately 90 degrees, the longitudinal axis of the first folded portion 514a is approximately coplanar with the longitudinal axis of the second folded portion 514b.
[0094] The first folded portion 514a can include one or more recesses 517 (e.g., 517a), as best shown in Figures 5A and 5C. Each of the recesses 517a defines a portion of the first folded portion 514a having a cross-sectional area smaller than the cross-sectional area of the elongated body 502. In some aspects, the distal end of the first folded portion 514a can include the recess 517a that defines a plane, while the outer surface 508 of the elongated body 502 is rounded to define a radius. The mirror 516 (e.g., the substantially planar mirror 516) can be disposed on this plane. In some aspects, the proximal end of the first folded portion 514a includes the recess 517a to allow the first folded portion 514a to rotate relative to the second folded portion 514b.
[0095] Continuing to refer to FIGS. 5A-5C, the disclosure now turns to the second folding portion 514b. The second folding portion 514b is rotatably coupled to the third folding portion 514c along a second folding axis FA″. In this manner, the second folding portion 514b can rotate about the second folding axis FA″ relative to the third folding portion 514c. In some embodiments, the second folding axis FA″ is approximately perpendicular to the longitudinal axis LAP of the periscope device 500 (e.g., the longitudinal axis of the folding portion 514). For example, the second folding axis FA″ may be approximately perpendicular to the longitudinal axis of the second folding portion 514b and / or may be approximately perpendicular to the longitudinal axis of the third folding portion 514c. In some embodiments, the second folding axis FA'' is substantially parallel to the first folding axis FA'. As mentioned above, the second folding portion 514b may be constructed of a rigid or semi-rigid material such that the longitudinal axis of the second folding portion 514b remains substantially straight as the second folding portion 514b rotates about the second folding axis FA''.
[0096] In some embodiments, the second folding axis FA'' is defined by the second pin 510b. In other words, the second pin 510b secures the second folding portion 514b to the third folding portion 514c while rotating the second folding portion 514b about the second folding axis FA''. In some embodiments, as best shown in FIG. 5B, a proximal end of the second folding portion 514b can include one or more knuckles 511b and a distal end of the third folding portion 514c can include one or more knuckles 511c. The second pin 510b can join the knuckles 511b, 511c (e.g., the knuckles 511b, 511c can receive the second pin 510b therethrough) to rotatably connect the second folded portion 514b to the third folded portion 514c.
[0097] The second rotation angle can be defined as the angle between the longitudinal axis of the second folding portion 514b and the longitudinal axis of the third folding portion 514c. In other words, the second rotation angle is changed by the second folding portion 514b rotating about the second folding axis FA'' relative to the third folding portion 514c. In some embodiments, the second rotation angle can range from 180 degrees (i.e., the longitudinal axis of the second folding portion 514b is approximately parallel or collinear with the longitudinal axis of the third folding portion 514c) to about 90 degrees (i.e., the longitudinal axis of the second folding portion 514b is approximately perpendicular to the longitudinal axis of the third folding portion 514c). In some embodiments, the second rotation angle is approximately 180 degrees when the periscope device 500 is in the undeployed position. In some embodiments, the second rotation angle is between 60 degrees and 120 degrees when the periscope device 500 is in the deployed position. In some embodiments, the second rotation angle is approximately 90 degrees when the periscope device 500 is in the deployed position.
[0098] In some embodiments, the second folding axis FA'' is approximately perpendicular to both the longitudinal axis of the second folding portion 514b and the longitudinal axis of the third folding portion 514c, regardless of the second rotation angle. For example, when the second rotation angle is approximately 180 degrees (e.g., when the periscope device 500 is undeployed), the second folding axis FA'' is approximately perpendicular to both the longitudinal axis of the second folding portion 514b and the longitudinal axis of the third folding portion 514c. When the second rotation angle is approximately 90 degrees (e.g., when the periscope device 500 is deployed), the second folding axis FA'' is approximately perpendicular to both the longitudinal axis of the second folding portion 514b and the longitudinal axis of the third folding portion 514c. In some embodiments, the longitudinal axis of the second folded portion 514b is approximately coplanar with the longitudinal axis of the third folded portion 514c regardless of the second rotation angle. For example, when the second rotation angle is approximately 180 degrees, the longitudinal axis of the second folded portion 514b is approximately coplanar with the longitudinal axis of the third folded portion 514c. When the second rotation angle is approximately 90 degrees, the longitudinal axis of the second folded portion 514b is approximately coplanar with the longitudinal axis of the third folded portion 514c.
[0099] The second folded portion 514b can include one or more recesses 517 (e.g., 517b), as best shown in Figures 5A and 5C. Each of the recesses 517b defines a portion of the second folded portion 514b having a cross-sectional area smaller than the cross-sectional area of the elongated body 502. In some embodiments, a distal end of the second folded portion 514b includes the recess 517b to allow the first folded portion 514a to rotate relative to the second folded portion 514b. In some embodiments, a proximal end of the second folded portion 514b includes the recess 517b to allow the second folded portion 514b to rotate relative to the third folded portion 514c.
[0100] Continuing to refer to FIGS. 5A-5C, the disclosure now turns to the second folding portion 514b. The third folding portion 514c is rotatably coupled to the elongated portion 512 along a third folding axis FA'''. In this manner, the third folding portion 514c can rotate about the third folding axis FA''' relative to the elongated portion 512. In some embodiments, the third folding axis FA''' is approximately perpendicular to the longitudinal axis LAP of the periscope device 500 (e.g., the longitudinal axis of the folding portion 514). For example, the third folding axis FA''' may be approximately perpendicular to the longitudinal axis of the third folding portion 514c and / or may be approximately perpendicular to the longitudinal axis of the elongated portion 512 (e.g., the longitudinal axis of the distal end of the elongated portion 512). In some embodiments, the third folding axis FA''' is approximately parallel to the first folding axis FA'. In some embodiments, the third folding axis FA''' is approximately parallel to the second folding axis FA''. As mentioned above, the third folding portion 514c may be constructed of a rigid or semi-rigid material such that the longitudinal axis of the third folding portion 514c remains approximately straight as the third folding portion 514c rotates about the third folding axis FA''.
[0101] In some embodiments, the third folding axis FA''' is defined by the third pin 510c. In other words, the third pin 510c secures the third folding portion 514c to the elongated portion 512 while allowing the third folding portion 514c to rotate about the third folding axis FA'''. In some embodiments, as best shown in FIG. 5C, a proximal end of the third folding portion 514c can include one or more knuckles 511c and a distal end of the elongated portion 512 can include one or more knuckles 511d. The third pin 510c can join the knuckles 511c, 511d (e.g., the knuckles 511c, 511d can receive the third pin 510c therethrough) to rotatably couple the third folding portion 514c to the elongated portion 512.
[0102] The third rotation angle can be defined as the angle between the longitudinal axis of the third folding portion 514c and the longitudinal axis of the elongated portion 512. In other words, the third rotation angle varies with the rotation of the third folding portion 514c about the third folding axis FA'''' relative to the elongated portion 512. In some embodiments, the third rotation angle can range from 180 degrees (i.e., the longitudinal axis of the third folding portion 514c is approximately parallel or collinear with the longitudinal axis of the elongated portion 512) to about 90 degrees (i.e., the longitudinal axis of the third folding portion 514c is approximately perpendicular to the longitudinal axis of the elongated portion 512). In some embodiments, the third rotation angle is approximately 180 degrees when the periscope device 500 is in the undeployed position. In some embodiments, the third rotation angle is between 60 degrees and 120 degrees when the periscope device 500 is in the deployed position. In some embodiments, the third rotation angle is approximately 90 degrees when the periscope device 500 is in the deployed position.
[0103] In some embodiments, the third fold axis FA''' is approximately perpendicular to both the longitudinal axis of the third folding portion 514c and the longitudinal axis of the elongated portion 512, regardless of the third rotation angle. For example, when the third rotation angle is approximately 180 degrees (e.g., when the periscope device 500 is undeployed), the third fold axis FA''' is approximately perpendicular to both the longitudinal axis of the third folding portion 514c and the longitudinal axis of the elongated portion 512. When the third rotation angle is approximately 90 degrees (e.g., when the periscope device 500 is deployed), the third fold axis FA''' is approximately perpendicular to both the longitudinal axis of the third folding portion 514c and the longitudinal axis of the elongated body. In some embodiments, the longitudinal axis of the third folded portion 514c is approximately coplanar with the longitudinal axis of the elongated portion 512, regardless of the third rotation angle. For example, when the third rotation angle is approximately 180 degrees, the longitudinal axis of the third folded portion 514c is approximately coplanar with the longitudinal axis of the elongated portion 512 (e.g., the longitudinal axis of the distal end of the elongated portion 512). When the third rotation angle is approximately 90 degrees, the longitudinal axis of the third folded portion 514c is approximately coplanar with the longitudinal axis of the elongated portion 512.
[0104] The third folded portion 514c can include one or more recesses 517 (e.g., 517c), as best shown in Figures 5B and 5C. Each of the recesses 517c defines a portion of the third folded portion 514c having a cross-sectional area smaller than the cross-sectional area of the elongated body 502. In some embodiments, the distal end of the third folded portion 514c includes the recess 517c to allow the second folded portion 514b to rotate relative to the third folded portion 514c, as shown in Figure 5C. In some embodiments, the proximal end of the third folded portion 514c includes the recess 517c to allow the third folded portion 514c to rotate relative to the elongated portion 512, as shown in Figure 5B. In some embodiments, the distal end of the elongated portion 512 includes the recess 517d to allow the third folded portion 514c to rotate relative to the elongated portion 512.
[0105] 6A-6D, there is shown one embodiment of a periscope device 500 for use with the duodenoscope 10. The periscope device 500 is advanced through the instrument channel 22 of the duodenoscope 10 and can be deployed in the same or similar manner as the periscope device 100 (as shown in FIGS. 1A-3C), as previously described.
[0106] FIG. 6A shows a perspective view of the duodenoscope 10 alone (e.g., without the periscope device 500 therein). The distal end 506 of the periscope device 500 can be advanced through the instrument channel 22 of the duodenoscope 10, for example, as shown in FIG. 6B, such that the distal end 506 of the periscope device 500 extends from the distal end of the instrument channel 22. The periscope device 500 can then be deployed to position the mirror 516 to reflect a field of view from the optical lens 26 of the duodenoscope 10 (e.g., reflect a side field of view and provide a forward-looking field of view), for example, as shown in FIGS. 6C-6D. The first folding portion 514a can rotate about a first folding axis FA' relative to the second folding portion 514b, for example, as shown in FIG. 6C. The second folding portion 514b is rotatable about a second folding axis FA'' (e.g., defined by the longitudinal axis of the second pin 510b recessed into the page) relative to the third folding portion 514c, as shown, for example, in FIG. 6D.
[0107] In some embodiments, as shown, for example, in FIGS. 6A-6D , the periscope device 500 can be deployed to position a mirror over the optical lens 26 of the duodenoscope 10 without the need for an elevator (e.g., actuating an elevator to raise a portion of the elongated body 502 of the periscope device 500). For example, the folding portion 514 (or a portion of the folding portion 514) can be lifted without the elevator 20. Rotation about one or more folding axes FA, e.g., the first folding axis FA', the second folding axis FA'' and / or the third folding axis FA'' can properly position the periscope device 500 within the duodenoscope 10 without the use of the elevator 20. In one aspect, rotation of the second folding portion 514b about the second folding axis FA'' raises a portion of the folding portion 514 within the duodenoscope 10 without the use of an elevator.
[0108] 6D shows the periscope device 500 in a deployed position with the mirror 516 of the elongated body 502 positioned to reflect the field of view from the optical lens 26 of the duodenoscope 10 such that a forward-facing field of view is provided. In some embodiments, the longitudinal axis LAP of the elongated body 502 (e.g., the longitudinal axis of the first folded portion 514a) is perpendicular to the longitudinal axis LAO of the optical lens when the periscope device 500 is deployed, as shown, for example, in FIG. 6D. In some embodiments, the longitudinal axis LAP of the elongated body 502 (e.g., the longitudinal axis of the first folded portion 514a) is coplanar with the longitudinal axis LAO of the optical lens when the periscope device 500 is deployed.
[0109] FIG. 6D, for example, shows the light source 513 near the second folding axis FA″ (the second folding axis FA″ is not visible in FIG. 6). In some embodiments, during and / or after deployment of the periscope device 500, the longitudinal axis of the light source 513 may be approximately parallel to the longitudinal axis LAD of the duodenoscope 10, such that when the light source 513 is illuminated (e.g., turned on), the light source illuminates at least a portion of the field of view (e.g., the forward-facing field of view provided by the mirror 516). In some embodiments, the longitudinal axis of the light source 513 may be approximately perpendicular to the second folding axis FA″. For example, during and / or after deployment of the periscope device 500, the second folding axis FA″ may be approximately perpendicular to the longitudinal axis LAD of the duodenoscope 10, and the longitudinal axis of the light source 513 may be approximately parallel to the longitudinal axis LAD of the duodenoscope 10).
[0110] 7A-7D, there is shown one embodiment of a periscope device 500 for use with the duodenoscope 10. The periscope device 500 is advanced through the instrument channel 22 of the duodenoscope 10 and can be deployed in the same or similar manner as the periscope device 100 (as shown in FIGS. 1A-3C), as previously described.
[0111] FIG. 7A shows a perspective view of the duodenoscope 10 alone (e.g., without the periscope device 500 therein). The distal end 506 of the periscope device 500 can be advanced through the instrument channel 22 of the duodenoscope 10, for example, as shown in FIG. 7B, such that the distal end 506 of the periscope device 500 extends from the distal end of the instrument channel 22. The periscope device 500 can then be deployed to position the mirror 516 to reflect a field of view from the optical lens 26 of the duodenoscope 10 (e.g., reflect a side field of view and provide a forward-looking field of view), for example, as shown in FIGS. 7B-7D. The first folding portion 514a can rotate about a first folding axis FA' relative to the second folding portion 514b, for example, as shown in FIGS. 7B-7C. The second folding portion 514b can rotate about a second folding axis FA'' relative to the third folding portion 514c, as shown, for example, in FIG. 7C. The elongated body 502 within the channel 22 of the duodenoscope 10 can be advanced or retracted to position the mirror 516 relative to the optical lens 26 of the duodenoscope 10. For example, the elongated body 502 is shown advanced from FIG. 7C to FIG. 7D to position the mirror 516 in line with the optical lens 26. In some embodiments, as shown, for example, in FIGS. 7A-7D, the periscope device 500 can be deployed to position the mirror over the optical lens 26 of the duodenoscope 10 without the need for an elevator (e.g., actuating an elevator to raise a portion of the elongated body 502 of the periscope device 500).
[0112] 7D shows the periscope device 500 in a deployed position with the mirror 516 of the elongate body 502 positioned to reflect the field of view from the optical lens 26 of the duodenoscope 10 such that a forward-facing field of view is provided. In some embodiments, the longitudinal axis LAP of the elongate body 502 (e.g., the longitudinal axis of the first folding portion 514a) is perpendicular to the longitudinal axis LAO of the optical lens 26 when the periscope device 500 is deployed, as shown, for example, in FIG. In some embodiments, the longitudinal axis LAP of the elongate body 502 (e.g., the longitudinal axis of the first folding portion 514a) is coplanar with the longitudinal axis LAO of the optical lens 26 when the periscope device 500 is deployed. In some embodiments, the longitudinal axis LAO of the optical lens 26 is approximately perpendicular to the longitudinal axis LAD of the duodenoscope 10, as shown, for example, in FIGS. 2A-2C and 4A-4C. However, in other examples, as shown in FIGS. 7A-7D, the longitudinal axis LAO of the optical lens 26 defines an angle with respect to a line perpendicular to the longitudinal axis LAD of the duodenoscope 10. In some examples, the angle may be between 0 degrees and 15 degrees.
Claims
1. A periscope device for use with a duodenoscope, said periscope device comprising: an elongate body defining a longitudinal axis and having a proximal end, a distal end, and an exterior surface, the elongate body configured to be inserted into a working lumen of the duodenoscope; a folding portion of the elongate body, the folding portion configured to rotate about a folding axis; a mirror coupled to the folding portion of the elongated body; and a deployment mechanism coupled to the proximal end of the elongate body; By deploying the deployment mechanism, the folding portion rotates around the folding axis. A periscope device for use with a duodenoscope.
2. 2. The periscope device of claim 1, wherein the folding axis defines an elongated portion of the elongated body, the elongated portion extending from the proximal end of the elongated body to the folding axis, and the folding portion extending from the distal end of the elongated body to the folding axis.
3. The periscope device of claim 2 , wherein the elongated portion is constructed from a flexible material and the folding portion is constructed from a rigid or semi-rigid material.
4. 3. The periscope device of claim 2, wherein the folding axis is defined by the pin such that the folding portion rotates about the pin, the folding portion includes one or more knuckles, the elongated portion includes one or more knuckles, the one or more knuckles of the folding portion correspond to the one or more knuckles of the elongated portion, and the one or more knuckles of the folding portion and the one or more knuckles of the elongated portion have the pin extending therethrough.
5. The periscope device of claim 2 , wherein the deployment mechanism is configured to rotate the folding portion about the folding axis to a rotation angle relative to the elongated portion, the rotation angle being between 0 degrees and 180 degrees.
6. 3. The periscope device of claim 2, wherein the fold axis defines a fold axis angle relative to the longitudinal axis of the elongated body, the fold axis angle being approximately 45 degrees.
7. 2. The periscope device of claim 1, wherein the folding portion is a first folding portion, the folding axis is a first folding axis, and the periscope device further comprises a second folding portion configured to rotate about a second folding axis, and when the deployment mechanism is deployed, the second folding portion rotates about the second folding axis.
8. 8. The periscope device of claim 7, further comprising a third folding portion configured to rotate about a third folding axis, wherein upon deployment of the deployment mechanism, the third folding portion rotates about the third folding axis.
9. 9. The periscope device of claim 8, wherein the first fold axis, the second fold axis, and the third fold axis are each substantially perpendicular to the longitudinal axis of the elongated body.
10. 9. The periscope device of claim 8, wherein a longitudinal axis of the first folding portion is generally coplanar with a longitudinal axis of the second folding portion, and the longitudinal axis of the second folding portion is generally coplanar with a longitudinal axis of the third folding portion.
11. The periscope device of claim 8 , wherein the longitudinal axis of the first folding portion is perpendicular to a longitudinal axis of an optical lens of the duodenoscope.
12. 2. The periscope device of claim 1, wherein the elongated body defines a height after the deployment mechanism rotates the folding portion about the folding axis, the height being less than 4 millimeters.
13. The periscope device of claim 1 , wherein the mirror is configured to reflect a field of view of an optical lens of the duodenoscope.
14. The periscope device of claim 1, wherein the deployment mechanism transitions the elongated body from a non-deployed position to a deployed position, the periscope device does not obstruct a side-facing view from an optical lens of the duodenoscope when the periscope device is in the non-deployed position, and the folding portion reflects the side-facing view from the optical lens to provide a forward-facing view when the periscope device is in the deployed position.
15. 15. The periscope apparatus of claim 14, wherein the longitudinal axis of the forward field of view is approximately perpendicular to the longitudinal axis of the optical lens.
16. 3. The periscope device of claim 2, wherein the elongated body has a generally circular cross-section, and the folding portion and the elongated portion each include a recess to accommodate rotation of the folding portion about the folding axis.
17. 2. The periscope device of claim 1, further comprising a light source coupled to the folding portion, the light source defining a longitudinal axis, and after the folding portion rotates about the folding axis, the longitudinal axis of the light source is approximately parallel to a longitudinal axis of the duodenoscope.
18. 2. The periscope device of claim 1, wherein the elongated body defines a length between the proximal and distal ends, the length being at least 124 centimeters, and the outer surface of the elongated body has a circular cross-section defining a diameter, the diameter being less than 4.2 millimeters.
19. The periscope device of claim 1 , wherein the folding axis of the elongated body is oriented at an angle of approximately 45 degrees relative to the longitudinal axis of the elongated body.
20. The periscope device of claim 1 , wherein the angle of rotation of the folding portion relative to the elongated portion of the elongated body is between 0 degrees and 180 degrees.
21. The periscope device of claim 1 , wherein the elongated body has a length greater than 124 centimeters.
22. 2. The periscope device of claim 1, wherein the folded portion of the elongated body has a length of approximately 0.5 centimeters.
23. 10. The periscope device of claim 1, wherein the elongated body has a diameter of less than 4.2 millimeters.
24. 2. The periscope system of claim 1, wherein said mirror has a width of about 0.4 centimeters and a length of about 0.4 centimeters.
25. The periscope device of claim 1 , wherein said elongated body is made of plastic.
26. 1. A system for providing forward viewing with a duodenoscope, the system comprising: The duodenoscope, a duodenoscope body defining a longitudinal axis and having a proximal end, a distal end, and an exterior surface; an optical lens disposed on the exterior surface near the distal end of the duodenoscope body and configured to provide imaging; a working lumen within the duodenoscope body and defining a proximal end and a distal end, the distal end of the working lumen being proximate the optical lens; and an elevator associated with the distal end of the working lumen, the elevator being operable to adjust to an elevation angle; The duodenoscope comprising:
1. A periscope device, comprising: an elongate body defining a longitudinal axis and having a proximal end, a distal end, and an exterior surface; a folding axis of the elongated body defining an elongated portion of the elongated body and a folded portion of the elongated body; a mirror attached to the folding portion of the elongated body; and a deployment mechanism coupled to the proximal end of the elongate body; the deployment mechanism is configured to rotate the folding portion of the elongated body about the folding axis at a rotation angle relative to the elongated portion of the elongated body; 1. A system for providing forward viewing with a duodenoscope, comprising:
27. 27. The system of claim 26, wherein the folding axis of the elongate body is oriented at an angle of approximately 45 degrees relative to the longitudinal axis of the elongate body.
28. 28. The system of claim 27, wherein the rotation angle is between 0 degrees and 180 degrees.
29. 27. The system of claim 26, wherein the elongate body has a length greater than 124 centimeters.
30. 27. The system of claim 26, wherein the folded portion of the elongate body has a length of about 0.5 centimeters.
31. 27. The system of claim 26, wherein the elongate body has a diameter of less than 4.2 millimeters.
32. 27. The system of claim 26, wherein the mirror has a width of about 0.4 centimeters and a length of about 0.4 centimeters.
33. 27. The system of claim 26, wherein the elongate body is made of plastic.
34. 1. A method of using a periscope device to provide forward viewing through a duodenoscope, the method comprising: inserting a distal end of an elongated body of the periscope device into a proximal end of a working lumen of a duodenoscope, wherein a folding axis is incorporated into the elongated body, the folding axis defining an elongated portion of the elongated body and a folded portion of the elongated body, and a speculum is attached to the folded portion of the elongated body; advancing the elongate body of the periscope device until the folded portion of the elongate body extends from the distal end of the working lumen of the duodenoscope; activating a deployment mechanism coupled to the proximal end of the elongated body of the periscope device, thereby rotating the folded portion of the elongated body about the folding axis at a rotation angle relative to the elongated portion of the elongated body; and orienting the mirror to reflect a field of view from an optical lens of the duodenoscope at a field of view angle; A method comprising:
35. The method of claim 34, wherein the rotation angle is between 0 degrees and 180 degrees.
36. 35. The method of claim 34, wherein the viewing angle is about 45 degrees.
37. inserting a distal end of the duodenoscope into a patient; and advancing the distal end of the duodenoscope to a desired location within the patient; 35. The method of claim 34, further comprising:
38. 40. The method of claim 37, further comprising raising an elevator of the duodenoscope to an elevation angle.
39. 39. The method of claim 38, wherein the elevation angle is about 90 degrees.
40. removing the elongate body of the periscope device from the working lumen of the duodenoscope; and removing the duodenoscope from the patient; 38. The method of claim 37, further comprising:
41. inserting the distal end of the duodenoscope into the patient's mouth; and advancing the duodenoscope through the patient's mouth, through the patient's throat, through the patient's stomach, and into the patient's duodenum; 38. The method of claim 37, further comprising: