The present disclosure pertains to medical devices. More particularly, the present disclosure pertains to expandable guide devices and related systems and methods, particularly as may increase the effectiveness and efficiency of endoscopic procedures.
Endoscopes, for example, are used in medical procedures to examine and treat conditions within the digestive tract. ERCP procedures, for example, are used to examine, diagnose and treat areas in the common bile duct and pancreatic ducts. In some procedures, cannulation of the bile duct can be difficult, with movement in the duodenum making positioning and stabilization of the endoscope hard to achieve. Peristaltic movements in the duodenum can require medicating the patient to suppress such movements. Further, the tightly contracted musculature of the duodenal papilla may require precise maneuvering of a catheter through the papilla opening. Consequently, the effectiveness and efficiency of the procedure may become compromised, and the inability to cannulate the common bile duct may result in a failed or prolonged ERCP procedure and/or may result in procedural or post-procedural complications, such as infection.
Further, a colonoscope is a type of endoscope used for colonoscopies. Due to the length of the colonoscope and the tortuous anatomy of the colon, during some procedures, for example, during polyp removal, the colonoscope can become deformed or “loop” within the colon, causing pain for the patient and prolonging the procedure time. When looping occurs, the potential movements of the endoscopist may become limited. Consequently, it may become necessary to restart the colonoscopy procedure and the effectiveness and efficiency of the procedure may be compromised. Although endoscopists are trained in methods to reduce the prevalence of looping, it remains a recurring issue.
It is with the above considerations in mind that the improvements of the present disclosure may be useful.
The present disclosure, in its various aspects, is directed generally to expandable guide devices, implementation methods, and related systems. Embodiments according to the present disclosure, including those described herein, may increase particularly the effectiveness and efficiency of procedures used for the examination and treatment of conditions within the body, e.g., cannulation of the bile duct during an ERCP procedure or maneuvering within the colon during a colonoscopy procedure.
In an aspect, embodiments of the disclosure describe an expandable guide device that may comprise a first body comprising a proximal end, a distal end, the first body defining an instrument lumen extending therethrough along a longitudinal axis of the first body. The instrument lumen may be configured to slidingly receive a length of an instrument extendible therethrough. The expandable guide device may comprise a plurality of expandable members disposed circumferentially about the first body, each member of the plurality of expandable members of the first body extending between a proximal end and a distal end along the longitudinal axis of the first body. Each member of the plurality of expandable members of the first body may be independently expandable radially. Each expandable member may be independently expandable between an unexpanded configuration, partially expanded configuration, and expanded configuration, such that a first length of the instrument extendible through the instrument lumen of the first body is positionable radially, angularly, or both, relative to a central axis of a body lumen.
In various embodiments described herein and otherwise within the scope of the disclosure, wherein two or more of the plurality of expandable members of the first body are expandable, the expandable guide device may further comprise a plurality of first elongate fluid delivery members. Each first delivery member may be in fluid communication with a respective expandable member of the plurality of expandable members of the first body that are expandable. The expandable guide device may comprise a second body proximal to the first body, the second body may comprise a proximal end, a distal end, the second body defining an instrument lumen extending therethrough along a longitudinal axis of the second body. The instrument lumen may be configured to slidingly receive a second length of the instrument extendible therethrough. The second body may comprise a plurality of expandable members disposed circumferentially about the second body. Each member of the plurality of expandable members of the second body may be extending between a proximal end and a distal end along the longitudinal axis of the second body. Each member of the plurality of expandable members of the second body may be independently expandable radially between an unexpanded configuration, partially expanded configuration, and expanded configuration, such that the second length of the instrument extendible through the instrument lumen of the second body may be positionable radially, angularly, or both, relative to the central axis of the body lumen. Two or more members of the plurality of expandable members of the second body may be expandable and may further comprise one or more second elongate fluid delivery members. Each second delivery member may be in fluid communication with a respective expandable member of the plurality of expandable members of the second body that are expandable.
The plurality of expandable members may comprise a non-compliant material or a compliant material, or a combination thereof. The device may further comprise a handle and an actuating member may be attached at a proximal end to the handle and may be attached at a distal end to the first body, the second body, or both. The instrument lumen of the first body, the second body, or both, may be selectively slidably positionable along the respective first and second lengths of the instrument with the actuating member. The plurality of expandable members of the first body, the second body, or both, may comprise two, three, or four expandable members. The actuating member may comprise a lumen. The plurality of expandable members of the first body, the second body, or both, may be spherical, oblong, bean-shaped, kidney-shaped, finger-shaped or ellipsoidal, or any combinations thereof. Two or more members of the plurality of expandable members of the second body may be expandable and non-compliant. The one or more second elongate fluid delivery members may comprise a single elongate fluid delivery member in fluid communication with the two or more non-compliant expandable members.
In various embodiments described herein and otherwise within the scope of the disclosure, the expandable guide device may further comprise a second and third body aligned axially with each other and the first body, each comprising a proximal end and a distal end. The second body and the third body each may define an instrument lumen extending therethrough along a longitudinal axis of the second body and the third body. The instrument lumen of the second body and the third body may be configured to slidingly receive a respective second length and third length of the instrument extendible therethrough. The second body and the third body may comprise a plurality of expandable members disposed circumferentially about the first body, second body, and the third body. The expandable members may be extending from the proximal end of the second body to the distal end of the first body, and from the distal end of the second body to the proximal end of the third body, along the longitudinal axis of the first, second, and third body. The expandable members extending between the first and second bodies may be configured to expand radially from the longitudinal axis of the first and second bodies when an axial length between the first and second bodies is decreased. The expandable members extending between the first and second bodies may be configured to expand radially from the longitudinal axis of the second and third bodies when an axial length between the second and third bodies is decreased. The first, second, or third bodies, or combinations thereof, may be configured to be pushed or pulled along one or more of the longitudinal axes of the first, second and third bodies to selectively expand the expandable members between the first and second bodies, or the expandable members between the second and third bodies, or both. The plurality of expandable members of the first body may comprise a plurality of turns forming a coil, and wherein the coil may be disposed along the first body. The coil and the first body may be expandable radially when the distal end of the first body is fixed to the instrument and the proximal end of the first body is rotated about the longitudinal axis of the first body. The at least one expandable member may comprise a compliant material. The at least one expandable member may comprise one, two, three, or four expandable members. The at least one non-compliant expandable members may comprise one, two, three, or four expandable members.
In various embodiments described herein and otherwise within the scope of the disclosure, the actuating member may comprise a lumen. The at least one expandable member of the first body, the at least one non-compliant expandable member of the second body, or both, may be spherical, oblong, bean-shaped, kidney shaped, finger-shaped or ellipsoidal, or any combinations thereof. Two or more members of the plurality of expandable members of the second body may be expandable and non-compliant. One or more of the second elongate delivery member may comprise a single elongate fluid delivery member in fluid communication with the two or more non-compliant expandable members. The expandable guide device may further comprise a sleeve slidably disposed about the expandable guide device. The at least one expandable member of the first body, the second body, or both, may be adhered to the respective first body and the second body and may be arranged about the respective first body and second body with annularly symmetrical spacing. The second elongate fluid delivery member may comprise a single elongate fluid delivery member in fluid communication with a plurality of the non-compliant expandable members. The expandable guide device may be configured to be positioned proximal to an articulation joint of the instrument. The plurality of expandable members of the first body may comprise a shape memory metal or plastic material and may be formed from round wires, flat wire, or woven mech, or combinations thereof.
In an aspect, embodiments of this disclosure describe an endoscopic system that may comprise an instrument and an expandable guide device slidably disposed about the instrument. The expandable guide device may comprise a first body comprising a proximal end, a distal end, the first body may define an instrument lumen extending therethrough along a longitudinal axis of the first body, and the instrument lumen may be configured to slidingly receive a first length of the instrument extendible therethrough. The system may comprise a plurality of expandable members disposed circumferentially about the first body. Each member of the plurality of expandable members may be extending between a proximal end and a distal end along the longitudinal axis of the first body. Each member of the plurality of expandable members of the first body may be independently expandable radially between an unexpanded configuration, partially expanded configuration, and expanded configuration, such that the first length of the instrument extendible through the instrument lumen of the first body may be positionable radially, angularly, or both, relative to a central axis of a body lumen. The expandable guide device may comprise an actuating member and a handle may be attached to the first body. The handle may be configured to selectively position the instrument lumen of the first body along the length of the instrument by sliding the first body along the instrument with the actuating member.
In various embodiments described herein and otherwise within the scope of the disclosure, two or more members of the plurality of expandable members of the first body may be expandable, and further comprising a plurality of first elongate fluid delivery members. Each first delivery member may be in fluid communication with a respective expandable member of the plurality of expandable members of the first body that are expandable. The system may comprise a second body proximal to the first body. The second body may comprise a proximal end, a distal end, the second body may define an instrument lumen extending therethrough along a longitudinal axis of the second body, and the instrument lumen may be configured to slidingly receive a second length of the instrument extendible therethrough. It may comprise a plurality of expandable members disposed circumferentially about the second body. Each member of the plurality of expandable members of the second body may be extending between a proximal end and a distal end along the longitudinal axis of the second body. Each member of the plurality of expandable members of the second body may be independently expandable radially between an unexpanded configuration, partially expanded configuration, and expanded configuration, such that the second length of the instrument extendible through the instrument lumen of the second body may be positionable radially, angularly, or both, relative to the central axis of the body lumen. Each second elongate fluid delivery member may be configured to circulate fluid within the respective non-compliant expandable member. The first expandable guide device may be fixed by the first body, the second body, or both.
In various embodiments described herein and otherwise within the scope of the disclosure, the system may comprise one, two, three, four, five or more expandable members of the first body, the second body, or both, of the expandable guide device. Each expandable member may comprise a compliant or non-compliant material. The system may comprise an over-sleeve slidably disposed about the expandable guide device. The expandable member of the first body may comprise a compliant or a non-compliant material.
In an aspect, embodiments of the disclosure describe a method of performing an endoscopic procedure within a patient. The method may comprise inserting an endoscope into an instrument lumen of an expandable guide device, advancing the endoscope and the expandable guide device through a body lumen to a treatment site within the patient. The expandable guide device may include a plurality of expandable members disposed circumferentially about the expandable guide device, wherein each member of the plurality of expandable members may be independently expandable radially between an unexpanded configuration, partially expanded configuration, and expanded configuration. The method may comprise expanding one or more members of the plurality of expandable members at the first treatment site within the patient, such that the endoscope inserted through the instrument lumen of the expandable guide device is positionable radially, angularly, or both, relative to a central axis of the body lumen.
In various embodiments described herein and otherwise within the scope of the disclosure, the instrument may comprise an endoscope, such as a colonoscope, duodenoscope, bronchoscope, gastroscope, and the like. The plurality of expandable members may comprise a non-compliant material or a compliant material, or combinations thereof.
In various embodiments described herein and otherwise within the scope of the disclosure, the expandable guide device of the method may comprise one, two, three, four, five or more expandable members. The expandable member may be non-compliant. The expandable member may be compliant. Expanding the at least one expandable member may bend the endoscope. Expanding the at least one expandable member may straighten the endoscope. Expanding the at least one expandable member may stabilize the endoscope in position. The expandable members may be independently expanded. The method may comprise advancing a second device toward a treatment site. Expanding the at least one expandable member may adjust the position of the endoscope within the body lumen. Expanding the at least one expandable member may comprise inflation of the expandable member with air, CO2, or fluid contrast.
Non-limiting examples of the present disclosure are described by way of example with reference to the accompanying figures, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the disclosure shown where illustration is not necessary to allow those of skill in the art to understand the disclosure. In the figures:
It is noted that the drawings are intended to depict only typical or exemplary embodiments of the disclosure. Accordingly, the drawings should not be considered as limiting the scope of the disclosure. The disclosure will now be described in greater detail with reference to the accompanying drawings.
It is the case, generally, that with any form of endoscopy or other procedure where any other instrument is inserted in the body it may be important to be able to stabilize the instrument in place once it is navigated to a desired position, to locate the instrument in a particular radial position defined by a cross-section of the body lumen, to orient an instrument in a particular manner dictated by a specific procedure, and the like.
Various embodiments according to the present disclosure are described below. As used herein, “proximal end” refers to the end of a device that lies closest to the medical professional along the device when introducing the device into a patient, and “distal end” refers to the end of a device or object that lies furthest from the medical professional along the device during implantation, positioning, or delivery.
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used in connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
The detailed description should be read with reference to the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
Embodiments of the present disclosure may include expandable guide devices for use with an instrument. An instrument may be an endoscope, bronchoscope, duodenoscope, colonoscope, gastroscope, ureteroscope, a catheter, or the like. The devices may include various components and configurations. Embodiments of this disclosure may comprise a medical device system. A medical device system may include an instrument, an expandable guide device, tools for use with the instrument, a proximal handle to, e.g., actuate the device, which extends to the body of the expandable guide device, and/or in embodiments including a balloon as an expandable member, a source of inflation fluid, or the like. Embodiments of the devices and systems may be used to substantially fill the space within a body lumen around the instrument, e.g., during an endoscopy, to enable the operator to stabilize the instrument within the body. Various embodiments described herein comprise an expandable guide device having plurality of expandable members about a body forming an instrument lumen that can slidingly receive a length of an instrument, such as an endoscope, within the instrument lumen. The expandable member(s) once expanded within the body lumen may advantageously inhibit or reduce movement of the instrument within the body lumen. In some embodiments, such as an expandable member comprising a balloon, the inflation fluid may be a gas, a liquid, or both. In some embodiments, the body lumen may include a lumen, organ, vessel, passage, or the like, within, e.g., the digestive system, or the like. In various embodiments, an expandable member may expand to a greater or lesser degree, may assume a different shape, and/or may exhibit different other properties than another expandable member. In various embodiments, the expandable guide device may be disposable. In alternate embodiments, the expandable guide device may be reusable.
ERCP procedures are used to examine, diagnose and treat areas in the common bile duct and pancreatic duct. An endoscope may be introduced into the patient, e.g., via the mouth, through the stomach and advanced through at least a portion of the small intestine. The endoscope may be used to access the ampulla of Vater in order to reach the pancreatic and bile ducts. The positioning, stabilization and/or angle of approach of the endoscope relative to the ampulla of Vater may be important to the success of the procedure and may be made difficult by movement and breathing of the patient, movement of the duodenum and operation of tools within or in relation to the endoscope. In order for a user to perform ERCP, the distal end of an instrument must be sufficiently stabilized within the body lumen at the ampulla or papilla of Vater, which requires extreme precision. Once placed in position, the instrument (e.g., endoscope) needs to be kept stable enough to facilitate access to and entry into and through the ampulla or papilla of Vater by the instrument and/or by an accessory device (e.g., biopsy tool) delivered through a working channel of the instrument and/or the expandable guide device.
Colonoscopies are a type of endoscopic procedure used to examine and treat the colon using an instrument (e.g., a colonoscope). The colonoscope, as an instrument with which an expandable guide device may be useful, is introduced into the patient via the anus and rectum, and through the colon. The instrument may be used to examine and diagnose tissue, take samples and/or remove polyps from the intestines during the examination. Due to the tortuous anatomy of the colon, when attempting to navigate the colonoscope through the curves of the colon, looping of the colonoscope, and consequently looping of intestines, can occur during the procedure, which may cause pain for the patient and may slow the procedure. Looping may cause the instrument to become undesirably positioned within the body lumen and require additional steps to be taken by the physician. The loop may be an alpha loop, a reverse alpha loop, an N loop, a reverse splenic flexure, a gamma loop, or a reverse sigmoid spiral. Current methods of resolving these loops involve proximal translation or removal of part or all of the instrument and restarting or continuing the procedure from the point at which the loop is no longer present, whereby the anatomy is substantially returned to a typical configuration. This process may cause additional discomfort and/or prolong the procedure further for the patient.
A number of medical procedures, including intravascular procedures, procedures along the digestive, urinary, respiratory, reproductive and/or biliary tracts, thoracic and pulmonary procedures, etc., utilize instruments, such as endoscopes, to access tissue intended for diagnosis or treatment (e.g., “target tissue”) within the body. In some instances, an endoscope may incorporate features which assist the physician in visualizing and performing a treatment on the tissue. For example, some endoscopes may include a light and/or camera designed to illuminate and/or visualize the body lumen as the endoscope is navigated and positioned adjacent to a target tissue site. Additionally, some endoscopes may also include a lumen (e.g., a working channel) through which a resecting device, grasping member, or other accessory devices may be deployed and utilized. Additional visualization and/or external and/or internal imaging methods may be alternatively or additionally employed, e.g., fluoroscopy.
Embodiments of the expandable guide devices, systems and methods of the present disclosure may be used with various endoscopes or other instruments, within different body lumens and with respect to a range of applications, such as described above, to enable the physician to perform procedures with greater precision, accuracy, and ease than without the expandable guide devices.
As used herein to describe the various embodiments described herein or otherwise within the scope of the disclosure, an inner surface of a body refers to a surface facing the instrument lumen and instrument when received therein. An outer surface of a body refers to a surface facing the body lumen.
In various embodiments described herein and otherwise within the scope of the disclosure, an expandable guide device may include a plurality of expandable members. The expandable members may be segmented or chambered and each segment or chamber may be independently expandable radially, e.g., to affect different shapes of the expandable member around the circumference of the device by maintaining unexpanded, or partially expanding, or expanding, various of the chambers of the expandable member. An expandable member may be a balloon, a mesh, a braid, a flap, a wire, or the like, and may be mechanically actuated, electrically actuated, pneumatically actuated, inflated, or the like. An expandable guide device may include one, two, three, four, five, or more expandable members. An expandable member may be adhered to a body, sheath, or the like, utilizing an adhesive, a tape, flowed material, welding (e.g., laser, ultrasonic, hot jaw thermal, etc.), melt/re-melt flow processes, or the like. An expandable member may be spherical, oblong, bean-shaped, kidney-shaped, finger-shaped or ellipsoidal, or any combinations thereof, or the like. An expandable member may be an expandable elastic material that may be compliant, non-compliant, or both, and may comprise latex, silicone, Pebax, a combination thereof, or the like. A compliant expandable member may be configured to expand to fill a body lumen. A non-compliant expandable member may be configured to expand to a set dimension and/or shape. An expandable member may be filled with fluid or gas. An expandable member may be transitioned from an unexpanded configuration to an expanded configuration (including a partially expanded configuration) to occlude, stretch, establish patency, or maintain patency of a body lumen. An expandable member may be used to center or position an instrument within the body lumen. An expandable member may be used to manipulate tissue of a body lumen for viewing or operation.
An expandable member or other portions of the device may comprise one or more radiopaque markers at various positions about and along the device. The radiopaque markers may be imaged during a procedure allowing, e.g., the position of the device or devices with respect to each other, with respect to the instrument, and/or with respect to a portion of the body lumen, to be determined, changed, confirmed, etc., and the like. The degree of expansion of the expandable members may be confirmed as well. Also, contrast fluid that is imageable may be injected in the body lumen or the inflation fluid for the expandable members may be made radiopaque. Radiopaque markers may include radiopaque filler compounded into the material of the expandable member and/or independent markers may be affixed to the interior or exterior of the expandable members, to the surfaces of the body, or to other portions of the device.
In various embodiments described herein and otherwise within the scope of the disclosure, an expandable guide device may include an actuating member. A proximal end of the actuating member may be manipulated to move the expandable guide device within a patient. The actuating member may have a lumen. The lumen may accept a stylet for manipulation and/or axial movement of the body with expandable members. The lumen for expansion and manipulation/movement may be separate or shared. Expandable members may be configured to be expanded in unison or may be configurate to be independently expanded. Expandable members may be expanded to different volume or degrees around the circumference of an expandable guide device and/or among expandable members on other expandable guide devices along the instrument, if desired, in order to affect orientation of the instrument, steer the instrument, and/or locate the instrument offset from the central axis, within the body lumen of the patient. The actuating members may be used to push and pull devices along the instrument. They may be used to position and/or reposition the device before expanding. The instrument lumen of the first body, second body, or both, may be selectively slidably positionable along the respective first and second lengths of the instrument with the actuating member.
Exemplary devices, systems, and methods with which embodiments of the present disclosure may be implemented include, but are not limited to, those described in the complete disclosures of U.S. Provisional Patent application having Attorney Docket No. 8150.0728Z, titled Devices, Systems, and Methods for Pyloric Occlusion, filed Aug. 27, 2020; U.S. Provisional Patent application having Attorney Docket No. 8150.0729Z, titled Stabilization and Leverage Devices, Systems, and Methods, filed Aug. 28, 2020; U.S. Provisional Patent application having Attorney Docket No. 8150.0722Z, titled Expandable Guide Devices, Systems, and Methods, filed even date herewith; and U.S. Provisional Patent application having Attorney Docket No. 8150.0723Z, titled Expandable Guide Devices, Systems, and Methods, filed even date herewith, each of which disclosures are herein incorporated by reference in their entirety.
Examples of expandable guide devices for use with instruments are described herein with respect several embodiments. Referring to
In an exemplary method of performing an endoscopy, such as an ERCP procedure, a distal end of an endoscope may be advanced through the stomach and into the small intestine via the mouth of a patient. Once inside the patient, the digestive system may be visually examined and the pancreatic and bile ducts may be accessed using various tools passed through the working channel of the endoscope from the handle at the proximal end of the endoscope that remains outside of the body.
Examples of expandable guide devices for use with instruments, such as the endoscope of
In various embodiments described herein and otherwise within the scope of the disclosure, an expandable member may be expanded in order to contact the body lumen, partially expanded when the user is positioning the device and does not want to unexpand the expandable member, and unexpanded when moving the device through the body lumen. The expandable members may be expanded independently so that the instrument may be moved radially within the body lumen. This radial movement may assist with stabilization, positioning, and movement of the device through difficult portions of the body lumen.
In various embodiments described herein and otherwise within the scope of the disclosure, an expandable guide device with pneumatically or expandable members may have a fluid inlet that may extend through the outer surface of an expandable member. The fluid inlet may supply and remove an inflation fluid for expanding and un-expanding or collapsing the expandable member. A single elongate fluid delivery member may be in fluid communication with a single expandable member, or with two or more expandable members, via the fluid inlets.
The one or more inflation fluid delivery members may extend along the instrument and/or along or through the body of an expandable guide device and through the outer surface of an expandable member. In some embodiments, an expandable member may comprise an expandable balloon, and the inflation fluid may be fluid, such as a gas, a liquid, or both. An inflation fluid delivery member may extend to the proximal end of the instrument and be connectable with a fluid source, e.g., a gas or liquid inlet/outlet at the handle of the guide device. Fluid (e.g., saline, air, etc.) may be inserted and removed from the inflation fluid delivery member by a source e.g., a syringe. The insertion of fluid may cause the expandable members to expand, and removal of fluid may cause the expandable members to un-expand, or collapse or deflate in the case, e.g., of a balloon as an expandable member. An inflation fluid delivery member may extend within a working channel or inflation lumen of an instrument. An inflation fluid delivery member may be in fluid communication with an inflation lumen of an instrument, while the instrument is extended within the instrument lumen of the body of an expandable guide device.
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In various embodiments described herein and otherwise within the scope of the disclosure, a stylet may also extend from a handle portion of the expandable guide device, e.g., kept at the proximal end of the instrument, through an actuating member or delivery member of the expandable guide device. The stylet can be used to push and/or pull the device in tandem with the instrument or relative to the instrument in order to position or reposition the device along the surface of the instrument. The stylet may hold the device in place when only the instrument is moved relative to the device. When moving the guide device with the stylet relative to the instrument or moving the guide device and the instrument in tandem, the expandable members can be partially expanded or unexpanded in the body lumen. The movement of the device along the instrument can be in a distal or proximal direction. Alternatively, the expandable member may be expanded, and the stylet is used to keep the device in place, facilitating movement of the instrument through the body lumen while the expanded expandable member keeps the body lumen stabilized. Two or more of a plurality of expandable members may be expanded in order to contact the body lumen, partially expanded when the user is positioning the device and does not want to unexpand the expandable member, and unexpanded when moving the device through the body lumen.
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In combination, with this embodiment and other embodiments described, a system having an instrument and one or more expandable guide devices with expandable members provides the capability of a stable platform for the instrument once in position for diagnostic or treatment procedures to be performed with multiple, simultaneous tool access to the treatment site.
In various embodiments described herein and otherwise within the scope of the disclosure, a stylet may also extend from a handle portion of the guide device, e.g., kept at the proximal end of the instrument, through an actuating member or delivery member of the device. The stylet can be used to push and/or pull the device or portions of the device relative to the instrument in order expand or unexpand the device along the surface of the instrument. The stylet may hold the device in a chosen configuration. When moving the device with the stylet relative to the instrument or moving the guide device and the instrument in tandem, the expandable member may not be expanded. The movement of the device along the instrument can be in a distal or proximal direction. Alternatively, when the expandable member is expanded and the stylet may be used to keep the device in place, facilitating movement of the instrument through the body lumen while the expanded expandable member keeps the body lumen stabilized. An expandable member may be expanded in order to contact the body lumen, partially expanded when the user is positioning the device and does not want to unexpand the expandable member, and unexpanded when moving the device through the body lumen.
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In various embodiments described herein and otherwise within the scope of the disclosure, the expandable members have sensors for measuring temperature, pressure, and the like. The sensors may alert the user as to when the expandable member has expanded into the body lumen wall. The sensors may further inform the user when to stop expanding the expandable member based on a reading of pressure or temperature. The sensor may trigger an automatic response, stopping expansion once a threshold is reached.
In various embodiments described herein and otherwise within the scope of the disclosure, an expandable member may have an expanded configuration (including partially expanded configuration) and a collapsed configuration. An expandable member may comprise a variety of compliant, semi-compliant, or non-compliant materials. These materials may comprise silicone, latex, polyurethane, rubber, isobutylene or the like. The thickness of the expandable member may vary with the material and may relate to the outer diameter of the expandable member in the collapsed and the expanded configuration. An expandable member may be expanded and collapsed or otherwise stretched once or a plurality of times to increase its elasticity prior to use within a patient, which may improve a symmetrical inflation of the expandable member and may improve the centering mechanics of the expandable member. An expandable member may be expanded via a supply of an inflation fluid through the fluid delivery members and one or more fluid inlets that are part of the expandable members. The same fluid delivery member and inlet may be used to expand and deflate the expandable member. Alternatively, a supply fluid inlet and a return fluid inlet may be intermittently or continuously used to circulate inflation fluid through an expandable member. A continuous flow of inflation fluid through a supply fluid inlet and a return fluid inlet may substantially maintain a desired pressure of the inflation fluid within the expandable member, or the inflation fluid may be heated and circulated to maintain a desired temperature within the expandable member.
In various embodiments described herein and otherwise within the scope of the disclosure, the distal end of the instrument may or may not extend past the distal end of the expandable guide device.
In various embodiments described herein and otherwise within the scope of the disclosure, an expandable member may expand to a greater or lesser degree than other expandable members.
In various embodiments described herein and otherwise within the scope of the disclosure, the expandable guide device may be disposable. In alternate embodiments, the expandable guide device may be reusable.
In various embodiments described herein and otherwise within the scope of the disclosure, a method of performing an endoscopy may include inserting an endoscope into an instrument lumen of an expandable guide device. The instrument and expandable guide device may be together inserted into a patient. The endoscope and expandable guide device may be advanced through a body lumen to a treatment site within the patient. The expandable guide device may include a plurality of expandable members disposed circumferentially about the expandable guide device, wherein each member of the plurality of expandable members may be independently expandable radially between an unexpanded configuration, partially expanded configuration, and expanded configuration. The method may include expanding one or more members of the plurality of expandable members at the treatment site within the patient, such that the endoscope inserted through the instrument lumen of the expandable guide device is positionable radially, angularly, or both, relative to a central axis of the body lumen. The expandable members can be expanded within the patient, dilating or expanding into contact with the patient's body lumen, e.g., the duodenum, the intestines, or the like. Expanding the expandable member may facilitate holding the instrument still while using the instrument to examine other areas of the body. This can occur due to the outer diameter of the expandable member being dilated or pushing up in close contact to the body lumen, and inhibiting movement of the expandable guide device, as well as through selective expansion of expandable members to position the instrument at a particular radial position in the body lumen and/or at a particular angle of approach to the target tissue.
In various embodiments, multiple expandable guide devices can be used with a single instrument.
Variations, modifications, and other implementations of the present disclosure in addition to the various embodiments described herein will occur to those of ordinary skill in the art. Accordingly, the present disclosure is to be defined not by the preceding illustrative description but instead by the following claims:
The present application is a non-provisional of and claims the benefit of priority under 35 USC § 119 to, U.S. Provisional Application Ser. No. 63/083,962, filed Sep. 27, 2020, the disclosure of which is herein incorporated herein by reference in its entirety and for all purposes.
Number | Date | Country | |
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63083962 | Sep 2020 | US |