DEVICES AND METHODS FOR EXTENDING A WORKING CHANNEL
20230059972 · 2023-02-23
Assignee
Inventors
- Martyn G. Folan (Loughrea / Co. Galway, IE)
- Matthew Montague (Oranmore / Galway, IE)
- Louis McNern (Co. Donegal / Donegal, IE)
Cpc classification
A61B1/00121
HUMAN NECESSITIES
A61B1/0014
HUMAN NECESSITIES
International classification
A61B1/00
HUMAN NECESSITIES
Abstract
The present disclosure relates to the field of medical devices. Specifically, the present disclosure relates to devices, systems and methods for extending a working channel of an endoscope, such as for delivery of a stent.
Claims
1. An extension device, comprising: a tubular inner member including a lumen extending therethrough; a tubular outer member including a lumen extending therethrough, the lumen of the outer member configured to receive the inner member, the outer member and inner member slidable relative to each other in a telescoping fashion to a desired position that corresponds to an adjustable length of the extension device; a locking assembly configured to fix the outer member and the inner member with respect to each other at the desired position; a proximal connector at a proximal end of the outer member configured to connect to a distal end of a handle of a first medical device; and a distal connector at a distal end of the inner member configured to connect to a proximal end of a second medical device; wherein the extension device is configured to facilitate an extension of the first medical device therethrough such that the first medical device extends beyond a distal end of the second medical device to deliver a stent from a distal end of a shaft extending distally from the handle of the first medical device; and wherein the extension device is removable from about the shaft of the first medical device without drawing the shaft proximally through the lumens of the inner and outer members.
2. The extension device of claim 1, wherein the shaft of the first medical device is extendable through the lumen of the outer and inner members of the extension device, through a lumen extending from the proximal end to a distal end of the second medical device, and beyond the distal end of the second medical device a predetermined distance.
3. The extension device of claim 1, wherein the desired position includes at least one predetermined fixed position of the locking assembly.
4. The extension device of claim 1, wherein the desired position includes a plurality of predetermined fixed positions of the locking assembly.
5. The extension device of claim 1, further comprising: a channel extending along the inner member, the distal connector, and through to the lumen of the inner member; a channel extending along the outer member, the proximal connector, and through to the lumen of the outer member, and wherein the channels of the inner and outer member are configured to align with each other, such that the extension device may be placed and removed from about the shaft of the first medical device.
6. The extension device of claim 5, wherein one or both of the outer member and the inner member are rotatable with respect to each other, such that the device may be transitioned between an open configuration with the channel of the inner member and the channel of the outer member substantially aligned, and a closed configuration with the channel of the inner member and the channel of the outer member not substantially aligned.
7. The extension device of claim 1, further comprising a pivotable joint disposed at a distal portion of the inner member proximal to the distal connector, wherein the joint has a first longitudinal axis alignable with a longitudinal axis of the second medical device and a portion of the inner member distal to the pivotal joint, and wherein the joint has a second longitudinal axis alignable with a longitudinal axis of a remaining portion of the inner member.
8. The extension device of claim 7, wherein the joint comprises: a spherical body at the distal portion of the inner member, the spherical body having a lumen therethrough that is in fluid communication with the lumen of the inner member; and a cupped body at the distal portion of the inner member disposed about the spherical body, the cupped body having a lumen therethrough that is in fluid communication with the lumen of the spherical body; and wherein the spherical body is pivotable within the cupped body while maintaining the lumens of the inner member, spherical body, and cupped body in fluid communication.
9. An extension system, comprising: an endoscope having a working channel; a delivery device having a shaft extending distally from the delivery device and receivable within the working channel; and an extension device comprising: a tubular inner member including a lumen extending therethrough; a tubular outer member including a lumen extending therethrough, the lumen of the outer member configured to receive the inner member, the outer member and inner member slidable relative to each other in a telescoping fashion to a desired position that corresponds to an adjustable length of the extension device; a locking assembly configured to fix the outer member and the inner member with respect to each other at the desired position; a proximal connector at a proximal end of the outer member configured to connect to a distal end of a handle of the delivery device; and a distal connector at a distal end of the inner member configured to connect to a proximal end of the endoscope; wherein the delivery device is configured to extend through and beyond a distal end of the endoscope to deliver a stent from a distal end of the delivery device; and wherein the extension device is removable from about the shaft of the delivery device without withdrawing the shaft proximally through the lumens of the inner and outer members.
10. The system of claim 9, wherein the adjustable length of the extension device is such that the shaft is extendable through the lumen of the outer and inner members of the extension device, through the working channel extending from the proximal end to a distal end of the endoscope, and beyond the distal end of the endoscope a predetermined distance.
11. The system of claim 9, wherein the locking assembly has a predetermined fixed position coinciding with a length of the shaft between the proximal end of the endoscope and the distal end of the delivery device.
12. The system of claim 9, further comprising: a channel extending along the inner member, the distal connector, and through to the lumen of the inner member; and a channel extending along the outer member, the proximal connector, and through to the lumen of the outer member, wherein the channels of the inner and outer member are configured to align with each other, such that the extension device may be removed from about the shaft of the delivery device while the shaft is in the working channel.
13. The system of claim 12, wherein one or both of the outer member and the inner member are rotatable with respect to each other, such that the extension device may be transitioned between an open configuration with the channel of the inner member and the channel of the outer member substantially aligned, and a closed configuration with the channel of the inner member and the channel of the outer member not substantially aligned.
14. The system of claim 9, further comprising a pivotable joint disposed at a distal portion of the inner member proximal to the distal connector, wherein the joint has a first longitudinal axis alignable with a longitudinal axis of the endoscope and a portion of the inner member distal to the pivotable joint, and wherein the joint has a second longitudinal axis alignable with a longitudinal axis of a remaining portion of the inner member.
15. A method of extending a length of a working channel, comprising: inserting an endoscope having a working channel into a patient; inserting a catheter into the patient through the working channel; placing an extension device having a lumen extending therethrough about a shaft of the catheter, wherein the extension device is removable from about the shaft of the catheter without withdrawing the catheter proximally through the lumen of the extension device; attaching the extension device to a proximal end of the working channel; attaching the catheter to a proximal end of the extension device; adjusting the extension device to a desired position that corresponds to an adjustable length of the extension device; locking the extension device at the desired position; and delivering a stent through the catheter and through the working channel.
16. The method of claim 15, wherein adjusting the extension device to a desired position is such that a distal tip of the catheter extends at most 8 centimeters from a distal end of the endoscope.
17. The method of claim 15, further comprising removing the extension device from about the shaft of the catheter while the catheter remains within the working channel of the endoscope.
18. The method of claim 15, wherein the placing step comprises placing the extension device about the shaft after inserting the catheter into the patient.
19. The method of claim 15, wherein the adjustable length of the extension device is such that the shaft is extendable through the lumen of the outer and inner members of the extension device, through the working channel extending from the proximal end to a distal end of the endoscope, and beyond the distal end of the endoscope a predetermined distance
20. The method of 15, wherein the extension device comprises: a channel extending along the inner member, the distal connector, and through to the lumen of the inner member; and a channel extending along the outer member, the proximal connector, and through to the lumen of the outer member, wherein the channels of the inner and outer member are configured to align with each other, such that the extension device may be removed from about the shaft of the delivery device while the shaft is in the working channel
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Non-limiting embodiments 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 shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figures:
[0010]
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DETAILED DESCRIPTION
[0018] The present disclosure is not limited to the particular embodiments described. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.
[0019] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” or “includes” and/or “including” when used herein, specify the presence of stated features, regions, steps elements and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups thereof.
[0020] As used herein, the conjunction “and” includes each of the structures, components, features, or the like, which are so conjoined, unless the context clearly indicates otherwise, and the conjunction “or” includes one or the others of the structures, components, features, or the like, which are so conjoined, singly and in any combination and number, unless the context clearly indicates otherwise.
[0021] As used herein, the term “distal” refers to the end farthest away from the medical professional when introducing a device into a patient, while the term “proximal” refers to the end closest to the medical professional when introducing a device into a patient.
[0022] All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about”, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Other uses of the term “about” (i.e., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.
[0023] The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
[0024] It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment(s) described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless contemplated as being combinable or arrangeable with each other to form other additional embodiments or to complement and/or enrich the described embodiment(s), as would be understood by one of ordinary skill in the art.
[0025] Embodiments of the present disclosure include devices and systems, and methods used to extend a working channel. Medical devices (e.g., a catheter) that may be designed to extend to certain treatment sites of a patient and/or to be compatible with a specific auxiliary medical device (e.g., an endoscsope) may be used with extension devices of the present disclosure in order to reach into other treatment sites and/or to be compatible with other auxiliary medical devices.
[0026] Using an echoendoscope, as an example, a delivery catheter may be used for delivering a self-expanding drainage stent. The stent delivery device may be designed to connect to and work with an echoendoscope. Placement of a drainage stent within the body may be performed by insertion of a catheter carrying the stent under ultrasound guidance. The catheter is passed through the wall of a first body lumen (e.g., gastrointestinal tract) into an adjacent lumen (e.g., pseudocyst) and a distal retention member of the stent is deployed. The catheter may then be retracted and a proximal retention member deployed within the GI tract (e.g., stomach). Such an ultrasonic procedure may be performed using an echoendoscope in which a shaft of the delivery device is inserted through the echoendoscope. The working channel of an echoendoscope typically has a specific length, e.g., about 125 cm to about 130 cm, and a delivery catheter or device will typically extend through the length of the working channel with a shaft length of about 137 cm to about 138 cm such that about 8 cm of a distal end of the catheter will extend out of a distal end of the working channel a predetermined distance within the patient. This predetermined distance may be within the working range of the echoendoscope to display the treatment site, including the catheter tip and stent, to the user via ultrasound. A distal end length of the catheter that extends longer than this may be beyond the functioning range of the echoendoscope for the procedure, while an extended distal end length shorter than this may not allow for proper insertion, placement, and delivery of the stent.
[0027] With reference to
[0028] A medical professional may desire to use a medical device designed for a particular auxiliary medical device (e.g., an echoendoscope) having a given working channel length, with a different auxiliary medical device (e.g., a direct imaging endoscope or different brand or configuration of endoscope) having a different working channel length. Should professional user connect the device to the different auxiliary device, the functioning parts of the device (e.g., the length of the catheter shaft) may fail the needs of the procedure. For example, the distance that the medical device extends from a distal end of a working channel of a different auxiliary device may vary with the different lengths of the various auxiliary devices. For example, it may be necessary or desirable for the medical device to be locked to the endoscope, e.g., so that it is capable of being manipulated along with the endoscope by a single hand of the user, or so that the medical device cannot be partially or inadvertently withdrawn or extended from the endoscope to maintain a desired predetermined distance of extension beyond the working channel.
[0029] With reference to
[0030] In various embodiments described here or otherwise within the scope of the present disclosure, the predetermined distance of the shaft from the distal end of the endoscope may be, e.g., in the range of about 7.5 cm to about 8.5 cm. An extension device may be removable from about the shaft of the auxiliary medical devices, such as an endoscope and a delivery device, without withdrawing the shaft proximally through the lumens of the inner and outer members of the extension device. The adjustable length of the extension device may be, e.g., a minimum of about 0 centimeters and a maximum of about 3 centimeters, or a minimum of about 0 centimeters and a maximum of about 8 centimeters. The lumens of the inner member and the outer member may be coaxial. The lumen of the inner member may have a diameter that substantially matches a diameter of a working channel of an endoscope. The lumen of the outer member may have a lumen that substantially matches an outer diameter of the inner member. The extension device may include a locking assembly, such as the set screw shown in
[0031] With reference to
[0032] With reference to
[0033] With reference to
[0034] In various embodiments described here or otherwise within the scope of the present disclosure, the inner member and outer member may comprise various polymer and/or metallic materials. Materials may include stainless steel, aluminum, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex® high-density polyethylene, Marlex® low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, and/or polyvinylidene chloride (PVdC). Materials may be selected to withstand forces associated with advancement and withdrawal of medical devices and endoscopes within the patient.
[0035] With reference to
[0036] In various embodiments described here or otherwise within the scope of the present disclosure, the proximal and/or distal connector may be a male or female luer fitting. The one or more connectors may include a rotating luer nut and/or a winded luer fitting. The connectors may removably connect and tighten to a variety of endoscopes and medical devices.
[0037] In various embodiments described here or otherwise within the scope of the present disclosure, the locking assembly may comprise a quick release locking nut, a twist frictional fit lock, a slotted fit lock, a button fit lock, a detent lock, or the like.
[0038] In various embodiments described here or otherwise within the scope of the present disclosure, the extension device may be a tubular member of a length corresponding to an endoscope such that a shaft of a catheter extends distally from the endoscope a predetermined distance. The tubular member may have a proximal connector at a proximal end of the member that is configured to connect to a distal end of a medical device. The tubular member may have a distal connector at a distal end of the member that is configured to connect to a proximal end of an endoscope.
[0039] In various embodiments, a method of extending a length of a working channel may include inserting an endoscope having a working channel into a patient. A catheter may be inserted into the patient through the working channel. An extension device may have a lumen extending therethrough about a shaft of the catheter. The extension device may be attached to a proximal end of the working channel. The catheter may be attached to a proximal end of the extension device. The extension device may be adjusted to a desired position that corresponds to an adjustable length of the extension device. The extension device may be locked at the desired position. The extension device may be adjusted to a desired position such that a distal tip of the catheter extends at most about 8 cm from a distal end of the endoscope. A tip of the catheter may be visualized using the endoscope. The extension device may be removed from the endoscope and from about a shaft of the catheter while the catheter remains within the working channel of the endoscope. The placing step may include placing the extension device about the shaft after inserting a catheter into the patient. The placing step may include placing the extension device about the shaft prior to inserting a catheter into the patient. The desired position may include at least one pre-determined fixed position of a locking assembly of the extension device configured to fix the adjustable length. The desired position may include a plurality of predetermined fixed positions. A plurality of channels of the extension device may be aligned with each other, such that the extension device may be placed and removed from about the shaft of the catheter. The extension device may be transitioned between an open configuration with the channels substantially aligned, and a closed configuration with the channels not substantially aligned.
[0040] All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of this disclosure have been described in terms of certain embodiments, it may be apparent to those of skill in the art that variations can be applied to the devices and/or methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the present disclosure.