Patent Description:
The present disclosure systems and methods for removing medical devices, instruments, accessories or components that are placed over, or on, other medical devices, instruments or components, and more particularly, to systems and methods for removing endoscopic devices from medical instruments or endoscopes.

Recent advances in optical imaging technology have allowed many medical procedures to be performed today in a minimally invasive manner. The evolution of the more sophisticated, flexible scope with advanced visual capabilities has allowed access to regions deep within the human body that could only be achieved before with invasive surgical intervention. This modem day convenience has resulted in an increase in the demand for, as well as the number of, endoscopic, laparoscopic, arthroscopic, ophthalmoscopic, or other remote imaging visualization procedures performed every year in the U. While these procedures are relatively safe, they are not without risks.

Endoscopes are medical instruments that are used for the visual examination of the interior of the body, including lumens, a body cavity or various organs like the heart, liver, pancreas, stomach, colon, bladder, reproductive systems and other parts of the body. Typical endoscopes are long and slender, with a lighted optical feature, to allow ease of introduction into the patient as well as visualization in the process. Endoscopes can be used with other medical devices, instruments or components, such as for example, cutting or cauterizing instruments, for treatment in addition to examination of the body cavity or organ. Some of these endoscopic companion devices or components can be placed over, or onto, the endoscope, such as for example, endoscopic caps, endoscopic shields, sheaths, optical couplers, lenses, variceal banding devices, and endoscopic submucosal resection devices, to name a few. These devices further enhance the functionality of the endoscope and/or provide protection from contamination.

Increasing amounts of evidence show that continuous removal of these various devices from endoscopes over time results in the loosening of epoxy joints and other areas that are supposed to remain sealed to avoid contamination from biomatter during an endoscopic procedure, as well as subjecting the endoscopes to unnecessary wear and tear. Failure to maintain these seals results in areas where biomatter can accumulate, making cleaning and reprocessing of the scope or instrument difficult and therefore potentially prone to harboring pathogens that can colonize and lead to dangerous drug resistant infections, as well as increased scope maintenance costs and shorter useful life for the scopes.

Accordingly, it would be desirable to provide an improved system for effective removal of these endoscopic devices from the endoscope or medical instrument.

Document <CIT> discloses a system for removing a device from an endoscopic instrument, the system being according to the preamble of claim <NUM>.

The present disclosure addresses a long-standing need for a removal system to make the removal of various endoscopic devices from instruments and endoscopes more precise, predictable and less traumatic to the instrument or the endoscope upon which the device is installed. According to one aspect of the present disclosure, a system for removing a device from an endoscopic instrument is defined in claim <NUM> and includes a removal element for gripping the device and an insertion element coupled to the removal element. The removal element has a body comprising a central portion and first and second gripping arms pivotally coupled to the central portion for allowing the operator to obtain a firm grip on the device. The insertion device has a projection configured for advancement into an opening within the device. The insertion device provides a firmer grip on the device for the operator. In addition, it allows the operator to apply a force from within the device to facilitate withdrawal of the device from the endoscopic instrument.

According to the invention, the projection comprises an elongate shaft configured to pass through the opening into an internal channel of the device. The elongate shaft of the insertion device is collapsible such that at least a portion of the shaft has a reduced diameter for advancing through the internal channel of the device. This facilitates advancement of the shaft into the device and allows for the shaft to then expand outwards and create a friction fit within the internal channel of the device to provide a firmer grip on the device. This friction fit also allows the user to apply a force from within the device as it is withdrawn. Applying a force from within the device spreads the application of force so that it is applied from the outside of the device (through the gripping arms) and from the inside through the insertion device. This reduces the local pressure applied to any one portion of the device, which results in a more precise and atraumatic removal, thereby reducing the wear and tear on the instrument and minimizing damage to epoxy joints and other sealed areas.

In an exemplary embodiment, the shaft comprises one or more slits extending in a substantially longitudinal direction to allow for the shaft to collapse upon external pressure from the internal channel of the device. This facilitates advancement of the shaft into the device to be removed. In another exemplary embodiment, the shaft includes ridges on at least one portion of its outer surface to enhance the grip between the shaft and the device.

In certain embodiments, the removal system further comprises an expanding instrument configured for insertion into the insertion device. The expanding instrument preferably has at least one portion with a larger diameter than the internal diameter of the insertion device (at least in its collapsed configuration). The expanding instrument expands the shaft of the insertion device against the internal channel of the device to be removed to further increase the friction fit therebetween. In an exemplary embodiment, the expanding instrument comprises an elongate shaft with an enlarged head on a distal end portion of the shaft. The enlarged head serves to expand the shaft of the insertion device as it advances therethrough. In an exemplary embodiment, the expanding instrument terminates in a tapered tip to facilitate advancement of the expanding instrument into the insertion device.

According to the invention, the first and second gripping arms are pivotally coupled to the central portion of the removal element. In certain embodiments, the first and second gripping arms are configured to pivot from a substantially parallel orientation relative to the central portion to a transverse or perpendicular orientation. This design allows the operator to pivot the gripping arms against the device. In an exemplary embodiment, the gripping arms further include one or more ridges on their inner surfaces for providing additional grip against the device. The gripping arms may also include finger gripping elements on their outer surfaces to facilitate handling of the gripping arms. In an exemplary embodiment, the finger gripping elements comprise a projection extending laterally outward from each of the gripping arms. The projection may include a curved distal surface (distal being the surface away from the operator) that allows the operator to place his/her fingers against the curved surfaces. The finger gripping elements provide additional leverage for the operator to provide sufficient force to pull the removal element and device away from the endoscopic instrument.

In some embodiments, the device to be removed is selected from the group consisting of endoscopic caps, endoscopic shields, sheaths, optical couplers, lenses, variceal banding devices, and endoscopic submucosal resection devices. For example, the device to be removed may be an endoscopic device, such as an optical coupler or an endoscopic cap, attached to the distal or proximal end portion of an endoscope.

In another aspect of the invention, a non claimed method for removing a device from an endoscopic instrument comprises gripping a portion of the device with a removal element, inserting a projection of the removal element into an opening in the device and applying a force to the removal element to withdraw the device from the endoscopic instrument. In certain embodiments, the projection comprises an elongate shaft coupled to the removal element. The elongate shaft is advanced through an internal channel in the device to be removed. In an exemplary embodiment, the elongate shaft is collapsed as it advances into the internal channel to facilitate the insertion of the shaft into the device.

In certain embodiments, the method further comprises expanding at least a portion of the elongate shaft after it has been inserted into the channel or opening of the device. The shaft may be expanded by inserting an expanding instrument through an internal channel in the shaft. The expanding instrument may include an elongate shaft with an enlarged head that serves to expand the insertion device.

In certain embodiments, the method further includes contacting first and second sides of the device with first and second gripping arms of the removal element. The gripping arms may be pivotally coupled to a central portion of the removal element such that the operator pivots the gripping arms into position against the device. The applying step may include gripping the first and second gripping arms against the device and pulling the central portion of the removal element away from the device to remove the device from the endoscopic instrument.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure. Additional features of the disclosure will be set forth in part in the description which follows or may be learned by practice of the disclosure.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure.

This description and the accompanying drawings illustrate exemplary embodiments and should not be taken as limiting, with the claims defining the scope of the present disclosure, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the disclosure. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Moreover, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.

It is noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the," and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term "include" and its grammatical variants are intended to be nonlimiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.

The present disclosure provides a system that enables the precise, predictable and less traumatic removal of a variety of devices used in endoscopic procedures. The devices that can be removed include, for example, endoscopic caps, endoscopic shields, sheaths, optical couplers, lenses, variceal banding devices, endoscopic submucosal resection devices, balloons and other such devices that can be placed on, within, or over an endoscope or other devices used endoscopically, interventionally or in other procedures where an instrument or other device is inserted in a body. The present disclosure is particularly useful for removing devices from endoscopes, such as optical couplers and conductive optical elements that may be removably coupled to the distal end portion of an endoscope. Optical coupling devices suitable for removal by the systems and methods of the present invention, for example, are described in International Application Nos: <CIT>, <CIT> and <CIT>.

According to one exemplary embodiment shown in <FIG>, a removal system <NUM> includes a removal element <NUM> configured to atraumatically grip and apply force to the outer surface or end of the device being removed, allowing the user to grasp and apply force to the device subject to removal from the endoscope or instrument. The removal element <NUM> comprises an elongate body <NUM> having a central portion <NUM> flanked by adjacent tabs or gripping arms 26a, 26b connected to the central portion <NUM> at scored areas <NUM>. The scored areas <NUM> between central portion <NUM> and gripping arms 26a, 26b enable the gripping arms 26a, 26b to fold or pivot relative to the central portion <NUM>, as shown in <FIG>. Of course, other configurations are possible. For example, gripping arms 26a, 26b may be pivotally coupled to central portion <NUM> through a variety of different mechanisms, such as a hinge or other suitable articulation mechanisms.

On the inner surface <NUM> of the removal element <NUM>, surface protrusions, such as ridges <NUM> or other suitable gripping elements, can be provided, as shown in <FIG>, to increase the grip and application of force to grasp and remove the device subject to removal. The removal element <NUM> or any other aspect of the system <NUM> may include finger grip elements <NUM> on its outer surface <NUM>, as shown in <FIG>, to improve the ergonomic aspects of the system by making it easier to hold and apply force to the system <NUM>. In one embodiment, finger grip elements <NUM> are protrusions extending outwardly from gripping arms 26a, 26b. These protrusions preferably include a curved inner surface configured for contacting the operator's fingers to allow the operator to hold onto grip elements <NUM> as removal element <NUM> is being pulled in the proximal direction (or the direction opposite the curved surfaces).

According to the present invention, the system <NUM> includes an insertion device <NUM>, as shown in <FIG>, which may be a collet or other suitable element capable of being inserted into the working channel of an endoscopic shield, an optical coupler, an endoscopic cap or other device subject to removal that includes an internal channel. The insertion device <NUM> may be attachable to the removal element <NUM>, so that the insertion element is advanced into the internal channel of the device subject to removal. Alternatively, insertion device <NUM> may be an integral part of removal element <NUM> (i.e., manufactured together in the same mold). The insertion device <NUM> preferably comprises an elongate shaft <NUM> with slits <NUM> or other suitable cutout or design features that allow the insertion device <NUM> to collapse or otherwise reduce the diameter of its elongate shaft <NUM> upon insertion. This allows insertion device <NUM> to be advanced easily through the internal channel of the device subject to removal. In addition, insertion device <NUM> will then naturally expand outward within the device to create a friction fit between insertion device <NUM> and the device to be removed. This friction fit allows the user to apply a force from within the device as it is withdrawn. Applying a force from within the device spreads the application of force so that the force being applied is from the outside of the device (through gripping arms 26a, 26b) and from the inside through insertion device <NUM>. This reduces the local pressure applied to any one portion of the device, which results in a more precise and atraumatic removal.

It is of course understood that the removal element <NUM> may be configured to provide a radial pressure or force from the inside of the device to be removed, or it may be used to spread the ends to capture the device to be removed. In other words, the removal element <NUM> may be used to effectively grab and pull the device away from the instrument or endoscope on which it is attached by spreading the opening end and pulling the device towards the user.

In alternative embodiments, the insertion device <NUM> comprises a projection (not shown), such as a knob, flange, lip, extension or other protrusion, that can be inserted into an opening in the device to be removed. In these embodiments, the projection is configured to expand outward upon insertion into the opening to create a friction fit within the device. The projection may, for example, comprise a flexible material that is biased outward by a spring or the natural composition of the material. The user may exert force upon the projection to collapse it and insert it into the opening, whereby it then expands outward to create the friction fit. In one such embodiment, the projection is configured to spread outward upon insertion into the opening such that the projection applies force to the inside proximal surface of the device as it is being withdrawn by the user. In these embodiments, the insertion device <NUM> may, for example, be used to remove devices that have an opening, but no internal channel therein.

In some embodiments, the insertion device <NUM> can have one or more ridges <NUM> or other surface features or variations on its outer surface to increase the amount of adhesion and grip in the internal channel when the removal system <NUM> is applied to remove the device. Ridges <NUM> may, for example, be disposed on the outer or distal surfaces of shaft <NUM>.

As shown in <FIG>, an expanding instrument <NUM> may be provided for use with the removal system <NUM>. According to another aspect of the exemplary embodiment, insertion device <NUM> may include an opening <NUM> (see <FIG>) leading into an internal channel (not shown) within elongate shaft <NUM> for receiving expanding instrument <NUM>. In some embodiments, expanding instrument <NUM> has a larger outer diameter than the inner diameter of the internal channel of insertion device <NUM> such that expanding instrument <NUM> expands insertion device <NUM>. In some cases, the outer diameter of expanding instrument <NUM> is only larger than the collapsed internal dimeter of insertion device <NUM> (i.e., after it has been inserted into device and collapsed due to the slits <NUM> on shaft <NUM>). In other embodiments, the expanding instrument <NUM> may include an enlarged head portion <NUM> and an elongate shaft <NUM> extending from the head portion <NUM>. In these embodiments, the enlarged head portion <NUM> serves to expand insertion device <NUM> (i.e., the outer diameter of expanding instrument <NUM> may be equal to or less than the inner diameter of insertion device <NUM>). In all of these embodiments, advancing insertion device <NUM> through opening <NUM> and into the internal channel of insertion device <NUM> increases the diameter of elongate shaft <NUM> and therefore the amount of resistance and transfer of force when the insertion device <NUM> is used to remove the device subject to removal.

The elongate shaft <NUM> of expanding instrument <NUM> may terminate in a tip <NUM>. In some embodiments, the tip <NUM> may be tapered and either blunt or sharp. Tip <NUM> serves to facilitate advancement of expanding instrument through the internal channel in insertion device <NUM>.

Referring now to <FIG>, an exemplary method of removing a representative device <NUM> that is attached onto an instrument or endoscope according to the present disclosure will now be described. Insertion device <NUM> is advanced through an opening and into the interior of device, as shown in <FIG>. Slits <NUM> allow shaft <NUM> of insertion device <NUM> to collapse to facilitate its advancement through the opening of device <NUM>. The gripping arms 26a, 26b of removal element <NUM> may then be folded onto the device <NUM>, as shown in <FIG>. The ridges <NUM> on the inner surface <NUM> of the removal element <NUM> may allow a secure grip when the user applies pressure using the finger grip elements <NUM> to fold the removal element <NUM> over the device <NUM> to be removed. Next, the expanding instrument <NUM> may be inserted through opening <NUM> of the insertion device <NUM>, as shown in <FIG>. This expands the diameter of the elongate shaft <NUM> of the insertion device <NUM> and further secures the device <NUM> within the removal system, as shown in <FIG>. Once the insertion device <NUM> has been inserted, the user may grip the entire removal system <NUM> and pull the device <NUM> away from the instrument or endoscope, thereby removing the device <NUM> in a precise, predictable and less traumatic manner than current methods.

The components of the removal system <NUM> may be made of any medical grade material, including for example, but not by way of limitation, elastomeric materials, rigid materials, combinations of materials to achieve various performance elements that may include both elastic and rigid materials, which may include polypropylenes, PET materials, PTFE materials, thermoplastic elastomers, polycarbonates, acrylics, and any other elastic or rigid medical grade material.

Claim 1:
A system for removing a device from an endoscopic instrument, the system comprising:
a removal element for gripping the device, the removal element having a body comprising a central portion and first and second gripping arms coupled to the central portion; and
an insertion device coupled to and extending from the central portion of the removal element and having an elongate shaft configured for advancement through an opening within the device into an internal channel in the device,
wherein the elongate shaft is collapsible such that an outer diameter of at least a portion of the elongate shaft is reduced upon advancement into the internal channel of the device,
characterised in that the first and second gripping arms are pivotally coupled to the central portion.