Patent Description:
Endoscopic procedures often require the introduction of multiple devices in parallel or in series through the internal working lumen of an endoscope. For example, in an endoscopic retrograde cholangiopancreatography (ERCP) procedure, multiple devices need to be introduced into the lumen of a duodenosope to diagnose and treat certain problems of the biliary or pancreatic ductal systems. Typically, an initial operation is performed to introduce a first device through the ampullary orifice (papilla of Vater), and then into the biliary tree until the distal end of the first device is proximate to a desired site in the biliary tree. The first device may be a cannula (catheter) or a sphinceterotome. The initial operation can be diagnostic, such as injecting contrast agents through the device to visualize the biliary tree, or therapeutic, such as enlarging the ampullary orifice.

In many instances, initial visualization could reveal one or more sites in the biliary tree that require further therapeutic operations, such as to remove a stone, open a stricture, or sample tissue at these sites. In such instances, additional devices, such as a balloon, a basket, or a stent delivery catheter, may need to be subsequently introduced into the lumen of the duodenoscope to a desired treatment site. Thus, to facilitate introducing these additional devices to the desired treatment site, a guidewire introduced with the first device is typically held in place in the endoscope to maintain access to the desired treatment site. Removing the first device and introducing the additional devices over the guidewire would allow for continued access to the desired treatment site of the additional devices. However, displacement of the guidewire during this exchange process can result in loss of access to the desired treatment site, which then requires a difficult, time-consuming, and tedious operation to re-direct the guidewire to the desired treatment site.

Two techniques are generally used for device exchange. One is termed the "long wire" or "over the wire" technique, and the other is termed the "short wire" technique. The long wire technique uses an extra-long guidewire, whose length is typically longer than the lumen of the endoscope plus the length of the device introduced over the guidewire. In other words, the length of the guidewire extending out of the endoscope needs to be at least as long as that of the device to be replaced. This allows a proximal end of the guidewire to be securely controlled at all times by the physician or an assistant to maintain the position of the guidewire and thus the access to the desired treatment site. To remove the first device off the guidewire, the physician and the assistant must make a series of precise and coordinated maneuvers until the first device is completely off the guidewire. Then, a second device can be introduced over the guidewire through a similarly tedious coordination between the physician and assistant. Throughout this exchange process, the physician lacks or has a limited control of the guidewire, which could result in movement or displacement of the distal end of the guidewire and thus loss of access to the desired treatment site.

To address the shortcomings of the long wire technique, the short wire technique allows the physician to maintain control of the guidewire most of the time during the exchange. In the short wire technique, the guidewire is enclosed in the first device for a short distance from the distal end to a proximal point of the first device. While the guidewire is held in place, typically by a locking device installed on the biopsy port of the endoscope, a physician can remove the first device by splitting or tearing away the device from the guidewire up to the proximal point of the first device. Then, the physician can perform a short wire exchange that does not require the series of precise coordination between the physician and the assistant as in the long wire exchange. The second device can be introduced by feeding its distal end over the proximal end of the guidewire for the short distance. However, during this short wire exchange, the guidewire is unlocked from the locking device and re-locked after the second device is introduced over the guidewire for the short distance. The locking and unlocking of the guidewire during the short wire exchange still require the physician or the assistant to manually hold the guidewire in place during the device exchange. This is time-consuming and could result in movement or displacement of the distal end of the guidewire and thus loss of access to the desired treatment site.

Therefore, an improved system or apparatus is needed that allows the guidewire to remain locked in a desired position to maintain access to the desirable treatment site during the device exchange in an endoscopic procedure. Such apparatus or system may be capable of reducing the time taken for a physician to perform an endoscopic procedure and increasing the effectiveness of the procedure.

<CIT> discloses a locking device that is mounted on an endoscope or the like for selectively securing the position of a guide wire and/or catheter relative to the endoscope or the like. The locking device preferably includes a side wall with an opening therein for receiving the proximal end of a guide wire or catheter. Once a guide wire or catheter is in a desired position within a body cavity, the portion of the guide wire or catheter that extends outside of the endoscope or the like may be moved into the opening. More particularly, a portion of the guide wire or catheter may be inserted by an operator through the entry end of the opening and into the locking end, wherein the locking end frictionally secures the position of the guide wire or catheter relative to the endoscope or the like.

<CIT> discloses endoscopes and methods for making and using endoscopes. An example endoscope includes a handle portion and a shaft portion. The shaft portion may include one or more channels. A catheter and/or wire locking member may be coupled to a channel.

Specific embodiments are defined by the dependent claims.

The exemplary embodiments of the present disclosure include apparatuses, systems, and methods for exchanging elongated devices in an endoscopic procedure. Advantageously, the exemplary embodiments allows for locking a guidewire in a desired position to maintain access to a desirable treatment site during the exchange, thereby improving the efficiency and effectiveness of the endoscopic procedure.

According to an exemplary embodiment of the present disclosure, a system for device exchange in an endoscopic procedure is described. The system includes an elongated device, a main block, and an adapter. The elongated device has a slit extending over its length. The main block is configured to be affixed to a port of an endoscope. The main block includes a main channel for receiving a guidewire and the elongated device. The adapter can be fixedly or removably engaged with the main block and configured to merge the guidewire into the elongated device. The adapter includes a working channel for receiving the elongated device and a working member raising from an inner wall of the working channel. When the elongated device passes through the working channel, the working member wedges open a portion of the slit of the elongated device such that a portion of the guidewire merges into the elongated device through the opened portion of the slit.

According to a further exemplary embodiment of the present disclosure, an apparatus for device exchange in an endoscopic procedure is described. The apparatus includes a main block configured to be affixed to a port of an endoscope and an adapter configured to be fixedly or removably engaged with the main block. The main block includes a main channel for receiving a guidewire and an elongated device having a slit extending over its length. The adapter is configured to merge the guidewire into the elongated device. The adapter includes a working channel for receiving the elongated device and a working member raising from an inner wall of the working channel. When the elongated device passes through the working channel, the working member wedges open a portion of the slit of the elongated device such that a portion of the guidewire merges into the elongated device through the opened portion of the slit.

According to a yet further exemplary embodiment of the present disclosure, a method for device exchange in an endoscopic procedure is described. The method includes providing an elongated device having a slit extending over its length and an apparatus for device exchange. The apparatus includes a main block configured to be affixed to a port of an endoscope and an adapter configured to be fixedly or removably engaged with the main block. The main block includes a main channel for receiving a guidewire and the elongated device. The adapter includes a working channel for receiving the elongated device and a working member raising from an inner wall of the working channel. The method further includes receiving the elongated device through the working channel of the adapter such that the elongated device passes by the working member. The method also includes wedging open a portion of a slit of the elongated device by the working member and merging a portion of the guidewire into the elongated device through the opened portion of the slit.

Additional features and advantages of the disclosed embodiments will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the disclosed embodiments. The features and advantages of the disclosed embodiments will be realized and attained by the elements and combinations particularly pointed out in the appended claims.

It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory only and are not restrictive of the disclosed embodiments as claimed.

The accompanying drawings constitute a part of this specification. The drawings illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the disclosed embodiments as set forth in the accompanying claims.

The disclosed embodiments relate to systems, apparatuses, and methods for efficient and effective device exchange in an endoscopic procedure. Embodiments of the present disclosure can be implemented in an endoscopic system for performing suitable diagnostic and/or therapeutic operations to one or more desired treatment sites in the cardiovascular system, the gastrointestinal system, or the respiratory system. Advantageously, embodiments of the present disclosure allow for fixing at least one guidewire to a desired position during the exchange of devices through the lumen of an endoscope, thereby maintaining access to at least one desired treatment site.

As described herein, an endoscope typically includes a proximal end and a distal end, and has an internal lumen extending between the distal end and the proximal end. A proximal end may refer to a point or a location along the length of the endoscope closer to a physician or a medical practitioner. A distal end may refer to a point or location along the length of the endoscope closer to a treatment site in the body of a patient during an endoscopic procedure. A device is typically introduced into the lumen of the endoscope from the proximal end to the distal end of the endoscope until a distal end of the device approximates or reaches a desired treatment site.

According to an aspect of the present disclosure, a system for device exchange in an endoscopic procedure may include one or more elongated devices (for example, cannula, sphincterotome, balloon, basket, brushes, forceps, etc.) to be exchanged. The elongated devices may each have a slit extending over at least a substantial the length of the device, for example, extending from a distal end to a proximal end of the device. Unlike devices used in the short wire exchange technique, the slit allows the elongated device to be removed off a guidewire by being split or separated from the guidewire via the slit at the proximal end of the endoscope continuously up to the distal end of the elongated device. The slit also allows the elongated device to be introduced over the guidewire by merging with the guidewire via the slit continuously until the distal end of the elongated device reaches the desired treatment site. Advantageously, during the device exchange, the guidewire can remain locked in a desired position by a locking device, thereby eliminating the need to manually holding the guidewire by a physician and effectively maintaining a previously obtained access to the desired treatment site.

In some embodiments, a natural width of the slit may be substantially smaller than the diameter of the guidewire. To introduce an elongated device over the guidewire, a portion of the slit is opened or widened, allowing for a portion of the guidewire to merge into a portion of an elongated device. The opened portion of the slit then returns to its natural width after the merge. In some instances, after merging into the elongated device, the guidewire is received by a partially enclosed channel across the longitudinal axis of the elongated device. Advantageously, the transient opening and closing (or widening and narrowing) of the slit allows the introduction of the elongated device over the guidewire as well as retaining the guidewire within the elongated device during a medical operation after the device exchange.

As described herein, the longitudinal axis of the elongated device may refer to a central axis of the elongated device or of an internal channel of the elongated device. Alternatively, the longitudinal axis of the elongated device may refer to an off-center axis of the elongated device or of an internal channel of the elongated device.

According to an aspect of the present disclosure, a system for device exchange in an endoscopic procedure may include an adapter that allows for the introduction of the elongated device over a guidewire. The adapter may include a working channel for receiving the elongated device and a working member raising from an inner wall of the working channel. As the elongated device passes through the working channel, the working member may wedge open a portion of the slit of the elongated device, allowing a portion of the guidewire to merge into a corresponding portion of the elongated device through the opened portion of the slit. After passing by the working member, the opened portion of the slit may return to the natural width, allowing the merged portion of the guidewire to be retained in the elongated device.

The adapter can merge the guidewire into the elongated device as the elongated device passes through the working channel continuously from a distal end of the elongated device until the distal end reaches a desired treatment site. Advantageously, during this continuous merging of the guidewire into the elongated device, rather than being unlocked and manually held in place, the guidewire can remain locked in a desired position, thereby reducing the risk of displacement of the guidewire and thus the risk of losing access to the desired treatment site.

According to an aspect of the present disclosure, a system for device exchange in an endoscopic procedure may include a main block to be affixed to a port of an endoscope. The main block may include a main channel configured to receive at least one guidewire. The main block may fixedly or removably engage with the adapter to introduce an elongated device over a guidewire received in the main channel. When the adapter is engaged with the main block, the longitudinal axis of the working channel of the adapter may align with the longitudinal axis of the main channel. The main block may further include a main groove that may lead the guidewire to be aligned with the longitudinal axis of the main channel, and thus the longitudinal axis of the working channel of the adapter. In such instances, an elongated device passing through the working channel of the adapter would align with the guidewire in the main channel of the main block, which facilitates the merging of the guidewire into the elongated device. Advantageously, the use of the main block and the adapter for introducing an elongated device over a guidewire eliminates the need to perform a long wire or short wire exchange, thereby improving the efficiency and accuracy of device exchange during an endoscopic procedure.

As described herein, the longitudinal axis of the main channel of the main block may refer to a central axis or an off-center axis of the main channel. The longitudinal axis of the working channel of the adapter may refer to a central axis or an off-center axis of the working channel. The longitudinal axis of the elongated device may refer to a central axis or an off-center axis of the elongated device or an inner channel of the elongated device.

In some embodiments, the main block may further include a locking device for fixing the guidewire in a desired position. The desired position may be predetermined after an initial operation before performing the device exchange. The locking device may include zigzag locking features that retain the guidewire in the predetermined desired position by frictionally holding the guidewire in place. The zigzag locking features may be used in combination with other mechanical features that can bend, twist, pinch, clamp, or lock the guidewire in place. In some embodiments, the main groove of the main block may incline from the bottom of the locking device to the longitudinal axis of the main channel such that the guidewire is led towards the longitudinal axis of the main channel, prepared to be merged into an elongated device.

In some embodiments, the main block may include more than one locking devices for locking one or more additional guidewires. The locking devices may use the same or different locking features and/or mechanisms. The main channel may further include secondary grooves for retaining and holding the additional guidewires in place. Each guidewire may be locked or unlocked from the locking features of the locking devices independently, and may be merged into a different elongated device. The ability to receive and lock more than one guidewires advantageously provides the physician more flexibility in selecting and using a suitable number and types of devices for conducting medical operations during an endoscopic procedure.

Reference will now be made in detail to embodiments and aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Where possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

<FIG> is a perspective view of an exemplary system <NUM> for device exchange. As shown in <FIG>, system <NUM> may be used in combination with an exemplary endoscope <NUM> (partially shown) during an endoscopic procedure. System <NUM> includes an adapter <NUM>, a main block <NUM>, and at least one elongated device <NUM>. Adapter <NUM> is fixedly or removably engaged with main block <NUM> and is configured to receive an elongated device <NUM> to be introduced over a guidewire <NUM>. Main Block <NUM> includes a main body portion <NUM> and a fastener <NUM> that affixes main block <NUM> to an exemplary port <NUM> of endoscope <NUM>. Port <NUM> may be a biopsy port of endoscope <NUM> that provides access to an inner lumen of endoscope <NUM>. Port <NUM> may be normally closed by a biopsy valve before use.

<FIG> is a partial perspective view of system <NUM> and <FIG> is a component view of system <NUM>. As shown in <FIG> and <FIG>, adapter <NUM> includes a working channel <NUM> and a working member <NUM>. Working member <NUM> may align with a longitudinal axis of working channel <NUM> such that when elongated device <NUM> passes though working channel <NUM>, a slit extending along elongated device <NUM> would pass by working member <NUM>. Working member <NUM> may open or widen the slit of elongated device <NUM> as it passes by, as described further below in reference to <FIG>.

Adapter <NUM> and main block <NUM> may include one or more complementary fitting structures that allow adapter <NUM> to fixedly or removably engage with main block <NUM>. For example, adaptor <NUM> may removably engage with main block via frictional fit, threaded fit, snap fit, etc. In some embodiments, as shown in <FIG> and <FIG>, adapter <NUM> includes a body <NUM> that can be fitted within an opening of a main channel <NUM> of main block <NUM>. For example, body <NUM> may be jammed in the opening of main channel <NUM>, thereby securing adapter <NUM> on main block <NUM>.

Adapter <NUM> and main block <NUM> may further include other complementary fitting structures. In some embodiments, as shown in <FIG> and <FIG>, adapter <NUM> includes a protrusion <NUM> that can engage with a clamp <NUM> of main block <NUM>. Alternatively or additionally, adapter <NUM> may further include one or more bars <NUM> and/or grooves <NUM> that can engage with complementary channels or protrusions (not shown) in the interior surface of main channel <NUM>. Other suitable mechanical structures may be used alone or in combination with the above-described fitting structures to engage adapter <NUM> with main block <NUM>. For example, a detent structure or a fastener may be used to engage adapter <NUM> with main block <NUM>. Accordingly, adaptor <NUM> may be securely held in main block <NUM> during the introduction of elongated device <NUM> over guidewire <NUM>.

<FIG> is partial top plan view of main block <NUM>. As shown in <FIG> and <FIG>, main block <NUM> further includes a groove <NUM> that provides a path for guidewire <NUM> and a locking device <NUM> for fixing guidewire <NUM> in a desired position. Groove <NUM> may incline from locking device <NUM> towards the longitudinal axis of main channel <NUM> such that guidewire <NUM> is led to be aligned with the longitudinal axis of main channel <NUM> at a distal end <NUM> of groove <NUM>. This alignment allows elongated device <NUM> to be introduced over guidewire <NUM> as it passes through working channel <NUM> of adapter <NUM> as further described below in reference to <FIG>.

More than one guidewires may be received and held in main channel <NUM>. In some embodiments, main channel <NUM> includes at least one secondary groove for fixing at least one secondary guidewire <NUM> in a desired position. Guidewire <NUM> and secondary guidewire <NUM> may be held to maintain access to the same treatment site or to different treatment sites, for example. In such instances, main block <NUM> may include at least one additional locking device <NUM> for locking guidewire <NUM> in place. Alternatively, as shown in <FIG>, a secondary locking device <NUM> may be used for fixing guidewire <NUM> in place, for example, by pinching, grapping, clamping, or locking guidewires <NUM>. In some embodiments, different elongated devices <NUM> can be introduced over guidewire <NUM> and secondary guidewire <NUM> to perform different operations to the same treatment site or to perform different operations to different treatment sites. In other embodiments, same elongated devices <NUM> can be introduced over guidewire <NUM> and secondary guidewire <NUM> to perform the same operations to different treatment sites.

For example, after a first elongated device <NUM> is introduced over guidewire <NUM>, guidewire <NUM> may be moved from main groove <NUM> to a secondary groove and locked by a secondary locking device <NUM>. The movement may be performed in a controlled fashion such that the access to a treatment site maintained by the distal end of guidewire <NUM> is maintained. Then, guidewire <NUM> may be moved into main groove <NUM> and locked by locking device <NUM> so that a second elongated device <NUM> may be introduced over guidewire <NUM>. After the introduction of the second elongated device <NUM>, guidewire <NUM> may be moved back to a secondary groove and locked by a secondary lock device <NUM>. The use of multiple guidewires and the capability to introduce different devices over multiple guidewires advantageously provide a physician more flexibility in performing desired operations to one or more treatment sites during an endoscopic procedure.

<FIG> are two different partial perspective views of locking device <NUM> of main block <NUM>. As shown in <FIG>, locking device <NUM> may include zigzag locking features that fix guidewire <NUM> in a desired position by frictionally maintaining guidewire <NUM> in place. For example, the zigzag locking features of locking device <NUM> may include a plurality of gaps <NUM> and slots <NUM>. The size of gaps <NUM> and slots <NUM> may be approximately the same or smaller than the diameter of guidewire <NUM> such that guidewire <NUM> is frictionally held in place by passing through gaps <NUM> and slots <NUM>. In some embodiments, the zigzag locking features of locking device <NUM> may be used in combination with other mechanical features that can bend, twist, pinch, clamp, or lock guidewire <NUM> in place. As shown in <FIG> and <FIG>, guidewire <NUM> locked by locking device <NUM> may extend over main groove <NUM>, which leads guidewire <NUM> towards the longitudinal axis of main channel <NUM>, prepared to be merged with elongated device <NUM>.

<FIG> is a perspective view of guidewire <NUM> juxtaposed with elongated device <NUM>. As shown in <FIG>, elongated device <NUM> includes a slit <NUM> and a partially enclosed channel <NUM> connected to slit <NUM>. Channel <NUM> and/or slit <NUM> may extend from a distal end of elongated device <NUM> to a proximal end of elongated device <NUM>. As described herein, the distal end of elongated device <NUM> may refer to the distal tip of elongated device <NUM>. The proximal end of elongated device may refer to the proximal tip of elongated device <NUM> or a location close to the proximal tip of elongated device <NUM>. In some embodiments, as shown in <FIG>, channel <NUM> and/or slit <NUM> extend over the length or a substantial length of elongated device <NUM> along its longitudinal axis.

Guidewire <NUM> may be merged into channel <NUM> through slit <NUM>. In addition, slit <NUM> allows elongated device <NUM> to be removed off guidewire <NUM> merged into channel <NUM> by being split or separated from guidewire <NUM> via slit <NUM>. In some embodiments, elongated device <NUM> may include at least one inner lumen <NUM> for receiving a secondary device (not shown) or injecting fluids such as contrast to perform a medical operation. The secondary device may be introduced into elongated device <NUM> before or after it is merged with guidewire <NUM>.

In some embodiments, as shown in <FIG>, the diameter of guidewire <NUM> is substantially greater than a natural width of slit <NUM>. This allows guidewire <NUM> to be retained within channel <NUM> of elongated device <NUM> after merging into channel <NUM> to effectively guide elongated device <NUM> to desired treatment sites. However, to merge guidewire <NUM> into channel <NUM> of elongated device <NUM> through slit <NUM>, the width of slit <NUM> needs to be temporarily enlarged for guidewire <NUM> to enter as described further below.

As described herein, elongated device <NUM> may be any device that is normally introduced over a guidewire for performing a medical operation, such as to remove a stone, open a stricture, or sample tissue. For example, elongated device <NUM> may be a device selected from the group including cannula, sphinceterotome, balloon, basket, forceps, snare, biopsy brush, dilator, stent delivery catheter, brachytherapy catheter, and lithotripter.

<FIG> illustrates the use of adapter <NUM> for merging guidewire <NUM> into elongated device <NUM> through slit <NUM>. As shown in <FIG>, elongated device <NUM> is passed through working channel <NUM> of adapter <NUM> along a longitudinal axis <NUM> of working channel <NUM>. Guidewire <NUM> is merged into slit <NUM> of elongated device <NUM> when elongated device <NUM> passes by working member <NUM> (not shown), which opens or widens slit <NUM> to receive the nearby portion of guidewire <NUM> there through. Features of adapter <NUM> that allow for merging of guidewire into elongated device <NUM> are described below in reference to <FIG>. The working mechanism of adapter <NUM> is described in detail below in reference to <FIG>.

As described herein, adapter <NUM> may have any suitable geometry and/or mechanical features to be securely fit into main block <NUM> and/or to merge guidewire <NUM> into elongated device <NUM>. Exemplary embodiments and/or features of adaptor <NUM> are described below with reference to <FIG>.

<FIG> are different perspective views of an exemplary embodiment of adapter <NUM>. <FIG> is a bottom plan view of the exemplary embodiment of adapter <NUM> of <FIG>. <FIG> is a perspective view of another exemplary embodiment of adapter <NUM>. <FIG> are cross-sectional views of the exemplary embodiment of adapter <NUM> of <FIG>.

As described above and shown in <FIG>, adapter <NUM> includes working channel <NUM>, working member <NUM>, and body <NUM>. Working member <NUM> of adapter <NUM>, as shown in <FIG>, extends from an inner surface of working channel <NUM> to longitudinal axis <NUM> of working channel <NUM>. In one exemplary embodiment, working channel <NUM> extends beyond body <NUM>, as shown in <FIG>. In another exemplary embodiment, working channel <NUM> extends through body <NUM>, as shown in <FIG>. In a further exemplary embodiment, working channel <NUM> extends through body <NUM> of adaptor <NUM> over a short distance, and working member <NUM> extends across the length of working channel <NUM>, as shown in <FIG>.

As shown in <FIG>, working member <NUM> may include a wedge 120a and a guide 120b. Wedge 120a may be a thin plate, such as a fin-shaped plate, that stems from the inner wall of working channel <NUM>. Wedge 120a may extend up to the longitudinal axis of working channel, where it is connected with guide 120b. Guide 120b may have a tapered elongated shape that aligns with the longitudinal axis of working channel <NUM>. When elongated device <NUM> is inserted though working channel <NUM>, the distal end of elongated device <NUM> passes by working member <NUM>. Wedge 120a of working member <NUM> opens up or widens a portion of slit <NUM> at the distal end of device <NUM>, thereby allowing guidewire <NUM> to merge into slit <NUM>. Wedge 120a also maintains the opening of slit <NUM> as device <NUM> passes by working member <NUM>, thereby allowing for continuous merging of guidewire <NUM> into slit <NUM>. Guide 120b may enter device <NUM>, such as channel <NUM> of device <NUM>, to maintain the direction of insertion of device <NUM> during its merge with guidewire <NUM>. After the portion of slit <NUM> passes through working member <NUM>, it returns to its natural width out of its own elasticity. Guidewire <NUM> may further merge into channel <NUM> of elongated device <NUM>.

Adapter <NUM> may further include a side groove <NUM>. In some embodiments, side groove <NUM> may extend across a ramp extending across body <NUM>. When adapter <NUM> is engaged with main block <NUM>, side groove <NUM> complement main groove <NUM> of main block <NUM> to provide a path for leading guidewire <NUM> towards main channel <NUM>. In some embodiments, as shown in <FIG>, side groove <NUM> may extend up to a distal point <NUM> of working member <NUM> such that guidewire <NUM> is led towards longitudinal axis <NUM>. This allows guidewire <NUM> to be aligned with elongated device <NUM> when elongated device <NUM> passes through working channel <NUM> along longitudinal axis <NUM>, thereby naturally merging into elongated device <NUM> as elongated device <NUM> passes by working member <NUM> at distal point <NUM>.

In some embodiments, main block <NUM> and adaptor <NUM> include suitable complementary fitting structures that allow adaptor <NUM> to be fixedly engaged with main block <NUM>. <FIG> shows another exemplary embodiment of main block <NUM>. <FIG> show another exemplary embodiment of adaptor <NUM> fixedly engaged with the exemplary main block <NUM> of <FIG>. <FIG> is a perspective view and <FIG> is a cross-sectional view of the exemplary embodiment of adaptor of <FIG>.

As shown in <FIG>, main block <NUM> may include a protrusion <NUM> and a conduit <NUM> configured to engage with a hole <NUM> and a fitting protrusion <NUM> of adaptor <NUM> respectively. Fitting protrusion <NUM> may include, for example, one or more prongs <NUM>. When fitting protrusion <NUM> is inserted into conduit <NUM>, for example, prongs <NUM> may deflect slighted inward so as to form a friction fit with conduit <NUM>. The end of prongs <NUM> may have one or more stops <NUM> to engage with an opening of conduit <NUM> such that adaptor <NUM> is fixedly engaged with main block <NUM>. As described herein, any suitable mechanical structures or connecting mechanisms may be used to securely engage adaptor <NUM> with main block <NUM>.

Exemplary embodiments of adaptor <NUM> that can be fixedly engaged with main block <NUM> may have two working modes, an introduction-device mode, as shown in <FIG>, and a second-device mode, as shown in <FIG>. Adaptor <NUM> may be switched between these two modes as needed by a physician during an endoscopic procedure, such as by turning a control <NUM>.

For example, when adaptor <NUM> is positioned in the introduction-device mode, working channel <NUM> of adaptor <NUM> is moved away the opening of main channel <NUM> such that a first elongated device <NUM> containing guidewire <NUM> (an introduction device) can be introduced directly into endoscope <NUM> through main channel <NUM> to approximate a desired treatment site. A diagnostic operation may be performed to determine the desired treatment site and guidewire <NUM> may be fixed in position by locking device <NUM> to maintain access to the desired treatment site.

To exchange the first elongated device <NUM> with a second elongated device <NUM>, the first elongated device <NUM> may then be removed off guidewire <NUM> by being continuously split or torn away from guidewire <NUM> through slit <NUM> while guidewire <NUM> remain fixed by locking device <NUM>. After the removal of the first elongated device <NUM>, adaptor <NUM> is positioned in the second-device mode such that working channel <NUM> of adaptor <NUM> is aligned with main channel <NUM>. The second elongated device <NUM> can then be merged with guidewire <NUM> as it is inserted into working channel <NUM> and then into endoscope <NUM> to reach the desired treatment site as further described below with reference to <FIG>.

<FIG> are perpendicular cross-sectional views of system <NUM> receiving elongated device <NUM> at different time points. As described above, before introducing elongated device <NUM> over guidewire <NUM>, guidewire <NUM> can be held by locking device <NUM> in a predetermined position to maintain access to a desired treatment site. As shown in <FIG>, after passing through the locking features of locking device <NUM>, guidewire <NUM> is received in a path formed by main groove <NUM> and side groove <NUM> and led towards distal end <NUM> of working member <NUM>.

As shown in <FIG>, to introduce elongated device <NUM> over guidewire <NUM>, a physician or an assistant may insert elongated device <NUM> into working channel <NUM> of adapter <NUM>. In some embodiments, to facilitate the alignment of elongated device <NUM> with working member <NUM> and/or guidewire <NUM>, the inner diameter of working channel <NUM> may be selected to substantially match an outer diameter of elongated device <NUM>. As elongated device <NUM> passes through working channel <NUM>, the distal end of elongated device <NUM> meets and passes by working member <NUM>, which then wedges open a portion of slit <NUM> of elongated device <NUM>. As shown in <FIG>, this in turn allows a portion of guidewire <NUM> at distal end <NUM> of working member <NUM> to merge into a corresponding portion of elongated device <NUM>, e.g., a portion of channel <NUM>, through the opened portion of slit <NUM>. After guidewire <NUM> merges into the distal end of elongated device <NUM>, as shown in <FIG>, guidewire <NUM> can continuously merge into elongated device <NUM> as elongated device <NUM> passes though working channel <NUM> until the distal end of elongated device <NUM> approximates or reaches the desired treatment site.

As described above, guidewire <NUM> is held in place by locking device <NUM> throughout the merging of guidewire <NUM> into elongated device <NUM>. This advantageously reduces the risk of losing the access to the desired treatment site in the body of a patient and increases the effectiveness of the introduction of elongated device <NUM> over guidewire <NUM> in a minimum amount of time.

<FIG> are parallel cross-sectional views illustrating the merging of guidewire <NUM> into elongated device <NUM>. As shown in <FIG>, the diameter of guidewire <NUM> is substantially greater than a natural width of slit <NUM>. As described above in reference to <FIG>, before introducing elongated device <NUM>, guidewire <NUM> has been aligned with distal point <NUM> of working member <NUM>. When the distal end of elongated device <NUM> passes by working member <NUM>, working member <NUM> then wedges open slit <NUM>. Therefore, as shown in <FIG>, the opening of slit <NUM> provides a passage for guidewire <NUM> to merge into channel <NUM> of elongated device <NUM>. After elongated device <NUM> passes by working member <NUM>, as shown in FIG. 3C, slit <NUM> is no longer wedged opened and returns to its natural width, thereby at least partially enclosing guidewire <NUM> in channel <NUM> of elongated device <NUM>. This advantageously allows guidewire <NUM> to be retained in channel <NUM> to effectively guide elongated device <NUM> to a desired treatment site before and during a medical operation.

As describe above, guidewire <NUM> may start merging into elongated device <NUM> from the distal end of elongated device <NUM> continuously up until the distal end of elongated device <NUM> approximate or reaches the desired treatment site. Advantageously, throughout the introduction of elongated device <NUM> over guidewire <NUM>, guidewire <NUM> remains locked by locking device <NUM> to maintain access to the desired treatment site, thereby eliminating the need to manually holding guidewire <NUM> and reducing the risk of displacement of guidewire <NUM>.

As described herein, elongated device <NUM> with slit <NUM> may be made of any suitable compliant polymeric material with adequate stiffness such that it can be wedged open and can close on its own. Such polymeric material may be selected from PTFE, Pebax, Nylon, Polyethylene, etc..

To retrieve elongated device <NUM> introduced over guidewire <NUM>, a physician or an assistant may remove adapter <NUM> from main block <NUM> and pull elongated device <NUM> out of the lumen of endoscope <NUM> and main channel <NUM>. Guidewire <NUM> can remain locked by locking device <NUM> so that another elongated device <NUM> may be introduced to the treatment site. During the retrieval of elongated device <NUM>, to remove elongated device <NUM> off guidewire <NUM>, the physician or assistant may separate elongated device <NUM> from guidewire <NUM> by continuously splitting or tearing elongated device <NUM> from guidewire <NUM> through slit <NUM>.

System <NUM> described herein may be utilized in a variety of systems and methods for performing device exchange during endoscopic procedures. An exemplary method <NUM> may use system <NUM> or one or more features of the embodiments of system <NUM> described above in reference to <FIG>. Exemplary embodiments of method <NUM> are described below with reference to <FIG> and <FIG>.

As described herein, some or all steps of method <NUM> may be performed by system <NUM> or one or more components of system <NUM>. The sequence of the steps of method <NUM> may change, and may be performed in various exemplary embodiments. Additional steps may be added to method <NUM>. Some steps may be omitted or repeated, and/or may be performed simultaneously.

As described above, in some embodiments, adaptor <NUM> can be removably engaged with main block <NUM>. In such instances, method <NUM> may include steps <NUM>-<NUM> as shown in <FIG>. Step <NUM> may include affixing main block <NUM> of system <NUM> to port <NUM> of endoscope <NUM>. For example, fastener <NUM> may be used to securely attach main block <NUM> on top of port <NUM> such that main channel <NUM> aligns with the inner lumen of port <NUM>.

Step <NUM> may include introducing a first elongated device <NUM> containing a guidewire <NUM> through port <NUM> into endoscope <NUM> to approximate a desired treatment site. Step <NUM> may further include performing a diagnostic operation to determine the desired treatment site.

Step <NUM> may include fixing guidewire <NUM> in place to maintain access to the desired treatment site. Step <NUM> may further include frictionally fixing guidewire <NUM> in place by a plurality of zigzag locking features of locking device <NUM> of main block <NUM>.

Step <NUM> may include retrieving the first elongated device <NUM> from endoscope <NUM> while fixing guidewire <NUM> in place by locking device <NUM>. Step <NUM> may further include continuously splitting the first elongated device <NUM> from a proximal end of guidewire <NUM> through slit <NUM> until the first elongated device <NUM> is completely removed off guidewire <NUM>.

Step <NUM> may include removably engaging adapter <NUM> with main block <NUM>. Step <NUM> may further include removably engaging adapter <NUM> with an opening of main channel <NUM> of main block <NUM>. For example, adaptor <NUM> may engage with main channel <NUM> via frictional fit, threaded fit, or other suitable fitting mechanism. Additionally or alternatively, step <NUM> may include engaging adaptor <NUM> with main block <NUM> using a detent, a fastener, and/or other suitable structures to securely hold adapter <NUM> thereon.

Step <NUM> may include introducing a second elongated device <NUM> through working channel <NUM> of adapter <NUM>. Step <NUM> may further include passing the distal end of the second elongated device <NUM> by working member <NUM> of adapter <NUM> and wedging open a portion of slit <NUM> of the second elongated device <NUM> by working member <NUM>.

Step <NUM> may include merging a portion of guidewire <NUM> into the second elongated device <NUM> through the opened portion of slit <NUM>. Step <NUM> may further include, after merging the portion of guidewire <NUM> into the second elongated device <NUM>, receiving the portion of guidewire <NUM> in partially enclosed channel <NUM> of second elongated device <NUM>. Step <NUM> may further include closing or narrowing the opened portion of slit <NUM> to retain the portion of guidewire <NUM> in channel <NUM> after the corresponding portion of the second elongated device <NUM> passes by working member <NUM>. Steps <NUM> and <NUM> may be performed continuously until the distal end of the second elongated device <NUM> reaches the desired treatment site.

In other embodiments, adaptor <NUM> can be fixedly engaged with main block <NUM>, as described above with reference to <FIG>. In such instances, method <NUM> may further include steps <NUM> and <NUM> as shown in <FIG>. Step <NUM> may include positioning adaptor <NUM> in the introduction-device mode such that a first elongated device <NUM> containing guidewire <NUM> can be introduced into endoscope <NUM> to approximate a desired treatment site. Step <NUM> may further include performing a diagnostic operation to determine the desired treatment site. Step <NUM> may include positioning adaptor <NUM> in the second-device mode. In such instances, rather than performing step <NUM> to engage adaptor <NUM> with main block <NUM>, step <NUM> adjusts the position of adaptor <NUM> that has been fixedly engaged with main block <NUM>, allowing for the alignment of working channel <NUM> of adaptor <NUM> with main channel <NUM>.

The foregoing description has been presented for purposes of illustration. It is not exhaustive and is not limited to precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. For example, the described implementations include hardware and software, but systems and methods consistent with the present disclosure can be implemented as hardware alone. In addition, while certain components have been described as being coupled to one another, such components may be integrated with one another or distributed in any suitable fashion.

Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as nonexclusive. Further, the steps of the disclosed methods can be modified in any manner, including reordering steps and/or inserting or deleting steps.

The features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended that the appended claims cover all systems and methods falling within the scope of the disclosure. As used herein, the indefinite articles "a" and "an" mean "one or more. " Similarly, the use of a plural term does not necessarily denote a plurality unless it is unambiguous in the given context. Words such as "and" or "or" mean "and/or" unless specifically directed otherwise. Further, since numerous modifications and variations will readily occur from studying the present disclosure, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure.

Claim 1:
A system (<NUM>) for device exchange in an endoscopic procedure, the system comprising:
an elongated device (<NUM>) having a slit (<NUM>) extending from a distal tip to a proximal end of the elongated device;
a main block (<NUM>) configured to be affixed to a port (<NUM>) of an endoscope (<NUM>), the main block comprising:
a main channel (<NUM>) for receiving at least one guidewire (<NUM>) and the elongated device, and
a main groove (<NUM>) that provides a path leading the guidewire towards a longitudinal axis of the main channel (<NUM>); and
an adapter (<NUM>) engaged with the main block and configured to merge the guidewire into the elongated device, the adapter comprising:
a working channel (<NUM>) for receiving the elongated device; and
a working member (<NUM>) raising from an inner wall of the working channel;
wherein when the elongated device passes through the working channel, the working member wedges open a portion of the slit of the elongated device such that a portion of the guidewire merges into the elongated device through the opened portion of the slit.