Medical device for use in endoscopic procedure

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.

FIELD

The present invention pertains to endoscopes and methods for making and using endoscopes. More particularly, the present invention pertains to endoscopes that include a wire and/or catheter locking member.

BACKGROUND

A wide variety of endoscopes and endoscopic procedures have been developed. Of the known endoscopes and endoscopic procedures, each has certain advantages and disadvantages. There is an ongoing need to provide alternative endoscopes as well as methods for making and using endoscopes.

SUMMARY

The invention provides design, material, and manufacturing method alternatives for endoscopes and for 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. The locking member can be actuated to secure the position of a medical device disposed in a channel. Additional details regarding these and other embodiments are described in more detail below.

The above summary is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures and Detailed Description which follow more particularly exemplify these embodiments.

DETAILED DESCRIPTION

A vast number of endoscopic devices exist that have a wide variety of applications. In at least some applications, the position of the endoscopic device and/or the position of a particular medical device disposed in the endoscopic device is important. This is at least partially due to challenges in precisely navigating the endoscope or endoscopic instruments through the anatomy of a patient. For example, when an endoscope and medical device disposed in a working channel therein are used for biliary applications, it may be difficult to advance the medical device through the papilla of Vater and toward the bile duct. Moreover, once a device is successfully advanced through the papilla of Vater, subtle movement of the device can result in the device being withdrawn back out from the papilla of Vater, necessitating another round of skilled maneuvering in order to proceed with the intervention.

Because of this potential complication, a number of endoscopes include (e.g., as an accessory to the endoscope) a proximal “wire lock” outside of the patient or similar means for maintaining the position of a guidewire or catheter disposed in the working channel of the endoscope. These devices are situated near the handle of the endoscope, near the opening of the working channel.

For a number of reasons, it has been found to be desirable to lock a guidewire, catheter and/or other medical device in a different manner and using a different structure, for example near the distal end of the endoscope. This is because a guidewire or other medical device disposed in a working channel may not be fully taut or may have a small amount of “slack”, which could shift in position and potentially displace the guidewire from the papilla of Vater. A proximal locking means, thus, may not account for slack in the guidewire or other medical device and otherwise may not properly hold the position of the guidewire or other medical devices in desired applications.

FIG. 1is an example endoscopic instrument assembly10that addresses this need as well as provides a number of desirable features. Assembly10includes an endoscope12having a shaft portion14and a handle portion16. Shaft portion14includes a distal end region18and a distal port20(best seen inFIG. 2) where one or more medical devices (e.g., a guidewire22and/or a catheter24) disposed within a working channel26(best seen inFIG. 2) formed in shaft portion14with medical devices capable of extending distally from distal port20. An elevator36can be disposed adjacent port20that, when actuated, alters the angle at which guidewire22and/or catheter24exits port20. Handle portion16includes one or more openings or a control region28where instruments (e.g., endoscopic instruments, guidewires, catheters, and the like) can gain access to working channel26and be extended through shaft portion14and out from port20. Control region28may also include a control wire (not shown) for controlling elevator36.

For the reasons stated above, it may be desirable for assembly10to include a locking means that is capable of securing the position of guidewire22and/or catheter24. Turning now toFIG. 2, it can be seen that distal end region18of shaft portion14includes a locking member30. According to this embodiment, locking member30takes the form of a notch or slot32formed in a side wall34of distal end region18and adjacent to distal port20(which is also formed in side wall34). Notch32can take a number of different shapes (e.g., “V”-shaped, “U”-shaped, “C”-shaped, round, oval, polygonal, etc.) but is generally configured to house, for example, guidewire22in a manner that allows guidewire22to be secured from axial movement relative to the endoscope. Therefore, guidewire22can be held in place by actuating the elevator36so that elevator36presses against guidewire22(housed in notch32) as shown inFIG. 3.

In use, endoscope12can be disposed in a body lumen. For example, shaft portion14can be advanced through the mouth and into the digestive tract of a patient. Once positioned, guidewire22can be advanced through working channel26to the desired target location. With guidewire22positioned, elevator36can be activated so that it raises and presses guidewire22into notch32, thereby securing the position of guidewire22. Catheter24can be advanced over guidewire22to the target region or, in some other embodiments, catheter24can be advanced through working channel26to the target region prior to advancing guidewire22. Elevator36may be similarly utilized to press against catheter24to hold the position of catheter24while catheter24is disposed adjacent notch32or at any other suitable location. In addition, catheter24may be proximally withdrawn far enough to expose guidewire22so that elevator36can be used to secure guidewire22. It can be appreciated that a number of variations to these generally stated methods are contemplated and can be utilized without departing from the spirit of the invention.

FIGS. 4-33illustrate a number of different embodiments of endoscope locking members that can be used with assembly10or similarly configured endoscopic assemblies. Turning now toFIGS. 4 and 5, example endoscope locking member130is shown that includes an inflatable balloon or bladder138disposed within the working channel adjacent distal end region118of shaft portion114and one or more inflation conduits140coupled to balloon138. According to this embodiment, inflation media can be infused through conduit140and into balloon138so that balloon138enlarges, as shown inFIG. 5, so as to secure the position of guidewire22. This mechanism may be similarly utilized to secure the position of catheter24or any other suitable medical device. Deflating balloon138releases guidewire22.

In some embodiments, balloon138is a single or multi-lobed balloon138that is coupled to one or more conduits140. Accordingly, guidewire22is captured within a small longitudinal channel defined through the middle of balloon138. This embodiment may be desirable, for example, because it effectively centers guidewire22in working channel126. Alternatively, balloon138may be configured to press guidewire22against an interior wall of shaft portion114.

In some embodiments, balloon138and conduit140are fused to the inside surface of shaft portion114. In addition, balloon138may be disposed within a notch or slot formed in the wall of shaft portion114. In other embodiments, balloon138and conduit140comprise a separate component that can be slid into any suitable working channel so as to provide locking capabilities to essentially any endoscope. This embodiment desirably adds distal guidewire22locking capabilities to a number of different endoscopes.

In still other embodiments, balloon138may have a basket or cage (not shown) disposed on its outer surface. Alternatively, balloon138may be omitted in lieu of a basket or cage. In these later embodiments, the cage may be actuated in any suitable manner. For example, the cage may be made from a shape memory material (including nickel-titanium alloys, shape memory polymers, etc.) that can shift to a pre-set shape (e.g., to a shape where the basket expands into channel126and locks guidewire22) when exposed to different thermal conditions. The changes in temperature may be achieved by any convenient mechanism such as through the use of electrical current, heated fluids, etc.

Embodiments that utilize a cage may also benefit from the fact that the cage can alter the surface of the locking member. This may aid the locking member in achieving a suitable “grip” on guidewire22. A wide variety of other surface modifications are contemplated for the various locking members disclosed herein. For example, a locking member may include a surface that is roughened, includes ridges or threads, includes an adhesive or “sticky” material, and the like. Essentially any of the locking members disclosed herein can benefit from these or other surface modifications.

FIGS. 6 and 7illustrate another example endoscope locking member230that is similar in form and function to locking member130. Locking member230includes inflatable balloon238and one or more inflation conduits240in fluid communication with balloon238. Conduit240, rather than being disposed along the inside surface of shaft portion214, is formed within the wall of shaft portion214. This embodiment functions essentially the same as the embodiment shown inFIGS. 4-5.

FIGS. 8-9illustrate another example endoscope locking member330that utilizes inflatable balloon338and conduit340. Balloon338and conduit340are both disposed within the wall of shaft portion314(e.g., a secondary lumen341formed in the wall of shaft portion314). In at least some embodiments, the wall of shaft portion314is reinforced with a reinforcing structure such as a braid or coil. Reinforced shaft portion314athus helps to provide column strength to shaft portion314and/or otherwise contributes to the overall integrity of shaft portion314. In some embodiments, an unreinforced region314bof shaft portion314may be defined that does not include the reinforcement structure. Balloon338may be disposed adjacent unreinforced region314bso that when balloon338is inflated, balloon338exerts a force onto unreinforced region314bsufficient to deflect unreinforced region314binto working channel326and secure the position of guidewire22as shown inFIG. 9.

The exact form of locking member330can vary. For example, a hydraulic mechanism may be utilized to deflect unreinforced region314binstead of inflating balloon338. This embodiment functions similar to how a hydraulic braking system functions in automobiles. In addition, unreinforced region314b(as well as the region of shaft portion314directly opposite therefrom) may have a surface modification that alters its shape so that a “clamp” or similarly configured structural arrangement can be formed that assists the locking of guidewire22. Numerous shapes and arrangements for this type of configuration are contemplated. For example, region314bmay include one or more ridges.

Another example endoscope locking member430is shown inFIGS. 10-11. Locking member430includes a clamp member442coupled to a pull wire444. Locking member430may be mounted on the exterior of shaft portion414or within the wall of shaft portion (as shown). In some embodiments, shaft portion414includes both reinforced region414aand unreinforced region414b. Clamp member442may take the form of a compression ring or compression spring that generally exerts an inward force on shaft portion414. The force exerted by clamp member442is not sufficient to deflect reinforced region414a, but it is sufficient to deflect unreinforced region414b. Thus, pull wire444can be withdrawn to displace clamp member442from a position adjacent reinforced region414ato a position adjacent unreinforced region414b, thereby deflecting unreinforced region414binto working channel426to lock guidewire22as shown inFIG. 11. Unlocking guidewire22may include further retracting pull wire444so that clamp member442becomes disposed adjacent reinforced region414aor distally pushing clamp member442back to its original position.

Another example endoscope locking member530is depicted inFIGS. 12-13. Locking member530includes a pair of sloped wedge members546a/546b. One of the wedge members546ais movable within the wall of shaft portion514. The other wedge member546bis fixed relative to the wall of shaft portion514. Locking member530is actuated by pushing wedge member546adistally so the sloped edges of wedge members546a/546bcause wedge member546ato exert force inward onto unreinforced region514b. This deflects unreinforced region514bof shaft portion514into channel526, thereby securing the position of guidewire22. Alternatively, wedge member546bcan be coupled to a pull wire so that member546bcan be proximally retracted to create the same effect. It can be appreciated that a number of differently configured wedge members546a/546bare contemplated that can generate sufficient force to deflect unreinforced region514bof shaft portion514.

Another example endoscope locking member630is depicted inFIGS. 14-15. Locking member630is similar to locking member530. As shown inFIGS. 14-15, wedge members646a/646bare disposed along the interior wall of shaft portion614so that actuating wedge member646adisplaces wedge member646adirectly onto guidewire22.

Another example endoscope locking member730is depicted inFIGS. 16-17. Locking member730includes a hinged clamp member742coupled to a pull wire744. Hinge748, which connects clamp member742to shaft portion714is biased to be deflected inward into working channel726(as shown inFIG. 17) by a spring or similar means. Proximally pulling pull wire744exerts enough force to overcome the bias and shift clamp member742into alignment with shaft portion714(as shown inFIG. 16). Thus, a clinician can secure the position of guidewire22by allowing hinge748to force closed clamp member742. This may include gently urging pull wire744in the distal direction.

In some embodiments, locking member730is disposed along an exterior surface of shaft portion714. In other embodiments, locking member730may be disposed within the wall of shaft portion714. This later embodiment is illustrated via a phantom line750drawn inFIGS. 16-17that represents the outer wall of shaft portion714.

Endoscope locking member830is depicted inFIGS. 18-19. Locking member830includes a plurality of clamping members852a/852b/852c, each having a wire854a/854b/854ccoupled thereto. Clamping members852a/852b/852cand wires854a/854b/854cmay be disposed along the exterior of shaft portion814or may be disposed within the wall of shaft portion814as depicted by phantom line850. Clamping members852a/852b/852cmay be actuated in a number of ways in order to secure the position of guidewire22. For example, in some embodiments, clamping members852a/852b/852cform an electric pin vise that is activated by sending current down wires854a/854b/854c. Upon activation, clamping members852a/852b/852care drawn together to secure guidewire22. Alternatively, clamping members852a/852b/852cmay be magnetized (e.g., clamping members852a/852b/852cinclude electromagnets) so that activation of clamping members852a/852b/852csecures guidewire22.

Another example endoscope locking member930is shown inFIGS. 20-21. Locking member930takes the form of an elongated wedge that can advance through a lumen941formed in shaft portion914. Locking member930is actuated by advancing it distally within lumen941so that it can exert force inward onto shaft portion914. This deflects shaft portion914into channel926, thereby securing the position of guidewire22as seen inFIG. 21.

In at least some embodiments, the locking of guidewire22with locking member930may also be aided by structural modifications of shaft portion914. For example, shaft portion914may include one or more reinforced regions and one or more unreinforced regions, which may be similar to others disclosed herein. According to these embodiments, locking member930may deflect shaft portion914when it is positioned adjacent to one of the unreinforced regions. In other embodiments, lumen941may have a “wedge-like” or narrowing shape so that a mandrel or shaft locking member can be advanced therein to lock guidewire22.

FIGS. 22-23illustrate another example endoscope locking member1030. Locking member1030may include a stent-like or cage-like section1038and an actuation wire1040coupled thereto. Stent-like section1038may be configured to constrict shaft portion1014. For example, stent-like section1030may constrict shaft portion1014when actuation wire1040is pulled in the proximal direction. To assist this constriction, stent-like section1030may have a pull ring (not shown) disposed at one or both of its ends. When stent-like section1030constricts shaft portion1014, shaft portion1014deflects into channel1026and locks guidewire22as shown inFIG. 23.

Numerous variations are contemplated for the configuration of locking member1030. For example, stent-like section1038may take the form of a coil, braid, helix, or any other suitable structure that, when actuated, constricts shaft portion1014. In additional embodiments, stent-like section1038may be made from a shape memory material (e.g., like nickel-titanium alloy, shape memory polymer, etc.) that is “trained” to have a shape suitable for constricting shaft portion1014at a certain temperature. In some embodiments, stent-like section1038can be heated (e.g., by delivering electrical current to stent-like section1038along wire1040or in any other manner) to the pre-set temperature, which causes the shape memory locking member1030to return to the pre-set shape and lock guidewire22. Any other of the locking members disclosed herein, to the extent applicable, may similarly utilize shape memory materials in their functioning. Various other mechanisms are also contemplated for actuating locking member1030or any of the other locking members disclosed herein including servomechanisms.

Shaft portion1014may also include structural features described for any of the other shaft portions disclosed herein. For example, a lumen (not shown) may be formed in the wall of shaft portion1014. In some of these embodiments, locking member1030may be disposed in the lumen. In others, locking member1030is disposed along the exterior of shaft portion1014. Shaft portion1014may also include reinforced and/or unreinforced regions that may be similar in form and function to others disclosed herein.

Another example endoscope locking member1130is shown inFIGS. 24-25. Locking member1130includes an expandable or elastic “brake”1138disposed along an interior wall surface of shaft portion1114. Brake1138is configured to shift between a collapsed configuration and an expanded configuration. In at least some embodiments, brake1138may be held in the collapsed configuration by a sleeve or covering1156. Sleeve1156may be proximally retracted within channel1126, thereby allowing brake1138to expand into channel1126so as to lock guidewire22as seen inFIG. 25.

A variety of brakes are contemplated that resemble brake1138in form and function. For example, brakes are contemplated that extend around the full circumference of shaft portion1114, while others extend along only a portion. In addition, the length and/or shape of the brakes may vary. For example,FIG. 26illustrates locking member1230with a brake1238that has an increased longitudinal length (i.e., is “long”) along shaft portion1214. Conversely,FIG. 27illustrates locking member1330with a brake1338that has a shortened longitudinal length (i.e., is “short”) along shaft portion1314. It can be appreciated that essentially any length of brake may be utilized without departing from the spirit of the invention.FIGS. 28-29illustrate that any suitable number of brakes (e.g., 1, 2, 3, 4, 5, or more) may be utilized along with a number of different configurations. For example,FIG. 28depicts locking member1430having two brakes1438a/1438b. Brakes1438a/1438bcan be disposed along the same section of shaft portion1414(e.g., they longitudinally align) as shown inFIG. 28. Conversely,FIG. 29depicts locking member1530having two brakes1538a/1538bdisposed on opposing sides of shaft portion1514. Thus, not only can the number of brakes vary, the position of the various brakes relative to one another can also vary.

Expandable region1638may be configured to buckle in any of a number of different ways. For example, expandable region1638may have a number of pre-formed bends or bendable regions that renders expandable region1638amenable to shifting from a longitudinally straight configuration to the buckled configuration. Essentially any other suitable mechanism may be utilized for shifting expandable region1638into the buckled configuration.

Another example endoscope locking member1730is shown inFIGS. 32-33. Locking member1730takes the form of a twistable region formed in shaft portion1714. Accordingly, twisting shaft portion1714shifts the arrangement of the walls of shaft portion1714so that a region extends into or otherwise pinches channel1726and locks guidewire22as shown inFIG. 33.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size and arrangement of steps without exceeding the scope of the disclosure. The invention's scope is, of course, defined in the language in which the appended claims are expressed.