Device sending tools and systems

Abstract

Provided are tools and systems for delivery of medical devices or components, more particularly tools and systems that assist or facilitate the delivery of one or more medical devices over, onto, into, or against another medical device or component, more particularly delivery tools and systems for placement of an endoscopic device over, onto, into, or against another instrument or endoscope. [Selection diagram] Figure 8

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 614,999, filed January 8, 2018, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to tools and systems for the delivery of medical devices or components, and particularly to tools and systems that assist or facilitate the delivery of one or more medical devices over, onto, into, or relative to another medical device or component. More particularly, the present disclosure provides delivery tools and systems for the placement of an endoscopic device over, onto, into, or relative to another instrument or endoscope. [Background technology]

[0003] Recent advances in optical imaging technology have enabled many medical procedures to be performed in a minimally invasive manner today. Advances in more sophisticated flexible scopes with enhanced visual capabilities have enabled access to deeper regions of the human body that were previously achievable only through invasive surgical intervention. This modern tooling has resulted in an increase in the demand for, and the number of, endoscopy, laparoscopy, arthroscope, ophthalmoscope, borescope, and other remote imaging visualization procedures performed each year in the United States.

[0004] For example, endoscopy is a procedure in which an illuminated visualization device called an endoscope is inserted into a patient's body to view the inside of a body cavity or organ for the purposes of examination, diagnosis, or treatment. Endoscopes can be inserted through a small incision or through the patient's natural orifice. In bronchoscopy, the endoscope is inserted through the mouth, while in sigmoidoscopy, the endoscope is inserted through the rectum. Unlike most other medical imaging devices, endoscopes are inserted directly into organs.

[0005] Most endoscopes are used in combination with other medical devices or accessories available today for additional benefits. For example, devices have recently been developed that function as convenient accessories for existing endoscopes, reducing the risk of contamination and infection that occurs with endoscope reuse while also improving the performance of the endoscope. In some cases, the accessories can be configured for duodenoscopes and allow the user to simultaneously protect the working end from bacterial contamination and allow instruments to easily exit the working end of the duodenoscope at different angles. Other endoscope accessories include, for example, distal caps, varicose vein banding devices, and scope sheaths. All of these scope accessories are designed to fit over the endoscope and rely on the precise fit of the accessory on the distal or working end of the endoscope. If an accessory or component becomes damaged, the performance of the accessory and the endoscope itself will be adversely affected. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] US Patent Application Publication No. 2018 / 0206708 Al Summary of the Invention [Problem to be solved by the invention]

[0007] Thus, there is a need to improve the process of attaching these scope accessories onto existing scopes. As is the case whenever one medical device or accessory is intended to be attached over, on, within, or against another medical device or accessory where a very limited range of space or clearance exists between the two components, the attachment and delivery process can be difficult. This is especially true when the different components have different diameters, lengths, surface finishes, coefficients of friction, shapes, geometries, tapers, dimensions, and other material properties or characteristics or features that must function in a compatible manner for efficient delivery and compatibility of one or more components with one another. Thus, there is a practical need to properly attach the medical components to one another in a rapid manner without causing damage to any of these medical components (most of which are highly sensitive and fragile to physical disturbances) so as to avoid improper attachment, excessive handling, and lost time during the procedure. [Means for solving the problem]

[0008] The present disclosure provides device delivery assistance for properly attaching medical devices or components to one another in a rapid manner. Specifically, the present disclosure provides tools and systems that assist or facilitate the delivery of one or more medical devices or components over, onto, into, or to another medical device or component.

[0009] According to one aspect of the invention, one of the medical devices or components is an endoscopic accessory, such as, for example, a distal cap, a varicose vein banding device, a scope sheath, a scope seal, or other accessory for coupling to an endoscope, while the other medical device is, for example, a scope, such as an endoscope or duodenoscope.

[0010] In some embodiments, the delivery system can include a delivery assist tool and an introducer tool. The delivery assist tool can be configured to attach to the proximal end of the scope accessory, while the introducer tool can be configured to attach to the distal end of the scope accessory. The delivery assist tool serves to expand the proximal end or opening of the scope accessory, thus allowing for an easier insertion process onto the scope. The insertion tool allows for steady handling and proper alignment of the scope accessory onto the scope. The combination of the delivery assist tool and the insertion tool can provide an accurate, fast, and easy attachment process of the scope accessory 10 onto the scope in one smooth motion, including temporarily expanding the scope accessory as it is delivered onto the scope by the delivery system, and then allowing the scope accessory to contract to a different size when the delivery system or a portion thereof is removed.

[0011] The insertion tool can include a gripping portion for a user to hold the tool, while the main body of the tool can be configured to grip and securely support a scope accessory. In some embodiments, the main body of the insertion tool can further include a pair of stabilizing arms that can extend into pads that can cooperate with flanged pads on either side of the delivery assist tool. A user can grip both pads during use to better stabilize and more accurately position the scope accessory during the delivery process.

[0012] The delivery assist tool can include a squeeze paddle at its proximal end that can be inserted into the opening of the scope accessory and allows for rapid expansion of the scope accessory opening for placement over the scope. However, in its resting position, the delivery assist tool does not stretch or expand the scope accessory. The delivery assist tool can be formed from wireform and overmolded onto the scope accessory, or it can be a separate plastic part that is inserted into and packaged with the scope accessory. The tab can be provided with the tool for ease of handling. The tool can be formed from an elastomeric material to facilitate expansion. It is contemplated that the tool can be released to pull or separate the accessory when it is inserted onto the scope. This can be achieved by providing a weakened and scored section for the release portion, or by using a weakened material in the area that breaks free.

[0013] In some embodiments, the delivery assist tool can include a flared insertion collar with a trumpet-like shape that can be detached from the scope after the scope accessory is in place. The insertion collar can be formed of a rigid or semi-rigid material to hold the scope accessory open during insertion and stabilize it from crumpling or bunching. In addition to its flared shape, the collar 48 can include a cutout portion, such as a V-cut, to provide a user with a view through the insertion collar as they aim the insertion tool's working channel extension shaft through the accessory. The insertion collar's angled shape guides the device or accessory into and over the scope during use. Furthermore, the collar's grooved shape creates a flanged ring grip for easily pulling the insertion collar 48 to separate it from the accessory 10 once the delivery process is complete.

[0014] The flared portion of the insertion collar can be attached to the main shaft that is inserted into the accessory with an adhesive bond that allows the flared portion to be torn away from the accessory once delivery is complete. In an alternative embodiment, the insertion collar can include a tear-away portion, such as a scored or hatched marked area, that allows for quick release of the flared ring from the scope accessory. The main shaft of the delivery assist tool can include surface features, such as hard inner ribs, that support and stabilize the scope accessory during this delivery process.

[0015] In some embodiments, the scope accessory can be attached to the delivery tool in a resting state (i.e., unexpanded state). In some embodiments, a hard plastic co-molded component can be provided that cooperates with an elastomeric portion of the scope accessory such that upon squeezing the nose of the scope accessory, a molded structure, which can be part of the optical window component, opens, thereby also expanding the elastomer of the scope accessory, allowing it to be more easily fitted onto the scope. Releasing the force on the nose returns the scope accessory to its resting state.

[0016] In some embodiments, the hard plastic protrusion can be provided as part of a scope accessory. For example, the scope accessory can be provided with its elastomeric skirt pushed back on itself to expose the protrusion, which serves to help secure the elastomeric skirt and prevent it from bunching, while also providing a sliding surface for easier insertion over the scope. Once the elastomeric skirt is pushed back up, the scope accessory seals properly against the scope.

[0017] According to another aspect of the present disclosure, the elastomeric skirt of the scope accessory can be further secured onto the scope after delivery by the application of heat. For example, the application of low heat to an elastomeric skirt formed of a heat shrink material such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyester (PET), polyvinyl chloride (PVC), polyolefin, or any other suitable polymeric material can cause the skirt portion of the scope accessory to shrink around the scope to form a tight seal.

[0018] In yet another exemplary embodiment, a delivery system is provided. The delivery system may include an inserter and an associated end cap or spacer. The delivery system may be provided with a pre-loaded scope accessory to provide an integrated tool for delivery. The inserter may have a handle portion or end and an actuation or delivery end. The inserter generally has the structure and functionality of delivery pliers and may include a first or upper arm and a second or lower arm. The arms may be connected to each other with a hinged or pivotal connection through respective secondary arm extensions. The inserter may further include a main bracket and a backplate or wall connected to the main bracket for positioning the scope accessory relative thereto. The bracket is stationary relative to the arm. The backplate may be connected to a stabilizing extension shaft that may be inserted through the working channel opening of the scope accessory and also serves as an alignment guide during the assembly process.

[0019] Each of the upper and lower arms may also include a stabilizing or side bar. Each of the stabilizing side bars may have ratchet surfaces or features including teeth, ridges, or other surface protrusions that allow the stabilizing side bars to lock together and prevent movement of the arms relative to one another.

[0020] An end cap or spacer is provided for use with the insertion instrument. This spacer includes a two-piece design and includes a removable spacer component. The spacer can be placed at the working end of the insertion instrument to enclose an attached scope accessory. The spacer can be configured to expand the opening of the scope accessory for placement over the distal end of the scope. Collectively, these spacer elements 340a, 340b form an additional delivery assistance tool for delivering the scope accessory to the scope at the working or delivery end of the insertion instrument. Markings can also be provided on the delivery system to guide proper positioning of the scope accessory relative to the scope on which it is placed.

[0021] 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 present disclosure. Additional features of the present disclosure will be set forth in part in the description which follows, or may be learned by practice of the present disclosure.

[0022] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 is an exploded view of a delivery system for use with a scope accessory according to an exemplary embodiment of the present disclosure. [Figure 2] FIG. 2 shows the delivery system of FIG. 1 coupled to a scope accessory. [Figure 3A] FIG. 10 is a perspective view of a delivery assistance tool according to another exemplary embodiment of the present disclosure. [Figure 3B] FIG. 3B is a side view of the system used with the scope accessory and delivery assistance tool of FIG. 3A. [Figure 4A] FIG. 10 is a perspective view of a delivery assistance tool and delivery system for use with a scope accessory according to yet another exemplary embodiment of the present disclosure. [Figure 4B] FIG. 4B is a side view of the delivery system of FIG. 4A. [Figure 4C] FIG. 4C is a partial cutaway view of the system of FIG. 4B. [Figure 4D] FIG. 4D is an exploded view of the system of FIG. 4C. [Figure 5A] FIG. 10 illustrates a method of delivering a scope accessory onto a scope in accordance with yet another exemplary embodiment of the present disclosure. [Figure 5B] FIG. 10 illustrates a method of delivering a scope accessory onto a scope in accordance with yet another exemplary embodiment of the present disclosure. [Figure 5C] FIG. 10 illustrates a method of delivering a scope accessory onto a scope in accordance with yet another exemplary embodiment of the present disclosure. [Figure 6A] 1. FIG. 4 is a partial cutaway view of yet another exemplary embodiment of the present disclosure in which the scope accessory of FIG. 1 used with the delivery system of FIG. 1 may include internal ribs. [Figure 6B] 1. FIG. 4 is a partial cutaway view of yet another exemplary embodiment of the present disclosure in which the scope accessory of FIG. 1 used with the delivery system of FIG. 1 may include internal ribs. [Figure 7A] 6C illustrates how the scope accessory of FIGS. 6A and 6B is inserted prior to the application of heat. FIG. [Figure 7B] 6C illustrates a method for inserting the scope accessory of FIGS. 6A and 6B after application of heat. FIG. [Figure 8] 1 illustrates a top view of an exemplary embodiment of a delivery system of the present disclosure attached to a scope accessory. [Figure 9A] 9A-9C illustrate a method of inserting a scope accessory onto a scope using the delivery system of FIG. 8. [Figure 9B] 9A-9C illustrate a method of inserting a scope accessory onto a scope using the delivery system of FIG. 8. [Figure 9C] 9A-9C illustrate a method of inserting a scope accessory onto a scope using the delivery system of FIG. 8. [Figure 9D]9A-9C illustrate a method of inserting a scope accessory onto a scope using the delivery system of FIG. 8. [Figure 9E] 9A-9C illustrate a method of inserting a scope accessory onto a scope using the delivery system of FIG. 8. [Figure 9F] 9A-9C illustrate a method of inserting a scope accessory onto a scope using the delivery system of FIG. 8. [Figure 9G] 9A-9C illustrate a method of inserting a scope accessory onto a scope using the delivery system of FIG. 8. [Figure 9H] 9A-9C illustrate a method of inserting a scope accessory onto a scope using the delivery system of FIG. 8. DETAILED DESCRIPTION OF THE INVENTION

[0024] To illustrate the principles of the invention, embodiments of the invention are shown and described with reference to a scope accessory, such as, for example, a distal cap, a varicose vein banding device, a scope sheath, a scope seal or cap, or other scope accessory, and a scope, such as, for example, an endoscope or duodenoscope. It is contemplated that the scope can include a side-viewing scope or an end-viewing scope.

[0025] Turning now to the drawings, FIGS. 1 and 2 illustrate an exemplary embodiment of the presently disclosed device delivery system 100 that can be used with a scope accessory 10 of the type used with an endoscope. The scope accessory 10 can be of the type that seals and covers sensitive areas of the scope to prevent the ingress of debris, fluids, or other unwanted substances that may couple to the endoscope working end and lead to bacterial contamination and performance degradation of the scope. Additionally, the scope accessory 10 can provide a flexible working channel for instruments inserted into the scope. The flexible working channel can be easily angled. By way of example, a suitable scope accessory that can be used with the delivery system and tools of the present disclosure is described in U.S. Patent Application Publication No. 2018 / 0206708 A1, the contents of which are incorporated herein by reference.

[0026] As shown in FIG. 1 , the scope accessory 10 can include a main body 12, a proximal end 14 and a distal end 16, an inferior surface 18, and an superior surface 20. The proximal end 14 is attached to the working or distal end of the scope, extending the working end portion of the scope. The delivery system 100 can include a delivery assist tool 40 and an insertion tool 60. The delivery assist tool 40 can be configured to attach to the proximal end 14 of the scope accessory 10, as shown in FIG. 2 , while the insertion tool 60 can be configured to attach to the distal end 16 of the scope accessory 10. The delivery assist tool 40 serves to enlarge the proximal end 14 or opening of the scope accessory 10, thus allowing for an easier insertion process into the scope. The insertion tool 60 allows for steady handling and proper alignment of the scope accessory 10 relative to the scope. The combination of the delivery assist tool 40 and the insertion tool 60 can provide an accurate, quick, and convenient attachment process of the scope accessory 10 to the scope in one smooth motion.

[0027] The delivery assist tool 40 may include a tubular main body 42 for insertion into the receiving or proximal end 14 of the scope accessory 10. The main body 42 may include slits 46, or notches, slots, or other designs that allow the tubular main body 42 to expand and contract in diameter. The tubular main body 42 extends to a flared collar 44, which may also include slits 46, as shown in FIGS. 1 and 2. The flared collar 44 also includes a flared fastening pad 50 to aid in manipulation of the delivery assist tool 40.

[0028] The insertion tool 60 can include a gripping portion 62 for a user to hold the tool 60, while the main body 64 of the tool 60 can be configured to grip and securely support the scope accessory 10, as shown in FIG. 2 . In some embodiments, the main body 64 can have a tulip-shaped internal receiving cavity for supporting the scope accessory 10. In some embodiments, the main body 64 of the insertion tool 60 can further include a working channel extension shaft 66 and a pair of stabilizing arms 68 that can include flanged fastening pads 70 that can cooperate with flanged fastening pads 50 on either side of the delivery assist tool 40. The working channel extension shaft 66 can be inserted through the working channel opening of the scope accessory 10. A user can grasp both pads 50, 70 during use to better stabilize and more accurately position the scope accessory 10 during the delivery process. Collectively, the delivery assist tool 40 and the insertion tool 60 expand the receiving end of the scope accessory 10 while maintaining firm control over the scope accessory 10 as it is inserted over and onto the scope.

[0029] It is contemplated that either the delivery assist tool 40 or the insertion tool 60 can be pulled apart or pulled free when the accessory 10 is inserted over the scope by releasing the tool 40, 60. This can be accomplished by providing a weakened and scored section for the release portion, or it can be achieved by using a more fragile material in the area that breaks free. Additional details, including optional features, of the delivery assist tool 40 and the insertion tool 60 are described below.

[0030] 3A and 3B illustrate another exemplary embodiment of a delivery assistance tool 140 of the present disclosure. The delivery assistance tool 140 includes a tubular main body 142 that can be inserted into the receiving end or opening of the scope accessory 10 at its proximal end 14. The tubular main body 142 can be formed as a sheet of material having extension tabs 146 that, when rolled into a cylinder, allow the extension tabs 146 to cross each other as shown in FIG. 3A. The extension tabs 146 can terminate in angled squeeze paddles 146 that allow a user to apply force or pressure to push the paddles 146 together, rapidly expanding the diameter of the tubular main body 142 and, consequently, the opening of the scope accessory 10 for placement over the scope. However, in the rest position, the delivery assistance tool 140 does not stretch or expand the scope accessory 10, as shown in FIG. 3B. As shown, the delivery assistance tool 140 can be used with the insertion tool 60, as described above. The delivery assist tool 140 can be formed from wireform and overmolded onto the scope accessory 10, or it can be a separate plastic part that is inserted into and packaged with the scope accessory 10. A holder tab 156 can be provided with the tool 140 for ease of handling. The tool 140 can be formed from an elastomeric material to facilitate expansion.

[0031] 4A-4D illustrate another exemplary embodiment of a delivery assist tool 240 that can be used with the insertion tool 60 of the delivery system 100. As shown, the delivery assist tool 240 can include a tubular main body 242 extending into a flared insertion collar 244 having a trumpet-like shape that can be disengaged from the scope after the scope accessory 10 is in place. The tubular main body 242 can include slits 246, or notches, slots, or other designs that allow the tubular main body 242 to expand and contract in diameter. The insertion collar 244 can be formed of a rigid or semi-rigid material to hold the opening of the scope accessory 10 during insertion, stabilizing it from wrinkling or bunching. In addition to its flared shape, the collar 244 can include a cutout portion 252, such as a V-cut, to create a viewing window to allow a user to view through the insertion collar 244 as they aim the working channel extension shaft 66 of the insertion tool 60 through the accessory 10. The angled shape of the insertion collar 48 guides the device or accessory 10 into and over the scope during use. Additionally, the grooved shape of the collar 244 creates a flanged ring grip for easily pulling the insertion collar 244 away from the accessory 10 once the delivery process is complete.

[0032] 4C and 4D show, the flared collar 244 can be attached to the main tubular body 242 that is inserted into the accessory 10 by an adhesive bond that allows the flared collar 244 to be torn away from the accessory 10 once delivery is complete. In an alternative embodiment, the flared collar 244 can include a tear-away portion, such as a scored or hatched marked area 248, that allows for quick removal of the flared collar 244 from the scope accessory 10. The main tubular body 242 of the delivery assist tool 240 can include surface features, such as rigid inner ribs 256, that support and stabilize the scope accessory 10 during this delivery process.

[0033] 5A-5C illustrate an exemplary method of applying the delivery system 100 to deliver a scope accessory 10 of the type having an elastomeric skirt over a scope 30, with FIGS. 5A and 5B showing the scope accessory 10 attached to a delivery tool 60 in a resting state (i.e., unexpanded). In some embodiments, a hard plastic co-molded component 78 can be provided that cooperates with the elastomeric portion of the scope accessory 10 such that when the nose of the scope accessory 10 is squeezed in the direction of the arrow, a molded structure 78, which can be part of the optical window component, opens as shown in FIG. 5B, thereby also expanding the elastomer of the scope accessory 10 and allowing it to be more easily fitted over the scope 30 as shown in FIG. 5B. Releasing the force on the nose returns the scope accessory to its resting state as shown in FIG. 5C.

[0034] As shown in Figures 6A and 6B, a hard plastic protrusion 28 can be provided as part of the scope accessory 10. For example, the scope accessory 10 can be provided with its elastomeric skirt 24 pushed back over itself to expose the protrusion 28, which helps secure the elastomeric skirt 24 and prevents it from bunching, while also providing a sliding surface to facilitate insertion over the scope. When the elastomeric skirt 24 is pushed back over it, the scope accessory 10 is properly sealed against the scope, as shown in Figure 6B.

[0035] The elastomeric skirt 24 of the scope accessory 10 can be further secured onto the scope 30 after delivery by the application of heat, as shown in Figures 7A and 7B. For example, the application of low heat to an elastomeric skirt formed of a heat shrink material such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyester (PET), polyvinyl chloride (PVC), polyolefin, or any other suitable polymeric material can cause the skirt 24 portion of the scope accessory to shrink around the scope 30 to form a tight seal.

[0036] As will be appreciated, the delivery systems of the present disclosure provide delivery assistance techniques that improve the delivery of one or more medical devices or components over, onto, into, or against another medical device or component. Delivery assistance techniques can have the ability to modify the shape of one of the devices or components as it is delivered over the other device or component and create a variety of functions, including by delivering force, expanding or modifying geometry, and adding different coefficients of friction and other required material properties to enable effective delivery of one component over, onto, into, or against another component.

[0037] The application of heat is shown and described with respect to Figures 7A and 7B. However, it is understood that other applications can include the use of energy, temperature, surface modifications, and additives to facilitate smooth delivery of a component or device. For example, a temperature-sensitive material such as Nitinol or other electrically responsive or shape-memory alloy or material can be utilized in conjunction with the application of heat (from body heat when inside the body) to adjust its shape and change from an open to a closed configuration. Additionally, additives such as polymer oils, silicone oils, or the addition of a polymer coating such as PTFE can be utilized to reduce the coefficient of friction and facilitate a smooth sliding-out motion during delivery. In yet other embodiments, surface modifications can be utilized to facilitate delivery. A highly polished, mirror-like finish can be utilized to provide a smooth sliding surface during delivery, while alternative designs can utilize roughened surfaces to reduce grip or sticking between the component and the delivery system, allowing for faster release from the delivery tool 40, 60 and onto the scope 30.

[0038] Figure 8 illustrates another exemplary embodiment of a delivery system 300 of the present disclosure. The delivery system 300 includes an inserter 310 and an end cap or spacer 340. The inserter 310 can be provided with a pre-loaded scope accessory 10 in the configuration shown in Figure 8. The inserter 310 has a handle portion or end 310a and an actuation or delivery end 310b.

[0039] As shown, the insertion tool 310 generally has the structure and functionality of delivery pliers and can include a first or upper arm 312 and a second or lower arm 314. These arms 312, 314 can be connected to one another at a hinged or pivotal connection 326 through secondary arm extensions 322, 324, respectively. The insertion tool 310 can also include an attached main bracket 332 that is stationary relative to the pivotable or movable arms 312, 314. A back plate or wall 334 can be connected to the main bracket 332 for supporting the scope accessory 10 within the delivery system. The back plate 334 can be connected to a stabilizing extension shaft 338 that can be inserted through the working channel opening of the scope accessory 10, similar to the extension shaft 66 of the insertion tool 60. The stabilizing extension shaft 338 can have a blunt tip, for example, to avoid damaging the scope accessory 10 or the scope 30 during use. In its pre-assembled configuration, the scope accessory 10 is secured to the back plate 334 of the main bracket as shown.

[0040] As further shown, each of the upper and lower arms 312, 314 also includes a stabilizing or side bar 316, 318, respectively. The stabilizing side bars 316, 318 are configured to work with one another. As shown, each of the stabilizing side bars 316, 318 can have ratcheting surfaces or features 320, such as teeth, ridges, or other surface protrusions, that allow the stabilizing side bars 316, 318 to lock together and prevent movement of the arms 312, 314 relative to one another.

[0041] An end cap or spacer 340 is provided for use with the insertion instrument 310. The spacer 340 comprises a two-piece design and includes spacer components 340a, 340b. The spacer 340 can be placed at the working end 310b of the insertion instrument 310 and can be configured to attach to the scope accessory 10. In one embodiment, the spacer 340 is configured to expand the opening of the scope accessory 10 for placement over the distal end of the scope 30. Collectively, these spacer elements 340a, 340b form an additional delivery assistance tool for delivering the scope accessory 10 to the scope 30 at the working or delivery end 310b of the insertion instrument 310.

[0042] 9A-9H show an exemplary method of inserting a scope accessory 10 onto a scope 30 using an insertion tool 310 of the present disclosure. With the scope 30 securely held in one hand and properly aligned and positioned to receive the scope accessory 10, the user can grasp the handle portion 310a of the insertion tool 310 with the other hand. The user can squeeze the upper and lower arms 312, 314 in the direction of the arrows shown in FIG. 9A to release or unlock the arms from one another.

[0043] The extension shaft 338 of the inserter 310 can serve as an alignment guide in the next step shown in FIG. 9B, allowing the user to guide the inserter 310 with the pre-assembled scope accessory 10 toward the scope 30 and into its working channel. With the extension shaft 338 introduced through the working channel of the scope, the inserter 310 can be advanced. In one embodiment, advancement occurs at an angle of approximately 45°. However, it will be understood that the inserter 310 can be advanced at any angle, including between approximately 30° and approximately 60°, depending on the configuration of the scope 30 and using the user's best judgment. Additionally, the angle at which the inserter 310 is advanced will vary depending on the stage of the assembly process. In other words, the approach angle will change as the scope accessory 10 is advanced further onto the scope 30.

[0044] The inserter 310 can be advanced or pushed forward until the receiving end of the scope accessory 10 is over the distal end of the scope, as shown in FIG. 9C. Markings 352 on the inserter 310 serve as a convenient visual alignment guide, allowing the user to determine the proper position of the scope accessory 10 during assembly, as shown in FIG. 9D. By checking the markings 352, the user can ensure that the optical section of the scope accessory 10 is aligned with the optical section of, for example, the scope 30, thus ensuring a properly aligned fit. The inserter 310 should not be advanced any further at this point. As further shown in FIG. 9C, the delivery end 310b of the inserter 310 is expanded, while the handle end 310a remains in an unexpanded state.

[0045] Turning now to FIG. 9E, after proper positioning and alignment of the scope accessory 10 on the scope 30 has been confirmed, the upper and lower arms 312, 314 of the inserter 310 can be unlocked. This can be accomplished by squeezing the stabilizing side bars 316, 318 together to unseat them from each other. This unlocking of the arms 312, 314 allows the inserter 310 to return to its resting or unextended state, as shown in FIG. 9E. Grasping the spacer 340 as a single unit, the user can then pull the spacer 340 away from the delivery end 310b of the inserter 310. Removal of the spacer 340 then allows the inserter 310 to be withdrawn along the diagonal arrow direction, as shown in FIG. 9F, to avoid any damage to the scope in the process.

[0046] Upon completion of the assembly process, the spacer 340 remaining on the scope 30 can be released and each of the components 340a, 340b can be removed, as shown in Figure 9G. If the scope accessory 10 is misaligned or improperly positioned on the scope 30, the user can manually remove the scope accessory 10 by pulling it upward, away from the scope 30, as shown in Figure 9H, and begin the process again.

[0047] It is contemplated that the systems 100, 300, including the tools 40, 60, 140, 240, may be formed from any material, including, but not limited to, elastic, plastic, or deformable or malleable materials, whether metal or polymer or derivatives or combinations thereof.

[0048] It will of course be understood that the delivery systems 100, 300 may be sterilized using any acceptable method, or may be non-sterile. For example, the delivery systems 100, 300 may be provided as disposable or single-use systems or devices.

[0049] Furthermore, although the illustrations of the present invention show embodiments in which the scope accessory 10 is expanded or stretched to fit over or onto the scope 30, it is also contemplated that a delivery system can be provided in which the scope accessory 10 is configured to fit inside the scope 30 and then expand the scope accessory into its original resting state, thereby contracting or compressing it to form a tight seal within the scope 30.

[0050] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the embodiments disclosed herein. The specification and examples are intended to be considered as exemplary only. [Explanation of symbols]

[0051] 10 Pre-installed Scope Accessories 300 Transmission System 310 Insertion Instruments 310b Actuating or sending end 312 First or Upper Arm

Claims

1. 1. A device delivery system for use with a removable cap for an endoscope, comprising: an insertion tool having a pair of pivotable arms extending from a device delivery portion into a handle portion of the insertion tool and connected to one another at a pivotable connection, a device delivery end, a bracket connected to a backplate for placement of the removable cap, and an extension shaft configured as an alignment guide and extending from the backplate for placement of the removable cap through an actuation channel when the device delivery system is in use; a removable spacer removably coupled to the device delivery end of the insertion instrument and configured to expand an opening in the removable cap; Including, the device delivery end is an end of the pivotable arm; 10. A device delivery system, wherein the pivotable arms are movable away from each other at the device delivery portion upon movement of the pivotable arms at portions opposite the device delivery portion.

2. 10. The delivery system of claim 1, wherein the pivotable arms further include stabilizing side bars configured to enable the pivotable arms to lock together.

3. 3. The delivery system of claim 2, wherein the stabilizing side bar includes a ratchet surface.

4. 10. The delivery system of claim 1, wherein the bracket is stationary relative to the pivotable arm.

5. 10. The delivery system of claim 1, wherein the removable spacer comprises two detachable components.

6. 10. The delivery system of claim 1, further comprising indicia for use as alignment guides.

7. 7. The delivery system of claim 6, wherein the indicia indicate alignment of an optical section of the removable cap with an optical section of the endoscope.

8. 10. The delivery system of claim 1, wherein the removable cap at least partially seals the distal end of the endoscope.

9. 10. The delivery system of claim 8, wherein the removable cap includes a flexible working channel for use with an instrument inserted within the endoscope.

10. 10. The delivery system of claim 9, wherein the flexible working channel is angularly adjustable.

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