Component delivery tool and system

Abstract

Tools and systems for delivering medical devices or components are provided. In particular, assistance or facilitation of delivery of one or more medical devices or components over, to, other medical devices or components is provided, to deliver one or more medical devices or components to, other medical devices or components, tools and systems for delivering one or more medical devices or components into or in close proximity to other medical devices or components. In particular, delivery tools and systems are provided for disposing an endoscope component over, onto, into, or in close proximity to another instrument or endoscope.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 201980007248.1, filed on January 6, 2019.

[0002] Cross - reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 614,999, filed on January 8, 2018, the entire content of which is incorporated herein by reference. Technical field

[0004] The present disclosure relates to tools and systems for delivering medical devices or components, and more particularly to tools and systems for assisting or facilitating the delivery of one or more medical devices or components onto, to, into, or against other medical devices or components. Specifically, the present disclosure provides delivery tools and systems for positioning endoscopic components onto, to, into, or against another instrument or endoscope. Background art

[0005] Recent developments in optical imaging technology have now enabled many medical procedures to be performed in a minimally invasive manner. The evolution of more complex and flexible scopes with advanced vision capabilities has allowed access to regions deep within the human body that were previously only reachable using invasive surgery. This modern convenience has led to an increased demand for, and number of, endoscopic, laparascopic, arthroscopic, ophthalmoscopic, borescopic, or other remote imaging visualization procedures performed annually in the United States.

[0006] For example, endoscopy is a procedure in which a lighted visualization device, called an endoscope, is inserted into a patient's body to observe the interior of a body cavity or organ for examination, diagnosis, or treatment purposes. The endoscope can be inserted through a small incision or natural opening in the patient. In bronchoscopy, the endoscope is inserted through the mouth, and in sigmoidoscopy, the endoscope is inserted through the rectum. Unlike most other medical imaging devices, the endoscope is inserted directly into the organ.

[0007] Most endoscopes can be used in combination with other medical devices or accessories, which can now provide additional benefits. For example, components have recently been developed as convenient accessories for currently available endoscopes to reduce the risk of contamination and infection due to reusing endoscopes, while also improving the performance of the endoscopes. In some cases, the accessory can be configured for a duodenoscope and allows the user to easily withdraw the instrument from the working end of the endoscope at different angles while protecting the working end from bacterial contamination. Other endoscope accessories include, for example, distal caps, variceal ligation devices, and endoscope sheaths. All of these endoscope accessories are designed to be assembled onto the endoscope and rely on a precise fit of the accessory at the distal or working end of the endoscope. If the accessory or component is damaged, it will have an adverse effect on the performance of both the accessory and the endoscope itself.

[0008] Accordingly, there is a need to improve the attachment process for attaching these endoscope accessories to existing endoscopes. When it is desired to assemble one medical device or accessory on top of, onto, into, or against another medical device or accessory, the installation and delivery process is a challenge when the space or gap between the two components is very limited. This challenge is especially the case 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 but must operate in a compatible manner to achieve the effective delivery and matching of one or more components to another component. Thus, there is a pressing desire to correctly assemble medical components together in a rapid manner without damaging any of these medical components (most medical components are very sensitive to physical interference and are easily damaged by physical interference) in order to avoid improper assembly, improper operation, and wasted time during the procedure. Summary of the Invention

[0009] The present disclosure provides component delivery aids for correctly assembling medical devices or components together in a rapid manner. Specifically, the present disclosure provides tools and systems for assisting or facilitating the delivery of one or more medical devices or components on top of, onto, into, or against another medical device or component.

[0010] According to one aspect of the invention, one of the medical devices or components is an endoscope accessory, such as a distal cap, variceal ligation device, endoscope sheath, endoscope seal, or other accessory for attachment to an endoscope, and the other medical device is an endoscope, such as an endoscope or a duodenoscope.

[0011] In some embodiments, the delivery system may include a delivery aid and an insertion tool. The delivery aid may be configured to attach to the proximal end of the endoscopic accessory, while the insertion tool may be configured to attach to the distal end of the endoscopic accessory. The delivery aid is used to expand the proximal end or opening of the endoscopic accessory, thereby making the insertion process of the endoscope easier. The insertion tool allows for stable manipulation and correct alignment of the endoscopic accessory with respect to the endoscope. The combination of the delivery aid and the insertion tool can provide a process of accurately, quickly, and conveniently attaching the endoscopic accessory to the endoscope in a smooth motion manner, including temporarily expanding the endoscopic accessory when it is delivered onto the endoscope by means of the delivery system, and then contracting the endoscopic accessory to a different size when the delivery system or a part thereof is removed.

[0012] The insertion tool may include a grip portion for the user to hold the tool, and the body of the tool may be configured to grasp and firmly bracket support the endoscopic accessory. In some embodiments, the body of the insertion tool may further include a pair of stabilizing arms that may extend into pads that can mate with flange pads located on the side of the delivery aid. The user can grasp the pads during use to better stabilize and more accurately position the endoscopic accessory during delivery.

[0013] The delivery aid may be inserted into the opening at the proximal end of the endoscopic accessory and includes squeezing blades, so that the opening of the endoscopic accessory can be quickly expanded to be placed on the endoscope. However, in the rest position, the delivery aid does not stretch or expand the endoscopic accessory. The delivery aid may be formed by a wire and overmolded with respect to the endoscopic accessory, or may be a separate plastic part that is inserted and packaged with the endoscopic accessory. The tool may be provided with a gripping tab for easy operation. The tool may be formed of an elastomeric material to facilitate expansion. It is conceivable that when the accessory is inserted onto the endoscope by disengaging the tool, the tool can be pulled away or separated. This can be achieved by providing a weakened, scored section to the detachment portion, or by using a weaker material at the area to be disconnected.

[0014] In some embodiments, the delivery aid may be provided with a flared insertion collar having a trumpet-like shape that can be disconnected and detached from the endoscope after the endoscopic accessory is in place. The insertion collar may be formed of a rigid or semi-rigid material to keep the endoscopic accessory open during insertion so that it is stable and does not wrinkle or bunch up. In addition to its flared shape, the collar may include a cutout portion such as a V-shaped cutout to provide the user with a view through the insertion collar when the user aims the working channel extension shaft of the insertion tool through the accessory. The angled shape of the insertion collar guides the device or accessory into and onto the endoscope during use. Additionally, the grooved shape of the collar forms a flange ring grip to easily pull the insertion collar 48 away from and separate it from the accessory after the delivery process is complete.

[0015] The flared portion of the insertion collar may be attached to the spindle by an adhesive that is inserted into the accessory and that allows the flared portion to be torn away from the accessory once delivery is complete. In an alternative embodiment, the insertion collar may include a tear-away portion such as a scored or shaded marked area that allows the flared ring to be quickly detached from the endoscopic accessory. The spindle of the delivery aid may include surface features such as hard internal ribs that support and stabilize the endoscopic accessory during the delivery process.

[0016] In some embodiments, the endoscopic accessory may be attached to the delivery tool in a stationary (i.e., non-expanded) state. In some embodiments, a hard plastic co-molded component may be provided that mates with the elastomeric portion of the endoscopic accessory such that when the nose of the endoscopic accessory is squeezed in the direction of the arrow, a molded structure that can be part of an optical window component opens, further expanding the elastomeric portion of the endoscopic accessory and making it easier to fit onto the endoscope. Releasing the force on the nose causes the endoscopic accessory to return to its stationary state.

[0017] In some embodiments, hard plastic pins may be provided as part of the endoscopic accessory. For example, the endoscopic accessory may be provided such that the elastomeric skirt of the endoscopic accessory is rolled back on itself to expose the pins, which helps to splint the elastomeric skirt and prevent it from bunching up while also providing a gliding surface to facilitate insertion onto the endoscope. When the elastomeric skirt is rolled back, the endoscopic accessory is properly sealed onto the endoscope.

[0018] According to another aspect of the present disclosure, the elastomeric skirt of the endoscopic accessory may be further secured to the endoscope after delivery by applying heat. Applying low heat to the elastomeric skirt formed of a heat-shrinkable material such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyester (PET), polyvinyl chloride (PVC), polyolefin, or any other suitable polymeric material causes the skirt portion of the endoscopic accessory to shrink around the endoscope, thereby forming a tight seal.

[0019] In yet another exemplary embodiment, a delivery system is provided. The delivery system includes an insertion instrument and an end cap or spacer. The delivery system may be provided with a pre-mounted endoscopic accessory and provides an integral tool for delivery. The insertion instrument may have a handle portion or end, and a working or delivery end. The insertion instrument generally may have the structure and function of a delivery forceps and includes a first or upper arm and a second or lower arm. These arms may be connected to each other at a hinge or pivot connection by respective secondary arm extensions. The insertion instrument may further include a main bracket and a back plate or wall, the back plate or wall being connected to the main bracket for the endoscopic accessory to be disposed thereagainst. The back plate is fixed relative to the arms. The back plate may be connected to a stabilizing extension shaft, which may be inserted through the working channel opening of the endoscopic accessory and serves as an alignment guide during assembly.

[0020] Each of the upper and lower arms further includes a stabilizing bar or side bar, respectively. The stabilizing side bars may each have a ratchet surface or feature including teeth, ridges, or other surface protrusions that allow the stabilizing side bars to lock together and prevent relative movement of the arms with respect to each other.

[0021] An end cap or spacer is provided for use with the insertion instrument. The spacer includes a two-piece design and includes a removable spacer member. The spacer may be disposed at the working end of the insertion instrument for enclosing the attached endoscopic accessory. The spacer may be configured such that it expands the opening of the endoscopic accessory for being disposed on the distal end of the endoscope. These spacer elements 340a and 340b together form an additional delivery aid for delivering the endoscopic accessory to the endoscope at the working or delivery end of the insertion instrument. Marks may also be provided on the delivery system to guide the correct positioning of the endoscopic accessory relative to the endoscope on which the endoscopic accessory is to be disposed.

[0022] It should be understood that the foregoing general description and the following detailed description are merely exemplary and explanatory and do not limit the present disclosure. Additional features of the present disclosure will be set forth in part in the following description, or may be learned by practice of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The drawings incorporated in and forming a part of this specification illustrate certain embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0024] Figure 1 A exploded view of a delivery system for use with an endoscopic accessory in accordance with an exemplary embodiment of the present disclosure is shown.

[0025] Figure 2 Shown is a delivery system coupled with an endoscopic accessory Figure 1 thereof.

[0026] Figure 3A A perspective view of a delivery aid according to another exemplary embodiment of the present disclosure is shown.

[0027] Figure 3B A side view of a system and a delivery aid used with an endoscopic accessory is shown. Figure 3A of the system and the delivery aid.

[0028] Figure 4A A perspective view of a delivery aid and a delivery system used with an endoscopic accessory according to yet another exemplary embodiment of the present disclosure is shown.

[0029] Figure 4B A side view of a delivery system is shown. Figure 4A of the delivery system.

[0030] Figure 4C A partial cross-sectional view of a system is shown. Figure 4B of the system.

[0031] Figure 4D A exploded view of a system is shown. Figure 4C of the system.

[0032] Figures 5A to 5C A method of delivering an endoscopic accessory to an endoscope according to yet another exemplary embodiment of the present disclosure is shown.

[0033] Figure 6A and Figure 6B A partial cross-sectional view according to still another exemplary embodiment of the present disclosure is shown, wherein Figure 1 the endoscopic accessory may include internal ribs for use with Figure 1 a delivery system.

[0034] Figure 7A and Figure 7B A method of inserting an endoscopic accessory before and after applying heat is shown. Figure 6A and Figure 6B the endoscopic accessory.

[0035] Figure 8 A top view of an exemplary embodiment of a delivery system attached to an endoscopic accessory of the present disclosure is shown.

[0036] Figures 9A to 9H A method of inserting an endoscopic accessory onto an endoscope using Figure 8 a delivery system is shown. Detailed Description

[0037] To illustrate the principles of the present invention, embodiments are shown and described with respect to endoscopic accessories (such as distal caps, variceal ligation devices, endoscopic sheaths, endoscopic seals or caps, or other endoscopic accessories) and endoscopes (such as endoscopes or duodenoscopes). It is contemplated that the endoscope may include a side-view endoscope or a forward-view endoscope.

[0038] Turning now to the drawings, Figure 1 and Figure 2 an exemplary embodiment of a component delivery system 100 of the present disclosure is shown, which can be used with an endoscopic accessory 10, where the endoscopic accessory 10 is of the type for use with an endoscope. The endoscopic accessory 10 can be of the type that is coupled to the working end of an endoscope and seals and covers the infection-prone area of the endoscope to prevent debris, fluids, or other harmful substances that may cause bacterial contamination and degradation of the performance of the endoscope from entering. Additionally, the endoscopic accessory 10 can provide a flexible working channel for inserting instruments into the endoscope. The flexible working channel can be easily angle-adjusted. For example, suitable endoscopic accessories that can be used with the delivery system and tools of the present disclosure are described in U.S. Patent Application Publication No. 2018 / 0206708A1, the content of which is incorporated by reference.

[0039] As Figure 1 shown, the endoscopic accessory 10 can include a body 12, a proximal end 14, a distal end 16, a lower surface 18, and an upper surface 20. The proximal end 14 is attached to the working end or the distal end of the endoscope, thereby extending the working end portion of the endoscope. The delivery system 100 can include a delivery assist tool 40 and an insertion tool 60. As Figure 2 shown, the delivery assist tool 40 can be configured to be attached to the proximal end 14 of the endoscopic accessory 10, while the insertion tool 60 can be configured to be attached to the distal end 16 of the endoscopic accessory 10. The delivery assist tool 40 is used to expand the proximal end 14 or the opening of the endoscopic accessory 10, thereby making the insertion process with respect to the endoscope easier. The insertion tool 60 allows for stable manipulation and proper alignment of the endoscopic accessory 10 with respect to the endoscope. The combination of the delivery assist tool 40 and the insertion tool 60 can provide a process of accurately, quickly, and conveniently attaching the endoscopic accessory 10 to the endoscope in a smooth motion manner.

[0040] The delivery assist tool 40 can include a tubular body 42 for insertion into the receiving end or the proximal end 14 of the endoscopic accessory 10. The body 42 can include a slit 46 or incision, slot, or other design to allow the tubular body 42 to expand and contract in a diametrical direction. As Figure 1 and Figure 2As shown, the tubular body 42 extends into a flared collar 44, which may also include a slit 46. The flared collar 44 further includes a flared pad 50 to assist in manipulating the delivery aid 40.

[0041] As Figure 2 shown, the insertion tool 60 may include a grip portion 62 for a user to hold the insertion tool 60, and the body 64 of the insertion tool 60 may be configured to grasp and securely cradle the endoscopic accessory 10. In some embodiments, the body 64 may have a tulip-shaped internal receiving cavity for cradling the endoscopic accessory 10. In some embodiments, the body 64 of the insertion tool 60 may further include a working channel extension shaft 66 and a pair of stabilizing arms 68, and the pair of stabilizing arms 68 may include flange pads 70 that can cooperate with the flange pads 50 provided on the side of the delivery aid 40. The working channel extension shaft 66 may be inserted through the working channel opening of the endoscopic accessory 10. The user may grip pads 50 and 70 during use to better stabilize and more accurately position the endoscopic accessory 10 during delivery. When the endoscopic accessory 10 is inserted onto the endoscope, the delivery aid 40 and the insertion tool 60 together expand the receiving end of the endoscopic accessory 10 while maintaining reliable control of the endoscopic accessory 10.

[0042] It is contemplated that when inserting the accessory 10 onto the endoscope by disengaging the tools 40, 60, either the delivery aid 40 or the insertion tool 60 may be pulled away or separated. This may be achieved by providing a weakened, scored section to the disengaging portion, or by using a weaker material in the area to be disconnected. Additional details of the delivery aid 40 and the insertion tool 60 including optional features will be described below.

[0043] Figure 3A and Figure 3B shows another exemplary embodiment of the delivery aid 140 of the present disclosure. The delivery aid 140 includes a tubular body 142 that may be inserted into the receiving end or opening of the endoscopic accessory 10 at the proximal end 14. The tubular body 142 may be formed as a sheet of material having extending tabs 146, as Figure 3A shown, which allow the extending tabs 146 to cross each other when rolled into a cylinder. The extending tabs 146 may terminate in angled squeezing blades 146 that allow a user to apply force or pressure to push the blades 146 together, thereby enabling the diameter of the tubular body 142 to rapidly expand and thus enabling the opening of the endoscopic accessory 10 for placement on the endoscope to rapidly expand. However, as Figure 3BAs shown, in the stationary position, the delivery aid 140 does not extend or deploy the endoscopic accessory 10. As shown, the delivery aid 140 can be used with the insertion tool 60 described above. The delivery aid 140 can be formed of wire and overmolded about the endoscopic accessory 10, or can be a separate plastic component that is inserted and packaged with the endoscopic accessory 10. The tool 140 can be provided with a gripping tab 156 for ease of operation. The tool 40 can be formed of an elastomeric material to facilitate dilation.

[0044] Figures 4A to 4D Another exemplary embodiment of a delivery aid 240 that can be used with the insertion tool 60 of the delivery system 100 is shown. As shown, the delivery aid 240 can be provided with a tubular body 242 that extends into a flared collar 244 having a flared shape, and the flared collar 244 can be disconnected from the endoscope after the endoscopic accessory 10 is in place. The tubular body 242 can include a slit 246 or incision, slot or other design to allow the tubular body 242 to expand and contract diametrically. The insertion collar 244 can be formed of a rigid or semi-rigid material to keep the endoscopic accessory 10 open during insertion, thereby stabilizing it against wrinkling or bunching. In addition to its flared shape, the collar 244 can also include an incision portion 252 such as a V-shaped incision to form an observation window and provide the user with a view through the insertion collar 244 when the user aims 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 the endoscope and guides the device or accessory 10 over the endoscope during use. Additionally, the grooved shape of the collar 244 forms a flange ring grip to easily pull the insertion collar 244 away from the accessory 10 and separate them after the delivery process is complete.

[0045] As Figure 4C and Figure 4D shown, the flared collar 244 can be attached to the tubular body 242 by an adhesive, and the tubular body 242 is inserted into the accessory 10, and the adhesive allows the flared collar 244 to be torn off the accessory 10 once the delivery is complete. In an alternative embodiment, the flared collar 244 can include a tear portion, such as a scored or shaded marked area 248, which allows the flared collar 244 to be quickly detached from the endoscopic accessory 10. The tubular body 242 of the delivery aid 240 can include surface features such as rigid internal ribs 256 that support and stabilize the endoscopic accessory 10 during the delivery process.

[0046] Figures 5A to 5C An exemplary method of applying the delivery system 100 to deliver an endoscopic accessory 10 of the type having an elastomeric skirt to the endoscope 30 is shown, wherein, Figure 5A and Figure 5BShown is an endoscopic accessory 10 attached to a delivery tool 60 and in a stationary state (i.e., not expanded). In some embodiments, a rigid plastic co-molded component 78 may be provided that mates with an elastomeric portion of the endoscopic accessory 10 such that when the nose of the endoscopic accessory 10 is squeezed in the direction of the arrow, a molded structure 78 that can be part of an optical window component opens as Figure 5B shown, thereby further expanding the elastomer of the endoscopic accessory 10 and making it easier to assemble onto an endoscope 30, as Figure 5B shown. Releasing the force on the nose causes the endoscopic accessory to return to the stationary state, as Figure 5C shown.

[0047] As Figure 6A and Figure 6B shown, rigid plastic pins 28 may be provided as part of the endoscopic accessory 10. For example, the endoscopic accessory 10 may be provided such that an elastomeric skirt 24 of the endoscopic accessory 10 is rolled back on itself to expose the pins 28, which helps to splint the elastomeric skirt 24 and prevent it from bunching while also providing a glide surface to facilitate insertion onto the endoscope. As Figure 6B shown, when the elastomeric skirt 24 is rolled back, the endoscopic accessory 10 is properly sealed onto the endoscope.

[0048] As Figure 7A and Figure 7B shown, the elastomeric skirt 24 of the endoscopic accessory 10 may be further secured to the endoscope 30 after delivery by applying heat. Applying low heat to the elastomeric skirt formed of a heat-shrinkable material causes the skirt 24 portion of the endoscopic accessory to contract around the endoscope 30, thereby forming a tight seal, such heat-shrinkable materials being, for example, fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyester (PET), polyvinyl chloride (PVC), polyolefin, or any other suitable polymeric material.

[0049] As will be appreciated, the delivery system of the present disclosure provides a delivery assist technology that improves the delivery of one or more medical devices or components onto, to, into, or against another medical device or component. The delivery assist technology has the ability to modify the shape of the delivery of one of the devices or components when delivering it onto, to, into, or against another device or component, and has the ability to form various functions (including by transferring force, deploying or modifying geometry, and increasing different coefficients of friction and other desired material properties) to enable effective delivery of one component onto, to, into, or against another component.

[0050] has been described with respect toFigure 7A and Figure 7B Heat is shown and described. However, it should be understood that other applications may include using energy, temperature, surface modification, and additives to facilitate smooth delivery of a component or device. For example, temperature-sensitive materials such as nitinol or other electro-responsive or shape memory alloys or materials can be used in conjunction with heat application (e.g., heat from the human body when in the human body) to adjust and change the shape from an open configuration to a closed configuration. Additionally, additives can be used to reduce the coefficient of friction and facilitate smooth slippage movement during delivery, such as polymeric oils, silicone oils, or polymeric coatings (such as PTFE) added. In other embodiments, surface modification can be provided to facilitate delivery. A highly polished mirror-like finish can be used to form a smooth sliding surface during delivery, while in an alternative design, a rough surface can be utilized to reduce the grip or adhesion between the component and the delivery system, enabling faster release of the component from the delivery tools 40, 60 onto the endoscope 30.

[0051] Figure 8 Another exemplary embodiment of the delivery system 300 of the present disclosure is shown. The delivery system 300 includes an insertion instrument 310 and an end cap or spacer 340. In Figure 8 the configuration shown, the insertion instrument 310 can be provided with a pre-mounted endoscope attachment 10. The insertion instrument 310 has a handle portion or end 310a and a working or delivery end 310b.

[0052] As shown, the insertion instrument 310 generally can have the structure and function of a delivery forceps and includes a first or upper arm 312 and a second or lower arm 314. These arms 312 and 314 can be connected to each other at a hinge or pivot connection 326 by secondary arm extensions 322 and 324, respectively. The insertion instrument 310 can also include an attached main bracket 332, which is fixed 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 endoscope attachment 10 within the delivery system. The back plate 334 can be connected to a stabilizing extension shaft 338, which is similar to the extension shaft 66 of the insertion tool 60 and can be inserted through the working channel opening of the endoscope attachment 10. The stabilizing extension shaft 338 can have a blunt end, for example, to avoid damaging the endoscope attachment 10 or the endoscope 30 during use. As shown, in the pre-assembled configuration of the endoscope attachment 10, it is fixed against the back plate 334 of the main bracket.

[0053] As further shown, each of the upper arm 312 and the lower arm 314 also includes a stabilizer bar or side bar 316 and 318, respectively. The stabilizing side bars 316 and 318 are configured to work together with each other. As shown, each of the stabilizing side bars 316 and 318 may have a pawl surface or feature 320, such as teeth, ridges, or other surface protrusions, which allow the stabilizing side bars 316 and 318 to lock together and prevent the arms 312 and 314 from moving relative to each other.

[0054] An end cap or spacer 340 is provided for use with the insertion instrument 310. The spacer 340 includes a two-piece design and includes spacer components 340a and 340b. The spacer 340 may be disposed at the working end 310b of the insertion instrument 310 and may be configured for attachment to the endoscopic accessory 10. In one embodiment, the spacer 340 is configured such that it expands the opening of the endoscopic accessory 10 for setting on the distal end of the endoscope 30. These spacer elements 340a and 340b together form an additional delivery aid for delivering the endoscopic accessory 10 to the endoscope 30 at the working or delivery end 310b of the insertion instrument 310.

[0055] Figures 9A to 9H An exemplary method of inserting the endoscopic accessory 10 onto the endoscope 30 using the insertion instrument 310 of the present disclosure is shown. With the endoscope 30 firmly held in one hand such that the endoscope 30 is properly aligned and positioned to receive the endoscopic accessory 10, the user can grasp the handle portion 310a of the insertion instrument 310 with the other hand. The user can squeeze the upper arm 312 and the lower arm 314 in the Figure 9A direction of the arrow shown to release or unlock the arms relative to each other.

[0056] The extension shaft 338 of the insertion instrument 310 can be used as an alignment guide in the next step as Figure 9B shown, to allow the user to guide the insertion instrument 310 with the pre-assembled endoscopic accessory 10 towards the endoscope 30 into its working channel. Once the extension shaft 338 is introduced through the working channel of the endoscope, the insertion instrument 310 can be advanced. In one embodiment, the advancement is completed at an angle of approximately 45 degrees. However, it should be understood that the insertion instrument 310 can be advanced at any angle, including angles in the range of approximately 30 degrees to approximately 60 degrees, depending on the configuration of the endoscope 30 and the best judgment of the user. Additionally, the angle at which the insertion instrument 310 advances will change depending on the stage of the assembly process. In other words, the approach angle will change as the endoscopic accessory 10 is further advanced onto the endoscope 30.

[0057] The insertion instrument 310 can be advanced forward or pushed until the receiving end of the endoscopic accessory 10 as Figure 9Cis located at the distal end of the endoscope as shown. As Figure 9D shown, the marker 352 on the insertion instrument 310 serves as a convenient visual alignment guide to enable the user to determine the proper position of the endoscope accessory 10 during assembly. For example, the marker 352 can be inspected to ensure that the optical region of the endoscope accessory 10 is aligned with the optical region of the endoscope 30, thereby ensuring a properly aligned assembly. At this time, the insertion instrument 310 should not be advanced further. As Figure 9C further shown, the delivery end 310b of the insertion instrument 310 has been expanded, but the handle end 310a remains unexpanded.

[0058] Now turning to Figure 9E , after it has been confirmed that the endoscope accessory 10 is properly positioned and aligned on the endoscope 30, the upper arm 312 and the lower arm 314 of the insertion instrument 310 can be unlocked. This can be achieved by pushing the stabilizing side rods 316 and 318 so that they disengage from each other. This unlocking of the arms 312, 314 allows the insertion instrument 310 to return to its resting or unexpanded state, as Figure 9E shown. Grasping the spacer 340 as a single unit, the user can then pull the spacer 340 off the delivery end 310b of the insertion instrument 310. Removing the spacer 340 then allows the insertion instrument 310 to be withdrawn in the direction of the arrow's inclination as Figure 9F shown, to avoid damaging the endoscope during the process.

[0059] After completing the assembly process, the spacer 340 remaining on the endoscope 30 can be separated, and each part 340a and 340b can be removed, as Figure 9G shown. If the endoscope accessory 10 is not aligned or not properly set on the endoscope 30, the user can manually remove the endoscope accessory 10 by pulling it apart and pulling it up and away from the endoscope 30, as Figure 9H shown, and then start the process again.

[0060] It is contemplated that the systems 100, 300 including the tools 40, 60, 140, 240 can be formed of any material, including but not limited to elastic, plastic, or deformable or extensible materials, whether metallic or polymeric, or derivatives or combinations thereof.

[0061] Of course, it should be understood that the delivery systems 100, 300 can be sterilized using any acceptable method, or can be non-sterile. For example, the delivery systems 100, 300 can be provided as disposable or single-use systems or instruments.

[0062] Additionally, while the drawings illustrate embodiments in which the endoscopic accessory 10 is expanded or deployed for fitting onto or onto the endoscope 30, it is also contemplated that a delivery system may be provided that is configured to contract or compress the endoscopic accessory 10 so that the endoscopic accessory 10 can be fitted inside the endoscope 30 and subsequently allowed to expand to its natural resting state to form a tight seal within the endoscope 30.

[0063] Other embodiments will be apparent to those of skill in the art upon consideration of the specification and practice of the disclosed embodiments. The specification and examples are only to be considered exemplary.

Claims

1. A medical component delivery system for delivering an attachment device to an endoscope, the medical component delivery system comprising: An insertion instrument including a proximal end and a distal end, a pair of pivotable arms extending from the distal end, and a handle portion at the proximal end; And An extension shaft coupled to the insertion instrument for passing through the attachment device.

2. The medical component delivery system according to claim 1, wherein, The handle portion is pivotally coupled to the arms.

3. The medical component delivery system according to claim 1, wherein The insertion instrument further includes a bracket coupled to a back plate, and the extension shaft extends from the back plate.

4. The medical component delivery system according to claim 1, wherein The medical component delivery system further includes a removable spacer for closing a portion of the insertion instrument.

5. The medical component delivery system according to claim 1, wherein The pivotable arms further include stabilizing side bars configured to allow the pivotable arms to lock together.

6. The medical component delivery system according to claim 1, wherein The extension shaft is configured as an alignment guide for delivering the attachment device.

7. The medical component delivery system according to claim 1, wherein The extension shaft is configured to extend through a working channel of the endoscope.

8. A system comprising: An attachment device for use with an endoscope having a working channel, wherein the attachment device includes a body having a proximal end configured to be attached to a distal portion of the endoscope; and An insertion instrument for coupling the attachment device to the endoscope, the insertion instrument having a gripping portion and an extension shaft configured to advance into the working channel of the endoscope, the insertion instrument further including a pair of pivotable arms.

9. The system according to claim 8, wherein The pivotable arms extend from a component delivery portion of the insertion instrument at a first end to a handle portion at an opposite second end.

10. The system according to claim 9, wherein The pivotable arms are connected together at a pivotable connection.

11. The system according to claim 8, wherein The system further includes a bracket connected to a back plate for the attachment device to be disposed against.

12. The system according to claim 9, wherein The system further includes a removable spacer for closing the component delivery end of the insertion instrument.

13. The system according to claim 8, characterized in that, The extension shaft is configured as an alignment guide for delivering the attachment device against the distal portion of the endoscope.

14. The system according to claim 13, wherein The endoscope includes an optical element, and the insertion instrument further includes a marker serving as an alignment guide, wherein the marker indicates the positioning of the optical region of the attachment device relative to the optical element of the endoscope.

15. The system according to claim 12, wherein The proximal end of the attachment device includes an opening, and the removable spacer is configured to expand the opening.

16. The system according to claim 8, wherein The pivotable arms further include stabilizing side bars configured to allow the pivotable arms to lock together.

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