Medical seal assembly and method of use

Abstract

A medical device including a shaft having a distal end and a cap at the distal end defining a reservoir for storing a substance, the medical device including a deployment mechanism configured to expel the substance from the reservoir, and the deployment mechanism configured to apply a force to the reservoir, the cap including a seal or perforation configured to contain the substance in the reservoir in the absence of a force applied to the substance by the deployment mechanism.

Description

[Technical Field]

[0001] Various aspects of the present disclosure relate generally to medical sealing systems, devices, and related methods. Examples of the present disclosure relate, among other aspects, to systems, devices, and related methods for providing a deployable seal on a medical instrument. [Background technology]

[0002] Advances in technology have provided users of medical systems, devices, and methods with the ability to perform increasingly complex procedures on subjects. One challenge in the field of minimally invasive surgery relates to promoting healing by delivering substances (e.g., adhesives, therapeutic agents, regenerative drugs, etc.) to treatment areas within the body. Summary of the Invention

[0003] Aspects of the present disclosure relate particularly, among other aspects, to systems, devices, and methods for providing medical devices capable of delivering and releasing healing substances to a subject. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

[0004] According to one example, a medical device includes a shaft having a distal end and a cap at the distal end defining a reservoir for storing a substance. The medical device includes a deployment mechanism configured to expel the substance from the reservoir, the deployment mechanism configured to apply a force to the reservoir. The cap includes a seal or perforations configured to contain the substance in the reservoir in the absence of a force applied to the substance by the deployment mechanism.

[0005] Any of the medical devices described herein may include one or more of the following features. The deployment mechanism includes a movable floor distal to the distal end of the shaft. The deployment mechanism further includes a movable rod disposed within the shaft and extending from the distal end. The movable rod is configured to push the movable floor distally away from the distal end of the shaft to discharge a substance from the reservoir. The shaft includes a lumen and the distal end includes an opening, and the movable rod is configured to extend through the opening. The movable floor includes a notch configured to be received within the opening and to align the movable floor with the movable rod. The deployment mechanism includes a pressurized media source, and the pressurized media is configured to be delivered from the pressurized media source through the shaft. The seal includes a movable cover coupled to the cap, and the movable cover is configured to move to form an opening through which a substance can exit the cap. The medical device may include an actuator coupled to the movable cover, and actuation of the actuator is configured to move the movable cover to form the opening. The actuator is configured to move the movable cover in response to receiving a proximally pulling force. The actuator includes a wire, cable, or thread. The perforation is configured to expand to form an opening through which a substance can exit the cap, and the opening is larger in size than the perforation. The cap includes a frangible portion adjacent to the perforation, and the frangible portion is configured to break and expand in response to expansion of the perforation to form an opening through which the substance can pass and exit the cap. The outer surface of the cap includes a biodegradable material configured to decompose within seconds or minutes upon contact with tissue. The cap includes a plurality of staggered perforations arranged in a continuous pattern along the longitudinal direction of each other.

[0006] According to another example, the medical device includes a cap configured to be attached to the distal end of the scope, the cap defining a reservoir for storing a substance. The cap includes a removable seal configured to expose the reservoir and the substance when the seal is removed from the remainder of the cap. The cap includes a deployment mechanism configured to discharge the substance from the reservoir. The deployment mechanism is configured to generate a positive pressure within the reservoir.

[0007] Any of the medical devices described herein may include one or more of the following features. The removable seal is formed of a biodegradable material and is configured to degrade over a predetermined duration when the removable seal is exposed to the target site.

[0008] According to another example, a cap configured to be attached to the distal end of the scope, the cap defining a reservoir for storing a substance. The cap includes a plurality of perforations configured to expand to allow the substance to exit the cap and a deployment mechanism configured to discharge the substance from the reservoir via the plurality of perforations. The deployment mechanism is configured to apply a force to the substance within the reservoir.

[0009] Any of the medical devices described herein may include one or more of the following features. The plurality of perforations are configured to contain the substance within the cap when the deployment mechanism is in an initial position. The plurality of perforations are configured to expand in response to the deployment mechanism extending distally into the cap toward the plurality of perforations.

[0010] It is to be understood that both the foregoing summary and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0011]

Figure 1

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 5A

Figure 5B

DETAILED DESCRIPTION OF THE INVENTION

[0012] Examples of the present disclosure provide a medical device for storing a substance, delivering the medical device to a target treatment site within a subject (e.g., a patient), and a system, apparatus, and method for removing a seal to deliver the substance to the target treatment site.

[0013] As used herein, the term "distal" refers to the portion that is farthest from the user when the device is introduced into the patient's body, and the term "proximal" refers to the portion that is closest to the user when the device is placed within the subject's body. The terms "comprise," "comprising," or any other variation thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises elements of a list does not necessarily include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "an example" rather than "an ideal." As used herein, the terms "about," "substantially," and "approximately" mean values within ±10% of the stated value.

[0014] Examples of the present disclosure may relate to devices and methods for performing various medical procedures and / or treating the large intestine (colon), small intestine, cecum, portions of the esophagus, any other portion of the gastrointestinal tract, and / or any other suitable patient anatomical structure (collectively referred to herein as the "target treatment site"). The various examples described herein include single-use, i.e., disposable, medical devices. Reference is now made in detail to the examples of the present disclosure described above and shown in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts.

[0015] FIG. 1 shows an exemplary medical system 100 according to an example of the present disclosure. The medical system 100 may include a medical instrument 110. For example, the medical instrument 110 may include an endoscope, a duodenoscope, a gastroscope, a colonoscope, a ureteroscope, a bronchoscope, and / or various other delivery systems. The medical instrument 110 may include a handle 112, at least one actuator 114, one or more ports 116, 118, and a shaft 120. The handle 112 may be defined by a proximal end including the actuator 114 and a distal end, and includes a shaft 120 extending distally from the distal end. The one or more ports 116, 118 may extend outwardly from the handle 112 and may be configured to facilitate receiving one or more devices into the medical instrument 110. It should be recognized that the medical instrument 110 may include additional and / or fewer ports 116, 118 than those illustrated and described herein.

[0016] The handle 112 may have one or more lumens (not shown) that communicate with the lumens of one or more other components of the medical instrument 110. The one or more ports 116, 118 may open into the one or more lumens of the handle 112 and may be sized and shaped to receive one or more devices, such as a mechanical rod 140, a tube 152, etc., therethrough. The shaft 120 may include a sufficiently flexible tube and may be configured to selectively bend, rotate, and / or twist when the shaft 120 is being inserted into and / or through the tortuous anatomical structure of a subject to a target treatment site.

[0017] Although not shown, the shaft 120 may have one or more lumens extending therethrough, which should be understood to include, for example, working lumens. The working lumen is for receiving instruments such as a mechanical rod 140 received by the medical device 110 at the port 116, for example. The shaft 120 may further include a fluid lumen for delivering fluid from, for example, a pressurized media source 150 that is fluidly connected to the medical device 110 via a tube 152 at the port 118. The shaft 120 may also include an additional fluid lumen for carrying fluid away from the distal end of the medical device 110. It should be recognized that the medical system 100 may include various other suitable devices other than those illustrated and described herein.

[0018] In other examples, the shaft 120 may include additional lumens, such as a control wire lumen for receiving one or more control wires for actuating one or more distal portions / tools (e.g., articulating joints, elevators, etc.), a lighting lumen for receiving at least a portion of a lighting assembly (Figs. 3A - 3B), and / or an imaging lumen for receiving at least a portion of an imaging assembly (Figs. 3A - 3B). The shaft 120 may further include a distal end 122 that defines one or more openings in communication with one or more lumens of the shaft 120.

[0019] Referring further to FIG. 1, the mechanical rod 140 can be a plunger having a generally flexible and elongated body 142 defined between a distal end (not shown in FIG. 1) and a proximal end 142. In some examples, the mechanical rod 140 can be a deployment mechanism that includes a handle 146 adjacent to the proximal end 142 for selectively controlling the movement of the mechanical rod 140 through the working lumen of the shaft 120. The pressurized media source 150 can be another deployment mechanism and can include a fluid pressure system, a pneumatic system, etc. For example, the pressurized media source 150 can be configured to store the pressurized media and deliver it through the fluid lumen of the shaft 120. In some examples, the pressurized media can include compressed air, fluid, liquid, gas, etc.

[0020] The medical system 100 can further include an actuator 130 having a longitudinal length defined by a distal end 132 and a proximal end 134. The actuator 130 can have a substantially flexible body and can include, for example, a cable, a thread, a string, a wire, a bundle of any of the above elements, etc. As will be described in more detail below, during use in a procedure, the proximal end 134 is disposed adjacent to the handle 112, the distal end 132 is disposed adjacent to the distal end 122, and the elongated body of the actuator 130 is disposed alongside the shaft 120, and the actuator 130 can be disposed adjacent to the medical device 110.

[0021] 1 , proximal end 134 can be configured to facilitate selective control of actuator 130. In some embodiments, actuator 130 can be coupled to an indexing mechanism 136 configured to facilitate movement of actuator 130 relative to the working lumen. For example, indexing mechanism 136 can include a rotatable wheel, knob, lever, button, switch, etc. Actuator 130 can be coupled to indexing mechanism 136 along proximal end 134 such that actuation of indexing mechanism 136 can move actuator 130 by pulling actuator 130 proximally with indexing mechanism 136. In other embodiments, indexing mechanism 136 and / or actuator 130 can be omitted entirely.

[0022] The medical system 100 may further include a cap assembly 160 disposed at the distal end 122. The cap assembly 160 may be configured to seal and / or surround one or more openings, such as those along the distal end 122, corresponding to one or more lumens in the shaft 120. As described in further detail herein, the cap assembly 160 may also be configured to deliver one or more substances from the medical device 110 during a procedure, such as to a target treatment site within a subject's body. In that example, the actuator 130 may extend distally relative to the distal end 122, and the distal end 132 may be fastened (e.g., by adhesive, a knot, etc.) to a distally facing outer surface of the cap assembly 160.

[0023] Referring now to FIG. 2A, the cap assembly 160 is shown partially transparent to show a reservoir (e.g., a partitioning chamber) defined by the cap assembly 160. For example, the cap assembly 160 can include an outer body 162, a distal face 164, a removable cover 166, and a partition wall 168. The outer body 162 can include various suitable sizes and / or shapes that can appropriately surround the distal end 122 of the shaft 120. The distal face 164 and the removable cover 166 can be disposed at the distal end of the outer body 162, opposite the proximal end fixed to the distal end of the shaft 120. In some embodiments, the distal face 164 is either non-removable or otherwise fixed to the outer body 162.

[0024] Thus, the distal face 164 and the removable cover 166 can be sized and / or shaped to collectively define the distal end of the cap assembly 160. In other examples, the removable cover 166 can be disposed along various other portions of the outer body 162 such that the non-removable and / or fixed distal face 164 defines the entire distal end. In the illustrated example, the distal end of the outer body 162 can have a circular shape, and each of the distal face 164 and the seal assembly 160 can have a semi-circular shape. As further described below, the distal face 164 and the removable cover 166 can be disposed at the distal end along opposite sides of the partition wall 168.

[0025] Referring further to FIG. 2A, the distal surface 164 may be formed of a generally transparent material so that one or more devices disposed within the outer body 162 can be seen through the distal surface 164 and so that a user can visualize the distal field of view of the outer body 162 using, for example, an imaging device located at the distal end 122 of the shaft 120. The removable cover 166 may be disposed over the opening 186 (FIG. 2B) at the distal end of the outer body 162. For example, the removable cover 166 may be securely coupled over the opening 186 at the distal end by various suitable mechanisms (e.g., adhesives, mechanical engagement, etc.). In that example, the removable cover 166 may include a flexible tab that is selectively removable from the opening 186 in response to a force applied thereto. In other examples, the removable cover 166 may be coupled to the outer body 162 by a hinge bracket or integral hinge.

[0026] The partition wall 168 may be disposed within the cap assembly 160 and extend through an internal cavity defined by the outer body 162. In that example, the partition wall 168 may divide the internal cavity and at least partially define and separate reservoirs 170, 180 within the outer body 162. Thus, the partition wall 168 may separate the visualization reservoir / space 170 from the substance reservoir 180 such that one or more devices of the medical instrument 110 and / or the cap assembly 160 within the visualization reservoir 170 may be shielded and / or isolated from one or more devices within the substance reservoir 180 and vice versa. As briefly described above, the shaft 120 may include one or more openings 172, 174 at the distal end 122. It should be understood that one or more lumens of the shaft 120 may terminate at the openings 172, 174. In yet other examples, the cap assembly 160 does not cover the entire distal surface of the shaft 120 to keep the imaging device unobstructed.

[0027] In some examples, medical system 100 may include an illumination device (not shown) and an imaging device (not shown). These devices may be coupled to medical instrument 110 via one or more ports 116, 118. An illumination device (e.g., fiber optics) and an imaging device (e.g., a camera, a sensor, etc.) may be received through respective lumens in handle 112 and shaft 120. In that example, the illumination device may be disposed within first opening 172 at distal end 122, and the imaging device may be disposed within second opening 174 at distal end 122. It should be understood that distal end 122 may include additional and / or fewer openings to facilitate access to one or more lumens within shaft 120.

[0028] 2A , first opening 172 and second opening 174 may be disposed within visualization reservoir 170 when cap assembly 160 is attached to distal end 122. Distal surface 164 may thus be longitudinally aligned with openings 172, 174, such that an illumination device may be configured to provide illumination distal to cap assembly 160 through transparent distal surface 164, and an imaging device may be configured to capture images of locations distal to cap assembly 160 through distal surface 164.

[0029] Cap assembly 160 may further include a movable floor 182 disposed within substance reservoir 180 and having a top surface and a bottom surface. The top surface of movable floor 182 may be a distally facing surface facing removable cover 166 and define a boundary for receiving one or more substances 10 therein. In that example, substance reservoir 180 may be pre-loaded with substance 10 such that substance 10 may be contained between removable cover 166 and movable floor 182 prior to assembly of cap assembly 160 on shaft 120. In some examples, substance 10 may include an adhesive, a therapeutic agent, a regenerative drug, and / or various other substances for delivery to a subject by medical device 110.

[0030] 2A , the movable floor 182 may be a deployment mechanism configured to act as a mechanical piston configured to move relative to the outer body 162 within the substance reservoir 180. As described in more detail below, the movable floor 182 may be movable in response to actuation of one or more other components of the medical system 100, such as the mechanical rod 140 ( FIG. 1 ). In some embodiments, the movable floor 182 is non-removable from the cap assembly 160, such as before assembly of the cap assembly 160 to the medical device 110. In this case, the substance 10 may be maintained within the substance reservoir 180 and inhibited or prevented from expelling by the movable floor 182 falling proximally outward from the outer body 162. The movable floor 182 may be, for example, a coated rubber piston similar to those used in syringes and injection devices. The movable floor 182 may include one or more features that inhibit proximal movement relative to the outer body 162, and / or the outer body 162 may include one or more stops that extend radially inward and are positioned proximal to the movable floor 172, thereby obstructing or preventing proximal movement of the movable floor 182.

[0031] The actuator 130 may be attached to the cap assembly 160 along with the removable cover 166. For example, the distal end 132 may be secured to an exterior of the removable cover 166 (i.e., facing the substance reservoir 180 and opposite an interior disposed within the substance reservoir), and the actuator 130 may be configured to apply a distal (pulling) force to detach the removable cover 166 from the outer body 162. In this case, the actuator 130 may expose the opening 186 ( FIG. 2B ). As described further below, the actuator 130 may apply a force to the removable cover 166 in response to proximal movement of the actuator 130 at the proximal end 134.

[0032] Returning to FIG. 1 and explaining, according to an exemplary method of using the medical system 100 during a procedure, the medical device 110 can receive the cap assembly 160 by attaching the outer body 162 to the distal end 122. The cap assembly 160 can be pre-loaded with a substance 10 in a substance reservoir 180 (FIG. 2A), and the substance 10 contains a drug for delivery to a target treatment site within the body of a subject (e.g., a patient). Alternatively, the substance 10 can be inserted into the substance reservoir 180 through the opening 186 after the cap assembly 160 is coupled to the shaft 120. A lighting device and / or an imaging device can be coupled to the medical device 110 and received through respective lumens of the shaft 120 such that the distal end of the device is disposed at the openings 172, 174. However, it is further contemplated that the lighting device and / or the imaging device can be integral with the shaft 120.

[0033] Referring to FIG. 3A and explaining, the shaft 120 is inserted into the body of a subject and navigated to a target treatment site using a lighting device 60 (received within the illumination lumen 126 of the shaft 120) and an imaging device 50 (received within the imaging lumen 128 of the shaft 120). The distal end 122 can be disposed at or adjacent to the site by visually identifying the location of the target treatment site (e.g., a perforation, a wound, a stenosis, etc.) using the imaging device 50 through the distal surface 164. The actuator 130 can be actuated to remove the removable cover 166 from the outer body 162 or otherwise displace the removable cover 166 to expose the opening 186 by applying a proximally directed force to the actuator 130.

[0034] Returning to FIG. 1 for example, actuator 130, particularly the proximal end 134, can be pulled proximally to move the actuator 130 in the proximal direction relative to the shaft 120, thereby pulling the distal end 132 in the proximal direction. In an example where the actuator 130 includes an indexing mechanism 136 (FIG. 1), the user rotates the indexing mechanism 136 to wind the proximal end 134 onto the indexing mechanism 136, thereby pulling the distal end 132 proximally. It should be appreciated that the distal end 132 can be secured to the removable cover 166 to the extent that the distal end 132 is attached to the removable cover 166. Accordingly, the actuator 130 can be configured to pull the removable cover 166 away from the outer body 162.

[0035] Referring now to FIGS. 2B and 3B, the removable cover 166 can be at least partially removed from the outer body 162 by the actuator 130 to expose the opening 186. After the removable cover 166 is peeled off or otherwise displaced relative to the outer body 162, the opening 186 can be left unsealed and the substance reservoir 180 can be exposed. In some embodiments, the removable cover 166 can be completely removed from the outer body 162 in response to continued operation of the actuator 130, while in other embodiments, at least a portion of the removable cover 166 can remain at least partially attached to the outer body 162 (e.g., when the removable cover 166 is connected to the outer body 162 by a hinge).

[0036] The movable floor 182 can be moved distally relative to the outer body 162 within the substance reservoir 180 in response to the mechanical rod 140 moving distally through the working lumen 124 of the shaft 120. For example, the distal end 122 can include a third opening 184, and the working lumen 124 can terminate at the third opening 184 (shown only in FIG. 4A). The third opening 184 can be aligned with the substance reservoir 180 when the cap assembly 160 is first secured to the shaft 120.

[0037] In some embodiments, the cap assembly 160 may include an alignment undulation 188. The alignment undulation 188 is for aligning the movable floor 182 with the third opening 184 while the cap assembly 160 is engaging with the distal end 122. For example, the alignment undulation 188 may be a notch, a protrusion, and / or various other members that extend proximally and outwardly from the proximal face of the movable floor 182. The alignment undulation 188 may be sized and shaped according to the contour of the working lumen 124 and / or the third opening 184. Accordingly, the alignment undulation 188 may be configured to extend into the working lumen 124 via the third opening 184 when the cap assembly 160 is coupled to the distal end 122.

[0038] By actuation of the handle 146, the mechanical rod 140 can be moved through the working lumen 124, thereby extending the distal end of the mechanical rod 140 distally with respect to the distal end 122 and outwardly from the third opening 184. With the movable floor 182 disposed in contact with the distal end 122 and the alignment undulation 188 received in the working lumen 124, the mechanical rod 140 may be configured to push the movable floor 182 toward the opening 186 by engaging the alignment undulation 188.

[0039] Thus, the substance 10 can be pushed through the substance reservoir 180 and discharged outwardly from the cap assembly 160 via the opening 186. The substance 10 can be delivered to the target treatment site when discharged outwardly from the substance reservoir 180. It should be understood that the cap assembly 160 may be configured to prevent the outward deployment of the movable floor 182 from the substance reservoir 180. For example, the opening 186 may be sized and / or shaped smaller than the movable floor 182 to prevent the removal of the movable floor 182 from the substance reservoir 180.

[0040] In other embodiments, the mechanical rod 140 can move within the storage reservoir 180 and, in response to pushing the substance 10 towards the seal assembly 160, the actuator 130 can be completely omitted so that the seal assembly 160 can be removed from the outer body 162. The mechanical rod 140 can be operable to generate pressure against the removable cover 166 in response to moving the movable floor 182 distally. In this case, an increase in pressure in the distal direction can cause the removable cover 166 to be deployed distally from the outer body 162, thereby enabling the release of the substance 10 to the target treatment site. Alternatively, a pressurizing medium can be delivered into the storage reservoir 180 via the third opening 186 to generate pressure against the removable cover 166. In this case, the mechanical rod 140 is omitted and a pressurizing medium source can deliver the pressurizing medium to the cap assembly 160, move the movable floor 182 distally, deploy the removable cover 166, and release the substance 10.

[0041] The removable cover 166 can be formed of a biodegradable and / or bioabsorbable material such that the removable cover 166 can be configured to be decomposed and / or absorbed by one or more features (e.g., tissue) around the cap assembly 160 after deployment. For example, the removable cover 166 can be operable to dissolve after being exposed to one or more surrounding features at the target treatment site for a predetermined duration (e.g., minutes, hours, days, weeks, etc.). In other examples, the removable cover 166 can simply be received at the target treatment site and naturally passed through the subject's body (e.g., within the gastrointestinal (GI) tract) and then released therefrom.

[0042] Referring now to FIG. 4A, another exemplary cap assembly 160' according to an example of the present disclosure is shown. It should be understood that the cap assembly 160' can be easily incorporated into the medical device 110 in the manner described above. It should also be understood that the cap assembly 160' can function substantially the same as the cap assembly 160 described above, except for the differences explicitly noted herein.

[0043] For example, the cap assembly 160' may include one or more perforations 166' formed along the distal surface 164' of the outer body 162. The perforations 166' may include small openings, holes, and / or apertures sized, shaped, and configured to facilitate access to the cap assembly 160'. As will be described in detail below, the perforations 166' may be configured to retain a substance within the cap assembly 160' when in a default state (e.g., including a small opening in the distal surface 164'), and further configured to allow for the release of the substance from the cap assembly 160' when these perforations transition to an expanded state to form a relatively large opening. In that example, the cap assembly 160' may include a pair of perforations 166' disposed in the distal surface 164'. It should be recognized that, without departing from the scope of the present disclosure, additional and / or fewer perforations 166' may be included in various portions of the outer body 162 as contrasted with what is illustrated and described herein.

[0044] The perforations 166' may include any suitable structure that is configured to assist in retaining the substance 10 within the outer body 162 in an initial form and, after applying a suitable pressure or force to the perforations 166', configured to break or open to allow the substance 10 to escape from the outer body 162. The perforations 166' may include one or more small holes formed in the material by a piercing tool that penetrates the outer surface of the outer body 162. In some examples, the perforations 166' may be formed by molding and punching or by a laser.

[0045] The size (e.g., diameter) of the perforations 166’ can be based on a plurality of factors, such as, but not limited to, the thickness of the outer body 162, the spacing between each of the perforations 166’, the viscosity of the drug delivered through the perforations 166’, the desired amount of force necessary to break the outer body 162 and / or the perforations 166’ to allow drug delivery therethrough, etc. It should be appreciated that, for example, in embodiments where a relatively low viscosity drug (e.g., a liquid) is stored within the cap assembly 160’, the diameter of the perforations 166’ can range from about 0.0254 mm (0.001 inches) to about 0.0508 mm (0.002 inches). As a further example, in embodiments where a relatively high viscosity liquid drug (e.g., a gel) is stored within the cap assembly 160’, the diameter of the perforations 166’ can range from about 0.127 mm (0.005 inches) to about 0.254 mm (0.010 inches). The above diameters are merely illustrative, and it should be understood that the openings of the perforations 166’ in the outer body 162 are described as being of a size that can still maintain the drug within the cap assembly 160’.

[0046] The spacing and / or offset of the perforations 166’ along the outer body 162 can be based on a plurality of factors, such as, but not limited to, the thickness of the outer body 162, the size (e.g., diameter) of the perforations 166’, the viscosity of the drug delivered through the perforations 166’, the desired amount of force necessary to break the outer body 162 and / or the perforations 166’ to allow drug delivery therethrough, etc. It should be further appreciated that, for example, the perforations 166’ can be spaced from each other by about 0.0254 mm (0.001 inches) to about 1.27 mm (0.050 inches).

[0047] In some examples, the perforation 166’ can open into a larger aperture 186 (FIG. 4B) in response to applying sufficient additional force to each perforation 166’. That is, in response to the initial force applied, the perforation 166’ can allow the substance 10 to be ejected therethrough, and in response to a greater level of force being applied, the space surrounding and / or adjacent to the perforation 166’ can be broken to form an enlarged aperture (e.g., aperture 186). Therefore, by increasing the size and / or shape of the perforation 166’, additional substance 10 can be deployed at a faster rate.

[0048] Referring further to FIG. 4A, the region of the outer body 162 disposed around each perforation 166’ can be formed of a material configured to break open, thereby converting the perforation 166’ into a larger aperture. For example, the perforation 166’ can be enlarged in response to the mechanical rod 140 moving within the storage reservoir 180 to push the substance 10 toward the distal surface 164’. Therefore, the mechanical rod 140 can generate pressure against the perforation 166’ when moving the movable floor 182’ distally. The increased pressure breaks the perforation 166’ and forms the aperture 186 (FIG. 4B), thereby allowing the substance 10 to be released to the target treatment site.

[0049] The cap assembly 160’ can further include one or more weak and / or breakable portions 169 along the outer body 162. In that example, the cap assembly 160’ can include at least one weak portion 169 disposed between the perforations 166’ of the distal surface 164’. It should be recognized that additional and / or fewer weak portions 169 can be included in various portions of the outer body 162 other than those illustrated and described herein without departing from the scope of the present disclosure. The weak portion 169 can be configured to break open adjacent portions of the distal surface 164’ disposed between the perforations 166’ due to additional force being applied by the movable floor 182’ to enlarge the perforation 166’, thereby increasing the cross-sectional dimensions of the aperture 186 formed along the distal surface 164’.

[0050] As described in detail herein, increasing the size of the opening 186 allows for the delivery of more of the substance 10 from the cap assembly 160' at a higher flow rate. In other examples, portions of the distal surface 164' disposed around the perforations 166' and / or the frangible portion 169 may be formed of a biodegradable and / or bioabsorbable material such that the distal surface 164' and / or the frangible portion 169 are configured to be degraded and / or absorbed by the tissue surrounding the cap assembly 160'. Degradation may occur within seconds or minutes of contact between the distal surface 164' and the tissue.

[0051] Referring further to FIG. 4A, the cap assembly 160' may further define a dual-purpose reservoir 180' within the cavity of the outer body 162. In other words, the cap assembly 160' may omit the wall extending through the cavity such that a single dual-purpose reservoir 180' is formed within the outer body 162. Further, the cap assembly 160' may include a movable floor 182' sized and shaped to conform to the contour of the reservoir 180'. It should be appreciated that the movable floor 182' may be configured and operable in substantially the same manner as the movable floor 182 described above, except for the differences described explicitly below.

[0052] In an example not shown, it is assumed that the cap assembly 160' does not cover or interfere with the illumination / imaging device of the shaft 120. Alternatively, the movable floor 182' may be formed of a substantially transparent material, and one or more devices (e.g., an illumination device, an imaging device, etc.) disposed within the outer body 162 may be visible through the movable floor 182'. In this embodiment, the actuator 130 and the mechanical rod 140 may be completely omitted, and a pressurized media source 150 (e.g., a deployment mechanism) may be fluidly connected to the medical instrument 110 at the port 118, for example, via a tube 152 or the like. The port 118 may be in fluid communication with a fluid lumen of the shaft 120 that terminates at a third opening 184 (FIG. 4B). As will be described in more detail below, the pressurized media source 150 may be configured to deliver the pressurized media to the reservoir 180' via the third opening 184. In other embodiments, the mechanical rod 140 may be received within the medical instrument 10 instead of and / or in addition to the pressurized media source 150 to deploy the substance 10 from the cap assembly 160'.

[0053] Referring now to FIG. 4B, according to an exemplary method of using the medical system 100 during a procedure using the cap assembly 160', the medical instrument 110 may receive the cap assembly 160' by attaching the outer body 162 to the distal end 122. The cap assembly 160' may be pre-loaded with the substance 10 within the reservoir 180', and one or more devices (e.g., an illumination device, an imaging device, etc.) may be coupled to the medical instrument 110. Alternatively, the substance 10 may be inserted into the substance reservoir 180' through the perforation 166' and / or the opening 186 after the cap assembly 160' is coupled to the shaft 120. The shaft 120 may be inserted into the subject's body in accordance with the above description, and the distal end 122 may be positioned at the target treatment site.

[0054] When the distal end 122 is placed at the target treatment site, the user can activate the pressurizing media source 150 to deliver the pressurizing media 20 through the working channel of the shaft 120 and into the reservoir 180' via the third opening 184. By delivering the pressurizing media 20, the movable floor 182' can be moved within the reservoir 180' towards the distal surface 164'. When the movable floor 182' is forced to move towards the distal surface 164', at least a portion of the substance 10 can be delivered from the cap assembly 160" through the perforations 166'. Further, the pressure within the reservoir 180' can increase as the movable floor 182' moves towards the distal surface 164', thereby weakening the portion of the outer body 162 around each perforation 166' and / or the weakening portion 169.

[0055] Referring further to FIG. 4B, the portion of the outer body 162 formed around the perforation 166' can collapse (e.g., break) in response to the increased pressure applied when the movable floor 182' is moved within the reservoir 180'. An enlarged opening 186 can be formed in the distal surface 164' at the location of each perforation 166' on the outer body 162. Further, the weakening portion 169 can collapse, allowing the respective openings 186 to interconnect with each other, thereby forming a single continuous opening 186 along the distal surface 164'. In this case, the perforations 166' can be further enlarged to have a larger cross-sectional dimension for the delivery of the substance 10.

[0056] Accordingly, the substance 10 can be pushed through the reservoir 180' and discharged outwardly from the cap assembly 160' via the opening 186. When the substance 10 is discharged outwardly from the reservoir 180', it can be delivered to the target treatment site. In some examples, the perforations 166' and the frangible portions 169 can include a relatively small portion of the surface area of the distal surface 164', and the substance 10 is controlled and intensively applied to the target treatment site. In other examples, the perforations 166' and the frangible portions 169 can include a relatively large portion of the surface area of the distal surface 164', providing an outflow of the substance in a wider zone from the cap assembly 160'. In some examples, the cap assembly 160' can include a plurality of perforations 166' aligned in a continuous manner (e.g., in a linear form) on the distal surface 164', arranged in a matrix form in one or more rows and / or columns, or arranged around the distal surface 164' in an annular array, or can include a single large perforation 166' at the center of the distal surface 164'. Various other forms and / or amounts of perforations 166' can be suitable.

[0057] Referring further to FIG. 4B, by including the frangible portion 169 on the distal surface 164', the size and / or geometric shape of the opening 186 can be expanded, allowing additional substance 10 to be delivered from the cap assembly 160' at an amplified / increased flow rate. In other embodiments, it should be understood that additional and / or fewer perforations 166' and / or frangible portions 169 may be included in the cap assembly 160' without departing from the scope of the present disclosure.

[0058] For example, referring to FIG. 5A, another exemplary cap assembly 160” may include one or more perforations 166’ disposed along the sidewall of the outer body 162 (e.g., along the outer periphery of the outer body 162). The perforations 166’ may be arranged in various configurations and / or may have various geometric shapes. For example, they may be linearly and longitudinally continuously aligned from the proximal end of the cap assembly 160” (adjacent to the distal end 122) to the distal end (adjacent to the distal surface 164’). In that example, the cap assembly 160” may include four perforations 166’ along the outer periphery of the outer body 162 and longitudinally separated from each other. Although not shown, it should be understood that one or more frangible portions 169 may be included in the sidewall of the outer body 162, for example, longitudinally between one or more of the perforations 166’.

[0059] Referring now to FIG. 5B, the cap assembly 160” may be configured such that a positive pressure is generated within the outer body 162 as the movable floor 182’ moves distally toward the distal surface 164’. With the perforations 166’ disposed in the outer body 162 at various longitudinal locations relative to each other, the pressure applied inside each perforation 166’ may depend on the current position of the movable floor 182’ within the reservoir 180’. For example, as the movable floor 182’ moves within the reservoir 180’ and reaches or approaches a particular longitudinal position of a perforation 166’, the pressure applied inside the perforation 166’ may cause the perforation 166’ to expand, forming an opening 186.

[0060] Other perforations 166' are arranged along other portions of the outer body 162 and / or at different lengths (longitudinal positions), and the pressure applied to some perforations 166' (e.g., the most proximal perforations 166') cannot or will not cause the expansion of other perforations 166' arranged along other regions of the outer body 162 (i.e., the most distal perforations 166'). Thus, it should be recognized that at least some of the one or more perforations 166' (e.g., the most distal perforations 166') can be maintained in their original non-expanded state, while at least some of the other perforations 166' (e.g., the most proximal perforations 166') can be expanded into the opening 186.

[0061] In some embodiments, the perforations 166' disposed adjacent to the proximal end of the cap assembly 160" may include a predefined thickness that is relatively thinner than the perforations 166' disposed adjacent to the distal end of the cap assembly 160". Thus, the perforations 166' with a thinner thickness can be configured to expand into a larger opening 186 than the perforations 166' with a relatively thicker thickness when subjected to a small positive pressure. In other words, the perforations 166' disposed adjacent to the proximal end can break and open into the opening 186 or, otherwise, expand more rapidly than the perforations 166' disposed adjacent to the distal end.

[0062] Referring further to FIG. 5B, continued distal movement of the movable floor 182' relative to the outer body 162 can result in additional expansion of the perforations 166' into the openings 186. Thus, the material 10 can be moved through the reservoir 180' and, as additional openings 186 are enlarged / formed in the outer body 162, can be progressively delivered laterally and radially outwardly from the cap assembly 160". It should be understood that the pressure applied to each perforation 166' can be maximized when the position of the movable floor 182' relative to the outer body 162 is substantially radially aligned with the location of a particular perforation 166' in the sidewall of the outer body 162. It should further be recognized that the additional perforations 166' can be expanded as the movable floor 182' continues to move relative to the outer body 162.

[0063] In some embodiments, the perforations 166' can have a size and / or shape sufficient to prevent release of the material 10 from the reservoir 180' when no delivery force, such as by movement of the movable floor 182', is applied to the material 10. In that instance, the perforations 166' are not configured and / or operable to expand (e.g., break open, dissolve, disintegrate, etc.) and, instead, the material 10 can be forced to move through the perforations 166' when the pressure within the reservoir 180' increases. Thus, one or more larger openings 186 may not be formed at the location of the perforations 166' because a positive pressure is created within the reservoir 180' (e.g., as the movable floor 182' moves relative to the outer body 162).

[0064] In this case, the substance 10 is delivered through the perforation 166’, and the flow rate and / or amount of the substance 10 is controlled by the original size and / or shape of the opening formed by the perforation 166’. In an embodiment, the substance 10 may generally have a high viscosity, and when no pushing force is applied thereto by the movable floor 182’, the release of the substance 10 through the small perforation 166’ is blocked. In other words, the substance 10 may not be deliverable from the reservoir 180’ unless the movable floor 182’ forcibly applies the substance 10 against the perforation 166’.

[0065] Each of the systems, devices, assemblies, and methods described above can be used to provide a substance adjacent to a target treatment site within a subject (e.g., a patient), where the substance is contained within a cap assembly and deployed from the cap assembly to the target treatment site within the subject's body. By providing a medical device that includes a cap assembly having one or more removable seals or perforations, a user can selectively deploy the substance from the device during a procedure. In this case, the user can shorten the overall treatment time, increase the efficiency of the treatment, and / or avoid unnecessarily injuring the subject's body due to medical instruments that require the introduction of additional devices to inadvertently release or deploy the contained substance.

[0066] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed devices and methods without departing from the scope of the disclosure. Other aspects of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and examples be considered as exemplary only.

Claims

**Claim 1** A shaft having a distal end, A cap at the distal end, the cap defining a reservoir for storing a substance, A deployment mechanism configured to discharge the substance from the reservoir, the deployment mechanism including a movable floor distal to the distal end of the shaft and configured to apply a force to the reservoir, A movable rod disposed within the shaft and extendable from the distal end, the shaft including a lumen and the distal end including an opening, the movable rod configured to extend through the opening, Comprising, The cap includes a seal or a perforation, the seal or the perforation configured to contain the substance within the reservoir in the absence of the force applied to the substance by the deployment mechanism, a medical device. **Claim 2** The medical device according to claim 1, wherein the movable rod is configured to push the movable floor distally away from the distal end of the shaft to discharge the substance from the reservoir. **Claim 3** A shaft having a distal end including an opening, A movable rod disposed within the shaft and extendable from the distal end, A cap at the distal end, the cap defining a reservoir for storing a substance, A deployment mechanism configured to discharge the substance from the reservoir, the deployment mechanism configured to apply a force to the reservoir, Comprising, The cap includes a seal or a perforation, the seal or the perforation configured to contain the substance within the reservoir in the absence of the force applied to the substance by the deployment mechanism, The shaft includes a lumen and the distal end includes an opening, the movable rod configured to extend through the opening, a medical device. **Claim 4** A shaft having a distal end including an opening, A movable floor distal to the distal end of the shaft, A cap at the distal end, the cap defining a reservoir for storing a substance, A deployment mechanism configured to discharge the substance from the reservoir, the deployment mechanism configured to apply a force to the reservoir, A movable rod disposed within the shaft and extendable from the distal end, Comprising, The cap includes a seal or a perforation, and the seal or the perforation is configured to contain the substance within the reservoir in the absence of the force applied to the substance by the deployment mechanism. The medical device, wherein the movable floor includes a protrusion received within the opening and is configured such that the movable floor aligns with the movable rod.

5. The medical device according to claim 4, wherein the deployment mechanism includes a pressurized media source, and the pressurized media is configured to be delivered from the pressurized media source through the shaft.

6. The medical device according to claim 4, wherein the seal includes a movable cover coupled to the cap, and the movable cover is configured to move to form an opening through which the substance can pass and exit the cap.

7. A shaft having a distal end that includes an opening, A cap at the distal end that defines a reservoir for storing a substance, A deployment mechanism configured to expel the substance from the reservoir, the deployment mechanism being configured to apply a force to the reservoir Comprising The cap includes a perforation, and the perforation is configured to contain the substance within the reservoir in the absence of the force applied to the substance by the deployment mechanism. The perforation is configured to expand to form an opening through which the substance can exit the cap, and the opening is larger in size than the perforation. The medical device.

8. The medical device according to claim 7, wherein the cap includes a frangible portion adjacent to the perforation, and the frangible portion is configured to break and expand in response to the expansion of the perforation to form an opening through which the substance can pass and exit the cap.

9. The medical device according to claim 7, wherein an outer surface of the cap includes a biodegradable material configured to contact tissue and degrade within seconds or minutes.

10. A shaft having a distal end that includes an opening, A movable rod disposed within the shaft and extending from the distal end, A cap at the distal end that defines a reservoir for storing a substance, A deployment mechanism configured to expel the substance from the reservoir, the deployment mechanism being configured to apply a force to the reservoir Comprising The cap includes a plurality of perforations, and the perforations are configured to contain the substance within the reservoir in the absence of the force applied to the substance by the deployment mechanism. The plurality of perforations are arranged in an alternating pattern that is continuous along the length of each other, a medical device.

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