Patent ID: 12201284

DETAILED DESCRIPTION

Examples of the disclosure include systems, devices, and methods for providing a medical instrument storing a material, delivering the medical instrument to a target treatment site within a subject (e.g., a patient), and removing a seal to deliver the material to the target treatment site.

As used herein, the term “distal” refers to a portion farthest away from a user when introducing a device into a patient and the term “proximal” refers to a portion closest to the user when placing the device into the subject. The terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements 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 “example,” rather than “ideal.” As used herein, the terms “about,” “substantially,” and “approximately,” indicate a range of values within +/−10% of a stated value.

Examples of the disclosure may relate to devices and methods for performing various medical procedures and/or treating portions of the large intestine (colon), small intestine, cecum, esophagus, any other portion of the gastrointestinal tract, and/or any other suitable patient anatomy (collectively referred to herein as a “target treatment site”). Various examples described herein include single-use or disposable medical devices. Reference will now be made in detail to examples of the disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

FIG.1shows an exemplary medical system100in accordance with an example of this disclosure. Medical system100may include a medical instrument110. For example, medical instrument110may include an endoscope, duodenoscope, gastroscope, colonoscope, ureteroscope, bronchoscope, and/or various other delivery systems. Medical instrument110may include a handle112, at least one actuator114, one or more ports116,118, and a shaft120. Handle112may be defined by a proximal end including actuator114and a distal end including shaft120extending distally therefrom. The one or more ports116,118may extend outwardly from handle112and be configured to facilitate receipt of one or more devices into medical instrument110. It should be appreciated that medical instrument110may include additional and/or fewer ports116,118than those shown and described herein.

Handle112may have one or more lumens (not shown) that communicate with a lumen(s) of one or more other components of medical instrument110. The one or more ports116,118may open into the one or more lumens of handle112and are sized and shaped to receive one or more devices therethrough, such as, for example, a mechanical rod140, a tube152, and more. Shaft120may include a tube that is sufficiently flexible such that shaft120is configured to selectively bend, rotate, and/or twist when being inserted into and/or through a subject's tortuous anatomy to a target treatment site.

Although not shown, it should be understood that shaft120may have one or more lumens extending therethrough that include, for example, a working lumen for receiving instruments, such as mechanical rod140received in medical instrument110at port116. Shaft120may further include a fluid lumen for delivering a fluid, such as, for example, from a pressurized medium source150fluidly coupled to medical instrument110at port118via tube152. Shaft120also may include an additional fluid lumen for conveying fluid away from the distal end of medical instrument110. It should be appreciated that medical system100may include various other suitable devices than those shown and described herein.

In other examples, shaft120may include additional lumens such as a control wire lumen for receiving one or more control wires for actuating one or more distal parts/tools (e.g., an articulation joint, an elevator, etc.), an illumination lumen for receiving at least a portion of an illumination assembly (FIGS.3A-3B), and/or an imaging lumen for receiving at least a portion of an imaging assembly (FIGS.3A-3B). Shaft120may further include a distal end122defining one or more openings that are in communication with the one or more lumens of shaft120.

Still referring toFIG.1, mechanical rod140may be a plunger having an elongated body142that is substantially flexible and defined between a distal end (not shown inFIG.1) and a proximal end142. In some examples, mechanical rod140may be a deployment mechanism including a handle146adjacent to proximal end142for selectively controlling a movement of mechanical rod140through the working lumen of shaft120. Pressurized medium source150may be another deployment mechanism and may include a hydraulic system, a pneumatic system, and/or the like. For example, pressurized medium source150may be configured to store and deliver a pressurized medium through the fluid lumen of shaft120. In some examples, the pressurized medium may include compressed air, fluid, liquid, gas, and the like.

Medical system100may further include an actuator130having a longitudinal length defined by a distal end132and a proximal end134. Actuator130may have a substantially flexible body and may include, for example, a cable, a thread, a string, a wire, a bundle of any of the aforementioned elements, and the like. As described in further detail below, actuator130may be disposed adjacent to medical instrument110during use in a procedure with proximal end134positioned adjacent to handle112, distal end132positioned adjacent to distal end122, and an elongated body of actuator130disposed alongside shaft120.

Still referring toFIG.1, proximal end134may be configured to facilitate a selective control of actuator130. In some embodiments, actuator130may be coupled to an indexing mechanism136configured to facilitate movement of actuator130relative to the working lumen. For example, indexing mechanism136may include a rotatable wheel, a knob, a lever, a button, a switch, etc. Actuator130may be coupled to indexing mechanism136along proximal end134such that actuation of indexing mechanism136may cause actuator130to move by pulling actuator130proximally about indexing mechanism136. In other embodiments, indexing mechanism136and/or actuator130may be omitted entirely.

Medical system100may further include a cap assembly160disposed on distal end122. Cap assembly160may be configured to seal and/or enclose one or more openings along distal end122, such as, for example, one or more openings corresponding to the one or more lumens of shaft120. As described in further detail herein, cap assembly160may be further configured to deliver one or more materials from medical instrument110, such as, for example, to a target treatment site within a subject during a procedure. In the example, actuator130may extend distally relative to distal end122and distal end132may be fastened to an outer and distally-facing surface of cap assembly160(e.g., via an adhesive, a knot, etc.).

Referring now toFIG.2A, cap assembly160is depicted in a partially transparent manner such that a reservoir (e.g., compartment) defined by cap assembly160is shown. For example, cap assembly160may include an outer body162, a distal face164, a removable cover166, and a partition wall168. Outer body162may include various suitable sizes and/or shapes that may adequately enclose distal end122of shaft120. Distal face164and removable cover166may be positioned at a distal end of outer body162, opposite of a proximal end secured to distal end122of shaft120. In some embodiments, distal face164is not removable or is otherwise fixed to outer body162.

Accordingly, distal face164and removable cover166may be sized and/or shaped to collectively define a distal end of cap assembly160. In other examples, removable cover166may be positioned along various other portions of outer body162such that a non-removable and/or fixed distal face164may define an entirety of the distal end. In the example shown, the distal end of outer body162may have a circular shape and each of distal face164and seal assembly160may have a semicircular shape. As described further below, distal face164and removable cover166may be positioned on the distal end along opposing sides of partition wall168.

Still referring toFIG.2A, distal face164may be formed of a substantially transparent material such that one or more devices disposed within outer body162may be visible through distal face164, and so that a user may be able to visualize a field of view distal of outer body162, using, e.g., imaging equipment located at distal end122of shaft120. Removable cover166may be disposed over an opening186(FIG.2B) on the distal end of outer body162. For example, removable cover166may be securely coupled over opening186on the distal end by various suitable mechanisms (e.g., an adhesive, a mechanical engagement, etc.). In the example, removable cover166may include a flexible tab that is selectively removable from opening186in response to an application of force applied thereto. In other examples, removable cover166may be coupled to outer body162by a hinge bracket or a living hinge.

Partition wall168may be disposed within cap assembly160and extend through an inner cavity defined by outer body162. In the example, partition wall168may divide the inner cavity and at least partially define and separate reservoirs170,180within outer body162. Accordingly, partition wall168may separate a visualization reservoir/space170from a material reservoir180such that one or more devices of medical instrument110and/or cap assembly160in visualization reservoir170may be shielded and/or isolated from one or more devices in material reservoir180, and vice versa. As briefly described above, shaft120may include one or more openings170,172on distal end122. It should be understood that the one or more lumens of shaft120may terminate at openings170,172. In yet other examples, cap assembly160does not cover the entire distal face of shaft120, so that imaging devices remain unobstructed.

In some examples, medical system100may include an illumination device (not shown) and an imaging device (not shown). The devices may be coupled to medical instrument110via the one or more ports116,118. The illumination device (e.g., optical fiber) and the imaging device (e.g., camera, sensor, etc.) may be received through respective lumens of handle112and shaft120. In the example, the illumination device may be positioned at distal end122in a first opening172; and the imaging device may be positioned at distal end122in a second opening174. It should be understood that distal end122may include additional and/or fewer openings for facilitating access to one or more lumens in shaft120.

Still referring toFIG.2A, first opening172and second opening174may be disposed within visualization reservoir170when cap assembly160is attached to distal end122. Accordingly, distal face164may be longitudinally aligned with openings172,174such that the illumination device may be configured to provide lighting distally relative to cap assembly160through transparent distal face164, and the imaging device may be configured to capture images of a distal position from cap assembly160through distal face164.

Cap assembly160may further include a movable floor182disposed within material reservoir180and having a top surface and a bottom surface. The top surface of movable floor182may be a distally-facing surface that faces removable cover166, and defines an interface for receiving one or more materials10thereon. In the example, material reservoir180may be prefilled with material10such that material10may be included between removable cover166and movable floor182prior to an assembly of cap assembly160onto shaft120. In some examples, material10may include an adhesive, a therapeutic agent, a regenerative substance, and/or various other materials for delivery by medical instrument10to a subject.

Still referring toFIG.2A, movable floor182may be a deployment mechanism configured to act as a mechanical piston configured to translate within material reservoir180and relative to outer body162. As described in detail below, movable floor182may be movable in response to an actuation of one or more other components of medical system100, such as, for example, mechanical rod140(FIG.1). In some embodiments, movable floor182is not removable from cap assembly160, such as, for example, prior to assembling cap assembly160onto medical instrument110. In this instance, material10may be maintained in material reservoir180and inhibited or prevented from being released due to movable floor182falling proximally outward from outer body162. Movable floor182could be, for example, a coated rubber piston similar to those used in syringes and injection devices. Movable floor182could include one or more features that prohibit proximal movement relative to outer body162, and/or outer body162could include one or more stops extending radially inward and positioned proximal of movable floor172that blocks or prevents proximal movement of movable floor182.

Actuator130may be attached to cap assembly160along removable cover166. For example, distal end132may be secured to an exterior of removable cover166(i.e. opposite of an interior facing and disposed within material reservoir180) and actuator130may be configured to apply a distal (pulling) force thereto to remove removable cover166from outer body162. In this instance, actuator130may expose opening186(FIG.2B). As described further below, actuator130may apply the force to removable cover166in response to a proximal translation of actuator130at proximal end132.

Referring back toFIG.1and according to an exemplary method of using medical system100during a procedure, medical instrument110may receive cap assembly160by attaching outer body162to distal end122. Cap assembly160may be preloaded with material10within material reservoir180(FIG.2A), with material10including a substance for delivery to a target treatment site within a subject (e.g., a patient). Alternatively, material10could be inserted into material reservoir180through opening186, after cap assembly160is coupled to shaft120. An illumination device and/or an imaging device may be coupled to medical instrument110and received through respective lumens of shaft120such that the distal ends of the devices are positioned at openings172,174. It is further contemplated, however, that the illumination device and/or imaging device are integral with shaft120.

Referring toFIG.3A, shaft120may be inserted into the subject and navigated to the target treatment site with use of an illumination device60(received within an illumination lumen126of shaft120) and an imaging device50(received within an imaging lumen128of shaft120). Distal end122may be positioned at or adjacent the target treatment site (e.g., a perforation, a wound, stricture formation, etc.) by visually identifying a location of the site with imaging device50through distal face164. Actuator130may be actuated by applying a proximally-directed force on actuator130, to remove removable cover166from outer body162or otherwise displace removable cover166and expose opening186.

For example, referring back toFIG.1, actuator130, and particularly proximal end134may be pulled proximally to translate actuator130in a proximal direction relative to shaft120, thereby pulling distal end132in a proximal direction. In examples where actuator130includes indexing mechanism136(FIG.1), a user may rotate indexing mechanism136to wind proximal end134about indexing mechanism136, thereby pulling distal end132proximally. It should be appreciated that distal end132may be secured to removable cover166to an extent such that distal end132is fixed to removable cover166. Accordingly, actuator130is configured to pull removable cover166away from outer body162.

Referring now toFIGS.2B and3B, removable cover166may be at least partially removed from outer body162by actuator130to expose opening186. After removable cover166is pulled off of or otherwise displaced relative to outer body162, opening186may become unsealed and material reservoir180may be exposed. In some embodiments, removable cover166may be completely removed from outer body162in response to a continued actuation of actuator130; while in other embodiments, at least a portion of removable cover166may remain at least partially fixed to outer body162(for example, when removable cover166is connected to outer body162by a hinge).

Movable floor182may be moved distally within material reservoir180and relative to outer body162in response to mechanical rod140moving distally through a working lumen124of shaft120. For example, distal end122may include a third opening184and working lumen124may terminate at third opening184(shown only inFIG.4A). Third opening184may be aligned with material reservoir180when cap assembly160is initially secured to shaft120.

In some embodiments, cap assembly160may include an alignment feature188to position movable floor182in alignment with third opening184during engagement of cap assembly160with distal end122. For example, alignment feature188may be a notch, a protrusion, and/or other various members extending proximally and outwardly from a proximal surface of movable floor182. Alignment feature188may be sized and shaped in accordance with a profile of working lumen124and/or third opening184. Accordingly, alignment feature188may be configured to extend into working lumen124via third opening184when cap assembly160is coupled to distal end122.

Actuation of handle146may cause mechanical rod140to translate through working lumen124, thereby causing a distal end of mechanical rod140to extend distally relative to distal end122and outwardly from third opening184. With movable floor182positioned against distal end122and alignment feature188received within working lumen124, mechanical rod140may be configured to push movable floor182towards opening186by engaging alignment feature188.

Accordingly, material10may be pushed through material reservoir180and ejected outwardly from cap assembly160via opening186. Material10may be delivered to the target treatment site when ejected outwardly from material reservoir180. It should be understood that cap assembly160may be configured to inhibit deployment of movable floor182outwardly material reservoir180. For example, opening186may be sized and/or shaped relatively smaller than movable floor182to inhibit removal of movable floor182from material reservoir180.

In other embodiments, actuator130may be omitted entirely such that seal assembly160may be removed from outer body162in response to mechanical rod140moving within containment reservoir180and pushing material10toward seal assembly160. Mechanical rod140may be operable to generate a pressure against removable cover166in response to moving movable floor182distally. In this instance, an increase in pressure in a distal direction may cause removable cover166to be deployed distally from outer body162, thereby permitting release of material10to the target treatment site. Alternatively, a pressurized medium may be delivered into containment reservoir180via third opening186to generate the pressure against removable cover166. In this instance, mechanical rod140is omitted and a pressurized medium source may deliver the pressurized medium to the cap assembly160to move movable floor182distally to deploy removable cover166and release material10.

Removable cover166may be formed of a biodegradable and/or bioabsorbable material such that removable cover166may be configured to degrade and/or be absorbed by one or more features (e.g., tissue) surrounding cap assembly160after deployment. For example, removable cover166may be operable to dissolve after a predetermined duration (e.g., minute(s), hour(s), day(s), week(s), etc.) of exposure to the one or more surrounding features at a target treatment site. In other examples, removable cover166may be simply received in the target treatment site and naturally passed through the subject (e.g., in a gastrointestinal (GI) tract) until released therefrom.

Referring now toFIG.4A, another exemplary cap assembly160′ according to an example of this disclosure is shown. It should be understood that cap assembly160′ may be readily incorporated onto medical instrument110in the manner described above. It should also be understood that cap assembly160′ functions substantially similar to cap assembly160described above except for the differences explicitly noted herein.

For example, cap assembly160′ may include one or more perforations166′ formed along a distal face164′ of outer body162. Perforations166′ may include small openings, holes, and/or apertures that are sized, shaped, and configured to facilitate access to cap assembly160′. As described in detail below, perforations166′ may be configured to retain a material within cap assembly160′ when in a default state (e.g., including a small opening on distal face164′), and may be further configured to permit release of the material from cap assembly160′ when transitioned to an expanded state forming a relatively larger opening. In the example, cap assembly160′ may include a pair of perforations166′ positioned on distal face164′. It should be appreciated that additional and/or fewer perforations166′ may be included on various portions of outer body162as opposed to those shown and described herein without departing from a scope of this disclosure.

Perforations166′ may include any suitable structure that, in an initial configuration, is configured to help retain material10within outer body162, and, after application of a suitable pressure or force against perforation166′, is configured to break or open, to enable material10to be dispensed out of outer body162. Perforations166′ may include one or more small holes formed in the material by a perforating tool that punctures the outer surface of outer body162. In some examples, perforations166′ may be formed by a die and punch, or by a laser.

It should be appreciated that a size (e.g., diameter) of perforations166′ may be based on a plurality of factors, including, but not limited to, a thickness of outer body162, a spacing between each perforations166′, a viscosity of a substance delivered through perforations166′, a desired amount of force required to break outer body162and/or perforations166′ to deliver a substance therethrough, and the like. For example, in embodiments in which a substance having a relatively low viscosity (e.g., a liquid) is stored within cap assembly160′, a diameter of perforations166′ may range from about 0.001 inches to about 0.002 inches. By way of further example, in embodiments in which a liquid substance having a relatively high viscosity (e.g., a gel) is stored within cap assembly160′, a diameter of perforations166′ may range from about 0.005 inches to about 0.010 inches. It should be understood that the diameters discussed above are merely exemplary and describe possible size openings that may still maintain the substance within cap assembly160′ despite perforations166′ forming an opening on outer body162.

It should be further appreciated that a spacing and/or offset of perforations166′ along outer body162may be based on a plurality of factors, including, but not limited to, a thickness of outer body162, a size (e.g., diameter) of perforations166′, a viscosity of a substance delivered through perforations166′, a desired amount of force required to break outer body162and/or perforations166′ to deliver a substance therethrough, and the like. For example, perforations166′ may be spaced apart from one another between about 0.001 inches to about 0.050 inches.

In some examples, perforations166′ may open into a larger opening186(FIG.4B) in response to an application of sufficient additional force against each perforation166′. That is, in response to an initial level of force applied, perforations166′ may enable material10to be expelled therethrough, and upon a greater level of force applied, the space surrounding and/or adjacent to perforations166′ may be broken to form an enlarged opening (e.g., opening186). Thus, increasing a size and/or shape of perforations166′ may enable additional material10to be deployed at a faster rate.

Still referring toFIG.4A, a region of outer body162positioned about each perforation166′ may be formed of a material configured to break open, thereby converting perforations166′ into larger openings. For example, perforations166′ may be enlarged in response to mechanical rod140moving within containment reservoir180and pushing material10toward distal face164′. Thus, mechanical rod140may generate a pressure against perforations166′ when moving movable floor182′ distally. The pressure increase may cause perforations166′ to break down and form openings186(FIG.4B), thereby permitting release of material10to the target treatment site.

Cap assembly160′ may further include one or more weakened and/or breakable portions169along outer body162. In the example, cap assembly160′ may include at least one weakened portion169positioned on distal face164′ between perforations166′. It should be appreciated that additional and/or fewer weakened portions169may be included on various portions of outer body162than those shown and described herein without departing from a scope of this disclosure. Weakened portion169may be configured to break open an adjacent portion of distal face164′ positioned between perforations166′ as perforations166′ are enlarged as additional force is applied by movable floor182′, thereby increasing a cross-sectional dimension of openings186formed along distal face164′.

As described in greater detail herein, increasing a size of opening186may allow material10to be delivered from cap assembly160′ at a greater flow rate. In other examples, a portion of distal face164′ disposed about perforations166′ and/or weakened portions169may be formed of a biodegradable and/or bioabsorbable material such that distal face164′ and/or weakened portions169may be configured to degrade and/or be absorbed by tissue surrounding cap assembly160′. The degradation may occur within seconds or minutes of contact between distal face164′ and tissue.

Still referring toFIG.4A, cap assembly160′ may further define a dual-purpose reservoir180′ within a cavity of outer body162. In other words, cap assembly160′ may omit a wall extending through the cavity such that a single, dual-purpose reservoir180′ is formed in outer body162. Additionally, cap assembly160′ may include a movable floor182′ that is sized and shaped in accordance with a profile of reservoir180′. It should be appreciated that movable floor182′ may be configured and operable in a substantially similar manner as movable floor182described above except for the differences explicitly described below.

In one example, not shown, it is contemplated that cap assembly160′ does not cover or obstruct the illumination/imaging devices of shaft120. Alternatively, movable floor182′ may be formed of a substantially transparent material such that one or more devices (e.g., illumination device, imaging device, etc.) disposed within outer body162may be visible through movable floor182′. In the embodiment, actuator130and mechanical rod140may be omitted entirely and pressurized medium source150(e.g., deployment mechanism) may be fluidly coupled to medical instrument110at port118, such as, for example, via tube152. Port118may be in fluid communication with a fluid lumen of shaft120which terminates at third opening184(FIG.4B). As described in further detail below, pressurized medium source150may be configured to deliver a pressurized medium to reservoir180′ via third opening184. In other embodiments, mechanical rod140may be received within medical instrument10in lieu of and/or in conjunction with pressurized medium source150for deployment of material10from cap assembly160′.

Referring now toFIG.4Band according to an exemplary method of using medical system100during a procedure with cap assembly160′, medical instrument110may receive cap assembly160′ by attaching outer body162to distal end122. Cap assembly160′ may be preloaded with material10within reservoir180′ and one or more devices (e.g., illumination device, imaging device, etc.) may be coupled to medical instrument110. Alternatively, material10could be inserted into material reservoir180′ through perforations166′ and/or opening186, after cap assembly160′ is coupled to shaft120. Shaft120may be inserted into a subject to position distal end122at a target treatment site consistent with the description above.

Upon positioning distal end122at the target treatment site, a user may actuate pressurized medium source150to deliver a pressurized medium20through the working channel of shaft120and into reservoir180′ via third opening184. Delivery of pressurized medium20may cause movable floor182′ to move within reservoir180′ and toward distal face164′. As movable floor182′ is forced toward distal face164′ at least a portion of material10may be delivered from cap assembly160″ via perforations166′. Additionally, a pressure within reservoir180′ may increase when movable floor182′ moves toward distal face164′, thereby weakening a portion of outer body162about each perforation166′ and/or weakened portion169.

Still referring toFIG.4B, the portion of outer body162formed about perforations166′ may disintegrate (e.g., break) in response to the increased pressure applied thereto when movable floor182′ is moved within reservoir180′. An enlarged opening186may be formed on distal face164′ at a location of each perforation166′ on outer body162. Further, weakened portions169may disintegrate such that each opening186may be interconnected with one another, thereby forming a single continuous opening186along distal face164′. In this instance, perforations166′ may be further enlarged to have a greater cross-sectional dimension for delivering material10.

Accordingly, material10may be pushed through reservoir180′ and ejected outwardly from cap assembly160′ via opening186. Material10may be delivered to the target treatment site when ejected outwardly from reservoir180′. In some examples, perforations166′ and weakened portions169may comprise a relatively small portion of the surface area of distal face164′ to provide a controlled and focused application of material10to the target treatment site. In other examples, perforations166′ and weakened portions169may comprise a relatively large portion of the surface area of distal face164′ to provide a larger zone of material discharge from cap assembly160′. In some examples, cap assembly160′ may include a plurality of perforations166′ aligned in series (e.g., in a linear configuration) on distal face164′, arranged in a matrix configuration in one or more rows and/or columns, disposed about a perimeter of distal face164′ in an annular array, or include a single large perforation166′ at a center of distal face164′. Various other configurations and/or quantities of perforations166′ may be suitable.

Still referring toFIG.4B, inclusion of weakened portions169on distal face164′ may expand a size and/or geometry of opening186such that additional material10may be delivered from cap assembly160′ at an enhanced/increased flow rate. It should be understood that, in other embodiments, additional and/or fewer perforations166′ and/or weakened portions169may be included on cap assembly160′ without departing from a scope of this disclosure.

For example, referring toFIG.5A, another exemplary cap assembly160″ may include one or more perforations166′ disposed along a sidewall of outer body162(e.g., along an outer circumference of outer body162). Perforations166′ may be positioned in various configurations and/or have varying geometries, such as, for example, aligned linearly and longitudinally in a series from a proximal end of cap assembly160″ (adjacent to distal end122) to a distal end (adjacent to distal face164′). In the example, cap assembly160″ may include four perforations166′ along the circumference of outer body162and longitudinally separated from one another. Although not shown, it should be understood that one or more weakened portions169may be included on the sidewall of outer body162, such as, for example, longitudinally between the one or more perforations166′.

Referring now toFIG.5B, cap assembly160″ may be configured such that a positive pressure is generated within outer body162as movable floor182′ moves distally toward distal face164′. With perforations166′ positioned on outer body162at varying longitudinal locations relative to one another, the pressure applied to an interior side of each perforation166′ may be dependent on a current position of movable floor182′ within reservoir180′. For example, as movable floor182′ moves within reservoir180′ and arrives at or near a longitudinal position of a particular perforation166′, the pressure applied against an interior of said perforation166′ may cause perforation166′ to expand such that opening186is formed.

With the other perforations166′ positioned along other portions and/or at different lengths (longitudinal positions) of outer body162, a pressure applied to some perforations166′ (e.g., the proximalmost perforations166′) may not or will not cause expansion of other perforations166′ (i.e., the distalmost perforations166′) positioned along other regions of outer body162. Accordingly, it should be appreciated that at least some of the one or more perforations166′ (e.g., the distalmost perforations166′) may be maintained in an original, unexpanded state while at least some of the other perforations166′ (e.g., the proximalmost perforations166′) may be enlarged into openings186.

In some embodiments, perforations166′ positioned adjacent to a proximal end of cap assembly160″ may include a predefined thickness that is relatively less than perforations166′ positioned adjacent to a distal end of cap assembly160″. Accordingly, perforations166′ having a smaller thickness may be configured to expand into larger openings186upon receipt of a smaller positive pressure than perforations166′ having a relatively greater thickness. Stated differently, perforations166′ positioned adjacent to the proximal end may break open into openings186or otherwise expand quicker than perforations166′ positioned adjacent to the distal end.

Still referring toFIG.5B, a continued distal translation of movable floor182′ relative to outer body162may provide additional expansion of perforations166′ into openings186. Accordingly, material10may be moved through reservoir180′ and delivered laterally and radially outward from cap assembly160″ in a progressive manner as additional openings186are enlarged/formed on outer body162. It should be understood that a pressure applied against each perforation166′ may be greatest when a position of movable floor182′ relative to outer body162is substantially radially aligned with a location of the particular perforation166′ on a sidewall of outer body162. It should further be appreciated that additional perforations166′ may be expanded as movable floor182′ continues to move relative to outer body162.

In some embodiments, perforations166′ may have a size and/or shape that is sufficiently sized to inhibit release of material10from reservoir180′ absent a delivery force applied to material10, such as, for example, by movement of movable floor182′. In the example, perforations166′ are not configured and/or operable to be enlarged (e.g., break open, dissolve, disintegrate, etc.) and instead material10may be forced through perforations166′ as a pressure within reservoir180′ increases. Accordingly, larger opening(s)186may not be formed at a location of perforations166′ as a positive pressure is formed within reservoir180′ (e.g., when movable floor182′ translates relative to outer body162).

In this instance, material10is delivered through perforations166′ and a flow rate and/or quantity of material10is controlled by the original size and/or shape of an opening formed by perforations166′. In the embodiment, material10may have a generally high viscosity such that release of material10through the small perforations166′ is inhibited without a pushing force applied thereto by movable floor182′. In other words, material10may not be deliverable from reservoir180′ absent movable floor182′ forcibly applying material10against perforations166′.

Each of the aforementioned systems, devices, assemblies, and methods may be used to provide a material adjacent a target treatment site in a subject (e.g., a patient), while the material is sealed in a cap assembly, and deploy the material from the cap assembly to the target treatment site within the subject. By providing a medical device including a cap assembly having one or more removable seals or perforations, a user may selectively deploy the material from the device during a procedure. In this instance, a user may reduce overall procedure time, increase efficiency of procedures, and/or avoid unnecessary harm to a subject's body caused by the medical instrument inadvertently releasing the material or requiring introduction of additional devices to deploy the sealed material.

It will be apparent to those skilled in the art that various modifications and variations may be made in 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.