Patent Description:
Technological developments have given users of medical systems, devices, and methods, the ability to conduct increasingly complex procedures on subjects. One challenge in the field of minimally invasive surgeries is associated with promoting healing by delivering a material (e.g., adhesive, therapeutic agent, regenerative substance, etc.) to internally-treated areas.

<CIT> discloses an auxiliary device for injecting material between the jaws of a surgical stapler. The auxiliary device includes a nozzle assembly having a discharge port and a compression assembly having at least one compression roller for forcing material out of the discharge port. The disclosed compression rollers may be formed of an incompressible or compressible material. The auxiliary device also includes a drive mechanism for moving the compression assembly within a nozzle body of the nozzle assembly. There is also disclosed a rupturable capsule for retaining material to be dispensed.

<CIT> discloses a surgical tissue fusion instrument having two gripping structures which are movable relative to each other, are designed for gripping and bringing together biological tissue sections, and are assigned heat-generating means designed in such a way that tissue fusion takes place between the biological tissue sections by heat being supplied in the area of the gripping structures. At least one gripping structure is assigned a fluid-conducting system, which is designed to supply at least one liquid or flowable additive to the tissue sections during a tissue fusion process.

The presently claimed invention provides a medical device according to claim <NUM>. Further developments of the herein claimed invention are described in the dependent claims.

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

According to an example, a medical device includes a shaft having a distal end and a cap at the distal end that defines a reservoir for storing a material. The medical device includes a deployment mechanism configured to eject the material from the reservoir, and the deployment mechanism is configured to apply a force to the reservoir. The cap includes a seal or a perforation that is configured to contain the material in the reservoir in the absence of the force applied by the deployment mechanism to the material.

Any of the medical devices described herein may include one or more of the following features. The deployment mechanism includes a movable floor that is distal of the distal end of the shaft. The deployment mechanism further includes a movable rod disposed within the shaft and extendable from the distal end. The movable rod is configured to push the movable floor distally away from the distal end of the shaft to eject the material from the reservoir. The shaft includes a lumen and the distal end includes an opening, wherein the movable rod is configured to extend through the opening. The movable floor includes a notch that is received within the opening and is configured to align the movable floor with the movable rod. The deployment mechanism includes a source of pressurized medium, wherein the pressurized medium is configured to be delivered through the shaft from the pressurized medium source. The seal includes a movable cover coupled to the cap, wherein the movable cover is configured to move to form an opening through which the material is able to exit the cap. The medical device may include an actuator coupled to the movable cover, wherein 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 proximal pulling force. The actuator includes a wire, a cable, or a thread. The perforation is configured to expand and form an opening through which the material can exit the cap, wherein the opening has a greater size than the perforation. The cap includes a breakable portion adjacent to the perforation, wherein the breakable portion is configured to break in response to expansion of the perforation and form an enlarged opening through which the material is able to exit the cap. An outer surface of the cap includes a biodegradable material that is configured to degrade within seconds or minutes of contact with tissue. The cap includes a plurality of perforations staggered in series and in a longitudinal configuration relative to one another.

According to another example, a medical device includes a cap configured to be attached to a distal end of a scope, wherein the cap defines a reservoir for storing a material. The cap includes a removable seal configured to expose the reservoir and the material upon removal of the seal from a remainder of the cap. The cap includes a deployment mechanism configured to eject the material from the reservoir. The deployment mechanism is configured to generate a positive pressure within the reservoir.

Any of the medical devices described herein may include one or more of the following features. The removable seal is formed of biodegradable material such that the removable seal is configured to degrade upon exposure to a target site for a predetermined duration.

According to another example, a cap configured to be attached to a distal end of a scope, wherein the cap defines a reservoir for storing a material. The cap includes a plurality of perforations configured to expand and allow the material to exit the cap, and a deployment mechanism configured to eject the material from the reservoir via the plurality of perforations. The deployment mechanism is configured to apply a force to the material within the reservoir.

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

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 +/- <NUM>% 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.

<FIG> shows an exemplary medical system <NUM> in accordance with an example of this disclosure. Medical system <NUM> may include a medical instrument <NUM>. For example, medical instrument <NUM> may include an endoscope, duodenoscope, gastroscope, colonoscope, ureteroscope, bronchoscope, and/or various other delivery systems. Medical instrument <NUM> may include a handle <NUM>, at least one actuator <NUM>, one or more ports <NUM>, <NUM>, and a shaft <NUM>. Handle <NUM> may be defined by a proximal end including actuator <NUM> and a distal end including shaft <NUM> extending distally therefrom. The one or more ports <NUM>, <NUM> may extend outwardly from handle <NUM> and be configured to facilitate receipt of one or more devices into medical instrument <NUM>. It should be appreciated that medical instrument <NUM> may include additional and/or fewer ports <NUM>, <NUM> than those shown and described herein.

Handle <NUM> may have one or more lumens (not shown) that communicate with a lumen(s) of one or more other components of medical instrument <NUM>. The one or more ports <NUM>, <NUM> may open into the one or more lumens of handle <NUM> and are sized and shaped to receive one or more devices therethrough, such as, for example, a mechanical rod <NUM>, a tube <NUM>, and more. Shaft <NUM> may include a tube that is sufficiently flexible such that shaft <NUM> is 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 shaft <NUM> may have one or more lumens extending therethrough that include, for example, a working lumen for receiving instruments, such as mechanical rod <NUM> received in medical instrument <NUM> at port <NUM>. Shaft <NUM> may further include a fluid lumen for delivering a fluid, such as, for example, from a pressurized medium source <NUM> fluidly coupled to medical instrument <NUM> at port <NUM> via tube <NUM>. Shaft <NUM> also may include an additional fluid lumen for conveying fluid away from the distal end of medical instrument <NUM>. It should be appreciated that medical system <NUM> may include various other suitable devices than those shown and described herein.

In other examples, shaft <NUM> may 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 (<FIG>), and/or an imaging lumen for receiving at least a portion of an imaging assembly (<FIG>). Shaft <NUM> may further include a distal end <NUM> defining one or more openings that are in communication with the one or more lumens of shaft <NUM>.

Still referring to <FIG>, mechanical rod <NUM> may be a plunger having an elongated body <NUM> that is substantially flexible and defined between a distal end (not shown in <FIG>) and a proximal end <NUM>. In some examples, mechanical rod <NUM> may be a deployment mechanism including a handle <NUM> adjacent to proximal end <NUM> for selectively controlling a movement of mechanical rod <NUM> through the working lumen of shaft <NUM>. Pressurized medium source <NUM> may be another deployment mechanism and may include a hydraulic system, a pneumatic system, and/or the like. For example, pressurized medium source <NUM> may be configured to store and deliver a pressurized medium through the fluid lumen of shaft <NUM>. In some examples, the pressurized medium may include compressed air, fluid, liquid, gas, and the like.

Medical system <NUM> may further include an actuator <NUM> having a longitudinal length defined by a distal end <NUM> and a proximal end <NUM>. Actuator <NUM> may 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, actuator <NUM> may be disposed adjacent to medical instrument <NUM> during use in a procedure with proximal end <NUM> positioned adjacent to handle <NUM>, distal end <NUM> positioned adjacent to distal end <NUM>, and an elongated body of actuator <NUM> disposed alongside shaft <NUM>.

Still referring to <FIG>, proximal end <NUM> may be configured to facilitate a selective control of actuator <NUM>. In some embodiments, actuator <NUM> may be coupled to an indexing mechanism <NUM> configured to facilitate movement of actuator <NUM> relative to the working lumen. For example, indexing mechanism <NUM> may include a rotatable wheel, a knob, a lever, a button, a switch, etc. Actuator <NUM> may be coupled to indexing mechanism <NUM> along proximal end <NUM> such that actuation of indexing mechanism <NUM> may cause actuator <NUM> to move by pulling actuator <NUM> proximally about indexing mechanism <NUM>. In other embodiments, indexing mechanism <NUM> and/or actuator <NUM> may be omitted entirely.

Medical system <NUM> may further include a cap assembly <NUM> disposed on distal end <NUM>. Cap assembly <NUM> may be configured to seal and/or enclose one or more openings along distal end <NUM>, such as, for example, one or more openings corresponding to the one or more lumens of shaft <NUM>. As described in further detail herein, cap assembly <NUM> may be further configured to deliver one or more materials from medical instrument <NUM>, such as, for example, to a target treatment site within a subject during a procedure. In the example, actuator <NUM> may extend distally relative to distal end <NUM> and distal end <NUM> may be fastened to an outer and distally-facing surface of cap assembly <NUM> (e.g., via an adhesive, a knot, etc.).

Referring now to <FIG>, cap assembly <NUM> is depicted in a partially transparent manner such that a reservoir (e.g., compartment) defined by cap assembly <NUM> is shown. For example, cap assembly <NUM> may include an outer body <NUM>, a distal face <NUM>, a removable cover <NUM>, and a partition wall <NUM>. Outer body <NUM> may include various suitable sizes and/or shapes that may adequately enclose distal end <NUM> of shaft <NUM>. Distal face <NUM> and removable cover <NUM> may be positioned at a distal end of outer body <NUM>, opposite of a proximal end secured to distal end <NUM> of shaft <NUM>. In some embodiments, distal face <NUM> is not removable or is otherwise fixed to outer body <NUM>.

Accordingly, distal face <NUM> and removable cover <NUM> may be sized and/or shaped to collectively define a distal end of cap assembly <NUM>. In other examples, removable cover <NUM> may be positioned along various other portions of outer body <NUM> such that a non-removable and/or fixed distal face <NUM> may define an entirety of the distal end. In the example shown, the distal end of outer body <NUM> may have a circular shape and each of distal face <NUM> and seal assembly <NUM> may have a semicircular shape. As described further below, distal face <NUM> and removable cover <NUM> may be positioned on the distal end along opposing sides of partition wall <NUM>.

Still referring to <FIG>, distal face <NUM> may be formed of a substantially transparent material such that one or more devices disposed within outer body <NUM> may be visible through distal face <NUM>, and so that a user may be able to visualize a field of view distal of outer body <NUM>, using, e.g., imaging equipment located at distal end <NUM> of shaft <NUM>. Removable cover <NUM> may be disposed over an opening <NUM> (<FIG>) on the distal end of outer body <NUM>. For example, removable cover <NUM> may be securely coupled over opening <NUM> on the distal end by various suitable mechanisms (e.g., an adhesive, a mechanical engagement, etc.). In the example, removable cover <NUM> may include a flexible tab that is selectively removable from opening <NUM> in response to an application of force applied thereto. In other examples, removable cover <NUM> may be coupled to outer body <NUM> by a hinge bracket or a living hinge.

Partition wall <NUM> may be disposed within cap assembly <NUM> and extend through an inner cavity defined by outer body <NUM>. In the example, partition wall <NUM> may divide the inner cavity and at least partially define and separate reservoirs <NUM>, <NUM> within outer body <NUM>. Accordingly, partition wall <NUM> may separate a visualization reservoir/space <NUM> from a material reservoir <NUM> such that one or more devices of medical instrument <NUM> and/or cap assembly <NUM> in visualization reservoir <NUM> may be shielded and/or isolated from one or more devices in material reservoir <NUM>, and vice versa. As briefly described above, shaft <NUM> may include one or more openings <NUM>, <NUM> on distal end <NUM>. It should be understood that the one or more lumens of shaft <NUM> may terminate at openings <NUM>, <NUM>. In yet other examples, cap assembly <NUM> does not cover the entire distal face of shaft <NUM>, so that imaging devices remain unobstructed.

In some examples, medical system <NUM> may include an illumination device (not shown) and an imaging device (not shown). The devices may be coupled to medical instrument <NUM> via the one or more ports <NUM>, <NUM>. The illumination device (e.g., optical fiber) and the imaging device (e.g., camera, sensor, etc.) may be received through respective lumens of handle <NUM> and shaft <NUM>. In the example, the illumination device may be positioned at distal end <NUM> in a first opening <NUM>; and the imaging device may be positioned at distal end <NUM> in a second opening <NUM>. It should be understood that distal end <NUM> may include additional and/or fewer openings for facilitating access to one or more lumens in shaft <NUM>.

Still referring to <FIG>, first opening <NUM> and second opening <NUM> may be disposed within visualization reservoir <NUM> when cap assembly <NUM> is attached to distal end <NUM>. Accordingly, distal face <NUM> may be longitudinally aligned with openings <NUM>, <NUM> such that the illumination device may be configured to provide lighting distally relative to cap assembly <NUM> through transparent distal face <NUM>, and the imaging device may be configured to capture images of a distal position from cap assembly <NUM> through distal face <NUM>.

Cap assembly <NUM> may further include a movable floor <NUM> disposed within material reservoir <NUM> and having a top surface and a bottom surface. The top surface of movable floor <NUM> may be a distally-facing surface that faces removable cover <NUM>, and defines an interface for receiving one or more materials <NUM> thereon. In the example, material reservoir <NUM> may be prefilled with material <NUM> such that material <NUM> may be included between removable cover <NUM> and movable floor <NUM> prior to an assembly of cap assembly <NUM> onto shaft <NUM>. In some examples, material <NUM> may include an adhesive, a therapeutic agent, a regenerative substance, and/or various other materials for delivery by medical instrument <NUM> to a subject.

Still referring to <FIG>, movable floor <NUM> may be a deployment mechanism configured to act as a mechanical piston configured to translate within material reservoir <NUM> and relative to outer body <NUM>. As described in detail below, movable floor <NUM> may be movable in response to an actuation of one or more other components of medical system <NUM>, such as, for example, mechanical rod <NUM> (<FIG>). In some embodiments, movable floor <NUM> is not removable from cap assembly <NUM>, such as, for example, prior to assembling cap assembly <NUM> onto medical instrument <NUM>. In this instance, material <NUM> may be maintained in material reservoir <NUM> and inhibited or prevented from being released due to movable floor <NUM> falling proximally outward from outer body <NUM>. Movable floor <NUM> could be, for example, a coated rubber piston similar to those used in syringes and injection devices. Movable floor <NUM> could include one or more features that prohibit proximal movement relative to outer body <NUM>, and/or outer body <NUM> could include one or more stops extending radially inward and positioned proximal of movable floor <NUM> that blocks or prevents proximal movement of movable floor <NUM>.

Actuator <NUM> may be attached to cap assembly <NUM> along removable cover <NUM>. For example, distal end <NUM> may be secured to an exterior of removable cover <NUM> (i.e. opposite of an interior facing and disposed within material reservoir <NUM>) and actuator <NUM> may be configured to apply a distal (pulling) force thereto to remove removable cover <NUM> from outer body <NUM>. In this instance, actuator <NUM> may expose opening <NUM> (<FIG>). As described further below, actuator <NUM> may apply the force to removable cover <NUM> in response to a proximal translation of actuator <NUM> at proximal end <NUM>.

Referring back to <FIG> and according to an exemplary method of using medical system <NUM> during a procedure, medical instrument <NUM> may receive cap assembly <NUM> by attaching outer body <NUM> to distal end <NUM>. Cap assembly <NUM> may be preloaded with material <NUM> within material reservoir <NUM> (<FIG>), with material <NUM> including a substance for delivery to a target treatment site within a subject (e.g., a patient). Alternatively, material <NUM> could be inserted into material reservoir <NUM> through opening <NUM>, after cap assembly <NUM> is coupled to shaft <NUM>. An illumination device and/or an imaging device may be coupled to medical instrument <NUM> and received through respective lumens of shaft <NUM> such that the distal ends of the devices are positioned at openings <NUM>, <NUM>. It is further contemplated, however, that the illumination device and/or imaging device are integral with shaft <NUM>.

Referring to <FIG>, shaft <NUM> may be inserted into the subject and navigated to the target treatment site with use of an illumination device <NUM> (received within an illumination lumen <NUM> of shaft <NUM>) and an imaging device <NUM> (received within an imaging lumen <NUM> of shaft <NUM>). Distal end <NUM> may 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 device <NUM> through distal face <NUM>. Actuator <NUM> may be actuated by applying a proximally-directed force on actuator <NUM>, to remove removable cover <NUM> from outer body <NUM> or otherwise displace removable cover <NUM> and expose opening <NUM>.

For example, referring back to <FIG>, actuator <NUM>, and particularly proximal end <NUM> may be pulled proximally to translate actuator <NUM> in a proximal direction relative to shaft <NUM>, thereby pulling distal end <NUM> in a proximal direction. In examples where actuator <NUM> includes indexing mechanism <NUM> (<FIG>), a user may rotate indexing mechanism <NUM> to wind proximal end <NUM> about indexing mechanism <NUM>, thereby pulling distal end <NUM> proximally. It should be appreciated that distal end <NUM> may be secured to removable cover <NUM> to an extent such that distal end <NUM> is fixed to removable cover <NUM>. Accordingly, actuator <NUM> is configured to pull removable cover <NUM> away from outer body <NUM>.

Referring now to <FIG> and <FIG>, removable cover <NUM> may be at least partially removed from outer body <NUM> by actuator <NUM> to expose opening <NUM>. After removable cover <NUM> is pulled off of or otherwise displaced relative to outer body <NUM>, opening <NUM> may become unsealed and material reservoir <NUM> may be exposed. In some embodiments, removable cover <NUM> may be completely removed from outer body <NUM> in response to a continued actuation of actuator <NUM>; while in other embodiments, at least a portion of removable cover <NUM> may remain at least partially fixed to outer body <NUM> (for example, when removable cover <NUM> is connected to outer body <NUM> by a hinge).

Movable floor <NUM> may be moved distally within material reservoir <NUM> and relative to outer body <NUM> in response to mechanical rod <NUM> moving distally through a working lumen <NUM> of shaft <NUM>. For example, distal end <NUM> may include a third opening <NUM> and working lumen <NUM> may terminate at third opening <NUM> (shown only in <FIG>). Third opening <NUM> may be aligned with material reservoir <NUM> when cap assembly <NUM> is initially secured to shaft <NUM>.

In some embodiments, cap assembly <NUM> may include an alignment feature <NUM> to position movable floor <NUM> in alignment with third opening <NUM> during engagement of cap assembly <NUM> with distal end <NUM>. For example, alignment feature <NUM> may be a notch, a protrusion, and/or other various members extending proximally and outwardly from a proximal surface of movable floor <NUM>. Alignment feature <NUM> may be sized and shaped in accordance with a profile of working lumen <NUM> and/or third opening <NUM>. Accordingly, alignment feature <NUM> may be configured to extend into working lumen <NUM> via third opening <NUM> when cap assembly <NUM> is coupled to distal end <NUM>.

Actuation of handle <NUM> may cause mechanical rod <NUM> to translate through working lumen <NUM>, thereby causing a distal end of mechanical rod <NUM> to extend distally relative to distal end <NUM> and outwardly from third opening <NUM>. With movable floor <NUM> positioned against distal end <NUM> and alignment feature <NUM> received within working lumen <NUM>, mechanical rod <NUM> may be configured to push movable floor <NUM> towards opening <NUM> by engaging alignment feature <NUM>.

Accordingly, material <NUM> may be pushed through material reservoir <NUM> and ejected outwardly from cap assembly <NUM> via opening <NUM>. Material <NUM> may be delivered to the target treatment site when ejected outwardly from material reservoir <NUM>. It should be understood that cap assembly <NUM> may be configured to inhibit deployment of movable floor <NUM> outwardly material reservoir <NUM>. For example, opening <NUM> may be sized and/or shaped relatively smaller than movable floor <NUM> to inhibit removal of movable floor <NUM> from material reservoir <NUM>.

In other embodiments, actuator <NUM> may be omitted entirely such that seal assembly <NUM> may be removed from outer body <NUM> in response to mechanical rod <NUM> moving within containment reservoir <NUM> and pushing material <NUM> toward seal assembly <NUM>. Mechanical rod <NUM> may be operable to generate a pressure against removable cover <NUM> in response to moving movable floor <NUM> distally. In this instance, an increase in pressure in a distal direction may cause removable cover <NUM> to be deployed distally from outer body <NUM>, thereby permitting release of material <NUM> to the target treatment site. Alternatively, a pressurized medium may be delivered into containment reservoir <NUM> via third opening <NUM> to generate the pressure against removable cover <NUM>. In this instance, mechanical rod <NUM> is omitted and a pressurized medium source may deliver the pressurized medium to the cap assembly <NUM> to move movable floor <NUM> distally to deploy removable cover <NUM> and release material <NUM>.

Removable cover <NUM> may be formed of a biodegradable and/or bioabsorbable material such that removable cover <NUM> may be configured to degrade and/or be absorbed by one or more features (e.g., tissue) surrounding cap assembly <NUM> after deployment. For example, removable cover <NUM> may 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 cover <NUM> may 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 to <FIG>, another exemplary cap assembly <NUM>' according to an example of this disclosure is shown. It should be understood that cap assembly <NUM>' may be readily incorporated onto medical instrument <NUM> in the manner described above. It should also be understood that cap assembly <NUM>' functions substantially similar to cap assembly <NUM> described above except for the differences explicitly noted herein.

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

Perforations <NUM>' may include any suitable structure that, in an initial configuration, is configured to help retain material <NUM> within outer body <NUM>, and, after application of a suitable pressure or force against perforation <NUM>', is configured to break or open, to enable material <NUM> to be dispensed out of outer body <NUM>. Perforations <NUM>' may include one or more small holes formed in the material by a perforating tool that punctures the outer surface of outer body <NUM>. In some examples, perforations <NUM>' may be formed by a die and punch, or by a laser.

It should be appreciated that a size (e.g., diameter) of perforations <NUM>' may be based on a plurality of factors, including, but not limited to, a thickness of outer body <NUM>, a spacing between each perforations <NUM>', a viscosity of a substance delivered through perforations <NUM>', a desired amount of force required to break outer body <NUM> and/or perforations <NUM>' 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 assembly <NUM>', a diameter of perforations <NUM>' may range from about <NUM> inches (<NUM>,<NUM>) to about <NUM> inches (<NUM>,<NUM>). 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 assembly <NUM>', a diameter of perforations <NUM>' may range from about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>). 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 assembly <NUM>' despite perforations <NUM>' forming an opening on outer body <NUM>.

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

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

Still referring to <FIG>, a region of outer body <NUM> positioned about each perforation <NUM>' may be formed of a material configured to break open, thereby converting perforations <NUM>' into larger openings. For example, perforations <NUM>' may be enlarged in response to mechanical rod <NUM> moving within containment reservoir <NUM> and pushing material <NUM> toward distal face <NUM>'. Thus, mechanical rod <NUM> may generate a pressure against perforations <NUM>' when moving movable floor <NUM>' distally. The pressure increase may cause perforations <NUM>' to break down and form openings <NUM> (<FIG>), thereby permitting release of material <NUM> to the target treatment site.

Cap assembly <NUM>' may further include one or more weakened and/or breakable portions <NUM> along outer body <NUM>. In the example, cap assembly <NUM>' may include at least one weakened portion <NUM> positioned on distal face <NUM>' between perforations <NUM>'. It should be appreciated that additional and/or fewer weakened portions <NUM> may be included on various portions of outer body <NUM> than those shown and described herein without departing from a scope of this disclosure. Weakened portion <NUM> may be configured to break open an adjacent portion of distal face <NUM>' positioned between perforations <NUM>' as perforations <NUM>' are enlarged as additional force is applied by movable floor <NUM>', thereby increasing a cross-sectional dimension of openings <NUM> formed along distal face <NUM>'.

As described in greater detail herein, increasing a size of opening <NUM> may allow material <NUM> to be delivered from cap assembly <NUM>' at a greater flow rate. In other examples, a portion of distal face <NUM>' disposed about perforations <NUM>' and/or weakened portions <NUM> may be formed of a biodegradable and/or bioabsorbable material such that distal face <NUM>' and/or weakened portions <NUM> may be configured to degrade and/or be absorbed by tissue surrounding cap assembly <NUM>'. The degradation may occur within seconds or minutes of contact between distal face <NUM>' and tissue.

Still referring to <FIG>, cap assembly <NUM>' may further define a dual-purpose reservoir <NUM>' within a cavity of outer body <NUM>. In other words, cap assembly <NUM>' may omit a wall extending through the cavity such that a single, dual-purpose reservoir <NUM>' is formed in outer body <NUM>. Additionally, cap assembly <NUM>' may include a movable floor <NUM>' that is sized and shaped in accordance with a profile of reservoir <NUM>'. It should be appreciated that movable floor <NUM>' may be configured and operable in a substantially similar manner as movable floor <NUM> described above except for the differences explicitly described below.

In one example, not shown, it is contemplated that cap assembly <NUM>' does not cover or obstruct the illumination/imaging devices of shaft <NUM>. Alternatively, movable floor <NUM>' may be formed of a substantially transparent material such that one or more devices (e.g., illumination device, imaging device, etc.) disposed within outer body <NUM> may be visible through movable floor <NUM>'. In the embodiment, actuator <NUM> and mechanical rod <NUM> may be omitted entirely and pressurized medium source <NUM> (e.g., deployment mechanism) may be fluidly coupled to medical instrument <NUM> at port <NUM>, such as, for example, via tube <NUM>. Port <NUM> may be in fluid communication with a fluid lumen of shaft <NUM> which terminates at third opening <NUM> (<FIG>). As described in further detail below, pressurized medium source <NUM> may be configured to deliver a pressurized medium to reservoir <NUM>' via third opening <NUM>. In other embodiments, mechanical rod <NUM> may be received within medical instrument <NUM> in lieu of and/or in conjunction with pressurized medium source <NUM> for deployment of material <NUM> from cap assembly <NUM>'.

Referring now to <FIG> and according to an exemplary method of using medical system <NUM> during a procedure with cap assembly <NUM>', medical instrument <NUM> may receive cap assembly <NUM>' by attaching outer body <NUM> to distal end <NUM>. Cap assembly <NUM>' may be preloaded with material <NUM> within reservoir <NUM>' and one or more devices (e.g., illumination device, imaging device, etc.) may be coupled to medical instrument <NUM>. Alternatively, material <NUM> could be inserted into material reservoir <NUM>' through perforations <NUM>' and/or opening <NUM>, after cap assembly <NUM>' is coupled to shaft <NUM>. Shaft <NUM> may be inserted into a subject to position distal end <NUM> at a target treatment site consistent with the description above.

Upon positioning distal end <NUM> at the target treatment site, a user may actuate pressurized medium source <NUM> to deliver a pressurized medium <NUM> through the working channel of shaft <NUM> and into reservoir <NUM>' via third opening <NUM>. Delivery of pressurized medium <NUM> may cause movable floor <NUM>' to move within reservoir <NUM>' and toward distal face <NUM>'. As movable floor <NUM>' is forced toward distal face <NUM>' at least a portion of material <NUM> may be delivered from cap assembly <NUM>" via perforations <NUM>'. Additionally, a pressure within reservoir <NUM>' may increase when movable floor <NUM>' moves toward distal face <NUM>', thereby weakening a portion of outer body <NUM> about each perforation <NUM>' and/or weakened portion <NUM>.

Still referring to <FIG>, the portion of outer body <NUM> formed about perforations <NUM>' may disintegrate (e.g., break) in response to the increased pressure applied thereto when movable floor <NUM>' is moved within reservoir <NUM>'. An enlarged opening <NUM> may be formed on distal face <NUM>' at a location of each perforation <NUM>' on outer body <NUM>. Further, weakened portions <NUM> may disintegrate such that each opening <NUM> may be interconnected with one another, thereby forming a single continuous opening <NUM> along distal face <NUM>'. In this instance, perforations <NUM>' may be further enlarged to have a greater cross-sectional dimension for delivering material <NUM>.

Accordingly, material <NUM> may be pushed through reservoir <NUM>' and ejected outwardly from cap assembly <NUM>' via opening <NUM>. Material <NUM> may be delivered to the target treatment site when ejected outwardly from reservoir <NUM>'. In some examples, perforations <NUM>' and weakened portions <NUM> may comprise a relatively small portion of the surface area of distal face <NUM>' to provide a controlled and focused application of material <NUM> to the target treatment site. In other examples, perforations <NUM>' and weakened portions <NUM> may comprise a relatively large portion of the surface area of distal face <NUM>' to provide a larger zone of material discharge from cap assembly <NUM>'. In some examples, cap assembly <NUM>' may include a plurality of perforations <NUM>' aligned in series (e.g., in a linear configuration) on distal face <NUM>', arranged in a matrix configuration in one or more rows and/or columns, disposed about a perimeter of distal face <NUM>' in an annular array, or include a single large perforation <NUM>' at a center of distal face <NUM>'. Various other configurations and/or quantities of perforations <NUM>' may be suitable.

Still referring to <FIG>, inclusion of weakened portions <NUM> on distal face <NUM>' may expand a size and/or geometry of opening <NUM> such that additional material <NUM> may be delivered from cap assembly <NUM>' at an enhanced/increased flow rate. It should be understood that, in other embodiments, additional and/or fewer perforations <NUM>' and/or weakened portions <NUM> may be included on cap assembly <NUM>' without departing from a scope of this disclosure.

For example, referring to <FIG>, another exemplary cap assembly <NUM>" may include one or more perforations <NUM>' disposed along a sidewall of outer body <NUM> (e.g., along an outer circumference of outer body <NUM>). Perforations <NUM>' 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 assembly <NUM>" (adjacent to distal end <NUM>) to a distal end (adjacent to distal face <NUM>'). In the example, cap assembly <NUM>" may include four perforations <NUM>' along the circumference of outer body <NUM> and longitudinally separated from one another. Although not shown, it should be understood that one or more weakened portions <NUM> may be included on the sidewall of outer body <NUM>, such as, for example, longitudinally between the one or more perforations <NUM>'.

Referring now to <FIG>, cap assembly <NUM>" may be configured such that a positive pressure is generated within outer body <NUM> as movable floor <NUM>' moves distally toward distal face <NUM>'. With perforations <NUM>' positioned on outer body <NUM> at varying longitudinal locations relative to one another, the pressure applied to an interior side of each perforation <NUM>' may be dependent on a current position of movable floor <NUM>' within reservoir <NUM>'. For example, as movable floor <NUM>' moves within reservoir <NUM>' and arrives at or near a longitudinal position of a particular perforation <NUM>', the pressure applied against an interior of said perforation <NUM>' may cause perforation <NUM>' to expand such that opening <NUM> is formed.

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

In some embodiments, perforations <NUM>' positioned adjacent to a proximal end of cap assembly <NUM>" may include a predefined thickness that is relatively less than perforations <NUM>' positioned adjacent to a distal end of cap assembly <NUM>". Accordingly, perforations <NUM>' having a smaller thickness may be configured to expand into larger openings <NUM> upon receipt of a smaller positive pressure than perforations <NUM>' having a relatively greater thickness. Stated differently, perforations <NUM>' positioned adjacent to the proximal end may break open into openings <NUM> or otherwise expand quicker than perforations <NUM>' positioned adjacent to the distal end.

Still referring to <FIG>, a continued distal translation of movable floor <NUM>' relative to outer body <NUM> may provide additional expansion of perforations <NUM>' into openings <NUM>. Accordingly, material <NUM> may be moved through reservoir <NUM>' and delivered laterally and radially outward from cap assembly <NUM>" in a progressive manner as additional openings <NUM> are enlarged/formed on outer body <NUM>. It should be understood that a pressure applied against each perforation <NUM>' may be greatest when a position of movable floor <NUM>' relative to outer body <NUM> is substantially radially aligned with a location of the particular perforation <NUM>' on a sidewall of outer body <NUM>. It should further be appreciated that additional perforations <NUM>' may be expanded as movable floor <NUM>' continues to move relative to outer body <NUM>.

In some embodiments, perforations <NUM>' may have a size and/or shape that is sufficiently sized to inhibit release of material <NUM> from reservoir <NUM>' absent a delivery force applied to material <NUM>, such as, for example, by movement of movable floor <NUM>'. In the example, perforations <NUM>' are not configured and/or operable to be enlarged (e.g., break open, dissolve, disintegrate, etc.) and instead material <NUM> may be forced through perforations <NUM>' as a pressure within reservoir <NUM>' increases. Accordingly, larger opening(s) <NUM> may not be formed at a location of perforations <NUM>' as a positive pressure is formed within reservoir <NUM>' (e.g., when movable floor <NUM>' translates relative to outer body <NUM>).

In this instance, material <NUM> is delivered through perforations <NUM>' and a flow rate and/or quantity of material <NUM> is controlled by the original size and/or shape of an opening formed by perforations <NUM>'. In the embodiment, material <NUM> may have a generally high viscosity such that release of material <NUM> through the small perforations <NUM>' is inhibited without a pushing force applied thereto by movable floor <NUM>'. In other words, material <NUM> may not be deliverable from reservoir <NUM>' absent movable floor <NUM>' forcibly applying material <NUM> against perforations <NUM>'.

Claim 1:
A medical device, comprising:
a shaft (<NUM>) having a distal end;
a cap (<NUM>) at the distal end, wherein the cap (<NUM>) defines a reservoir (<NUM>) for storing a material (<NUM>); and
a deployment mechanism configured to eject the material (<NUM>) from the reservoir (<NUM>), wherein the deployment mechanism is configured to apply a force to the reservoir (<NUM>);
wherein the cap (<NUM>) includes a seal or a perforation (<NUM>'), wherein the seal or the perforation (<NUM>') is configured to contain the material (<NUM>) in the reservoir (<NUM>) in the absence of the force applied by the deployment mechanism to the material (<NUM>),
wherein the seal includes a movable cover (<NUM>) coupled to the cap (<NUM>), wherein the movable cover (<NUM>) is configured to move to form an opening through which the material (<NUM>) is able to exit the cap (<NUM>).