The present disclosure relates generally to a medical device that administers an agent. More particularly, at least some embodiments of the present disclosure relate to a medical device including a system that can be actuated to administer a dosage of an agent to a lumen.
In certain medical procedures, it may be necessary to stop or minimize bleeding internal to the body. For example, an endoscopic medical procedure may require hemostasis of bleeding tissue within the gastrointestinal tract, for example in the esophagus, stomach, or intestines.
During an endoscopic procedure, a user inserts a sheath of an endoscope into a body lumen of a patient. The user utilizes a handle of the endoscope to control the endoscope during the procedure. Tools are passed through a working channel of the endoscope via, for example, a port in the handle, to deliver treatment at the procedure site near a distal end of the endoscope. The procedure site is remote from the operator.
To achieve hemostasis at the remote site, a hemostatic agent may be delivered by a device inserted into the working channel of the endoscope. Agent delivery may be achieved through mechanical systems, for example. Such systems, however, may require numerous steps or actuations to achieve delivery, may not achieve a desired rate of agent delivery or a desired dosage of agent, may result in the agent clogging portions of the delivery device, may result in inconsistent dosing of agent, or may not result in the agent reaching the treatment site deep within the GI tract. The current disclosure may solve one or more of these issues or other issues in the art.
According to an example, a medical device may comprise an enclosure defining a cavity for containing agent, a lumen for receiving a pressurized gas, and a barrier positioned between the cavity and the lumen, the barrier including at least one opening for storing agent, wherein rotation of the barrier relative to the lumen establishes fluid communication between the at least one opening and the lumen for delivering agent from the at least one opening to the lumen. A bottom end of the cavity may include a wall adjacent to the barrier, wherein the wall includes a wall opening, wherein the wall opening is located on an area of the wall so that the wall opening is aligned with the at least one opening via rotation of the barrier. Alignment of the wall opening with the at least one opening may permit agent from the enclosure to enter the at least one opening. The enclosure may be rotatable relative to the barrier and/or the lumen. The barrier may be rotatable relative to the enclosure. The agent may remain in the at least one opening until fluid communication between the at least one opening and the lumen is established. The enclosure may feed the at least one opening with agent via gravity. The at least one opening for storing agent may feed the lumen with agent via gravity when fluid communication between the at least one opening and the lumen is established.
In another example, the at least one opening for storing agent may be a plurality of openings arranged radially about the barrier. The plurality of openings may be symmetrically arranged. Each of the plurality of openings may be different in size. When fluid communication is established between one opening of the plurality of openings and the lumen, the other openings of the plurality of openings and the lumen are not in fluid communication.
In another example, the medical device may further comprise an intermediary barrier, wherein the intermediary barrier is positioned between the barrier and the lumen, and wherein the intermediary barrier includes an intermediary opening positioned to be aligned with one of the plurality of openings via rotation of the barrier. The intermediary barrier may be rotatable relative to the barrier. The lumen may be a flexible catheter capable of traversing a tortuous body lumen, and further comprising a source of the pressurized gas.
According to an example, a medical device may comprise a cartridge including a plurality of chambers, wherein each of the chambers stores a pre-filled amount of agent, a lumen for receiving a pressurized gas, a channel establishing fluid communication between a first end of the cartridge and the lumen for delivering agent from the cartridge to the lumen, and a plunger coupled to a second end of the cartridge so that the plunger is aligned with one chamber of the plurality of chambers, wherein the plunger advances longitudinally into the one chamber, thereby pushing the pre-filled amount of agent towards the channel, and wherein the cartridge is rotatable relative to the plunger to align the plunger with another of the plurality of chambers. The plunger may be coupled to the cartridge so that the plunger is spring-biased to a position outside of the one chamber and aligned with the one chamber. The medical device may further comprise a trigger including a lever coupled to a linkage via a first articulating joint and a linkage coupled to a plunger via a second articulating joint.
According to an example, a method of administering an agent via a medical device may comprise positioning the medical device, including an enclosure, a barrier, and a lumen, so that a distal end of the lumen is adjacent to a targeted site, wherein the barrier is positioned between the enclosure and the lumen, the enclosure containing agent, and the barrier including at least one opening for storing the agent, providing a pressurized gas to the lumen, and rotating the barrier relative to the lumen so that fluid communication is established between the at least one opening and the lumen to deliver the agent from the at least one opening to the lumen. The method may further comprise rotating the barrier relative to the lumen so that the at least one opening and the lumen are not in fluid communication after a dose of the agent is delivered from the at least one opening to the lumen.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments.
Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term “distal” refers to a portion farthest away from a user when introducing a device into a subject (e.g., patient). By contrast, the term “proximal” refers to a portion closest to the user when placing the device into the subject.
Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations 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 include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, “about,” “substantially,” “generally,” and “approximately” are used to indicate a possible variation of ±10% in a stated value or characteristic.
The present disclosure may solve one or more of the limitations in the art. The scope of the disclosure, however, is defined by the attached claims and not the ability to solve a specific problem. The present disclosure is drawn to medical devices configured to administer doses of agents, e.g., therapeutic agents, among other aspects. The agent may be in any suitable form, including a powder form, which may be delivered to a stream of propellant/pressurized gas, e.g., CO2, nitrogen, air, etc. Said medical devices allow for the administration of agents in metered doses, which allows for a greater consistency in the quantity of the agent that reaches a target site.
Referring to
In addition, one or more electrical cables (not shown) may extend from the proximal end of endoscope 5 to the distal end of flexible shaft 50 and may provide electrical controls to imaging, lighting, and/or other electrical devices at the distal end of flexible shaft 50, and may carry imaging signals from the distal end of flexible shaft 50 proximally to be processed and/or displayed on a display. Handle 52 may also include ports 54, 46 for introducing and/or removing tools, fluids, or other materials from the patient. Port 54 may be used to introduce tools. Port 46 may be connected to an umbilicus for introducing fluid, suction, and/or wiring for electronic components. For example, as shown in
As shown in
Barrier 11 may be an annular, disk-like structure with openings and a passage therethrough. For example, barrier 11 includes a first opening 12a on the barrier surface (e.g., an upper surface) adjacent to the cavity of enclosure 10, for receiving agent 1000 in a passage 14 that extends through barrier 11. Barrier 11 further includes a second opening 12b on the opposite barrier surface (e.g., a bottom surface) adjacent to tube 100 and lumen 100a, from which agent 1000 may be dispensed into lumen 100a. It is noted that the size and shape of first opening 12a and second opening 12b are not particularly limited, and may be any suitable size or shape. First opening 12a and second opening 12b are located on opposite ends of barrier 11, but are connected via passage 14 extending across the length and thickness of barrier 11. Tube 100 also includes an opening 101 which may or may not be aligned with second opening 12b of barrier 11, depending on the rotational position of barrier 11 relative to tube 100 and lumen 100a. Thus, the rotation of barrier 11 relative to tube 100 may establish fluid communication between opening 12b and lumen 100a for delivering agent 1000 from passage 14 to lumen 100a. Enclosure 10 feeds opening 12a with agent 1000 via gravity, and passage 14 storing agent 1000 feeds lumen 100a with agent 1000 via gravity when second opening 12b and lumen opening 101 are aligned. In other embodiments, agent 1000 may be delivered to opening 12a and/or lumen 100a via other suitable mechanisms. Barrier 11 may also be rotated so that second opening 12b and opening 101 of lumen 100a are not aligned, thereby inhibiting the delivery of agent 1000 from passage 14 to lumen 100a. In this instance, passage 14 receives and stores agent 10000, until fluid communication between opening 12b of passage 14 and lumen 100a is established. It is noted that enclosure 10, in any rotational position of barrier 11, is not in fluid communication with lumen 100a. Furthermore, in embodiments prior to any use, passage 14 may be empty an without agent 1000.
In some embodiments, a bottom end of the cavity of enclosure 10 may include a wall 105 adjacent to barrier 11. Wall 105 may include an opening 105a that may or may not be aligned with opening 12a of barrier 11, depending on the rotational position of barrier 11 relative to enclosure 10. Thus, in such embodiments, barrier 11 and/or enclosure 10 may be rotated to align opening 105a with opening 12a of barrier 11 to deliver agent 1000 from enclosure 10 to passage 14 through opening 12a. This is illustrated in
Referring to
In
Barrier 21, as shown in both
By rotation of barrier 21 relative to tube 100 and lumen 100a, one of openings 22a-22f may align with opening 101, thereby establishing fluid communication between the one opening and lumen 100a for delivering agent 1000 from the one opening to lumen 100a via gravity. In some embodiments, enclosure 10′ may further include a seal 205, which is positioned adjacently above barrier 21, above where one of openings 22a-22f may be located, and directly above opening 101 of tube 100. Thus, as one opening of openings 22a-22f aligns with opening 101 via rotation of barrier 21, an excess amount of agent 1000 above the one opening is shaved off by seal 205 and the one opening is sealed from receiving further agent 1000 from enclosure 10′ when that opening aligns with opening 101 of tube 100. This allows for medical device 1′ to administer a metered dose, i.e., the amount of agent 1000 stored in openings 22a-22f, per each degree of rotation, e.g., 60°, of barrier 21 and/or enclosure 10′. It is noted that as a result of such configuration, when fluid communication is established between one of openings 22a-22f and lumen 100a, no fluid communication is established between the other remaining openings and lumen 100a, as the bottom of the remaining openings is sealed by tube 100.
As shown in
Referring to
In
Barrier 41, as shown in both
To help a user differentiate between the different sizes of openings 42a-42c, enclosure 10′″ and/or barrier 41 may further include markings on their outer surfaces that indicate the locations of openings 42a-42c relative to one another, and to openings 16 and 101. Thus, a user may rotate barrier 41 and/or enclosure 10″, relative to intermediary barrier 15, tube 100, and lumen 100a, to select one of openings 42a-42c based on a desired amount or dose of agent 1000.
Intermediary barrier 15, as shown in both
Any one of openings 42a-42c may be aligned with intermediary opening 16 and lumen opening 101 via rotation of barrier 21. Such alignment establishes fluid communication between one of openings 42a-42c and lumen 100a for delivering agent 1000 from one of openings 42a-42c to lumen 100a via gravity. Similar to that of medical device 1′, as one opening of openings 42a-42c aligns with opening 16 of intermediary barrier 15 and opening 101 via rotation of barrier 41, an excess amount of agent 1000 above the one opening is shaved off by seal 205 and the one opening is sealed from further receiving agent 1000 from enclosure 10′″. This allows for medical device 1′″ to administer a metered dose, the amount of agent 1000 stored in openings 42a-42c, per each degree of rotation, e.g., 120°, of barrier 41. As a result of such configuration, when fluid communication is established between one of openings 42a-42c and lumen 100a, no fluid communication is established between the other remaining openings 42a-42c and lumen 100a.
Barrier 41 may also be rotated so that none of openings 42a-42c is aligned with intermediary opening 16 and lumen opening 101, thereby inhibiting the delivery of agent 1000 from enclosure 10′″ to lumen 100a. In this instance, varying amounts of agent 1000 are stored in openings 42a-42c until fluid communication between openings 42a-42c and lumen 100a is established.
It is further noted in some embodiments, intermediary barrier 15 may also be rotatable relative to enclosure 10′″, barrier 41, tube 100, and lumen 100a, so that opening 16 does not align with any of the openings of barrier 41, and/or opening 101 as well. This is applicable in embodiments having barriers with multiple openings. By being able to misalign opening 16 from opening 101, a user may select another opening 42a, 42b, 42c, etc., via rotation of barrier 41, that is not adjacent to the currently aligned opening, without having to inadvertently dispense agent 1000 stored in openings adjacent to the currently aligned opening, via the necessary degree of rotation to select other non-adjacent openings.
Referring to
Referring to
Trigger 18 includes a lever 18a coupled to a linkage 18c via an articulating joint 18b, and linkage 18c coupled to a plunger 18e via another articulating joint 18d. A distal portion of plunger 18e is housed within a proximal portion of cartridge 31, and is coupled to cartridge 31 in any suitable manner so that the distal end of plunger 18e faces one of chambers 32a-32f with which plunger 18e is aligned. A spring 19 coils around a distal portion of plunger 18e outside of cartridge 31 up until a stop 17 fixated on plunger 18e, thereby spring-biasing plunger 18e in its aforementioned position of facing one of chambers 32a-32f. Spring 19 is not particularly limited and may be any suitable spring. Likewise, stop 17 may be of any suitable material, such as rubber.
Trigger 18 is configured so that when lever 18a is pulled proximally, linkage 18c likewise pivots proximally relative to plunger 18e via articulating joint 18d. Such movements of lever 18a and linkage 18c result in plunger 18e longitudinally advancing towards cartridge 31 and into one of chambers 32a-32f, thereby propelling the pre-filled amount of agent 1000 towards and through channel 14, which extends downward to tube 100, thereby feeding agent 1000 to tube 100 via gravity. The longitudinal advancement of plunger 18e may be actuated by any suitable mechanisms, including, but not limited to, mechanical, electrical, or pneumatic mechanisms. Plunger 18e advances within cartridge 31 and one of chambers 32a-32f up until spring 19 is fully compressed, thereby inhibiting any further advancement of plunger 18e towards cartridge 31. Once lever 18 is released, spring-biased plunger 18e automatically reverts back to its initial position of being outside of and facing one of chambers 32a-32f.
Cartridge 31 is rotatable relative to plunger 18e so that any one of chambers 32a-32f is aligned with plunger 18e. In some embodiments, cartridge 31 may be configured to rotate or revolve automatically, after one of chambers 32a-32f is emptied by plunger 18e, so that an adjacent chamber 32a-32f storing a pre-filled amount of agent 1000 is aligned with plunger 18e.
It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application claims the benefit of priority from U.S. Provisional Application No. 62/942,988, filed on Dec. 3, 2019, which is incorporated by reference herein in its entirety.
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