The present disclosure relates generally to endoscopic medical devices and related methods of use. More particularly, in some embodiments, the disclosure relates to endoscopic medical tools and methods related to accessing target sites and dispensing materials to the target sites.
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 not achieve a desired rate of agent delivery or a desired dosage of agent, 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 embodiment, a medical system includes a handle, a sheath extending from the handle, and an end effector connected to a distal end of the sheath, wherein the end effector is configured to direct a mass of material towards a target site of a body and cause release of the material onto the target site.
The medical system may include a catheter including a catheter lumen, wherein the sheath may be configured to extend through the catheter lumen, and wherein the catheter may further include a fluid lumen, fluidly decoupled from the catheter lumen, wherein the fluid lumen may be configured to be attached to a fluid source and may dispense a fluid from a fluid opening at a distal end of the catheter.
The medical system may further include a capsule containing the mass of material, wherein the end effector may be configured to advance the capsule along the catheter lumen and to the target site via a lumen opening at a distal end of the catheter.
The end effector may include a pair of jaws, and wherein the capsule may include a tether configured to be grasped by the pair of jaws.
The end effector may be configured to pull on the tether to open the capsule.
An outer covering of the capsule may include a material configured to adhere to the target site when exposed to fluid.
An outer covering of the capsule may include a material that dissolves when contacted with fluid.
The end effector may be configured to move from a collapsed configuration to an expanded configuration, wherein the end effector may have an umbrella-like shape in the expanded configuration such that a diameter of a distal end of the end effector may be greater than a diameter of a proximal end of the end effector.
The catheter may include the capsule within the catheter lumen.
The end effector may include a shape memory material, wherein a temperature of the end effector may be configured to be increased by a heat from the body, and wherein the end effector may expand from the collapsed configuration to the expanded configuration when the end effector is above a temperature threshold.
The catheter may include a capsule containing the mass of material, wherein a diameter of a distal opening of the catheter lumen may be less than a diameter of the capsule.
The distal end of the catheter lumen may include a protrusion extending from a wall of the catheter lumen toward a central longitudinal axis of the catheter configured to rupture the capsule.
A diameter of the end effector may be less than the diameter of the distal opening of the catheter lumen, and wherein the end effector may be configured to extend out of the catheter lumen and distal of a distalmost end of the catheter.
The end effector may have a disc-shaped distal surface for applying pressure to the material at the target site.
The material may be a hemostatic agent or a therapeutic agent.
According to another embodiment, a medical system includes an actuation handle, a sheath extending from a distal end of the handle, a catheter including a catheter lumen, wherein the sheath is configured to extend through the catheter lumen, a capsule containing a material wherein the capsule includes a tether, and an end effector connected to a distal end of the sheath and configured to grasp the tether, wherein the end effector is configured to advance the capsule along the catheter lumen and to a target site via a catheter lumen opening at a distal end of the catheter, wherein an outer portion of the capsule includes a material configured to adhere to the target site when exposed to a fluid, and wherein the end effector is configured to cause release of the material from the capsule and onto the target site by applying a force on the tether once the capsule is adhered to the target site.
A distal end of the catheter or the sheath may be configured to bend when the distal end of the sheath is distal of a distalmost end of the catheter.
According to yet another embodiment, a method of performing a medical procedure includes positioning a catheter adjacent a target site within a body, advancing a sheath distally along a lumen of the catheter, pushing a capsule containing a material along the lumen using an end effector on a distal end of the sheath, expelling the capsule from a distal end of the lumen towards the target site, and releasing the material from the capsule.
The method may further include attaching the capsule to the target site, and maneuvering the end effector away from the target site after the capsule is attached to the target site, causing the capsule to rupture.
The method may further include actuating the end effector to release the capsule in the body after the capsule is ruptured, and moving the sheath proximally to cause the end effector to reenter 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.
The present disclosure is now described with reference to an exemplary medical system that may be used to dispense materials endoscopically. However, it should be noted that reference to this particular procedure is provided only for convenience and not intended to limit the disclosure. A person of ordinary skill in the art would recognize that the concepts underlying the disclosed device and application method may be utilized in any suitable procedure, medical or otherwise. The present disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.
For ease of description, the term “distal” refers to a portion farthest away from a user when introducing the system into a patient. By contrast, the term “proximal” refers to a portion closest to the user when introducing the system into the patient. As used herein, 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.” 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.
Referring to
In addition, one or more electrical cables (not shown) may extend from the proximal end of endoscope 10 to the distal end of flexible shaft 20 and may provide electrical controls to imaging, lighting, and/or other electrical devices at the distal end of flexible shaft 20, and may carry imaging signals from the distal end of flexible shaft 20 proximally to be processed and/or displayed on a display. Handle 40 may also include ports 44, 46 for introducing and/or removing tools, fluids, or other materials from the patient. Port 44 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
As further illustrated in
Referring to
With continued reference to
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Once capsule 150 is properly positioned and attached to target site T, sheath 120 may be moved away from target site T to pull on tether 152 and release a material (e.g., a powder) 160, such as a medical or therapeutic agent, as shown in
In this manner, target sites that may be difficult to access, such as sites on a roof (top) of a gastrointestinal lumen, may have therapeutic powders applied thereto. It otherwise may be more difficult to apply powdered agents to target sites due to the gravitational forces applied to such powders. It will be understood that while catheter 20 is advanced to target site T and sheath 120 is advanced along first lumen 22 to target site T, catheter 20 is not necessary to deploy capsule 150. For example, sheath 120, including end effector 130 attached to capsule 150 via tether 152, may be advanced along a body lumen to target site T without the use of catheter 20.
A method of applying a therapeutic powder 160 will now be described.
Catheter 20 is inserted into a body through a natural orifice or an incision in a patient. Catheter 20 is advanced along a body lumen to target site T. Once catheter 20 is advanced to target site T, sheath 120 is inserted into port 44 and advanced along first lumen 22. It will be understood that sheath 120 may be inserted into port 44 prior to the beginning of the procedure, e.g., before inserting catheter 20 into the body, and sheath 120 may be advanced to target site T at a same time as catheter 20.
For example, capsule 150 may be inserted into port 44 prior to a distal end of sheath 120, or end effector 130 may grasp tether 152 prior to inserting capsule 150 and the distal end of sheath 120. Once both capsule 150 and sheath 120 are inserted into port 44, sheath 120 is advanced distally toward a distal end of catheter 20. As sheath 120 is advanced distally, end effector 130 pushes on a proximal end of capsule 150, causing capsule 150 to advance through lumen 22 of catheter 20. In an embodiment in which sheath 120 is inserted into a body without catheter 20, capsule 150 can also be moved to target site T in a similar manner. Alternatively, end effector 130 may pull capsule 150 along a body lumen Las sheath 120 is advanced distally toward target site T.
After positioning catheter 20 and sheath 120 adjacent target site T, handle 140 is manipulated to move sheath 120 along first lumen 22 in a distal direction with respect to catheter 20. Moving sheath 120 in the distal direction forces end effector 130 against the proximal side of capsule 150 and out first opening 22a in distal end face 28.
After capsule 150 is positioned outside first lumen 22, sheath 120 is maneuvered to urge capsule 150 against target site T. According to an example, urging capsule 150 against target site T may include bending a distal end of catheter 20 and/or bending an articulation section of sheath 120. In some examples, urging capsule 150 against target site T includes dispensing a fluid from openings 24a or 26a to moisten capsule 150 and activate an adhesive material on an outer surface of capsule 150.
Once capsule 150 is adhered to target site T, sheath 120 is moved away from target site T by moving sheath 120 proximally. Alternatively, end effector 130 may grasp capsule 150 between a pair of jaws. The jaws of end effector 130 may be actuated to increase pressure on capsule 150, thereby breaking the outer casing of capsule 150 and causing powder 160 to be dispersed at target site T. Sheath 120 is subsequently retracted into lumen 22 and catheter 20 may be removed from the body lumen. According to another example, prior to retracting sheath 120 into lumen 22, tether 152 may be released by pushing distally on spool 144 and opening the jaws of end effector 130. In an example where capsule 150 is dissolvable due to interaction with liquid, irrigation may be used to dissolve capsule 150 and release agent 160.
A distal end of medical system 10 according to another example is illustrated in
As shown in
Referring to
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An operation of sheath 220 will now be described.
As discussed above, capsule 250 may be inserted through port 44, and a distal end of sheath 220 may be subsequently inserted through port 44, As with sheath 120, sheath 220 is pushed distally along lumen 22 using handle 140. End effector 230 pushes against a proximal end of capsule 250 to advance capsule 250 to a distal end of catheter 20, thereby causing end effector 230 and capsule 250 to exit first opening 22a.
When capsule 250 exits lumen 22, the medical professional may cause fluid to be emitted from opening 24a or opening 26a to cause an outer covering of capsule 250 to begin to dissolve or to fully dissolve. Alternatively, as discussed above, capsule 250 may dissolve based on the moisture already present in lumen L. At a same time or subsequently, as end effector 230 exits lumen 22 through opening 22a, end effector 230 expands from a collapsed shape to an expanded, umbrella shape, as shown in
Subsequently, sheath 220 is maneuvered to capture partially dissolved capsule 250 and/or powder 260. Sheath 220 is then maneuvered so that a distal surface of end effector 230 faces target site T via, e.g., articulation section 222, and the inner, distal surface of end effector 230 is urged toward target site T, allowing powder 260 to coat target site T. The distal surface of end effector 230 then may be placed in contact with target site T (and powder 260 coating target site T) and pressed against target site T. After a predetermined time period has elapsed, sheath 220 is moved proximally, causing end effector 230 to move into lumen 22 and collapse into the low-profile shape.
A distal end of medical system 10 according to another example is illustrated in
As shown in
An operation of sheath 320 will now be described.
Sheath 320 is pushed distally along lumen 22 using handle 140. End effector 330 exits first opening 22a and expands in a similar manner as end effector 230, e.g., based on the physical properties of the material forming end effector 330 or via actuation of actuating cables (not shown) to expand end effector 330.
After end effector 330 is exposed from first opening 22a, end effector 330 is maneuvered to cover target site T as shown in
Once end effector 330 is positioned against target site T, powder 360, e.g., a fluidized powder, a capsule, or some other delivery mechanism containing a therapeutic agent, is transmitted along central lumen 324 from a proximal end of sheath 320 to end effector 330. The powder is expelled from central lumen 324 via central opening 324a. Dispersal of powder 360 is limited to target site T surrounded by the outer periphery of end effector 330. Once powder 360 (transmitted via, e.g., fluidized powder, a capsule, or the like) contacts target T, powder 360 adheres via the moisture of the mucosal and/or a fluid which may be emitted via central lumen 324 and/or openings 24a, 26a. It will be understood that powder 360 may be transmitted along central lumen 324 by any actuation device, e.g., by actuation device 540 shown in
Another example of a sheath 420 for deploying therapeutic material is shown in
Capsule 450 is positioned distally of end effector 430 in lumen 22. First opening 22a in
An operation of sheath 420 will now be described.
As with the other sheaths described herein, capsule 450 is inserted through port 44 prior to inserting a distal end of sheath 420 into port 44. Sheath 420 is pushed distally along lumen 22 using handle 140, which causes end effector 430 to push against the proximal end of capsule 450, causing end effector 430 and capsule 450 to approach first opening 22a. As capsule 450 and end effector 430 approach first opening 22a, a distal end of capsule 450 contacts a surface of ring 22b facing an interior of lumen 22 and/or teeth 24 or other sharp structure arranged on an inner face or inner circumference of ring 22b. A force of end effector 430 against the proximal end of capsule 450 and a force of ring 22b and/or teeth 24 against the distal end of capsule 450 causes capsule 450 to rupture, expelling powder 460.
A user continues to push sheath 420 distally, causing powder 460 to contact a distalmost end of end effector 430. Sheath 420 is then maneuvered to face target site T in any manner described herein, e.g., via articulation of articulation section 422, urging end effector 430 toward target site T. End effector 430 tamps or pushes powder 460 against target tissue T. Powder 460 may be activated by moisture, e.g., a mucosal fluid at target site T and/or fluid sprayed via openings 24a, 26a. After a predetermined time period has elapsed, sheath 420 is moved proximally, causing end effector 430 move back into lumen 22.
An actuation device 540 for dispensing powder and/or a capsule 550 is shown in
Fluid connector 544 is connected to internal chamber 548, which may contain capsule 550 or a powder not contained within a capsule. Capsule 550 may be added individually, or a hopper or other container (not shown) may be attached to actuation device 540 to supply capsules or powder to internal chamber 548. A catheter connector 549 may connect a catheter 520, having a lumen 522, to body 542. Once trigger mechanism 546 is actuated, a propellant fluid, e.g., CO2, is released from pressurized fluid source 570, and may transmit capsule 550 distally down lumen 522 to an outlet (not shown) at a distal end of catheter 520. According to an example, an amount of gas released may be approximately 16 liters or less, e.g., equal to an amount of gas, such as CO2, stored in two standard cartridges, at a pressure of approximately 1 to 10 Standard Liters per Minute (SLPM), or approximately 5 SLPM. This amount of propellant gas is sufficient to transmit capsule 550 along lumen 522, while also being a safe amount of propellant fluid to supply to a body that is insufflated.
An operation of actuation device 540 will now be described.
Capsule 550 is loaded into internal chamber 548. Catheter 520 is introduced to a body via a natural orifice or an incision and advanced to a target site. Once the distal end of catheter 520 is positioned adjacent the target site, the user actuates trigger mechanism 546, causing propellant fluid to exit fluid source 570 and enter internal chamber 548. The propellant fluid causes capsule 550 to travel distally from internal chamber 548 to the target tissue via catheter 520. The propellant fluid is sufficient to transmit capsule 550 along catheter 520, while being a safe amount of propellant fluid to introduce to a body that is insufflated. Additional capsules 550 may be transmitted to the same or different target sites until the treatment is complete, at which point catheter 520 is removed from the body.
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. For example, any material or fluid may be contained in the capsules and/or transmitted in powder form to be expelled from the application device to a target location, including but not limited to materials having therapeutic effects. Additionally, or alternatively, unless otherwise specified, the medical device described herein may be formed of any metal, alloy, plastic, or ceramic, or any combination thereof, suitable for use in medical applications. 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. 62/942,919, filed on Dec. 3, 2019, which is incorporated by reference herein in its entirety.
Number | Date | Country | |
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62942919 | Dec 2019 | US |